真实世界桂枝茯苓胶囊临床应用特征研究

Study on the clinical characteristics of Guizhi Fuling capsule in the real world

目的探索桂枝茯苓胶囊真实世界的临床特征和联合用药规律。方法该研究基于中国中医科学院中医临床基础医学研究所构建的全国16家大型三级甲等医院的电子医疗病例数据库,912例至少使用过一次桂枝茯苓胶囊患者。应用SAS9.3统计软件进行描述性统计分析。结果用药患者以中青年女性为主。年龄分层以18～45岁患者最多,其次为46～65岁。患者门诊方式入院最多,占87.47%。患者诊断以正常分娩最多。中医辨证最多的为气虚血瘀证,占21.31%。服药日剂量最常见为9粒/日,用药疗程分段最多为3～6d。16家医院912个病例中,没有见到ADR记载。联合用药以化药为主,联合用药前三名分别是缩宫素(439例)、头孢唑林(268例)、甲硝唑(266例)。常联合抗病毒药、抗生素类药、活血化瘀剂、扶正剂等使用。结论临床用药比较合理,基本符合说明书的要求。基于真实世界得出的研究结果客观真实,可以为临床实际提供线索,为进一步研究提供依据。

Objective To explore clinical features and the law of drug combination of using Guizhi Fuling Capsule in the real world.Methods This research is based on the electronic medical case database of 16 Grade A of Level Ⅲ Hospital in China, and 912 cases taking Guizhi Fuling Capsule at least one dose. The SAS 9.3 statistical software is used to carry out descriptive statistical analysis. Results The majority of the patients were young and middle-aged women, the largest number of patients was 18-45 years old, followed by 46-65 years. The admission of outpatients was 87.47%, the patient who was diagnosed with normal delivery was the most. The most combined disease is gestation. The most TCM syndrome is syndrome of blood stasis due to Qi deficiency, accounting for 21.31%. The most common daily dose of medicine was 9 grains per day, and the maximum of the treatment course was 3-6 days. No record of ADR was found in 912 cases of the 16 hospitals. Guizhi Fuling capsule was often used in combination with western medicine, such as Oxytocin(439 cases), Cefazolin(268 cases) and Metronidazole(266 cases), it is often combined with antiviral drugs, antibiotics, blood stasis, righting agent use agent. Conclusion The clinical pharmacy of Guizhi Fuling Capsule is reasonable, the using is in line with the instructions. The research results based on the real world are objective reality, which can provide clues for clinical practice and provide evidence for further research.