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CONTENTS 2024, 21(7): 0-0.  Abstract ( 128 )   PDF (493KB) ( 187 )   Related Articles | Metrics

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Toxicity associated with antibody-drug conjugates and corresponding research strategies LIU Lianqi, XIAO Dian, ZHONG Wu, ZHOU Xinbo, LI Song 2024, 21(7): 721-729.  DOI: 10.19803/j.1672-8629.20240356 Abstract ( 180 )   PDF (1701KB) ( 322 )   Objective To explore the toxicity, causes of toxicity, and strategies to minimize toxicity of antibody-drug conjugates (ADCs), an emerging class of anticancer therapeutics, in order to provide reference for the development of the next generation of ADCs with high efficacy and low toxicity. Methods The data on toxicity of ADCs that had been marketed and were in clinical trials was summarized and analyzed. By focusing on the structure of ADCs, the relationship between structure of ADCs and generated toxicities was revealed. By referring to effective strategies for minimizing toxicities in place, the future developments of the next generation of ADCs with high efficacy and low toxicity were predicted. Results and Conclusion Research strategies for preventing toxicities are provided for different stages of ADC development. Among them, updated and core concepts of the design of ADCs are crucial to addressing the toxicities of ADCs. References | Related Articles | Metrics

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Proteolysis targeting chimeric drugs and their potential risks JIANG Hailun, ZHOU Xinbo, XIAO Dian, ZHONG Wu, LI Song 2024, 21(7): 730-734.  DOI: 10.19803/j.1672-8629.20240423 Abstract ( 157 )   PDF (1552KB) ( 188 )   Objective To introduce the mechanism and design principles of protein hydrolysis targeting chimeras (PROTACs) in Targeted Protein Degradation (TPD) technology, and to discuss the potential risks of and solutions to existing PROTACs based drugs in order to provide reference for the development of new, efficient and safe PROTAC drugs. Methods Relevant literature published in recent years was analyzed. The mechanism of PROTACs technology, design principles of each component, identified potential risks, and corresponding response strategies were summarized. Results For the design of PROTAC drugs, suitable sites and connecting chains should be selected from the solvent exposure areas of target protein binding molecules. At the same time, this design should be based on high-resolution crystal structures and avoid changes in the binding affinity between small molecules and target proteins. For the selection of E3 ligases and their ligands, screening usually starts with the widely used CRBN and VHL ligands. In the design of connecting chains, screening often starts from flexible PEG chains. In terms of potential risks, PROTAC drugs can cause such problems as excessive degradation, off target toxicity, Hook effect, metabolite toxicity, involvement of aldehyde oxidase in metabolism, and linker cleavage product toxicity. Conclusion PTOTAC compounds should be viewed as a whole, and proteomics and other technical methods should be flexibly applied to prevent, monitor and analyze the toxicity of their metabolites so as to facilitate the development of more active and safe PROTAC drugs. References | Related Articles | Metrics

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Course of development of pharmocovigilance systems in China WANG Dan, DONG Duo, TIAN Chunhua 2024, 21(7): 735-740.  DOI: 10.19803/j.1672-8629.20240314 Abstract ( 298 )   PDF (1217KB) ( 597 )   Objective To analyze the background and reasons for the establishment of the pharmacovigilance system(PVS) in China, summarize the experience related to the PVS, and provide reference for the development of a new system. Methods Starting with the construction of the legal system, the origin and development of the Adverse Drug Reaction Reporting System (ADRRS) were traced, problems with and new challenges to this system were identified, ways in which the PVS was implemented in the past five years were studied, and tips were given about the implementation of the new system in terms of ideas and range of pharmacovigilance, and system construction. Results The PVS was a natural by-product of the ADRRS, and developed out of the international environment for pharmacovigilance. In the first five years since the implementation of the PVS, the legal system, organizational system, and technical system came to be established and improved, research made steady progress, and the notions of pharmacovigilance took shape. At the same time, new problems emerged. Conclusion The PVS in China is unlikely be an instant success. Strategies involving in-depth research, consideration of all the factors as a whole, step-by-step implementation, and division of labor and cooperation are required. Reform and innovation should be given top priority to promote steady development and constant improvement. References | Related Articles | Metrics

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Review of pharmacovigilance of traditional Chinese medicine SHAO Bo, GUO Xiaoxin 2024, 21(7): 741-745.  DOI: 10.19803/j.1672-8629.20240307 Abstract ( 211 )   PDF (1370KB) ( 341 )   Objective To explore a pharmacovigilance system of traditional Chinese medicine（TCM）that is compatible with the characteristics of traditional Chinese medicine in order to provide reference for safe use of TCM. Methods The origin and development of pharmacovigilance of TCM were reviewed, the undertakings by regulatory agencies in the field of pharmacovigilance of TCM in recent years were summarized, and the determinants of pharmacovigilance of TCM were discussed. Results Since the establishment of the pharmacovigilance system, the laws and regulations on pharmacovigilance of TCM have been improved, and pharmacovigilance of TCM has proved fruitful enough to provide reference for safe use of TCM. Conclusion Pharmacovigilance of TCM should always be guided by the TCM theories of “holistic view” and “syndrome differentiation and treatment”. Effort should be made to establish evaluation methods in line with the characteristics of modern TCM so as to facilitate the safe and effective use of traditional Chinese medicine in clinical practice and promote the high-quality development of pharmacovigilance of TCM. References | Related Articles | Metrics

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Current situation and suggestions concerning the implementation of MedDRA in drug monitoring in China ZHU Yan, LI Qingna, ZHU Lan, XIE Jiang’an, YAO Keyu, HUANG Guangrui, YANG Xiaolin, GUAN Jian 2024, 21(7): 746-751.  DOI: 10.19803/j.1672-8629.20240103 Abstract ( 217 )   PDF (1741KB) ( 318 )   Objective To point out the problems with and challenges to the implementation of the Medical Dictionary for Regulatory Activities (MedDRA) in drug monitoring in China in order to provide reference for applications of MedDRA. Methods MedDRA was outlined. Issues and challenges facing the product itself, management mechanisms, training of users, and construction of the community of users were analyzed. Countermeasures were recommended, such as improving management mechanisms, expanding the Chinese version, building a shared coding case database, continuous review and improvement of the Chinese version of MedDRA, supplementing definitions, and increasing the content of traditional Chinese medicine. Results and Conclusion With collaborated efforts, the introduction, popularization, and implementation of MedDRA started smoothly. Due to such factors as the characteristics of MedDRA products and existing management mechanisms, there were several issues and challenges. All parties concerned needed to coordinate and work together to address related issues and challenges to make MedDRA compatible with internationally-accepted practices and achieve mutual recognition, and to promote the high-quality development of innovative drugs in China. References | Related Articles | Metrics

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Mining and analysis of cardiac disorders risk signals based on adverse drug reaction monitoring data ALATENG Hua, WANG Zhenxing, ZHANG Xiaomeng, SHI Wei, XI Chengwei, WANG Conghui, WANG Liqun, ZHANG Bing 2024, 21(7): 752-758.  DOI: 10.19803/j.1672-8629.20240296 Abstract ( 192 )   PDF (1348KB) ( 287 )   Objective To mine and analyze the risk signals of adverse drug reactions (ADR) leading to cardiac disorders in the adverse drug reaction monitoring database in order to provide reference for safe and rational drug use and for research on post-marketing drug safety. Methods The ADR reports from the adverse drug reaction monitoring system database of one province collected between 2021 and 2023 were retrieved and subjected to data cleaning. The reporting odds ratio (ROR) method was employed for detection of ADR signals, and the ROR values and their 95% confidence intervals of drugs causing cardiac disorders risks were calculated. The risk signals mined were analyzed and assessed. Results A total of 72 398 ADR reports were retrieved over the past three years. After excluding duplicate and incomplete reports, 3 697 ADR reports involving the cardiovascular system were finally included in the analysis. Female patients outnumbered male ones, and ADR occurred predominantly in patients over 65 years old after medication. Diseases related to the respiratory system, mediastinal diseases, vascular and lymphatic diseases and heart diseases accounted for nearly 60% of the primary diseases. In over half of the reports, ADR occurred within less than one day of medication, and more than 60% of the ADR occurred on the very day of medication. The overall outcome of adverse reactions was favorable. Among the 263 suspected drugs analyzed, 70 risk signals of cardiac disorders were identified using the ROR method, including 62 anticipated signals documented in the package inserts and 8 unanticipated ones not documented in the package inserts. Conclusion The ROR method is generally reliable for mining and analyzing risk signals of cardiac disorders. However, the signals generated by this method are far from conclusive in that their credibility and robustness are influenced by the quantity, quality, and confounding factors of the data. In addition to focusing on drugs that may cause cardiac disorders, pharmacovigilance personnel should also take into consideration the differences between individual patients and clinical medication risk factors to minimize drug-induced cardiac risks and ensure safe medication. References | Related Articles | Metrics

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Traditional Chinese medicine for prevention and treatment of adriamycin cardiotoxicity and an empirical study of evidence elements LIU Yadi, ZHANG Xiaomeng, CAI Haili, CHEN Siying, WANG Yu, ZHANG Bing 2024, 21(7): 759-764.  DOI: 10.19803/j.1672-8629.20240294 Abstract ( 120 )   PDF (1666KB) ( 189 )   Objective To validify the evidence of adriamycin cardiotoxicity via animal experiments based on the analysis of TCM medications used for the prevention and treatment of adriamycin cardiotoxicity in order to provide data for related treatment. Methods Literature related to the prevention and treatment of anthracycline cardiotoxicity with TCM and published between the inception to March 1st, 2024 was searched for from some databases to analyze the pattern of medications and to establish a rat model of anthracycline cardiotoxicity via injection with doxorubicin at 3.5 mg•kg-1. Results A total of 104 Chinese herbal medicines, such as Astragalus, Glycyrrhiza glabra, Maitong, Ginseng, Radix et Rhizoma Ginseng, Radix et Rhizoma Ginseng, and Salviae Miltiorrhizae, were included. The efficacy of these drugs was determined as tonifying deficiency, activating blood circulation, removing blood stasis, clearing heat, eliminating phlegm, and expelling dampness. Anthracycline cardiotoxic rats showed dirty fur, hair loss, loose stools, stasis of blood, depression, lethargy, decrease in anal temperatures, and dark tongue color. The serum contents of antidiuretic hormone, aldosterone, and antithrombin Ⅲ were significantly decreased while the content of D-dimer was significantly increased. Conclusion The development of drugs for prevention and treatment of anthracycline cardiotoxicity should involve tonifying the deficiency, stimulating blood circulation, eliminating stasis, expelling dampness and resolving turbidity. References | Related Articles | Metrics

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Progress in construction and evaluation of a drug-induced cardiotoxicity model CAI Haili, ZHANG Xiaomeng, LIU Yadi, LIU Shujia, GAO Fujun, WANG Yu, ZHANG Bing 2024, 21(7): 765-770.  DOI: 10.19803/j.1672-8629.20240345 Abstract ( 144 )   PDF (2255KB) ( 193 )   Objective To find out about the establishment and applications of animal models for drug-induced cardiotoxicity, and to provide data for the prevention and treatment of drug-induced cardiotoxicity. Methods Literature research was conducted using “cardiotoxicity” as the key term. Related literature on applications of drug-induced cardiotoxicity models published since 2015 was selected from the CNKI and Web of Science Core Collection databases. Literature about experimental research on applications of animal models for drug-induced cardiotoxicity was screened based on the inclusion criteria. Analysis software Citespace 6.3 R1 (64-bit) Basic as well as Excel was used to visualize the selected literature. Results A total of 731 articles were included. The model animals used in studies of drug-induced cardiotoxicity were mostly rats, mice and zebrafish while the modeling agents were chiefly adriamycin, aconitine and bupivacaine. The toxicity mechanism involved oxidative stress and apoptosis. Most studies used such multi-category indicators as general indicators, histopathological indicators, and cardiac function test indicators for comprehensive evaluation. The applications were also relatively concentrated, and there were great differences in the criteria for evaluating drug-induced cardiotoxicity models. Conclusion Research on drug-induced cardiotoxicity models remains promising, which can facilitate systematic development of Traditional Chinese Medicine for the prevention and treatment of drug-induced cardiotoxicity. References | Related Articles | Metrics

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Roles of Yangwei Anshen decoction in improving sleep quality in mouse model of insomnia induced by chronic unpredictable stress YE Anping, WEI Xue, HUANG Mingyue, ZHANG Xianxie, MA Zengchun, GAO Yue 2024, 21(7): 771-775.  DOI: 10.19803/j.1672-8629.20240014 Abstract ( 105 )   PDF (1690KB) ( 185 )   Objective To explore the effect and mechanism of Yangwei Anshen decoction (YWASD) on sleep quality in insomnia mice induced by chronic unpredictable stress combined with p-chlorophenylalanine (PCPA). Methods A total of 48 ICR mice were randomly divided into six groups with eight mice in each, including the normal control group, model group, positive drug group (diazepam 2.5 mg·kg-1) and high, medium and low doses of YWASD groups (50, 25, 12.5 g·kg-1, equivalent to 18, 9 and 5 times that of the clinical dose for adults). After 14 days of multi-factor stimulation, the ICR mice were intraperitoneally injected with PCPA suspension (30 mg·mL-1) for two consecutive days to establish an insomnia model. ICR mice were treated with diazepam and three different doses of YWASD (12.5, 25, 50 g·kg-1·d-1) for 14 days. Behavioral tests and sleep tests induced by sodium pentobarbital were performed. Serum levels of norepinephrine (NE), 5-hydroxytryptamine (5-HT) and dopamine (DA) were detected with enzyme-linked immunosorbent assay (ELISA) kits. Western blot (WB) was used to detect the expression of 5-HT1A receptor (5-HTR1A). Results Compared with the control group, the mice in the model group had abnormal circadian rhythm and mental state, rough hair, dark hair color, irritability, turbid urine, and slow weight gain. In the elevated plus maze test, the number of open-arm entries and duration of residence of the mice in the model group were significantly reduced (P<0.05). In the open field test, the total distance covered by the model group was significantly reduced (P<0.05), and the time spent on activity in the central area was significantly shortened (P<0.05). The general state and nervous and anxiety-like behaviors of the mice were improved by YWASD. The sleep latency of the mice in the YWASD group was shortened while sleep time was prolonged (P<0.05). In the model group, the content of 5-HT in serum was obviously decreased while those of NE and DA were significantly increased (P<0.01), and the administration of YWASD could regulate the homeostasis of the three neurotransmitters. Compared with the control group, the expression of 5-HTR1A in the hypothalamus of the model group was largely decreased, and the expressions of 5-HTR1A in the middle- and high-dose groups of YWASD were significantly increased. YWASD had the same effect as the positive drug diazepam in terms of sedation and neurotransmitter. Conclusion YWASD has a good hypnotic effect on the model mice induced by PCPA combined with multiple-factor stimulation. In addition, YWASD can improve sleep quality by regulating the levels of neurotransmitters, manifested as reduced sleep latency and extended sleep duration. References | Related Articles | Metrics

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Improving DILI prediction methods based on defined daily dose HU Xiaowen, ZHANG Caiyu, WANG Fengfeng, PU Hengting, LIU Yang, CHEN Hua 2024, 21(7): 776-780.  DOI: 10.19803/j.1672-8629.20230409 Abstract ( 96 )   PDF (1531KB) ( 152 )   Objective To evaluate the impact of the defined daily dose on the performance of drug-induced liver injury (DILI) prediction models based on the support vector machine (SVM). Methods A total of 207 pieces of data on the structure and daily defined dose (DDD) were collected from public databases. The dataset was randomly split into a training set and a test set at the ratio of 4 : 1. Quantitative estimates of drug-likeness properties were extracted and the DDD was added as a new feature. The SVM was used to construct a DILI prediction model. Four metrics were used to evaluate the model performance. The dataset was randomly split 100 times to establish the predictive model, and the changes in the predictive performance of the model after DDD features were added were investigated. Results The prediction results of the SVM showed that most metrics were improved after DDD was added so that the mean accuracy, recall, precision and area under the receiver operating characteristic curve were 0.763, 0.773, 0.779 and 0.832, respectively, which were 0.088, 0.103, 0.074 and 0.105 higher than those without DDD, respectively. Conclusion The DDD can significantly improve the accuracy of the DILI prediction model. References | Related Articles | Metrics

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MCOLN1 ameliorates atherosclerosis by regulating lysosomal autophagy YUAN Zhexin, WANG Wenqing, HUANG Yifan, ZHANG Rongzhen, TANG Yucheng, ZHANG Linghan, ZHANG Haiying, LIU Yan 2024, 21(7): 781-786.  DOI: 10.19803/j.1672-8629.20240204 Abstract ( 82 )   PDF (2235KB) ( 207 )   Objective To assess the role of transient receptor potential channel mucolipin 1(MCOLN1) in the formation of aortic plaque in atherosclerotic mice and investigate the mechanism. Methods Wild-type C57BL/6 and ApoE-/- mice were divided into four groups: control, model, MCOLN1 overexpression, and overexpression negative control groups. An atherosclerosis model was established by feeding the mice with a high-fat diet. Oil red O and hematoxylin-eosin(HE) staining were used to determine the histopathological changes of the aorta. Western blot and immunofluorescence staining were used to detect the expressions of related proteins and autophagy markers, and evaluate the effect of MCOLN1 expressions on macrophage autophagy and atherosclerosis. Results Overexpression of MCOLN1 reduced aortic lipid accumulation, inhibited plaque formation, and attenuated the development of atherosclerosis. MCOLN1 improved lysosomal function, promoted macrophage autophagy, and inhibited cellular foaminess. Conclusion MCOLN1 has been found to decelerate the progression of atherosclerosis by promoting macrophage autophagy, which provides new potential drug targets for the prevention and treatment of atherosclerosis. References | Related Articles | Metrics

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Safety evaluation of haemocoagulase agkistrodon for injection in children based on real world data CHENG Yijing, LI Tao, LIU Junting, HUANG Guimin, ZHONG Xuli, LIN Aihua, PAN Shoudong, LI Long, BAI Dongsheng, ZHAN Xiaojun, LIU Zhenjiang, REN Wei, NIE Xiaolu, TAI Jun 2024, 21(7): 787-790.  DOI: 10.19803/j.1672-8629.20230298 Abstract ( 116 )   PDF (590KB) ( 175 )   Objective To evaluate the safety of haemocoagulase agkistrodon for injection in children by means of single-arm observational study in order to provide reference for the safe use and risk control of this drug. Methods A real world database on the use of pediatric drugs was constructed, and an automatic monitoring model of ADR was established using the AI mining technology of big data. Electronic medical records of hospitalized children who received haemocoagulase agkistrodon for injection in the Capital Institute of Pediatrics from February 25, 2014 to January 28, 2021 were monitored. Cases alarmed by the system were artificially evaluated and statistically analyzed so as to find out about the adverse drug reactions and analyze the risk factors for drug safety. Results A total of 35 720 patients were included in the study. Among children using haemocoagulase agkistrodon for injection, the incidence of such ADR as rash, vomiting, headache, and anaphylactic shock was 0.008％, 0.003％, 0.003％, 0.003％ in the real world, but no new ADR was observed. Prudent selection of the course of medication, modes of delivery and single administration doses could help reduce the incidence of ADR. Conclusion Haemocoagulase agkistrodon used in pediatric patients is relatively safe, with few ADR. Post-marketing safety evaluation of drugs for children, a special population, is of great significance. References | Related Articles | Metrics

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Clinical use of cinobufagin preparations in cancer patients ZHOU Xiuli, LIU Baosheng, MA Wenming, WANG Qi, WANG Yang, ZHAO Shipeng 2024, 21(7): 791-797.  DOI: 10.19803/j.1672-8629.20240298 Abstract ( 94 )   PDF (1565KB) ( 169 )   Objective To conduct a retrospective study of usage of cinobufagin preparations in hospitalized tumor patients in order to provide reference for rational use of cinobufagin. Method The PASSPharmaAssist system was used to retrieve data of patients from Weifang People’s Hospital who used cinobufagin preparations between 1 January, 2020 and 31 August, 2023. The demographic data, diagnostic information, and usage were statistically analyzed using Excel 2016 software. Results A total of 463 patients were enrolled, and 629 cases of the use of cinobufagin preparations. The survey found that among tumor patients, males [with an average age of (63.00 ± 9.70) years, accounting for (57.02%)] outnumbered females [with an average age of (59.11 ± 10.83) years, accounting for (42.98%)], with an average age of (61.31 ± 10.37) years. The top five types of cancers involved were lung cancer (44.45%), colorectal cancer (28.94%), gastric cancer (9.51%), esophageal cancer (4.10%), and liver cancer (3.02%), The dominating medication regimens involving cinobufagin were combined chemotherapy (36.57%). In addition, there were cases of combined use with immune checkpoint inhibitors, targeted drugs, analgesics and radiotherapy (230 cases). Among them, 77 cases (33.48%) had no ADR, 119 cases (51.74%) were general ADR and 34 cases (14.78%) were serious ADR. In clinical practice, there was excessive dosage, and the courses of medication were mostly less than 10 days. Conclusion Cinobufagin is primarily used in the treatment of lung cancer and gastrointestinal cancer, especially before and during chemotherapy. The clinical efficacy and mechanism of action remain to be verified and elucidated, and there is still a lack of consensus on the course of medication. It is necessary to be vigilant against cardiac toxicity caused by excessive doses. References | Related Articles | Metrics

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Impact of comparator selection on signal detection in adverse events following immunization in China XIA Lanfang, LI Keli, WANG Lei, LI Yan, WANG Huaqing 2024, 21(7): 798-804.  DOI: 10.19803/j.1672-8629.20240076 Abstract ( 75 )   PDF (1418KB) ( 173 )   Objective To investigate the impact of comparator selection on results of signal detection in order to contribute to signal detection in adverse events following immunization (AEFI) in China. Methods All the vaccines and specified vaccines selected were subject to signal detection using two control groups separately, one of which was composed of other types of vaccines, and the other consisted of vaccines of the same type. The number of signals detected using either control group was recorded. Numbers of the same signals, those of new signals and those of missed signals compared with the two control groups were calculated. Results The number of signals detected using all other vaccines on the same technical platform as control (n=501) was reduced compared with the control that used other different vaccines(n=254). Using other different vaccines of the same type as control, the percentage of new signals related to polysaccharide vaccines was the highest [24.39% (10/41)]. The AEFI category of new signals included common reactions(n=10), rare reactions(n=3) and coincidental events(n=2). Using other vaccines on the same technical platform as control, recombinant protein vaccines manifested the highest percentage of missed signals [94.92% (56/59)]. The AEFI category of missed signals included coincidental events(n=53), rare reactions(n=23) and common reactions(n=13). Using other vaccines on the same technical platform as control, the overall sensitivity decreased during detection of both common reactions and rare ones, but increased when it came to common reactions in live attenuated vaccines and polysaccharide vaccines. Overall specificity increased. Conclusion Significant variations are found in signal detection using all other vaccines as control and using all other vaccines of the same type as control respectively. Compared with signal detection using all other vaccines as control, the ability to detect common reactions is increased using all other vaccines of the same type as control. However, signals of rare reactions may be missed. The use of all other vaccines as control is recommended in order to detect rare reactions. References | Related Articles | Metrics

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Simple febrile seizures within 30 days of vaccination with the measles, mumps and rubella combined attenuated live vaccine in U-12 children in the real world LIU Yan, AN Jing, JIAO Yongzhuo, LIANG Xuefeng, ZHANG Xiaoshu 2024, 21(7): 805-810.  DOI: 10.19803/j.1672-8629.20240208 Abstract ( 70 )   PDF (1433KB) ( 138 )   Objective To analyze the way in which simple febrile seizures (SFS) occur within 30 days of vaccination with the measles, mumps and rubella combined attenuated live vaccine (MMR) in children under 12 in Gansu Province using the real-world data. Methods Cases diagnosed with “febrile seizures” were screened out from the electronic medical records of Gansu Province between 2021 to 2023. The patient identity information was used to match the vaccination information in Gansu Province Immunization Information System. An observational epidemiological approach was employed to analyze the characteristics of SFS after MMR. Results A total of 10 614 patients with SFS were included. The overall incidence of SFS in children under 12 was 92.42 per 100 000, with the highest incidence observed among children ages 12 to 24 months (297.67 per 100 000). The risk of SFS in males was higher than in females (RR= 1.61, P < 0.001). The risk of SFS increased within 30 days of MMR vaccination (RR= 2.66, P < 0.001). The incidence after the first dose (27.98 per 100 000) was higher than after the second dose (24.13 per 100 000). In children ages 12 to 24 months, the risk of SFS within 6 to 14 days after the first dose of MMR vaccine was higher than among those under 12 months, aged 25 months to 6 years (RR=4.06 and 2.64, respectively, both P < 0.001). Conclusion The risk of SFS within 6 to 14 days of MMR vaccination increases in children ages 12 to 24 months, so this age group is the most vulnerable. High-risk populations should be closely monitored. References | Related Articles | Metrics

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Adverse reaction reports of vancomycin in a hospital ZHAO Xuan, ZHENG Tingting, LI Xuemei, MAO Lu, GUO Jing, ZHANG Wei 2024, 21(7): 811-815.  DOI: 10.19803/j.1672-8629.20240311 Abstract ( 200 )   PDF (1339KB) ( 257 )   Objective To analyze the incidence of adverse drug reactions of vancomycin so as to provide reference for clinical safety warning, reduce the risk and ensure rational drug use. Methods Reports of adverse drug reactions by our hospital between 2017 and 2023 were collected and analyzed using Excel 2016. Results A total of 1 023 cases of adverse drug reactions were collected and reported in our hospital in the past 7 years Among these cases, 71 were caused by vancomycin, only one was determined as “serious”, and the rest were “mild”. Male patients outnumbered female ones, and the age of these patients mostly ranged from 18 to 65. In 81.69% of the cases, the daily dose was 2 g. The primary diseases included infections caused by fractures, artificial joint replacement, osteomyelitis, multiple injuries, skin injuries and burns. Nearly 45.07% of the patients with adverse drug reactions showed different reactions on the day of infusion, and 34.38% developed pruritus, rash, flushing, red man syndrome, headache, and stomach discomfort within 1h. The dominating adverse reaction after 7 days was hemopenia. Conclusion Vancomycin is the drug that has induced the largest number of adverse reactions in our hospital. The vulnerable gender and age group deserve more attention. The daily dose should be standardized and blood concentration should be monitored. Pharmacists should inform patients of possible adverse reactions and formulate targeted medication plans while nurses should closely monitor patients’ conditions during infusion. References | Related Articles | Metrics

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Two cases of allergic reactions in children caused by compound polyethylene glycol electrolyte powder ZHAO Jie, GAO Ming'e, CHANG Hong, FAN Huixia 2024, 21(7): 816-818.  DOI: 10.19803/j.1672-8629.20240336 Abstract ( 101 )   PDF (1170KB) ( 156 )   Objective To explore such adverse reactions as anaphylactic symptoms caused by polyethylene glycol electrolyte powder, and to provide reference for the study of the mechanism underlying allergies caused by polyethylene glycol electrolyte powder. Methods Two cases of allergic reactions in children of the same father and mother caused by polyethylene glycol electrolyte powder were analyzed. Tips for medication were given by searching the literature for similar cases. Results Two children developed allergic symptoms after taking polyethylene glycol electrolyte powder. Symptoms gradually disappeared after discontinuing the drug and giving anti-allergy treatment. Analysis of the causes and review of related literature showed that the adverse reaction in these two children were likely related to polyethylene glycol electrolyte powder. Conclusion Allergic reactions caused by compound polyethylene glycol electrolyte powder reported in this paper tend to run in families, which may be associated with specific gene loci, so the association with gene molecular biology needs to be investigated. There is a risk of allergic reactions when cotrimoxazole polyethylene glycol powder is used for intestinal cleansing prior to colonoscopy operations. Patients need to be reminded to avoid self-administration and to discontinue medication and seek immediate medical attention in case of discomfort. References | Related Articles | Metrics

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One case of hyponatremia induced by venlafaxine hydrochloride sustained-release capsules ZHANG Xian, QU Jianchang, ZHAO Qiang, XU Xin, MA Rui 2024, 21(7): 819-821.  DOI: 10.19803/j.1672-8629.20240146 Abstract ( 114 )   PDF (1201KB) ( 173 )   Objective To explore the adverse reactions and influencing factors of hyponatremia caused by venlafaxine and provide reference for safe clinical use of venlafaxine. Methods One case of hyponatremia caused by venlafaxine hydrochloride sustained-release capsules was analyzed and medications were recommended after related literature was reviewed. Results One patient who had been treated with venlafaxine for vestibular migraine for five years developed recurring hyponatremia. After discontinuation of venlafaxine and sodium supplementation therapy, the serum level of sodium gradually returned to normal, suggesting that venlafaxine had caused hyponatremia. Conclusion Venlafaxine is widely used in the treatment of depression. Doctors should be alert to the risk of hyponatremia caused by venlafaxine, have a good knowledge of the indications, contraindications, drug interactions and treatment courses of venlafaxine, and use this drug cautiously among such vulnerable populations as the elderly, females, those using diuretics, and those with a history of hyponatremia. Regular monitoring of electrolytes during medication, starting with small doses, early detection, and management of adverse drug reactions are essential to patients’ safety during medication. References | Related Articles | Metrics

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Research and development of novel p-21 activated kinase 4 inhibitors YAO Hailiang, DENG Meiyan, LI Xinyang, MENG Fanhao 2024, 21(7): 822-828.  DOI: 10.19803/j.1672-8629.20240194 Abstract ( 85 )   PDF (1383KB) ( 174 )   Objective To investigate the applications of p-21 activated kinase 4 (PAK4) inhibitors in tumor therapy in order to provide reference for the development of novel PAK4 inhibitors. Methods Small molecule PAK4 inhibitors were elaborated in terms of structural scaffold, eutectic structure, activity and pharmacokinetics. Results Among various structures of PAK4 inhibitors, the benzofuran inhibitor KPT-9274 exhibited significant inhibitory effects and had anti-tumor effects on various cancers. It was currently the only PAK4 inhibitor in clinical trials and could facilitate future design of PAK4 inhibitors. Conclusion Optimization of the structure of benzofuran compounds is expected to lead to better PAK4 inhibitors for tumor treatment. References | Related Articles | Metrics

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Pathogenesis and diagnosis of drug-induced thrombocytopenia NIE Xiaolu, MA Jingyao, SUN Feng, ZHAN Siyan 2024, 21(7): 829-835.  DOI: 10.19803/j.1672-8629.20240054 Abstract ( 177 )   PDF (1414KB) ( 266 )   Drug-Induced Thrombocytopenia (DITP) is the most common secondary thrombocytopenia in clinical practice. Based on the pathogenic mechanism, thrombocytopenia can be divided into two major categories: non-immune-mediated and drug-induced immune thrombocytopenia (DIIT). The latter is again classified into four categories based on different immune-mediated mechanisms. In addition to the classical pathway of drug-induced immune thrombocytopenia caused by drug-dependent platelet-reactive antibodies (DDAbs) binding to platelets, other categories include heparin-induced thrombocytopenia (HIT) and immune checkpoint inhibitors-induced thrombocytopenia(ICI-ITP). With the intensified development of vaccines and mass vaccinations following the global COVID-19 pandemic, a newly emerged category within DITP is vaccine-induced thrombotic thrombocytopenia (VITT). This article, in conjunction with related literature published in recent years, reviews the pathogenic characteristics and diagnosis of the aforementioned types of DITP, sorts out databases related to DITP and predicts the prospects of research. References | Related Articles | Metrics

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Methods for signal management using the global safety database VigiBase HJELMSTRÖM Peter, BOWRING Geoffrey, YUE Qun-Ying, NORÉN G. Niklas 2024, 21(7): 836-840.  DOI: 10.19803/j.1672-8629.20240373 Abstract ( 360 )   PDF (1584KB) ( 397 )   The WHO database of adverse event reports for medicines and vaccines, VigiBase, has been developed and maintained by UMC since 1978. VigiBase now holds over 39 million anonymised reports of suspected adverse effects of medicines and vaccines suffered by patients (as of June 2024). To support of members of the WHO Programme for International Drug Monitoring (WHO PIDM) in developing, implementing, and strengthening safety surveillance programmes, UMC has developed several systems, tools and methods to facilitate the use of VigiBase. This paper describes six such vigi Methods; vigiGrade, vigiMatch, vigiRank, vigiPoint, vigiGroup, vigiVec. VigiBase depends on unsolicited reporting of adverse drug effects and, regretfully, underreporting of adverse drug effects continues to be a major issue. Artificial intelligence methods for augmentation to increase efficiency, quality, and capability of case processing in the large databases such as VigiBase are evolving to meet the higher demands to manage the increasing volume of safety data. Continued development of existing and new methods to translate the information in the reports in VigiBase and other databases into valuable knowledge will be paramount for safer use of medicines and vaccines for patients in all countries globally. References | Related Articles | Metrics