壮心口服液治疗血瘀水停型慢性心衰的临床研究

发布时间：2018-09-10 21:44

【摘要】：背景壮心口服液是由解放军第371中心医院生产的纯中药制剂,是一种治疗慢性心力衰竭的中成药,此药物的研制是根据疾病的发生机理与特点所制,采用了中医的病症结合,是一种临床应用药物剂量与疾病严重程度相关的口服液。大量实验及临床研究证明其具有益气活血、祛湿利水的功效。本课题主要是探讨壮心口服液对慢性心衰的治疗疗效。目的观察壮心口服液对血瘀水停型慢性心衰患者的临床疗效,监测药物的安全性,探索壮心口服液治疗慢性心衰的机制,为壮心口服液的临床广泛应用提供依据。方法本研究将100例符合血瘀水停型诊断标准的慢性心衰患者按照随机数据法进行分组,分为试验组与对照组,每组各50例,对照组予以西医规范化治疗,试验组在此西医规范化治疗基础上合用壮心口服液(解放军第371中心医院制剂中心制,制剂许可证号:济20110008HZQ),口服,10-30ml,一日3次;根据心衰程度即II、III度分别应用20ml、30ml;两组疗程均为4周。观察两组患者治疗前后症状积分、心功能分级、LVEF、6MWT、BNP、明尼苏达生活质量调查积分以及安全性指标检测的变化,对两组以上指标进行统计和分析。结果两组患者的性别、年龄、病程、心功能分级等基本资料,经均衡性检验,P0.05,具有可比性。两组治疗后临床症状积分均有所下降,试验组与对照组的总有效率分别为92%和76%,组间比较χ2=4.76,P0.05。两组心功能均较治疗前有所改善,试验组与对照组的总有效率分别为90%和74%,组间比较χ2=4.34,P0.05。两组治疗后患者的LVEF及6MWT均有所提高,且试验组优于对照组,组间比较P0.05。两组治疗后患者的血浆BNP及生活质量积分均较治疗前有所下降,且试验组优于对照组,组间比较P0.05。治疗前后两组患者血、尿、粪常规及肝、肾功等无明显变化,P0.05,无不良反应。结论壮心口服液联合西医规范化治疗血瘀水停型慢性心衰患者,能显著改善其临床症状、心功能,提高LVEF,延长6MWT,降低BNP,提高生活质量,是一种安全有效的治疗方法。
[Abstract]:Background Zhuangxin Oral liquid is a pure traditional Chinese medicine prepared by 371 Central Hospital of PLA. It is a traditional Chinese patent medicine for the treatment of chronic heart failure. The preparation of this medicine is based on the mechanism and characteristics of the disease and adopts the combination of traditional Chinese medicine (TCM). It is a kind of oral liquid which is related to the severity of the disease. A large number of experiments and clinical studies prove that it has the effect of supplementing qi and activating blood circulation, dispelling dampness and promoting water. This subject is mainly to explore the effect of Zhuangxin oral liquid on chronic heart failure. Objective to observe the clinical effect of Zhuangxin oral liquid on patients with chronic heart failure with blood stasis and water stagnation, to monitor the safety of drugs, and to explore the mechanism of Zhuangxin oral liquid in treating chronic heart failure, so as to provide the basis for the wide clinical application of Zhuangxin oral liquid. Methods in this study, 100 patients with chronic heart failure who met the diagnostic criteria of blood stasis and water stasis were divided into two groups: the experimental group and the control group, 50 cases in each group. The control group was treated with western medicine standardized therapy. The experimental group was combined with Zhuangxin oral liquid on the basis of standardized western medicine treatment (preparation center system of 371st central hospital of PLA, preparation license number: 20110008HZQ), taking orally 10 ~ (-30) ml, three times a day; According to the degree of heart failure (II,III), the two groups were treated with 20 ml or 30 ml for 4 weeks. The changes of symptom score, LVEF6 MWTBNPs, Minnesota quality of life score and safety index were observed before and after treatment, and the above indexes were statistically analyzed. Results the basic data of sex, age, course of disease and cardiac function grade of the two groups were comparable by balance test (P 0.05). The total effective rates of the two groups were 92% and 76%, respectively. The total effective rates of the two groups were 90% and 74%, respectively. The LVEF and 6MWT of the two groups were improved after treatment, and the experimental group was superior to the control group (P 0.05). The plasma BNP and quality of life score of the two groups were lower than those before treatment, and the experimental group was superior to the control group, and the comparison between the two groups was P0.05. Before and after treatment, there were no significant changes in blood, urine, fecal routine, liver and renal function in both groups. Conclusion Zhuangxin oral liquid combined with western standardization in the treatment of chronic heart failure with blood stasis and water stagnation can significantly improve its clinical symptoms, cardiac function, increase LVEF, prolongation of 6 MWTT, reduce BNP, and improve the quality of life. It is a safe and effective treatment method.
【学位授予单位】：新乡医学院
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R259

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