Duffett Mark, Choong Karen, Foster Jennifer, Gilfoyle Elaine, Lacroix Jacques, Cook Deborah J
, PhD, RPh, is with the Department of Pediatrics, McMaster University, Hamilton, Ontario.
MB, BCh, MSc, is with the Departments of Pediatrics and of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario.
Can J Hosp Pharm. 2017 Jul-Aug;70(4):288-293. doi: 10.4212/cjhp.v70i4.1679. Epub 2017 Aug 31.
Stress ulcer prophylaxis is commonly used in pediatric critical care, to prevent upper gastrointestinal bleeding. The most frequently used agents are histamine-2 receptor antagonists (H2RAs) and proton pump inhibitors (PPIs). The risk-benefit ratio for stress ulcer prophylaxis is uncertain, because data from randomized clinical trials (RCTs) on the effectiveness and harms of prophylaxis in children are limited.
To describe the views of Canadian pediatric intensivists about a future RCT of stress ulcer prophylaxis.
We conducted an online survey of Canadian pediatric critical care physicians. We e-mailed information about the study and a link to a 10-item survey to 111 potential respondents, with 2 reminders for nonrespondents. We assessed the relationship between respondents' characteristics and their views about the need for and potential participation in a trial using logistic regression and assessed regional differences using the χ test.
The 68 physicians who replied (61% of potential respondents) had a median of 12 (interquartile range 5-20) years of experience. Forty-four (65%) of the respondents stated that a large, rigorous RCT of stress ulcer prophylaxis in children is needed, and 94% (62 of 66) indicated that it should include a placebo group. The 3 most common designs suggested were a 3-arm trial comparing PPI, H2RA, and placebo (56% [37 of 66 respondents to this question]) and 2-arm trials comparing PPI with placebo (15% [ = 10]) and H2RA with placebo (8% [ = 5]). The 5 patient groups that respondents most commonly stated should be excluded (because they should not receive placebo) were children receiving acid suppression at home (66% [42 of 64 respondents to this question]) or corticosteroids (59% [ = 38]), those with severe coagulopathy or receiving extracorporeal membrane oxygenation (both 36% [ = 23]), and those with burns (31% [ = 20]). Most respondents indicated a willingness to participate in an RCT (64% [42 of 66 respondents to this question]), whereas some (29% [ = 19]) indicated that participation would depend on trial design or funding; only 8% ( = 5) were disinclined to participate.
There is considerable interest in a placebo-controlled RCT of stress ulcer prophylaxis among pediatric critical care physicians in Canada, but consensus on key elements of the trial design is needed.
应激性溃疡预防常用于儿科重症监护，以预防上消化道出血。最常用的药物是组胺-2受体拮抗剂（H2RAs）和质子泵抑制剂（PPIs）。应激性溃疡预防的风险效益比尚不确定，因为关于儿童预防有效性和危害的随机临床试验（RCTs）数据有限。
描述加拿大儿科重症监护医师对应激性溃疡预防未来RCT的看法。
我们对加拿大儿科重症监护医师进行了一项在线调查。我们通过电子邮件向111名潜在受访者发送了有关该研究的信息和一份10项调查问卷的链接，并对未回复者进行了2次提醒。我们使用逻辑回归评估受访者特征与其对试验必要性和潜在参与度看法之间的关系，并使用χ检验评估地区差异。
回复的68名医生（占潜在受访者的61%）中位经验为12年（四分位间距5 - 20年）。44名（65%）受访者表示需要在儿童中进行一项大型、严谨的应激性溃疡预防RCT，94%（66名中的62名）表示应包括安慰剂组。最常建议的3种设计是比较PPI、H2RA和安慰剂的三臂试验（56%[该问题的66名受访者中的37名]）以及比较PPI与安慰剂的双臂试验（15%[ = 10]）和比较H2RA与安慰剂的双臂试验（8%[ = 5]）。受访者最常表示应排除（因为不应接受安慰剂）的5个患者组是在家接受抑酸治疗的儿童（66%[该问题的64名受访者中的42名]）或接受皮质类固醇治疗的儿童（59%[ = 38]）、患有严重凝血障碍或接受体外膜肺氧合的儿童（两者均为36%[ = 23]）以及烧伤儿童（31%[ = 20]）。大多数受访者表示愿意参与RCT（64%[该问题的66名受访者中的42名]），而一些人（29%[ = 19]）表示参与将取决于试验设计或资金；只有8%（ = 5）不愿意参与。
加拿大儿科重症监护医师对应激性溃疡预防的安慰剂对照RCT有相当大的兴趣，但需要就试验设计的关键要素达成共识。
