Kleijnen Systematic Reviews Ltd, York, UK.
Curr Med Res Opin. 2012 May;28(5):833-45. doi: 10.1185/03007995.2012.678938. Epub 2012 Apr 25.
To systematically assess efficacy and safety of buprenorphine patch versus fentanyl patch in patients with chronic moderate to severe pain.
Fifteen databases were searched up to December 2010. Randomised and quasi-randomised trials assessing the efficacy in patients with chronic pain were included. Quantitative methods for data synthesis were used and two network meta-analyses were conducted.
Fourteen unique trials (17 publications) were included. No head-to-head randomised trials of buprenorphine patch compared with fentanyl patch were identified. Therefore, less robust evidence from indirect comparisons was used. Results from a network meta-analysis of non-enriched designs (eight trials), using trials versus placebo and trials versus morphine for indirect comparisons, indicated that transdermal fentanyl, in comparison with transdermal buprenorphine, showed significantly more nausea (odds ratio [OR] 4.66, 95% confidence interval (CI) 1.07 to 20.39), a significantly higher number of treatment discontinuations due to adverse events (OR 5.94, 95% CI 1.78 to 19.87), and non-significant differences on all other outcomes, including pain measures. In comparison with morphine, transdermal buprenorphine had a significantly higher decrease of pain intensity (MD [mean difference] -16.20, 95% CI -28.92 to -3.48) while morphine caused more cases of constipation (OR 7.50, 95% CI 1.45 to 38.85) and a significantly higher number of treatment discontinuations due to adverse events (OR 5.80, 95% CI 1.68 to 20.11). All other outcomes showed non-significant differences between transdermal buprenorphine and morphine. The results were similar when also including six trials using enriched designs with the exception of more cases of vomiting for fentanyl (OR 17.32, 95% CI 4.43 to 67.71) and morphine (OR 15.85, 95% CI 3.92 to 64.13) compared to buprenorphine.
The findings indicate comparability of transdermal buprenorphine and transdermal fentanyl for pain measures with significantly fewer adverse events (nausea and treatment discontinuation due to adverse events) caused by transdermal buprenorphine.
系统评估丁丙诺啡贴剂与芬太尼贴剂治疗慢性中重度疼痛患者的疗效和安全性。
检索了截至 2010 年 12 月的 15 个数据库。纳入了评估慢性疼痛患者疗效的随机和半随机试验。采用定量方法进行数据综合,并进行了两项网络荟萃分析。
共纳入 14 项独特的试验(17 篇文献)。未发现丁丙诺啡贴剂与芬太尼贴剂的头对头随机试验。因此,使用间接比较的证据质量较低。使用试验与安慰剂和试验与吗啡进行间接比较的非富集设计的网络荟萃分析结果表明,与丁丙诺啡相比,透皮芬太尼导致恶心的发生率显著更高(比值比 [OR] 4.66,95%置信区间 [CI] 1.07 至 20.39),因不良事件导致的治疗中止率显著更高(OR 5.94,95% CI 1.78 至 19.87),所有其他结局,包括疼痛测量值,均无显著差异。与吗啡相比,丁丙诺啡透皮贴剂可显著降低疼痛强度(MD [平均差值] -16.20,95% CI -28.92 至 -3.48),而吗啡导致更多的便秘病例(OR 7.50,95% CI 1.45 至 38.85)和更高的因不良事件导致的治疗中止率(OR 5.80,95% CI 1.68 至 20.11)。丁丙诺啡和吗啡之间的所有其他结局均无显著差异。纳入 6 项使用富集设计的试验后,结果也相似,除芬太尼(OR 17.32,95% CI 4.43 至 67.71)和吗啡(OR 15.85,95% CI 3.92 至 64.13)的呕吐病例数增加外。
研究结果表明,丁丙诺啡透皮贴剂与芬太尼透皮贴剂在疼痛测量方面具有可比性,丁丙诺啡透皮贴剂引起的不良反应(恶心和因不良反应导致的治疗中止)明显更少。