目的 基于电子病历数据，初步探究真实世界研究的背景下，紫龙金对肺部肿瘤患者术后长期的治疗效果。方法 采用回顾性队列研究的方法，以2015-2017年于天津医科大学总医院肺部肿瘤外科住院期间实施"病灶手术切除"的1256例患者为研究对象，以紫龙金暴露作为分组因素，以手术出院后至2017年12月31日间的再次住院（即接受包括化疗在内的后续治疗方案）作为终点事件，统计分析患者性别、年龄、手术情况、住院情况、紫龙金用药医嘱以及出院转归相关情况，探讨紫龙金暴露组与非暴露组患者的临床特点和转归诊疗过程是否具有显著性差异，并对暴露组患者的用药医嘱的依从性进行分析。结果 患者再住院的比例方面，暴露组为71.79%，显著高于非暴露组的29.32%。在连续服用4个疗程（8个月）紫龙金片后，暴露组中仍有112名患者坚持于本院取药进行治疗，占全部暴露组人数的95.72%。经Logistic回归分析验证显示，紫龙金暴露与相对更晚的临床分期以及更复杂的后续诊疗计划相关（OR=4.343），提示无人为因素干预下暴露组对紫龙金用药的自主选择性和坚持服药倾向性均较高。结论 坚持使用紫龙金片治疗对暴露组患者的术后后续治疗和提高生活质量方面，具有一定程度的积极影响和保护性作用。

Objective To preliminarily explored Zilongjin Tablet (紫龙金片) in the long-term therapeutic effect of patients with lung tumors after operation under the background of real-world research based on the electronic medical record data. Methods According to the method of retrospective cohort study, total of 1256 patients who received "surgical resection of lesions" during their hospitalization in the Department of Pulmonary Tumor Surgery of Tianjin Medical University General Hospital from 2015 to 2017 were selected as the research subjects. Zilongjin Tablet exposure was taken as the grouping factor, and the rehospitalization (i.e. receiving follow-up treatment including chemotherapy) from discharge to December 31, 2017 was taken as the end event. The patient's gender, age, operation, hospitalization, Zilongjin Tablet medication orders and discharge outcomes were statistical analyzed. To explore whether there were significant differences in the clinical characteristics, prognosis and diagnosis and treatment process between Zilongjin Tablet exposed group and non exposed group. The compliance of medical advice for the patients in the exposed group was analyzed. Results The proportion of rehospitalization in the exposed group was 71.79%, which was significantly higher than the non exposed group (29.32%). After taking Zilongjin Tablets for four consecutive courses (eight months), 112 patients in the exposure group still insisted on taking Zilongjin Tablets in Tianjin Medical University General Hospital for treatment, accounting for 95.72% of the total number of patients in the exposure group. In addition to showing that Zilongjin Tablets exposure was related to relatively later clinical stages and more complex follow-up diagnosis and treatment plans (OR=4.343), it was suggested that without human intervention, the exposure group had higher self selectivity and adherence to Zilongjin Tablets medication were verified by Logistic regression analysis. Conclusion The persistent use of Zilongjin Tablets has a certain degree of positive influence and protective effect on the postoperative follow-up treatment and improvement of life quality of patients in the exposed group.

R285.64

“十三五”国家新药科技重大专项（2019ZX09734001）