摘要
目的了解中药注射剂不良反应特点及规律,促进其合理应用。方法采用回顾性研究方法。从广东省药品不良反应监测中心数据库下载2010年至2011年深圳市各单位上报的不良反应/事件报告表,筛选出中药注射剂不良反应/事件报告表进行分类统计、分析。结果共筛选出与报告1 001例,涉及92个生产厂家的48个中药注射剂品种,几乎全部采用静脉滴注给药方式,多发生在给药后30 min内。累及的器官/系统主要为皮肤及其附件,其次为全身性损害、循环系统等。不良反应/事件包括各年龄段人群,无明显性别差异,0～9岁婴幼儿不良反应发生率最高(19.48%),低年龄段给药剂量普遍偏高。新的不良反应/事件446例次,占44.56%。对症处理后,绝大多数转归良好。严重不良反应/事件比例为6.89%,主要表现为呼吸、循环系统症状及过敏性休克。结论中药注射剂不良反应/事件具有普遍性,应加强对中药注射制剂不良反应/事件的监测。临床应按中医理论合理使用中药注射剂,减少或避免中药注射剂在儿童人群中的使用;有关部门应加强对中药制剂说明书内容的监管与完善,保障患者用药安全。
Objective To find out the occurrence features and the regularity of the adverse drug reactions/events （ADR/ADE） induced by traditional Chinese medicine injections for promoting their rational use. Methods By using the retrospective analysis method, all ADR/ADE reported by various medical institutions in Shenzhen city from 2010 to 2011 were downloaded from the database of the Guangdong Provincial Center for ADR Monitoring in the form of Excel electronic forms. ADR/ADE reports of traditional Chinese medicine injections were screened out and analyzed. Results 1 001 cases of ADR/ADE of traditional Chinese medicine injections were screened out and involved 48 traditional Chinese medicine products from 92 manufacturers. The intravenous administration routes were used in the absolutely most of cases. The onset time of ADR/ADE was mainly within 30 rain after injection. The lesions of ADR/ADE involved primarily in skin and its accessories, followed by the systemic lesions, circulation system and nerve system, etc. All age groups were involved in ADR/ADE without significant gender difference. Children 0-9 years old had the highest occurrence rate of ADR/ ADE （19.48%）. The prescribed single dosage in children with low age was on the high side. Among all ADR/ADE reports, 446 cases （44.56%） of new ADR/ADE were presented and had good prognosis after symptomatic treatment. The severe ADR/ADE accounted for 6.89%, mainly manifested by respiratory system, circulation system symptoms and allergy shock. Conclusion ADR/ADE induced by tra-ditional Chinese medicine injections is universal and its monitoring should be enhanced. The traditional Chinese medicine injections should be rationally used in clinic according to the traditional Chinese medicine theory, their use in children population should be re-duced or avoided. The relative administration departments should strengthen the supervision and perfect the instruction contents of tradi-tional Chinese medicine preparations for ensuring the patient＇s medication safety.
出处
《中国药业》
CAS
2013年第15期70-72,共3页
China Pharmaceuticals
关键词
中药注射剂
药品不良反应
回顾分析
Chinese medicine injections
adverse drug reactions/events
retrospective analysis
作者简介
张开礼（1963-），主管药师，研究方向为医院药学，（电话）0755—83982222—30876（电子信箱）zhangk104@163．com；
李东，主任药师，研究方向为临床药学，本文通讯作者，（电话）0755-22942817（电子信箱）szlidong@126．com。
