Oxybutynin vs Placebo for Hot Flashes in Women With or Without Breast Cancer: A Randomized, Double-Blind Clinical Trial (ACCRU SC-1603).
Oxybutynin vs Placebo for Hot Flashes in Women With or Without Breast Cancer: A Randomized, Double-Blind Clinical Trial (ACCRU SC-1603).
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奥昔布宁与安慰剂治疗患有或不患有乳腺癌的女性潮热：一项随机、双盲临床试验 (ACCRU SC-1603)。
DOI：
10.1093/jncics/pkz088
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发表时间：
2020
影响因子：
4.4
通讯作者：
Loprinzi,CharlesL
中科院分区：
文献类型：
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作者：
Leon-Ferre,RobertoA;Novotny,PaulJ;Wolfe,EricG;Faubion,StephanieS;Ruddy,KathrynJ;Flora,Daniel;Dakhil,ChristopherSR;Rowland,KendrithM;Graham,MarkL;Le-Lindqwister,Nguyet;Smith,ThomasJ;Loprinzi,CharlesL
背景：潮热（HFs）对围绝经期和绝经后妇女的生活质量产生负面影响。本研究考察了奥昔布宁与安慰剂在降低HFs方面的疗效。方法：在这项随机、多中心、双盲研究中，每周HFs≥28例、持续时间超过30天、不适合雌激素治疗的乳腺癌妇女被分配口服奥昔布宁（2.5 mg /天两次或5 mg /天两次）或安慰剂6周。使用重复测量混合模型，主要终点是每次奥施布宁剂量和安慰剂之间每周HF评分的患者内基线变化。次要终点包括每周HF频率的变化、HF相关的每日干扰量表问卷和自我报告的症状。结果：我们招募了150名女性。基线特征平衡良好。平均（SD）年龄为57（8.2）岁。三分之二（65%）的患者正在服用他莫昔芬或芳香酶抑制剂。两种剂量的奥昔布宁组患者每周HF评分的降低幅度更大（5mg每日两次：- 16.9 [SD 15.6]， 2.5 mg每日两次：- 10.6 [SD 7.7]），安慰剂组为- 5.7 (SD 10.2)， P<。奥昔布宁剂量与安慰剂相比为0.005)，HF频率(每天5mg两次：−7.5 [SD 6.6]，每天2.5 mg两次：−4.8 [SD 3.2]，安慰剂：−2.6 [SD 4.3]；P<。003（奥昔布宁剂量与安慰剂相比），以及大多数hf相关的日常干扰量表测量和总体生活质量的改善。服用两组奥施布宁的患者报告的副作用都比服用安慰剂的患者多，尤其是口干、排尿困难和腹痛。大多数副作用为1级或2级。因不良反应而中止研究的情况没有差异。结论奥施布宁是一种有效且耐受性较好的治疗方法。
BackgroundHot flashes (HFs) negatively affect quality of life among perimenopausal and postmenopausal women. This study investigated the efficacy of oxybutynin vs placebo in decreasing HFs.MethodsIn this randomized, multicenter, double-blind study, women with and without breast cancer with 28 or more HFs per week, lasting longer than 30 days, who were not candidates for estrogen-based therapy, were assigned to oral oxybutynin (2.5 mg twice a day or 5 mg twice a day) or placebo for 6 weeks. The primary endpoint was the intrapatient change from baseline in weekly HF score between each oxybutynin dose and placebo using a repeated-measures mixed model. Secondary endpoints included changes in weekly HF frequency, HF-related daily interference scale questionnaires, and self-reported symptoms.ResultsWe enrolled 150 women. Baseline characteristics were well balanced. Mean (SD) age was 57 (8.2) years. Two-thirds (65%) were taking tamoxifen or an aromatase inhibitor. Patients on both oxybutynin doses reported greater reductions in the weekly HF score (5 mg twice a day: −16.9 [SD 15.6], 2.5 mg twice a day: −10.6 [SD 7.7]), placebo −5.7 (SD 10.2);P< .005 for both oxybutynin doses vs placebo), HF frequency (5 mg twice a day: −7.5 [SD 6.6], 2.5 mg twice a day: −4.8 [SD 3.2], placebo: −2.6 [SD 4.3];P< .003 for both oxybutynin doses vs placebo), and improvement in most HF-related daily interference scale measures and in overall quality of life. Patients on both oxybutynin arms reported more side effects than patients on placebo, particularly dry mouth, difficulty urinating, and abdominal pain. Most side effects were grade 1 or 2. There were no differences in study discontinuation because of adverse effects.ConclusionOxybutynin is an effective and relatively well-tolerated treatment option for women with HFs.