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[摘要]
目的 对红花注射液在临床应用中的不良反应进行综合定量分析,以期为临床安全应用提供依据。方法 检索PubMed、Cochrane Library、中国期刊全文数据库(CNKI)、维普中文科技期刊全文数据库(VIP)和万方数据库中与红花注射液不良反应有关的文献,检索时间为建库至2017年11月30日。根据纳入标准以及排除标准筛选文献,用RevMan 5.3软件对提取数据进行Meta-分析。结果 共纳入25篇文献,Meta-分析结果显示,红花注射液组的不良反应发生率[OR=1.70,95%CI(1.19,2.42),P=0.003]明显高于对照组。体温中枢损害亚组[OR=7.90,95%CI(2.17,28.83),P=0.002]、5%葡萄糖注射液溶媒亚组[OR=2.05,95% CI (1.06,3.9),P<0.05]、用药疗程>14天亚组[OR=2.91,95%CI(1.34,6.30),P<0.05]、用药剂量 ≤ 20 mL亚组[OR=1.58,95%CI(1.02,2.43),P<0.05]、用药剂量>20 mL亚组[OR=1.91,95%CI(1.00,3.62),P=0.05]中,不良反应发生率均明显高于对照组,差异无统计学意义。结论 红花注射液不良反应发生率高于对照组,以发热、皮肤黏膜及胃肠道反应为主,不良反应发生与溶媒、剂量、疗程有一定关系,临床应用须密切关注。
[Key word]
[Abstract]
Objective To systematically review the incidence rate of adverse drug reaction for Honghua Injection and to assess the safety of the drug using meta-analysis and provide a basis for clinical applications.Methods Literature were searched and screened from the databases as PubMed, Cochrane Library, CNKI, VIP, Wanfang from database building to September 30th, 2017. Randomized controlled trials (RCTs) related to Honghua Injection according to the inclusion and exclusion criteria were included. RevMan 5.3 software was used to conduct meta-analysis for the rate of adverse reaction of Honghua Injection.Results A total of 25 articles were included in the study. The result of meta-analysis showed that the incidence rate of adverse reaction in Honghua Injection group was significant higher than that in the control group[OR=1.70, 95%CI (1.19, 2.42), P=0.003]. Body temperature center damage subgroup[OR=7.90, 95%CI (2.17, 28.83), P=0.002], 5% glucose injection vehicle subgroup[OR=2.05, 95%CI (1.06, 3.9), P < 0.05], medication course > 14 d subgroup[OR=2.91, 95%CI(1.34, 6.30), P < 0.05], doses ≤ 20 mL subgroup[OR=1.58, 95%CI (1.02, 2.43), P < 0.05], with the dose of > 20 mL subgroup[OR=1.91, 95%CI (1.00, 3.62), P=0.05], the incidence of adverse reactions of Honghua Injection was significantly higher than the control group, the difference was statistically significant.Conclusion The incidence rate of adverse reaction in Honghua Injection group was significantly higher than that in the control group, and the main adverse reactions were fever, skin mucous membrane, and gastrointestinal reactions. And there were relations between the adverse drug reaction and solvent, dose of drug, and administration time. In summary, the safety of Honghua Injection was lower than that of the control group, which needed to be paid attention to in clinical application.
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[基金项目]
中国药科大学药学基地科研训练及科研能力提高项目(J1310032);江苏省级大学生创新创业训练计划项目