关键词: NGF TNF‐α autoimmunity interstitial cystitis/bladder pain syndrome monoclonal antibody

来  源:   DOI:10.1002/nau.25547

Abstract:
OBJECTIVE: This study aimed to assess the efficacy and safety of monoclonal antibody therapies (MATs) for interstitial cystitis/bladder pain syndrome (IC/BPS).
METHODS: A systematic search was conducted across databases including PubMed, Embase, clinicalTrial.gov, and the Cochrane Library Central Register of Controlled Trials. Randomized controlled trials (RCTs) comparing MATs versus placebo were included. Primary outcomes comprised the Global Response Assessment (GRA) scale and the O\'Leary-Sant Interstitial Cystitis Symptom Index (ICSI). Additional analyses encompassed mean daily frequency of voids, the O\'Leary-Sant Interstitial Cystitis Problem Index, pain scores, and complications. Statistical analyses were performed using Review Manager 5.3.
RESULTS: Five high-quality RCTs, comprising 263 patients with IC/BPS, were ultimately selected. MATs were generally effective in treating IC/BPS. Patients receiving MATs exhibited a higher satisfaction rate (odds ratio [OR]: 2.7, confidence interval [CI]: 1.31-5.58, p = 0.007) and lower ICSI scores (mean difference [MD]: -1.44, CI: -2.36 to -0.52, p = 0.002). Moreover, MAT recipients experienced reduced pain (MD: -0.53, CI: -0.79 to -0.26, p < 0.0001) and decreased frequency of urination (MD: -1.91, CI: -2.55 to -1.27, p < 0.00001). Importantly, there were no disparities regarding complication incidence in the MAT and control groups.
CONCLUSIONS: The current findings indicate that MATs are effective and safe for treating IC/BPS. Nonetheless, future RCTs with larger sample sizes and long-term follow-up are warranted.
摘要:
目的:本研究旨在评估单克隆抗体治疗间质性膀胱炎/膀胱疼痛综合征(IC/BPS)的疗效和安全性。
方法:在包括PubMed、Embase,clinicalTrial.gov,和Cochrane图书馆中央控制试验登记册。纳入比较MATs与安慰剂的随机对照试验(RCTs)。主要结果包括全球反应评估(GRA)量表和O'Leary-Sant间质性膀胱炎症状指数(ICSI)。其他分析包括平均每日空隙频率,O\'Leary-Sant间质性膀胱炎问题指数,疼痛评分,和并发症。使用ReviewManager5.3进行统计分析。
结果:五个高质量的RCT,包括263例IC/BPS患者,最终被选中。MATs通常可有效治疗IC/BPS。接受MATs的患者满意度较高(比值比[OR]:2.7,置信区间[CI]:1.31-5.58,p=0.007),ICSI评分较低(平均差[MD]:-1.44,CI:-2.36至-0.52,p=0.002)。此外,MAT患者疼痛减轻(MD:-0.53,CI:-0.79至-0.26,p<0.0001),排尿频率降低(MD:-1.91,CI:-2.55至-1.27,p<0.00001)。重要的是,MAT组和对照组的并发症发生率没有差异.
结论:目前的研究结果表明,MATs治疗IC/BPS是有效和安全的。尽管如此,未来需要更多样本量和长期随访的随机对照试验.
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