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 点击下载
| 论文标题： | 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 |
| 英文标题： | |
| 中文摘要： | 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10mg，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0.93g，每天3次，治疗3个月经周期。主要研究结果为治疗3个月经周期后两组视觉模拟评分量表（VAS）评分的变化，次要研究结果为治疗3个月经周期后COX痛经症状评分（CMSS）、生活质量健康调查简表（SF-36）评分和糖类抗原125（CA125）、白细胞介素6（IL-6）水平的变化，其他研究结果包括额外获益和药物安全性。结果意向性分析与遵循研究方案分析数据集结果均显示，两组治疗痛经1、2、3个月经周期后的VAS评分均较治疗前下降，治疗时间越长VAS评分下降越明显（P＜0.05），且地屈孕酮组VAS评分下降优于对照组（P＜0.05）。治疗3个月经周期后，两组患者CMSS的严重程度、持续时间评分均较治疗前显著下降（P＜0.05），且地屈孕酮组CMSS的严重程度、持续时间评分下降优于对照组（P＜0.05）。治疗3个月经周期后，生活质量SF-36量表的8个维度中，地屈孕酮组在生理机能、生理职能、躯体疼痛、情感职能、社会功能、一般健康状况、精力7个维度的评分较治疗前显著升高（P＜0.05），且躯体疼痛、社会功能、一般健康状况、精力4个维度评分升高优于对照组（P＜0.05）。两组CA125、IL-6水平治疗前后差异均无统计学意义（P＞0.05）。治疗3个月经周期后，地屈孕酮组月经周期、经期较治疗前缩短，经量显著下降（P＜0.05），对照组上述指标则无明显改变（P＞0.05）。治疗3个月经周期后，地屈孕酮组药物不良事件和不良反应发生率分别为32.69％（17/52）、28.85％（15/52），两组均未发生血栓等严重药物不良事件或不良反应。结论地屈孕酮治疗痛经可有效降低患者VAS评分，缓解痛经相关症状，提高生活质量，疗效优于桂枝茯苓胶囊；且无严重不良反应，药物耐受性好。 |
| 英文摘要： | OBJECTIVE To evaluate the efficacy and safety of dydrogesterone in the treatment of dysmenorrhea. METHODS The prospective ，random-controlled，open-labeland 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 the 5th-25th 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 CA 125 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）. After 3 menstrual cycles ，the incidence of adverse drug events and adverse reactions in dydrogesterone group was 32.69％（17/52）and 28.85％（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. |
| 期刊： | 2022年第33卷第03期 |
| 作者： | 李碧钦，张颖，周祖妹，金文艳，李荔，周嘉禾，张小伟，许秋仪，池瑞招，李金艳，马娟 |
| 英文作者： | LI Biqin，ZHANG Ying， ZHOU Zumei，JIN Wenyan，LI Li，ZHOU Jiahe，ZHANG Xiaowei，XU Qiuyi，CHI Ruizhao，LI Jinyan，MA Juan |
| 关键字： | 地屈孕酮；痛经；有效性；安全性；视觉模拟评分；COX痛经症状评分 |
| KEYWORDS： | dydrogesterone；dysmenorrhea；effectiveness；safety；visual analogue scale ；COX menstrual symptom scale |
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