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[摘要]
目的 以利巴韋林為對照藥,系統評價金蓮清熱泡騰片治療小兒急性上呼吸道感染的有效性和安全性。方法 計算機檢索中國期刊全文數據庫(CNKI)、中國生物醫(yī)學文獻數據庫(CBM)、萬方數據庫、中文科技期刊全文數據庫(VIP)、PubMed、EMbase、Cochrane Library有關金蓮清熱泡騰片治療小兒急性上呼吸道感染的隨機對照試驗和半隨機對照試驗,檢索時限均為從建庫至2016年12月,采用RevMan 5.3軟件進行Meta分析。結果 共納入7項研究,入選782例患者,其中金蓮清熱泡騰片組392例,利巴韋林組390例。Meta分析結果顯示:金蓮清熱泡騰片在疾病總有效率[RR=1.26,95% CI=(1.18,1.34),P<0.000 01]、縮短熱程[MD=-1.54,95% CI=(-1.79,-1.30),P<0.000 01]、咳嗽消失時間[MD=-1.53,95% CI=(-1.79,-1.27),P<0.000 01]、咽痛消失時間[MD=-1.29,95% CI=(-1.88,-0.70),P<0.000 1]和咽充血消失時間[MD=-2.80,95% CI=(-3.11,-2.49),P<0.000 01]方面均優(yōu)于利巴韋林組,差異有統計學意義。金蓮清熱泡騰片組有3例出現輕度腹瀉。結論 金蓮清熱泡騰片治療小兒急性上呼吸道感染臨床應用安全,在疾病總有效率、縮短熱程和單項癥狀消失時間等方面均較好于利巴韋林。但由于納入研究的局限,上述結論仍需設計嚴謹、大樣本的隨機對照臨床試驗加以驗證。
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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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