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A comparative progress and prospect for drug technological guidances system in China SHA Mingquan, ZHANG Yawei, ZHOU Hongjie, WEN Baoshu 2022, 19(10): 1045-1049.  DOI: 10.19803/j.1672-8629.20220351 Abstract ( 334 )   PDF (1352KB) ( 330 )   Objective To provide some benefit references for being perfected to the Drug Technological Guidances System and promotes drug quality assurance mechanism. Methods By consulting regulations and literatures, the published drug technological guidances by National Medical Products Administration(NMPA), Food and Drug Administration (FDA) and European Medicines Agency (EMA) were compared, and the development status and practical experience of China's drug technical guidelines in recent years were reviewed. Results and Conclusion The countermeasures and suggestions for strengthening drug technological guidances system in china are put forward. References | Related Articles | Metrics

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The practice and consideration of pharmacovigilance during clinical trials in China CUI Huanhuan, PEI Xiaojing, LI Yanrong, LIU Wendong, WANG Haixue, LAN Gongtao, WANG Tao 2022, 19(10): 1050-1054.  DOI: 10.19803/j.1672-8629.20220242 Abstract ( 607 )   PDF (671KB) ( 564 )   Objective To compare the construction of pharmacovigilance between United States and European Union, especially on the monitoring and managing of the safety signal; to meditating the future development direction of pharmacovigilance of China during the clinical trial. Methods The organizational framework, law and regulation system, the concept and management of safety signal for the implementation of pharmacovigilance between United States and European Union were compared, combined with the implementation experience of relevant work in China, suggestions for improving the level of pharmacovigilance during clinical trials in China were put forward. Results and Conclusion The pharmacovigilance system of United States and European Union are relatively perfect, the monitoring of safety information and mechanism of risk management are relatively mature. The pharmacovigilance system of clinical trial of China has been basically in place. The advance foreign experience can be referenced and through strengthening the law and regulation and organization system, carrying out focusing monitoring to improve the level of informationization to improve the level of pharmacovigilance of clinical trial in China. References | Related Articles | Metrics

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Research and reflection on regulatory science developments of U.S. FDA SHA Mingquan, LI Nannan, XIA Wenjing, WEI Qun, WEN Baoshu 2022, 19(10): 1055-1059.  DOI: 10.19803/j.1672-8629.20220453 Abstract ( 292 )   PDF (1239KB) ( 282 )   Objective To introduce the regulatory developments of U.S. Food and Drug Administration (FDA), so as to provide reference for the drug regulation in China. Methods New initiatives and their latest progress in FDA are introduced by translation and research on related regulations and documents, and the correlation to the reform of drug review and approval in China is analyzed. Results and Conclusion According to the drug regulation in China, it is suggested that experiences of drug regulation from FDA should be overviewed and classified into regulatory methods and regulatory tools, providing methodological reference to regulators, so as to improve the quality and efficiency of drug regulation, as well as the internationalization of regulatory capacities. References | Related Articles | Metrics

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The TLC characteristic analysis of cattle bile and sheep bile based on RGB multichannel data of images SHI Yan, WEI Feng, MA Shuangcheng 2022, 19(10): 1060-1066.  DOI: 10.19803/j.1672-8629.20210403 Abstract ( 47 )   PDF (2395KB) ( 48 )   Objective To investigate the Thin-layer Chromatography (TLC) characteristic of cattle bile and sheep bile. Methods TLC method was developed with isooctane-ether-glacial acetic acid-n-butanol-water (6:5:5:3:1) as developer, 10% sulfuric acid ethyl alcohol solution as chromogenic reagent. After heating at 105 ℃ until spots marked, TLC was checked and stored as a image. Then RGB multichannel data of TLC image were extracted out and analyzed by Hierarchical Cluster Analysis (HCA), Principal Components Analysis (PCA) and Orthogonal Projections to Latent Structures - Discrimination Analysis (OPLS-DA). Results The data of channel of B had the most characteristic for the difference of cattle bile and sheep bile. In TLC, spots of glycocholic acid, glycidodeoxycholic acid and spot 4 (unknown) were markers for distinguishing cattle bile and sheep bile. Conclusion The TLC analysis method could be a reference due to its simplicity, sensitivity and accuracy compared with traditional TLC method. References | Related Articles | Metrics

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Quality evaluation and quality research of domestic hydroxyethyl starch 130/0.4 injection WANG Yue, SONG Yujuan, LIU Qian, ZHAO Xiangmei, DENG Lijuan, FAN Huihong 2022, 19(10): 1067-1072.  DOI: 10.19803/j.1672-8629.20220224 Abstract ( 115 )   PDF (1440KB) ( 100 )   Objective To evaluate the quality status and existing problems of domestic hydroxyethyl starch 130/0.4 injection, and provide a basis for the establishment and revision of national drug standards. Methods All of the samples by national sampling evaluation were tested, and the results were statistically analyzed. Exploratory research works were carried out on items such as molar degree of substitution, C2/C6 ratio, molecular weight and molecular weight distribution, and residual solvents. Results 146 batches of samples from 15 manufacturers were tested, and 6 batches were unqualified, the overall unqualified rate was 4.1%, and the unqualified items were the loading and visible particles. The exploratory study found that the relative molecular weight and its distribution, the molar substitution degree and the accuracy of the sodium chloride determination method in some registration standards should be revised. Conclusion At present, the quality of domestic hydroxyethyl starch 130/0.4 injection is just passable. Quality standards are numerous and varied. It is recommended to unify and improve the quality standards as soon as possible. References | Related Articles | Metrics

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Therapeutic effect and anti-inflammatory mechanism of Qihuang Yiqi Shexue Formula in ITP model mice LUO Yaqin, CAI Qiang, HUANG Wei 2022, 19(10): 1073-1077.  DOI: 10.19803/j.1672-8629.20210203 Abstract ( 71 )   PDF (1441KB) ( 61 )   Objective To explore the therapeutic effect and anti-inflammatory mechanism of Qihuang Yiqi Shexue Formula in immune thrombocytopenia (ITP) model mice. Methods Fifty BALB/c mice were randomly divided into the normal group, model group, high and low dose groups of Qihuang Yiqi Shexue Formula, and the prednisone group, with 10 mice in each. The intraperitoneal injection of guinea pig anti-mouse platelet serum (APS) was used to establish an ITP mouse model. On the 8th day after the injection of APS, each group was given intragastric administration for 14 consecutive days. The general condition of each group of mice was observed, changes in peripheral blood platelet count (PLT) and hemoglobin (Hb) concentrations were detected, and the Elisa method was used to detect serum levels of thrombopoietin (TPO), pro-inflammatory factor interleukin-2 (IL-2), IL-6, tumor necrosis factor-α(TNF-α), interferon-γ(IFN-γ), anti-inflammatory factor IL-4, IL-10, and transforming growth factor-β1 (TGF-β1). The spleen and thymus tissues were separated, weighed, and the organ index was calculated. The sternum was taken as a bone marrow smear, and the bone marrow megakaryocytes were classified under a microscope. Results Compared with the normal group, the levels of PLT, Hb, TPO, IL-4, IL-10 and TGF-β1 in the model group significantly decreased (P<0.05 or P<0.01), the number of megakaryocytes in the bone marrow plate became significantly smaller (P<0.01), and serum levels of IL-2, IL -6, TNF-α and IFN-γ were significantly decreased (P<0.05 or P<0.01). Compared with the model group, the levels of PLT, TPO, IL-4, IL-10, and TGF-β1in each administration group were significantly increased (P<0.05 or P<0.01), so was the number of megakaryocytes in the bone marrow plate (P<0.01) , but serum levels of IL-2, IL-6, TNF-α and IFN-γ were significantly decreased (P<0.05 or P<0.01). Compared with the low-dose group, the levels of PLT, IL-4 and TGF-β1 were significantly increased in the high dose group and the prednisone group, but TNF-α was significantly decreased (P <0.05 or P <0.01). There was no statistically significant difference in other indicators (P>0.05). Conclusion Qihuang Yiqi Shexue Formula is effective for ITP by regulating the unbalanced secretion of pro-inflammatory factors and anti-inflammatory factors in ITP model mice, increasing the levels of bone marrow-producing megakaryocytes and TPO. References | Related Articles | Metrics

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Antioxidant effect of Dendrobium devonianum polysaccharides on oxidative damage mice induced by D-galactose DONG Shoutang, ZHANG Xuqiang, WANG huaibin, CHAI Lianzhou, YANG Hongqin, HU Yan 2022, 19(10): 1078-1081.  DOI: 10.19803/j.1672-8629.20210196 Abstract ( 58 )   PDF (1374KB) ( 62 )   Objective To study the antioxidant effect of polysaccharides from Dendrobium devoninum on mice with oxidative damage induced by D-galactose. Methods Seventy-two mice were randomly divided into six groups: the control group, model group,vitamin C group, and high, medium, low dose groups of Dendrobium devonianum polysaccharides. Except the control group,mice in the other groups were injected with D-galactose 120 mg·kg-1·d-1 to establish a model of oxidative damage. For six weeks, the control group and model group were given normal saline of the equal volume by gavage, while the vitamin C group, high, medium and low dose groups of Dendrobium devonianum polysaccharides were treated with 100 mg·kg-1·d-1, 400 mg·kg-1·d-1, 200 mg·kg-1·d-1 and 100 mg·kg-1·d-1, respectively. One hour after the last administration,the activity of superoxide dismutase(SOD) and the contents of malondialdehyde (MDA),glutathione(GSH), and protein carbonyl in the serum and liver were detected. Results Compared with the model group, Dendrobium devonianum polysaccharides could significantly improve the activity of SOD and content of GSH, but decrease the contents of MDA and protein carbonyl in the serum and liver of mice with oxidative damage induced by D-galactose. Conclusion Dendrobium devonianum polysaccharides have antioxidant effect. References | Related Articles | Metrics

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Introduction and enlightenment of pharmacovigilance systems in South Korea ZHANG Yajuan, JIANG Yang 2022, 19(10): 1082-1086.  DOI: 10.19803/j.1672-8629.20210331 Abstract ( 287 )   PDF (1343KB) ( 347 )   Objective To analyze the current pharmacovigilance system policies in South Korea and give advice on the construction of pharmacovigilance systems in China. Methods By analyzing the organizational system, laws and regulations, and the monitoring and reporting system in South Korea, and comparing them with those in China, it was possible to provide reference for the construction of more effective pharmacovigilance systems in China by optimizing the functions of technical institutions for pharmacovigilance, improving the pharmacovigilance reporting system, and ensuring rational drug use. Results and Conclusion According to the newly revised pharmaceutical law, South Korea established the Institute of Drug Safety and Risk Management, improved the monitoring and reporting system of pharmacovigilance. China should optimize the functions of technical institutions for pharmacovigilance, improve the reporting system of pharmacovigilance, and assess the rationality of drug use. References | Related Articles | Metrics

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Influencing factors of quality risk management of drug recall in China SONG Mingyue, ZHANG Ran, WU Zhiang 2022, 19(10): 1087-1090.  DOI: 10.19803/j.1672-8629.20210304 Abstract ( 207 )   PDF (1254KB) ( 291 )   Objective To provide suggestions for improving the quality of defective drug recalls through the extraction and importance ranking of risk factors affecting the quality of drug recalls in China. Methods Factors affecting the quality of drug recalls in China are extracted, revised, and weighted guided by risk management theory, based on literature research, using Likert scale method and analytic hierarchy process. Results and Conclusion Constructing China's drug recall quality risk index system, combining the importance of drug recall risk elements, and putting forward recommendations to control the quality risk of China's drug recalls. References | Related Articles | Metrics

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Introduction and inspiration of international medical device regulators forum patient registry guidelines ZHAO Yifei, ZHAO Yan, DONG Fang, ZHENG Lijia, LI Dong, SONG Yana 2022, 19(10): 1091-1096.  DOI: 10.19803/j.1672-8629.20220194 Abstract ( 112 )   PDF (1429KB) ( 115 )   Objective To provide a reference for the implementation of medical device patient registry research in China by analyzing domestic and international practices and the technical guidelines of International Medical Device Regulators Forum(IMDRF). Methods The technical principles were understood by learning the guidelines of IMDRF, the foundation, operation, study questions and population coverage were known by studying the medical device patient registry practices of different countries. Results Medical device patient registry was an important positive surveillance method, and it could be an important supplement of medical device adverse event surveillance in our country, which would benefit different interested groups. Conclusion To assiste the post-market surveillance of medical device, the related cooperation of patient registry should be positively encouraged and established. References | Related Articles | Metrics

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Risk analysis of dextromethorphan abuse WANG Dan, WU Chen, REN Jingtian 2022, 19(10): 1097-1099.  DOI: 10.19803/j.1672-8629.20220376 Abstract ( 207 )   PDF (1161KB) ( 203 )   Objective To explore the risk of dextromethorphan abuse and provide basis for clinical rational drug use. Methods The occurrence and characteristics of dextromethorphan abuse cases in literature reports in CNKI and Wanfang from 1999 to 2020 and related drug safety databases were analyzed. The causes of dextromethorphan abuse and the measures taken by the regulatory authorities were discussed. Results and Conclusion Dextromethorphan preparations are at risk of abuse for non-medical purposes, including in the adolescent. The availability of over-the-counter drugs and improper self-medication can increase the risk of abuse. References | Related Articles | Metrics

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Cardiovascular safety of haloperidol preparations WU Chen, LIU Cuili, WANG Tao 2022, 19(10): 1100-1102.  DOI: 10.19803/j.1672-8629.20220137 Abstract ( 129 )   PDF (1187KB) ( 100 )   Objective To analyze the risk of haloperidol preparations so as to provide reference for clinical rational drug use. Methods The reports about adverse drug reactions (ADR) induced by haloperidol that were collected in China adverse drug reaction database from, January 1, 2004 to December 31, 2019 as well as those collected in domestic and foreign database from inception to May 31, 2020, and the relevant risk control measures for haloperidol issued by domestic and foreign drug regulatory agencies were retrieved and analyzed. Results A total of 13 936 reports of adverse drug reactions involving haloperidol preparations were received the China Adverse Drug Reaction Monitoring Database for suspected and concurrent use of drugs including 624 cases involving the cardiovascular system and 111 cases of serious adverse reactions. The risk of cardiovascular-related adverse reactions of haloperidol preparations was suggested by domestic and foreign literature reports. Conclusion It is recommended that regulatory authorities urge the drug marketing authorization holders to strengthen the monitoring and evaluation of adverse reactions of haloperidol preparations, revise product instructions in a timely manner, and promote the rational use of drugs by medical staff and patients. References | Related Articles | Metrics

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Total dosage of Chinese herbal pieces from changes of traditional Chinese medicine prescriptions LIU Tiantian, GONG Ying, GU Yuanyuan, HE Ting, ZHANG Zitong, CAO Junling 2022, 19(10): 1103-1106.  DOI: 10.19803/j.1672-8629.20210126 Abstract ( 110 )   PDF (1164KB) ( 123 )   Objective To analyze the problems with the total dose of clinical prescriptions and the effects of dosage forms, extraction technology and dose-effect relationships on the total dose of prescriptions so as to provide reference for clinical rational use of drugs. Methods The daily dosage and prescribed daily dosage of different dosage forms of Chinese patent medicines prepared according to 10 classic prescriptions of traditional Chinese medicines in Volume One of Pharmacopoeia of People's Republic of China (2020 edition) were compared and analyzed. The factors that influenced the dosage of Chinese patent medicines were discussed in terms of extraction methods and dose-response relationships. Results The daily dosage and prescribed daily dosage of classical prescriptions included in the Pharmacopoeia varied widely after the drugs were made into different dosage forms. The prescribed daily dosage was basically within 100 g, and the daily dosage was considerably different between different dosage forms of Chinese patent medicines. Further analysis showed that the solvent selected, solvent dosage, temperature and time for extraction, drug particle size and extraction methods all had effects on the dissolution and total dose of prescriptions. Conclusion The total prescription dose of traditional Chinese medicines is closely related to the curative effect and drug safety. It is of great significance for clinicians to formulate a unified prescription dose standard for traditional Chinese medicines. References | Related Articles | Metrics

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Adverse reactions of tumor immunotherapy drugs—PD-1/PD-L1 inhibitors CHEN Shuang, ZHENG Shufen, ZHANG Shuyao, ZHONG Shilong 2022, 19(10): 1107-1112.  DOI: 10.19803/j.1672-8629.20210124 Abstract ( 122 )   PDF (1295KB) ( 113 )   Objective To provide data for rational and safe use of ICI in clinical practice via a comparison of the adverse drug reactions (ADR) caused by four types of PD-1/PD-L1 inhibitors, whose imported immune checkpoint inhibitors (ICI) are marketed in China. Methods The data on PD-1/PD-L1 inhibitors collected between January 21, 2013 and September 30, 2020 was cleaned and summarized by the FDA Adverse Event Reporting System (FAERS) and OpenVigil platform. Signals of ADR were screened, counted and compared using the report odds ratio (ROR). Results A total of 44 220 ADR cases were reported (27 773 cases related to nivolumab, 12 424 cases to pembrolizumab, 2 875 cases to atezolizumab, and 1 148 cases to durvalumab). The ADR covered a wide range according to the system organ classification (SOC). Most of those ADR were immune-related adverse events (irAE), such as colitis, pneumonia, liver dysfunction, hyperthyroidism and type I diabetes. Deeper mining exposed other ADR that were not mentioned in the instructions, including cholangitis, muscle Inflammation, myocarditis, arthritis, neurological diseases (such as cerebral infarction), and cerebral edema. Conclusion The information about ADR of PD-1/PD-L1 has been updated. Most of these ADR are irAE, involving multiple organs and systems of the body, which could be fatal in some cases. It is recommended that medication regimens be optimized to reduce the health care cost and ADR. References | Related Articles | Metrics

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Detection of report signals of adverse drug reactions by fuzzy BCPNN LIU Jing, YE Guoju, WANG Qiming, LIU Wei, ZHAO Dafang, SUN Jun, LI Guoliang, WANG Xinmin, LI Ming 2022, 19(10): 1113-1117.  DOI: 10.19803/j.1672-8629.20210189 Abstract ( 160 )   PDF (1654KB) ( 125 )   Objective To fully tap the reports of adverse drug reactions and detect adverse drug reaction signals so as to provide reference for signal verification and clinical medications. Methods The fuzzy number was introduced to quantify the fuzzy semantic information in reports of adverse reactions. The fuzzy Bayesian confidence propagation neural network (FBCPNN) method was established to be compared with the Bayesian confidence propagation neural network(BCPNN) method in order to analyze the consistency. Finally, the results of signal detection of compound osteopeptide were analyzed. Results 11 454 signals of ADR reports provided by Jiangsu ADR Monitoring Center were detected using the FBCPNN method between January 1, 2014 and December 31, 2019, including 534 new signals (not in the manual). 10 915 signals were detected using the BCPNN method, including 545 new signals. Compared with the BCPNN method algorithm, the sensitivity, specificity and Youden index of this algorithm were 0.910 3, 0.976 6 and 0.886 9 respectively. Conclusion The FBCPNN method based on uncertain information can make full use of the uncertain information of adverse reaction reports and bring about effective detection of adverse reactions. References | Related Articles | Metrics

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Effect and safety of sacubatril/valsartan sodium in the treatment of hypertension: a Meta-analysis ZHENG Li, ZHANG Xuqian, SUN Xuelin, DING Huihua 2022, 19(10): 1118-1122.  DOI: 10.19803/j.1672-8629.20210154 Abstract ( 141 )   PDF (1564KB) ( 100 )   Objective To evaluate the difference in effect and safety of sacubitril/valsartan sodium and angiotensin receptor blockers (ARB) in the treatment of hypertension. Methods Data on randomized controlled trials (RCT) of sacubatril/valsartan sodium (test group) versus angiotensin II receptor antagonist (ARB) (control group) was retrieved from PubMed, Embase, Medline, Cochrane Library , CNKI, Wanfang Database published from inception to October 20, 2020. The quality of the included literature was evaluated using the bias risk assessment tool recommended by Cochrane System Reviewer Manual 5.2.2, and the RevMan 5.3 software was used for Meta analysis. Results Eight RCT were included, involving 4 313 patients. Compared with ARB, sacubatril/valsartan sodium could more effectively reduce systolic blood pressure (msSBP), diastolic blood pressure (msDBP), ambulatory systolic blood pressure (maSBP) and ambulatory diastolic blood pressure(maDBP). Sacubatril/valsartan sodium was basically as safe as ARB, but was more likely to cause cough. Conclusion sacubatril/valsartan sodium can significantly reduce blood pressure of patients with hypertension, but clinicians should be alert to any cough caused by this drug. References | Related Articles | Metrics

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Factors related to ADR/ADE of albumin bound paclitaxel WU Yingqi, ZHU Ting, TONG Tong, LI Min, SHEN Aizong 2022, 19(10): 1123-1127.  DOI: 10.19803/j.1672-8629.20210148 Abstract ( 164 )   PDF (1372KB) ( 135 )   Objective To find out about adverse drug reactions/events(ADR/ADE) caused by albumin-bound paclitaxel(ABP) in patients with gynecological tumors in our hospital and analyze the correlations between various influencing factors so as to provide reference for ensuring medication safety of patients. Methods The reports of ADR/ADE among patients who used ABP submitted by our hospital to the national adverse drug reactions monitoring system and the Chinese hospital pharmacovigilance system between January 1 and September 30, 2020 were retrieved and analyzed. Inpatients with gynecological cancer who had taken ABP and developed ADR in this period were selected as the subjects. The incidence of ADR/ADE was statistically analyzed. Results Eighty-five reports of ADR/ADE involving 43 patients were retrieved. The dominating disease was ovarian malignant tumor (73 cases, 85.88%). The results of correlation factor analysis showed that the incidence of ADR/ADE was not significantly correlated with the age of patients or with manufacturers. Body mass index (BMI) was of statistical significance for elevated transaminase (χ2=1.29, P=0.02), while dosage for the incidence of anemia (χ2=0.74, P=0.02). The combination of different chemotherapy drugs was correlated with the elevation of bone marrow inhibitors (χ2=1.09, P=0.03) and transaminase (χ2=0.00, P=0.01). There were 85 cases (100%) of off-label drug use, and 3 cases (3.53%) of improper doses. Conclusion Medical institutions should minimize off-label drug use, standardize medical records and review clinicians' instructions in earnest so as to prevent serious ADR/ADE and improve the life quality of patients. References | Related Articles | Metrics

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Assessment of usage of linezolid by a pediatric department based on weighted TOPSIS method HU Zhanghai, YANG Wanzhi 2022, 19(10): 1128-1131.  DOI: 10.19803/j.1672-8629.20210258 Abstract ( 95 )   PDF (1315KB) ( 70 )   Objective To establish a method based on the weighted technique for order preference by similarity to ideal solution(TOPSIS) method to assess the usage of linezolid by a pediatric department, and to provide reference for rational use of linezolid for pediatric patients. Methods Based on instructions about linezolid, expert consensus, related guidelines for diagnosis and treatment, and the TOPSIS method, explicit rules for assessment of the ways in which linezolid was prescribed by a pediatric department were established before the usage of linezolid among 57 pediatric patients in Anqing First People's Hospital between September 1, 2020 and March 31, 2021 was assessed. Results Among the 57 cases, the relative approach degree was 100% in two cases(3.51%), ranged from 80% to less than 100% in three cases (5.26%), from 60% to less than 80% in thirty-six cases (63.16%), from 50% to less than 60% in sixteen cases (28.07%), and was 60% or above in 41 cases (71.93%). Conclusion The weighted TOPSIS method can be used to assess the usage of linezolid among pediatric patients. The results of assessment suggest that linezolid has been properly used in our hospital, but the rational use can be standardized in terms of consultations, duration of medication, evaluation of efficacy and monitoring of drug adverse reactions. References | Related Articles | Metrics

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Adverse drug reactions of oral and lip numbness caused by mexiletine hydrochloride and precautions ZHANG Qingxia, XIAN Ying, DONG Yuexin, YAN Suying, YUE Qunying 2022, 19(10): 1132-1135.  DOI: 10.19803/j.1672-8629.20201246 Abstract ( 135 )   PDF (1140KB) ( 99 )   Objective To explore the causality, possible mechanism and influencing factors of such adverse events as oral and lip numbness associated with mexiletine so as to provide data for precautions. Methods Literature related to adverse events of oral and lip numbness caused by mexiletine were retrieved from such databases as Wanfang, CNKI, VIP, PubMed and VigiBase before being analyzed. The causality of single cases or a series of cases was explored. Results As of April 26, 2020, there were 10 cases of oral and lip numbness associated with mexiletine: 3 cases from online consultation, 3 cases from VigiBase, and 4 cases from literature. Causal analysis by Naranjo criteria delivered a causality score that supported causality between mexiletine and adverse reactions. The possible mechanism was that mexiletine was structurally similar to lidocaine, so it had a local anesthetic effect, which could cause oral and lip numbness. The onset time of oral and lip numbness ranged from shortly after administration to 5 days after administration, but the patients recovered after withdrawal. Routes of administration might play a role. Conclusion Mexiletine can cause oral and lip numbness, which is related to the local anesthetic effect. Therefore, oral preparations should be taken as a whole along with beverages or foods rather than being chewed to prevent adverse reactions. References | Related Articles | Metrics

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Effect evaluation of adverse drug reactions monitoring based on the Chinese hospital pharmacovigilance system BAI Hehe, NIE Xiaojing, XIA Li, MA Li, WANG Jinping, PENG Lirong 2022, 19(10): 1136-1139.  DOI: 10.19803/j.1672-8629.20210011 Abstract ( 266 )   PDF (1277KB) ( 282 )   Objective To study the role of the Chinese hospital pharmacovigilance system (CHPS) in the monitoring of adverse drug reactions (ADR) in medical institutions. Methods The ADR that occurred in our hospital between 2019 to 2020 were collected. The ADR reported in 2019 were assigned to the pre-operation group, while those reported in 2020 to the post-operation group based on the time the CHPS started to operate in China. The ADR reports before and after the operation of the CHPS were analyzed. The numbers, sources, types and quality of ADR reports as well as drugs and organ and systems involved were compared. Results Two hundred and sixty ADR reports were collected before the operation of the CHPS and 573 after that. The number of ADR reports increased by 120.38%. The proportion of reports by the medical staff increased from 13.08% to 36.30% (P<0.001). New/serious ADR reports increased by 363.16%. The proportion of serious ADR reports increased from 7.69% to 24.43% (P<0.001). The standardization of reports, completeness of drug information, timeliness of reports and the efficiency of reporting were significantly improved (P<0.001). Conclusion The CHPS can identify and monitor suspicious ADR, improve the quantity and quality of ADR reports, deliver risk signal warning, and provide technical support for the safety of hospital medications. References | Related Articles | Metrics

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One case of clinical and literature case analysis on tirofiban-induced thrombocytopenia WANG Yuan, WANG Pingping, GUO Guili, FENG Yingnan, MA Qingfeng 2022, 19(10): 1140-1144.  DOI: 10.19803/j.1672-8629.20210664 Abstract ( 143 )   PDF (1325KB) ( 126 )   Objective To explore the clinical characteristics of tirofiban-induced thrombocytopenia. Methods The diagnosis and treatment of a patient with thrombocytopenia induced by tirofiban were reported. The main clinical data of the case and relevant cases collected from PubMed, Sinomed, CNKI, and Wanfang database (as of 26 January, 2021) were summarized and analyzed. Results An acute ischemic stroke patient receiving thrombolysis combined with tirofiban was reported six hours after the application of tirofiban, the routine blood test showed thrombocytopenia. Tirofiban was discontinued and the platelet count returned to the normal range on the fourth day. A total of 13 patients were enrolled in the analysis, including 10 males and 3 females, with an average age of 60.4±12.4 years. There were 11 cases of acute coronary syndrome and 2 cases of acute ischemic stroke. 1 patient received intravenous recombinant tissue plasminogen activator combined with tirofiban, 2 patients were treated with tirofiban alone and 10 were treated with tirofiban combined with other antithrombotic drugs. The median time from the application of tirofiban to onset of thrombocytopenia was 6.0 (2.5, 22.3) hours. All the patients were defined as severe thrombocytopenia. After the onset of thrombocytopenia, tirofiban was discontinued in all the 13 patients. Of them, 1 case was improved with intravenous platelet transfusion, 2 cases received human immunoglobulin combined with platelet transfusion. With drug discontinuation, the platelet count returned to the normal range in about 5 days. Conclusion tirofiban‐related thrombocytopenia may occur in 6 hours after the first medication, which could be improved by drug withdrawal alone or combination with symptomatic treatments as appropriate. References | Related Articles | Metrics

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Research progress in influence of gender difference on drug therapy of common chronic diseases of the cardiovascular system JIANG Ruiqi, MEI Shenghui, ZHAO Zhigang 2022, 19(10): 1145-1148.  DOI: 10.19803/j.1672-8629.20210413 Abstract ( 67 )   PDF (1533KB) ( 88 )   Gender-related differences can make a difference to pathogenesis, pharmacokinetics, pharmacodynamics and drug treatment regimens, which is of great significance for prevention and treatment of diseases. Diseases of the circulatory system have become a major health issue that poses a threat to human health in the 21st century. Such databases as CNKI, Wangfang, VIP, PubMed and Web of Science were searched from January 1, 2010 to April 5, 2021. Gender differences in pharmacotherapy of common chronic diseases of the circulatory system (hypertension, chronic cardiac insufficiency, coronary heart disease and atrial fibrillation) were outlined in terms of pathogenesis, pharmacokinetics, pharmacodynamics, efficacy and the incidence of adverse reactions in order to provide reference for individualized medications and promote rational drug use. References | Related Articles | Metrics

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Clinical application of ursodeoxycholic acid SUN Xuelin, HU Xin, ZHANG Yatong 2022, 19(10): 1149-1153.  DOI: 10.19803/j.1672-8629.20210604 Abstract ( 158 )   PDF (1232KB) ( 135 )   Ursodeoxycholic acid is a natural hydrophilic bile acid derived from cholesterol, which can inhibit the reabsorption of cholesterol in the intestine and reduce the secretion of cholesterol into bile. Thereby reducing the saturation of cholesterol, it is mainly used clinically for the treatment of cholelithiasis, cholestatic liver disease, bile reflux gastritis, primary sclerosing cholangitis, etc. This article summarizes the clinical application of ursodeoxycholic acid and the recommendations of the guidelines, summarizes its application in diseases, adverse reactions and pharmaceutical monitoring, etc., and provides a reference for the reasonable clinical application of ursodeoxycholic acid. References | Related Articles | Metrics

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Research progress in Yi medicine Geranium strictipes Knuth and predictive analysis of quality markers XI Zhongwen, TIAN Yurou, FENG Yu, MA Jingmei, WANG Xinguo, NIU Liying 2022, 19(10): 1154-1159.  DOI: 10.19803/j.1672-8629.20210301 Abstract ( 57 )   PDF (1413KB) ( 46 )   As an ethnic medicine unique to Yunnan Province, Geranium strictipes Knuth has been long used in clinical medicine to treat blood in the stool, hemorrhoids, blood dysentery, uterine bleeding, water and fire burns, carbuncle and sore. It is widely used in people of the Yi nationality. Based on research on the chemical constituents and pharmacological effects of Geranium strictipes Knuth, predictive analysis is made of the Q-markers of this drug in terms of original plant phylogeny, specificity of chemical components, traditional efficacy and medicinal properties, new medicinal uses, and measurable chemical components in order to help clarify the quality markers of Geranium strictipes Knuth and establish workable quality control methods. References | Related Articles | Metrics

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Pharmacovigilance Newsletter 2022, 19(10): 1160-1160.  Abstract ( 368 )   PDF (905KB) ( 442 )   Related Articles | Metrics