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20 March 2019, Volume 16 Issue 3 Previous Issue    Next Issue

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Current Status of Pharmacovigilance Research Based on Administrative Claims Database SHEN Zhuojie, XU Jinfang, YE Xiaofei, JIA Zheyu, LIANG Jizhou, WANG Meng, GUO Xiaojing 2019, 16(3): 129-133.  Abstract ( 640 )   PDF (992KB) ( 497 )   ：With the continuous improvement of the administrative claims database, more and more researchers are using the data for drug safety research. Several main administrative claims database and applications based on these database, especially pharmacovigilance research, were introduced. Additionally, two relevant regulations for the use of administrative claims data for pharmacovigilance research are also briefly introduced. We expect that the above will do some help on the pharmacovigilance research based on the insurance database of China. References | Related Articles | Metrics

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Explore on Safety Evaluation Mode Based on Electronic Medical Records in China WANG Wen, TAN Jing, YU Chuan, WU Guizhi, XIONG Weiyi, DONG Duo, SUN Xin 2019, 16(3): 134-138.  Abstract ( 524 )   PDF (655KB) ( 321 )   Electronic medical records (EMRs) may represent an important data source for drug safety evaluation, and have received wide attention. However, the framework and approaches to use EMRs for drug safety evaluation have not been well established in Chinese setting. On the basis of empirical studies, we explored framework and methods for drug safety evaluation by using EMRs. Hopefully, this paper may offer a general guidance for rigorous production and appropriate use of real-world drug safety evidences based on the data from EMRs. References | Related Articles | Metrics

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Application of Bayesian Instrumental Variable in Active Surveillance Data of Adverse Drug Reactions:a Simulation Study WANG Meng, GUO Xiaojing, YE Xiaofei, XU Jinfang, HU Fangyuan, HE Jia 2019, 16(3): 139-143.  Abstract ( 417 )   PDF (853KB) ( 227 )   Objective To establish the model of Bayesian instrumental variable analysis in the active surveillance data of adverse drug reactions for controlling unmeasurable confounding and acquiring the accurate causal relation between the drug and adverse reaction. Methods Hamilton Markov Chain Monte Carlo method was used to perform data simulation and parameter estimation. Further, the established model was compared with traditional models on bias and accuracy to assess the performance of different methods. Results Bayesian instrumental variable analysis performed well and was the optimal method under the small sample, weak instrumental variable, strong unmeasurable confounding and rare treatments and outcomes. Conclusion Bayesian instrumental variable analysis could improve bias and accuracy compared with traditional instrumental variable methods in active surveillance data of adverse drug reactions. References | Related Articles | Metrics

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Interpretation of the Guidance for Reporting of Pharmacoepidemiology Studies Conducted Using Observational Routinely Collected Health Data: RECORD-PE Statement HU Fangyuan, YE Xiaofei, XU Jinfang, GUO Xiaojing, HE Jia 2019, 16(3): 144-148.  Abstract ( 430 )   PDF (679KB) ( 195 )   Routinely collected data plays more and more important role in pharmacoepidemiology studies. Current available guidance for routinely collected data is the REporting of studies Conducted using Observational Routinely collected health data(RECORD) statement based on Strengthing the Reporting of OBservational studies in Epidemiology(STROBE) statement, but the RECORD statement is not fully suitable for pharmacoepidemiology studies. This study interprets each of the new items of the RECORD-PE (RECORD for Pharmacoepidemiology research) statement extended from the RECORD statement using related examples. We hope this interpretation will give scholars a better understanding and use of the RECORD-PE statement. References | Related Articles | Metrics

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Retrospective Analysis of 346 Cases of Drug Eruptions WU Xiaofeng, LIN Zhen, Li Yang, Chang Hualei, SHI Tao 2019, 16(3): 149-153.  Abstract ( 535 )   PDF (691KB) ( 321 )   Objective To analyze the clinical characteristics and patterns of drug eruptions in a hospital to provide reference for prevention and standardized treatment of drug eruptions. Methods 346 cases of drug eruptions in the hospital from 2014 to 2017 were analyzed retrospectively in terms of age, sex, latency and duration of drug eruptions, sensitization drugs, drug eruption types, prognoses and so on. Results Among the 346 cases of drug eruptions, 187 were male (54.05%) and 159 were female (45.95%). The cases of drug eruptions were evenly distributed in all age groups. The shortest latency was 5 minutes, the longest was 28 days. The shortest duration was half an hour, and the longest duration was unknown for it had not improved. The main types of drug eruption were mild drug eruption in 334 cases (96.53%), including measles like eruption type, fixed type, mild erythema multiforme, urticaria type. Severe drug eruptions occurred in 12 cases (4.47%), including severe erythema multiformes and epidermolysis bullosas. The main antimicrobial agents causing drug eruptions were cephalosporins and quinolones. Conclusion Drug eruptions can occur in all age groups and the latencies and durations of drug eruptions were various. Allergenic drugs were mainly antibacterial drugs (35.43%). Majority drug eruptions were mild and curable, but severe drug eruptions that have not be timely diagnosed and treated can cause serious consequences and even be life-threatening. It is suggested that clinical attention should be paid to prevention of drug allergies. Rational selection of drugs, early detection, early diagnosis and timely standard treatment of drug eruptions must be done to avoid the occurrence of severe drug eruptions and reduce their harms. References | Related Articles | Metrics

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Literature Analysis of HLA-B*5801 Polymorphisms and Cutaneous Adverse Reactions Induced by Allopurinol PEI Yuan, WANG Rui, WANG Dandan, GUO Lina, WANG Bo, KANG Heyao 2019, 16(3): 154-156.  Abstract ( 445 )   PDF (660KB) ( 261 )   Objective To investigate the association between alleles of HLA-B*5801 and cutaneous adverse reactions induced by allopurinol, and predict potential adverse effects of allopurinol, so as to provide references for clinical safe and rational use of drugs. Methods Chinese Academic Journal (online), Wanfang Database, Chinese Science and Technology Journal Full-text Database (VIP), and PubMed databases were retrieved from March 2005 to May 2018, and then the documents of alleles of HLA-B*5801 and cutaneous adverse reactions(CAR) induced by allopurinol were collected for statistical analysis. Results A total of 46 literatures with 342 cutaneous adverse reactions patients were retrieved. There are 310 cases with positive allele of HLA-B*5801, with a positive rate of 90.64%. The males(188) are more than females(122) and the age distribution was 18~91 years old, especially 61~75 years old patients were more. Among the 310 patients with HLA-B*5801 positive allele, 256 cases were severe cutaneous adverse reactions (SCAR), accounting for 82.58%, and 54 cases were mild cutaneous adverse reactions, accounting for 17.42%. In addition, patients taking 100 mg allopurinol and taking it for 21~30 days had a higher incidence of adverse reactions. Conclusion There was strong association between alleles of HLA-B*5801 and cutaneous adverse reactions induced by allopurinol. In addition, gender, age, duration and dosage of medication were also influence factors of the adverse reactions. In clinical use of allopurinol, we should pay attention to these factors, and pharmaceutical care should be strengthened to avoid the occurrence of adverse reactions to ensure medication safety. References | Related Articles | Metrics

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Analysis of Adverse Drug Reaction Case Reports Induced by Cardiovascular Drugs Based on WHOART LIN Xin, GUO Jinjing, REN Huiling 2019, 16(3): 157-163.  Abstract ( 498 )   PDF (867KB) ( 231 )   Objective To analyze the occurrence of adverse drug reactions (ADRs) induced by cardiovascular drugs in China and the possible influencing factors of their severity. Methods 1 201 case records of ADRs induced by cardiovascular drugs were obtained from National Science Data Sharing Platform for Population and Health. Based on Martindale: the Complete Drug Reference and WHOART, the ADR symptoms were extracted and cleaned by Jieba. Other fields were normalized simultaneously, and the patients' genders, ages, routes of administration and so on in ADR records were statistically analyzed. Results In all records, male patients were slightly more than female patients and mostly aged 50~79 years; ADRs induced by intravenous administration were the most common and occurred within 10 minutes of administration; the main ADR symptoms were chest tightness. Traditional Chinese medicines were the most common drugs which induced ADRs, followed by anti-arrhythmic drugs. Most ADRs were mild and the route of administration had a significant effect on the severity of ADRs. Conclusion The method proposed in this study could effectively analyze the ADRs induced by cardiovascular drugs, and clinical medical staffs should strengthen the monitoring of ADRs induced by cardiovascular drugs, ensure rational clinical use and standardize the safety of cardiovascular drug use. References | Related Articles | Metrics

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105 Cases of Adverse Drug Reactions Indcued by Ibuprofen in Our Hosptial XU Shungui 2019, 16(3): 164-167.  Abstract ( 572 )   PDF (706KB) ( 347 )   Objective To investigate the occurrence of adverse reactions induced by ibuprofen in children in our hospital, so as to provide evidence for rational drug use in clinic. Methods 105 cases of adverse drug reactions in children treated with ibuprofen in our hospital from 2000 to 2018 were collected and analyzed according to sex, age, drugs, adverse reactions types and clinical manifestations. Results The adverse drug reactions of ibuprofen were related to dosage, course of treatment and combined use of drugs. Allergic reaction was the main clinical manifestation, and anaphylactic shock could occur. Conclusion Attention should be paid to the adverse drug reactions of ibuprofen in children, especially in children aged 0~6 years, and rational use of ibuprofen should be strictly in accordance with the labelling. References | Related Articles | Metrics

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Investigation and Suggestion on Labeling of 75 Instructions for Intravenous Infusion Anti-infective Drugs HU Xue, ZHANG Yueming, LIU Xin, ZHANG Yongkai 2019, 16(3): 168-170.  Abstract ( 357 )   PDF (669KB) ( 119 )   Objective To investigate the instructions of intravenous infusion anti-infective drugs so as to provide reference for reasonable use and standard management. Methods Collecting instructions of intravenous infusion anti-infective drugs in a hospital and then analyzing the labeling information including the media selection, preparation process, infusion rate (time), preparation liquid preservation, flushing and sensitive test, at last the labeling information and existing problems in the instructions of intravenous infusion anti-infective drugs were investigated. Results Of the 75 instructions for intravenous infusion anti-infective drugs, 60 were labeled with the solvent selection (95.24%), 58 were labeled with the preparation process(92.06%), 27 were labeled with the preparation(42.86%), 47 were labeled with infusion rate (time) (62.67%), 6 were labeled with flushing (8.00%) and 15 were labeled with sensitive test (48.39%). Conclusion The labeling of infusion rate (time), preparation solution preservation, administration course, flushing and sensitive test are seriously insufficient in 75 instructions for intravenous infusion anti-infective drugs. The revision and check of the instructions should be strengthened to standardize the instruction management. References | Related Articles | Metrics

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Analysis and Consideration on Risk of Bromhexine Hydrochloride Injection WANG Tao, WU Guizhi, DONG Duo 2019, 16(3): 171-173.  Abstract ( 483 )   PDF (676KB) ( 625 )   Objective To analyze the risk of bromhexine hydrochloride injections in China, so as to provide reference for clinical rational drug use. Methods The individual adverse drug reaction cases in WHO Vigilyze and China Adverse Drug Reaction Database, domestic literatures, and the domestic and foreign risk management measures were analyzed. Results The risk of serious allergic reaction and use of medicines in children should be concerned. Conclusion We should strengthen the clinical application monitoring of bromhexine hydrochloride injections, timely update the drug labeling and promote the rational application of medicine. References | Related Articles | Metrics

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Analysis of 93 Reports of Adverse Drug Reactions Induced by Edaravone Injection LIU Chen, CHU Yanqi, YAN Suying, JIN Chao, LIU Tong, XING Liqiu, ZHANG Xiao 2019, 16(3): 174-178.  Abstract ( 512 )   PDF (670KB) ( 235 )   Objective To analyze the adverse drug reactions (ADR) reports induced by edaravone injection,so as to provide reference for rational drug use. Methods Reports from Beijing Adverse Drug Reaction Monitoring Center about adverse drug reaction induced by edaravone from January 2012 to December 2016 were analyzed. Patients' age, gender, disease, primary diseases, medication regimen, occurrence time, systems involved and clinical manifestations, severity and prognosis were collected. Results A total of 93 cases of adverse drug reaction reports induced by edaravone were collected, in which 9 cases (9.68%) were serious adverse drug reactions. There were 49 cases of elderly patients, accounting for 52.69%. Clinical manifestations involved skin and appendages disorders, liver and biliary system disorders ,nervous system disorders. 67 cases(72.04%) happened from the day starting edaravone to the fifth day. 23 cases(24.73%) have off-label use in indication. 1 case(1.07%) have contraindication. 29 cases(31.18%) have overuse or underuse of edaravone. 3 cases(3.23%) have a longer treatment time than that indicated in the label. Conclusion Medication regimen should be made in accordance to indication and dosage in drug labels. Patients should be under close attention so that adverse drug reactions could be detected as soon as possible. Once adverse drug reaction occurred, strategies such as stopping the medication and treatment should be quickly undertaken. References | Related Articles | Metrics

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Study Progress of Norcantharidin Based Structural Modification and Drug Combination for Cancer LI Yiqun, SUN Zhenxiao 2019, 16(3): 179-184.  Abstract ( 375 )   PDF (836KB) ( 640 )   Norcantharidin (NCTD) is an anticancer drug developed in China. It has broad-spectrum anticancer activity and can increase the level of peripheral blood leukocytes. It is often used alone or in combination with other drugs to treat liver cancer, esophageal cancer, stomach cancer, lung cancer, etc. To improve the antitumor activity and reduce its possible adverse reaction, the structure modification and drug combination of NCTD have made some progress in recent years. This paper tried to summarize the latest progress in structure modification and anticancer screening of NCTD, basic research and clinical studies of NCTD combined with other anticancer drugs, providing reference data for NCTD based new drug development and clinical application. References | Related Articles | Metrics

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One Case of Seizure Induced by Voriconazole for Injection SHAO Heng, YUAN Hongzhong, JIANG Junjie 2019, 16(3): 185-185.  Abstract ( 371 )   PDF (523KB) ( 164 )   References | Related Articles | Metrics

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One Case of Severe Attack of Asthma Induced by Diclophenac Sodium TONG Huan, GUO Junfang 2019, 16(3): 186-187.  Abstract ( 412 )   PDF (578KB) ( 262 )   References | Related Articles | Metrics

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One Cases of Photosensitization Induced by Fenofibrate Capsules DONG Shasha, LI Haifeng, ZHANG Lin, WANG wanxiong, FANG Liping 2019, 16(3): 188-188.  Abstract ( 428 )   PDF (522KB) ( 414 )   References | Related Articles | Metrics

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One Case of Severe Liver Injury Induced by Cefotaxime Sodium and Sulbactam Sodium for Injection GUO Tingting 2019, 16(3): 189-190.  Abstract ( 450 )   PDF (541KB) ( 195 )   References | Related Articles | Metrics

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One Case of Pulmonary Interstitial Edema and Edema of Lower Extremities Induced by Sucrose Iron Injection LI Hongmei, SI Junling, WANG Yanmin 2019, 16(3): 191-192.  Abstract ( 345 )   PDF (543KB) ( 292 )   References | Related Articles | Metrics