目的 評價文拉法辛和卡馬西平治療痛性糖尿病周圍神經(jīng)病變的療效和安全性。 方法 本試驗(yàn)是一個隨機(jī)雙盲雙模擬多中心臨床試驗(yàn)。3個臨床中心共納入132例患者。隨機(jī)分為試驗(yàn)組，文拉發(fā)辛膠囊， 25 mg，每日2次，66例和陽性對照組，卡馬西平片，0.1 g，每日2次， 66例，療程為14天。主要的療效指標(biāo)為數(shù)字強(qiáng)度分級法評價疼痛強(qiáng)度。次要指標(biāo)為生活質(zhì)量評價。 結(jié)果 共119例患者完成試驗(yàn)。在試驗(yàn)的第5、7、10和14天時，文拉法辛組較卡馬西平組明顯改善疼痛強(qiáng)度（各組的P值分別為：P=0.02，P=0.03，P=0.003，P=0.001）。在治療的第10天和第14 天文拉法辛較卡馬西平明顯改善生活質(zhì)量評價的總分（P=0.02；P=0.01）。文拉法辛和卡馬西平都能明顯改善患者的睡眠和情緒，但文拉法辛的效果優(yōu)于卡馬西平。文拉法辛最常見的不良反應(yīng)是胃腸道不適、頭昏和嗜睡。文拉法辛組的不良反應(yīng)發(fā)生率為43.90%（4例患者因?yàn)椴涣挤磻?yīng)退出試驗(yàn)）；卡馬西平組的不良反應(yīng)發(fā)生率為25.76%（2例患者因?yàn)椴涣挤磻?yīng)退出試驗(yàn)）。 結(jié)論 文拉發(fā)辛和卡馬西平均有減輕糖尿病神經(jīng)病變性疼痛以及改善患者生活質(zhì)量的作用，但文拉發(fā)辛在減輕疼痛、改善生活質(zhì)量方面的作用優(yōu)于卡馬西平，兩組的不良反應(yīng)和不良事件均相似，主要的不良事件是胃腸道不適，頭昏和嗜睡。
【摘要】 目的 探討降高血壓藥物聯(lián)合抗焦慮抑郁藥物萬拉法新治療老年性原發(fā)高血壓伴焦慮抑郁障礙的療效及安全性。 方法 納入2006年10月-2008年10月我院門診和住院診治的老年性原發(fā)高血壓伴焦慮抑郁障礙患者100例,隨機(jī)分為干預(yù)組和對照組。所有患者給予常規(guī)降壓藥物治療,干預(yù)組另外給予萬拉法新治療,治療12周后評價臨床療效。結(jié)果 干預(yù)組臨床降壓療效總有效率940%,顯著高于對照組總有效率800%(Plt;005)。兩組患者的收縮壓、舒張壓與治療前比較均顯著改善(Plt;005),干預(yù)組患者與對照組比較血壓明顯改善(Plt;005)。干預(yù)組臨床抗焦慮抑郁療效總有效率960%,顯著高于對照組總有效率580%(Plt;005)。兩組均無明顯的不良反應(yīng)。結(jié)論 降高血壓藥物聯(lián)合抗焦慮抑郁藥物萬拉法新治療老年性原發(fā)高血壓伴焦慮抑郁障礙療效肯定,且安全可靠,值得臨床推廣應(yīng)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.