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Meta-Analysis
. 2015 May 21;2015(5):CD010237.
doi: 10.1002/14651858.CD010237.pub2.

Tong-xin-luo capsule for patients with coronary heart disease after percutaneous coronary intervention

Chen Mao  1 , Xiao-Hong Fu, Jin-Qiu Yuan, Zu-Yao Yang, Vincent C H Chung, Ying Qin, Yafang Huang, Wilson Wai San Tam, Joey S W Kwong, Wei Xie, Jin-Ling Tang
Affiliations
Meta-Analysis

Tong-xin-luo capsule for patients with coronary heart disease after percutaneous coronary intervention

Chen Mao et al. Cochrane Database Syst Rev. .

Abstract

Background: Percutaneous coronary intervention (PCI) is a standard treatment for coronary heart disease (CHD). Restenosis, defined as a 50% reduction in luminal diameter at six months after PCI, indicates a need for revascularisation. Restenosis has proven to be a major drawback to PCI. Tong-xin-luo is one of the prophylactic strategies for cardiovascular events in patients after PCI that is widely used in China, but its efficacy and safety have not been systematically evaluated.

Objectives: To systematically assess the efficacy and safety of Tong-xin-luo capsules in preventing cardiovascular events after PCI in patients with CHD.

Search methods: We searched the Cochrane Central Register of Controlled Trials in The Cochrane Library, MEDLINE (OVID), EMBASE (OVID), WanFang, Chinese Biomedical Database, Chinese Medical Current Contents, and China National Knowledge Infrastructure from their inception to June 2014. We also searched other resources, including ongoing trials and research registries. We applied no language restrictions.

Selection criteria: Randomised controlled trials of participants with CHD after PCI were included. Participants in the intervention group received Tong-xin-luo capsules for at least three months.

Data collection and analysis: Two review authors independently extracted data and assessed the risk of bias. Any disagreements were resolved by discussion with a third review author. The primary outcomes included occurrence of angiographic restenosis and adverse events; the secondary outcomes included myocardial infarction, heart failure, angina, all cause mortality, mortality due to any cardiovascular event, use of revascularisation, patient acceptability, quality of life and cost-effectiveness. Dichotomous data were measured with risk ratios (RRs) with 95% confidence intervals (CIs).

Main results: Sixteen studies involving 1063 participants were identified. The risk of bias for fifteen studies was high and along with imprecision and possible publication bias, this lowered our confidence in the results. There was low quality evidence that Tong-xi-luo reduced the rates of angiographic restenosis (RR 0.16, 95% CI 0.07 to 0.34), myocardial infarction (RR 0.32, 95% CI 0.16 to 0.66), heart failure (RR 0.26, 95% CI 0.11 to 0.62), and use of revascularisation (RR 0.26, 95% CI 0.15 to 0.45). There was very low quality evidence for the effect of Tong-xin-luo on all-cause mortality (RR 0.38, 95% CI 0.06 to 2.56), angina (RR 0.24, 95% CI 0.17 to 0.34) and death due to any cardiovascular event (RR 0.31, 95% CI 0.08 to 1.12). Adverse events were seldom reported, and included gastrointestinal reactions and nausea.

Authors' conclusions: The addition of Tong-xin-luo to conventional Western medicine may possibly prevent restenosis and recurrence of cardiovascular events in patients with CHD after PCI. However, the data are limited by publication bias and high risk of bias for included studies. Further high-quality trials are required to evaluate the potential effects of this intervention.

PubMed Disclaimer

Conflict of interest statement

Nothing to declare.

Figures

1
1
Flow chart of study selection
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Funnel plot of comparison: 1 Tong‐xin‐luo + Conventional treatment vs. Conventional treatment, Outcome: 1.2 Occurence of myocardial infarction.
4
4
Funnel plot of comparison: 1 Tong‐xin‐luo + Conventional treatment vs. Conventional treatment, Outcome: 1.4 Occurrence of angina.
1.1
1.1. Analysis
Comparison 1 Tong‐xin‐luo + Convetional treatment vs. Convetional treatment, Outcome 1 Occurrence of angiographic restenosis.
1.2
1.2. Analysis
Comparison 1 Tong‐xin‐luo + Convetional treatment vs. Convetional treatment, Outcome 2 Occurence of myocardial infarction.
1.3
1.3. Analysis
Comparison 1 Tong‐xin‐luo + Convetional treatment vs. Convetional treatment, Outcome 3 Occurence of heart failure.
1.4
1.4. Analysis
Comparison 1 Tong‐xin‐luo + Convetional treatment vs. Convetional treatment, Outcome 4 Occurrence of angina.
1.5
1.5. Analysis
Comparison 1 Tong‐xin‐luo + Convetional treatment vs. Convetional treatment, Outcome 5 All‐cause mortality.
1.6
1.6. Analysis
Comparison 1 Tong‐xin‐luo + Convetional treatment vs. Convetional treatment, Outcome 6 Mortality due to any cardiovascular event.
1.7
1.7. Analysis
Comparison 1 Tong‐xin‐luo + Convetional treatment vs. Convetional treatment, Outcome 7 Use of revascularization.
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  • doi: 10.1002/14651858.CD010237

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References

References to studies included in this review

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Dai 2011 {published data only}
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Dong 2012 {published data only}
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Huang 2010 {published data only}
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Li 2004 {published data only}
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Liang 2010 {published data only}
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Wang 2009a {published data only}
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Wang 2010 {published data only}
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Wu 2010 {published data only}
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Xiao 2007 {published data only}
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Yang 2009a {published data only}
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Yao 2006 {published data only}
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Zhang 2009a {published data only}
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Zheng 2010 {published data only}
    1. Zheng H, Teng ZH, Ma LQ. The effect of Tongxinluo capsule on level of serum CRP and blood lipid in patients with ACS post PCI [通心络胶囊对急性冠状动脉综合征介入术后患者C‐反应蛋白、血脂的影响]. Chinese Journal of Difficult and Complicated Cases 2010;9(7):487‐8.
Zhou 2007b {published data only}
    1. Zhou J, Guo JT. Clinical Study of Tongxinluo on Preventing Re‐stenosis of Stents in CHD [通心络预防冠心病患者支架术后再狭窄的临床研究]. Hebei Medicine 2007;13(10):1188‐91.

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Chang 2004 {published data only}
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Chen 2007 {published data only}
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Fan 2008 {published data only}
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Fu 2012 {published data only}
    1. Fu DH, Song XL, Feng CH. Clinical observation of Tongxinluo capsules in treating patients with angina after PCI [通心络胶囊对冠心病介入术后心绞痛的疗效观察]. Journal of Guiyang College of Traditional Chinese Medicine 2012;34(3):171‐2.
Gao 2007 {published data only}
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Guo 2012 {published data only}
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Han 2009 {published data only}
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Kuang 2011 {published data only}
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Li 2008 {published data only}
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Li 2012 {published data only}
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Liu 2009 {published data only}
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Lu 2012 {published data only}
    1. Lu Y, Zhao XJ, Liao XC. The effect of Tongxinluo capsules on the change of hemorheology in patients with CHD after PCI [通心络胶囊对冠心病患者PCI 术后血液流变学的影响]. Inner Mongol Journal of Traditional Chinese Medicine 2012;14(4):1‐2.
Ma 2009 {published data only}
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Qu 2011 {published data only}
    1. Qu JQ, Ma JE, Bai RL. Clinical observation of Tongxinluo in treating patients with CHD [通心络胶囊治疗冠心病心绞痛疗效观察]. Chinese and Foreign Medical Research 2011;9(12):22.
Su 2000 {published data only}
    1. Su XY, Huang JX, Zhao ZJ, Zhao L, Hu YL, Su HR. Clinical observation of 96 cases of variant angina pectoris treated with Tongxinluo [通心络治疗变异型心绞痛96例临床观察]. Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Cricitical Care 2000;7(2):119.
Tao 2012 {published data only}
    1. Tao WG, Zhu KY. Curative effect of Tongxinluo in treatment of angina after percutaneous coronary intervention (PCI) operation [通心络治疗PCI 术后心绞痛的疗效观察]. Medical Innovation of China 2012;9(5):9‐10.
Tu 2006 {published data only}
    1. Tu YP, Lei MJ, Zeng LF, Gong AB, Wei WR, Wang LL, et al. Influence of Tongxinluo on C‐reactive Protein in patients with diabetes after percutaneous coronary intervention [通心络胶囊对糖尿病患者冠状动脉介入术后C反应蛋白的影响]. Chinese Remedies & Clinics 2006;6(3):229‐30.
Wang 2007 {published data only}
    1. Wang G. Clinical study Oil Lvedv and Lvef after blood flow reconstruction interfered by Tongxinluo capsule in patients with AMI after percutaneous coronary intervention [通心络胶囊对急性心肌梗死介入治疗后左室舒张末容积和射血分数的影响]. Chinese Journal of Primary Medicine and Pharmacy 2007;14(4):570‐1.
Wang 2009b {published data only}
    1. Wang WY, Liu YB, Sun Y. Effect of Tongxinluo on inflammatory factor in patients with ACS [通心络胶囊对急性冠脉综合症患者介入治疗后炎症因子的影响]. Prevention and Treatment of Cardio‐cerebral‐vascular disease 2009;9(4):308‐9.
Wang 2009c {published data only}
    1. Wang X, Li J. Clinical observation for Tongxinluo in the treatment of CHD [通心络胶囊治疗冠心病的临床疗效观察]. Chinese Journal of Modern Drug Application 2009;22(3):105‐6.
Wang 2012 {published data only}
    1. Wang L, Liu H, Hu YC. The effect of drug intervention on vascular inflammatory reaction and vascular endothelial function after percutaneous coronary intervention [冠状动脉介入术后血管炎症反应及内皮功能改变的药物干预探讨]. China Clinical Practical Medicine 2012;7(18):169‐70.
Xiao 2004 {published data only}
    1. Xiao YQ, Li WK. The effect of Tongxinluo in treating patients with unstable angina pectoris [通心络治疗不稳定型心绞痛的临床观察]. Acta medicinae Sinica 2004;17(2):152‐3.
Xu 2007 {published data only}
    1. Xu Z, Li X. Influence of Tongxinluo on inflammatory factor of acute coronary syndrome patients after interventional therapy and its early heart complication [通心络对急性冠脉综合征患者介入治疗术后炎性因子及早期心脏并发症的影响]. Modern Journal of Integrated Traditional Chinese Western Medicine 2007;16(2):156‐7.
Xu 2008 {published data only}
    1. Xu LD, Liu LY. The prevention of restenosis after percutaneous coronary intervention [冠状动脉支架内再狭窄的防治]. Practical Cardio‐cerebral Pulmonary Vascular Disease 2008;16(4):73‐6.
Yang 2009b {published data only}
    1. Yang GK. Inflammatory reaction and change of vascular endothelial function after percutaneous coronary intervention and the effect of drug intervention [冠心病介入术后血管炎症反应和内皮功能变化及药物干预作用]. Sichuan Medical Journal 2009;30(11):1788‐90.
Yang 2010 {published data only}
    1. Yang JX, Li MJ, Yang XH. Effect of Tongxinluo on Change of Vascular Inflammation and EndothelialFunction after Percutaneous Coronary Intervention [冠状动脉介入术后血管炎症反应和内皮功能改变及药物干预作用]. Journal of Liaoning University of TCM 2010;12(2):94‐6.
Yang 2012 {published data only}
    1. Yang W, Xu XH, Wang S, Zhang CF. The effect of Tongxinluo on serum PⅢNP and ventricular remodeling in patients with AMI after PCI [通心络胶囊对急性心肌梗死急诊PCI术后患者血清 Ⅲ型前胶原氨基端肽及左室重构的影响]. Chinese Journal of Difficult and Complicated Cases 2012;11(6):452‐3.
Zhang 2005 {published data only}
    1. Zhang W. Effect of Tongxinluo Capsule on Coagulant and Fibrinolysis System andAngiotension II in Patients with CHD after Intracoronary Stenting [通心络胶囊对冠脉内支架置入术后患者凝血纤溶系统和血管紧张素II的影响]. Hebei Medicine 2005;12(1):37‐9.
Zhang 2006 {published data only}
    1. Zhang JW, Yang DC. The protective effects of Tongxinluo on myocardium after reperfusion in PCI patients with acute myocardium infarction [通心络对急性心肌梗死急诊PCI患者再灌注损伤的保护性研究]. Medicine Industry Information 2006;3(21):8‐10.
Zhang 2007 {published data only}
    1. Zhang HW. Clinical analysis of integrated traditional and western medicine in treating 62 cases of CHD [中西医结合治疗冠心病62例临床分析]. Theory and Practice of Chinese Medicine 2007;17(7):722‐3.
Zhang 2008 {published data only}
    1. Zhang LJ, Li HT, Guo JT, Zhou J. The Effect of Tongxinluo Capsules on the Function of BloodVessel Endothelium(BVE)on the Patientswith Coronary Heart Disease [通心络胶囊对冠状动脉粥样硬化性心脏病人血管内皮功能的影响]. Hebei Medicine 2008;14(7):761‐7.
Zhang 2009b {published data only}
    1. Zhang TX, Zhou JZ. The effect of Tongxinluo on inflammatory cytokins in patients with ACS [通心络胶囊对急性冠脉综合症患者炎症因子的影响]. China Journal of Chinese Materia Medica 2009;34(14):1857‐8.
Zhang 2010 {published data only}
    1. Zhang HT, Jia ZH, Zhang J, Ye ZK, Yang WX, Tian YQ, et al. No‐reflow protection and long‐term efficacy for acute myocardialinfarction with Tongxinluo: a randomized double‐blind placebo—controlled multicenter clinical trial. Chinese Medical Journal 2010;123(20):2858‐64. - PubMed
Zhao 2010 {published data only}
    1. Zhao H, Tian JH, Hao XY, Ma L. Effects of Tongxinluo on Inflammatory factors in patients with coronary heart disease after percutaneous coronary intervention [通心络对冠心病病人PCI 术后炎症因子的影响]. Acta Academiae Mediciane Qindao Universitatis 2010;46(4):349‐351.
Zhao 2011 {published data only}
    1. Zhao X, Song ZJ, Hou LX. Clinical observation of Tongxinluo in treating patiens after percutaneous coronary intervention [通心络治疗支架置入术后患者的临床分析]. Medical Information 2011;24(7):173.

References to studies awaiting assessment

Deng 2013 {published data only}
    1. Deng X. Effect of Tongxinlou capsule on restenosis after PCI in patients with CHD [通心络胶囊干预冠心病PCI术后再狭窄临床观察]. China Medicine and Pharmacy 2013;3(12):67‐8.

References to ongoing studies

Han 2012 {published data only}
    1. NCT01721590. Tongxinluo improve high on Clopidogrel platelet reactivity in patients with coronary heart disease. http://clinicaltrials.gov/show/NCT01721590 (accessed November 2012).

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