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目的:观察丹参酮ⅡA磺酸钠治疗冠状动脉粥样硬化性心脏病(简称“冠心病”)心绞痛的临床疗效及安全性。方法:46例冠心病心绞痛患者入组疗效评价组,并按随机数字表法分为试验组(23例)和对照组(23例);另将45例冠心病心绞痛患者入组安全性评价组。所有患者均采用硝酸异山梨酯、阿司匹林、β受体阻滞药等常规药物治疗;试验组患者在常规治疗的同时应用丹参酮ⅡA磺酸钠注射液40 mg静脉滴注,qd,连续4 d。观察两组患者用药前后心绞痛发作频率、心绞痛持续时间、心电图以及可能存在的不良反应。安全性评价组患者治疗方案中包含丹参酮ⅡA磺酸钠注射液,剂量频次与试验组相同,不限定疗程,该组患者仅观察不良反应发生情况。结果:试验组患者心绞痛与心电图临床疗效的总有效率分别为86.96%、69.56%,显著高于对照组的65.22%、43.48%,差异有统计学意义(P<0.05)。与对照组比较,试验组患者治疗后的心绞痛发作次数明显减少,发作持续时间明显缩短,差异有统计学意义(P<0.01)。68例静脉滴注丹参酮ⅡA磺酸钠注射液的患者均未见不良反应发生。结论:在常规治疗冠心病心绞痛的基础上联合丹参酮ⅡA磺酸钠注射液治疗,能有效改善冠心病心绞痛的临床症状,且安全性较高。
OBJECTIVE: To observe the clinical efficacy and safety of tanshinone ⅡA sulfonate in the treatment of coronary atherosclerotic heart disease (CHD) angina. METHODS: 46 patients with CHD angina were included in efficacy evaluation group, and randomly assigned into trial group (23 cases) and control group (23 cases); other 45 patients with CHD angina were enrolled into safety evaluation group. All of them were treated with conventional therapy of isosorbide dinitrate, aspirin and β receptor blocker, etc.; trial group was additionally given Tanshinone ⅡA sulfonate injection intravenously, qd, for consecutive 4 d on the basis of routine therapy. The frequency and period of angina attacks, ECG before and after treatment and potential ADR were observed in 2 groups. Safety evaluation group were treated with Tanshinone ⅡA sulfonate injection with same dosage and frequency as trial group, but treatment course was not limited; only the occurrence of ADR was observed in the group. RESULTS: The total effective rates of clinical efficacy and ECG in trial group were 86.96% and 69.56%, which were significantly higher than the control group (65.22%, 43.48%), with statistical significance (P<0.05). Compared with control group, the frequency and period of angina attacks reduced significantly in trial group after treatment, with statistical significance (P<0.01). No ADR was observed in 68 patients treated with intravenous dripping of Tanshinone ⅡA sulfonate injection. CONCLUSIONS: Based on routine therapy, Tanshinone ⅡA sulfonate injection can effectively improve the clinical symptom of CHD angina, with good safety.
冠状动脉粥样硬化性心脏病心绞痛丹参酮ⅡA磺酸钠注射液疗效
Coronary atherosclerotic heart diseaseAnginaTanshinone ⅡA sulfonate injectionEfficacy
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