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目的:系统评价热毒宁注射液治疗手足口病的临床疗效及安全性,为临床治疗提供循证参考。方法:采用Cochrane系统评价方法,全面检索Cochrane Library,CBM,CNKI,Wanfang等数据库,查找热毒宁注射液治疗手足口病相关的随机对照试验(RCT),采用Rev Man 5.2软件进行Meta分析。结果:共24项随机对照研究符合纳入标准,其中热毒宁VS利巴韦林17项,合计2 412例患者,热毒宁联合利巴韦林VS利巴韦林7项,合计891例患者。Meta分析结果显示,与利巴韦林相比,热毒宁治疗手足口病的临床总有效率更高[OR=4.71,95%CI(3.46,6.42),P<0.000 01],退热时间[WMD=-1.20,95%CI(-1.44,-0.95),P<0.000 01],皮疹消退时间[WMD=-1.51,95%CI(-1.95,-1.07),P<0.000 01],口腔疱疹或溃疡消退时间[WMD=-1.36,95%CI(-1.76,-0.97),P<0.000 01],平均住院时间[WMD=-2.81,95%CI(-3.79,-1.82),P<0.000 01]均短于利巴韦林,差异均具有统计学意义。与利巴韦林单药治疗相比,热毒宁与利巴韦林联合用药在临床总有效率[OR=5.48,95%CI(3.06,9.80),P<0.000 01],退热时间[WMD=-1.70,95%CI(-2.05,-1.35),P<0.000 01],皮疹消退时间[WMD=-1.91,95%CI(-2.99,-0.83),P<0.000 01],口腔疱疹或溃疡消退时间[WMD=-1.81,95%CI(-2.09,-1.53),P<0.000 01],平均住院时间[WMD=-2.32,95%CI(-3.59,-1.05),P=0.000 3]更有优势,差异均具有统计学意义。纳入的24项研究中热毒宁的不良反应较利巴韦林表现轻微,使用更为安全。结论:当前证据表明热毒宁联用利巴韦林与单用热毒宁治疗手足口病的疗效优于单用利巴韦林,且安全性良好。但由于纳入的研究质量有限,尚需设计更多大样本、高质量的临床试验进一步验证。
Objective: To systematically evaluate the clinical efficacy and safety of Rendunning injection in the treatment of hand-foot-mouth disease and provide evidence-based reference for clinical treatment. Methods: Cochrane Library, CBM, CNKI, Wanfang and other databases were searched by Cochrane systematic review method. Randomized controlled trials (RTTs) related to Rendanen injection in the treatment of hand, foot and mouth disease were searched and analyzed by Rev Man 5.2 software. Results: A total of 24 RCTs met the inclusion criteria, of which 17 were VSR ribavirin, a total of 2 412 patients were treated with rebenstim and ribavirin VS ribavirin, with a total of 891 patients . Meta-analysis showed that compared with ribavirin, the clinical efficacy of Re toxin in the treatment of HFMD was higher (OR = 4.71, 95% CI 3.46, 6.42, P <0.000 01) WMD = -1.20, 95% CI (-1.44, -0.95), P <0.000 01], rash regression time [WMD = -1.51,95% CI -1.95, -1.07, P <0.000 01] Or ulcer regression [WMD = -1.36,95% CI -1.76, -0.97, P <0.000 01], mean length of stay [WMD = -2.81,95% CI -3.79, -1.82, P <0.000 01] were shorter than ribavirin, the differences were statistically significant. In combination with ribavirin monotherapy, the combination of Revinquine and ribavirin had a clinically relevant overall effect [OR = 5.48, 95% CI (3.06, 9.80), p <0.000 01], fever regimen WMD = -1.70, 95% CI (-2.05, -1.35), P <0.000 01], rash regression time [WMD = -1.91,95% CI (-2.99, -0.83), P <0.000 01] Or ulcer regression [WMD = -1.81,95% CI -2.09 -1.53, P <0.000 01], mean length of stay [WMD = -2.32,95% CI -3.59 -1.05), P 0.000 3] have more advantages, the differences were statistically significant. Among the 24 studies included in the study, adverse reactions were slightly less toxic and more safe to use than ribavirin. CONCLUSIONS: Current evidence suggests that the combination of Reverinara with ribavirin alone and Tretinoin is superior to ribavirin alone in the treatment of HFMD and is safe. However, due to the limited quality of the studies involved, more large samples need to be designed and further validated by high-quality clinical trials.