| 张云玲,阚晓宏,贺思勋,等.383例参麦注射液医院集中监测临床应用分析[J].安徽医药,2018,22(3):526-529. |
| 383例参麦注射液医院集中监测临床应用分析 |
| Clinical application of hospital centralized monitoring on 383 cases using Shenmai injection |
| 投稿时间：2017-02-06 |
| DOI： |
| 中文关键词: 参麦注射液 安全性再评价 医院集中监测 合理用药 |
| 英文关键词: Shenmai injection adverse reaction hospital centralized monitoring rational drug use |
| 基金项目:“重大新药创制”专项项目(2009ZX09502-030) |
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| 中文摘要: |
| 目的 通过参与参麦注射液上市后临床安全性监测的研究,为规范临床安全合理用药提供参考。 方法 采用医院集中监测法对医院2013年7月—2014年12月所有使用参麦注射液的383例住院患者进行用药监测,填写参麦注射液上市后再评价监测表,对数据进行统计分析。 结果 383例使用参麦注射液的住院患者中,8.16%的患者诊断和参麦注射液说明书上的适应证不符；47.26%的病例选用生理盐水作为溶媒,与说明书不尽相符；用药剂量、药物浓度、配伍用药、给药途径等方面符合说明书要求； 2例患者发生不良反应,发生率为0.52%,无新发或严重不良反应发生。 结论 参麦注射液不良反应的发生率低,临床使用相对安全,但仍需规范临床操作,合理使用。 |
| 英文摘要: |
| Objective To provide reference for the rational use of drugs by participating in Shenmai injection post-marketing clinical research of safety monitoring,to standardize the clinical safety. Methods By the method of hospital centralized monitoring,we collected 383 cases of hospitalized patients who used Shenmai injection from July 2013 to December 2014,filled in listed evaluation table and analyzed the data. Results Among the 383 inpatients,8.16% of the patients′ diagnoses were not in conformity with the indications listed in the drug instruction,and 47.26% of cases chose physiological saline as solvent,which was not in conformity with the drug instruction.The dosage,drug concentration,compatibility of drugs,and drug delivery way were consistent with the drug instruction.Two cases had adverse reactions,accounting for 0.52%.There were no serious or new adverse reactions. Conclusions The data up to now have revealed that Shenmai injection has low rates of adverse reaction,and its clinical application is safe relatively,but it still needs to standardize clinical operation and rational use. |
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