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既往健康状况对药物不良反应警报程序结果的影响:吡罗昔康和舒林酸治疗前的胃肠道疾病

Impact of preexisting health conditions on the outcome of an adverse drug reaction alerting program: gastrointestinal disorders before piroxicam and sulindac therapy.

作者信息

Rawson N S

机构信息

Merck Frosst/Medical Research Council of Canada, Saskatoon, Saskatchewan.

出版信息

Ann Pharmacother. 1995 Jul-Aug;29(7-8):676-80. doi: 10.1177/106002809502907-804.

DOI:10.1177/106002809502907-804
PMID:8520079
Abstract

OBJECTIVE

To assess the impact of data concerning preexisting serious gastrointestinal (GI) disorders before piroxicam and sulindac therapy in an acute adverse drug reaction alerting program.

DESIGN

Cohort study.

SETTING

Saskatchewan province's prescription drug and healthcare insurance system covering a population of approximately 1 million.

PARTICIPANTS

The first 20,000 new patients who were dispensed piroxicam in 1982 and the first 20,000 patients who were dispensed sulindac in 1979-1981 through the Saskatchewan drug plan.

MAIN OUTCOME MEASURES

Physician services and hospitalizations with a diagnosis of peptic ulceration or GI hemorrhage within 30 days of the first piroxicam or sulindac prescription.

RESULTS

Rates of physician services for peptic ulceration or GI hemorrhage in the 30 days after starting piroxicam or sulindac therapy for patients who had services or hospitalizations for serious stomach or duodenum disorders in the 90 days before their prescriptions were significantly greater than the corresponding rates for patients without a recent history of these conditions (piroxicam: odds ratio [OR] = 7.89; 95% confidence interval [CI] = 5.71 to 10.91; p < 0.001; sulindac: OR = 24.08; 95% CI = 18.99 to 30.54; p < 0.001). Also, the rate of hospitalizations for peptic ulceration or GI hemorrhage in the 30 days after starting sulindac therapy for patients who had services for the conditions in the previous 90 days was significantly greater than the rate for patients who did not (OR = 10.91; 95% CI = 5.70 to 20.87; p < 0.001).

CONCLUSIONS

Rates of serious GI disorders in patients taking piroxicam and sulindac with a recent history of such disorders were larger than those in the other patients. However, because the proportion of individuals with recent serious GI disorders is small, these differences are lost in an overall assessment of patients taking these drugs. Data regarding preexisting health conditions are essential in adverse drug reaction alerting program and, indeed, in all evaluations of adverse reactions.

摘要

目的

评估在急性药物不良反应警报程序中,有关服用吡罗昔康和舒林酸治疗前已存在的严重胃肠道(GI)疾病的数据所产生的影响。

设计

队列研究。

背景

萨斯喀彻温省的处方药和医疗保险系统,覆盖人口约100万。

参与者

1982年通过萨斯喀彻温省药物计划首次配给吡罗昔康的前20000名新患者,以及1979 - 1981年首次配给舒林酸的前20000名患者。

主要观察指标

在首次开具吡罗昔康或舒林酸处方后30天内,诊断为消化性溃疡或胃肠道出血的医生诊疗服务和住院情况。

结果

在处方前90天内有严重胃或十二指肠疾病的诊疗服务或住院史的患者,在开始服用吡罗昔康或舒林酸治疗后30天内,消化性溃疡或胃肠道出血的医生诊疗服务发生率显著高于近期无此类疾病史的患者(吡罗昔康:优势比[OR]=7.89;95%置信区间[CI]=5.71至10.91;p<0.001;舒林酸:OR = 24.08;95%CI = 18.99至30.54;p<0.001)。此外,在开始舒林酸治疗前90天内有相关疾病诊疗服务的患者,在开始治疗后30天内消化性溃疡或胃肠道出血的住院率显著高于无此情况的患者(OR = 10.91;95%CI = 5.70至20.87;p<0.001)。

结论

近期有此类疾病史的服用吡罗昔康和舒林酸的患者,严重胃肠道疾病的发生率高于其他患者。然而,由于近期有严重胃肠道疾病的个体比例较小,在对服用这些药物的患者进行总体评估时,这些差异并不明显。关于既往健康状况的数据在药物不良反应警报程序中至关重要,实际上,在所有不良反应评估中均是如此。

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