| BackgroundIn today’s world, Coronary heart disease (CHD) with high morbidity and mortality is not only a serious threat to human health, but also a heavy financial burden to low-and middle-income countries. Percutaneous coronary intervention (PCI) is considered to be a most commonly treatment of CHD. PCI results in possible complications, such as in-stent restenosis, in-stent thrombosis, and adverse events. Studies have reported that traditional Chinese medicine (TCM) has a good effect in the prevention of restenosis after PCI. Xiongshao Capsule (XSC) can prevent the formation of restenosis (RS) after PCI by improving the function of endothelial cell, inhibiting the aggregation of platelet, inhibiting the migration and proliferation of vascular smooth muscle cells (VSMC) and promoting the apoptosis of VSMC, inhibiting of intimal hyperplasia, improving pathological vascular remodeling, regulating blood lipid levels, stabling atherosclerotic plaques, increasing collagen degradation and reducing collagen deposition in vascular wall.ObjectiveThe aim of this study is to assess the efficacy and safety of XSC in preventing restenosis after PCI by the methods of the Cochrane systematic review, is to provide XSC preventing restenosis after PCI for evidence-based medicine, and to provide a basis for clinical decision-making.Methods1search methods We searched the following databases, without regard for time, language or publishing restrictions:PubMed, EMBASE, Cochrane Central Register of Controlled Trials (CCRCT), Web of Science-SCI Expanded, China National Knowledge Infrastructure/Chinese Academic Journals full-text Database (CNKI), Chinese Biomedical Database (CBM), WanFang Date, and VIP (a full-text database of Chinese journals). The latest update of the specialized register was in April2013.2selection criteriaRandomized controlled trials comparing the XSC combined with conventional western treatment to placebo combined with conventional western treatment, comparing the XSC combined with conventional western medicine treatment to conventional western medicine treatment in participants diagnosised with coronary heart disease after PCI. We excluded trials which did not report a minimum follow-up period of one month from start of treatment.3Data collection and analysisTwo authors collected the data independently. Different views were determined by the third author. We assigned the risk of bias according to the following methodological criteria:random sequence generation, allocation concealment, blinding, incomplete outcome data, selective outcome reporting and other sources of bias. Dichotomous data are presented as risk ratios (RR) and95%confidence intervals (CI); continuous outcomes are presented as mean differences (MD) and95%CIs. The data analyses were carried out by Review Manager5.1. We assigned the quality of evidence according to the following methodological criteria:the risk of bias, inconsistency, indirectness, imprecision, publication bias, largeeffect, plausible confounding would chang the effect, dose-response gradient.We assessed the quality of evidence and strength of recommendations by GRADEpro3.6. For cases in which necessary information was not reported in the paper, we contacted the primary authors for additional information. Resultswe retrieved100trials through electronic databases,but5trials were included after screening.2trials were included in meta-analysis due to the sub-center trail, subgroup analysis of the trail, the trail with incomplete data. These trials were included in descriptive analysis.1. The analysis showed that:The incidence of clinical events was significantly reduced in the XSC group as compared with those in the control group (RR=0.46,95%CI:0.30to0.70;2trials,422people), the quality of evidence and strength of recommendations was moderate; these studies were no cases in the event of death; there was no significant difference in non-fatal acute myocardial infarction (RR=0.20,95%CI:0.04tol.17,2trials,422people), the quality of evidence and strength of recommendations was low; The incidence of repeat target-vessel PCI was significantly reduced in the XSC group as compared with those in the control group (RR=0.53,95%CI:0.34to0.83,2trials,422people), the quality of evidence and strength of recommendations was moderate; there was no significant difference in the incidence of target-vessel coronary artery bypass graft surgery (CABG)(RR=0.34,95%CI:0.55to2.11,2trials,422people), the quality of evidence and strength of recommendations was low; Ths incidence of recurrent angina was significantly reduced in the XSC group as compared with those in the control group(RR=0.35,95%CI:0.18to0.68,2trials,422people), the quality of evidence and strength of recommendations was low; The restenosis rates were significantly reduced in the XSC group as compared with those in the control group (RR=0.55,95%CI:0.38to0.80,2trials,422people), the quality of evidence and strength of recommendations was low; the minimum lumen diameter(MLD) was significantly greater in the XSC group as compared with those in the control group (MD=0.35mm,95%CI:0.09to0.61,2trials,191vessels); The stenosis of luminal was significantly less in the XSC group as compared with those in the control group (MD=-12.30,95%CI:-19.72to-4.88,,2trials,191vessels); the stenosis of target-lesion was significantly less in the XSC group as compared with those in the control group (RR=0.59,95%CI:0.41to0.86,2trials,422people), the quality of evidence and strength of recommendations was low; there was no significant difference in the incidence of the stenosis of coronary, restenosis of drug-eluting stent and side effects.2. Subgroup analysis (Age>60years):The incidence of recurrent angina was significantly reduced in the XSC group as compared with those in the control group (RR=0.29,95%CI:0.15to0.56,1trials,152people); no death, no non-fatal acute myocardial infarction was; there was no significant difference in the incidence of clinical events, repeat target-vessel PCI, target-vessel CABG, restenosis cases, the restenosis of target-lesion and side effects.Conclusion1. According to the results of this systematic review, combined with the the quality of evidence, little number of included trials from the same research group, which may not yet fully confirmed the effect of XSC combined with western conventional treatment in preventing restenosis after PCI, and RCT with large-scale, multi-center, double-blind, placebo to be done, in order to verify preventing restenosis after PCI has a good effect.2. There are some problems in the research of traditional Chinese medicine. It is recommended that researching and reporting RCT should be strictly followed the CONSORT2010Statement and International Herbal CONSORT statement,which will make for getting the most accurate evidence of research, improving the level of research and international communication. |
