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莲子心治疗微血管性心绞痛的随机对照研究
作者:陈义  高枫  朱红俊  李磊  周浩  吴昀  史名妤  周元淳  陆曙 
单位:无锡市中医医院 心血管科, 江苏 无锡 214000
关键词:莲子心 冠状动脉微血管功能障碍 微血管性心绞痛 氧化应激 血管内皮功能 生存质量 
分类号:R259
出版年·卷·期(页码):2025·53·第十一期(1719-1726)
摘要:

目的: 评价莲子心治疗微血管性心绞痛(MVA)患者的有效性及安全性。方法: 招募2024年1—10月在无锡市中医医院心血管科住院的144例MVA患者,随机分为对照组(西医标准治疗)和试验组(西医标准治疗+莲子心),每组72例,疗程为3个月。主要疗效指标为西雅图心绞痛量表(SAQ)评分,次要疗效指标为血清血管内皮功能指标,包括白细胞介素6(IL-6)、丙二醛(MDA)、血管内皮生长因子(VEGF)、内皮素-1(ET-1)、可溶性fms样酪氨酸激酶-1(sFlt-1)、超氧物歧化酶(SOD)、一氧化氮(NO)。观察血压、血常规、血生化、心电图等安全性指标,记录不良反应。结果: 两组各有5例因失访而脱落,对照组及试验组各有67例完成研究,与本组治疗前比较,治疗后两组SAQ各项评分包括躯体活动受限程度(PL)、心绞痛稳定状态(AS)、心绞痛发作情况(AF)、治疗满意程度(TS)、疾病认识程度(DP)及血清SOD、NO水平显著升高(P<0.01),血清IL-6、MDA、VEGF、ET-1、sFlt-1水平显著降低(P<0.01)。与对照组同期比较,试验组治疗后SAQ各项评分及血清SOD、NO水平升高更显著(P<0.01),血清IL-6、MDA、VEGF、ET-1、sFlt-1水平降低更显著(P<0.01),两组间不良反应发生情况比较,差异无统计学意义(P>0.05)。结论: 莲子心可提高MVA患者生存质量,改善血管内皮功能,且未发生严重不良反应。

Objective: To evaluate the efficacy and safety of lotus plumule in patients with microvascular angina(MVA). Methods: A total of 144 MVA patients hospitalized in the Department of Cardiovascular Medicine, Wuxi Hospital of Traditional Chinese Medicine from Jan to Oct 2024 were recruited. They were randomly assigned to control group(standard Western medicine treatment) or experimental group(standard Western medicine treatment+lotus plumule), with 72 patients in each group. The treatment course was 3 months. The primary efficacy endpoint was the Seattle Angina Questionnaire(SAQ) score, and the secondary efficacy endpoints were serum vascular endothelial function indicators, including interleukin-6(IL-6), malondialdehyde(MDA), vascular endothelial growth factor(VEGF), endothelin-1(ET-1), soluble fms-like tyrosine kinase-1(sFlt-1), superoxide dismutase(SOD), and nitric oxide(NO). Safety indicators—including blood pressure, blood routine, blood biochemistry, and electrocardiogram—were monitored, and adverse reactions were recorded. Results: Five patients in each group were loss to follow-up, and 67 patients per group completed the study. Within each group, compared with baseline, both groups showed significant increases in the SAQ scores—including physical limitation(PL), angina stability(AS), angina frequency(AF), treatment satisfaction(TS), and disease perception(DP)—along with increases in serum SOD and NO levels (P<0.01); the serum levels of IL-6, MDA, VEGF, ET-1, and sFlt-1 were all significantly decreased(P<0.01). Compared with the control group at the same time point, the experimental group after treatment demonstrated more significant increases in the SAQ scores and serum SOD and NO levels(P<0.01), and more significant decreases in serum IL-6, MDA, VEGF, ET-1, and sFlt-1 levels(P<0.01). No significant difference in the incidence of adverse reactions was observed between the two groups(P>0.05). Conclusion: Lotus plumule can improve the quality of life and vascular endothelial function of MVA patients without serious adverse reactions.

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