Effect of Mifepristone vs Placebo for Treatment of Adenomyosis With Pain Symptoms: A Randomized Clinical Trial.
Effect of Mifepristone vs Placebo for Treatment of Adenomyosis With Pain Symptoms: A Randomized Clinical Trial.
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DOI：
10.1001/jamanetworkopen.2023.17860
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发表时间：
2023-06-01
影响因子：
13.8
通讯作者：
中科院分区：
文献类型：
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作者：
米非司酮对bbb治疗有效吗？在这项随机临床试验中，134名有b子宫腺肌症疼痛症状的参与者，米非司酮组和安慰剂组的参与者在疼痛评分方面的改善显著大于安慰剂组。所有次要指标，包括血红蛋白、血小板计数和子宫体积，米非司酮组均有显著改善，且无严重不良事件发生。这项随机临床试验发现，米非司酮治疗子宫腺肌症有效且安全，这支持了米非司酮作为子宫腺肌症治疗新选择的重新定位。这项随机临床试验评估米非司酮治疗子宫腺肌症是否有效和安全。子宫腺肌症是一种常见的慢性妇科疾病，其治疗是一个未满足的需求。需要开发新的治疗方法。米非司酮正在测试治疗子宫腺肌症。目的：确定米非司酮治疗子宫腺肌症是否安全有效。这项多中心、安慰剂对照、双盲随机临床试验在中国10家医院进行。共有134名患者出现子宫腺肌症疼痛症状。试验入组于2018年5月开始，2019年4月完成，分析于2019年10月至2020年2月进行。参与者按1:1随机分配，每天口服一次米非司酮10mg或安慰剂，持续12周。主要终点是腺肌病相关痛经强度的变化，在治疗12周后通过视觉模拟评分（VAS）进行评估。次要终点包括治疗12周后月经失血量的变化、贫血患者血红蛋白水平升高、CA125水平、血小板计数和子宫体积。根据不良事件、生命体征、妇科检查和实验室评估来评估安全性。共有134例子宫腺肌症合并痛经患者被随机分配，126例患者被纳入疗效分析，其中61例患者（平均[SD]年龄，40.2[4.6]岁）随机接受米非司酮治疗，65例患者（平均[SD]年龄，41.7[5.0]岁）随机接受安慰剂治疗。两组患者在基线时的特征相似。米非司酮组VAS评分的平均变化（SD）为- 6.63(1.92)，安慰剂组为- 0.95(1.75)，差异有统计学意义（P < 0.001）。米非司酮组痛经总缓解率显著优于安慰剂组（有效缓解：56例[91.8%]vs 15例[23.1%]；完全缓解：54例[88.5%]vs 4例[6.2%]）。所有次要终点在米非司酮治疗后月经失血、血红蛋白(平均[SD]较基线变化：2.13 [1.38]g/dL vs 0.48 [0.97] g/dL; P <。001), CA125(与基线的平均[SD]变化：- 62.23 [76.99]U/mL vs . 26.89 [118.70] U/mL; P <。0.001)，血小板计数(平均[SD]与基线的变化：−28.87 [54.30]×103/µL vs 2.06 [41.78]×103/µL；子宫体积（与基线相比平均[SD]变化：- 29.32 [39.34]cm3 vs . 18.39 [66.46] cm3; P < 0.001）。安全性分析显示两组间无显著差异，无严重不良事件报告。这项随机临床试验表明，基于其疗效和可接受的耐受性，米非司酮可能是治疗子宫腺肌症患者的新选择。ClinicalTrials.gov标识符：NCT03520439
Is mifepristone effective for adenomyosis treatment? In this randomized clinical trial of 134 participants with adenomyosis pain symptoms, the participants in the mifepristone group and had significantly greater improvement in pain scores than the placebo group. All the secondary outcomes, including hemoglobin, platelet count, and uterine volume, showed significant improvements in the mifepristone group, and there were no serious adverse events. This randomized clinical trial found that mifepristone was effective and safe for the treatment of adenomyosis, which supports the repositioning of this drug as a new treatment option for adenomyosis. This randomized clinical trial assesses whether mifepristone is effective and safe for the treatment of adenomyosis. Adenomyosis is a common chronic gynecological disorder, and its treatment is an unmet need. New therapies need to be developed. Mifepristone is being tested for adenomyosis treatment. To determine whether mifepristone is effective and safe for adenomyosis treatment. This multicenter, placebo-controlled, double-blind randomized clinical trial was conducted in 10 hospitals in China. In total, 134 patients with adenomyosis pain symptoms were enrolled. Trial enrollment began in May 2018 and was completed in April 2019, and analyses were conducted from October 2019 to February 2020. Participants were randomized 1:1 to receive mifepristone 10 mg or placebo orally once a day for 12 weeks. The primary end point was the change in adenomyosis-associated dysmenorrhea intensity, evaluated by the visual analog scale (VAS) after 12 weeks of treatment. Secondary end points included the change in menstrual blood loss, increased level of hemoglobin in patients with anemia, CA125 level, platelet count, and uterine volume after 12 weeks of treatment. Safety was assessed according to adverse events, vital signs, gynecological examinations, and laboratory evaluations. In total, 134 patients with adenomyosis and dysmenorrhea were randomly assigned, and 126 patients were included in the efficacy analysis, including 61 patients (mean [SD] age, 40.2 [4.6] years) randomized to receive mifepristone and 65 patients (mean [SD] age, 41.7 [5.0] years) randomized to received the placebo. The characteristics of the included patients at baseline were similar between groups. The mean (SD) change in VAS score was −6.63 (1.92) in the mifepristone group and −0.95 (1.75) in the placebo group (P < .001). The total remission rates for dysmenorrhea in the mifepristone group were significantly better than those in the placebo group (effective remission: 56 patients [91.8%] vs 15 patients [23.1%]; complete remission: 54 patients [88.5%] vs 4 patients [6.2%]). All the secondary end points showed significant improvements after mifepristone treatment for menstrual blood loss, hemoglobin (mean [SD] change from baseline: 2.13 [1.38] g/dL vs 0.48 [0.97] g/dL; P < .001), CA125 (mean [SD] change from baseline: −62.23 [76.99] U/mL vs 26.89 [118.70] U/mL; P < .001), platelet count (mean [SD] change from baseline: −28.87 [54.30]×103/µL vs 2.06 [41.78]×103/µL; P < .001), and uterine volume (mean [SD] change from baseline: −29.32 [39.34] cm3 vs 18.39 [66.46] cm3; P < .001). Safety analysis revealed no significant difference between groups, and no serious adverse events were reported. This randomized clinical trial showed that mifepristone could be a new option for treating patients with adenomyosis, based on its efficacy and acceptable tolerability. ClinicalTrials.gov Identifier: NCT03520439
影响因子：
3.3
作者：
Fiscella, Julietta;Bonfiglio, Thomas;Winters, Paul;Eisinger, Steven H.;Fiscella, Kevin
通讯作者：
Fiscella, Kevin