内镜下注射肉毒杆菌治疗贲门失弛缓症的Meta分析

Intrasphincteric Injection of Botulinum Toxin for Achalasia:Meta Analysis of Randomized Controlled Trials

目的评价内镜下注射肉毒杆菌治疗贲门失弛缓症的有效性和安全性。方法计算机检索CBM（1978～2012．6）、CNKI（1979～2012．6）、MEDLINE（1950～2012．6）、PubMed（1950～2012．6）、EMbase（1970～2012．6）和The Cochrane Library（2012年第2期），全面收集关于注射肉毒杆菌治疗贲门失弛缓症的随机对照试验（RCT）研究，并检索纳入研究的参考文献。由2位研究者按照纳入与排除标准筛选文献、评价文献及提取资料，采用Cochrane协作网的方法进行系统评价。结果共纳入18个RCT，包括885例患者。Meta分析显示：1）短期总有效率：注射肉毒杆菌毒素治疗高于安慰剂[OR=43．79，95％CI（7．39～259．49），P〈0．0001]；气囊扩张治疗高于注射肉毒杆菌毒素治疗[OR=0．47，95％CI（0．30～0．73），P=0．0007]。2）长期总有效率：气囊扩张治疗高于内镜下注射肉毒杆菌毒素治疗[OR=0．31，95％CI（0．13～0．70），P=0。005]；3）临床复发率：内镜下注射肉毒杆菌毒素治疗高于内镜下气囊扩张治疗[OR=8．88，95％CI（3．31～23．79），P〈0．0001]。4）不良反应及并发症发生率：气囊扩张治疗高于内镜下注射肉毒杆菌毒素治疗[OR=0．14，95％CI（0．04～0．44），P=0．0008]。结论目前的证据表明，内镜下注射肉毒杆菌治疗具有较好的短期疗效，且操作简单方便，不良反应少，建议在临床实践中依患者具体病情选用。

Objective To determine the effectiveness and safety of Intrasphincteric injection of botulinum toxin for achalasia of carolia. Methods Randomized controlled trials on relevant studies were retrieved from the database including CBM （1978-2012.6）, CNKI （1979-2012.6）, MEDLINE （1950-2012.6）, PubMed （1950-2012. 6） ,EMbase （1970-2012.6） and The Cochrane Library （Issue 2, 2012）. References of the included studies were also retrieved. Two reviewers independently screened the literature according to the inclusion and exclusion criteria, extracted data, and assessed the methodological quality of the included studies. Systematic review was conducted using the method recommended by the Cochrane collaboration. Results Eighteen trials involving 885 patients were included in the systematic review. Meta analysis showed： 1） Short term symptom relief： Intrasphincteric injection of botulinum toxin was superior to placebo （P 〈 0. 0001 ）, Pneumatic dilatation was superior to intrasphincteric botulinum toxin injection （P = 0. 0007）; 2）Long term symptom relief： Pneumatic dilatation was superior to intrasphincteric botulinum toxin injection（P= 0. 005）; 3）Clinical relapse rate.. Intrasphincteric botulinum toxin injection was superior to Pneumatic dilatation（P〈0. 0001）; 4） Complications： pneumatic dilatation was superior to intrasphincteric hotulinum toxin injection （P = 0. 0008）. Conclusion The current evidence showed that intrasphincteric injection of botulinum toxin is safe and effective in the short term treatment for achalasia of cardia.