【摘要】：背景壯心口服液是由解放軍第371中心醫(yī)院生產(chǎn)的純中藥制劑,是一種治療慢性心力衰竭的中成藥,此藥物的研制是根據(jù)疾病的發(fā)生機理與特點所制,采用了中醫(yī)的病癥結(jié)合,是一種臨床應(yīng)用藥物劑量與疾病嚴(yán)重程度相關(guān)的口服液。大量實驗及臨床研究證明其具有益氣活血、祛濕利水的功效。本課題主要是探討壯心口服液對慢性心衰的治療療效。目的觀察壯心口服液對血瘀水停型慢性心衰患者的臨床療效,監(jiān)測藥物的安全性,探索壯心口服液治療慢性心衰的機制,為壯心口服液的臨床廣泛應(yīng)用提供依據(jù)。方法本研究將100例符合血瘀水停型診斷標(biāo)準(zhǔn)的慢性心衰患者按照隨機數(shù)據(jù)法進行分組,分為試驗組與對照組,每組各50例,對照組予以西醫(yī)規(guī)范化治療,試驗組在此西醫(yī)規(guī)范化治療基礎(chǔ)上合用壯心口服液(解放軍第371中心醫(yī)院制劑中心制,制劑許可證號:濟20110008HZQ),口服,10-30ml,一日3次;根據(jù)心衰程度即II、III度分別應(yīng)用20ml、30ml;兩組療程均為4周。觀察兩組患者治療前后癥狀積分、心功能分級、LVEF、6MWT、BNP、明尼蘇達生活質(zhì)量調(diào)查積分以及安全性指標(biāo)檢測的變化,對兩組以上指標(biāo)進行統(tǒng)計和分析。結(jié)果兩組患者的性別、年齡、病程、心功能分級等基本資料,經(jīng)均衡性檢驗,P0.05,具有可比性。兩組治療后臨床癥狀積分均有所下降,試驗組與對照組的總有效率分別為92%和76%,組間比較χ2=4.76,P0.05。兩組心功能均較治療前有所改善,試驗組與對照組的總有效率分別為90%和74%,組間比較χ2=4.34,P0.05。兩組治療后患者的LVEF及6MWT均有所提高,且試驗組優(yōu)于對照組,組間比較P0.05。兩組治療后患者的血漿BNP及生活質(zhì)量積分均較治療前有所下降,且試驗組優(yōu)于對照組,組間比較P0.05。治療前后兩組患者血、尿、糞常規(guī)及肝、腎功等無明顯變化,P0.05,無不良反應(yīng)。結(jié)論壯心口服液聯(lián)合西醫(yī)規(guī)范化治療血瘀水停型慢性心衰患者,能顯著改善其臨床癥狀、心功能,提高LVEF,延長6MWT,降低BNP,提高生活質(zhì)量,是一種安全有效的治療方法。
[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.
【學(xué)位授予單位】：新鄉(xiāng)醫(yī)學(xué)院
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R259

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