不同剂量桂枝茯苓胶囊治疗原发性痛经疗效探索研究

Effects and safety of varying doses of Guizhi Fuling capsule in patients with primary dysmenorrhea: a multi-center,randomized,double-blind, placebo-controlled clinical study

评价不同剂量桂枝茯苓胶囊治疗原发性痛经的临床有效性及安全性。将240例年龄18～30岁的原发性痛经患者按1∶1∶1的比例随机分为试验高剂量组、试验低剂量组和安慰剂组,每组各80例,连续治疗3个月经周期并随访3个月经周期,采用视觉模拟标尺法(VAS)对痛经疼痛程度进行比较。治疗期试验高剂量组、试验低剂量组、安慰剂组治疗期有效率分别为68.42%,67.57%,47.89%,试验组均优于安慰剂组(P<0.001);随访期试验高剂量组、试验低剂量组、安慰剂组有效率分别为73.68%,72.97%,53.52%,试验组均优于安慰剂组(P<0.005);治疗期试验高剂量组、试验低剂量组、安慰剂组疼痛持续时间分别下降57.88%,46.17%,30.40%;随访期试验高剂量组、试验低剂量组和安慰剂组疼痛持续时间分别下降67.93%,53.56%,47.46%,试验组疼痛持续时间下降率均优于安慰剂组,差异有显著性统计学意义(P<0.000 1),试验高剂量组疼痛持续时间下降率优于低剂量组,差异有统计学意义(P<0.05)。试验高剂量组与低剂量组疗效呈现出一定的量效趋势,均无严重不良反应。桂枝茯苓胶囊高剂量组及低剂量组均能够显著缓解患者疼痛、改善患者症状,减少疼痛持续时间,对原发性痛经患者具有较好的总体治疗效果和远期治疗效应。

To evaluate the effects and safety of varying doses of Guizhi Fuling capsule on treating primary dysmenorrhea. From August 2010 to March 2011, 240 subjects（aged 18-30） with primary dysmenorrheal, were enrolled in 8 sites. They were randomized into Guizhi Fuling capsule high dose group, low dose group and placebo control group, 80 cases in each group. These patients were treated for three consecutive menstrual cycles, then were followed up in another three consecutive menstrual cycles. Visual analogue scales（VAS） was used to determine the pain intensity. During the treatment, the high-, low-dose and placebo groups efficiency on pain relief are 68.42% , 67.57% and 47. 89% respectively. Guzhi Fuling （included high- and low- dose group） significantly relieves the pain compared to placebo. In follow-up, Guzhi Fuling groups are still superior to the placebo group （73.68%, 72. 97% and 53.52% ）. During the treatment, pain duration reduces 57.88% in high dose group, while 46. 17% in low dose group, and 30. 40% in placebo group. In follow-up, pain lasting time decrease 67.93%, 53.56% , 47.46%, respectively. Guizhi Fuling significantly re- duces the pain duration compared to placebo and high-dose is better than low-dose. The efficacy of Guzhi Fuling （high- and low-dose） displays certain dosage-effect relationship. Among these group, no serious adverse event was reported. Guizhi Fuling capsule at high or low dose significantly relieves the pain, improves symptoms, reduces the duration of pain, and has a better overall treatment effect and long-term treatment effect in patients with primary dysmenorrhea.