目的 探讨真实世界中生脉注射液的临床应用特征及合理用药情况。方法 对全国33家医院住院患者信息系统（hospital information system，HIS）数据库中所有使用生脉注射液的43 396例患者临床特征进行描述性分析，采用SPSS 18.0、SAS 9.2软件进行统计分析，并利用Excel 2007辅助作图，运用Clementine 12.0对数据进行关联分析。结果 应用生脉注射液的患者中，女性略多于男性；以66～85岁的老年人最多，占35.14%。入院以门诊方式最多。住院以一般形式为最多，占54.56%。入院科室以内科最多，占52.44%。住院平均时间为17.11 d。以医保形式住院最多，占28.87%，其次为自费，占26.75%。从全人群入院以第一西医诊断排名前6位的疾病依次为恶性肿瘤、冠状动脉粥样硬化性心脏病、呼吸道感染、骨折、高血压、糖尿病。中医证候排名前5位的依次为气滞血瘀证、气阴两虚证、气虚血瘀证、痰瘀互结证、肝肾亏虚证。给药途径最多以静脉的方式，共39 351例（其中静脉滴注36 310例），占90.68%，绝大多数符合说明书给药途径。单次用药剂量41～60 mL最多，占53.64%，符合说明书剂量。发现雨水时节入院患者最多，共2403例，占5.54%，其次为惊蛰时节，共2278例，占5.25%；1年中以春季入院患者最多，共13 190例，占30.39%，其次为冬季，共10 533例，占24.27%。治疗结局中好转例数最多，20 996例，占48.38%，其次为治愈例数10 646例，占24.53%，无效例数395例，仅占0.91%。结论 从真实世界中获得患者的临床特征客观真实，发现生脉注射液已广泛应用于临床，疗效确切，用药基本符合药品说明书，为进一步规范和指导临床合理辨证用药提供可靠依据。

Objective To investigate the clinical characteristics and rational use of Shengmai Injection (生脉注射液) in real world. Methods A total of 43 396 patients with Shengmai Injection in the HIS database of 33 hospitals in China were analyzed by descriptive analysis. SPSS 18.0 and SAS 9.2 were used as statistical analysis software, and Excel 2007 was used to assist mapping, Clementine 12.0 was used to analyze the data. Results The number of female patients using Shengmai Injection was slightly more than male. The most elderly people aged 66-85 accounted for 35.14%. Outpatient admission was the most. The most common form of hospitalization was general, accounting for 54.56%. Internal medicine was the most hospitalized department, accounting for 52.44%. The average time in hospital was 17.11 d. Patients hospitalized in the form of medical insurance were the most, accounting for 28.87%, followed by their own expenses, accounting for 26.75%. From the whole population of patients admitted to Western medicine first diagnosis of the top 6 were in the order of malignant tumor, coronary atherosclerotic heart disease, respiratory tract infection, fracture, hypertension, diabetes. The top 5 traditional Chinese medicine (TCM) syndromes were qi stagnation and blood stasis syndrome, qi-yin deficiency syndrome, qi deficiency and blood stasis syndrome, phlegm and blood stasis syndrome, liver and kidney deficiency syndrome. Intravenous administration was the most common route, a total of 39 351 cases (36 310 cases of intravenous infusion), accounting for 90.68%, the vast majority follow the prescribed route of administration. A single dose range was 41-60 mL, accounting for 53.64%, in accordance with the instructions. It was found that 2403 patients were admitted to hospital in Rain Water season, accounting for 5.54%, followed by 2278 cases in Insects Awaken season, accounting for 5.25%. The most hospitalized patients were in spring (13 190 cases), accounting for 30.39%, followed by winter (10 533 cases), accounting for 24.27%. Among the treatment outcomes, 20 996 cases were improved, accounting for 48.38%, followed by 10 646 cured cases, accounting for 24.53%, and only 395 cases were invalid, accounting for 0.91%. Conclusion The clinical characteristics of the patients are objective and true from the real world. It is found that Shengmai Injection has been widely used in clinic, the curative effect is accurate, and the medication is basically in accordance with the drug instruction, which provide a reliable basis for further standardizing and guiding the rational drug use of Shengmai Injection based on syndrome differentiation.

R285.64

国家重点研发计划“十种中成药大品种和经典名方上市后治疗重大疾病的循证评价及其效应机制的示范研究”（2018YFC1707400）