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.
【摘要】 目的 探讨降高血压药物联合抗焦虑抑郁药物万拉法新治疗老年性原发高血压伴焦虑抑郁障碍的疗效及安全性。 方法 纳入2006年10月-2008年10月我院门诊和住院诊治的老年性原发高血压伴焦虑抑郁障碍患者100例,随机分为干预组和对照组。所有患者给予常规降压药物治疗,干预组另外给予万拉法新治疗,治疗12周后评价临床疗效。结果 干预组临床降压疗效总有效率940%,显著高于对照组总有效率800%(Plt;005)。两组患者的收缩压、舒张压与治疗前比较均显著改善(Plt;005),干预组患者与对照组比较血压明显改善(Plt;005)。干预组临床抗焦虑抑郁疗效总有效率960%,显著高于对照组总有效率580%(Plt;005)。两组均无明显的不良反应。结论 降高血压药物联合抗焦虑抑郁药物万拉法新治疗老年性原发高血压伴焦虑抑郁障碍疗效肯定,且安全可靠,值得临床推广应用。【Abstract】 Objective To investigate the efficacy and safety of antihypertensive drugs combined with antianxiety depression drug venlafaxine for treatment of patients with senile primary hypertension (SPH) and anxietydepression disorder (AD). Methods One hundred SPH patients with AD with were randomly divided into an intervention group and a control group. All cases were given antihypertensive drugs medication,while the intervention group was given venlafaxine. After 12 weeks of treatment,the clinical efficacy was evaluated. Results The antihypertensive efficacy rate in the intervention group was 940%,significantly higher than that of the control group 800% (Plt;005). The systolic blood pressure(SBP)and diastolic blood pressure (DBP) of the two groups significantly improved compared with those before treatment (Plt;005), and the intervention group’ SBP and DBP improved significantly than those of the control group (Plt;005). The total effective rate of antianxiety depression efficacy of the intervention group was 960%, significantly higher than that of the control group 580% (Plt;005). The two groups had no significant adverse reactions. Conclusion For patients with senile primary hypertension and anxietydepression disorder,the combination medication with antihypertensive drugs and venlafaxine was safe,reliable and worthy of clinical application.