清开灵注射液治疗缺血性脑血管病患者真实世界临床特征及联合用药分析

Clinical features and clinical analysis of Qingkailing injection for ischemic cerebrovascular disease

目的了解和分析清开灵注射液治疗缺血性脑血管病的临床特征和联合用药规律。方法本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,12 385例使用清开灵注射液的患者中的1323例缺血性脑血管病患者。采用Apriori算法建立模型,使用Clementine 12.0进行联合用药关联规则分析。结果性别缺失29例,男性795例,女性499例,年龄主要分布在45~89岁;以门诊方式入院占总人数70.38%;＂一般＂、＂急＂、＂危＂各个病情阶段都有所应用。最常合并的疾病为高血压、冠心病、上呼吸道感染病、糖尿病;中医辩证主要为痰湿内阻证（百分比46.19%）、痰火上扰证（百分比26.27%）、肝肾阴虚证（百分比12.71%）、阳气虚衰证（百分比8.05%）;患者入院率最多的节气为冬至（百分比6.05%）;死亡人数排第一位的节气是大暑（百分比7.14%）。临床联合2种西药时,最常联合阿司匹林＋肝素注射液组合、注射用头孢菌素类＋肝素注射液组合（支持度均为33.3%）;联合2种中药时,最常联合感冒清热颗粒＋鲜竹沥口服液组合（支持度7.79%）;联合3种西药时,最常联合注射用头孢菌素类＋肝素注射液＋维生素C组合（支持度24.0%）;联合3种中药时,最常联合疏血通注射液＋银杏叶提取物＋脉血康胶囊组合（支持度2.80%）。结论清开灵注射液治疗缺血性脑血管病人群特征以中老年人为主,且男性多于女性;清开灵注射剂联合用药以化药为主,一方面针对缺血性脑血管病及其并发症,一方面针对患者的基础病,联合用药比较合理;同时也存在不良反应,临床应重视。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信号挖掘线索,为进一步研究提供依据。

Objective To understand and analyze the clinical characteristics of Qingkailing injection for ischemic cerebrovascular diseases and the rule of combination therapy. Methods This study was based on the database of electronic medical cases of 16 Tier A hospitals in China. Data of 1323 ischemic cerebrovascular patients with Qingkailing injection out of 12 385 cases were used. Apriori algorithm was used to establish the model, and Clementine 12.0 was used to analyze the association rules. Results There were 795 males（61.44%） and 499 female（38.56%）. The age of the patients was 45- 89 years, 70.38% from the outpatient department. General and Crisis were applied in all stages of the disease. The most commonly associated diseases were hypertension, coronary heart diseases, upper respiratory tract infection and diabetes. The main dialectic of traditional Chinese medical（TCM） were phlegm-dampness internal resistance（46.19%）, phlegm-fire disturbance（26.27%）, liverkidney yin deficiency（12.71%）, Yang deficiency syndrome（8.05%）; The highest admission rate was on Winter Solstice（6.05%）; the number of deaths in the first solar term is the Great Heat（7.14%）. Qingkailing injection was used mainly in combination with chemical drugs. Combination of aspirin and heparin, and combination of cephalosporin and heparinand（with supporting rate 33.3%） were moste common; For TCM, the most common combination was Ganmao Qingre granules and Xianzhuli oral solution administration（supporting rate 7.79%）. The most common combination of 3 chemical drugs was cephalosporin, heparin and vitamin C（24.0%）; while for TCM was Shuxuetong injection, Ginkgo biloba extract and Maixuekang capsule（2.80%）. Conclusion Qingkailing injection for ischemic cerebrovascular disease is mainly for the elderly population, with more men than women. Qingkailing injection is mainly combination with chemical drugs for ischemic cerebrovascular disease and base disease. Combination of drug use is reasonable, but also there are adverse reactions, so clinical attention is need. Based on the real world research, the results are objective and true, and can provide clues for clinical practice.