论文部分内容阅读
目的 :本研究旨在评价曲马多治疗糖尿病性神经痛的有效性和安全性。背景 :糖尿病性神经痛是糖尿病患者的主要症状 ,其治疗和其他的末梢神经病变一样 ,不能令人满意。曲马多是作用于中枢的镇痛剂 ,用于治疗中到重度疼痛。方法 :多中心、门诊病例、随机、双盲、安慰剂做对照、设置平行组的研究 ,包括清洗期 (在此期间停用所有镇痛剂 )和一个为期 42天的双盲治疗期。总共有 1 31名患糖尿病性神经痛的患者按每日 4次接受了曲马多 (n =65)或看上去与曲马多相同的安慰剂胶囊治疗 (n =66)。 42天的治疗结束后或治疗中断后比较曲马多组和安慰剂组平均疼痛强度评分作出主要有效性分析 ;次要有效性分析为疼痛缓解率评分和根据日常活动和睡眠状况作出的对生活质量的评估。结果 :曲马多平均剂量为 2 1 0mg/天 ,治疗糖尿病性神经痛较安慰剂有显著疗效 (P≤ 0 .0 0 1 )。曲马多组患者生理(P =0 .0 2 )和社会功能 (P =0 .0 4 )的评分显著优于安慰剂组。未发现对睡眠有显著治疗作用。曲马多最常见的不良反应是恶心 ,便秘 ,头疼和嗜睡。结论 :安慰剂做对照的实验结果表明曲马多在治疗糖尿病性神经痛上是安全和有效的
Purpose: This study was designed to evaluate the efficacy and safety of tramadol in the treatment of diabetic neuropathic pain. Background: Diabetic neuralgia is a major symptom of diabetic patients and its treatment, like other peripheral neuropathy, is unsatisfactory. Tramadol is a central analgesic for the treatment of moderate to severe pain. METHODS: A multicenter, outpatient, randomized, double-blind, placebo-controlled study of parallel groups was set up including a washout period with all analgesics discontinued and a 42-day double-blind treatment period. A total of 131 patients with diabetic neuropathic pain received either tramadol (n = 65) 4 times a day or placebo capsules that looked identical to tramadol (n = 66) 4 times daily. The primary efficacy analysis was performed after 42 days of treatment or after treatment discontinuation comparing mean pain intensity scores for both tramadol and placebo groups; secondary efficacy analyzes were pain relief rate scores and scores for life based on daily activity and sleep status Quality assessment. Results: The mean tramadol dose was 210 mg / day. The treatment of diabetic neuropathic pain was more effective than placebo (P≤0.0001). Physiological (P = .0 2) and social function (P = .0 4) scores in the tramadol group were significantly better than those in the placebo group. No significant therapeutic effect on sleep was found. The most common adverse reactions to tramadol are nausea, constipation, headaches and lethargy. Conclusions: The placebo-controlled trial shows that tramadol is safe and effective in the treatment of diabetic neuropathic pain