舒肝颗粒治疗乳腺增生症肝郁气滞证患者最佳剂量探索——180例随机双盲对照研究

Study on Optimum Dose of Shugan Granules( 舒肝颗粒) for Women in Breast Hyperplasia with Liver Qi Stagnation Syndrome: A Randomize-Controlled Trial of 180 Cases

目的探索舒肝颗粒治疗乳腺增生症的最佳有效剂量。方法采用随机、双盲、安慰剂对照的方法,在5个中心纳入乳腺增生症肝郁气滞证患者240例,随机分为常规剂量组90例、高剂量组90例、安慰剂组60例,分别给予舒肝颗粒常规剂量(相当于原药材5 g)、高剂量(相当于原药材10 g)、安慰剂治疗3个月经周期。观察治疗后乳房疼痛最痛一日数字评分法(NRS)评分和乳房明显疼痛天数(NRS≥3的天数)下降值,触诊乳腺靶肿块大小变化值和治疗后单项症状消失率。结果治疗3个月经周期后乳房疼痛最痛一日的NRS评分、乳房明显疼痛天数、触诊靶肿块大小和各单项症状消失率,舒肝颗粒高剂量组和常规剂量组均优于安慰剂组(P <0. 05或P <0. 0125),但高剂量组和常规剂量组之间差异均无统计学意义(P> 0. 05或P> 0. 0125)。结论舒肝颗粒常规剂量,即每次5 g、每日2次口服,为治疗肝郁气滞证乳腺增生症的最佳有效剂量。

Objective To study the optimal effective dosage of Shugan Granule(舒肝颗粒)in relieving symptoms of women with breast hyperplasia.Methods A randomized,double-blind,placebo-controlled method was used to enroll 240 patients with hyperplasia of mammary glands with liver qi stagnation syndrome in 5 centers.Subjects were randomly divided into a conventional dose group(90 cases),a high-dose group(90 cases),and a placebo group(60 cases),and they were given 3 menstrual cycles treatment of Shugan Granule conventional dose(equivalent to 5 g of the original medicine),high dose(equivalent to 10 g of the original medicine),and the placebo treatment respectively.The post-treatment breast pain numeric rating scales(NRS)of the most painful day and the number of days of significant breast pain(days with NRS≥3),the change in the size of the target breast mass and the disappearance rate of individual symptoms after treatment were observed.Results After 3 menstrual cycles treatment,the Shugan Granule high dose and conventional dose treatment group were all better than placebo group in the reduction from baseline the most painful NRS score,the number of days with NRS≥3,mass size of target breast palpation and the symptoms disappearance rate(P<0.05 or P<0.0125),while there was no statistical differences between the high dose and conventional dose group(P>0.05 or P>0.0125).Conclusion Conventional dose of Shugan Granule is 5 g per time,twice a day as the optimal effective dose in relieving symptoms of women with breast hyperplasia of liver depression and qi stagnation syndrome.