Stricker B H, Tijssen J G
Netherlands Center for Monitoring of Adverse Reactions to Drugs, Rijswijk.
J Clin Epidemiol. 1992 Oct;45(10):1177-84. doi: 10.1016/0895-4356(92)90158-j.
In this study, we evaluated whether the high number of reports of serum sickness to cefaclor was present in every country and year, and whether these figures from voluntary reporting facilitated an estimation of the relative risk. A nested case-control study was performed with reports of all suspected adverse reactions (ADR) to cefaclor, amoxicillin and cephalexin in the period 1968-1987, as reported to the WHO Collaborating Center for International Drug Monitoring from the U.S.A., the U.K., Sweden, Canada and Germany. The ADR-reporting odds ratio was defined as the ratio of the odds of the number of ADR-reports of serum sickness to cefaclor and amoxicillin or cephalexin and the odds of similar reports of non-serum sickness to cefaclor and amoxicillin or cephalexin. The ADR-reporting odds ratio adjusted for country, age, gender, origin of the report and year of marketing was 12.4 for cefaclor vs amoxicillin and 18.5 for cefaclor vs cephalexin. In children (< 15 years of age) and in adults (> 15 years of age), the relative risk of developing serum sickness of cefaclor vs amoxicillin was estimated at 13.9 (95% confidence interval (95% CI): 6.0-32.2) and 2.9 (95% CI: 0.9-9.4) respectively in the U.S.A., and at 15.1 (95% CI: 7.2-31.5) and 5.5 (95% CI: 2.0-15.0) respectively in the other four countries together. In this study, the ADR-reporting odds ratio facilitated a valid estimation of the relative risk.
在本研究中，我们评估了各国每年头孢克洛血清病报告数量是否居高不下，以及这些来自自愿报告的数据能否用于估计相对风险。我们开展了一项巢式病例对照研究，研究对象为1968年至1987年期间向世界卫生组织国际药品监测合作中心报告的所有疑似头孢克洛、阿莫西林和头孢氨苄不良反应（ADR），这些报告来自美国、英国、瑞典、加拿大和德国。ADR报告比值比定义为头孢克洛血清病ADR报告数与阿莫西林或头孢氨苄报告数的比值，以及头孢克洛和阿莫西林或头孢氨苄非血清病类似报告数的比值。针对国家、年龄、性别、报告来源和上市年份进行调整后，头孢克洛与阿莫西林的ADR报告比值比为12.4，头孢克洛与头孢氨苄的ADR报告比值比为18.5。在美国，儿童（<15岁）和成人（>15岁）中，头孢克洛与阿莫西林相比发生血清病的相对风险估计分别为13.9（95%置信区间（95%CI）：6.0 - 32.2）和2.9（95%CI：0.9 - 9.4），在其他四个国家总体中分别为15.1（95%CI：7.2 - 31.5）和5.5（95%CI：2.0 - 15.0）。在本研究中，ADR报告比值比有助于有效估计相对风险。
