Ives Natalie J, Stowe Rebecca L, Marro Joanna, Counsell Carl, Macleod Angus, Clarke Carl E, Gray Richard, Wheatley Keith
Birmingham Clinical Trials Unit, University of Birmingham, Birmingham B15 2RR.
BMJ. 2004 Sep 11;329(7466):593. doi: 10.1136/bmj.38184.606169.AE. Epub 2004 Aug 13.
To quantify more reliably the benefits and risks of monoamine oxidase type B inhibitors (MAOBIs) in early Parkinson's disease.
Searches of the Cochrane Library, Medline, Embase, PubMed, and Web of Science for years 1966-2003, plus major journals in the field, abstract books, and proceedings of meetings, for randomised trials comparing MAOBIs with placebo or levodopa.
Available data on mortality, motor complications, side effects, treatment compliance, and clinician rated disability (for example, unified Parkinson's disease rating scale) were extracted from 17 trials and combined using standard meta-analytic methods.
No significant difference in mortality existed between patients on MAOBIs and control patients (odds ratio 1.13, 95% confidence interval 0.94 to 1.34; P = 0.2). Patients randomised to MAOBIs had significantly better total scores, motor scores, and activities of daily living scores on the unified Parkinson's disease rating scale at three months compared with patients taking placebo; they were also less likely to need additional levodopa (0.57, 0.48 to 0.67; P < 0.00001) or to develop motor fluctuations (0.75, 0.59 to 0.95; P = 0.02). No difference existed between the two groups in the incidence of side effects or withdrawal of patients.
MAOBIs reduce disability, the need for levodopa, and the incidence of motor fluctuations, without substantial side effects or increased mortality. However, because few trials have compared MAOBIs with other antiparkinsonian drugs, uncertainty remains about the relative benefits and risks of MAOBIs. Further large, long term comparative trials that include patient rated quality of life measures are needed.
更可靠地量化单胺氧化酶B型抑制剂(MAOBIs)在早期帕金森病中的益处和风险。
检索考克兰图书馆、医学在线数据库(Medline)、荷兰医学文摘数据库(Embase)、美国国立医学图书馆医学期刊数据库(PubMed)以及科学网1966年至2003年的数据,加上该领域的主要期刊、摘要书籍和会议论文集,以查找比较MAOBIs与安慰剂或左旋多巴的随机试验。
从17项试验中提取关于死亡率、运动并发症、副作用、治疗依从性以及临床医生评定的残疾情况(如统一帕金森病评定量表)的可用数据,并使用标准的荟萃分析方法进行合并。
服用MAOBIs的患者与对照患者在死亡率上无显著差异(优势比1.13,95%置信区间0.94至1.34;P = 0.2)。与服用安慰剂的患者相比,随机分配到MAOBIs组的患者在三个月时统一帕金森病评定量表的总分、运动评分和日常生活活动评分显著更好;他们也不太可能需要额外的左旋多巴(0.57,0.48至0.67;P < 0.00001)或出现运动波动(0.75,0.59至0.95;P = 0.02)。两组在副作用发生率或患者退出率方面无差异。
MAOBIs可减轻残疾程度、减少对左旋多巴的需求并降低运动波动的发生率,且无明显副作用或死亡率增加。然而,由于很少有试验将MAOBIs与其他抗帕金森病药物进行比较,MAOBIs相对的益处和风险仍存在不确定性。需要进一步开展包括患者自评生活质量指标的大型长期对照试验。