喜炎平与利巴韦林治疗小儿手足口病疗效和安全性的系统评价

Evaluation and Meta Analysis of Xiyanping and Ribavir in Treatment of Hand-Foot-and-Mouth Disease

摘要:

目的：从循证医学的角度系统评价喜炎平与利巴韦林治疗小儿手足口病的疗效和安全性。方法：通过全面检索喜炎平与利巴韦林治疗小儿手足口病相关的随机对照研究文献，进行质量评价，纳入合格文献进行Meta分析。结果：10个随机对照实验纳入系统评价，均为Jadad评分≥3分的研究。Meta分析结果显示喜炎平联合常规治疗在整体临床症状、退热、皮疹和口腔疱疹消退时间等方面均优于使用利巴韦林。整体临床疗效比较OR值为3.01，95%可信区间为2.41，4.23；退热、皮疹消退、口腔疱疹消退时间比较分别为[WMD=-0.85，95%CI（-0.99，-0.71），P<0.000 01]，[WMD=-1.65，95%CI（-1.82，-1.47），P<0.000 01]和[WMD=-0.87，95%CI（-1.03，-0.71），P<0.000 01]，不良反应发生率对比OR值为0.39，95%可信区间为0.19，0.78。结论：喜炎平联合常规治疗用于小儿手足口病可能取得较利巴韦林联合常规治疗更好的效果且安全性良好，但由于纳入的研究方法学质量不高，尚需更多设计合理的高质量临床试验加以验证。

Abstract:

Objective: To systematically appraise the effect and the safety of Xiyanping and Ribavirin in treatment of hand-foot-and-mouth disease (HFMD). Method: To search the reports about randomized controlled trials of Xiyanping, and evaluate the researching quality. Then the Meta analysis will be carried out for those reports satisfying some criteria. Result: 10 randomized controlled trials, which were equal or excess than 3 Jadad scores, were included into the systematic review. A Meta-analysis showed that the combination of Xiyanping and routine treatment had better efficacy on both overall clinical manifestations and diadynamic criteria than the Ribavirin monotherapy. The odds ratio (OR) and 95% confidence interval (95% CI) from the comparison of the improvement on overall clinical manifestations were 3.01 and 2.41-4.23 respectively. The results of improving levels of fever clearance time, deflorescence time and oral herpes subside time were the following:WMD=-0.85, 95%CI (from-0.99 to-0.71), P<0.000 01;WMD=-1.65, 95%CI (from-1.82 to-1.47), P<0.000 01 and WMD=-0.87, 95%CI (from-1.03 to-0.71), P<0.000 01, respectively. The OR and 95% CI of comparison of the incidence of ADR were 0.39 and 0.19-0.78 respectively. Conclusion: The combination of Xiyanping and routine treatment may have better effectiveness and safety for HFMD than the Ribavirin treatment had. Nevertheless, because of the unclear methodological quality of the included studies, the results of our Meta-analysis may possibly be of much bias. Further well-designed clinical studies are required for the evaluation of Xiyanping for the treatment of HFMD.