中药不良反应108例报告分析

目的 了解本院中药不良反应发生特点及一般规律,预防不良反应的发生,促进临床合理用药.方法 采用回顾性研究方法,收集山东省烟台市莱阳中心医院2010年1月至2011年9月的108例中药不良反应报告,分别从患者的一般情况、给药途径、药物种类及临床表现等方面进行统计分析.结果 不良反应报告中,51～60岁年龄段发生不良反应的比例最高,占29.6%（32/108）;静脉滴注最易导致不良反应,占66.7%（76例）,其次为口服给药,占22.2%（24例）;临床表现以皮肤及其附件损害最常见,占39.5%;不良反应发生在1 d以内者89例,占82.4%.中药注射剂不良反应发生率排名前3位的分别是艾迪注射液（9.3%）、丹红注射液（5.6%）、生脉注射液（4.6%）.中药口服制剂不良反应发生率排前3位的分别是茴三硫胶囊（6.5%）、先声咳喘宁（5.6%）、舒肝宁（3.7%）.给药途径以静脉滴注（72例,占66.7%）和口服给药（24例,占22.2%）为主.108例不良反应报告中,治愈40例,好转67例,无死亡病例,1例严重不良反应留有后遗症.结论 药品不良反应与多种因素有关,应辨证看待中药不良反应,加强对中药不良反应监测,提高临床用药安全.

Report of 108 cases of adverse reactions caused by common Chinese patent medicine

Objective To understand the characteristic and general rules of Chinese medicine adverse reaction to prevent the occurrence of adverse reactions. Methods Totally 108 cases of traditional Chinese medicine ADR reports from January 2010 to September 2011 in Yantai Laiyang Central Hospital of Shandong province were collected, including the patient＆#39;s general situation, dosing method, types of drugs and the clinical manifestation were analyzed. Results The male ADR incidence was significantly higher than female. Age 51 to 60 years old had the highest percentage of ADR, accounting for 29.6% （32/108）. Intravenous drips that the most easily led to ADR were 66.7%, followed by oral drugs that were 22.2%. The skin and its accessories damage was the most common （39.5%） ADR Clinical manifestations. ADR occurring mainly within the one day accounted for 82.4% （89 cases）. The top three ADR incidence of injection preparations of Chinese medicine were Aidi injection （9.3%）, Danhong injection （5.6%） and Shengmai injection （4.6%）. The top three ADR incidence of oral preparations of Chinese medicine were anethole capsule （6.5%）, Kechuanning oral liquid （5.6%） and shuganning capsule （3.7%）. 40 cases of 108 cases of ADR reports were cured, 67 cases were improved and one case of severe adverse reactions had sequela without deaths. Conclusion Adverse drug reactions are related to multiple factors. We should collect the traditional Chinese medicine adverse reactions, strengthen the ADR monitoring and improve clinical medication safety.