2013—2014年南京中医药大学附属医院丹红注射液临床用药合理性分析

临床用药的合理性分析是考察影响中药注射剂临床效益与风险相关因素的必要研究。该研究基于南京中医药大学附属医院信息系统(HIS)数据库,选取2013年1月—2014年12月使用丹红注射液的4 950例患者的病案与医嘱信息,运用回顾性研究、基本统计和关联规则分析方法,统计分析患者自然情况、疾病诊断、应用科室、用法用量、联合用药和不良反应等信息,对丹红注射液的临床应用进行合理性分析,寻找发生不良反应的相关因素。研究结果显示,患者主要分布在心内科(51.96%)与脑病中心(20.67%),年龄40岁以上占96.66%,主要西医诊断2项关联置信度最高为冠心病+心绞痛(97.15%),3项关联为冠心病+心绞痛+高血压(97.02%),不合理诊断主要为高血压(12.93%)和糖尿病(4.55%);中医诊断均属血瘀证。用法用量方面,单次剂量在药品说明书规定范围内者占98.93%,用药天数集中分布在1~21 d,以0.9%氯化钠注射液和5%葡萄糖注射液为稀释溶媒的占97.64%。用药记录中,99.26%为联合用药,平均联用8.41种药物。与西药联用频次最高的依次是抗血小板药(72.04%)、调血脂药(64.86%)和脑血管疾病药(60.26%)。出现并发感染时,联用频次最高的抗菌药物为头孢菌素类(8.81%)。与中药联用以活血化瘀类中药注射剂或中药单体注射剂为主(28.93%),其中与天麻素注射液联用频次最高(16.23%)。不良反应报告/事件发生12例,发生率0.24%。适应症、稀释溶媒与联合用药的不合理应用可能是丹红注射液发生不良反应的潜在风险因素,需进一步实验研究评价这3方面的临床效益与风险。

Rationality analysis of clinical application of Danhong injection in affiliated hospital of Nanjing university of Chinese medicine from 2013 to 2014

It is necessary to investigate the influence of the rationality of clinical drug use on the benefit and risk factors of traditional Chinese medicine injections. The retrospective survey was based on the medical records and information of 4 950 patients who used Danhong injection in the HIS database of the first affiliated hospital of Nanjing University of Chinese Medicine from 2013 to 2014. The basic statistical methods and associated rules analysis were utilized to analyze the HIS information of these patients, including the basic information, the diagnosis, the department, the dosage, the usage of medication, the drug combination and the adverse reactions. And the rationality analysis of the clinical application of Danhong injection was carried out to investigate relevant factors of the adverse reactions. The results showed that most cases came from the department of cardiology (51.95%) and encephalopathy center (20.67%). In the statistical period, the patients aged above 40 years old accounted for 96.65%. And the two western medicine diagnosis items with the highest confidence level were coronary heart disease and angina pectoris (97.15%), while the three items were coronary heart disease, angina pectoris and hypertension (97.02%). The irrational indications were mainly hypertension (12.93%) and diabetes (4.55%). All of them were diagnosed as blood stasis syndrome by the traditional Chinese medicine. About 98.93% of the single dosage was within the range stipulated on package insert, the duration mainly ranged between 1 and 21 days, and 97.64% of the menstrua contained 0.9% NS and 5% GS. According to the medication records, 99.26% were the use of combined drugs, with 8.41 drugs on average. Antiplatelet drugs (72.04%) were the most frequently combined with western medicine, followed by the cholesterol-regulating drugs (64.86%) and the cerebrovascular drugs (60.26%). When used in the combination with antibiotics for the infection, cephalosporin antibiotics were the most frequently applied (8.81%). When used with traditional Chinese medicines, traditional Chinese medicines for activating blood circulation and removing blood stasis or monomer traditional Chinese medicine injections (28.93%) were the dominance, in which Gastrodin injection was the most frequently applied (16.23%). And 12 cases of adverse reactions were reported, with the ADR rate of 0.24%. The indications, solvent compatibility and irrational drug combination may be the potential risk factors for ADRs induced by Danhong injection. Further experiments are required to evaluate the benefits and risks in these three aspects.