Zhou Xin, Yan Hui-Lei, Cui Yuan-Shan, Zong Huan-Tao, Zhang Yong
Department of Urology, Beijing Tian Tan Hospital, Capital Medical University; Neurourology Research Division, China National Clinical Research Center for Neurological Disease, Beijing 100050, China.
Chin Med J (Engl). 2015 Apr 5;128(7):963-8. doi: 10.4103/0366-6999.154318.
OnabotulinumtoxinA is widely used in treating neurogenic detrusor overactivity (NDO). We carried out a systematic review and meta-analysis to assess the efficacy and safety of the drug for treating NDO.
We searched the following databases: Medline, EMBASE, and the Cochrane Controlled Trials Register. All published randomized double-blind, placebo-controlled trials of onabotulinumtoxinA for the treatment of NDO were identified in the analysis. The reference lists of the retrieved studies were also investigated.
Four publications involving a total of 807 patients were identified in the analysis, which compared onabotulinumtoxinA with placebo. The changes of the mean number of urinary incontinence per week (the standardized mean difference [SMD] = -10.91, 95% confidence intervals [CIs] = -14.18--7.63, P < 0.0001); maximum cystometric capacity (SMD = 146.09, 95% CI = 126.19-165.99, P < 0.0001) and maximum detrusor pressure (SMD = -32.65, 95% CI = -37.83--27.48, P < 0.0001) indicated that onabotulinumtoxinA was more effective than the placebo, despite the doses of onabotulinumtoxinA. Safety assessments primarily localized to the urinary tract indicated onabotulinumtoxinA were often associated with more complications. Urinary tract infections (relative risk [RR] =1.48, 95% CI = 1.20-1.81, P = 0.0002); hematuria (RR = 1.81, 95% CI = 1.00-3.24, P = 0.05) and urinary retention (RR = 5.87, 95% CI = 3.61-9.56, P < 0.0001).
This meta-analysis indicates that onabotulinumtoxinA to be an effective treatment for NDO with side effects primarily localized to urinary tract.
A型肉毒毒素广泛应用于治疗神经源性逼尿肌过度活动症（NDO）。我们进行了一项系统评价和荟萃分析，以评估该药物治疗NDO的疗效和安全性。
我们检索了以下数据库：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。分析纳入了所有已发表的关于A型肉毒毒素治疗NDO的随机双盲、安慰剂对照试验。我们还对检索到的研究的参考文献列表进行了调查。
分析确定了4篇文献，共涉及807例患者，这些文献将A型肉毒毒素与安慰剂进行了比较。每周尿失禁平均次数的变化（标准化均数差[SMD]=-10.91，95%置信区间[CI]=-14.18-7.63，P<0.0001）；最大膀胱测压容量（SMD=146.09，95%CI=126.19165.99，P<0.0001）和最大逼尿肌压力（SMD=-32.65，95%CI=-37.83-27.48，P<0.0001）表明，无论A型肉毒毒素的剂量如何，其治疗效果均优于安慰剂。主要针对尿路的安全性评估表明，A型肉毒毒素常伴有更多并发症。尿路感染（相对危险度[RR]=1.48，95%CI=1.201.81，P=0.0002）；血尿（RR=1.81，95%CI=1.003.24，P=0.05）和尿潴留（RR=5.87，95%CI=3.619.56，P<0.0001）。
这项荟萃分析表明，A型肉毒毒素是治疗NDO的有效药物，其副作用主要局限于尿路。
