丹红注射液治疗不稳定性心绞痛（血瘀证）有效性及安全性的临床观察

发布时间：2018-06-16 14:14

本文选题：丹红注射液 + 不稳定性心绞痛　；参考：《黑龙江中医药大学》2017年硕士论文

【摘要】：目的:观察丹红注射液对不稳定性心绞痛临床疗效,并依托试验结果进一步确定药物的有效性及安全性。方法:选取黑龙江中医药大学附属第一医院,2014年11月到2015年5月之间的就诊的20例不稳定性心绞痛(血瘀证)患者。依据方案筛选入组。随机分为两组,试验组10例,其余10例为安慰剂对照组。试验疗程为7天,随访21±3天,共历时28±3天。期间观察记录患者的一般情况、心绞痛疗效、中医证候积分、以及西雅图量表。试验开始前患者签署知情同意书。试验结束后,整理及统计试验数据。依托数据,对试验结果进行初步探讨与分析。结果:1.临床有效性方面:(1)心绞痛疗效积分:两组治疗前试验组与对照组比较,心绞痛积分方面,差异无统计学意义(P0.05)。具有可比性。两组治疗后(第7天)心绞痛疗效积分方面,差异有统计学意义(P0.05)。(2)中医证候积分:两组治疗前试验组与对照组比较,中医证候积分方面,差异无统计学意义(P0.05)。具有可比性。两组治疗后(第7天)中医证候积分方面,差异有统计学意义(P0.05)。(3)西雅图心绞痛量表:两组治疗前试验组与对照组比较,西雅图量表加分。差异无统计学意义(P0.05),具有可比性。两组治疗后,西雅图量表积分,具有统计学意义(P0.05)。2.安全性方面:试验过程中,所有患者均未出现不良事件。结论:1.丹红注射液在不稳定型心绞痛(血瘀证)的有效性方面主要表现为:(1)降低心绞痛疗效积分,增强不稳定性心绞痛(血瘀证)患者心绞痛疗效;(2)降低中医证候积分,减轻患者中医症状;(3)西雅图心绞痛量表SAQ中,稳定患者心绞痛发作情况及心绞痛的稳定状态,提高心绞痛患者的治疗满意程度与疾病认知程度。2.丹红注射液在不稳定型心绞痛(血瘀证)的安全性方面主要表现为:(1)生命体征:患者试验过程中血压、心率均无明显异常改变;(2)实验室检查结果肝功肾功以及凝血均无异常改变,对于安全性无影响;
[Abstract]:Objective: to observe the clinical efficacy of Danhong injection in the treatment of unstable angina pectoris and to determine the efficacy and safety of the drug. Methods: twenty patients with unstable angina pectoris (blood stasis syndrome) were selected from the first affiliated Hospital of Heilongjiang University of traditional Chinese Medicine from November 2014 to May 2015. Select the group according to the scheme. They were randomly divided into two groups: the trial group (n = 10) and the control group (n = 10). The course of treatment was 7 days and the follow-up was 21 卤3 days, which lasted 28 卤3 days. During the period, the general condition, angina pectoris efficacy, TCM syndrome score, and Seattle scale were recorded. The patient signs an informed consent before the trial begins. After the test, collate and statistics the test data. Based on the data, the experimental results are preliminarily discussed and analyzed. The result is 1: 1. Clinical efficacy of angina pectoris score: there was no significant difference in angina pectoris score between the two groups before treatment compared with the control group (P 0.05). Comparable. Two groups after treatment (on the 7th day) angina pectoris curative effect integral aspect, the difference has the statistical significance (P 0.05. 0. 05%) traditional Chinese medicine syndromes integral: two groups before treatment the experimental group and the control group comparison, the traditional Chinese medicine syndromes integral aspect, the difference is not statistically significant (P 0. 05%). Comparable. Two groups after treatment (7 days) TCM syndromes integral, the difference was statistically significant (P 0.05. 0. 3) Seattle angina scale: the two groups before treatment compared with the control group, Seattle scale plus score. The difference was not statistically significant (P 0.05) and was comparable. After treatment, the Seattle scale score was statistically significant (P 0.05. 2). Safety: no adverse events occurred in all patients during the trial. Conclusion 1. The effectiveness of Danhong injection in unstable angina pectoris (blood stasis syndrome) mainly showed as follows: 1) reducing the score of angina pectoris curative effect, enhancing the curative effect of angina pectoris in patients with unstable angina pectoris (blood stasis syndrome) and reducing TCM syndrome score. In the Seattle angina scale (SAQ), the stable state of angina pectoris and angina pectoris were improved in order to improve the degree of treatment satisfaction and disease cognition of patients with angina pectoris. The safety of Danhong injection in unstable angina pectoris (blood stasis syndrome) is mainly manifested in the vital signs of "1: 1": blood pressure during the trial, There were no abnormal changes in heart rate. (2) the results of laboratory examination showed that there were no abnormal changes in liver function and kidney function and coagulation, which had no effect on safety.
【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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