地屈孕酮治疗痛经有效性及安全性的前瞻性、随机对照、开放标签、多中心临床研究

目的 评估地屈孕酮治疗痛经的有效性及安全性.方法 采用前瞻性、随机对照、开放标签、多中心临床研究.108例痛经患者按1:1比例随机分配到地屈孕酮组和对照组,每组54例.地屈孕酮组于月经周期第5～25天,口服地屈孕酮10 mg,每天2次,治疗3个月经周期.对照组于月经干净开始持续至下次月经第3天,口服桂枝茯苓胶囊0.93...

Effectiveness and safety of dydrogesterone in the treatment of dysmenorrhea:a prospective,randomcontrolled,open-label and multicenter clinical study

OBJECTIVE To evaluate the efficacy and safety of dydrogesterone in the treatment of dysmenorrhea.METHODS The prospective, random-controlled, open-label and multicenter clinical study was adopted. A total of 108 women with dysmenorrhea were randomly assigned into dydrogesterone group and control group according to the ratio of 1 ∶ 1,with 54 patients in each group. Dydrogesterone group was treated with dydrogesterone 10 mg orally,twice a day,on the5 th-25 th day of menstrual cycle,for 3 menstrual cycles. Control group received Guizhi fuling capsule 0.93 g orally,three times a day,since the end of menstrual bleeding to the third day of the next menstruation,for 3 menstrual cycles. Main results were the changes of visual analogue scale(VAS)scores in 2 groups after 3 menstrual cycles;secondary results were the changes of COX menstrual symptom scale(CMSS),quality life of 36-item short form(SF-36),levels of carbohydrate antigen 125(CA125)and interleukin 6(IL-6)after 3 menstrual cycles;other findings included additional benefits and drug safety. RESULTS The results of intention to analysis data set and the follow-up study protocol analysis data set showed that VAS scores of 2 groups after treatment of dysmenorrhea for 1,2 and 3 menstrual cycles were lower than those before treatment,the longer the treatment time,the more obvious the decrease of VAS score(P<0.05),and VAS score decline of dydrogesterone group was better than that of control group(P<0.05). After 3 menstrual cycles,both the two group showed significant reduction in the severity and duration scores of CMSS(P<0.05);and the decrease of the above scores in the dydrogesterone group was superior than in the control group(P<0.05). After 3 menstrual cycles,among 8 dimensions of SF-36 scale,the scores of 7 dimensions in dydrogesterone group were significantly higher than those before treatment, such as the scores of physiological function, physical role, physical pain,emotional function,social function,general health status and energy(P<0.05);the increase of the scores of four dimensions were higher than those in the control group,such as physical pain,social function,general health status,energy(P<0.05). There was no significant difference in the levels of CA125 and IL-6 between 2 groups before and after treatment(P>0.05). After 3 menstrual cycles,the menstrual cycle and menstrual period in the dydrogesterone group were shorter than those before treatment,and the menstrual volume decreased(P<0.05);but there was no significant change in the above indexes of control group(P>0.05). After3 menstrual cycles,the incidence of adverse drug events and adverse reactions in dydrogesterone group was 32.69%(17/52)and28.85%(15/52);no serious adverse drug events or adverse reactions such as thrombosis occurred in both groups. CONCLUSIONS Dydrogesterone can effectively reduce the VAS score,also relieve dysmenorrhea-related symptoms,and improve the quality of life.The efficacy of dydrogesterone is superior than that of Guizhi fuling capsule in treatment for dysmenorrheal,without serious adverse reactions. It is well tolerated.