Johannes Catherine B, Ziyadeh Najat, Seeger John D, Tucker Ed, Reiter Christoph, Faich Gerald
i3 Drug Safety, Waltham, MA 02451, USA.
Drug Saf. 2007;30(8):705-13. doi: 10.2165/00002018-200730080-00007.
Data on the incidence of serious allergic reactions to fluoroquinolone antibacterials are mainly derived from spontaneous reports that cannot be used to accurately estimate incidence.
This study estimated the drug-specific incidence of serious allergic reactions after fluoroquinolone, cephalosporin and phenoxymethylpenicillin potassium exposure, using claims for healthcare services with confirmation through medical record abstraction within a large health insurer database. Cohorts exposed to each antibacterial of interest (moxifloxacin, levofloxacin, ciprofloxacin, gatifloxacin, cephalosporins and penicillin) were identified, and followed for 14 days for anaphylaxis (9th revision of the International Classification of Diseases [ICD-9] code 995.0), other allergic drug reactions (ICD-9 995.2, 995.3) or cardiopulmonary resuscitation.
The incidence per 10,000 first dispensings of any allergic diagnosis made in the hospital or emergency department was similar for moxifloxacin (4.3; 95% CI 3.5, 5.3), penicillin (4.7; 95% CI 3.8, 5.7) and ciprofloxacin (5.4; 95% CI 4.4, 6.5). The incidence for moxifloxacin was lower than that for levofloxacin (8.7; 95% CI 7.4, 10.0), gatifloxacin (6.7; 95% CI 5.6, 7.9) and the cephalosporins (7.5; 95% CI 6.3, 8.8). The incidence of anaphylaxis/anaphylactoid reactions after first dispensings was similar for the fluoroquinolones: 0.1 (95% CI 0.0, 0.3) for ciprofloxacin, 0.3 (95% CI 0.1, 0.5) for moxifloxacin, 0.3 (95% CI 0.1, 0.6) for gatifloxacin and 0.5 (95% CI 0.3, 0.9) for levofloxacin; and comparable with that of the cephalosporins (0.2; 95% CI 0.0, 0.4) and penicillin (0.1; 95% CI 0.0, 0.3).
Anaphylactic reactions were rare and their incidence did not differ substantially among the drug groups studied. By determining the occurrence of reactions following defined exposures, these results provide a context for the interpretation of spontaneous reports of allergic reactions.
关于氟喹诺酮类抗菌药物严重过敏反应发生率的数据主要来自自发报告,这些报告无法用于准确估计发生率。
本研究利用大型健康保险公司数据库中医疗服务索赔数据,并通过病历摘要进行确认,估计了氟喹诺酮类、头孢菌素类和苯氧甲基青霉素钾暴露后特定药物的严重过敏反应发生率。确定了暴露于每种感兴趣抗菌药物(莫西沙星、左氧氟沙星、环丙沙星、加替沙星、头孢菌素类和青霉素)的队列,并随访14天,观察过敏反应(国际疾病分类第九版[ICD-9]编码995.0)、其他药物过敏反应(ICD-9 995.2、995.3)或心肺复苏情况。
每10000次首次配药后在医院或急诊科做出的任何过敏诊断的发生率,莫西沙星(4.3;95%可信区间3.5,5.3)、青霉素(4.7;95%可信区间3.8,5.7)和环丙沙星(5.4;95%可信区间4.4,6.5)相似。莫西沙星的发生率低于左氧氟沙星(8.7;95%可信区间7.4,10.0)、加替沙星(6.7;95%可信区间5.6,7.9)和头孢菌素类(7.5;95%可信区间6.3,8.8)。首次配药后过敏反应/类过敏反应的发生率在氟喹诺酮类药物中相似:环丙沙星为0.1(9�%可信区间0.0,0.3),莫西沙星为0.3(95%可信区间0.1,0.5),加替沙星为0.3(95%可信区间0.1,0.6), 左氧氟沙星为0.5(95%可信区间0.3,0.9);与头孢菌素类(0.2;95%可信区间0.0,0.4)和青霉素(0.1;95%可信区间0.0,0.3)相当。
过敏反应很少见,且在所研究的药物组中发生率没有实质性差异。通过确定特定暴露后反应的发生情况,这些结果为解释过敏反应的自发报告提供了背景信息。