心脑舒通胶囊治疗稳定型心绞痛（心血瘀阻证）的临床观察

发布时间：2019-02-13 03:57

【摘要】：目的观察心脑舒通胶囊治疗稳定型心绞痛(心血瘀阻证)的疗效,评价其有效性和安全性。方法选取2014年11月至2015年12月,就诊于黑龙江中医药大学附属第二医院心病科且符合入选标准的患者共54例,采用随机双盲平行对照方法分试验组和对照组,各27例。试验组基础治疗加心脑舒通胶囊(吉林敖东洮南药业股份有限公司生产);对照组基础治疗加心脑舒通胶囊模拟剂,疗程8周。记录试验前后的心绞痛疗效积分、中医证候积分、硝酸甘油使用数量、心电图、心电图运动试验;实验室理化检查及不良事件。数据统计分析采用软件Spss 17.0。结果1.心绞痛疗效评价:试验组的总有效率为70.83%;对照组的总有效率为40.74%;两组之间差异具有统计学意义(P0.05)。试验组心绞痛总有效率高于对照组。2.心电图疗效:试验组的总有效率为58.33%;对照组的总有效率为25.93%;两组之间差异具有统计学意义(P0.05)。两组疗效差别有统计学意义(P0.05)。试验组心电图总有效率高于对照组。3.中医证候疗效评价:试验组的总有效率为91.679%,对照组的总有效率为48.15%,两组之间差异具有显著统计学意义(P0.01)。试验组显著优于对照组。4.硝酸甘油使用量:试验组停减率为83.33%,对照组停减率为55.56%两组差异有统计学意义(P0.05),试验组显著优于对照组。5.运动时间:试验组治疗后运动时间较对照组延长。治疗前后两组组内比较有统计学意义(P0.05),两组组间比较差异无统计学意义(P0.05),但试验组略优于治疗组。6.治疗前及治疗4周、治疗8周的各组生命体征指标变化的情况,无统计学意义(P0.05)血、尿常规,肝、肾功,血脂四项均没有临床意义的异常变化,无毒副作用,无严重不良反应发生。结论1.心脑舒通胶囊能够有效的减少心绞痛发作次数,减轻疼痛程度,改善中医症状,提高生活质量。2.心脑舒通胶囊可以纠正异常心电图的缺血状态。3.心脑舒通胶囊对运动时间的改善效果不明显。4.心脑舒通胶囊具有安全性。
[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.
【学位授予单位】：黑龙江中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R259

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