摘要
目的系统评价雷沙吉兰治疗帕金森病的有效性和安全性。方法计算机检索The Cochrane Library(2013年第3期)、Web of Science、MEDLINE(Ovid)、PubMed、CBM、CNKI、WanFang Data和VIP数据库,收集雷沙吉兰治疗帕金森病的随机对照试验(RCT),检索时限均从建库至2013年3月。由2位研究者根据纳入与排除标准独立筛选文献、提取资料和评价纳入研究的方法学质量后,采用RevMan 5.1软件进行Meta分析。结果最终纳入6个RCT,共2865例患者。Meta分析结果显示:2 mg/d和1 mg/d雷沙吉兰的疗效均优于安慰剂[MD=–3.16,95%CI(–3.21,–3.11),P<0.00001;MD=–3.01,95%CI(–3.06,–2.96),P<0.00001],且1 mg/d雷沙吉兰的疗效优于2 mg/d雷沙吉兰[MD=–0.65,95%CI(–0.73,–0.57),P<0.00001]。在安全性方面,雷沙吉兰在恶心、头痛、头昏发生率方面与安慰剂相当,两组差异无统计学意义[OR=0.72,95%CI(0.49,1.07),P=0.60;OR=1.02,95%CI(0.70,1.49),P=0.91;OR=0.87,95%CI(0.49,1.55),P=0.35]。结论当前有限证据表明,雷沙吉兰可有效治疗早期帕金森病,且1 mg/d雷沙吉兰疗效优于2 mg/d雷沙吉兰。同时,雷沙吉兰具有良好的耐受性及安全性。由于本系统评价纳入研究较少,证据强度有限,上述结论仍需更多高质量研究加以验证。
Objective To systematically review the effectiveness and safety of rasagiline for Parkinson's disease. Methods Databases including The Cochrane Library (Issue 3, 2013), Web of Science, MEDLINE (Ovid), PubMed, CBM, CNKI, WanFang Data and VIP were electronically searched from inception to March 2013 for randomized controlled trials (RCTs) on rasagiline for Parkinson's disease. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted the data, and assessed the methodological quality of included studies. Meta-analysis was performed using RevMan 5. i software. Results In total, 6 studies involving 2 865 patients were included. The results of meta-analyses indicated that, compared with placebo, rasagiline 2 mg/d and 1 mg/d was significantly effective (MD= -3.16, 95%CI -3.21 to -3.11, P〈0.000 01; MD= -3.01, 95%CI -3.06 to -2.96, P〈0.000 02). Rasagiline 1 mg/d was more effective than rasagiline 2 mg/d in the treatment of early PD (MD= -0.65, 95%CI -0.73 to -0.57, P〈0.000 01). There was no significant difference between rasagiline and placebo in the incidences of nausea, headache, and dizziness (nausea: OR=0.72, 95%CI 0.49 to 1.07, P=0.60; headache: OR=1.02, 95%CI 0.70 to 1.49, P=0.91; dizziness: OR=0.87, 95%CI 0.49 to 1.55, P=0.35). Conclusion Rasagiline is effective for early Parkinson's disease, and the dosage 1 mg/d is better than 2 mg/d based on current limited evidence. Rasagiline has a good tolerance and safety. Due to the limited quantity of the included studies and the evidence with limited strength, further high-quality RCTs are needed to verify the aforementioned conclusion.
出处
《中国循证医学杂志》
CSCD
2014年第2期205-210,共6页
Chinese Journal of Evidence-based Medicine
基金
国家自然科学基金面上项目"LRRK2基因多态性/突变性与新疆地区维吾尔族人群帕金森病的相关研究"(编号:81160143)