【摘要】：目的觀察心腦舒通膠囊治療穩(wěn)定型心絞痛(心血瘀阻證)的療效,評(píng)價(jià)其有效性和安全性。方法選取2014年11月至2015年12月,就診于黑龍江中醫(yī)藥大學(xué)附屬第二醫(yī)院心病科且符合入選標(biāo)準(zhǔn)的患者共54例,采用隨機(jī)雙盲平行對(duì)照方法分試驗(yàn)組和對(duì)照組,各27例。試驗(yàn)組基礎(chǔ)治療加心腦舒通膠囊(吉林敖東洮南藥業(yè)股份有限公司生產(chǎn));對(duì)照組基礎(chǔ)治療加心腦舒通膠囊模擬劑,療程8周。記錄試驗(yàn)前后的心絞痛療效積分、中醫(yī)證候積分、硝酸甘油使用數(shù)量、心電圖、心電圖運(yùn)動(dòng)試驗(yàn);實(shí)驗(yàn)室理化檢查及不良事件。數(shù)據(jù)統(tǒng)計(jì)分析采用軟件Spss 17.0。結(jié)果1.心絞痛療效評(píng)價(jià):試驗(yàn)組的總有效率為70.83%;對(duì)照組的總有效率為40.74%;兩組之間差異具有統(tǒng)計(jì)學(xué)意義(P0.05)。試驗(yàn)組心絞痛總有效率高于對(duì)照組。2.心電圖療效:試驗(yàn)組的總有效率為58.33%;對(duì)照組的總有效率為25.93%;兩組之間差異具有統(tǒng)計(jì)學(xué)意義(P0.05)。兩組療效差別有統(tǒng)計(jì)學(xué)意義(P0.05)。試驗(yàn)組心電圖總有效率高于對(duì)照組。3.中醫(yī)證候療效評(píng)價(jià):試驗(yàn)組的總有效率為91.679%,對(duì)照組的總有效率為48.15%,兩組之間差異具有顯著統(tǒng)計(jì)學(xué)意義(P0.01)。試驗(yàn)組顯著優(yōu)于對(duì)照組。4.硝酸甘油使用量:試驗(yàn)組停減率為83.33%,對(duì)照組停減率為55.56%兩組差異有統(tǒng)計(jì)學(xué)意義(P0.05),試驗(yàn)組顯著優(yōu)于對(duì)照組。5.運(yùn)動(dòng)時(shí)間:試驗(yàn)組治療后運(yùn)動(dòng)時(shí)間較對(duì)照組延長(zhǎng)。治療前后兩組組內(nèi)比較有統(tǒng)計(jì)學(xué)意義(P0.05),兩組組間比較差異無(wú)統(tǒng)計(jì)學(xué)意義(P0.05),但試驗(yàn)組略優(yōu)于治療組。6.治療前及治療4周、治療8周的各組生命體征指標(biāo)變化的情況,無(wú)統(tǒng)計(jì)學(xué)意義(P0.05)血、尿常規(guī),肝、腎功,血脂四項(xiàng)均沒(méi)有臨床意義的異常變化,無(wú)毒副作用,無(wú)嚴(yán)重不良反應(yīng)發(fā)生。結(jié)論1.心腦舒通膠囊能夠有效的減少心絞痛發(fā)作次數(shù),減輕疼痛程度,改善中醫(yī)癥狀,提高生活質(zhì)量。2.心腦舒通膠囊可以糾正異常心電圖的缺血狀態(tài)。3.心腦舒通膠囊對(duì)運(yùn)動(dòng)時(shí)間的改善效果不明顯。4.心腦舒通膠囊具有安全性。
[Abstract]:Objective to evaluate the efficacy and safety of Xinnaoshutong capsule in the treatment of stable angina pectoris. Methods from November 2014 to December 2015, 54 patients in the Department of Heart Disease of the second affiliated Hospital of Heilongjiang University of traditional Chinese Medicine were selected and randomly divided into two groups: the experimental group and the control group. The experimental group was treated with Xinnao Shutong capsule (Jilin Aodong Tao Nan Pharmaceutical Co., Ltd.) and the control group was treated with Xinnao Shutong capsule mimic for 8 weeks. The scores of angina pectoris, TCM syndromes, nitroglycerin usage, electrocardiogram exercise test, laboratory physical and chemical examination and adverse events were recorded before and after the trial. The software Spss 17.0. Result 1. Angina pectoris efficacy evaluation: the total effective rate of the trial group was 70.83; the total effective rate of the control group was 40.74; the difference between the two groups was statistically significant (P0.05). The total effective rate of angina pectoris in the trial group was higher than that in the control group. Electrocardiogram efficacy: the total effective rate of the experimental group was 58.33; the total effective rate of the control group was 25.93; the difference between the two groups was statistically significant (P0.05). The difference between the two groups was statistically significant (P0.05). The total effective rate of ECG in the test group was higher than that in the control group. Evaluation of TCM syndrome efficacy: the total effective rate of the experimental group was 91.679 and the total effective rate of the control group was 48.15. The difference between the two groups was statistically significant (P0.01). The experimental group was significantly better than the control group. 4. The dosage of nitroglycerin: the rate of stopping and decreasing was 83.33 in the trial group and 55.56% in the control group (P0.05), and it was significantly better in the experimental group than in the control group (55.56%). Exercise time: the exercise time in the experimental group was longer than that in the control group. There was significant difference between the two groups before and after treatment (P0.05), but there was no significant difference between the two groups (P0.05), but the trial group was slightly better than the treatment group. 6. 6. There were no significant changes in the vital signs of each group before and after treatment for 4 weeks and 8 weeks. There were no significant changes in blood, urine routine, liver, kidney function, blood lipids, and no side effects. No serious adverse reactions occurred. Conclusion 1. Xinnao Shutong capsule can effectively reduce the number of angina pectoris attack, alleviate the degree of pain, improve the symptoms of traditional Chinese medicine, improve the quality of life. 2. Xinnao Shutong capsule can correct abnormal ischemic state of electrocardiogram. 3. The effect of Xinnaoshutong capsule on exercise time was not obvious. 4. Xinnao Shutong capsule is safe.
【學(xué)位授予單位】：黑龍江中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R259

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