Qi-shen-yi-qi dripping pills for the secondary prevention of myocardial infarction: a randomised clinical trial.

Qi-shen-yi-qi dripping pills for the secondary prevention of myocardial infarction: a randomised clinical trial.
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DOI:
10.1155/2013/738391
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发表时间:
2013
期刊:
Evidence-based complementary and alternative medicine : eCAM
影响因子:
--
通讯作者:
Zhang B
Zhang B
中科院分区:
其他
文献类型:
--
作者:
Shang H;Zhang J;Yao C;Liu B;Gao X;Ren M;Cao H;Dai G;Weng W;Zhu S;Wang H;Xu H;Zhang B

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背景几种类型的药物已被推荐用于心肌梗死(MI)的二级预防。然而,这些常规策略具有若干局限性,诸如低依从性、高成本和在长时间使用期间的副作用。仍然需要新的方法来解决这个问题。本试验旨在验证多成分中成药芪参益气滴丸(QSYQ)用于心肌梗死二级预防的有效性和安全性。方法和发现。共3505例符合条件的患者被随机分配到QSYQ组(1746例)或阿司匹林组(1759例)。患者接受了12个月的治疗。末次随访访视在试验药物结束后6个月进行。QSYQ组12个月和18个月主要结局的估计发生率分别为2.98%和3.67%。阿司匹林组为2.96%,阿司匹林组为3.81%。两组间无显著差异。结论.这项试验没有显示阿司匹林和QSYQ在MI患者中的主要和次要结局有显著差异。虽然没有结论,但结果表明,在MI的二级预防中,QSYQ具有与阿司匹林相似的效果。
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.
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