Mao Shuai, Wang Lei, Ouyang Wenwei, Zhou Yuanshen, Qi Jianyong, Guo Liheng, Zhang Minzhou, Hinek Aleksander
Second Clinical Medical College, Key Discipline of Integrated Traditional Chinese and Western Medicine, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.
Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
BMC Complement Altern Med. 2016 Nov 8;16(1):447. doi: 10.1186/s12906-016-1406-4.
Danlou tablets, a patented Chinese Medicine, have been long approved for the treatment of ischemic heart disease in China. While numerous empirical observations suggested Danlou tablets could decrease frequency and duration of angina pectoris attacks, evidence supporting its efficacy on cardiac remodeling remains inadequate. Therefore, this pilot trial was designed to determine whether Danlou tablets would reduce adverse left ventricular (LV) remodeling in patients with myocardial infarction (MI).
Eligible patients with acute MI were enrolled and randomly assigned to Danlou tablets or placebo groups, superimposed on standard treatment for MI. Then, in addition to assessment of the clinical outcome, the changes in LV volumes were evaluated by a serial echocardiography. In total, 83 patients (Danlou tablets 42 and placebo 41) completed 90 days of treatment and had complete baseline and outcome data. Standard echocardiographic evaluations revealed significant differences in the change of LV end-diastolic volume index (LVEDVi) between group of patients treated with Danlou tablets and the placebo group (-4.49 ± 7.29 vs. -0.34 ± 9.01 mL/m, P < 0.001). The reduction in LVEDVi was independent of beta-blocker, ACE inhibitors/ARBs use. Furthermore, treatment with Danlou tablets significantly reduced LV end-systolic volume index (-4.09 ± 5.85 vs. -0.54 ± 5.72 mL/m, P < 0.001) and improved the LV ejection fraction (4.83 ± 9.23 vs. 0.23 ± 8.15 %, P < 0.001), as compared to placebo. Meaningfully, the incidence of the major adverse cardiovascular events was also lower in patients receiving Danlou tablets (P < 0.05).
Superimposed on the standard pharmacologic treatment, Danlou tablets significantly reversed post-MI adverse LV remodeling, thereby contributed to the overall positive clinical outcome.
clinicaltrials.gov identifier NCT02675322 (February 1, 2016).
丹蒌片是一种已获专利的中药，在中国长期被批准用于治疗缺血性心脏病。尽管大量经验观察表明丹蒌片可减少心绞痛发作的频率和持续时间，但支持其对心脏重塑疗效的证据仍然不足。因此，本试点试验旨在确定丹蒌片是否能减少心肌梗死（MI）患者的不良左心室（LV）重塑。
符合条件的急性心肌梗死患者入组并随机分为丹蒌片组或安慰剂组，同时接受心肌梗死的标准治疗。然后，除了评估临床结局外，通过系列超声心动图评估左心室容积的变化。共有83例患者（丹蒌片组42例，安慰剂组41例）完成了90天的治疗，并拥有完整的基线和结局数据。标准超声心动图评估显示，丹蒌片治疗组与安慰剂组之间左心室舒张末期容积指数（LVEDVi）变化存在显著差异（-4.49±7.29 vs. -0.34±9.01 mL/m，P<0.001）。LVEDVi的降低与β受体阻滞剂、ACE抑制剂/ARB的使用无关。此外，与安慰剂相比，丹蒌片治疗显著降低了左心室收缩末期容积指数（-4.09±5.85 vs. -0.54±5.72 mL/m，P<0.001），并改善了左心室射血分数（4.83±9.23 vs. 0.23±8.15%，P<0.001）。有意义的是，接受丹蒌片治疗的患者主要不良心血管事件的发生率也较低（P<0.05）。
在标准药物治疗的基础上，丹蒌片显著逆转了心肌梗死后不良左心室重塑，从而促成了总体积极的临床结局。
clinicaltrials.gov标识符NCT02675322（2016年2月1日）。
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