A multi-center randomized double-blind placebo-controlled trial of Xiongshao Capsule in preventing restenosis after percutaneous coronary intervention: a subgroup analysis of senile patients / 中国结合医学杂志
Chinese journal of integrative medicine
; (12): 669-674, 2011.
Article
in English
| WPRIM (Western Pacific)
| ID: wpr-328435
Responsible library:
WPRO
ABSTRACT
<p><b>OBJECTIVE</b>To evaluate the safety and efficacy of Xiongshao Capsule (XS), consisting of Chuangxiongol and paeoniflorin, in preventing restenosis after percutaneous coronary intervention (PCI) in senile coronary heart disease (CHD) patients.</p><p><b>METHODS</b>A multi-center, randomized, double-blind, placebo-controlled trial was conducted. A total of 335 CHD patients were randomly assigned to treatment with oral administration of XS, or a placebo for 6 months after successful PCI. A clinical follow-up was performed at 1, 3 and 6 months after PCI and an angiographic follow-up was scheduled at 6 months. The primary endpoint was angiographic restenosis defined as a luminal stenosis ≥ 50% in follow-up. The secondary endpoints were combined incidence of death, target lesion nonfatal myocardial infarction, repeat target-vessel angioplasty, and coronary artery bypass graft surgery (CABG). The follow-up for the above clinical endpoint events was continued to 1 year after PCI.</p><p><b>RESULTS</b>The subgroup analysis of 152 senile patients (68 cases angiographic follow-up) showed that the restenosis rates tended to reduce in the XS group as compared with that in the placebo group (24.32% vs. 38.71%, P > 0.05), and the minimum lumen diameter (MLD) significantly increased in the follow-up (2.15 ± 0.84 for XS vs. 1.73 ± 0.91 for placebo, P < 0.05). The incidence of recurrent angina at 3 and 6 months after PCI was also significantly reduced in the XS group (4.11% and 12.33%) as compared with those in the placebo group (17.72% and 43.04%), but there was no significant difference in the combined incidence of clinical outcomes (6.85% in the XS group vs. 11.39% in the placebo group, P > 0.05). No significant adverse reactions occurred within the 6-month follow-up period in the XS group.</p><p><b>CONCLUSION</b>Administration of XS in addition to standardized Western medication for 6 months is demonstrated to be safe and effective in reducing post-PCI recurrent angina and inhibiting luminal restenosis after PCI in senile CHD patients.</p>
Full text:
Available
Health context:
Sustainable Health Agenda for the Americas
/
SDG3 - Health and Well-Being
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SDG3 - Target 3.4 Reduce premature mortality due to noncommunicable diseases
Health problem:
Goal 9: Noncommunicable diseases and mental health
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Target 3.4: Reduce premature mortality due to noncommunicable diseases
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Cardiovascular Disease
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Ischemic Heart Disease
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Sense Organ Diseases
Database:
WPRIM (Western Pacific)
Main subject:
Placebos
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Recurrence
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Capsules
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Diagnostic Imaging
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Drugs, Chinese Herbal
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Angioplasty, Balloon, Coronary
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China
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Double-Blind Method
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Epidemiology
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Coronary Angiography
Type of study:
Controlled clinical trial
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Diagnostic study
Limits:
Aged
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Female
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Humans
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Male
Country/Region as subject:
Asia
Language:
English
Journal:
Chinese journal of integrative medicine
Year:
2011
Document type:
Article