加味消渴丸治疗经前综合征(肝郁脾虚、血热证)的有效性和安全性:一项多中心、随机、安慰剂对照试验。

L I Xiyu, Yang Yanhong, Sun Jian, Nie Quanfang, Liu Lifen, L I Guifen, Y U Junping, Zhang Zhuangjin, X U Yi, Zou Ting, Shi Yun
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引用次数: 0

摘要

目的:探讨加味逍遥丸(JXP)治疗经前期综合征(PMS)相关症状的有效性和安全性:研究加味逍遥丸(JXP)治疗经前期综合征(PMS)相关症状的有效性和安全性:2017年8月至2018年12月,在中国的8个地点共招募了144名定期来月经的经前综合征女性,并随机接受JXP或匹配的安慰剂(12克/天,每天两次,每次6克)治疗3个月经周期。主要指标是治疗3个月后黄体期每日问题严重程度记录(DRSP)评分的降低。安全性结果包括临床不良事件(AE)、不良反应(AR)、生命体征变化和实验室检测:结果:在 3 个月经周期的治疗中,JXP 在降低黄体期 DRSP 评分(心理/症状功能障碍)方面优于安慰剂(PFAS = 0.002,PPPS = 0.001)。此外,两组间的AEs、严重AEs、因AEs和ARs而停药的发生率无显著差异(均P>0.05),也未观察到与试验药物相关的临床重大不良医疗事件:结论:JXP 在缓解经前综合征相关症状方面优于安慰剂,这表明 JXP 可作为一种有效、安全且耐受性良好的替代疗法。
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Effectiveness and safety of Jiawei Xiaoyao pill in the treatment of premenstrual syndrome (liver depression, spleen deficiency, and blood-heat syndrome): a multi-center, randomized, placebo-controlled trial.

Objective: To investigate the effectiveness and safety of Jiawei Xiaoyao pill (,JXP) in the treatment of symptoms associated with premenstrual syndrome (PMS).

Methods: A total of 144 regularly menstruating women with PMS were recruited at 8 sites in China from August 2017 to December 2018, and randomized to receive either a JXP or a matching placebo (12 g/d, 6 g twice a day) for 3 menstrual cycles. The primary indicator was the reduced Daily Record of Severity of Problems (DRSP) scores in the luteal phase after 3 months of treatment. The safety outcomes included clinical adverse events (AEs), adverse reactions (ARs), changes in vital signs, and laboratory tests.

Results: JXP surpassed the placebo in reducing DRSP scores (psychological/somatic dysfunction) in the luteal phase over 3 menstrual cycles of treatment (PFAS = 0.002, PPPS = 0.001). Additionally, there were no significant differences in the incidence of AEs, severe AEs, withdrawal due to AEs and ARs between the two groups (all P > 0.05), and no clinically significant adverse medical events related to the test drug observed.

Conclusions: JXP was superior to the placebo in relieving the symptoms associated with PMS, which signified that JXP may be effective, safe, and well-tolerated as an alternative therapy.

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