目的 探讨灵宝护心丹治疗稳定性冠心病的有效性和安全性。方法 选取 2022 年 10 月—2023 年 9 月在北京中医药大学第三附属医院心内科门诊就诊的稳定性冠心病患者 80 例，随机分为对照组和试验组。对照组采用西医常规治疗，试验组在对照组的基础上，给予灵宝护心丹每日 3 次、每次 4 粒治疗。两组患者均治疗 4 周，比较两组的心绞痛症状改善、硝酸甘油停减率、西雅图量表评分、中医证候积分及安全性指标。结果 最终纳入分析的患者共 77 例，其中试验组 39 例，对照组 38 例 ， 两组患者基线资料具有可比性 。经 4 周治疗后， 试验组心绞痛总有效率（89.74%）显著高于对照组（57.89%）（P＜0.01），试验组硝酸甘油总停减率（87.18%）显著高于对照组（50.00%）（P＜0.01）。两组患者治疗后西雅图量表和中医证候评分均较治疗前有显著改善（P＜0.05），试验组西雅图量表、中医证候总积分改善程度优于对照组 （P＜0.05），两组安全性指标无差异。结论 灵宝护心丹辅助西医常规治疗能够有效地加强稳定性冠心病的临床疗效，且具有安全性，值得临床推广。

Objective To explore the efficacy and safety of Lingbao Huxin Pill in the treatment of stable coronary artery disease. Methods A total of 80 patients who visited the Department of Cardiology Outpatient Clinic of Beijing University of Chinese Medicine Third Affiliated Hospital from October 2022 to September 2023 were randomly divided into control group and experimental group. The control group received conventional western medicine treatment, while the experimental group received Lingbao Huxin Pill in addition to the control group. Both groups were treated for four weeks, and the improvement of angina symptoms, nitroglycerin reduction rate, Seattle Scale score, traditional Chinese medicine (TCM) syndrome score, and safety indicators were compared between the two groups. Results A total of 77 patients were finally included in the analysis, including 39 patients in texperimental group and 38 patients in the control group. The baseline data of the two groups were similar and comparable. After four weeks of treatment, the effective rate of angina in experimental group was 89.74%, which was significantly higher than that in control group (57.89%) (P<0.01), and the nitroglycerin reduction rate in experimental group was 87.18%, which was significantly higher than that in control group (50.00%) (P<0.01). After treatment, both groups showed significant improvement in Seattle Scale and TCM syndrome scores compared with those before treatment (P<0.05), and the improvement of Seattle Scale and total TCM syndrome score in experimental group was better than that in control group (P<0.05). There was no difference in safety indicators between the two groups. Conclusion Lingbao Huxin Pill assisted with conventional western medicine treatment can effectively enhance the clinical efficacy of stable coronary artery disease, and is safe and worthy of clinical promotion.

R972

首都卫生发展科研专项（2022-2-7035）