中国中药杂志2025，Vol.50Issue(22)：6265-6272,8.DOI:10.19540/j.cnki.cjcmm.20250409.501
定坤丹口服液治疗寒凝血瘀型原发性痛经的随机、双盲双模拟、平行对照临床研究
Randomized,double-blind,double-simulated,parallel controlled clinical trial of Dingkundan Oral Liquid in treating primary dysmenorrhea with cold coagulation and blood stasis
摘要
Abstract
Dingkundan has the effect of warming Yang,dispelling cold,activating blood,resolving stasis,and relieving pain.It is used for treating dysmenorrhea,amenorrhea,menopausal disorders,infertility,and postpartum diseases caused by cold coagulation and blood stasis.Dingkundan Pills have some shortcomings,such as inconvenient administration,high sugar content,and slow absorption.Dingkundan Oral Liquid is a new dosage form developed on the basis of the pills,with a good taste,fast absorption,and convenient use,while there is no relevant research now.To evaluate the efficacy and safety of Dingkundan Oral Liquid in the treatment of primary dysmenorrhea with cold coagulation and blood stasis,a randomized controlled,double-blind,and double-simulated clinical trial was conducted.One hundred and eight subjects were randomized into test group,control group,and placebo group at a ratio of 1∶1∶1,with 36 subjects in each group.The test group,control group,and placebo group were treated with Dingkundan Oral Liquid+Ibuprofen Sustained Release Capsules simulator,Ibuprofen Sustained Release Capsules+Dingkundan Oral Liquid simulator,and two drug simulants,respectively.The course of treatment was 3 menstrual cycles.The effectiveness indicators included primary efficacy indicators[visual analogue scale(VAS)score difference],secondary efficacy indicators[total effective rate,COX menstrual symptom scale(CMSS)score difference,traditional Chinese medicine(TCM)syndrome score difference,single symptom disappearance rate,menstrual serum prostaglandin F2α(PGF2α),PGF2α/prostaglandin E2(PGE2),thromboxane B2(TXB2),6-keto-prostaglandin-F1α(6-keto-PGF1α),and pulsatility index(PI)and resistance index(RI)of uterine artery flow].Safety was evaluated based on clinical adverse reactions/events,vital signs,and laboratory tests.The results of the clinical trial showed that after 3 menstrual cycles of treatment,VAS scores difference of the three groups had statistically significant differences,and test group and control group demonstrated significantly better therapeutic effects than placebo group.Full analysis set(FAS)of the difference between the two groups was 0.33,95％CI[-0.19,0.86],and per-protocol set(PPS)was 0.35,95％CI[-0.27,0.97].The non-inferiority test was valid.There were statistically significant differences in total response rate,CMSS score difference,efficacy regarding TCM symptoms difference,single symptom disappearance rates,serum or plasma levels of PGF2α,PGF2α/PGE2,TXB2,and 6-keto-PGF1α,and PI and RI of uterine artery flow among the 3 groups.In terms of safety,no adverse reactions were observed in the 3 groups,and no obvious abnormalities were observed in liver and kidney function or electrocardiogram.According to the results,Dingkundan Oral Liquid is effective in the treatment of primary dysmenorrhea with cold coagulation and blood stasis,and its therapeutic effect is not inferior to that of Ibuprofen Sustained Release Capsules commonly used in clinical practice.Moreover,Dingkundan Oral Liquid has better therapeutic effects on TCM symptoms and accompanying symptoms of dysmenorrhea,with more stable long-term curative effect,demonstrating a clinical promotion and application value.关键词
定坤丹口服液/原发性痛经/寒凝血瘀/随机对照/临床试验Key words
Dingkundan Oral Liquid/primary dysmenorrhea/cold coagulation and blood stasis/randomized control/clinical trial引用本文复制引用
马堃,黄天娇,周芷聿,王玲,罗洁,陶钰,张涵,孙立华,高聪..定坤丹口服液治疗寒凝血瘀型原发性痛经的随机、双盲双模拟、平行对照临床研究[J].中国中药杂志,2025,50(22):6265-6272,8.基金项目
北京市科技计划委员会"首都特色"重点项目(Z171100001017104) （Z171100001017104）
北京中医药薪火传承"新3+3"工程示范案例项目(2023-ZYSF-21) （2023-ZYSF-21）
中国中医科学院西苑医院横向课题(06-115) （06-115）
