文拉法辛和卡马西平治疗痛性糖尿病周围神经病变的随机双盲双模拟多中心临床试验(英文)

Effects of Venlafaxine and Carbamazepine for Painful Peripheral Diabetic Neuropathy: A Randomized, Double-blind and Double-dummy, Controlled Multi-center Trial

目的评价文拉法辛和卡马西平治疗痛性糖尿病周围神经病变的疗效和安全性。方法本试验是一个随机双盲双模拟多中心临床试验。3个临床中心共纳入132例患者。随机分为试验组,文拉发辛胶囊,25mg,每日2次,66例和阳性对照组,卡马西平片,0.1g,每日2次,66例,疗程为14天。主要的疗效指标为数字强度分级法评价疼痛强度。次要指标为生活质量评价。结果共119例患者完成试验。在试验的第5、7、10和14天时,文拉法辛组较卡马西平组明显改善疼痛强度(各组的P值分别为:P=0.02,P=0.03,P=0.003,P=0.001)。在治疗的第10天和第14天文拉法辛较卡马西平明显改善生活质量评价的总分(P=0.02;P=0.01)。文拉法辛和卡马西平都能明显改善患者的睡眠和情绪,但文拉法辛的效果优于卡马西平。文拉法辛最常见的不良反应是胃肠道不适、头昏和嗜睡。文拉法辛组的不良反应发生率为43.90%(4例患者因为不良反应退出试验);卡马西平组的不良反应发生率为25.76%(2例患者因为不良反应退出试验)。结论文拉发辛和卡马西平均有减轻糖尿病神经病变性疼痛以及改善患者生活质量的作用,但文拉发辛在减轻疼痛、改善生活质量方面的作用优于卡马西平,两组的不良反应和不良事件均相似,主要的不良事件是胃肠道不适,头昏和嗜睡。

Objective To evaluate the safety and efficacy of venlafaxine and carbamazepine on painful peripheral diabetic neuropathy. Methods This was a randomized, parallel-group, double-blind, double-dummy clinical trial. 132 patients a venlafaxine group （n=66） and a carbamazepine group （n=66） with painful peripheral diabetic neuropathy were recruited from 3 clinical centers. The venlafaxine group took venlafaxine 25 mg plus one dummy carbamazepine tablet twice a day and the carbamazepine group took carbamazepine 0.1 g plus one dummy venlafaxine tablet twice a day both for 2 weeks. The primary efficacy measurement consisted of a numeric pain intensity scale and the secondary measurement assessed quality of life. Results One hundred and nineteen patients completed the trial. Venlafaxine was superior to carbamazepine in improving mean pain intensity scores at 5,7,10 and 14 days by per-protocol analysis （P=0.02, P=0.03, P=0.003 and P=0.001 respectively）. The effects of venlafaxine on the improvement in the total quality of life scores were better than those of carbamazepine at 10 and 14 days （P=0.02 and P=0.01 respectively）. Sleep interference and mood were improved by both venlafaxine and carbamazepine, but the efficacy of venlafaxine was superior to that of carbamazepine. The common adverse events of venlafaxine included mild gastrointestinal discomfort, dizziness and somnolence. The frequency of adverse events in the venlafaxine group was about 43.9% （4 patients withdrew because of adverse events） and in the carbamazepine group about 25.76% （2 patients withdrew because of adverse events） （P =0.06）. Conclusions Venlafaxine and carbamazepine are effective in the treatment of painful diabetic neuropathy, venlafaxine is superior to carbamazepine in improving pain and quality of life. Both drugs may be safe and well tolerated.