熄风定颤丸治疗帕金森病有效性与安全性的系统评价与Meta分析

Systematic Evaluation and Meta-analysis of Efficacy and Safety of Xifeng Dingchan Pills for Treatment of Parkinson's Disease

目的系统评价熄风定颤丸治疗帕金森病的疗效及安全性。方法计算机检索主要中英文医学数据库,收集所有熄风定颤丸治疗帕金森病的临床随机对照试验,根据Cochrane Handbook 5.1评价纳入研究的质量,并使用Rev Man 5.3软件对纳入研究进行Meta分析,用漏斗图及Egger检验分析发表偏倚。结果共纳入16项研究,根据干预措施的不同分为两大类,熄风定颤丸联合常规西药(阳性对照药)和单用熄风定颤丸。Meta分析显示熄风定颤丸联合常规西药可以改善帕金森病综合评分量表(UPDRS)评分(WMD=-5.67,95%CI[-7.84,-3.51]),帕金森病症状评分量表(Webster)评分(WMD=-2.7,95%CI[-4.24,-1.16]),有效率(RR=1.34,95%CI[1.23,1.47]),效果优于单用西药;熄风定颤丸单独使用相比于西药在改善帕金森病综合评分量表(UPDRS)评分(WMD=-1.24,95%CI[-4.20,1.72]),有效率(RR=0.99,95%CI[0.86,1.15]),差异无统计学意义。GRADE评价提示证据推荐等级为低级。结论熄风定颤丸联合美多巴,美多巴+泰舒达,美多巴+吡贝地尔效果优于美多巴组,美多巴+泰舒达组,美多巴+吡贝地尔组,安全性评价尚可,存在发表偏倚;熄风定颤丸单独使用疗效与抗帕金森药无明显差异。但由于本系统评价纳入研究的证据质量级别较低,临床医生使用该证据进行临床决策时尚需谨慎。

Objective To systematically evaluate the efficacy and safety of Xifeng Dingchan pills（XDP） in treating Parkinson＇s disease（PD）.Methods Randomized controlled trials（RCTs）for XDP in treating PD were collected from Chinese and English databases. Cochrane Handbook 5.1 software was used to access the quality of included trials,and Rev Man 5.3 was used to conduct Meta-analysis. Funnel plot and Egger＇s test was used to analyze the publication bias.Results A total of 16 studies were included. According to the intervention method,the included RCTs were classified into XDP combined with western medicine（combined intervention） RCTs and XDP alone RCTs. The results of Meta-analysis showed that XDP combined with western medicine（Levodopa and Benserazide Hydrochloride tablets,Piribedil tablets） had better effect on improving Unified Parkinson＇s Disease Rating Scale（UPDRS）scores（WMD=-5.67,95 % CI [-7.84,-3.51]）,PD symptom scale（Webster）scores（WMD=-2.7,95 % CI[-4.24,-1.16]）,and effective rate（RR=1.34,95 % CI[1.23,1.47]） than western medicine. XDP alone showed no statistical significant differences in improving UPDRS score（WMD=-1.24,95%CI[-4.2,1.72]） and effective rate（RR=0.99,95 % CI[0.86,1.15]）when compared with western medicine. The GRADE profile showed that the included RCTs were in low quality of evidence. Conclusion XDP combined with Madopar, Madopar＋Benserazide Hydrochloride tablets, or Madopar ＋Piribedil tablets are more effective and safe than western medicine alone,showing no publication bias. The effect of XDP alone is similar to that of the anti-PD drugs. However,for the low quality of methodology, small size of included studies and lower evidence grade,clinicians should be cautious to use the evidence.