摘要
目的：了解中成药用药合理性对用药安全性的影响。方法采用整群抽样方法，收集广东省药品不良反应监测中心2011年1月1日至12月31日收到的中成药（含中药注射剂）不良反应报告进行回顾性分析。从报告中提取患者性别、年龄、原发疾病、引起不良反应的可疑药物、合并用药及不良反应发生情况等信息，按照拟定的中成药处方评价标准，从适应证、辨证用药、用药方法、用药剂量、中成药联用、中西药联用和用药适宜性等7个方面分析报告中的不合理用药情况并计算不合理用药率。结果共收集到符合入选标准的中成药不良反应报告283份，涉及患者283例，其中男性150例，女性133例，年龄2个月-88岁，平均（44±23）岁。原发疾病排前3位者为呼吸系统疾病（71例）、神经系统疾病（45例）和肌肉骨骼系统疾病（42例）。不良反应报告中涉及的中成药品种主要有清热解毒剂、活血祛瘀剂及补益剂3大类。283份不良反应报告中针对适应证、用药方法、用药剂量、中成药联用、中西药联用及用药适宜性的不合理用药率分别为27.2%（77份）、6.0%（17份）、7.1%（20份）、5.3%（15份）、6.7%（19份）、0.7%（2份）。在32份能辨识中医证型的报告中，15份（46.8%）用药不符合辨证施治原则。结论不合理用药对中成药用药安全性有明显影响，可能是引起中成药不良反应的重要因素之一。临床使用中成药应以辨证用药为首要原则，避免超适应证用药，注意用法用量，谨慎联用功能相似的中成药和药理作用类似的中西药物。
Objective To understand the effect of rational use of traditional Chinese patent medicines on medication safety. Methods By using cluster sampling method,the adverse drug reaction （ADR）reports about traditional Chinese patent medicines（including traditional Chinese medicine for injections）derived from the Center for ADR Monitoring of Guangdong from January 1st,2011 to December 31st,2011,were collected and retrospectively analyzed. The information of the patients＇ gender,ages, primary diseases,the suspected drugs causing ADR,drug combination,and the situation of ADR occurrence were collected. The situation of irrational drug use in these reports at 7 aspects such as indications, syndrome differentiation treatment,medication methods,dosage,combination of traditional Chinese patent medicines,concomitant use of the traditional Chinese medicines and the Western medicines,and suitability of medication were analyzed according to the protocol of evaluation standards of traditional Chinese patent medicine prescription and the rate of irrational drug use were calculated. Results A total of 283 reports in accordance with the inclusion criteria were collected,which comprised 283 patients. Of them,150 were male and 133 were female with ages from 2 months to 88 years and an average age was（44 ± 23）years. The primary diseases ranking at the top three were respiratory system disease（ 71 patients ）,nervous system disease（45 patients）,and musculoskeletal system disease（42 patients）. The traditional Chinese patent medicines involved in these reports were mainly antipyretic-detoxicating agents,blood activating and stasis removing agents,and reinforcing agents. The rates of irrational drug use associated with indications, medication methods,dosage,combination of traditional Chinese patent medicines,concomitant use of the traditional Chinese medicines and the Western medicines,and suitability of medication were 27. 2%（77/283）, 6. 0%（17/283）,7. 1%（20/283）,5. 3%（15/283）,6. 7%（19/283）,0. 7%�
出处
《药物不良反应杂志》
CSCD
2014年第5期281-285,共5页
Adverse Drug Reactions Journal
关键词
中成药
不合理用药
Traditional Chinese patent drugs
Irrational drug use
