美洛昔康、昔布类药物及 older, non-specific non-steroidal anti-inflammatory drugs使用者的引导性偏倚与胃肠道出血发生率 （注：这里“older, non-specific non-steroidal anti-inflammatory drugs”表述不太准确规范，可能是指传统非特异性非甾体抗炎药之类的意思，但按要求直接翻译）
Channelling bias and the incidence of gastrointestinal haemorrhage in users of meloxicam, coxibs, and older, non-specific non-steroidal anti-inflammatory drugs.
作者信息
MacDonald T M, Morant S V, Goldstein J L, Burke T A, Pettitt D
机构信息
Medicines Monitoring Unit, Department of Clinical Pharmacology and Therapeutics, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.
出版信息
Gut. 2003 Sep;52(9):1265-70. doi: 10.1136/gut.52.9.1265.
BACKGROUND
Although clinical trial results suggest that meloxicam has less gastrointestinal toxicity than most other non-steroidal anti-inflammatory drugs (NSAIDs), in practice it has been associated with a large number of yellow card reports of gastrointestinal complications.
AIMS
To estimate whether meloxicam and the coxibs, rofecoxib and celecoxib, have been channelled towards high risk patients, and to estimate the risk of hospitalisation for gastrointestinal haemorrhage associated with the use of these drugs, allowing for the effects of channelling.
PATIENTS
Using the UK General Practice Research Database, this study included 7.1 thousand patient years (tpy) exposure to meloxicam, 1.6 tpy exposure to coxibs, and 628 tpy exposure to older non-specific NSAIDs.
METHODS
Cohort study of patients who received a prescription for an NSAID between June 1987 and January 2001. Exposure to newer NSAIDs (meloxicam, rofecoxib, celecoxib) and to older non-specific NSAIDs was identified. Channelling was assessed on factors including: demographic variables; diagnosis of arthritis; history of NSAID use or gastrointestinal events, including gastrointestinal haemorrhage; and use of ulcer healing drugs.
RESULTS
Most risk factors for gastrointestinal haemorrhage were more prevalent among patients prescribed the newer NSAIDs. Adjusting for these risk factors reduced the relative risks of gastrointestinal haemorrhage on meloxicam and coxibs versus older non-specific NSAIDs to 0.84 (95% confidence interval 0.60, 1.17) and 0.36 (0.14, 0.97), respectively.
CONCLUSIONS
Channelling towards high risk gastrointestinal patients occurred in the prescribing of newer NSAIDs. After attempting to correct for channelling bias, coxib exposure, but not meloxicam exposure, was associated with a significantly lower risk of gastrointestinal haemorrhage than older non-specific NSAID exposure.
背景
尽管临床试验结果表明，美洛昔康的胃肠道毒性低于大多数其他非甾体抗炎药（NSAIDs），但在实际应用中，它已与大量关于胃肠道并发症的黄卡报告相关联。
目的
评估美洛昔康、昔布类药物（罗非昔布和塞来昔布）是否被用于高危患者，并评估使用这些药物导致胃肠道出血住院的风险，同时考虑用药倾向的影响。
患者
利用英国全科医疗研究数据库，本研究纳入了7100患者年（tpy）的美洛昔康暴露、1600 tpy的昔布类药物暴露以及628 tpy的 older non-specific NSAIDs暴露。
方法
对1987年6月至2001年1月期间接受NSAIDs处方的患者进行队列研究。确定了对新型NSAIDs（美洛昔康、罗非昔布、塞来昔布）和 older non-specific NSAIDs的暴露情况。根据以下因素评估用药倾向：人口统计学变量；关节炎诊断；NSAIDs使用史或胃肠道事件史，包括胃肠道出血；以及溃疡愈合药物的使用情况。
结果
大多数胃肠道出血的危险因素在开具新型NSAIDs处方的患者中更为普遍。对这些危险因素进行调整后，美洛昔康和昔布类药物相对于 older non-specific NSAIDs导致胃肠道出血的相对风险分别降至0.84（95%置信区间0.60，1.17）和0.36（0.14，0.97）。
结论
在新型NSAIDs的处方中存在将药物用于高危胃肠道患者的用药倾向。在试图纠正用药倾向偏差后，与 older non-specific NSAIDs暴露相比，昔布类药物暴露而非美洛昔康暴露与显著更低的胃肠道出血风险相关。
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