Tianjin University of Traditional Chinese Medicine, 312 Anshanxi Road, Nankai District, Tianjin 300193, China.
Evid Based Complement Alternat Med. 2013;2013:738391. doi: 10.1155/2013/738391. Epub 2013 Jul 14.
Background. Several types of drugs have been recommended for the secondary prevention of myocardial infarction (MI). However, these conventional strategies have several limitations, such as low adherence, high cost, and side effects during long time use. Novel approaches to this problem are still needed. This trial aimed to test the effectiveness and safety of Qi-Shen-Yi-Qi Dripping Pills (QSYQ), a multi-ingredient Chinese patent medicine, for the secondary prevention of MI. Methods and Findings. A total of 3505 eligible patients were randomly assigned to QSYQ group (1746 patients) or aspirin group (1759). Patients took their treatments for 12 months. The final follow-up visit took place 6 months after the end of the trial drugs. The 12-month and 18-month estimated incidences of the primary outcome were 2.98% and 3.67%, respectively, in the QSYQ group. The figures were 2.96% and 3.81% in the aspirin group. No significant difference was identified between the groups. Conclusions. This trial did not show significant difference of primary and secondary outcomes between aspirin and QSYQ in patients who have had an MI. Though inconclusive, the result suggests that QSYQ has similar effects to aspirin in the secondary prevention of MI.
已有多种药物被推荐用于心肌梗死（MI）的二级预防。然而，这些常规策略存在依从性低、成本高以及长期使用时出现副作用等局限性。因此，仍需要探索新的方法来解决这一问题。本试验旨在检验芪参益气滴丸（QSYQ）作为一种多成分中药专利药物，在 MI 二级预防中的有效性和安全性。
共纳入 3505 名符合条件的患者，随机分配至 QSYQ 组（1746 例）或阿司匹林组（1759 例）。患者接受治疗 12 个月。最终随访在试验药物结束后 6 个月进行。QSYQ 组的主要结局 12 个月和 18 个月的估计发生率分别为 2.98%和 3.67%。阿司匹林组的相应数字分别为 2.96%和 3.81%。两组间未观察到显著差异。
在发生过 MI 的患者中，与阿司匹林相比，QSYQ 并未显著改善主要和次要结局。虽然结果尚无定论，但提示 QSYQ 在 MI 的二级预防中与阿司匹林具有相似的效果。
