复方益母片治疗血瘀证型月经过少患者的临床研究

Clinical trial of compound Yi-mu tablets in patients with oligomenorrhea with blood stasis syndrome

目的 研究复方益母片治疗血瘀证型月经过少患者的临床疗效和安全性。方法 将血瘀证型月经过少患者按照给药方案分为对照组和试验组。对照组给予雌二醇/雌二醇地屈孕酮片治疗,每天1片;试验组在对照组的基础上给予复方益母片(每次4片,早晚分服,每天2次)治疗;2组均治疗3个月经周期。评估试验组和对照组的临床疗效、月经失血图评分、子宫内膜厚度、中医证候积分和治疗期间的药物不良反应。结果 试验组及对照组的总有效率分别为93.30%和76.67%;试验组与对照组的月经失血图评分分别为(30.80±5.86)和(24.13±6.46)分;子宫内膜厚度分别为(9.78±1.48)和(8.94±1.87)mm;中医证候积分分别为(9.80±4.33)和(16.40±5.77)分,试验组上述指标与对照组比较,差异均有统计学意义(均P<0.05)。治疗后试验组和对照组药物不良反应发生率分别为10.00%和16.67%,试验组与对照组比较,差异无统计学意义(P>0.05)。结论 复方益母片能够通过改善中医证候积分和子宫内膜厚度显著增加血瘀证型月经过少患者的月经量,临床疗效显著,安全性好,优于单用雌孕激素治疗。

Objective To observe the clinical efficacy and safety of compound Yi-mu tablets in the treatment of oligomenorrhea patients with blood stasis syndrome.Methods Patients with hypomenorrhea of blood stasis syndrome were divided into control group and treatment group according to the dosage regimen.The control group was treated with estradiol/estradiol dydrogesterone tablets,1 tablet per day;the experimental group was treated with compound Yi-mu tablets(4 tablets each time,morning and evening,twice a day)on the basis of the control group.Both groups were treated for 3 menstrual cycles.The clinical efficacy,menstrual blood loss score,endometrial thickness,traditional chinese medicine(TCM)syndrome score and adverse drug reactions during treatment were evaluated in the treatment group and the control group.Results The total efective rates of the treatment group and the control group were 93.30%and 76.67%,respectively.The menstrual blood loss scores of the treatment group and the control group were(30.80±5.86)and(24.13±6.46),respectively.The endometrial thickness were(9.78±1.48)and(8.94±1.87)mm,respectively.The TCM syndrome scores were(9.80±4.33)and(16.40±5.77)points,respectively.The above indexes in the treatment group were significantly different from those in the control group(all P<0.05).Conclusion Compound Yi-mu tablets can significantly improve the TCM symptoms of patients as well as the endometrium thickens and increase the menstrual volume in the treatment of oligomenorrhea patients with blood stasis syndrome.The clinical effect is better than sequential therapy of estrogen and progesterone alone.