南京市2008～2010年抗感染相关药物的不良反应报告分析

Analysis of Anti-Infective Related Adverse Drug Reactions Reported in Nanjing City from 2008 to 2010

目的探讨南京地区抗感染药物相关不良反应(ADR)发生的一般规律及有关特点,对ADR发生率较高的头孢菌素类药物进行重点分析,为临床合理用药提供资料。方法回顾性研究方法与描述性研究方法相结合。将6549份报告,按患者年龄、性别、用药情况及ADR主要表现、发生时间及转归等进行统计。应用Access 2003和Excel 2003对数据进行汇总分析。运用SPSS 19.0进行统计学处理。结果6549例ADR病例共涉及抗感染药物9类、43种。表现类型以皮肤及其附件损害(24.75%)、全身性损害(20.16%)、胃肠道反应(19.82%)居多。药物以头孢菌素类占多数(41.18%);对于不同感染患者,头孢菌素类药物引起的ADR与其他抗感染药物比较(χ2=45.858,P<0.001),差异有统计学意义,说明头孢菌素类药物比其他抗感染药更易引起ADR。各代头孢菌素类药物在不同部位的分布比较结果为(χ2=55.388,P<0.001),提示其引起的ADR损害部位有差异,其中以皮肤及附件系统损害居多(68.63%)。结论抗感染药物引起的ADR涉及系统广泛,尤其是使用头孢菌素类药物,应着重考虑患者的性别、年龄、合并用药情况。加强ADR监测和预防,保证用药安全性,提高患者生命质量。

Objective To explore the general occurrence pattern and the features of the adverse drug reaction （ADR） of anti-infective drugs in Nanjing, especially cephalosporins with high incidence of ADR and provide information for rational clinical medication. Methods The retrospective study method combined with the descriptive study method was used. A total of 6549 reports were statistically analyzed in respects of patients＇ age, gender, medication condition, main ADR manifestation, onset time of ADR, and outcomes. The software Access 2003 and Excel 2003 were used for pooled analysis of data and SPSS 19.0 was used for statistical process. Results These 6549 ADR cases involved 9 categories, 43 kinds of antiinfective drugs. The major manifestation types were skin and appendage damage （24.75% ）, systemic damage （20.16 %） , and gastrointestinal tract reactions （19.82% ）. The main drug that induced ADR was eephalosporins （41. 18%）. For patients with different infections, there was a statistically significant difference between cephalosporins and other anti-infective drugs （x^2 = 45.858, P 〈 0.001 ） , indicating that cephalosporins were easier to cause ADR than other anti-infective drugs. Comparison results of ADR distribution in different body parts between each generation of cephalosporins suggested that there were differences in affected parts of induced ADR （x^2= 55. 388, P 〈 0. 001） and the majority damage occurred in gastrointestinal system （68. 63 %）. Conclusion The ADR of anti-infective drugs involved extensive organ systems, especially cephalosporin drugs. This study suggested that cephalosporins should be used with consideration of patients＇ sex, age, condition of concomitant medication. The ADR monitoring and prevention should be strengthened to ensure the safety of drug use and improve patients＇ quality of life.