摘要
目的观察麒麟丸治疗月经不调肾脾两虚、冲血不足证患者的月经改善程度及对卵巢储备功能的影响。方法研究纳入10个中心共120例患者,利用分层区组随机法分为治疗组60例和对照组60例,治疗组给予麒麟丸,对照组给予调经促孕丸,两组患者均每日口服包装编盲药物2次,每次6g,共服用3个月经周期。治疗后观察两组临床疗效,并比较两组患者治疗前后不同时间抗苗勒管激素(AMH)、基础卵泡刺激素(FSH)、基础雌二醇(E2)和双侧卵巢窦卵泡数(AFC)水平及其变化率,并进行安全性评价。结果两组患者访视2、访视3、访视4、访视5临床疗效总有效率比较差异无统计学意义(P>0.05),两组疗效相当。在基线AMH<1.4ng/ml的条件下,治疗组治疗后AMH较治疗前升高(P<0.05)。治疗组AMH变化率明显优于对照组[95%CI(-156.72,-0.26)],AFC、FSH及E2组间水平及变化率比较差异均无统计学意义(P>0.05)。治疗过程中两组均未发生严重不良反应。结论麒麟丸、调经促孕丸可显著改善患者的卵巢储备功能及月经情况,安全性好,且麒麟丸对AMH水平的改善优于调经促孕丸。
Objective To explore the clinical effects of Qilin Pills(麒麟丸)on irregular menstruation with the kidney and spleen deficiency syndrome and insufficient thoroughfare channel blood syndrome and its effects on ovarian reserve.Methods A total of 120 patients in 10 centers were included.The stratified block method was used to randomly divide them into a treatment group of 60 cases and a control group of 60 cases.The treatment group was given Qilin Pills,and the control group was given Tiaojing Cuyun Pills(调经促孕丸).Patients in both groups were orally taken blinded packaged drugs twice a day,6 g each time,for a total of 3 menstrual cycles.The clinical efficacy of both groups was observed,and the levels and differences of anti-mullerian hormone(AMH),basic follicle stimulating hormone(FSH),basic estradiol(E2)and ovarian follicles(AFC)were compared before and after treatment between groups.The safety was evaluated.Results There was no significant difference in the total clinical effective rates between groups at visit 2,visit 3,visit 4,and visit 5(P>0.05),and the effects were similar in the 2 groups.In the treatment group,under the condition of baseline AMH<1.4 ng/ml,the value of AMH after treatment was higher than that before treatment(P<0.05).Besides,the change rate of AMH in the treatment group was greater than that in the control group[95%CI(-156.72,-0.26)].There was no significant differences in AFC,FSH and E2 levels and change rate(P>0.05).There was no serious adverse reactions in both groups during the treatment.Conclusion Qilin Pills and Tiaojing Cuyun Pills may significantly improve the ovarian reserve function and menstrual condition,with good safety.
作者
廖慧妍
郜洁
邱嫔
孙建华
陈思
李净
刘晓荣
邓高丕
LIAO Huiyan;GAO Jie;QIU Pin;SUN Jianhua;CHEN Si;LI Jing;LIU Xiaorong;DENG Gaopi(The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou,510000)
出处
《中医杂志》
CSCD
北大核心
2019年第24期2107-2112,共6页
Journal of Traditional Chinese Medicine
基金
广东省名优中成药二次开发项目(粤中医办函[2017]19号)
邓高丕广东省名中医传承工作室(粤中医办函[2019]5号)
关键词
麒麟丸
月经不调
肾脾两虚
冲血不足
卵巢储备功能
Qilin Pills(麒麟丸)
abnormal menstruation
deficiency of both kidney and spleen
insufficient thoroughfare channel blood syndrome
ovary reserve
