摘要
目的 通过随机对照的临床研究来对比经口内镜下肌切开术(POEM)、肉毒素注射(BTI)和球囊扩张(BD)治疗贲门失弛缓症的安全性和有效性。方法 2011年11月至2012年5月45例贲门失弛缓症患者被随机平均分配到POEM组、BTI组和BD组。对治疗后3个月的疗效和安全性进行对比分析。主要结果是症状缓解率,次要结果是并发症发生率、下食管括约肌压力(LESP)和食管最大宽度。结果 所有45例患者均成功进行了内镜下的治疗,并且治疗后3个月随访成功率为100%。症状缓解率POEM组为100%,BTI组为66.7%,BD组为93.3%,其中POEM组和BTI组两组间的差异有统计学意义(P<0.05),而POEM组与BD组、BD组与BTI组之间差异无统计学意义。并发症发生率POEM组为13.3%,BTI组为0,BD组为6.7%,但3组间的差异无统计学意义。LESP、食管最大宽度在3组之间比较,术前和术后的差异均无统计学意义。结论 治疗后3个月,POEM的症状缓解率高于BTI和BD,而并发症发生率3种方法相似。
Objective Endoscopic treatments for achalasia include peroral endoscopic myotomy(POEM),botulinum toxin injection(BTI)and balloon dilation( BD),yet no randomized studies have compared POEM with the other two treatments.This study was aimed to compare the short term efficacy and safety of the three treatments in a randomized manner.Methods Forty-five patients were randomly allocated into three treatment groups,namely POEM,BTI and BD. Outcomes at 3 months after treatment were documented and compared among the groups from November 2011 to May 2012. The primary outcome was symptom remission,and the secondary outcomes were complication rate,lower esophageal sphincter pressure(LESP) and maximum width of esophagus by barium swallow. Results Endoscopic treatments were successfully performed in all of the 45 patients,and all patients were successfully followed up at 3 months after treatment.Symptom remission rate was 100 % in POEM group,66.7 % in BTI group and 93.3 % in BD group,and the difference was statistically significant between POEM and BTI (P<0.05),but not significant between POEM and BD or between BD and TBI.Complication rate was 13.3 % in POEM group,0 in BTI group and 6.7 % in BD group with no statistical difference found between the three groups. LESP,maximum width of esophagus were similar both before and after treatment among the three groups.Conclusions Symptom remission rate of POEM was higher than BTI and BD at 3 month after treatment,but only statistically different between POEM and BTI,not between any other two groups.Meanwhile,complication rates were similar among the three groups.
出处
《中华腔镜外科杂志（电子版）》
2012年第5期7-11,共5页
Chinese Journal of Laparoscopic Surgery(Electronic Edition)
关键词
经口内镜下肌切开术
肉毒素注射
球囊扩张
贲门失弛缓症
随机对照试验
Peroral endoscopic myotomy
Botulinum toxin injection
Balloon dilation
Achalasia of cardia
Randomized controlled trial
