儿童胃镜检查前不同时点口服或不口服西甲硅油胃镜视野清晰度的随机平行对照试验

Efficacy of the prior administration of simethicone on the quality of visual field in upper gastrointestinal endoscopy in pediatric patients : A randomized,parallel controlled trial

目的探讨儿童胃镜检查前不同时点口服或不口服西甲硅油乳剂对胃镜操作中视野清晰度的影响。方法以复旦大学附属儿科医院胃镜室接受胃镜检查的≥6岁儿童作为研究对象,以随机数字表法分为对照组、西甲硅油20 min和西甲硅油30 min组,分别不口服西甲硅油、胃镜检查前20和30 min口服西甲硅油10 m L,3组均于胃镜检查前5 min口服利多卡因胶浆。以胃镜下视野清晰度(A^D级)作为主要观察指标,以胃镜操作时间,胃镜检查前、检查后即刻和检查后30 min的不良事件,口服西甲硅油和利多卡因的依从性(Wong-Banker面部表情量表法,FPS-R)和患儿家属的候诊依从性(数字疼痛分级法)作为次要观察指标。对西甲硅油30 min组和对照组的视野清晰度行优效性检验(优效标准δ=0.10),西甲硅油20 min和西甲硅油30 min组的视野清晰度行非劣效性检验(等效标准δ=0.05)。结果 2005年3月1日至4月30日600例符合纳入标准行胃镜检查的患儿数据行中期分析,其中6例未记录主要结局指标,594例进入分析。对照组191例,男98例,年龄(10.0±2.6)岁;西甲硅油20 min组193例,男108例,年龄(10.0±2.7)岁;西甲硅油30 min组210例,男111例,年龄(9.8±2.5)岁。1视野清晰度B级及以上比例:对照组为73.8%(141/191),西甲硅油20 min组为95.3%(183/193),西甲硅油30 min组为92.8%(195/210);西甲硅油20 min和30 min组均显著高于对照组(P均<0.001)。西甲硅油30 min组和对照组间差值为19.0%(95%CI:11.9%~26.2%),P=0.006<0.025;西甲硅油20 min组和30 min组间差值为2.5%(95%CI:-2.1%~7.1%),P=0.000 69<0.025。2对照组、西甲硅油20 min和30 min组胃镜操作时间分别为(180±96)、(167±71)和(162±81)s,差异无统计学意义(P=0.08)。33组不良事件发生率相近。4西甲硅油20 min组和30 min组口服西甲硅油的依从性评分≤2分分别为99.0%和97.5%。对照组、西甲硅油20 min和30 min组口服利多卡因的依从性评分≤2分分别为84.0%、75.5%和67.9%,差异有统计学意义(P<0.001);家属候诊依从性≤2分分别为97.8%、95.7%和97.0%,差异无统计学意义(P=0.346)。结论主要结局指标中期分析支持优效性和非劣效性的假设,试验提前终止。在胃镜检查前20 min口服西甲硅油可提高视野清晰度,且不比胃镜检查前30 min口服效果差。

Objective To assess the relative efficacy of no premedication versus simethicone administered 20 or 30 minutes before upper gastrointestinal endoscopy in pediatric patients. Methods Patients older than 6 years who received upper gastrointestinal endoscopy in operating room of digestive endoscopy of Children＇s Hospital of Fudan University were included. They were randomly assigned to control group（ no simeithicone）,simethicone group 1（ receiving simeithicone 20 min before endoscopy）,simethicone group 2（ receiving simeithicone 30 min before endoscopy）. The 3 groups all received lidocaine（ 1 m L·year- 1） as preparation 5min before endoscopy. Primary outcome was the quality of visual field（ ranging from A to D）. Secondary outcomes were the time needed for the examination,adverse events,the acceptability and compliance. The superiority test was employed to compared the difference of quality of visual field between control and simeithicone groups 2（ δ = 0. 15） and the non-inferiority test was used to compared the difference between simeithicone 1 and 2 groups（ δ = 0. 05）. Results A total of 600 children enrolled in this study from March 1st to April 30 th in 2015 were used for preliminary analysis. Six patients loss of the primary outcome were excluded. There were 594 children in the final analysis. There were 191 children（ 98 boys） in the control group with the mean age of（ 10. 0 ± 2. 6）years,193 children（ 108 boys） in simethicone group 1 with the mean age of（ 10. 0 ± 2. 7） years,210 children（ 111 boys） in simethicone group 2 with the mean age of（ 9. 8 ± 2. 5） years. The percentage of children whose visual field quality graded as A or B was 73. 8% in the control group（ 141 /191）,95. 3% in simethicone group 1（ 183 /193） and 92. 8% in simethicone group 2（ 195 /210）. The percentage of children whose visual field quality graded as A or B either in simethicone 1 group or simethicone group 2 was higher than that in control group（ P 0. 001）. There was significant difference between control and simethicone 2groups（ 21. 3%,95% CI： 11. 9%- 26. 2%,P = 0. 006 0. 025）,and between simethicone group 1 and simethicone group 2（ 2. 5%,95% CI：- 2. 1% to 7. 1%,P = 0. 000 69 0. 025）. The time taken for the examination in 3 groups was（ 180 ± 96） vs（ 167 ± 71） vs（ 162 ± 81） s,without significant difference. The possibility of adverse events was similar among 3 groups. There were 99% and 97. 5% in simethicone group 1 and simethicone group 2 that the scores of compliance for receiving simethicone were below 2. And there were 84%,75. 5% and 67. 9% in the control group,simethicone group 1 and simethicone group 2 that the scores of compliance for receiving lidocaine were below 2（ P 0. 001）. There were 97. 8%,95. 7%,97% in 3 groups that the scores of compliance for waiting for the endoscopy were below 2（ P = 0. 346）. Conclusion According to the results of the current analsis,the trial was stopped early. Adding simethicone in preparation 20 min before upper gastrointestinal endoscopy can improve the quality of visual field,and the efficacy is not inferior to 30 min before endoscopy.