Department of Surgery, Section of Urology, Yale University, New Haven, Connecticut 06520-8041, USA.
J Urol. 2010 May;183(5):1853-8. doi: 10.1016/j.juro.2009.12.106. Epub 2010 Mar 29.
Amitriptyline is frequently used to treat patients with interstitial cystitis/painful bladder syndrome. The evidence to support this practice is derived mainly from a small, single site clinical trial and case reports.
We conducted a multicenter, randomized, double-blind, placebo controlled clinical trial of amitriptyline in subjects with interstitial cystitis/painful bladder syndrome who were naïve to therapy. Study participants in both treatment arms received a standardized education and behavioral modification program. The drug dose was increased during a 6-week period from 10 up to 75 mg once daily. The primary outcome was a patient reported global response assessment of symptom improvement evaluated after 12 weeks of treatment.
A total of 271 subjects were randomized and 231 (85%) provided a global response assessment at 12 weeks of followup. Study participants were primarily women (83%) and white (74%), with a median age of 38 years. In an intent to treat analysis (271) the rate of response of subjects reporting moderate or marked improvement from baseline in the amitriptyline and placebo groups was 55% and 45%, respectively (p = 0.12). Of the subgroup of subjects (207) who achieved a drug dose of at least 50 mg, a significantly higher response rate was observed in the amitriptyline group (66%) compared to placebo (47%) (p = 0.01).
When all randomized subjects were considered, amitriptyline plus an education and behavioral modification program did not significantly improve symptoms in treatment naïve patients with interstitial cystitis/painful bladder syndrome. However, amitriptyline may be beneficial in persons who can achieve a daily dose of 50 mg or greater, although this subgroup comparison was not specified in advance.
阿米替林常用于治疗间质性膀胱炎/膀胱疼痛综合征患者。支持这种治疗的证据主要来自一项小型的单中心临床试验和病例报告。
我们进行了一项多中心、随机、双盲、安慰剂对照的阿米替林治疗间质性膀胱炎/膀胱疼痛综合征患者的临床试验，这些患者对治疗均无经验。治疗组和安慰剂组的研究参与者均接受了标准化的教育和行为改变计划。在 6 周的时间内，药物剂量从 10 毫克增加到 75 毫克，每日 1 次。主要结局是在治疗 12 周后，患者报告的症状改善总体评估。
共有 271 名患者被随机分组，231 名（85%）在 12 周的随访中提供了总体评估。研究参与者主要为女性（83%）和白人（74%），中位年龄为 38 岁。在意向治疗分析（271 名）中，报告从基线开始中度或显著改善的患者，阿米替林组和安慰剂组的比例分别为 55%和 45%（p=0.12）。在达到至少 50 毫克药物剂量的亚组（207 名）中，阿米替林组的应答率（66%）明显高于安慰剂组（47%）（p=0.01）。
当考虑所有随机患者时，阿米替林加教育和行为改变计划并不能显著改善间质性膀胱炎/膀胱疼痛综合征初治患者的症状。然而，阿米替林可能对能达到每日 50 毫克或更高剂量的患者有益，尽管这一分组比较并未预先指定。
