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Thoughts on constructing vigilance system of Chinese medical device in the new era SHEN Chuanyong, SONG Yana, ZHAO Yan, ZHENG Lijia, ZHAO Yifei, LI Dong 2022, 19(7): 697-701.  DOI: 10.19803/j.1672-8629.2022.07.01 Abstract ( 438 )   PDF (1422KB) ( 415 )   Objective To analyze the current status as well as the opportunities and challenges facing post-marketing surveillance and evaluation of medical devices in my country, this paper puts forward the thinking of constructing vigilance system of Chinese medical device in the new era. Methods Based on China's national conditions, combined with the development status of my country's medical device industry and the reform of medical device supervision concepts brought about by deepening the review and approval system, this article analyzes the opportunities and challenges facing post-marketing surveillance and evaluation of medical devices in China by reviewing literature, data comparison and other method. Results Combined with the current situation of domestic and foreign regulatory regulations, ideas are offered as to how to improve the regulatory system of surveillance and evaluation quickly, enhance the capabilities of risk control of post-marketing medical device products, and construct vigilance system of Chinese medical device. Conclusion Exploring and promoting the construction of medical device vigilance system is an important subject of medical device supervision in the new era, new situation and new system under the guidance of regulatory science. References | Related Articles | Metrics

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Establishment of a bio-relevance dissolution method for lansoprazole enteric capsules ZHANG Jinlin, LI Yan, CHEN Tao, ZHOU Ying, SONG Yunfeng, JIA Huanhuan, YUAN Yaozuo, CAO Ling, ZHANG Mei, WANG Chen, XU Mingzhe 2022, 19(7): 702-707.  DOI: 10.19803/j.1672-8629.2022.07.02 Abstract ( 175 )   PDF (2233KB) ( 132 )   Objective To provide effective means for daily drug quality control and market supervision by establishing a bio-relevance dissolution method for lansoprazole enteric-soluble capsules. Methods According to the correlation model of lansoprazole enteric dissolved formulations constructed in previous studies, the biorelevant dissolution conditions was further developed by combining with in vitro dissolution data, formulations of enteric dissolved capsules, in vitro dissolution model and other information. Results The dissolution model was established successfully, and the possible biorelevant dissolution method was speculated: basket method using USP I method. Set the rotating speed of the instrument at 150 rpm; before 45 minutes, phosphate buffer with pH 5.8 was used. From 45 min to 90 min, the pH of the dissolved medium was adjusted to form a buffer with a pH of 7.5. After 90 minutes, the pH of the dissolution medium was adjusted to 10.0. The method was confirmed by in vitro dissolution experiments, which indicated that the dissolution method predicted by the model had good accuracy. Conclusion The biorelated dissolution method established in this study truly reflects the inherent quality of generic drugs, provides a simple and convenient means for drug quality control and consistency evaluation, and provides a new idea for scientific supervision. References | Related Articles | Metrics

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Physiological pharmacokinetic model based evaluation of the efficacy of penicillamine tablets against Wilson's disease WANG Chen, GAO Jie, LIU Ying, CHEN Tao, XU Mingzhe 2022, 19(7): 708-711.  DOI: 10.19803/j.1672-8629.2022.07.03 Abstract ( 124 )   PDF (1594KB) ( 92 )   Objective To study and evaluate the efficacy of penicillamine tablets against Wilson's disease based on a physiological pharmacokinetic model. Methods A physiologically based pharmacokinetic (PBPK) model of penicillamine was established using software and validated with data collected from literature. Plasma concentration-time curves in the corresponding tissues and organs were calculated. The efficacy was evaluated based on the plasma concentration-time curves in related organs via appropriate parameters. Determinants of efficacy were also identified. Results For the single oral administration of 250 mg of penicillamine tablets, the maxiumen concentrations (Cmax) were 3.172 and 3.050 μg·mL-1 respectively based on the model and literature, and the corresponding average areas under the curve (AUC0-24 h) were 22.928 and 23.549 μg·h·mL-1 respectively. The determining factor (r2 value) between the results of calculation by the model and actual measurement in literature was 0.947, suggesting that there was no difference between the two results. Further calculation showed that the cmax of the brain, muscle, liver, heart, brain and kidney was 4.962, 4,783, 2.385, 1.641 and 0.616 μg·mL-1 respectively, while the AUC0-24h was 35.863, 32.518, 17.240, 12.003 and 4.450 μg·h·mL-1 within 24 hours of oral administration. Conclusion There is difference in the distribution of penicillamine tablets in various organs after oral administration. The administration scheme has to be designed and optimized according to the purpose of treatment. Dosage forms that are more likely to exist in the liquid state in the jejunum should be recommended since they can improve the efficacy. The approach established in this study can be used to evaluate the efficacy of penicillamine tablets in the human body and investigate the determinants of efficacy. References | Related Articles | Metrics

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Rapid evaluation of potential neurotoxicity of levornidazole for injection and its main impurities based on computational models and database technology ZHANG Dousheng, WANG Chen, XU Mingzhe 2022, 19(7): 712-716.  DOI: 10.19803/j.1672-8629.2022.07.04 Abstract ( 94 )   PDF (2310KB) ( 86 )   Objective To quickly evaluate the potential neurotoxicity of levornidazole for injection and its main impurities so as to provide reference for safer clinical medications. Methods The modeling data were prepared using online databases. The artificial neural network and support vector machine algorithm were used to establish two classification prediction models with different principles for interactive rapid evaluation. The characteristic domain was used to explore the causes of toxicity. Results The false positive and false negative results of prediction of models numbered ANN-3 and SVM-2 were less than 4.0%, and these two models were highly sensitive, accurate and robust. The new models were used to predict and evaluate the potential neurotoxicity of levornidazole for injection and its three main impurities, and the reliability exceeded 90%. Analysis of the characteristic domain showed that hydroxyl substitution in the structure increased molecular polarity, which might account for its potential neurotoxicity. Conclusion Levononidazole and its main impurities show potential neurotoxicity, so we need to keep close watch on the safety of the injection in clinical use. This study is expected to provide reference for rapid identification and evaluation of the toxicity of other antibiotics and their impurities. References | Related Articles | Metrics

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Evaluation on the efficacy of cefazolin sodium based on physiological pharmacokinetic models WANG Chen, GAO Jie, ZHANG Dousheng, XU Mingzhe 2022, 19(7): 717-720.  DOI: 10.19803/j.1672-8629.2022.07.05 Abstract ( 91 )   PDF (1692KB) ( 92 )   Objective To research and evaluate the efficacy of cefazolin sodium based on physiological pharmacokinetic models. Methods Physiologically based pharmacokinetic (PBPK) model of cefazolin was established using software and then further validated with the data collected from literatures. Plasma concentration-time curves in corresponding tissues and organs were calculated. Treatment efficacy was evaluated based on the plasma concentration-time curves in relevant organs with specific parameters. Those factors which have influence on the efficacy were also discussed meanwhile. Results For the single intravenous administration of cefazolin by 0.5, 1.0 and 4.0 g. The determining factor (r2 values) of the results of model established and actual measurement with literature data were 0.863 0.933 and 0.905. The rates of model established and actual measurement of the corresponding average value of the area under the curve (AUC0-t) were 101.1% 108.3% and 105.3%. Further calculation shown the effectiveness of lung, heart, kidney, skin and reproductive system with minimum inhibitory concentration of streptococcus pneumoniae, streptococcus haemolyticus, staphylococcus aureus, escherichia coli and roteus mirabilis were 18.7%~99.7%. Conclusion The PBPK model of cefazolin preparations can be described the pharmacokinetic of drugs in human, it is suitable for the efficacy evaluation of anti-infective drugs. Combined with the susceptibility test of antibiotics results, to achieve the better effectiveness by adjust the plan according to the treatment purpose. References | Related Articles | Metrics

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Advances in pediatric drug for central sedation based on pharmacokinetic/pharmacodynamic modeling and simulation ZHU Jinying, ZHOU Sufeng, WANG Lu, XU Mingzhe, SHAO Feng 2022, 19(7): 721-727.  DOI: 10.19803/j.1672-8629.2022.07.06 Abstract ( 100 )   PDF (1255KB) ( 74 )   Objective To summarize the pharmacokinetic/pharmacodynamic (PK/PD) models of central sedative pediatric drugs in order to provide references for quantitative pharmacological models in pediatric drug research and development. Methods The related literature of quantitative pharmacology of central sedative pediatric drugs were collected, analyzed, and summarized in the recent 20 years. Results Clearance was a key parameter to fit the PK/PD models, so it could be critical for determining the doses for pediatrics at different ages. Moreover, there was also a good correlation between the clearance and body weight in pediatric population. Conclusion A close attention should be paid on the physiological characteristics of pediatric patients, especially for investigating drugs acting on the central nervous system. Based on the physiological pharmacokinetic differences and drug exposure-response differences between pediatrics and adults, and considering the practice points of pediatric clinical trials, the PK/PD model supports the pediatric individualized treatment with central sedation drugs. References | Related Articles | Metrics

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Hepatotoxicity of alcohol extract Polygoni Multiflori Radix and related monomer compositions in liver cells CHEN Zihan, YANG Jianbo, CHEN Zhiwei, MA Shuangcheng, WEI Feng, SUN Hua 2022, 19(7): 728-732.  DOI: 10.19803/j.1672-8629.2022.07.07 Abstract ( 112 )   PDF (1917KB) ( 98 )   Objective To investigate the hepatotoxicity of 70% alcohol extract of Polygonum multiflorum, different eluted components and some monomer compounds isolated from the components in vitro. Methods The cell viability of HepG2 and L02 cells were detected by MTT colorimetry. Hepatocyte apoptosis and cell cycle were analyzed by flow cytometry. Results Significant toxicity in HepG2 cells was observed in 95% ethanol-eluted component (HSW-D) of 70% alcohol extract of Polygonum multiflorum and the monomer compound aloe emodin obtained from the component with 48 h treatment. Furthermore, significant toxicity of HSW-D was also presented in L02 cells after 48 h treatment. In addition, cell proliferation of HepG2 and L02 cells were inhibited through S-phase arrest. In comparison, little toxicity in HepG2 and L02 cells were observed in the 70% alcohol extract, other eluted components, two stilbene glycosides, two phenols and 10 monomer compounds such as chrysophanol, emodin methyl ether, rhein acid and emodin monanthrone of Polygonum polygonum. Conclusion The toxic substances were presented in the liposoluble constituent of alcohol extract of Polygonum multiflorum, by which aloe emodin is one of the essential toxic elements . References | Related Articles | Metrics

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Therapeutic effect of interferon atomization against COVID-19 GE Ziruo, TIAN Di, WANG Aibin, ZHANG Tingyu, REN Xingxiang, QIAN Fang, LI Xingwang, CHEN Zhihai 2022, 19(7): 733-739.  DOI: 10.19803/j.1672-8629.2022.07.08 Abstract ( 134 )   PDF (1601KB) ( 69 )   Objective To evaluate the therapeutic effect of interferon α2b (IFNα2b) aerosol inhalation against COVID-19 and to explore the effect of timing of treatment on the time taken by nucleic acid to become negative. Methods 271 cases of patients with COVID-19 who had been hospitalized in Beijing Ditan Hospital between January 20, 2020 and May 31, 2020 were included. According to whether interferon aerosol inhalation was used during hospitalization, these patients were divided into the interferon treatment group (n=218) and the control group (n=43). After the baseline data of the two groups was matched by the Logistic score nearest distance method, 86 cases in the interferon treatment group and 43 cases in the control group were included in this study. The severity of the disease, 28-day outcomes, the time their conditions began to improve, the length of hospital stay, the time of nucleic acid conversion and the time of imaging inflammation absorption were compared between the two groups. The influence of timing of interferon application on the speed at which nucleic acid turned negative was assessed. Results In terms of disease severity, patients who received IFNα2b aerosol treatment were mainly of the mild type (17.44%) and common type (66.28%), compared with (30.23%) and (46.51%) for the control group in which the proportions of severe (9.30%) and critical (13.95%) patients were higher, and the difference was statistically significant (P=0.032). There was difference in the 28-day outcomes of patients between the two groups. More patients were transferred to ICUs or died in the interferon treatment group than in the control group (P=0.011). The interferon treatment group improved more significantly than the control group (P=0.030). In terms of symptoms, the incidence of fever in the interferon treatment group was lower than that of the control group (P<0.001). As for laboratory indicators, the proportion of abnormal WBC and NE on the 14th day of admission and the proportion of abnormal NE on the 28th day in the interferon treatment group were lower than those of the control group (P=0.015, 0.015, 0.014). The proportion of patients whose nucleic acid test results turned negative after receiving interferon treatment within 7 days of admission was significantly higher than among patients who received medication 7 days after admission (P=0.047). Conclusion Aerosol inhalation of IFNα2b can help to improve the clinical conditions of patients with COVID-19 and reduce the severity of the disease. Early use of IFNα2b can quicken the rate at which nucleic acid turns negative. References | Related Articles | Metrics

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Influencing factors of suspected allergic reactions related to cervus and cucumis polypeptide for injection in the real world YAO Yu, LI Yuanyuan, WEI Xu, XIE Yanming, WANG Zhifei, GAO Minghui 2022, 19(7): 740-743.  DOI: 10.19803/j.1672-8629.2022.07.09 Abstract ( 120 )   PDF (1239KB) ( 91 )   Objective To explore the influencing factors of suspected allergic reactions caused by cervus and cucumis polypeptide for injection in the real world. Methods The study was based on information about patients who had used cervus and cucumis polypeptide for injection in the hospital information system of 26 large-scale tertiary hospitals in China from July 1, 2003 to December 31, 2014. A retrospective nested case-control study was conducted to compare the group of suspected allergic patients with the group of non-allergic patients. The logistic regression method was used to analyze the influencing factors of suspected allergic reactions based on such information as complications, combined medications, length of hospital stay, courses of medication and dosage. Results A total of 5 745 cases were included in this study, including 1 149 suspected allergic reactions (the allergic group) and 4 596 patients who had not developed any allergic reactions (the control group). Logistic regression analysis found that complications, combined medications, length of hospital stay, courses of medication and single dose had no significant effect on the incidence of suspected allergic reactions caused by cervus and cucumis polypeptide for injection. However, the difference was statistically significant when cervus and cucumis polypeptide for injection was combined with norfloxacin (P=0.011 3). Conclusion The combined use with norfloxacin may be a determinant of suspected allergic reactions related to cervus and cucumis polypeptide for injection (P<0.05). Which provides a reference to the rational use of drugs in clinic. References | Related Articles | Metrics

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Safety of medications for cardiovascular diseases in community clinics WANG Juli, ZHANG Xiaomeng, ZHANG Bing, LYU Jintao 2022, 19(7): 744-748.  DOI: 10.19803/j.1672-8629.2022.07.10 Abstract ( 177 )   PDF (1897KB) ( 173 )   Objective To explore the characteristics of adverse drug reactions/adverse drug events (ADR/ADE) caused by drugs for cardiovascular diseases in community clinics and to recommend targeted warning and prevention measures. Methods Using frequency statistics and association rules, 180 cases of ADR/ADE caused by drugs for cardiovascular diseases reported by four community clinics between January 1, 2004 and June 30, 2021 were retrospectively analyzed. Results Patients ages 70 to 79 were the most vulnerable, and intravenous administration was the main route reported. Only 7.78% of the cases had a drug allergy history. Pruritus and rash were the main symptoms. Most of the ADR/ADE related to Chinese and western medicines involved blood lipid modulators and blood-removing agents, while those caused by Chinese medicines involved drugs which were bitter in taste, warm in nature, liver-targeting and contained cinnabar. ADR/ADE were more likely when gastrodin, cinnamazide maleate, theophylline, ambroxol, salvia miltiorrhiza safflower preparation and ginkgo biloba extract were used together. Conclusion Community clinicians should be alert to the influence of patients' age, routes of administration, history of drug allergy, properties of traditional Chinese medicine, toxic drugs, and combination of drugs (traditional Chinese medicine and western medicine) on the incidence of ADR/ADE related to cardiovascular drugs, and strengthen rational use of drugs by whatever means available. References | Related Articles | Metrics

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Safety of propranolol tablets for infantile hemangioma MENG Kangkang, WANG Chunting, XIONG Weiyi 2022, 19(7): 749-751.  DOI: 10.19803/j.1672-8629.2022.07.11 Abstract ( 138 )   PDF (1218KB) ( 113 )   Objective To analyze the risk of propranolol tablets in the treatment of infantile hemangioma so as to provide reference for clinical rational drug use. Methods The reports about adverse drug reactions (ADR) induced by propranolol tablets for infantile hemangioma that were collected in China adverse drug reaction database from January 1, 2004 to July 10, 2020 and those collected in WHO Vigilyze, CNKI, VIP and Wanfang database from inception to December 1, 2020 were retrieved and analyzed, while related domestic and foreign drug Instructions were also reviewed. Results Treatment of infantile hemangioma with propranolol tablets was off-label, and children were vulnerable to the risk of serious adverse reactions such as hypoglycemia and sleep disturbance. Conclusion It is recommended that medical institutions should carry out physical examinations and screening for children before prescribing this drug and monitor blood pressure and heart rate during medication. Drug manufacturers should make more effort to monitor adverse reactions of their products, improve the information on safety in drug inserts in time, and ensure the safety of patients' medication. References | Related Articles | Metrics

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Safety evaluation and comparative analysis of rituximab and adalimumab based on openFDA REN Yuqin, LI Xin, YU Min, SU Yuwen 2022, 19(7): 752-756.  DOI: 10.19803/j.1672-8629.2022.07.12 Abstract ( 242 )   PDF (1206KB) ( 140 )   Objective To search and evaluate the adverse drug events (AE) of monoclonal antibody drugs rituximab and adalimumab in the database of the US Food and drug administration public data open project (OpenFDA), and to compare and analyze their AE. Methods The reporting odds ratio (ROR) method was used for quantitative detection of signals from the API module in the interactive chart section in OpenFDA database, the AE report data of rituximab and adalimumab from January 1, 2004 to October 15, 2021 were detailed retrieval. The profile of AE of both drugs was also analyzed from multiple perspectives simultaneously. Results A total of 131 408 adverse event reports referring to rituximab (including 376 203 adverse reaction signals) and 515 782 adverse event reports of adalimumab (including 1 238 760 adverse reaction signals) were obtained. Most of the reported persons of rituximab were personnel of other health systems, and most of adalimumab were consumers or non health system personnel. Due to the large number of adverse reaction signals, this study only screened the top 9 adverse reaction signals of rituximab and adalimumab for analysis. There were 9 379 cases of rituximab and 6 441 cases of adalimumab. The strongest signal of adverse events of rituximab was infectious and infectious diseases, and the strongest signal of adverse events of adalimumab was skin and subcutaneous tissue diseases. Conclusion In-depth analysis of the adverse drug event data of rituximab and adalimumab in the OpenFDA database would provide reference for clinical safe drug use. Paying attention to the adverse events of the above two drugs would help to take corresponding preventive measures and promote clinical rational drug use. References | Related Articles | Metrics

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Literature review of eosinophilic pneumonia induced by daptomycin SUN Bao, BAI Yanning, ZHANG Yuanyuan, QIAO Yi, YANG Zhifu, WANG Jingwen, WEN Aidong 2022, 19(7): 757-761.  DOI: 10.19803/j.1672-8629.2022.07.13 Abstract ( 93 )   PDF (1339KB) ( 87 )   Objective To explore the regularity and characteristics of daptomycin-induced adverse reactions, and to provide reference for clinical rational drug use. Methods Such databases as CNKI, Wanfang, VIP, and PubMed were searched for articles about daptomycin-induced ADR that had been published between January 1, 2004 and July 31, 2019. Data on conditions of patients, medications, occurrence of ADR and prognosis was statistically analyzed. Results A total of 29 articles involving 51 cases of daptomycin-induced ADR-eosinophilic pneumonia-were included in this study. In these cases, the ratio of males to females was 5.25∶1. Most of the ADR occurred among elderly patients, accounting for 54.91% (28/51). 27.45% (14/51) of these ADR occurred within one to two weeks of medication. The main clinical manifestations were eosinophilia, dyspnea and febrile. The risk factors of eosinophilic pneumonia in patients might be related to age and dosage rather than to gender, the ADR history and combination of drugs. Conclusion Daptomycin-induced ADR vary, which deserve the attention of clinicians, clinical pharmacists and nurses so as to improve the rational use of drugs, and ensure the safety of medication. References | Related Articles | Metrics

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Analysis of Adverse drug reactions of intravenous medication in pediatric inpatients in a tertiary children's hospital LIU Chang, LIN Huijun, SHEN Hongxia, YAN Meixing 2022, 19(7): 762-766.  DOI: 10.19803/j.1672-8629.2022.07.14 Abstract ( 168 )   PDF (1262KB) ( 133 )   Objective To study the patterns and characteristics of adverse drug reactions(ADR) among the real-world pediatric inpatients in order to provide reference for clinical rational drug use and for safety evaluation of drugs in pediatric populations. Methods In this retrospective study, the data on pediatric inpatients treated with intravenous administration and reports about adverse drug reactions in a tertiary children's hospital collected between 2018 to 2019 were analyzed in terms of patients' age, medications, time of occurrence, and organs/systems involved. Results Among the 50 194 pediatric inpatients who had received intravenous administration, a total of 423 ADR reports in our hospital were collected. The incidence of adverse reactions of intravenous medicines averaged 8.43%. The incidence of ADR was the highest among patients ages 7 to 12 (10.24‰) and 4 to 6 (8.93‰), but was the lowest in newborns (3.40‰). The 423 ADR reports involved 61 types of drugs. 259 of these ADR involved anti-infectious drugs, accounting for 61.23%, 35 involved drugs for regulation of electrolytes and acid-base balance and nutritional drugs, accounting for 8.27%, and 24 were related to traditional Chinese medicine injections, accounting for 5.67%. Intravenous ADR mainly occurred within one hour of medication (67.38%), and 51.88% of the ADR occurred within 30 minutes of injection. ADR involving organs/systems were mostly the damage to the skin and its accessories (62.27%), followed by gastrointestinal side effects (20.61%) and systemic damage (5.56%). Conclusion More attention should be paid to the regularity and characteristics of adverse reactions during intravenous administration in children. Preventive measures should be taken to ensure the safety and effectiveness of pediatric drugs. References | Related Articles | Metrics

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989 cases of adverse drug reactions caused by multivitamins for injection (12) CAO Lujuan, MA Danhua, WANG Xinmin 2022, 19(7): 767-769.  DOI: 10.19803/j.1672-8629.2022.07.15 Abstract ( 182 )   PDF (1240KB) ( 165 )   Objective To investigate the incidence of adverse drug reactions (ADR) caused by multivitamins for injection (12) so as to provide reference for clinical rational drug use. Methods 989 cases of ADR related to multivitamins for injection (12) were collected from the national adverse drug reaction monitoring system in Jiangsu between January 1, 2015 and May 31, 2020 before being analyzed retrospectively. Results 52.88% of these cases involved new ADR. Most of the adverse reactions involved females, and most of the patients ranged from 41 to 70 years old (56.32%). As for SOCs, systemic reactions accounted for 26.95%, skin and its accessories 20.41%, and the gastrointestinal system 10.87%. Serious ADR mainly involved the immune system (27.55%), systemic reactions (21.43%), and skin and its accessories (15.31%). Conclusion Marketing authorization holders should strengthen the post-marketing surveillance of drugs. More attention should be paid to the safe use of drugs and serious adverse reactions such as anaphylactic shock. References | Related Articles | Metrics

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Analysis of 107 reports of ADR induced by ribavirin LI Meiyun, TANG Guangliang, CHEN Zhihong, HE Xin, CHEN Shenjue, LI Xin, LIU Lihua 2022, 19(7): 770-774.  DOI: 10.19803/j.1672-8629.2022.07.16 Abstract ( 204 )   PDF (1251KB) ( 194 )   Objective To analyze the adverse drug reactions (ADR) of ribavirin in order to provide reference for the safety of clinical medications. Methods Adverse reaction reports of ribavirin collected between January 22, 2015 and February 28, 2020 in Changsha were statistically analyzed. Results The clinical manifestations of ADR caused by ribavirin were complicated and diverse, involving 107 patients. Forty-three different clinical manifestations of nine types of ADR were observed in various age groups. The proportion of children and the elderly was higher, and males slightly outnumbered females. Intravenous administration was more common than oral or inhaled administration. The main ADR were systemic damage and damage to the gastrointestinal system. There were 55 cases of severe ADR. ADR occurred within 30 minutes of medication in 69 patients, and most of them were relieved after drug withdrawal or symptomatic treatment. Conclusion Adverse reactions of ribavirin have various clinical manifestations, to which children, the elderly and patients receiving intravenous administration are more vulnerable. Adverse reactions should be closely monitored within 30 minutes of RBV administration. References | Related Articles | Metrics

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Adverse reactions induced by anlotinib hydrochloride CAO Yajie, XU Han, ZHOU Ningning, ZHONG Chunsheng 2022, 19(7): 775-778.  DOI: 10.19803/j.1672-8629.2022.07.17 Abstract ( 169 )   PDF (1162KB) ( 116 )   Objective To summarize the characteristics of adverse reactions caused by anlotinib, and provide reference for clinically safe use of tumor targeted therapy drugs. Methods The clinical data on 36 patients who had developed adverse reactions after using anlotinib targeted therapy between October 1, 2018 and December 31, 2019 in the Department of Oncology of our hospital was analyzed in terms of gender, age, types of disease, previous adverse reactions, and system-organs involved. Clinical manifestations, time of occurrence, grades of severity, outcomes and correlations were analyzed. Results A total of 65 cases of adverse reactions occurred in 36 patients who had taken anlotinib, including 49 cases of mild adverse reactions and 16 cases of severe ones. The main adverse reactions were hypertension, proteinuria, hand-foot syndrome, fatigue, oral ulcers. Conclusion With the increasing use of anlotinib in clinic, both the efficacy and related adverse reactions deserve attention in order to make medication safer. References | Related Articles | Metrics

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Taking wrong medicines by children and precautions WANG Zhonglan, WANG Yu, HAO Lina, HU Lihua, WANG Xiaoling, ZHAO Zhigang 2022, 19(7): 779-781.  DOI: 10.19803/j.1672-8629.2022.07.18 Abstract ( 146 )   PDF (1232KB) ( 145 )   Objective To investigate the problems with the use of commonly-used medicines at home and children's medication behaviors and to explore the countermeasures for reducing the incidence of taking wrong medicines by children. Methods Convenience sampling was adopted to investigate the storage of commonly-used medicines at home, the incidence of children taking wrong medicines and ways of safe medications among children ages 0 to 18 in 16 cities in Shandong Province. The data was statistically analyzed. Results A total of 3 005 valid questionnaires were obtained 92.41% of the families surveyed stored commonly-used medicines, including medicines for children's colds (88.33%), antipyretic and analgesic medicines for children (67.81%), adult medicines (59.7%) , and those for cough and phlegm (58.26%).4.83% of the children surveyed had the experience of taking wrong medicines, 66.9% of whom were aged 1 to 3, and 13.79% 4 to 6. There was significant difference in the incidence of taking the wrong medicines between urban and rural kids (P<0.05). Medicines taken by mistake included medicines for colds (31.72%), for cough and phlegm (17.24%), and antipyretic and analgesic ones (16.55%). The incidence of taking wrong medicines was the highest(41.38%), followed by overdose (31.72%) and wrong routes of administration (12.41%). The main reason was that children took wrong drugs themselves (44.14%). Conclusion There are hidden hazards in the management of commonly-used drugs at home and the medication behavior of children. It is suggested that the research and development of pharmaceuticals intended for children be promoted, packaging of drugs be improved, and ways to ensure safe medication among children be made better-known. References | Related Articles | Metrics

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Pharmaceutical care of a case of severe ulcerative colitis treated with vedolizumab SUN Xuelin, ZHANG Pan, HU Xin 2022, 19(7): 782-785.  DOI: 10.19803/j.1672-8629.2022.07.19 Abstract ( 130 )   PDF (1120KB) ( 80 )   Objective To explore the role of clinical pharmacists in the treatment of severe ulcerative colitis (UC) with vedolizumab and pharmaceutical care model. Methods The clinical pharmacist participated in the drug treatment of a case of severe UC, and the patient's symptoms were not significantly improved by 5-aminosalicylic acid and glucocorticoid treatment. Considering the patient's condition, the pharmacist recommended vedolizumab for treatment, and the patient was given full pharmaceutical monitoring. Results Patients with UC symptoms gradually improved after medication, and no serious adverse reactions occurred during the treatment with vedolizumab. Vedolizumab was effective in UC patients whose symptoms were not significantly improved after treatment with mesalazine and glucocorticoid. Conclusion The participation of clinical pharmacists in the formulation of treatment plans and the provision of pharmaceutical care are helpful to improve of the drug efficacy in severe UC, ensuring the safety of drugs, and improving the prognosis and quality of life of patients with UC. References | Related Articles | Metrics

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Pharmaceutical care by a clinical pharmacists in the treatment of parenteral nutrition related hepatic damage: a case report TANG Jingya 2022, 19(7): 786-788.  DOI: 10.19803/j.1672-8629.2022.07.20 Abstract ( 142 )   PDF (1205KB) ( 100 )   Objective To explore the role of a clinical pharmacist in the treatment of a patient with parenteral nutrition related hepatic damage so as to provide reference for rational use of nutritional drugs. Methods One clinical pharmacist participated in the treatment of a patient with hepatic insufficiency, who not only identified the cause of hepatic injury, but also suggested that the parenteral nutrition formula be adjusted to 500 mL of 50% glucose injection, 1 500 mL of 8.5% compound amino acid injection (18AA-V), and 250 mL of 20% medium / long chain fat emulsion injection. The rest of the recipes remained unchanged. The amount of PN was decreased gradually and replaced by enteral nutrition (EN). Results Physicians adopted the suggestions of clinical pharmacist so that such liver function indexes as alanine aminotransferase and alkaline phosphatase returned to normal. Conclusion The duration of PN use and the types of lipids in PN may further aggravate liver injury. The participation of a clinical pharmacist in pharmaceutical care for patients can assure effective and safe use of nutritional drugs, and minimize complications and adverse drug reactions. References | Related Articles | Metrics

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Infant ankle edema and lactic acid increase induced by diazoxide: a case study YANG Jia, LI Gen, JIANG Yongxian, TAO Wanjun, CHEN Wenwen, LIANG Hua 2022, 19(7): 789-791.  DOI: 10.19803/j.1672-8629.2022.07.21 Abstract ( 94 )   PDF (1180KB) ( 72 )   Objective To study the safety of diazoxide in the treatment of congenital hyperinsulinemia in infants. Methods A one-month-old baby with congenital hyperinsulinemia and brain injury treated with diazoxide was observed. The decrease in the urine volume and edema of both ankles as well as the increase in blood lactic acid were recorded. Diuretics were given to the patient to mitigate the edema of ankle joints and blood lactic acid was monitored dynamically. Results After discharge, the patient was followed up for 4 months by the outpatient department, during which time no ankle edema or water and sodium retention occurred, and blood lactic acid never exceeded 4.0 mmol·L-1 after regular review. After the discontinuation of diazepine treatment, the blood glucose of the patient remained stable, and blood lactic acid returned to 2.0 mmol·L-1. Conclusion It is recommended that thiazide diuretics be used to prevent water and sodium retention while monitoring blood lactic acid when diazoxide is used. In case of the increase of blood lactic acid, dynamic and timely monitoring is recommended so as to adjust the dose as required. However, for children with a severe lactic acid increase accompanied by blood gas abnormality and metabolic acidosis, the treatment with diazoxide should be suspended. References | Related Articles | Metrics

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Acute liver and kidney injury due to rhabdomyolysis induced by rosuvastatin calcium tablets combined with probucol tablets CHEN Jing, CHENG Hua, LIU Xianjun 2022, 19(7): 792-794.  DOI: 10.19803/j.1672-8629.2022.07.22 Abstract ( 174 )   PDF (1079KB) ( 146 )   Objective To explore ways to treat rhabdomyolysis along with acute liver injury and acute kidney injury induced by rosuvastatin calcium and probucol. Methods The process of treating one case of rhabdomyolysis along with acute liver injury and acute kidney injury due to rosuvastatin calcium and probucol was analyzed based on literature review. The mechanism by which rosuvastatin calcium and probucol induced rhabdomyolysis complicated with acute liver injury and acute kidney injury was investigated. Results The patient was diagnosed with rhabdomyolysis along with acute liver injury and acute kidney injury 14 days after rosuvastatin calcium and probucol were used. These two drugs were withdrawn on the same day and the patient was given sufficient rehydration, dieresis and hemodialysis. The level of CK and indexes of the liver and kidney of the patient decreased gradually and returned to the previous level 34 days after drug withdrawal. Conclusion The use of rosuvastatin calcium and probucol should be discontinued immediately in case of rhabdomyolysis along with acute liver injury and acute kidney injury. The patient should be given active fluid rehydration and hemodialysis if it is necessary. References | Related Articles | Metrics

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One case of anaphylactic shock caused by risedronate sodium tablets YANG Liandi 2022, 19(7): 795-798.  DOI: 10.19803/j.1672-8629.2022.07.23 Abstract ( 167 )   PDF (1131KB) ( 138 )   Objective To alert clinicians to adverse drug reactions induced by risedronate sodium tablets. Methods The clinical data of one case of anaphylactic shock caused by risedronate sodium tablets in March 2020 was analyzed while literature related to the common adverse reactions and pathogenesis of anaphylactic shock caused by risedronate sodium tablets was reviewed. Results Based on the patient's clinical manifestations and the correlations between the drug and the time of medication, it was suspected that risedronate sodium tablets might have caused anaphylactic shock. The patient's symptoms were relieved after active anti-allergic treatment and symptomatic treatment. Conclusion For patients with a history of drug allergy, oral drugs prescribed for the first time should be selected with caution. References | Related Articles | Metrics

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Chemical constituents of Polygonum multiflorum Thunb. based on its origins and methods of processing LI Yanyi, ZHANG Yujie, WANG Qi, MA Shuangcheng 2022, 19(7): 799-802.  DOI: 10.19803/j.1672-8629.2022.07.24 Abstract ( 73 )   PDF (1245KB) ( 78 )   Polygonum multiflorum Thunb. is a typical traditional Chinese medicine, the medicinal effect and material basis of which are one of the current research hotspots. This article summarizes the related literature that has been published over the past ten years. It is found that three-year-old P. multiflorum is best harvested between October and December. The ways in which its chemical components vary are also studied. It is hoped that this research can contribute to the establishment of quality standards and the in-depth study of its toxic substances. References | Related Articles | Metrics

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Research progress in comprehensive evaluation methods of drugs YANG Ping, LU Song, DONG Xianzhe, ZHANG Lan 2022, 19(7): 803-806.  DOI: 10.19803/j.1672-8629.2022.07.25 Abstract ( 253 )   PDF (1135KB) ( 268 )   With the deepening of health care reforms, amid refined pharmaceutical management by the state and medical institutions and along with patients' demand for precise pharmaceutical services, comprehensive drug evaluation has become imperative. The scientific and standardized comprehensive evaluation of drugs and the application of the results will provide data for the revision of the national drug-related catalogs and technical specifications, the rational clinical use of drugs in medical institutions, and for standardized management. By searching the literature related to comprehensive drug evaluation methods, the methods currently available at home and abroad are reviewed, and the characteristics and key elements of different methods are discussed so as to provide reference for the construction and improvement of a standardized comprehensive drug evaluation system in China. References | Related Articles | Metrics

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Evidence-based ibrutinib-related adverse reactions and pharmaceutical care LI Yanming, ZHAO Zhigang 2022, 19(7): 807-811.  DOI: 10.19803/j.1672-8629.2022.07.26 Abstract ( 139 )   PDF (1181KB) ( 131 )   Ibrutinib, a small molecule BTK inhibitor, is the first targeted drug mainly used for B cell malignant tumors. With the increase of related research at home and abroad, more and more adverse reactions induced by ibrutinib have been discovered, such as bleeding, atrial fibrillation, hypertension, infection, diarrhea, arthralgia/myalgia, skin toxicity, and hematological toxicity. Ibrutinib has been associated with an increased risk of grade 1 ~ 2 toxicities. Serious adverse events are rare. Based on literature, this article summarizes the types, incidence, prevention, management, and pharmaceutical care of common as well as rare but important toxicities of ibrutinib. It is expected to provide evidence-based recommendations and minimize side effects. References | Related Articles | Metrics