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Safe doses of Lingyang Ganmao oral liquid for children based on the multi-animal model SUN Qiyue, ZHAO Ronghua, BAO Lei, GUO Shanshan, GENG Zihan, LI Shuran, XU Yingli, ZHANG Jingsheng, CUI Xiaolan, SUN Jing 2024, 21(2): 121-126.  DOI: 10.19803/j.1672-8629.20230388 Abstract ( 309 )   PDF (1550KB) ( 736 )   Objective To determine the effectiveness and range of optimal dosages of Lingyang Ganmao oral liquid for children, and to provide reference for medication in children. Methods Based on multi-animal models, five corresponding young animal models that targeted the major properties were used, including the mouse pneumonia model caused by influenza A (H1N1) virus infection, the mouse acute inflammation model for increased permeability of abdominal capillaries caused by glacial acetic acid, the mouse cough model caused by ammonia nebulization, the mouse pain model caused by glacial acetic acid and the rabbit fever model caused by lipopolysaccharide (LPS). To observe the antiviral, anti-inflammatory, antitussive, analgesic and antipyretic efficacy of Lingyang Ganmao oral liquid in six dosage groups, namely 0.1, 0.2, 0.4, 0.6, 0.8 and 1.0 mL·kg-1·d-1 for human use (children's dosage).The animal dosages were calculated using the body surface area conversion formula, based on the human dose. For mice, the dosages were 1, 2, 4, 6, 8, and 10 mL·kg-1·d-1, while for rabbits, the dosages were 0.3, 0.6, 1.2, 1.8, 2.4, and 3.0 mL·kg-1·d-1. The results are used to determine the optimal dose range for children. Results Lingyang Ganmao oral liquid could reduce lung indexes, inhibit capillary permeability, reduce the number of times mice coughed and writhed and help lower the body temperature of rabbits. The doses of stable efficacy ranged from 4.0 to 8.0 mL·kg-1·d-1 and from 1.2 to 2.4 mL·kg-1·d-1, respectively, which were equivalent to 0.4-0.8 mL·kg-1·d-1 for human use. Conclusion Lingyang Ganmao oral liquid produces stable and effective antiviral, anti-inflammatory, anti-cough, analgesic and antipyretic effects within the dose range of 0.4 to 0.8 mL·kg-1·d-1. The recommended dosage is 5mL each time and 1-2 times daily for children ages 1 to 3, 5mL each time and 1-3 times daily for those ages 4 to 6, and 5mL each time and 2-4 times daily for those between 7 and 12. References | Related Articles | Metrics

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Multiple pharmacological effects of Lingyang Ganmao Oral Liquid SUN Qiyue, ZHAO Ronghua, GUO Shanshan, BAO Lei, GENG Zihan, LI Shuran, XU Yingli, ZHANG Jingsheng, CUI Xiaolan, SUN Jing 2024, 21(2): 127-131.  DOI: 10.19803/j.1672-8629.20230649 Abstract ( 147 )   PDF (1420KB) ( 106 )   Objective To evaluate the pharmacological effects of Lingyang Ganmao Oral Liquid at the animal level, and to provide theoretical basis and data to support clinical precision medicine. Methods Six animal models were established according to the functional indications and clinical indications of Lingyang Ganmao Oral Liquid, the pneumonia model of mice infected by influenza virus FM1 strain and Streptococcus pneumoniae, the peritoneal capillary permeability model and body twisting model of mice induced by ice acetic acid, the cough model of mice induced by ammonia water, the trachea phenol red excretion model of mice. The antiviral, antibacterial, anti-inflammatory, analgesic, relieving cough and eliminating phlegm effects of Lingyang Ganmao Oral Liquid were evaluated by observing pulmonary index, inhibitory rate of lung index, OD value of Evanslan, writhing times, coughing times and phenol red excretion. Results Lingyang Ganmao Oral Liquid 20 mL·kg-1·d-1 can significantly inhibit the increase of lung index caused by influenza virus FM1, and significantly increase the secretion of phenol red in the tracheal of mice. The lung index and peritoneal capillary permeability of Streptococcus pneumoniae infected mice were increased. Lingyang Ganmao Oral Liquid 20, 15, 10 mL·kg-1·d-1 three dose groups had significant inhibitory effect on both of them, which could significantly reduce the frequency of cough caused by ammonia water in mice and prolong the incubation period of cough. Both 20 and 15 mL·kg-1·d-1 dose groups could significantly reduce the number of writhe caused by acetic acid in mice. Conclusion Lingyang Ganmao Oral Liquid of different doses has different degrees of action and multiple pharmacological effects, including antiviral, antibacterial, anti-inflammatory, analgesic, cough and expectorant. References | Related Articles | Metrics

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Mechanisms of Gegen Tang granules against viral pneumonia in mice based on immune regulation ZHAO Ronghua, SUN Jing, BAO Lei, GENG Zihan, TAO Xiali, ZHANG Jingsheng, PANG Bo, XU Yingli, CAO Shan, LI Shuran, GUO Shanshan, WANG Daohan, CUI Xiaolan 2024, 21(2): 132-136.  DOI: 10.19803/j.1672-8629.20230612 Abstract ( 75 )   PDF (1841KB) ( 73 )   Objective To study the efficacy and immunomodulatory effects of Gegen Tang granules on viral pneumonia induced by influenza A virus (IAV) in mice. Methods ICR mice, 13~15 g, were divided into the normal control group, model control group, oseltamivir phosphate positive control group and high-, medium- and low-dose Gegen Tang granule groups (6.6, 3.3 and 1.7 g-1·kg-1·d-1), with 10 mice in each group. A viral pneumonia model of mice was established by IAV (FM1 strain) while relevant medication was given. Lung indexes and their inhibitory rate were observed. Levels of nucleic acid in lung tissue were detected by RT-PCR, while interleukin-6 (IL-6), interleukin-10 (IL-10) and tumor necrosis factor TNF-α in lung tissue were detected by ELISA. AV (FM1 strain) virus was used to infect mice with nasal drops, resulting in a death protection model. The death toll of mice within 2 weeks of infection was observed, and the mortality rate, death protection rate, average survival days and life extension rate of mice were calculated. Results The pulmonary index and viral load of lung tissue were significantly decreased (P<0.01), and the inhibitory rate of lung indexes was 50.73%. The content of lung inflammatory factor IL-10 in high and medium dose groups of Gegen Tang granules was significantly decreased (P<0.01), so was the content of lung inflammatory factor TNF-α in medium and low dose groups of Gegen Tang granules (P<0.01). The content of inflammatory factor IL-6 in lung tissue was significantly decreased in the three dose groups of Gegen Tang granules (P<0.01). The mortality rate of mice in the model group was 90%, and the average survival was 9.45 days, both of which were significantly decreased in the three dose groups of Gegen Tang granules, while the life extension rate was significantly increased (P<0.01). Conclusion Gegen Tang granules can improve the immune function of mice with viral pneumonia by adjusting the level of immune inflammatory factors while significantly reducing the lung index and viral load of the model mice so as to alleviate the pulmonary inflammatory damage to the model mice. They can help protect model mice from death. References | Related Articles | Metrics

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The critical role of TRP channels in the progression of viral pneumonia BAO Lei, GENG Zihan, LI Shuran, JI Zuen, ZHAO Ronghua, SUN Jing, GUO Shanshan, CUI Xiaolan 2024, 21(2): 137-140.  DOI: 10.19803/j.1672-8629.20230618 Abstract ( 54 )   PDF (1433KB) ( 56 )   Objective To conduct a comprehensive review of the potential mechanisms of occurrence between viral pneumonia infection and the TRP channel family. Methods By searching CNKI and PubMed, the reports from the past 30 years on the relationship between the TRP channel family and viral pneumonia, as well were as discussions the underlying mechanisms were discussed. Results As ion receptor channels on the cell membrane, TRP channels can regulate the balance of calcium ions inside and outside the cell, inhibiting or accelerating virus invasion into the host. By accelerating the influx of calcium ions, they intensify cellular oxidative stress responses, speeding up cell autophagy or apoptosis. Additionally, by promoting changes in cell morphology, they enhance the cell’s response to inflammatory mediators and cytokines. Conclusion TRP channels are crucial regulatory factors in the process of viral infection of hosts, exerting direct or indirect effects on various physiological processes during the infection. Therefore, a deeper study of the TRP channel family can offer new targets for antiviral drug development, providing fresh perspectives for clinical treatment of viral pneumonia. References | Related Articles | Metrics

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Evaluation methods for aerodynamic particle size distribution of fine particles in inhaled products JIA Yinyin, ZHANG Caishu, ZHOU Ying, LIU Li, GENG Ying, WEI Ningyi, NIU Sijing, CHEN Hua, XU Hui 2024, 21(2): 141-146.  DOI: 10.19803/j.1672-8629.20230411 Abstract ( 153 )   PDF (1447KB) ( 278 )   Objective To improve the quality, safety, and effectiveness of drugs by evaluating the aerodynamic particle size distribution (APSD) of inhaled formulations. Methods The methods and related standards for detecting APSD specified in different national pharmacopoeias were compared and contrasted. APSD was characterized using multiple econometric parameters. The size of the fine particle dose and its proportion in the total collected dose were used as the key indicators for evaluating inhaled products. Results The Anderson cascade impactor (ACI) and the next generation impactor (NGI) were currently the most widely used and included in the US Pharmacopoeia. The Chinese Pharmacopoeia also included a glass twin impinger while the European Pharmacopoeia also included a multi-stage liquid impactor. The mass median aerodynamic diameter (MMAD) was an important variable to control the deposition position of particles in the lung. The geometric standard deviation (GSD) represented the shape of the drug particle size distribution curve. The closer to 1 the distribution curve, the narrower the distribution of particles. The changes in APSD could be detected by measuring both the ratio of the large particle mass (LPM) to the small particle mass (SPM) and the impactor-sized mass (ISM) in effective data analysis (EDA). The size and distribution of drug particles largely determined the location and amount of particle deposition in the respiratory system, thereby affecting the efficacy of drugs. The delivery of active pharmaceutical ingredients (APIs) in the inhaled formulations to the lungs through the respiratory system required that the aerodynamic particle size of aerosols range from 1 to 5 μm. Conclusion Appropriate testing methods can ensure the quality, safety, and effectiveness of inhaled products. Well-designed dosages and drug particle sizes are the key indicators that determine the performance of inhaled formulations. Therefore, successive improvement of testing methods for fine particles and in-depth research on the correlation between in vitro and in vivo use can facilitate the research and development of inhaled products. References | Related Articles | Metrics

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Determination of particle size distribution of chiglitazar sodium by laser diffraction method GUO Ningzi, LIU Li, YUE Ruiqi, FENG Huiqing, YANG Huaxin, WEI Ningyi, CHEN Hua 2024, 21(2): 147-151.  DOI: 10.19803/j.1672-8629.20230434 Abstract ( 63 )   PDF (1739KB) ( 64 )   Objective To establish a laser diffraction method for determination of the particle size distribution of chiglitazar sodium so as to provide reference for the development and quality control of methods for determination of drug particle size. Methods The Malvern Mastersizer 3000 laser particle size analyzer with an AEROS dry sampler was used to establish a laser diffraction method for determination of the particle size distribution of chiglitazar sodium. As for the AEROS injector, the conditions of determination were as follows: the duration of background measurement was 7 s, the duration of sample measurement was 7 s, obscuration ranged from 0.5% to 5%, the sample dispersion pressure was 0.4 MPa, the injection speed was 60%, high energy venturis were used, and the hopper gap was 2.5 mm. Results The particle size distribution value of the three batches of samples ranged from 1.02 to 1.17 μm in d(0.1), 5.94 to 6.69 μm in d(0.5), and 20.70 to 22.40 μm in d(0.9). The RSD of the above values was below 1%. Conclusion A particle size determination method has been established for chiglitazar sodium, which can provide reference for the development of dry particle size determination methods for other hygroscopic drugs. References | Related Articles | Metrics

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Determination of erythromycin ointment content based on on-line column switching and liquid chromatography NING Xiao, GAO Guanghui, JIN Shaoming, LIU Tongtong, PEI Yusheng, CAO Jin 2024, 21(2): 152-155.  DOI: 10.19803/j.1672-8629.20230457 Abstract ( 44 )   PDF (1483KB) ( 51 )   Objective To establish an on-line column switching high performance liquid chromatography method for determination of the main drugs in erythromycin ointment, and to recommend an effective means for quality control of related preparations. Methods The samples were extracted at 80 ℃ and injected directly. Under the column switching system, the samples were initially separated on a C18 chromatographic column (50 mm×2.1 mm, 5 μm) before being transferred to a second C18 column (150 mm×2.1 mm, 5 μm) for analysis after 2.5 min. The flow rate was 0.2 mL·min-1 and the column temperature was 35 ℃. Results The linear relationship of erythromycin was good within the range of 1~100 μg·mL-1 (r=0.999 4). The average recovery was 96.9%. Intraday and interday precision was less than 1.29% (n=6). Conclusion This study has improved the sample extraction method and completed the purification and enrichment of target components through on-line column switching. This method is simple, accurate, sensitive and stable, which can be used for content determination of erythromycin ointment. References | Related Articles | Metrics

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Four exogenously-polluted components in Tianwang Buxin pills analyzed via TLC and UPLC-QQQ-MS ZHANG Zan, ZHANG Hui, HE Songhua, LUO Yi 2024, 21(2): 156-162.  DOI: 10.19803/j.1672-8629.20230572 Abstract ( 49 )   PDF (2046KB) ( 62 )   Objective To tentatively study abnormal components of Tianwang Buxin pills on sale that were found in quality analysis and establish an analytical method for simultaneous determination of four exogenously-polluted components using TLC and UPLC-QQQ-MS. Methods One hundred and fifty-eight batches of samples of Tianwang Buxin pills were qualitatively identified by using the TLC method and optimizing the unfolding system. For abnormal spots, HPLC-Q/TOF-MS was used for identification and confirmation of components. UPLC-QQQ-MS was adopted for quantitative analysis. Results Among the 158 batches of samples, four types of exogenously-polluted components, including Berberine hydrochloride, Epiberberine, Coptisine hydrochloride and Palmatine chloride, were detected in nine batches. These four types of components were linear within the range of 0.97~483.34, 0.98~98.49, 1.00~100.50 and 0.88~87.75 ng·mL-1, respectively. The recovery ranged from 99.30% to 103.99%, and the RSD from 0.90% to 2.62% (n=6). The contents of these components were 20.3~104.1, 1.0~17.6, 0.4~30.6 and 3.2~24.8 μg·g-1, respectively. Conclusion This method is simple, accurate, and highly specific, which can provide reference for quality control of Tianwang Buxin pills. References | Related Articles | Metrics

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Evaluation of the relevance of adverse drug reaction based on ERNIE-DPCNN JIA Jinsheng, LIU Hongliang, WANG Qing, HOU Yongfang, LI Xinling 2024, 21(2): 163-166.  DOI: 10.19803/j.1672-8629.20230632 Abstract ( 144 )   PDF (1457KB) ( 145 )   Objective To establish a model for evaluation of ADR correlations in order to make the related evaluation more efficient and objective. Methods A total of 7 301 pieces of annotated data on adverse reaction reports obtained from literature and Internet sources were used for knowledge extraction to construct a knowledge graph about adverse drug reactions before a knowledge-driven automatic evaluation model of ERNIE-DPCNN relevance was established. Results The precision, recall and F1 value of the knowledge graph combined with the ERNIE-DPCNN model in the test set reached 82.18%, 81.40% and 81.21%, respectively, which yielded higher values than other models. Conclusion The method based on knowledge graphs combined with the ERNIE-DPCNN model can effectively improve the efficiency and accuracy of correlation evaluation of adverse drug reactions and reduce errors that arise from subjective evaluation, which is of referential value for automated evaluation based on artificial intelligence. References | Related Articles | Metrics

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Drug traceability coding system in China MA Meiying, ZHAO Xiaopei, ZHANG Mengyao, HU Yilin 2024, 21(2): 167-172.  DOI: 10.19803/j.1672-8629.20230288 Abstract ( 236 )   PDF (1490KB) ( 224 )   Objective To ensure safety of medication, exercise a more rigorous control over drug safety, promote the improvement of China’s drug traceability coding system, and bring about effective traceability throughout the drug supply chain. Methods By studying the legislations and standards for drug traceability coding systems and related literature at home and abroad, the process of establishing China’s drug traceability coding system and various constraints were elaborated. Based on the experience related to drug traceability coding systems in the United States, the European Union, and Canada, ways were recommended to boost the improvement of China’s drug traceability coding system. Results and Conclusion Based on the legislations and regulations in place in China and by learning from foreign systems, ways to improve the drug traceability coding system in China have been explored. The establishment of a uniform drug traceability code and specification of the legal responsibilities of code issuers are critical to improving China’s drug traceability coding system, which can contribute to risk control and effective supervision in the field of drug safety and promote standardized and legal regulation of drug safety so that human well-being can be guaranteed. References | Related Articles | Metrics

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Nephrotoxic effects and usage of traditional Chinese medicines based on the Traditional Chinese Medicine Systems Toxicology Database LI Jiaxin, LIU Huimin, QIAN Wenxiu, MA Ning, SONG Lili, LI Yubo 2024, 21(2): 173-180.  DOI: 10.19803/j.1672-8629.20230346 Abstract ( 233 )   PDF (1789KB) ( 176 )   Objective To explore and summarize the nephrotoxic effects and usage of traditional Chinese medicines based on the Traditional Chinese Medicine Systems Toxicology Database(TCMSTD). Methods The TCMSTD was used to screen and analyze the toxic Chinese medicinal materials included according to their types of toxicity, and to summarize the properties, taste, efficacy, and meridian tropism of Chinese medicinal materials with nephrotoxicity. Results There were 101 types of traditional Chinese medicines that were found to cause nephrotoxicity, the nephrotoxic effects which could be divided into four types based on the locations of renal injury: renal tubular injury, acute tubular necrosis, glomerular injury and renal interstitial injury. The same traditional Chinese medicine might cause damage of varying degrees to different parts of the kidney. There were a total of 27 toxic components with renal toxicity in traditional Chinese medicines, which belonged to 13 types of components such as alkaloids and phenols. Statistical analysis of the targets of nephrotoxic components revealed that the targets with the highest repetition frequency were ESR1 and ALOX5, with a frequency of 21. One hundred and one types of nephrotoxic traditional Chinese medicines had mostly cold and warm properties. The medicinal taste was mainly bitter and spicy. The meridians were mostly attributed to the liver, lung, spleen, and kidney meridians. Conclusion The properties of traditional Chinese medicines with nephrotoxicity are mostly cold and warm, and the taste is mainly bitter and spicy. The distribution of drug efficacy is relatively uniform, indicating that TCM practitioners should pay attention to dosage and compatibility in daily use to reduce the drug-caused damage to the kidney. References | Related Articles | Metrics

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Effects of clinical pharmacist interventions on usage of alanyl-glutamine injections in a hospital FAN Kaikai, WANG Cong, LIU Hongfeng, WANG Xiyong 2024, 21(2): 181-184.  DOI: 10.19803/j.1672-8629.20230668 Abstract ( 126 )   PDF (1414KB) ( 116 )   Objective To investigate the effectiveness of interventions by clinical pharmacists for reducing the irrational rate of alanyl-glutamine injections in a hospital. Methods A simple random sampling method was adopted to select 200 medical orders related to alanyl-glutamine injections that were given by clinicians between June and August 2021 (before interventions) and another 200 between June and August 2022 (after interventions) before the corresponding problems were compared and analyzed. Results The irrational rate of alanyl-glutamine injections decreased from 77.50% to 41.00% after interventions (P<0.05), which was of statistical significance. Conclusion The interventions enforced by clinical pharmacists can help make drug use more rational, but continued tracking and improvement are needed. References | Related Articles | Metrics

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Applicability of evaluation standards for use of traditional Chinese medicine injections for promoting blood circulation and removing blood stasis ZHANG Jian, FANG Huihua 2024, 21(2): 185-189.  DOI: 10.19803/j.1672-8629.20230140 Abstract ( 113 )   PDF (1543KB) ( 1072 )   Objective To establish the standard for evaluation of clinical use of traditional Chinese medicine injections for promoting blood circulation and removing blood stasis. Methods According to the National Pharmacopoeia of the People’s Republic of China (2020 edition), the Drug Catalogues for National Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance (2021), the Guidelines for Clinical Application of Proprietary Chinese Medicine for Coronary Heart Disease (2020 edition) and the Guidelines for Clinical Application of Proprietary Chinese Medicine for Heart Failure (2021), all TCM injections for promoting blood circulation and removing blood stasis were sorted out. According to drug instructions, guidelines and clinical use, the indicators for evaluation were identified, and the standard for evaluation was established using the Delphi method. Data on TCM injections for promoting blood circulation and removing blood stasis used in the Department of Cardiology between January 1 and June 30, 2022 was collected. The Technique for Order Preference by Similarity to an Ideal Solution was used for evaluation. Results A total of 21 indications of TCM injections for promoting blood circulation and removing blood stasis were included before primary and secondary evaluation indexes were established in terms of indications, solvents, usage and dosage, excipients, compatibility and special populations. According to the results of evaluation, 107 patients (89.17%) with Ci≥60% were identified from among 120 patients receiving TCM injections for promoting blood circulation and removing blood stasis, indicating that the usage of these TCM injections in the Department of Cardiology was generally proper. Conclusion The establishment of a standard for evaluation can help improve the rationality of the way in which TCM injections for promoting blood circulation and removing blood stasis are used. References | Related Articles | Metrics

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Adverse event signals for celecoxib based on FAERS database WANG Shan, XIE Bo, LIU Huimin, LI Zhihao 2024, 21(2): 190-194.  DOI: 10.19803/j.1672-8629.20230502 Abstract ( 200 )   PDF (1382KB) ( 216 )   Objective To mine the signals of adverse drug events (ADE) related to celecoxib based on the US FDA Adverse Event Reporting System (FAERS) database, and to provide reference for safe use of drugs in clinic. Methods The reporting odds ratio method, MHRA and the information component method were used to mine ADE signals of celecoxib from the FAERS database between the first quarter of 2004 and the fourth quarter of 2022. Results A total of 37 020 cases of celecoxib-related ADE were retrieved, involving 4 068 types of ADE. After screening, 285 signals were obtained, which involved 23 different system organ classes (SOC). According to signal intensity, the top 5 signals were related to oesophageal fibrosis, primary headache associated with sexual activity, cerebrovascular disorders, gastrointestinal adenocarcinoma and cardiovascular disorders. The ADE signals not stated in instructions on celecoxib included retinal vein thrombosis, blindness, amnesia and anaphylactic shock. Conclusion Those who Adverse event reported ADE were mostly over 45 years old and female. Most of the reports came from the United States. signals were basically consistent with the instructions. The ADE of celecoxib mainly involved cardiac disorders, nervous system disorders, immune system disorders, and gastrointestinal disorders. ADE signals related to myocardial infarction, cardiovascular disorders, gastric ulcer, gastric haemorrhage and gastric ulcer perforation as described in black box warnings in the instructions were all detected. When celecoxib is used, clinicians should be alert to cardiovascular and cerebrovascular symptoms, gastrointestinal disorders and retinal diseases of patients while ensuring effective monitoring. References | Related Articles | Metrics

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Analysis of 319 cases of adverse drug reaction induced by cerebroprotein hydrolysate for injection LI Yingfen, HAN Lei 2024, 21(2): 195-198.  DOI: 10.19803/j.1672-8629.20230653 Abstract ( 143 )   PDF (1292KB) ( 184 )   Objective To analyze the adverse drug reactions (ADR) induced by cerebroprotein hydrolysate for injection and to find out about the characteristics of such ADR so as to provide data for safe clinical use of cerebroprotein hydrolysate for injection. Methods Data on ADR of cerebroprotein hydrolysate for injection between 2011 and 2022 was collected by Qujing Food and Drug Adverse Reaction and Drug Abuse Monitoring Center. Results Most of the 319 cases of adverse reaction caused by cerebroprotein hydrolysate for injection occurred in patients over 61 years old. Adverse reaction usually occurred within 30 minutes of medication and manifested themselves in skin and appendages disorders, gastrointestinal disorders, and respiratory disorders. There were a total of 56 cases of severe ADR that were characterized by anaphylactoid reaction and anaphylactic shock. Conclusion Clinicians should be alert to ADR caused by cerebroprotein hydrolysate for injection in clinical practice, standardize clinical medication, prevent the occurrence of such serious adverse reactions as anaphylaxis. References | Related Articles | Metrics

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285 cases of adverse drug reaction related to new antineoplastic drugs XU Weijia, PENG Qi, HUANG Haiyu, ZHANG Leijiao, XIAO Hua, WU Xue 2024, 21(2): 199-203.  DOI: 10.19803/j.1672-8629.20230358 Abstract ( 227 )   PDF (1352KB) ( 222 )   Objective To study the patterns and characteristics of adverse reaction (ADR) related to new antineoplastic drugs, and provide reference for clinical medication. Methods A total of 285 cases of ADR caused by new antineoplastic drugs were collected in a tertiary general hospital from January 2018 to March 2023. The data on the gender, age, systems-organs involved in ADR, clinical manifestations, off-label medication, grading and outcomes of ADR and correlations was analyzed via the Microsoft Excel and SPSS software. Results Among the 285 cases of ADR, 155 (54.39%) involved males and 130 (45.61%) involved females, and the average age was (54.98±13.175) years. There were 426 cases of clinical manifestations and 12 systems-organs were involved. The digestive system (44.13%) and blood and hematopoietic system(19.01%) were more vulnerable. There were 51 cases of severe ADR, and 6 cases of new general ADR. There were 33 new anti-tumor drugs involved. Macromolecular monoclonal drugs, especially immune checkpoint inhibitors, caused more ADR, among which carrelizumab caused the largest number of cases (66 cases). One hundred and eighteen of these cases involved off-label medication, and the rate was as high as 63.10%. Conclusion ADR associated with novel antineoplastic drugs can occur among patients of any age, and involve multiple organs-systems. New antineoplastic drugs induce more serious ADR than new ADR,and many of these ADR are related to off-label drug use. It is recommended that off-label drug use be adopted, pharmaceutical care provided, and the safety and effectiveness of drug use improved for patients. References | Related Articles | Metrics

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One case of multiple organ dysfunction syndrome caused by amlodipine overdose GUO Qinghua, PENG Xiaoxiao, ZHU Ping, LIU Xilin, YANG Yinghua, CHEN Zhihai 2024, 21(2): 204-207.  DOI: 10.19803/j.1672-8629.20230190 Abstract ( 201 )   PDF (1319KB) ( 270 )   Objective To emphasize the standardized use of amlodipine in the elderly living alone, and to improve clinicians’ awareness of adverse drug reaction or overdose. Methods The clinical data of a case of multiple organ dysfunction syndrome (MODS) caused by amlodipine overdose in an old man living alone was analyzed, relevant case reports at home and abroad were reviewed, and the clinical features, treatment methods and prognosis were summarized. Results Amlodipine overdose may cause MODS, mainly manifested as slow heart rate, severe myocardial depression, hyperlactic acidemia, refractory shock, liver and kidney insufficiency, and the treatment method is to stop the responsible drug and support the organ function. Conclusion Amlodipine has the risk of MODS in special populations. For patients with MODS of unknown cause, we should be alert to the risk of adverse drug reactions or overdose poisoning. Early identification and corresponding treatment measures can improve the prognosis. References | Related Articles | Metrics

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One case of generalized myalgia caused by oxaliplatin FANG Meilin, ZHENG Huimin, WANG Cunze, WANG Ling, RUAN Junshan 2024, 21(2): 208-210.  DOI: 10.19803/j.1672-8629.20230492 Abstract ( 159 )   PDF (1216KB) ( 174 )   Objective To study the safety of oxaliplatin for injection in patients with gastric cancer. Methods The process of treating one 51-year-old male patient who developed generalised myalgia as a result of postoperative chemotherapy for a malignant tumor after being given oxaliplatin was analyzed. Results The laboratory test tests were as follows: the level of carbohydrate antigen was 19-9 (CA19-9) 6.09 U·mL-1, CA72-4 was 2.6 U·mL-1, CA15-3 was 6.99 U·mL-1, carcinoembryonic antigen was 2.45 ng·mL-1, alpha fetoprotein was 1.76 ng·mL-1, creatine kinase (CK) was 49 U·L-1, and serum creatinine (SCr) was 83 μmoL·L-1. After other causes of generalized myalgia were ruled out, the possibility of adverse reactions being caused by oxaliplatin was taken into account. Upon discontinuation of oxaliplatin, the patient reported reduced muscle soreness, with a VAS score of 7. One week later, the patient’s muscle soreness completely disappeared, resulting in a VAS score of 0. Conclusion Oxaliplatin for injection may increase the risk of generalised muscle pain, so clinical vigilance is required. References | Related Articles | Metrics

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One case of delayed skin allergic reaction caused by asthma treated with omalizumab injection LI Na, GUO Jun, GUO Wenjia, LYU Yinyin, LI Caihong, MU Xiangdong 2024, 21(2): 211-212.  DOI: 10.19803/j.1672-8629.20230626 Abstract ( 86 )   PDF (1144KB) ( 104 )   Objective To warn against potential delayed large-area allergic skin rashes as an adverse reaction during the combined treatment of severe allergic asthma using omalizumab injection. Methods One case of delayed onset allergic large-area rash occurred during the treatment of moderate to severe allergic asthma with omalizumab injection. The possible drugs responsible for the adverse reaction and countermeasures were identified based on adverse reaction correlation analysis. Results The adverse reaction in this patient manifested as a delayed large-area allergic skin rash. After such factors as the patient’s condition and concurrent medication were ruled out, the injection of omalizumab was considered to be the cause of the severe skin rash. The adverse reaction correlation was evaluated as “definite”. Immediate discontinuation of the medication and appropriate symptomatic treatment led to the patient’s recovery without any residual effects. Conclusion In clinical practice, delayed adverse reactions caused by omalizumab injection have to be monitored and immediate measures taken to prevent serious consequences. References | Related Articles | Metrics

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One case of interstitial pneumonia caused by serplulimab injection CHEN Yuyan, ZHANG Mingxia, ZHANG Tao, ZHANG Jin 2024, 21(2): 213-215.  DOI: 10.19803/j.1672-8629.20230445 Abstract ( 125 )   PDF (1289KB) ( 115 )   Objective To analyze the incidence of lung injury caused by serplulimab injection and related risk factors so as to provide data for clinical use. Methods The clinical data of one case of adverse reactions - interstitial pneumonia - caused by serplulimab injection was analyzed while the related literature was reviewed and summarized. Results One patient was treated with chemotherapy using injectable nedaplatin and etoposide injection in combination with serplulimab injection, who developed interstitial pneumonia during the 2nd course of combined chemotherapy (a total of three courses), which was determined to be due to the serplulimab injection by correlation analysis. The incidence of lung injury caused by serplulimab injection ranged from 1.6% to 8.2% according to literature, and the associated risk factors included history of smoking, history of tobacco exposure, poor health status, age, underlying lung disease and history of lung radiotherapy. This injection was recommended for use in patients under 65. Conclusion Clinicians are to be alert to the risk of interstitial pneumonia attributed to serplulimab injection. Prior to medication, thorough assessment of potential risk factors is crucial, and precautions need to be taken. During medication, respiratory symptoms of the patient should be closely monitored. In case of drug-related lung injury, pulmonary imaging, pulmonary function and arterial blood gas of the patient have to be examined before the severity is assessed to ensure quick interventions and safety of the patient. References | Related Articles | Metrics

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One case of severe liver injury caused by Tianma Shouwu tablets CAO Guiping, DENG Linlin, ZHU Ganhong, LU Ying, MA Shuang, CHEN Linlin, Liu Lili 2024, 21(2): 216-218.  DOI: 10.19803/j.1672-8629.20230466 Abstract ( 157 )   PDF (1212KB) ( 194 )   Objective To explore the correlation between severe liver injury and Tianma Shouwu Tablets. Methods A case of adverse reactions of severe liver injury caused by Tianma Shouwu Tablets were analyzed. The traditional Chinese medicine that may cause hepatotoxicity was analyzed by consulting the literature. The classification of liver injury and the causal relationship with Tianma Shouwu Tablets were evaluated by using the relevant standards of Chinese guideline for diagnosis and management of drug-induced liver（2023 version) and the updated RUCAM scale, and the rationality of the treatment strategy was discussed and analyzed. The human leukocyte antigen (HLA) -B* 35:01 allele is a risk factor for liver injury of Polygonum multiflorum from literature review, and can be used as a potential biomarker to predict liver injury caused by polygonum multiflorum. Results The processed Radix Polygoni Multiflori and stir-fried Tribulus terrestris in Tianma Shouwu Tablets may cause liver damage. The patient’s liver injury is hepatocyte injury type, and the RUCAM score is 7 points (most likely). Treatment strategies usually include liver protection, cholagogue, and anti-inflammatory. Literature analysis found that the human leukocyte antigen (HLA)-B*35: 01 allele was a risk factor for liver injury caused by Polygonum multiflori, which could be used as a potential biomarker to predict it’s liver injury. Conclusion In this case, there were some correlations between severe liver injury and Gastrodia multiflorum tablets; Marketing authorization holders of drug should actively monitor the adverse reactions of related varieties and update the instructions in time to reduce the risk of patients’ medication. References | Related Articles | Metrics

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Adverse reaction monitoring of toothpaste in China under the new regulatory system ZHU Ying, SHEN Lu, LI Lan, WU Jianmin, GAO Xiaojie 2024, 21(2): 219-222.  DOI: 10.19803/j.1672-8629.20230720 Abstract ( 177 )   PDF (1333KB) ( 152 )   Objective To explore ways in which adverse reactions of toothpaste in China should be monitored after the official implementation of Measures for Supervision and Administration of Toothpaste. Methods On March 16, 2023, the State Administration of Market Regulation issued the Measures for Supervision and Administration of Toothpaste, which came into force as of December 1, 2023. In this paper, the related literature and regulations were consulted while the history of adverse reaction monitoring of toothpaste in China was reviewed. Based on the current practices in adverse reaction monitoring, the loopholes in this area were analyzed. Results China’s ability to monitor toothpaste needs to be improved, the incentive to report adverse reactions related to toothpaste is lacking, information about toothpaste products is not easily accessible, and the public needs to be better informed of adverse reactions of toothpaste. Conclusion The implementation of Measures for Supervision and Administration of Toothpaste marks the institutionalization, standardization, and perfection of China’s adverse reaction monitoring of toothpaste. All parties concerned should enhance their interpretation and implementation of the new regulations, improve the quality of reporting and monitoring, make the new regulations better-known and provide technical guidance on monitoring, construct a better system of technical support for monitoring adverse reactions to toothpaste, and safeguard the safety of consumers. References | Related Articles | Metrics

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Research progress in novel xanthine oxidase inhibitors and treatment of gout JIN Shengju, ZHOU Miao, ZHANG Jianing, GE Gonghui, ZHANG Tingjian, MENG Fanhao 2024, 21(2): 223-228.  DOI: 10.19803/j.1672-8629.20230584 Abstract ( 144 )   PDF (1465KB) ( 103 )   Objective To summarize the recent progress in research on xanthine oxidase (XO) inhibitors. Methods Small molecule XO inhibitors were elaborated in terms of structural scaffold, molecular docking, activity and pharmacokinetics. Results Carboxylic acid and amide based XO inhibitors showed a favorable potential with activities comparable to those of topiroxostat, which could be a hotspot for future design of XO inhibitors. Conclusion It is expected that further structural optimization of carboxylic acids and amides will lead to the discovery of more effective XO inhibitors. References | Related Articles | Metrics

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The role of MRPs transporters in drug-induced liver injury WANG Xin, SHI Leilei, ZHANG Yuhan, XIE Yundong, LIU Jiping 2024, 21(2): 229-234.  DOI: 10.19803/j.1672-8629.20230152 Abstract ( 65 )   PDF (1573KB) ( 80 )   The liver is the organ with the most active metabolic activity in the human body, and is also responsible for the detoxification of numerous drugs. Prolonged or excessive use of drugs may lead to drug-induced liver injury (DILI), making drug transporters a key area of investigation in DILI research. Multidrug resistance-associated-proteins (MRPs) are proteins found on the cell membrane and are responsible for multidrug resistance. They are capable of transporting multiple drugs and play important role in DILI. Inhibition and removal of drug transporter activity is a major contributor to drug-induced liver damage. This article concludes and integrates the structure, expression sites, and functions of MRPs, and summarizes the relationship between MRPs and DILI, as well as the mechanisms for improving DILI In order to better understand the relationship between MRPs transporters and DILI, and provide reference for the prevention and treatment of DILI in the future. References | Related Articles | Metrics

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Classification of anti-tumor active ingredients of Paridis Rhizoma and research progress in mechanisms of action XIN Lingyi, YANG Yang, ZHU Jing, HE Na, ZHANG Jingmei, WANG Hangtian, CHEN Qinhua, YANG Guangyi 2024, 21(2): 235-240.  DOI: 10.19803/j.1672-8629.20230494 Abstract ( 283 )   PDF (1390KB) ( 100 )   Paridis Rhizoma is a traditional Chinese medicine for clearing away heat and toxic materials. Polyphyllin, as the most important anti-tumor active ingredient of Paridis Rhizoma, contains more than 50 types of compounds, among which the ingredients with anti-tumor effects are polyphyllin I, II, VI, VII. It is effective in treating many types of tumor cancers, such as liver cancer, colon cancer, brain tumor, colorectal cancer, esophageal cancer, lung cancer and nasopharyngeal carcinoma. These ingredients are mostly isospirostanol saponins, dominated by polyphyllin I, followed by polyphyllin II, diosgenin, polyphyllin A, gracillin, polyphyllin VI, polyphyllin VII, polyphyllin H and polyphyllin E. In recent years, the anti-tumor effects of polyphyllin have been gradually discovered and applied in clinic, but the adverse effects of Paris saponins have also been reported, such as the toxic damage of polyphyllin I to the liver. In this paper, the saponin components in Paridis Rhizoma are classified while the latest progress in research on the anti-tumor mechanism of isospirostanol saponins is reviewed in order to summarize the active components and mechanism of action of the anti-tumor effect of Paris saponins and to provide reference for studies on anti-tumor effects of polyphyllin and the safety of medication. References | Related Articles | Metrics