Policy Analysis Inc., Brookline, MA, USA.
Ann Pharmacother. 2011 Dec;45(12):1483-90. doi: 10.1345/aph.1P777. Epub 2011 Nov 15.
To conduct a systematic review of available data from reports of randomized controlled trials on the efficacy, safety, and tolerability of drugs used to treat postherpetic neuralgia (PHN), a common type of neuropathic pain.
The MEDLINE (1950-June 30, 2009) and EMBASE (1974-June 30, 2009) databases were used to identify source studies, in conjunction with a review of reference citations from identified published reports.
We selected all English-language reports of randomized placebo-controlled trials of the efficacy, tolerability, and safety of drugs (oral or transdermal) used for treatment in patients with PHN. Studies with treatment duration less than 4 weeks were excluded. From each identified trial, we extracted information on (1) placebo-corrected percentage reductions in pain intensity from randomization to end of active treatment; (2) relative risks of withdrawal due to lack of efficacy; (3) relative risks of various adverse events; and (4) relative risks of withdrawal due to adverse events.
Twelve reports of randomized controlled trials in patients with PHN were identified, involving 8 different agents (amitriptyline, capsaicin, divalproex sodium, gabapentin, morphine, nortriptyline, pregabalin, tramadol). Most studies were small, involving fewer than 200 patients. Pain intensity was reported to have been reduced significantly with all drugs (range: 13.8% [tramadol] to 42.4% [amitriptyline]); data were pooled using techniques of meta-analysis when information was available from more than 1 trial. No clinical trial reported a significant reduction in risk of withdrawal as a result of lack of efficacy. Analysis of adverse events was greatly limited by erratic and inconsistent reporting and wide variation in sample sizes.
While available literature establishes the efficacy of 8 drugs in treatment of PHN, it does not provide adequate guidance as to which agents are best to treat this condition, in part because of inadequate reporting of data on tolerability and safety.
对治疗疱疹后神经痛(PHN)的药物的疗效、安全性和耐受性的随机对照试验报告中现有数据进行系统回顾,PHN 是一种常见的神经性疼痛。
使用 MEDLINE(1950 年-2009 年 6 月 30 日)和 EMBASE(1974 年-2009 年 6 月 30 日)数据库,结合对已发表报告的参考文献的审查,以确定原始研究。
我们选择了所有用英语发表的、关于治疗 PHN 患者的药物(口服或透皮)的疗效、耐受性和安全性的随机安慰剂对照试验报告。排除治疗时间少于 4 周的研究。从每个确定的试验中,我们提取了以下信息:(1)从随机分组到主动治疗结束时疼痛强度的安慰剂校正百分比降低;(2)因疗效不佳而退出的相对风险;(3)各种不良事件的相对风险;(4)因不良事件而退出的相对风险。
确定了 12 项 PHN 患者的随机对照试验报告,涉及 8 种不同的药物(阿米替林、辣椒素、丙戊酸钠、加巴喷丁、吗啡、去甲替林、普瑞巴林、曲马多)。大多数研究规模较小,涉及的患者少于 200 人。所有药物都显著降低了疼痛强度(范围:13.8%[曲马多]至 42.4%[阿米替林]);当有超过 1 项试验的信息时,使用荟萃分析技术汇总数据。没有临床试验报告因缺乏疗效而导致退出的风险显著降低。对不良事件的分析受到数据报告不规律、不一致以及样本量差异很大的极大限制。
虽然现有文献确定了 8 种药物治疗 PHN 的疗效,但由于缺乏对耐受性和安全性数据的充分报告,它并没有提供关于哪种药物最适合治疗这种疾病的足够指导。