化风丹联合基础方案治疗中风有效性和安全性Meta分析

Efficacy and Safety of Huafeng Dan Combined with Basic Therapy in the Treatment of Stroke:A Meta-Analysis

目的评价化风丹联合基础方案(包括西医疗法、针刺等)治疗中风的有效性和安全性。方法计算机检索中国期刊全文数据库、万方数据库、维普期刊全文数据库,以及PubMed,Web of Science,The Cochrane Library数据库,检索时限为各数据库自建库起至2021年8月23日。收集化风丹治疗中风的随机对照试验(RCT),提取资料,采用Cochrane偏倚风险评估工具评估文献质量,采用Rev Man 5.3统计学软件进行Meta分析。采用倒漏斗图分析潜在的文献发表偏倚,采用单研究逐次排除法进行敏感性分析检验,采用GRADE系统进行证据分级。结果最终纳入5篇文献,共392例患者。试验组总有效率显著高于对照组[RR=1.16,95%CI(1.07,1.27),P=0.0006],神经功能分级显著优于对照组[RR=1.64,95%CI(1.26,2.12),P=0.0002],不良反应发生率与对照组无显著差异[RR=1.08,95%CI(0.49,2.38),P=0.86]。上述3个指标的倒漏斗图中,仅不良反应发生率显示可能存在发表偏倚,各文献敏感性均较低,稳健性较高,证据等级均为低质量或极低质量。结论化风丹联合基础方案治疗中风的临床疗效相较于单独应用基础治疗方案效果更优,且无明显不良反应。但受纳入研究数量和质量的限制,上述结论尚需更多高质量研究验证。

ObjectiveTo evaluate the efficacy and safety of Huafeng Dan combined with basic therapy(including western medicine therapy,acupuncture and so on)in the treatment of stroke.Methods Cochrane Library database were searched from the inception to August 23,2021 to collect the randomized controlled trial(RCT)of Huafeng Dan in the treatment of stroke.The data was extracted and the Cochrane risk of bias assessment tool was used to assess the quality of literature,Rev Man 5.3 statistical software was used for Meta-analysis.An inverse funnel plot was used to analyze potential publication bias,a single-study sequential exclusion method was used to conduct sensitivity analysis tests,and the GRADE system was used to grade the evidence.Results effective rate of the test group was significantly higher than that of the control group[RR=1.16,95%CI(1.07,1.27),P=0.0006],and the neurological function grade of the test group was significantly better than that of the control group[RR=1.64,95%CI(1.26,2.12),P=0.0002].There was no significant difference in the incidence of adverse reactions between the two groups[RR=1.08,95%CI(0.49,2.38),P=0.86].In the inverse funnel plot of the three indicators,there may be publication bias only in the incidence of adverse reactions.The sensitivity of each literature was low,the robustness of each literature was high,and the levels of evidence were all low-quality or very low-quality.ConclusionThe clinical efficacy of Huafeng Dan combined with the basic therapy in the treatment of stroke is better than using the basic therapy alone,and there is no significant adverse reaction.However,due to the limitation of the quantity and quality of the included studies,the above conclusions need to be verified by more high-quality studies.