补益类中药注射剂不良反应流行病学特点研究

Epidemiological Characteristics of Adverse Drug Reactions Induced by Chinese Herbal Injection for Tonify

目的探讨补益类中药注射剂不良反应发生的流行病学特点,为补益类中药注射剂的安全评价与合理使用提供参考。方法通过检索1972-2011年国内文献,收集补益类中药注射剂不良反应详细个案,建立病案数据库,应用统计学方法对不良反应信息进行分析。结果共收集7个补益类注射剂品种的详细不良反应个案233例,其中黄芪注射剂病案数量最多(86例);不良反应涉及人体多个系统,以呼吸系统损伤数量最多(80例,27.0%);男性患者117例(50.2%),女性患者116例(49.8%);平均年龄(51.40±16.67)岁;不良反应多发生在静脉滴注开始后30 min内(64.5%);患者原患疾病多为癌症(19.3%)、冠心病(15.9%)及高血压(6.0%)等;仅有76例说明有合并用药情况,主要合并抗生素、其他中药制剂及维生素类制剂。结论补益类中药注射剂不良反应的发生与合并用药和医生辨证失误等因素有关,促进合理用药是减少中药注射剂不良反应发生的关键。

Objective To investigate the epidemiological characteristics of adverse drug reactions （ADRs） induced by Chinese herbal injection for tonify, and provide reference for safety evaluation and rational use. Methods The ADR cases that issued on the domestic medicinal periodicals from 1972 to 2011 in China were collected comprehensively to build a database, and analyzed by statistic methods. Results Totally 233 ADR cases involving 7 different kinds of Chinese herbal injection for tonify were collected, in which 86 cases weighted the most were related to Huangqi Injection. Chinese herbal injection for tonify may induce multiple systematic ADRs. The incidence of respiratory damage was 27.0%（80 cases）, which was dominated in the ADRs. The incidence of ADRs had no difference between the genders （male was 117 cases, 50.2%, and female was 116 cases, 49.8%）, and the average age of patients was （51.40±16.67） years old. ADRs often occurred within half an hour after the start of infusion （64.5%）. The diseases of patients mostly were cancer （19.3%）, coronary heart disease （15.9%）, and hypertension （6.0%）, etc. Only 76 cases mentioned the combination therapy, which mainly combined with the drugs of antibiotics, other traditional Chinese medicines and vitamin. Conclusion ADRs of Chinese herbal injection for tonify are always induced by drug combinations, inappropriate medication, and other factors. To use Chinese herbal injection more rational and enhance prevention awareness may be the key to reduce the occurrence of ADRs.