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目的对参芪扶正注射液上市后临床应用的安全性进行临床研究和综合评价。方法对438例用参芪扶正注射液的住院患者进行观察,记录患者的药品使用和不良反应发生情况,并进行数据统计分析。结果观察病例438份,参芪扶正注射液使用的适应证、用法用量基本符合说明书的规定,不良反应发生率为0.23%。结论我院参芪扶正注射液临床使用较为规范,参芪扶正注射液发生不良反应的概率较小,临床使用相对安全。
Objective To conduct a clinical study and comprehensive evaluation of the clinical safety of Shenqi Fuzheng Injection after its listing. Methods A total of 438 hospitalized patients who were treated with Shenqi Fuzheng Injection were observed. The patients’ drug use and adverse reactions were recorded, and statistical analysis was performed. RESULTS: Of the 438 cases observed, the indications, usage, and dosage of Shenqi Fuzheng Injection were basically in accordance with the specifications of the manual, and the incidence of adverse reactions was 0.23%. Conclusion The clinical use of Shenqi Fuzheng Injection in our hospital is more standardized, Shenqi Fuzheng Injection has a lower probability of adverse reactions, and clinical use is relatively safe.