128例口服卡马西平导致不良反应文献分析

Literature Analysis of 128 Cases With Carbamazepine Induced A dverse Reactions

目的探讨卡马西平(CMP)导致不良反应(ADR)的一般规律及特点,为临床合理用药提供参考。方法采用回顾性分析方法,选择2000年1月至2009年10月中国期刊全文数据库收载的国内医、药学期刊报道的128例口服CMP导致ADR患者纳入本研究,并对与ADR发生的相关数据进行统计学分析(本研究遵循的程序符合本院人体试验委员会所制定的伦理学标准,得到该委员会批准)。结果口服CMP导致ADR的临床表现复杂多样,皮肤及附件、中枢及外周神经系统和血液系统损害发生率分别为58.60%(75/128),14.84%(19/128)和10.16%(13/128)。口服CMP导致的男、女个体ADR发生率比较,差异有统计学意义(P<0.05),可发生于各年龄个体,但在11～40岁及>60岁个体的发生率较高。本组CMP联合用药导致的ADR较严重,包括大疱表皮坏死松解型药疹、全身性肌阵挛发作及白细胞计数降低等。128例患者中,治愈率为93.75%(120/128),后遗症发生率为0.78%(1/128),抢救无效死亡率为5.47%(7/128)。结论临床应重视口服CMP导致的ADR,尤其应警惕该药导致的重型药疹、再生障碍性贫血及急性肾衰竭等。另外,临床应特别重视CMP联合用药导致的大疱表皮坏死松解型药疹、全身性肌阵挛发作、白细胞计数降低等严重ADR。

Objective To explore the general characteristics of adverse drug reactions （ADR） caused by the earbamazepine （CMP）, and provide some information for clinical medication. Methods The related reports about ADR caused by CMP were searched and retrospective analyzed in medical and academic journals from China Journal Full Text Database between January 2000 and October 2009. At last, a total of 128 cases were include into this study. The study protocol was approved by the Ethical Review Board of Investigation in Human Being of Shanxi Medical University. Results Clinical manifestations of ADR caused by the CMP were complex and diverse. The top three incident rate of systemic injury were skin and its appendages injury （58.60%, 75/128）, central and peripheral nervous system injury （14.84%, 19/128） and blood disorders （10. 16%, 13/128）. There had significant difference of incident rate between males and females （P〈0.05）. The ADR can occur in any age stages, and patients older than 60-year-old had the highest incident rate （11.72%, 5/128）. The ADR caused by drug combination may have serious results, such as bullous epidermal necrolysis drug eruption, generalized myoclonic seizures and leukocyte reduction. In 128 patients, the cure rate was 93.75% （120/128）, occurrence rate of sequelae was 0.78% （1/128） and rate of rescue invalid death was 5.47% （7/128）. Conclusions Clinicians should pay attention to the ADR caused by CMP, especially guard against the occurrence of serious drug-induced rash, aplastic anemia and acute renal failure. And further knowledge about serious ADR, such as bullous epidermal necrolysis drug eruption, generalized myoclonic seizures and leukocyte reduction caused by drug combination, should be attention.