益母草颗粒治疗原发性痛经临床研究

Clinical Study on Yimucao Granules for Primary Dysmenorrhea

目的:观察益母草颗粒治疗原发性痛经的临床疗效。方法:选取100例原发性痛经患者,按照随机数字表法分为2组。对照组50例给予布洛芬缓释胶囊治疗,研究组50例采用益母草颗粒治疗。2组均治疗3个月经周期,随访3个月。比较2组临床疗效、不良反应发生率及复发率;比较2组治疗前后症状积分及血小板活化因子(PAF)、前列腺素F2α (PGF2α)、β-内啡肽水平。结果:研究组总有效率96.00%,高于对照组82.00%(P<0.05)。治疗后1个月,2组症状评分均较治疗前1个月降低(P<0.05),研究组症状评分低于对照组(P<0.05)。治疗1个、3个月经周期,2组PAF、PGF2α水平均较治疗前降低(P<0.05),β-内啡肽水平均较治疗前升高(P<0.05);研究组PAF、PGF2α水平均低于同期对照组(P<0.05),β-内啡肽水平高于同期对照组(P<0.05)。研究组不良反应发生率8.00%,与对照组6.00%比较,差异无统计学意义(P>0.05)。随访3个月,研究组复发率2.08%,低于对照组14.63%(P<0.05)。结论:益母草颗粒治疗原发性痛经安全有效,且复发率低,其作用机制可能与下调PAF、PGF2α水平及促进β-内啡肽分泌有关。

Objective:To observe the clinical effect of Yimucao granules for primary dysmenorrhea.Methods:A total of 100 cases of patients with primary dysmenorrhea were selected and divided into two groups according to the random number table method.The control group which has 50 cases was treated with ibuprofen sustained-release capsules,and the study group which has 50 cases was treated with Yimucao granules.Both groups were treated for three menstrual cycles and followed up for three months.Clinical effects,incidence of adverse reactions and recurrence rates were compared between the two groups.Before and after treatment,symptom scores and levels of platelet activating factors(PAF),prostaglandin F2α(PGF2α) and β-endorphin were compared between the two groups.Results:The total effective rate was 96.00% in the study group,higher than that of 82.00% in the control group(P<0.05).One month after treatment,symptom scores in the two groups were decreased when compared with those one month before treatment(P<0.05),and the symptom scores in the study group was lower than that in the control group(P<0.05).After treatment for one and three menstrual cycles,levels of PAF and PGF2α in the two groups were decreased when compared with those before treatment(P<0.05),and β-endorphin levels were increased(P<0.05);levels of PAF and PGF2α in the study group were lower than those in the control group in the same period(P<0.05),and β-endorphin level was higher(P<0.05).The incidence of adverse reactions was 8.00% in the study group and 6.00% in the control group,there being no significance in the difference(P>0.05).During three month follow-up,the recurrence rate was 2.08% in the study group,lower than that of 14.63% in the control group(P<0.05).Conclusion:Yimucao granules for primary dysmenorrhea is safe and effective,with a low recurrence rate.Its mechanism maybe related to the down-regulation of levels of PAF and PGF2α and the promotions of β-endorphin secretion.