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首页> 外文期刊>The Canadian journal of hospital pharmacy. >Need for a Randomized Controlled Trial of Stress Ulcer Prophylaxis in Critically III Children: A Canadian Survey
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Need for a Randomized Controlled Trial of Stress Ulcer Prophylaxis in Critically III Children: A Canadian Survey

机译：需要对批评性儿童的应激溃疡预防的随机对照试验：加拿大调查

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Background: 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. Objective: To describe the views of Canadian pediatric intensivists about a future RCT of stress ulcer prophylaxis. Methods: 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 chi~2 test. Results: 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% [n= 10]) and H2RA with placebo (8% [n= 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% [n = 38]), those with severe coagulopathy or receiving extracorporeal membrane oxygenation (both 36% [n = 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% [n = 19]) indicated that participation would depend on trial design or funding; only 8% (n = 5) were disinclined to participate. Conclusions: 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.
机译：背景：应激溃疡预防常用于儿科临界护理，以防止上胃肠道出血。最常用的药剂是组胺-2受体拮抗剂（H2RAS）和质子泵抑制剂（PPI）。压力溃疡预防的风险效益率不确定，因为来自随机临床试验（RCT）对儿童预防效力和危害的数据有限。目的：描述加拿大儿科强度对应激溃疡预防未来RCT的看法。方法：我们在加拿大儿科关键护理医生进行了在线调查。我们通过电子邮件发送有关该研究的信息和向111个潜在受访者提供10项调查的链接，其中有2个提醒无回应者。我们评估了受访者特征与他们关于使用逻辑回归的需要和潜在参与的意见的关系，并使用Chi〜2测试评估区域差异。结果：回答的68名医生（61％的潜在受访者）中位数为12年（第5-20岁）的经验。四十四（65％）的受访者表示，需要对儿童中的应激溃疡预防大规模RCT，94％（62个中的66个）表明它应包括安慰剂组。建议的3种最常见的设计是3手臂试验比较PPI，H2RA和安慰剂（56％[66名受访者中的37名受访者中的37名]）和2-ARM试验与安慰剂进行比较（15％[n = 10]）和安慰剂的H2RA（8％[n = 5]）。应排除最常见的受访者的5名患者组（因为它们不应该接受安慰剂）是在家中接受酸抑制的儿童（66％[64名受访者中的64名受访者]或皮质类固醇（59％[n = 38] ），具有严重凝血病或接受体外膜氧合的那些（36％[n = 23]），以及燃烧的那些（31％ n = 20]）。大多数受访者表示愿意参加RCT（64％[66名受访者中的64名受访者]），而一些（29％[N = 19]）表明参与取决于试验设计或资金;只有8％（n = 5）不愿意参加。结论：在加拿大儿科关键护理医生中，对压力溃疡预防的安慰剂溃疡预防患者有相当兴趣，但需要对试验设计的关键要素共识。

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