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作 者:王冰 冯亚楠 刘欣欣 赵俐 WANG Bing;FENG Yanan;LIU Xinxin;ZHAO Li(Center for Drug Monitoring and Evaluation of Hebei,Shijiazhuang,Hebei,China 050090)
机构地区:[1]河北省药品监测评价中心,河北石家庄050090
出 处:《中国药业》2021年第21期92-98,共7页China Pharmaceuticals
基 金:河北省市场监督管理局科研计划项目[2021YJ15]。
摘 要:目的系统评价双黄连注射剂治疗呼吸道感染的有效性和安全性。方法采用计算机检索PubMed、中国知网和维普数据库,收集双黄连注射剂治疗呼吸道感染的随机对照试验(RCT),检索时限为自建库起至2020年8月。由2名研究人员独立筛选文献,按Cochrane 5.1.0手册推荐的RCT偏倚风险评价工具评价纳入研究的偏倚风险,采用RevMan 5.3软件进行Meta分析。结果共纳入21个RCT,涉及患者3 197例。单用双黄连注射剂治疗呼吸道感染的总有效率显著优于单用对照药品[RR=1.13,95%CI(1.07,1.19), P <0.000 01],双黄连注射剂联合对照药品治疗呼吸道感染的总有效率显著优于单用对照药品[RR=1.16,95%CI(1.08,1.24), P <0.000 1];双黄连注射剂治疗呼吸道感染的退热时间显著短于对照药品[MD=-0.92,95%CI(-1.08,-0.77), P <0.000 01];单用双黄连注射剂治疗呼吸道感染的药品不良反应发生率显著高于对照药品[RR=6.05,95%CI(2.94,12.46), P <0.000 01],以5%葡萄糖注射液为溶剂的双黄连注射剂治疗呼吸道感染的药品不良反应发生率显著高于对照药品[RR=4.94,95%CI(2.15,11.39), P=0.000 2]。结论双黄连注射剂治疗呼吸道感染的有效性优于常规治疗方法,但应密切关注其不良反应。Objective To systematically review the efficacy and safety of Shuanghuanglian Injection in the treatment of respiratory infections.Methods The databases of PubMed,CNKI,and VIP were searched to collect randomized controlled trials(RCTs)of Shuanghuanglian Injection in the treatment of respiratory infections from the inception to August 2020.The studies were independently screened by two researchers.The bias risk of the included studies was evaluated according to the RCT bias risk evaluation tool recommended in the Cochrane reviewers’handbook 5.1.0,and the Meta-analysis was conducted by the Rev Man 5.3 software.Results A total of 21 RCTs and 3197 patients were included.The total effective rate of Shuanghuanglian Injection alone in the treatment of respiratory infections was significantly better than that of the control drug alone[RR=1.13,95%CI(1.07,1.19),P<0.00001].The total effective rate of Shuanghuanglian Injection combined with the control drug in the treatment of respiratory infections was significantly better than that of the control drug alone[RR=1.16,95%CI(1.08,1.24),P<0.0001].The antipyretic time of Shuanghuanglian Injection in the treatment of respiratory infection was significantly shorter than that of the control drug[MD=-0.92,95%CI(-1.08,-0.77),P<0.00001].The incidence of adverse reactions induced by Shuanghuanglian Injection alone in the treatment of respiratory infections was significantly higher than that induced by the control drug[RR=6.05,95%CI(2.94,12.46),P<0.00001].The incidence of adverse reactions induced by Shuanghuanglian Injection with 5%Glucose Injection as the solvent in the treatment of respiratory infections was significantly higher than that induced by the control drug[RR=4.94,95%CI(2.15,11.39),P=0.0002].Conclusion The efficacy of Shuanghuanglian Injection in the treatment of respiratory infection is better than the conventional treatment methods.However,we should pay close attention to its adverse reactions.
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