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Vibegron 治疗膀胱过度活动症的疗效和安全性:系统评价和随机对照试验的荟萃分析。

The efficacy and safety of Vibegron in treating overactive bladder: A systematic review and pooled analysis of randomized controlled trials.

机构信息

Department of Urology, General Hospital of Ningxia Medical University, Yinchuan, Ningxia, China.

Department of Urology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, China.

出版信息

Neurourol Urodyn. 2020 Jun;39(5):1255-1263. doi: 10.1002/nau.24387. Epub 2020 May 18.

DOI:10.1002/nau.24387
PMID:32421908
Abstract

OBJECTIVE

Vibegron is a new kind of β3-adrenergic receptor agonist. We performed a systematic review and pooled analysis to assess the efficacy, safety, and tolerability of Vibegron for treating overactive bladder (OAB).

METHODS

MEDLINE, the Cochrane Controlled Trial Register and EMBASE were used to pick out randomized controlled trials (RCTs) of Vibegron in treating OAB. The reference lists of the retrieved articles were also studied. We used RevMan version 5.3.0. to analyze the data.

RESULTS

Three high-quality RCTs involving a total of 2120 OAB patients were adopted in the systematic review and pooled analysis. The mean number of micturitions episodes/d (mean difference [MD] = -0.77; 95% confidence interval [CI] = -1.0 to -0.55; P < .00001); the mean number of urgency episodes/d (MD = -0.77; 95% CI = -1.03 to -0.52; P < .00001); mean number of urgency incontinence episodes/d (MD = -0.50; 95% CI = -0.64 to -0.35; P < .00001); mean number of incontinence episodes/d (MD = -0.45; 95% CI = -0.66 to -0.25; P < .0001); and mean volume voided/micturition (MD = 22.22; 95% CI = 17.36 to 27.07, P < .00001) showed that Vibegron was more efficacy in treating OAB than placebo. Dry mouth, drug-related treatment-emergent adverse event (TEAE), serious adverse event (SAE), and discontinuations due to adverse event (AE) suggested that Vibegron was well tolerated.

CONCLUSIONS

Our systematic review and pooled analysis demonstrate that Vibegron 75 mg or 100 mg/d statistically significant improved OAB symptoms. The treatment was well-tolerated, with a favorable safety profile.

摘要

目的

Vibegron 是一种新型的β3-肾上腺素能受体激动剂。我们进行了一项系统评价和荟萃分析,以评估 Vibegron 治疗膀胱过度活动症(OAB)的疗效、安全性和耐受性。

方法

使用 MEDLINE、Cochrane 对照试验登记处和 EMBASE 检索 Vibegron 治疗 OAB 的随机对照试验(RCT)。还研究了检索到的文章的参考文献列表。我们使用 RevMan 版本 5.3.0 进行数据分析。

结果

系统评价和荟萃分析纳入了三项高质量的 RCT,共纳入 2120 例 OAB 患者。排尿次数/天的平均次数(均数差 [MD] = -0.77;95%置信区间 [CI] = -1.0 至 -0.55;P < 0.00001);尿急次数/天的平均次数(MD = -0.77;95% CI = -1.03 至 -0.52;P < 0.00001);急迫性尿失禁次数/天的平均次数(MD = -0.50;95% CI = -0.64 至 -0.35;P < 0.00001);尿失禁次数/天的平均次数(MD = -0.45;95% CI = -0.66 至 -0.25;P < 0.0001);以及每次排尿量(MD = 22.22;95% CI = 17.36 至 27.07,P < 0.00001)表明 Vibegron 在治疗 OAB 方面比安慰剂更有效。口干、与药物相关的治疗后出现的不良事件(TEAE)、严重不良事件(SAE)和因不良事件(AE)而停药表明 Vibegron 具有良好的耐受性。

结论

我们的系统评价和荟萃分析表明,Vibegron 75mg 或 100mg/d 可显著改善 OAB 症状。该治疗方法具有良好的耐受性,安全性良好。

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