[关键词]
[摘要]
目的 系统评价罗匹尼罗治疗帕金森病的疗效与安全性。方法 计算机检索PubMed、The Cochrane Library、Embase、中国生物医学文献数据库(CBM)、中国学术期刊全文数据库(CNKI)、维普中文期刊全文数据库(VIP)和万方数据库,查找罗匹尼罗治疗帕金森的随机对照研究(RCTs),检索时限由建库至2019年12月,由2名评价员独立筛选文献、提取资料和评价纳入研究的偏倚风险,采用RevMan 5.3进行Meta-分析。结果 共纳入14篇RCTs,帕金森患者4 456例,其中罗匹尼罗组(试验组)2 397例,对照组2 059例。Meta-分析结果显示:UPDRS Ⅲ评分下降值试验组优于对照组[SMD=-2.06,95% CI(-3.49,-0.64),P=0.005];UPDRS降低30%的病例数有统计学差异[OR=1.72,95% CI(1.04,2.86),P=0.03];临床总体疗效改善率两组无统计学差异[OR=1.32,95% CI(0.90,1.95),P=0.16]。因不良事件退出率无统计学差异[OR=1.06,95% CI(0.87,1.29),P=0.58]。试验组引起疼痛、恶心、晕厥、运动障碍、幻觉的发生率高于对照组,引起挫伤的发生率低于对照组,差异有统计学意义,其余不良反应发生率差异无统计学意义。结论 罗匹尼罗能有效的控制帕金森患者的症状,耐受性较好,但增加了疼痛、恶心等不良事件发生的风险;受纳入研究的数量和质量限制,上述结论尚需更多高质量、大样本RCT予以验证。
[Key word]
[Abstract]
Objective This systematic review and Meta-analysis aimed to compare the efficacy and safety of ropinirole in the treatment of Parkinson disease. Methods A thorough search in The Cochrane Library, PubMed, Embase, CBM, CNKI, VIP, and Wanfang Data were conducted for studies published up to December 2019. Randomized controlled trials (RCTs) of ropinirole in the treatment of Parkinson disease. Quality assessment and data extraction were performed by two reviewers independently, and Meta-analysis was performed by using RevMan 5.3 software. Results Fourteen RCTs involving 4 456 patients were included. Experimental group omprised 2 397 and control group had 2 059 patients. The Meta-analysis indicated the superior effect of UPDRS Ⅲ[SMD=-2.06, 95%CI (-3.49,-0.64), P=0.005], 30% responder of UPDRS Ⅲ[OR=1.72, 95%CI (1.04, 2.86), P=0.03]. No significant effects were at improvement rate of CGI[OR=1.32, 95%CI (0.90, 1.95), P=0.16], tolerance[OR=1.06, 95%CI (0.87, 1.29), P=0.58]. The incidence of pain, nausea, syncope, dyskinesia, and hallucinations in the experimental group was higher than that in the control group, and the difference was statistically significant, The incidence of contusion was lower than that of the control group, the difference was statistically significant, and the incidence of other adverse reactions was not statistically significant. Conclusion Ropinirole can effectively control the symptoms of Parkinson's patients, and it is well tolerated, but it increases the risk of adverse events such as pain and nausea. Due to the quantity and quality limitations of the included studies, the above conclusions need more quality, large sample RCT is verified.
[中图分类号]
R971
[基金项目]