目的 观察注射用益气复脉（冻干）治疗不稳定型心绞痛的疗效及安全性。方法 选取2022年1月—2023年1月延边大学附属医院心内科因不稳定型心绞痛住院患者103例，根据治疗方案不同分为对照组（n=53）及试验组（n=50）。对照组患者给予常规治疗方案，包括一般治疗（吸氧、低盐低脂饮食、双联抗血小板治疗、调脂＋稳定斑块治疗、扩血管治疗）；试验组在与对照组相同的常规治疗基础上联用注射用益气复脉（冻干），每次取5.2 g加入0.9%氯化钠注射液或5%葡萄糖注射液250 mL，静脉滴注，每天1次，连续用药7 d。观察两组患者心绞痛症状（周发作频率、单次发作持续时间）、西雅图心绞痛（SAQ）评分、超敏-C反应蛋白（hs-CRP）及低密度脂蛋白-胆固醇（LDL-C）变化。观察两组治疗期间不良反应发生情况。结果 试验组在心绞痛症状（周发作频率、单次发作持续时间）改善、SAQ评分改善方面均优于对照组（P＜0.05）；试验组心电图有效率（86.00%）高于对照组（64.15%，P＜0.05）；试验组治疗总有效率（92.00%）也高于对照组（75.47%，P＜0.05）；治疗后，两组患者血清hs-CRP、LDL-C水平均较本组治疗前显著降低（P＜0.05）；相较于对照组，试验组治疗后hs-CRP水平及LDL-C水平更加降低（P＜0.05）。两组治疗期间各有1例患者出现皮疹或头晕，两组总不良反应发生率比较，差异无统计学意义（P＞0.05）。结论 注射用益气复脉（冻干）可减少心绞痛周发作次数、缩短单次发作时间、改善SAQ评分，也有着更高的心电图改善率及总有效率，疗效显著，安全性也较好。

Objective To observe the efficacy and safety of Yiqi Fumai Lyophilized Injection in treatment of unstable angina pectoris. Methods From January 2022 to January 2023, 103 inpatients with unstable angina pectoris in the Department of Cardiology of the Affiliated Hospital of Yanbian University were selected and divided into the control group (n=53) and the experimental group (n=50) according to the different treatment schemes. The patients in the control group were treated with traditional chemical drugs, including general treatment (oxygen inhalation, low salt low-fat diet, treatment of diabetes, hypertension and other complications, removal of incentives, etc.), dual antiplatelet therapy (aspirin+clopidogrel), lipid regulation+stable plaque therapy (atorvastatin or rosuvastatin), and vasodilator therapy. On the basis of the same routine treatment method as the control group, the experimental group was combined with Yiqi Fumai Lyophilized Injection. Each time, 5.2 g of Yiqi Fumai Lyophilized Injection was taken, and 250 mL of 0.9% Sodium Chloride Injection or 5% Glucose Injection was added for preparation. The drug was administered intravenously once a day for seven consecutive days. The changes in symptoms of angina pectoris (weekly frequency, duration of single episode), Seattle angina pectoris (SAQ) score, inflammation index hypersensitive C-reactive protein (hs-CRP), and blood lipid index low-density lipoprotein cholesterol (LDL-C) in two groups of patients were observed. The occurrence of adverse reactions during treatment in both groups were observed. Results The experimental group showed better improvement in angina symptoms (weekly frequency, duration of single episode) and SAQ scores compared to the control group (P＜0.05). The effective rate of electrocardiogram in the experimental group (86.0%) was higher than that in the control group (68.0%, P＜0.05). The overall effective rate of the experimental group (92.0%) was also higher than that of the control group (75.6%, P＜0.05). Compared to the control group, the experimental group showed even lower levels of hs-CRP and LDL-C after treatment (P＜0.05). During the treatment period, one patient in each group experienced rash or dizziness, and there was no statistically significant difference in the overall incidence of adverse reactions between the two groups (P＞0.05). Conclusion Yiqi Fumai Lyophilized Injection can reduce the number of weekly episodes of angina pectoris, shorten the time of single episode, improve SAQ score, and also have a higher electrocardiogram improvement rate and overall effective rate. The therapeutic effect is significant, and the safety is also good.

R972