摘要
目的研究参麦注射液不良反应(ADR)发生率、临床表现及影响因素等。方法对我院2014年8月至2016年12月使用参麦注射液的住院患者进行研究,记录患者基本信息、ADR发生时间、临床表现及转归等。结果共纳入监测病历1 425份,用于心肌梗死、冠心病、病毒性心肌炎等疾病的辅助治疗,其中共发生ADR 34例,ADR发生率为2.38%,主要累及器官以皮肤及附件、中枢神经系统和呼吸系统为主,与中药注射剂、抗菌药物联合用药时较易发生不良反应。经统计学检验,不同性别、不同年龄段、给药浓度在0.08~0.32 mL/mL范围内不良反应发生率差异无统计学意义(P>0.05);肿瘤患者、用药时间≤1 d的ADR发生率差异有统计学意义(P<0.05)。所有不良反应给予相应对症干预措施后明显好转,无加重或死亡患者。结论临床中应严格按照参麦注射液说明书中推荐的用法用量使用。同时,建议厂家及时完善药品说明书。
Objective To study the rate of adverse drug reaction （ADR）, clinical manifestations and influencing factors of Shenmai injection. Methods The patients who used Shenmai injection in our hospital from August 2014 to December 2016 were enrolled, the basic information of patients, the time of occurrence of ADR, the clinical manifestations and prognosis. Results A total of 1 425 patients were included, and the injection was mainly used in the adjuvant treatment of myocardial infarction, coronary heart disease, viral myocarditis and so on ; there were 34 cases of ADR,the rate of ADR was 2. 38% ;the main clinical manifestations of ADR were damage in the skin and accessory system, central nervous system and respiratory system; when Shenmal injection was used in combination with others traditional Chinese medicine injections and antibacterial drugs,ADR was more likely to occur. Statistical analysis showed that there were no differences in incidence rate of ADR in different gender, age or different drug concentration in the range of 0. 08 to 0. 32 mL/mL（ P 〉 0.05 ） ,but there were significant differences in the rate in patients with cancer and medication time less than one day （ P 〈 0.05 ）. All ADRs were significantly improved after symptomatic intervention, with no aggravation or death. Conclusion Shenmai injection should be used in accordance with drug instructions. Meanwhile, manufacturers should perfect the drug instruction in time.
出处
《实用药物与临床》
CAS
2018年第1期94-97,共4页
Practical Pharmacy and Clinical Remedies
关键词
参麦注射液
药物不良反应
合理用药
医院集中监测
Shenmai injection
Adverse drug reaction
Rational drug use
Intensive hospital monitoring
