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目的 以利巴韦林为对照药,系统评价金莲清热泡腾片治疗小儿急性上呼吸道感染的有效性和安全性。方法 计算机检索中国期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、万方数据库、中文科技期刊全文数据库(VIP)、PubMed、EMbase、Cochrane Library有关金莲清热泡腾片治疗小儿急性上呼吸道感染的随机对照试验和半随机对照试验,检索时限均为从建库至2016年12月,采用RevMan 5.3软件进行Meta分析。结果 共纳入7项研究,入选782例患者,其中金莲清热泡腾片组392例,利巴韦林组390例。Meta分析结果显示:金莲清热泡腾片在疾病总有效率[RR=1.26,95% CI=(1.18,1.34),P<0.000 01]、缩短热程[MD=-1.54,95% CI=(-1.79,-1.30),P<0.000 01]、咳嗽消失时间[MD=-1.53,95% CI=(-1.79,-1.27),P<0.000 01]、咽痛消失时间[MD=-1.29,95% CI=(-1.88,-0.70),P<0.000 1]和咽充血消失时间[MD=-2.80,95% CI=(-3.11,-2.49),P<0.000 01]方面均优于利巴韦林组,差异有统计学意义。金莲清热泡腾片组有3例出现轻度腹泻。结论 金莲清热泡腾片治疗小儿急性上呼吸道感染临床应用安全,在疾病总有效率、缩短热程和单项症状消失时间等方面均较好于利巴韦林。但由于纳入研究的局限,上述结论仍需设计严谨、大样本的随机对照临床试验加以验证。
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[Abstract]
Objective To systematically review the efficacy and safety of Jinlian Qingre Effervescent Tablet (JQET) compared to Ribavirin for acute upper respiratory tract infection in children. Methods CNKI, CBM, WanFang Data, VIP, PubMed, EM base, Web of science, and Cochrane Library databases were searched from the date of establishment to December 2016 for all randomized controlled trials (RCTs) and quasi-RCT on the use of JQET in children with acute respiratory infections. Meta-analysis by using Rev Man 5.3. Results A total of seven RCTs involving 782 patients were included, while the group of JQET involving 392 patients, Ribavirin involving 390 patients. The results of meta-analysis indicated that the efficacy in Jinlianqingre group was superior to that of Ribavirin control group, such as clinical effectiveness[RR=1.26, 95%CI=(1.18, 1.34), P<0.000 01], fever subsidence time[MD=-1.54, 95%CI(-1.79, -1.30), P<0.000 01], the time of subsided cough[MD=-1.53, 95%CI(-1.79, -1.27), P<0.000 01], the disappearance time of pharyngalgia[MD=-1.29, 95%CI(-1.88, -0.70), P<0.000 1], and Pharyngeal congestion disappearance time[MD=-2.80, 95%CI(-3.11, -2.49), P<0.000 01]. The difference was statistically significant. There were three adverse reactions reported in JQET group. Conclusion JQET is superior to the Ribavirin control group in clinical effectiveness, fever subsidence time, time of subsided cough, disappearance time of pharyngalgia, and pharyngeal congestion disappearance time to treat acute upper respiratory tract infection in children. However, these results should be carefully interpreted, and this conclusion has to be further verified by high quality, large scale RCTs.
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