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司来吉兰治疗帕金森病有效性及安全性的系统评价再评价
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| 篇名： | 司来吉兰治疗帕金森病有效性及安全性的系统评价再评价 |
| TITLE： | Efficacy and Safety of Selegiline for Parkinson ’s Disease ：A Reevaluation of Systematic Reviews |
| 摘要： | 目的：对司来吉兰治疗帕金森病（PD）有效性和安全性的系统评价/Meta分析进行再评价。方法：计算机检索PubMed、Embase、Cochrane图书馆、中国知网、万方数据等数据库以及国内外卫生技术评估机构官方网站，在手工检索、回顾参考文献的基础上，收集司来吉兰单药或联合其他抗PD药物（试验组）对比安慰剂或空白对照或其他抗PD药物（对照组）的系统评价/Meta分析，检索时限均为建库起至2020年11月。筛选文献并提取资料后，采用PRISMA声明评价纳入文献的报告质量，采用AMSTAR2量表评价纳入文献的方法学质量，采用GRADE方法评价纳入文献结局指标的证据质量并进行汇总分析。结果：共纳入12篇系统评价/Meta分析，其中4篇为系统评价、8篇为Meta分析，共包括31个结局指标。PRISMA评分为16.5～27.0分，其中2篇文献（16.67％）为15.0～21.0分、10篇（83.33％）为22.0～27.0分。AMSTAR2量表评价结果显示，2篇文献的方法学质量等级为高质量，3篇为低质量，7篇为极低质量。GRADE证据质量评价结果显示，高质量指标1个，中质量指标3个，低质量指标5个，极低质量指标21个，不可评价结局指标1个；导致降级的因素主要为偏倚风险（87.10％）、发表偏倚（77.42％）、不精确性（51.61％）和不一致性（41.94％）。在疗效方面，与对照组比较，无论是单用或联合其他抗PD药物，司来吉兰均可改善患者的统一帕金森病评分量表总评分，精神、行为和情绪评分，日常生活能力评分，运动评分和韦氏综合评定量表评分（P＜0.05）。在安全性方面，两组患者的不良事件发生率、病死率比较，差异均无统计学意义（P＞0.05），但使用司来吉兰患者的因不良事件退出率更高（P＜0.05）。结论：司来吉兰治疗PD的疗效和安全性均较好，但目前相关系统评价/Meta分析的方法学质量和证据质量均偏低，需进一步规范研究方法。 |
| ABSTRACT： | OBJECTIVE：To conduct reevaluation of systematic review/Meta-ana lysis on the efficacy and safety of selegiline in the treatment of Parkinson ’s disease （PD）. METHODS ：Retrieved from PubMed ，Embase，Cochrane L ibrary，CNKI，Wanfang database as well as official websites of domestic and foreign health technology assessment institutions ，based on manual retrieval and review of references ，systematic review/Meta-analysis on selegiline alone or combined with other anti-PD drugs （trial group ） versus placebo or blank control or other anti-PD drugs （control group ）were collected. The time limit was from database inception to November 2020. After literature screening and data extraction ，PRISMA statement was adopted to evaluate the quality of the included reports. AMSTAR 2 scale was used to evaluate the methodological quality ，and GRADE method was adopted to evaluate the evidence quality ，the outcome indicators of the included studies were summarised and analyzed. RESULTS ：A total of 12 systematic reviews/Meta-analysis were included ，involving 4 systematic reviews and 8 Meta-analysis；there were 31 outcome indexes in total. PRISMA scores of them ranged from 16.5 to 27.0，including 15.0 to 21.0 for 2 literatures（16.67％）and 22.0 to 27.0 for 10 literatures（83.33％）. Results of AMSTAR 2 scale showed that the methodological qualities of 2 literatures were classed as high quality ，3 as low quality and 7 as very low quality. Results of GRADE evidence quality evaluation showed that 1 evidence quality was high-level ，3 were medium-level ，5 were low-level ，21 were very low-level ，and 1 was no evaluable . The main factors leading to the degradation were bias risk （87.10％），publication bias （77.42％），inaccuracy （51.61％）and incon sistency（41.94％）. In terms of therapeutic efficacy ，compared with control group ，selegiline could improve the total score of UPDRS ，UPDRS Ⅰ score，UPDRS Ⅱ score，UPDRS Ⅲ score and Webster score in patients with Parkinson ’s disease，either monotherapy or in combination with other anti-PD drugs （P＜0.05）. In terms of safety ，there was no significant difference in the incidence of adverse events or mortality between 2 groups（P＞0.05），but the rate of withdrawal due to adverse events was higher（P＜0.05）. CONCLUSIONS ：Selegiline is effective and safe in the treatment of Parkinson ’s disease ，but current methodological quality and evidence quality of included systematic reviews /Meta-analysis are low，which requires further standardization of research methods. |
| 期刊： | 2021年第32卷第24期 |
| 作者： | 李佳芮，李燕飞，刘泽辉，易湛苗 |
| AUTHORS： | LI Jiarui，LI Yanfei ，LIU Zehui，YI Zhanmiao |
| 关键字： | 司来吉兰；帕金森病；系统评价再评价；有效性；安全性 |
| KEYWORDS： | Selegiline；Parkinson’s disease ；Reevaluation of systematic review ；Efficacy；Safety |
| 阅读数： | 401 次 |
| 本月下载数： | 4 次 |
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