Department of Urology, Institute of Urology (Laboratory of Reconstructive Urology), West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, People's Republic of China.
Center of Gerontology and Geriatrics, National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University, Chengdu, Sichuan, People's Republic of China.
Int Urogynecol J. 2021 May;32(5):1129-1141. doi: 10.1007/s00192-020-04659-w. Epub 2021 Feb 27.
The objective was to compare the clinical efficacy and safety of pharmacological interventions for interstitial cystitis and bladder pain syndrome (IC/BPS) with direct and indirect evidence from randomized trials.
We searched PubMed, the Cochrane library, and EMBASE for randomized controlled trials (RCTs) that assessed the pharmacological therapies for IC/BPS. Primary efficacy outcomes included ICSI (O'Leary Sant Interstitial Cystitis Symptom Index), ICPI (O'Leary Sant Interstitial Cystitis Problem Index), 24-h micturition frequency, visual analog scale (VAS), and Likert score for pain. Safety outcomes are total adverse events (AEs, intravesical instillation, and others), gastrointestinal symptoms, headache, pain, and urinary symptoms. A systematic review and Bayesian network meta-analysis were performed.
A total of 23 RCTs with 1,871 participants were identified. The ICSI was significantly reduced in the amitriptyline group (MD = -4.9, 95% CI: -9.0 to -0.76), the cyclosporine A group (MD = -7.9, 95% CI: -13.0 to -3.0) and the certolizumab pegol group (MD = -3.6, 95% CI:-6.5 to -0.63) compared with placebo group. Moreover, for ICPI, cyclosporine A showed superior benefit compared to placebo (MD = -7.6, 95% CI: -13 to -2.3). VAS score improved significantly in cyclosporine A group than pentosan polysulfate sodium (MD = 3.09, 95% CI: 0.13 to 6.07). None of the agents revealed a significant alleviation of 24-h micturition frequency. In terms of safety outcomes, the incidence rate on urinary symptoms for botulinum toxin A was the only variate higher than chondroitin sulfate (MD = -2.02, 95% CI: -4.99 to 0.66) and placebo (MD = -1.60, 95% CI:-3.83 to 0.17). No significant difference was found among the other treatments.
Cyclosporine A might be superior to other pharmacological treatments in efficacy. Amitriptyline and certolizumab pegol were capable of lowering the ICSI as well.
本研究旨在比较药物干预治疗间质性膀胱炎和膀胱疼痛综合征（IC/BPS）的临床疗效和安全性，通过来自随机试验的直接和间接证据进行评估。
我们检索了 PubMed、Cochrane 图书馆和 EMBASE 中评估 IC/BPS 药物治疗的随机对照试验（RCT）。主要疗效结局包括 O'Leary Sant 间质性膀胱炎症状指数（ICSI）、O'Leary Sant 间质性膀胱炎问题指数（ICPI）、24 小时排尿次数、视觉模拟量表（VAS）和疼痛的 Likert 评分。安全性结局为总不良事件（AE，膀胱内灌注和其他）、胃肠道症状、头痛、疼痛和尿路症状。进行了系统评价和贝叶斯网络荟萃分析。
共纳入 23 项 RCT 研究，共计 1871 名参与者。与安慰剂组相比，阿米替林组（MD=-4.9，95%CI：-9.0 至-0.76）、环孢素 A 组（MD=-7.9，95%CI：-13.0 至-3.0）和培塞利珠单抗组（MD=-3.6，95%CI：-6.5 至-0.63）的 ICSI 显著降低。此外，对于 ICPI，环孢素 A 与安慰剂相比具有更好的获益（MD=-7.6，95%CI：-13 至-2.3）。与戊聚糖多硫酸钠相比，环孢素 A 组的 VAS 评分显著改善（MD=3.09，95%CI：0.13 至 6.07）。没有一种药物能显著改善 24 小时排尿频率。在安全性结局方面，肉毒毒素 A 的尿路症状发生率是唯一高于硫酸软骨素（MD=-2.02，95%CI：-4.99 至 0.66）和安慰剂（MD=-1.60，95%CI：-3.83 至 0.17）的变量。其他治疗方法之间没有发现显著差异。
环孢素 A 在疗效上可能优于其他药物治疗。阿米替林和培塞利珠单抗也能降低 ICSI。
