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A型肉毒杆菌毒素治疗特发性膀胱过度活动症的疗效与安全性:一项系统评价与荟萃分析。

The efficacy and safety of onabotulinumtoxinA in treating idiopathic OAB: A systematic review and meta-analysis.

作者信息

Cui Yuanshan, Zhou Xin, Zong Huantao, Yan Huilei, Zhang Yong

机构信息

Department of Urology, Beijing Tian-Tan Hospital, Capital Medical University, Beijing, China.

出版信息

Neurourol Urodyn. 2015 Jun;34(5):413-9. doi: 10.1002/nau.22598. Epub 2014 Mar 28.

DOI:10.1002/nau.22598
PMID:24676791
Abstract

AIM

We carried out a systematic review and meta-analysis to assess the efficacy and safety of the drug for treating idiopathic OAB.

METHODS

A literature review was performed to identify all published randomized double-blind, placebo-controlled trials of onabotulinumtoxinA for the treatment of idiopathic OAB. The search included the following databases: MEDLINE, EMBASE, and the Cochrane Controlled Trials Register. The reference lists of the retrieved studies were also investigated.

RESULTS

Eight publications involving a total of 1,320 patients were used in the analysis, including six RCTs that compared onabotulinumtoxinA with placebo. OnabotulinumtoxinA significantly decreased the mean number of urinary incontinence (UI) per day -2.77 versus -1.01 (the standardized mean difference (SMD) = -1.68, 95% CI = -2.06 to -1.31, P < 0.00001); the mean number of micturitions per day -1.61 versus -0.87 (SMD = -1.82, 95% CI = -2.61 to -1.02, P < 0.00001); maximum cystometric capacity (MCC) 91.39 versus 32.32 (SMD = 63.82, 95% CI = 38.14 to 89.50, P < 0.00001) and volume voided 44.29 versus 7.36 (SMD = 33.05, 95% CI = 22.45 to 43.66, P < 0.00001) versus placebo and 29.20% versus 7.95% of patients became incontinence-free (odds ratio [OR] = 4.89, 95% confidence interval [CI] = 3.11 to 7.70, P < 0.00001). Safety assessments primarily localized to the urinary tract indicated onabotulinumtoxinA were often associated with complications resulting from postvoid residuals (PVR; P < 0.00001), urinary tract infections (UTI; P < 0.00001) and clean intermittent catheterization (CIC; P < 0.00001).

CONCLUSION

This meta-analysis indicates that onabotulinumtoxinA to be an effective treatment for idiopathic overactive bladder symptoms with side effects primarily localized to urinary tract.

摘要

目的

我们进行了一项系统评价和荟萃分析,以评估该药物治疗特发性膀胱过度活动症的疗效和安全性。

方法

进行文献综述,以确定所有已发表的关于A型肉毒毒素治疗特发性膀胱过度活动症的随机双盲、安慰剂对照试验。检索包括以下数据库:医学文献数据库(MEDLINE)、荷兰医学文摘数据库(EMBASE)和Cochrane对照试验注册库。还对检索到的研究的参考文献列表进行了调查。

结果

八项共涉及1320例患者的出版物用于分析,其中包括六项将A型肉毒毒素与安慰剂进行比较的随机对照试验。与安慰剂相比,A型肉毒毒素显著降低了每日尿失禁(UI)的平均次数——分别为-2.77次和-1.01次(标准化均数差(SMD)=-1.68,95%可信区间(CI)=-2.06至-1.31,P<0.00001);每日排尿次数分别为-1.61次和-0.87次(SMD=-1.82,95%CI=-2.61至-1.02,P<0.00001);最大膀胱测压容量(MCC)分别为91.39和32.32(SMD=63.82,95%CI=38.14至89.50,P<0.00001),排尿量分别为44.29和7.36(SMD=33.05,95%CI=22.45至43.66,P<0.00001),且与安慰剂相比,29.20%的患者与7.95%的患者不再有尿失禁(优势比[OR]=4.89,95%可信区间[CI]=3.11至7.70,P<0.00001)。主要局限于尿路的安全性评估表明,A型肉毒毒素常与残余尿量(PVR;P<0.00001)、尿路感染(UTI;P<0.00001)和清洁间歇性导尿(CIC;P<0.00001)引起的并发症相关。

结论

这项荟萃分析表明,A型肉毒毒素是治疗特发性膀胱过度活动症症状的有效方法,其副作用主要局限于尿路。

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