He Xingling, Liu Donghua, Ni Shihao, Li Ziru, Li Sijing, Wu Tingchun, Dong Xiaoming, Zhang Xiaojiao, Tang Yaqin, Ling Yan, Liao Huili, Kang Jinhua, Li Yue, Wu Hongyan, Luo Jing, Wan Xianming, Zhang Dan, Lu Lu, Long Wenjie, Yang Zhongqi
The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou 510405, China; Lingnan Medical Research Center, Guangzhou University of Chinese Medicine, Guangzhou 510405, China.
The Second Affiliated Hospital of Guizhou University of Chinese Medicine, Department of Cardiology, Guizhou 550001, China.
Phytomedicine. 2024 Apr;126:155264. doi: 10.1016/j.phymed.2023.155264. Epub 2024 Jan 11.
Stable angina pectoris (SAP) is a clinical condition characterized by reversible and temporary myocardial ischemia and hypoxia. A majority of SAP patients also experience depressive disorders, which adversely affect their disease prognosis and overall quality of life. However, the clinical utility of existing antidepressants is constrained by their side effects. Ginkgo biloba dropping pill (GBDP), a Chinese patented medication, has demonstrated efficacy in the treatment of both coronary heart disease and mental disorders. This prospective, randomized, double-blind, multicenter clinical trial aimed to assess the effectiveness and safety of GBDP as an adjuvant therapy for SAP complicated by depression.
Participants were randomly assigned in a 1:1 ratio to receive either GBDP or a placebo (5 pills, three times a day) in addition to standard therapy for a duration of 12 weeks. The Seattle Angina Questionnaire (SAQ) was administered every 4 weeks during the treatment, and angina event frequency was assessed weekly. The 36-item Short-Form (SF-36) and Hamilton Depression Scale (HAMD) scores were measured both before and after the treatment.
Out of the 72 patients, 68 (n = 34 per group) completed the entire study. At the first visit (4 weeks ± 3 days), the SAQ-Angina Stability score in the GBDP group was significantly higher than that in the placebo group (p < 0.05). While the average weekly frequency of angina episodes in the placebo group notably increased after 12 weeks of treatment (p < 0.05), it displayed an improving trend in the GBDP group (p > 0.05). By the endpoint, each subcategory score of SF-36 in the GBDP group exhibited significant improvement compared to baseline (p < 0.05). The comparison of score improvement between the two groups revealed that the SF-PCS score of the GBDP group was higher than that of the placebo group (p < 0.05). HAMD scores in both groups significantly increased after treatment (p < 0.05). No discernible difference in the incidence of adverse reactions was observed between the two groups (p > 0.05).
In patients with SAP complicated by depression, GBDP, when combined with standard treatment, rapidly and safely alleviates angina pectoris symptoms. It demonstrates therapeutic potential in enhancing the quality of life and alleviating depressive symptoms.
稳定型心绞痛（SAP）是一种以可逆性和暂时性心肌缺血缺氧为特征的临床病症。大多数SAP患者还患有抑郁症，这对他们的疾病预后和整体生活质量产生不利影响。然而，现有抗抑郁药的临床应用受到其副作用的限制。银杏叶滴丸（GBDP）是一种中国专利药物，已证明在治疗冠心病和精神障碍方面均有疗效。这项前瞻性、随机、双盲、多中心临床试验旨在评估GBDP作为SAP合并抑郁症辅助治疗的有效性和安全性。
参与者按1:1的比例随机分配，除接受标准治疗外，分别接受GBDP或安慰剂（每日3次，每次5丸），为期12周。治疗期间每4周进行一次西雅图心绞痛问卷（SAQ）评估，每周评估心绞痛事件发生频率。治疗前后均测量36项简明健康状况调查量表（SF-36）和汉密尔顿抑郁量表（HAMD）评分。
72例患者中，68例（每组34例）完成了整个研究。在首次就诊时（4周±3天），GBDP组的SAQ-心绞痛稳定评分显著高于安慰剂组（p<0.05）。安慰剂组治疗12周后心绞痛发作的平均每周频率显著增加（p<0.05），而GBDP组呈改善趋势（p>0.05）。到研究终点时，GBDP组SF-36的各子类别评分与基线相比均有显著改善（p<0.05）。两组评分改善情况比较显示，GBDP组的SF-PCS评分高于安慰剂组（p<0.05）。两组治疗后HAMD评分均显著升高（p<0.05）。两组不良反应发生率无明显差异（p>0.05）。
在SAP合并抑郁症患者中，GBDP与标准治疗联合使用时，能快速、安全地缓解心绞痛症状。它在提高生活质量和缓解抑郁症状方面显示出治疗潜力。
