Gastrointestinal tract bleeding associated with naproxen sodium vs ibuprofen.
Gastrointestinal tract bleeding associated with naproxen sodium vs ibuprofen.
复制标题
萘普生钠与布洛芬相关的胃肠道出血。
作者：
B. Strom;R. Schinnar;W. Bilker;H. Feldman;J. Farrar;J. Carson
背景
使用处方数据库来近似非处方剂量，比较了与布洛芬和萘普生钠相关的需要住院治疗的胃肠道出血风险。
目的
目的评价萘普生钠的安全性。
方法
一个包含1986年1月至1993年2月俄亥俄州医疗补助数据和1983年4月至1993年7月密歇根州医疗补助数据的索赔数据库被用来比较101,318例分配萘普生钠的患者和277,601例分配布洛芬的患者。采用病例队列设计，将来自全队列的所有59例在首次研究药物处方后14天内发生上消化道出血（UGIB）住院的患者与由从联合药物队列中选择的10%随机受试者样本组成的子队列进行比较。
结果
在首次处方后14天内发生UGIB的发生率在萘普生钠队列中为26/101，318（0.026%）（95%置信区间[CI]，0.017%-0.038%），而在布洛芬队列中为33/277，601（0.012%）（95%CI，0.008%-0.017%）。总体而言，使用萘普生钠与布洛芬相比，调整后的相对风险为2.0（95%CI，1.1-3.8）。在有多种处方的人群中，接受非处方药典型剂量治疗的人群的粗相对风险为4.1（95%CI，1.2-13.8）。
结论
两种药物的UGIB总体发生率均较低。与低剂量布洛芬相比，使用低剂量萘普生钠几乎没有额外的绝对风险，尽管相对风险增加。然而，鉴于这些药物的广泛使用，大量额外的UGIB病例可能是由使用萘普生钠引起的。应考虑这种风险增加，尤其是对于UGIB基线风险升高的患者。
BACKGROUND
The risk of gastrointestinal tract bleeding requiring hospitalization associated with naproxen sodium was compared with that with ibuprofen, using a prescription database to approximate over-the-counter dosing.
OBJECTIVE
To evaluate the safety of naproxen sodium.
METHODS
A claims database containing Ohio Medicaid data from January 1986 through February 1993 and Michigan Medicaid data from April 1983 through July 1993 was used to compare 101,318 patients dispensed naproxen sodium with 277,601 patients dispensed ibuprofen. Using a case-cohort design, all 59 patients from the full cohort who had been hospitalized with upper gastrointestinal tract bleeding (UGIB) that developed within 14 days after the first prescription for the study drugs were compared with a subcohort made up of a 10% random sample of subjects selected from the combined drug cohorts.
RESULTS
The incidence of UGIB occurring within 14 days after the first prescription in the naproxen sodium cohort was 26 (0.026%) of 101,318 (95% confidence interval [CI], 0.017%-0.038%), compared with 33 (0.012%) of 277,601 patients (95% CI, 0.008%-0.017%) in the ibuprofen cohort. Overall, the use of naproxen sodium vs ibuprofen was associated with an adjusted relative risk of 2.0 (95% CI, 1.1-3.8). Among people with multiple prescriptions, the crude relative risk for those receiving therapy in a dose typical of over-the-counter use was 4.1 (95% CI, 1.2-13.8).
CONCLUSIONS
The overall incidence of UGIB is low with both drugs. There is little additional absolute risk posed by the use of low-dose naproxen sodium, compared with low-dose ibuprofen, despite an increased relative risk. However, given the widespread use of these drugs, a substantial number of additional cases of UGIB could result from use of naproxen sodium. This increased risk should be considered, especially for patients whose baseline risk of UGIB is elevated.