CAJ | 학술논문

目的：探讨头孢哌酮/他唑巴坦药品不良反应（ADR）发生的一般特点与规律，并提出预防对策，为促进临床安全、有效、合理用药提供参考。方法采用回顾性研究方法，对我院2005年1月～2015年5月上报至国家不良反应监测中心的76例头孢哌酮/他唑巴坦 ADR 报告，从患者年龄、性别、原患疾病、用法用量、ADR 发生时间、ADR 临床表现等方面进行回顾性统计分析。结果76例头孢哌酮/他唑巴坦 ADR 报告中，患者在性别方面无统计学差异（P＞0.05），而在年龄、原患疾病等方面存在显著差异性（P＜0.01）。ADR 发生的时间以30 min内为主（59.21%）。ADR 以皮肤及其附件损害最多（55.22%），其次是全身性损害、血液系统损害等。76例中严重的 ADR 有7例，主要以过敏性休克和血液系统损害为主。结论临床应严格掌握头孢哌酮/他唑巴坦的适应证及用法用量，加强对头孢哌酮/他唑巴坦的用药监护，告知患者使用该药可能发生的 ADR，并做好突发严重 ADR 的应急处理措施。
목적：탐토두포고동/타서파탄약품불량반응（ADR）발생적일반특점여규률，병제출예방대책，위촉진림상안전、유효、합리용약제공삼고。방법채용회고성연구방법，대아원2005년1월～2015년5월상보지국가불량반응감측중심적76례두포고동/타서파탄 ADR 보고，종환자년령、성별、원환질병、용법용량、ADR 발생시간、ADR 림상표현등방면진행회고성통계분석。결과76례두포고동/타서파탄 ADR 보고중，환자재성별방면무통계학차이（P＞0.05），이재년령、원환질병등방면존재현저차이성（P＜0.01）。ADR 발생적시간이30 min내위주（59.21%）。ADR 이피부급기부건손해최다（55.22%），기차시전신성손해、혈액계통손해등。76례중엄중적 ADR 유7례，주요이과민성휴극화혈액계통손해위주。결론림상응엄격장악두포고동/타서파탄적괄응증급용법용량，가강대두포고동/타서파탄적용약감호，고지환자사용해약가능발생적 ADR，병주호돌발엄중 ADR 적응급처리조시。
Objective To summarize the characteristics and rules of adverse drug reactions (ADRs) induced by cefoperazone/tazobactam and provide prevention countermeasures for clinical safe, effective and rational use of antimicrobials by analysis of antibacterial-related ADR reports. Methods 76 ADR reports were statistically analyzed from Jan, 2005 to May, 2015 in our hospital to ADR monitoring center. The patient's age, gender, diseases, usage and dosage, ADR occurrence time and clinical manifestations were analyzed retrospectively. Results Among the 76 cases of ADR, the difference in gender aspect was not significant (P >0.05). There were statistically significant differences of the age, kinds of diseases (P <0.01). Less than 30 minutes after administration were ADR high -incidence period (59.21%). The main side effects were injuries of skin and its appendages (55.22%), and followed by systemic damage and hematological system damage, etc. 76 cases of ADR including 7 reports of serious adverse reactions, allergic shock and hematological system were involved in the most of cases. Conclusion The indication and dosage of cefoperazone/tazobactam should be strictly mastered by clinicians, and the pharmaceutical care of cefoperazone/tazobactam should be strengthened. The medical staff should tell patients potential ADR and prepare the emergency treatment measures for incidentally critical ADR.