A randomized controlled trial of intravesical bacillus Calmette-Guerin for treatment refractory interstitial cystitis
A randomized controlled trial of intravesical bacillus Calmette-Guerin for treatment refractory interstitial cystitis
复制标题
DOI：
10.1097/01.ju.0000152337.82806.e8
复制
发表时间：
2005-04-01
影响因子：
6.6
通讯作者：
Foster, HE
中科院分区：
文献类型：
--
作者：
Mayer, R;Propert, KJ;Foster, HE
目的：我们比较了膀胱内卡介苗（BCG）与安慰剂滴注治疗难治性间质性膀胱炎（IC）患者。材料和方法：符合美国国立卫生研究院-国家糖尿病、消化和肾脏疾病研究所IC标准，并且在入组研究前至少6个月报告至少中度疼痛和频率的受试者，被随机分配到6个每周一次的BCG或安慰剂的双盲膀胱内滴注，然后随访总共34周。主要结局是第34周时患者报告的总体缓解评估，并在第31 - 34周期间补充IC药物。次要结局包括24小时排尿日记、疼痛、尿急、经验证的IC症状指数和不良事件。目标样本量为260名参与者，旨在检测安慰剂和BCG之间的反应率的差异为30%和50%，respectively.Results：共有265名参与者被随机分组，17名（6%）患者退出研究。安慰剂组和BCG组的主要结局应答率分别为12%和21%（p = 0.062）。观察到所有次要结局都有小幅改善，BCG组更是如此，但这些差异具有边缘统计学意义。虽然大量的不良事件报告在BCG臂，有没有统计学上的显着差异，治疗组之间的总体不良事件rate.Conclusions：虽然BCG的安全性是可以接受的，反应率的主要结果是低。有效的药物治疗中度至重度间质性膀胱炎患者仍然难以捉摸。
Purpose: We compared intravesical bacillus Calmette-Guerin (BCG) to placebo instillations in patients with treatment refractory interstitial cystitis (IC).Materials and Methods: Subjects who met the National Institutes of Health-National Institute for Diabetes and Digestive and Kidney Diseases criteria for IC, and reported at least moderate pain and frequency for a minimum of 6 months before study entry, were randomized to 6 weekly double-blinded intravesical instillations of either BCG or placebo, and then followed for a total of 34 weeks. The primary outcome was a patient reported global response assessment at week 34, supplemented with medications for IC during weeks 31 to 34. Secondary outcomes included a 24-hour voiding diary, pain, urgency, validated IC symptom indexes and adverse events. The target sample size was 260 participants, designed to detect a difference in response rates between placebo and BCG of 30% and 50%, respectively.Results: A total of 265 participants were randomized and 17 (6%) patients withdrew from study. The response rates for the primary outcome were 12% for placebo and 21% for BCG (p = 0.062). Small improvements were observed for all secondary outcomes, some more so with BCG, but these differences were of borderline statistical significance. Although a large number of adverse events were reported in the BCG arm, there was no statistically significant difference between the treatment arms in overall adverse event rates.Conclusions: Although the BCG safety profile was acceptable, the response rate for the primary outcome was low. Effective medical treatment for patients with moderate to severe interstitial cystitis remains elusive.