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基于“真实世界”的某院丹参酮ⅡA磺酸钠注射液用药合理性与安全性分析
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| 篇名： | 基于“真实世界”的某院丹参酮ⅡA磺酸钠注射液用药合理性与安全性分析 |
| TITLE： | Study on Utilization Safety and Rationality of Sodium Tanshinone ⅡA Sulfonate Injection Based on “Real World ” |
| 摘要： | 目的：为临床安全、合理地使用丹参酮ⅡA磺酸钠（STS）注射液提供参考。方法：收集某三级医院2016年1月－2017年12月使用STS注射液的患者信息，根据药品说明书的相关建议，评价其用药合理性；采用成组设计和个人匹配法对其不良反应/事件（ADR/ADE）风险及影响因素进行单因素和多因素分析，考察其相关性。结果：共纳入3283例患者；STS注射液的平均用药频度均小于1.5，药物利用指数均小于1.0，提示该院使用STS注射液基本合理。STS注射液的不合理用药主要为适应证不恰当（46.48％），溶媒选择不合理（15.84％）和给药浓度过大（2.71％）。相关性分析结果显示，肾功能不全患者应用STS注射液后发生ADR/ADE的风险显著增加（P＜0.05）。结论：该院STS注射液临床使用中存在超适应证、超浓度和溶媒不当情况，要加强对该制剂的用药评估和监测，对肾功能不全患者尤其要防范ADR/ADE的发生。 |
| ABSTRACT： | OBJECTIVE：To provide reference for safe and rational use of Sodium tanshinone ⅡA sulfonate（STS）injection in the clinic. METHODS ：The information of the patients who received STS injection from Jan. 2016 to Dec. 2017 were collected from a Grade 3 hospital. According to relevant suggestions in drug package inserts ，drug utilization rationality was evaluated ，and single-factor and multi-factor analysis on the risk and influential factors for ADR/ADE were performed by group design and individual matching to examine their correlation. RESULTS ：Totally 3 283 patients were included in the study. The drug use frequency were less than 1.5，and the drug utilization indexes were less than 1.0，suggesting that the hospital using STS injection was basically reasonable. Irrational use of drugs mainly included that inappropriate indications （46.48％），unreasonable solvent selection（15.84％），and excessive concentration （2.71％）. Patients with renal insufficiency received STS injection ，and then the risk of ADR/ADE increased by correlation analysis （P＜0.05）. CONCLUSIONS ：Irrational use of STS injection in clinics existed ， mainly like off-label drug use ，excessive concentration ，irrational solvent selection. Drug use evaluation and monitoring should be strengthened. For patients with renal insufficiency ，it is necessary to prevent the occurrence of ADR/ADE ． |
| 期刊： | 2020年第31卷第02期 |
| 作者： | 张雷，李青松，黄豫 |
| AUTHORS： | ZHANG Lei，LI Qingsong ，HUANG Yu |
| 关键字： | 丹参酮ⅡA磺酸钠注射液；真实世界研究；药物利用研究；影响因素；成组设计法；个人匹配法 |
| KEYWORDS： | Sodium tanshinone ⅡA sulfonate injection ；Real world study ；Drug utilization research ；Influential factor ；Group |
| 阅读数： | 407 次 |
| 本月下载数： | 14 次 |
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