Loprinzi L, Barton Debra L, Sloan Jeff A, Zahasky Katherine M, Smith De Anne R, Pruthi Sandhya, Novotny Paul J, Perez Edith A, Christensen Bradley J
Division of Medical Oncology, Mayo Clinic, Rochester, Minn 55905, USA.
Mayo Clin Proc. 2002 Nov;77(11):1159-63. doi: 10.4065/77.11.1159.
To obtain pilot prospective data regarding the efficacy and tolerability of gabapentin for alleviating hot flashes.
This prospective single-arm clinical trial was conducted between July 26, 2001, and November 30, 2001. Patients underwent a baseline week and then 4 weeks of gabapentin treatment, with increasing doses during the first 3 weeks, from 300 to 600 to 900 mg/d. Data were obtained primarily from patient-completed questionnaires.
Data from 20 evaluable women (of 24 entered in the trial) were available. Four patients discontinued use of gabapentin for perceived drug-related untoward symptoms, primarily related to light-headedness and dizziness. The 16 patients who completed this clinical trial had a mean reduction in hot flash frequency, in the fourth treatment week compared to the baseline week, of 66%. Their corresponding hot flash score (frequency times average severity) reduction was 70%. Additionally, patients who completed the 4 treatment weeks had a strong tendency to report an improvement in several other symptoms.
Although a double-blind placebo-controlled clinical trial should be conducted to better elucidate the efficacy and toxicity of gabapentin in patients with hot flashes, the available data suggest that gabapentin is a reasonable treatment to consider in patients with hot flashes if they do not wish to use hormonal therapy.
获取关于加巴喷丁缓解潮热疗效和耐受性的初步前瞻性数据。
这项前瞻性单臂临床试验于2001年7月26日至2001年11月30日进行。患者先经历一周的基线期,然后接受4周的加巴喷丁治疗,在前3周剂量逐渐增加,从300毫克/天增至600毫克/天再到900毫克/天。数据主要来自患者填写的问卷。
在纳入试验的24名患者中,有20名可评估女性的数据。4名患者因察觉到与药物相关的不良症状而停用加巴喷丁,主要是与头晕和眩晕有关。完成这项临床试验的16名患者在治疗第四周时潮热频率相较于基线周平均降低了66%。其相应的潮热评分(频率乘以平均严重程度)降低了70%。此外,完成4周治疗的患者有强烈的趋势报告其他几种症状有所改善。
尽管应该进行双盲安慰剂对照临床试验以更好地阐明加巴喷丁对潮热患者的疗效和毒性,但现有数据表明,如果潮热患者不想使用激素疗法,加巴喷丁是一种可考虑的合理治疗方法。