真实世界中通络化痰胶囊治疗脑梗死恢复期痰瘀阻络证疗效的多因素分析

Multivariate Analysis of Therapeutic Effect of Tongluo Huatan Capsules in Treatment of Cerebral Infarction Recovery Phase with Phlegm-Stasis Obstructing Collaterals Syndrome: A Real-world Study

目的 观察真实世界通络化痰胶囊治疗脑梗死恢复期痰瘀阻络证的疗效及影响因素。方法 本研究为开放式、多中心、前瞻性、真实世界IV期临床研究,纳入2169例脑梗死恢复期痰瘀阻络证患者,给予口服通络化痰胶囊(30mg/次,每日3次),用药前及用药4周后观察NIHSS评分、改良Rankin评分和中医证候评分并进行疗效的多因素分析。结果 通络化痰胶囊可降低脑梗死恢复期痰瘀阻络证患者的NIHSS评分,改良Rankin评分和中医证候评分(P<0.01),而影响NIHSS评分,改良Rankin评分和中医证候评分改善的主要因素为年龄、合并疾病数量、疾病严重程度以及发病后开始服药时间(P<0.05)。合并高血压、冠心病和高脂血症影响NIHSS评分疗效(P<0.01),合并高血压和冠心病影响改良Rankin评分疗效(P<0.01),合并高血压、冠心病、高脂血症和糖尿病对中医证候疗效无影响。结论 患者年龄、合并疾病数量和种类、病情的严重程度及开始药物干预时间是影响通络化痰胶囊治疗脑梗死恢复期痰瘀阻络证疗效的因素。

Objective: To observe the therapeutic effects and influencing factors of Tongluo Huatan Capsules in the treatment of cerebral infarction recovery phase with phlegm-stasis obstructing collaterals syndrome in the real clinical environment. Methods: This study is an open, multicenter, prospective, real-world phase IV clinical trial. 2169 patients of cerebral infarction recovery phase with phlegm-stasis obstructing collaterals syndrome were given Tongluo Huatan capsules(30mg a time, 3 times a day). NIHSS score, modified Rankin score and TCM syndrome score were observed before and after four weeks’ treatment, and the multivariate analysis of curative effects was carried out. Results: Tongluo Huatan capsules reduced NIHSS score, modified Rankin score and TCM syndrome score of patients with cerebral infarction recovery phase and phlegm-stasis obstructing collaterals syndrome(P<0.01). The main factors affecting the improvement of NIHSS score, modified Rankin score and TCM syndrome score were age, number of combined diseases, disease severity and the time of starting medication after onset(P<0.05). The combination of hypertension, coronary heart disease and hyperlipidemia affected the curative effect of NIHSS score(P<0.01). The combination of hypertension and coronary heart disease affected the curative effect of modified Rankin score(P<0.01). The combination of hypertension, coronary heart disease, hyperlipidemia and diabetes had no effect on the efficacy of TCM syndrome. Conclusion: Patients’ age, numbers and types of combined diseases, disease severity and the time of starting drug intervention are the factors affecting the curative effects of Tongluo Huatan capsules in the treatment of cerebral infarction recovery phase with phlegm-stasis obstructing collaterals syndrome.