Huang Alison J, Cummings Steven R, Schembri Michael, Vittinghoff Eric, Ganz Peter, Grady Deborah
1Department of Medicine, University of California, San Francisco, California 2San Francisco Coordinating Center, California Pacific Medical Center Research Institute, San Francisco, California 3Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, California 4Department of Epidemiology and Biostatistics, University of California, San Francisco, California.
Menopause. 2016 Mar;23(3):330-4. doi: 10.1097/GME.0000000000000520.
To describe the efficacy and tolerability of continuous nitroglycerin for treatment of hot flashes.
Perimenopausal and postmenopausal women reporting at least seven hot flashes per day were recruited into a single-arm, dose-escalation trial of continuous transdermal nitroglycerin. Participants were started on a generic 0.1 mg/hour nitroglycerin patch applied daily without patch-free periods. During 4 weeks, participants escalated dosage weekly to 0.2, 0.4, or 0.6 mg/hour as tolerated, then discontinued nitroglycerin during the final week. Changes in hot flash frequency and severity were assessed using symptom diaries. Paired t tests examined change in outcomes between baseline and maximal-dose therapy and after discontinuation of nitroglycerin.
Of the 19 participants, mean age was 51.4 (±4.3) years. Women reported an average 10.6 (±3.0) hot flashes and 7.1 (±3.8) moderate-to-severe hot flashes per day at baseline. Eleven women escalated to 0.6 mg/hour, three to 0.4 mg/hour, two to 0.2 mg/hour, and one remained on 0.1 mg/hour nitroglycerin. Two discontinued nitroglycerin before the first outcomes assessment. Among the remaining 17 women, the average daily frequency of hot flashes decreased by 54% and the average frequency of moderate-to-severe hot flashes decreased by 69% from baseline to maximum-dose therapy (P < 0.001 for both). After discontinuing nitroglycerin, participants reported an average 23% increase in frequency of any hot flashes (P = 0.041) and 96% increase in moderate-to-severe hot flashes (P < 0.001).
Continuous nitroglycerin may substantially and reversibly decrease hot flash frequency and severity. If confirmed in a randomized blinded trial, it may offer a novel nonhormonal hot flash treatment.
描述持续使用硝酸甘油治疗潮热的疗效和耐受性。
招募每天至少有7次潮热的围绝经期和绝经后女性，进行持续经皮硝酸甘油的单臂剂量递增试验。参与者从每日使用通用的0.1毫克/小时硝酸甘油贴片开始，无停药期。在4周内，参与者根据耐受情况每周将剂量递增至0.2、0.4或0.6毫克/小时，然后在最后一周停用硝酸甘油。使用症状日记评估潮热频率和严重程度的变化。配对t检验用于检查基线与最大剂量治疗之间以及停用硝酸甘油后结局的变化。
19名参与者的平均年龄为51.4（±4.3）岁。女性在基线时每天平均有10.6（±3.0）次潮热和7.1（±3.8）次中度至重度潮热。11名女性将剂量递增至0.6毫克/小时，3名至0.4毫克/小时，2名至0.2毫克/小时，1名维持在0.1毫克/小时硝酸甘油剂量。2名在首次结局评估前停用硝酸甘油。在其余17名女性中，从基线到最大剂量治疗，潮热的平均每日频率降低了54%，中度至重度潮热的平均频率降低了69%（两者P均<0.001）。停用硝酸甘油后，参与者报告任何潮热的频率平均增加23%（P = 0.041），中度至重度潮热增加96%（P < 0.001）。
持续使用硝酸甘油可能会显著且可逆地降低潮热频率和严重程度。如果在随机双盲试验中得到证实，它可能提供一种新的非激素潮热治疗方法。
