Effect of Amitriptyline on Symptoms in Treatment Naive Patients With Interstitial Cystitis/Painful Bladder Syndrome
Effect of Amitriptyline on Symptoms in Treatment Naive Patients With Interstitial Cystitis/Painful Bladder Syndrome
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DOI：
10.1016/j.juro.2009.12.106
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发表时间：
2010-05-01
影响因子：
6.6
通讯作者：
Nyberg, Leroy M.
中科院分区：
文献类型：
--
作者：
Foster, Harris E., Jr.;Hanno, Philip M.;Nyberg, Leroy M.
目的：阿米替林常用于治疗间质性膀胱炎/痛性膀胱综合征。支持这一做法的证据主要来自一项小型、单站点的临床试验和病例报告。材料和方法：我们进行了一项多中心、随机、双盲、安慰剂对照的阿米替林临床试验，研究对象为对治疗天真的间质性膀胱炎/膀胱疼痛综合征患者。两个治疗组的研究参与者都接受了标准化的教育和行为矫正计划。在6周的时间里，药物剂量从每天10毫克增加到75毫克。主要结果是患者报告的症状改善的总体反应评估在治疗12周后进行评估。结果：共有271名受试者被随机抽样，231人(85%)在12周的随访中提供了总体反应评估。研究参与者主要是女性(83%)和白人(74%)，平均年龄为38岁。在意向治疗分析(271)中，阿米替林组和安慰剂组中报告较基线有中度或显著改善的受试者的应答率分别为55%和45%(p=0.12)。在药物剂量至少达到50毫克的受试者亚组(207人)中，阿米替林组(66%)的有效率显著高于安慰剂组(47%)(p=0.01)。结论：当考虑到所有随机受试者时，阿米替林加教育和行为矫正计划并不能显著改善初治的间质性膀胱炎/疼痛膀胱综合征患者的症状。然而，阿米替林对那些每天剂量达到50毫克或更高的人可能是有益的，尽管这一亚组比较事先没有明确规定。
Purpose: 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.Materials and Methods: We conducted a multicenter, randomized,double-blind, placebo controlled clinical trial of amitriptyline in subjects with interstitial cystitis/painful bladder syndrome who were naive 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.Results: 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).Conclusions: When all randomized subjects were considered, amitriptyline plus an education and behavioral modification program did not significantly improve symptoms in treatment naive 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.