炎琥宁注射液不良反应的Meta分析

发布时间：2018-04-06 03:35

  本文选题：炎琥宁注射液　切入点：不良反应　出处：《郑州大学》2017年硕士论文

【摘要】：研究目的本研究课题对炎琥宁注射液不良反应的相关文献进行Meta分析,评价其临床应用的安全性,以期为临床用药提供参考。研究方法由两位研究人员独立用CNKI、WanFang Data、VIP、CBM、PubMed、MEDLINE、Web of Science、ClinicalTrials.gov等数据库,对2000年1月至2016年12月国内外公开发表的与炎琥宁注射液不良反应相关的临床研究文献进行检索。制定文献纳入和排除标准,采用文献管理软件NoteExpress 3.0对文献进行整理和筛选,利用办公软件Excel 2010建立数据库,提取纳入研究文献中的数据资料。按照Cochrane协作网推荐的偏倚风险评价工具对纳入研究的文献质量进行评价。然后采用RevMan5.3软件,对注射用炎琥宁的不良反应进行Meta分析。通过Q检验法和I2统计量对不同研究间的异质性进行检验。同时按不同年龄段、不同疗程和不同对照措施分别对注射用炎琥宁的不良反应进行亚组分析。研究结果最后符合纳入标准的文献共50篇。Meta分析结果显示:纳入研究的注射用炎琥宁患者(试验组)共4090例,发生不良反应128例。纳入研究的对照组患者(使用其他药物)共3790例,发生不良反应288例。试验组与对照组的不良反应发生的风险比RR为0.48,95%置信区间为(0.34,0.69),两组结果之间有统计学意义(P0.0001)。亚组分析结果显示:⑴不同年龄段亚组:患者年龄小于14岁亚组中,炎琥宁注射液不良反应发生的风险显著低于对照组(P=0.0001)。炎琥宁注射液在儿科(≤14岁儿童)使用比例较高。⑵不同疗程亚组:用药疗程小于等于5天亚组(P=0.001)和大于5天亚组(P=0.01)中炎琥宁注射液不良反应发生的风险均显著低于对照组。⑶不同对照措施亚组:利巴韦林亚组(P=0.002)和α-干扰素亚组(P0.00001)中炎琥宁注射液不良反应发生的风险显著低于对照组。对炎琥宁注射液不良反应的临床表现进行统计分析,结果显示其临床症状以过敏反应和消化道反应为主。研究结论炎琥宁注射液与利巴韦林(P=0.002)、α-干扰素(P0.00001)相比,不良反应发生风险低且差异均有统计学意义。炎琥宁注射液在临床使用过程中的不良反应症状主要表现为皮疹、皮肤瘙痒、恶心、呕吐、腹痛、腹泻等,这些不良反应的发生可能与炎琥宁注射液的用药对象、用药疗程长短及是否严格按照药品说明书适应症用药等因素有关。
[Abstract]:Objective to evaluate the safety of Yanhuning injection by Meta analysis in order to provide reference for clinical use.Methods from January 2000 to December 2016, two researchers used the database CNKI Wan Fang data VIPP CBMN MEDLINEN Web of Science and Technology Clinical Trials.gov independently to search the clinical literatures published at home and abroad from January 2000 to December 2016, which were related to adverse reactions of Yanhuning injection.The standard of literature inclusion and exclusion was established, and the document management software NoteExpress 3.0 was used to sort and screen the documents. The database was established by using the office software Excel 2010, and the data materials which were included in the research documents were extracted.The quality of literature included in the study was evaluated according to the bias risk assessment tool recommended by Cochrane Cooperative Network.RevMan5.3 software was used to analyze the adverse reactions of Yanhuning for injection by Meta.The heterogeneity of different studies was tested by Q test and I 2 statistics.At the same time, the adverse reactions of Yanhuning for injection were analyzed according to different ages, different courses of treatment and different control measures.Results A total of 50 articles were included in the study. Meta-analysis showed that 4090 patients (trial group) with Yanhuning for injection were included in the study, and 128 patients had adverse reactions.A total of 3790 patients (using other drugs) in the study group had adverse reactions.The risk ratio of adverse reactions in the trial group and the control group was 0.48 卤95% confidence interval (CI = 0.34 0. 69), and there was statistical significance between the two groups (P 0.0001).The results of subgroup analysis showed that the risk of adverse reaction of Yanhuning injection was significantly lower than that of control group (P < 0.0001).The risk of adverse reactions of Yanhuning injection in paediatrics (鈮，

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