Hood S C, Moher D, Barber G G
Health Analysis and Modelling Group, Social and Economic Studies Division, Statistics Canada, Ottawa, Ont.
CMAJ. 1996 Oct 15;155(8):1053-9.
To evaluate the efficacy of pentoxifylline therapy in improving the walking capacity of patients with moderate intermittent claudication.
A search of MEDLINE for trials published between 1976 and 1994 inclusive, and a bibliographic review of all articles retrieved.
Randomized, placebo-controlled, double-blind clinical trials were selected that evaluated the pain-free walking distance (the distanced walked on a treadmill before the onset of calf pain) and the absolute claudication distance (the maximum distance walked on a treadmill) among patients with moderate intermittent claudication. Twelve study groups in 11 trials were included in the analysis.
In addition to information regarding the trial design, patient characteristics, dosages and treatment periods, the means and standard deviations were collected for both the pain-free walking and absolute claudication distances. Trial quality was also assessed.
Overall, there was a statistically significant improvement in the pain-free walking distance after pentoxifylline therapy (weighted mean difference 29.4 m [95% confidence interval (CI) 13.0 to 45.9 m]); this finding was based on a total sample of 612 patients (308 in the treatment groups and 304 in the control groups). A significant improvement was also noted in the absolute claudication distance (weighted mean difference 48.4 m [95% CI 18.3 to 78.6 m]); this was based on a total sample of 511 patients (258 in the treatment group and 253 in the control group). In a sensitivity analysis of the pain-free walking distance, significant treatment effects and no statistically significant heterogeneity were found when only trials were included that were "medically eligible" (involved patients with stage II disease and a pain-free walking distance of 50 to 200 m). In a similar sensitivity analysis of the absolute claudication distance, the two conditions resulting in a significant treatment effect and no significant heterogeneity were the inclusion of "medically eligible" trials and those with a shorter treatment duration (13 weeks or less).
Pentoxifylline therapy may be efficacious in improving the walking capacity of patients with moderate intermittent claudication. However, properly conducted clinical trials are required to provide a true estimate of the benefit.
评估己酮可可碱治疗对改善中度间歇性跛行患者步行能力的疗效。
检索MEDLINE数据库中1976年至1994年（含）发表的试验，并对检索到的所有文章进行文献综述。
选取随机、安慰剂对照、双盲临床试验，评估中度间歇性跛行患者的无痛步行距离（在跑步机上行走至小腿疼痛发作前的距离）和绝对跛行距离（在跑步机上行走的最大距离）。分析纳入了11项试验中的12个研究组。
除了有关试验设计、患者特征、剂量和治疗期的信息外，还收集了无痛步行距离和绝对跛行距离的均值及标准差。同时评估试验质量。
总体而言，己酮可可碱治疗后无痛步行距离有统计学显著改善（加权均值差29.4 m [95%置信区间（CI）13.0至45.9 m]）；这一结果基于总共612例患者的样本（治疗组308例，对照组304例）。绝对跛行距离也有显著改善（加权均值差48.4 m [95% CI 18.3至78.6 m]）；这基于总共511例患者的样本（治疗组258例，对照组253例）。在对无痛步行距离的敏感性分析中，当仅纳入“医学上符合条件”（涉及II期疾病且无痛步行距离为50至200 m的患者）的试验时，发现了显著的治疗效果且无统计学显著异质性。在对绝对跛行距离的类似敏感性分析中，导致显著治疗效果且无显著异质性的两个条件是纳入“医学上符合条件”的试验以及治疗持续时间较短（13周或更短）的试验。
己酮可可碱治疗可能对改善中度间歇性跛行患者的步行能力有效。然而，需要进行恰当实施的临床试验以准确评估其益处。
