MA Kun;HUANG Tian-jiao;ZHOU Zhi-yu;WANG Ling;LUO Jie;TAO Yu;ZHANG Han;SUN Li-hua;GAO Cong;Xiyuan Hospital, China Academy of Chinese Medical Sciences;the First Clinical Medical College of Heilongjiang University of Chinese Medicine;Tianjin University of Traditional Chinese Medicine;Guang′anmen Hospital, China Academy of Chinese Medical Sciences;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 F_(2α)(PGF_(2α)), PGF_(2α)/prostaglandin E_2(PGE_2), thromboxane B_2(TXB_2), 6-keto-prostaglandin-F_(1α)(6-keto-PGF_(1α)), 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 PGF_(2α), PGF_(2α)/PGE_2, TXB_2, and 6-keto-PGF_(1α), 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.
2025 22 v.50 [Abstract][OnlineView][Download 133K]