西罗莫司洗脱支架与紫杉醇洗脱支架介入治疗合并糖尿病的冠心病患者的meta分析

摘要

目的：目前有不少随机对照临床试验比较西罗莫司洗脱支架（SES）与紫杉醇洗脱支架（PES）的介入治疗对于合并糖尿病的冠心病患者的临床及影像结果，但是还缺乏循证医学的证据来进一步证实到底哪一种支架更适合这类人群。方法在循证医学思想的指导下，系统性搜索已发表的相关临床研究，并对纳入的研究进行质量评价，对相关结果进行meta分析，更好地评估两种支架在合并糖尿病的冠心病患者中的作用。结果共纳入5篇随机对照临床试验，这些研究共纳入1264例糖尿病合并冠状动脉病变的患者，其中有644例患者分配到S ES组，另外620例患者分配到PES组。meta分析结果证明，SES的介入治疗在以下几个方面优于PES的介入治疗，血管再狭窄率（OR：0．31，95％ CI：0．18～0．53，P＜0．01）、后期管腔丧失（WMD ：－0．32，95％ CI：－0．39～－0．25，P＜0．01）、靶病变血运重建（OR：0．41，95％ CI：0．25～0．66，P＝0．0002）以及主要心血管事件发生率（OR：0．42，95％C I：0．25～0．69，P＝0．0008）。但是其他方面包括最后的最小管腔直径、总的病死率、心脏原因的病死率、心肌梗死率以及支架血栓发生率，两种支架的介入治疗并没有明显差异。结论总的来说，SES优于PES ，至少在预防血管再狭窄、靶病变血运重建和主要心血管事件方面优于PES。%Objective To investigate the evidence‐based medicine evidences for further verifying whether the sirolimus‐eluting stent(SES) or the paclitaxel‐eluting stent (PES) is more suitable for the patients with coronary heart disease(CHD) complicating diabetes although some randomized controlled trials (RCT ) were conducted for comparing the clinical and image results of the interventional therapy of ESE and PES .Methods The related pub‐lished researches was systematically retrieved by searching electronic databases under the guidance of the evidence‐based medicine thinking .All included researches were performed the quality evaluation and the related results were conducted the meta analysis for better assessing the role of SES and PES in treating diabetes complicating CHD .Re‐sults 5 RCT were included ,involving 1 264 patients with diabetes complicating CHD (644 cases in the SES group and 620 cases in the PES group) .The meta analysis results indicated that SES was superior to PES in the aspects of angiographic binary restenosis(OR:0 .31 ,95% CI:0 .18-0 .53 ,P<0 .01) ,late luminal loss(WMD :-0 .32 ,95% CI:-0 .39- -0 .25 ,P<0 .01) ,target lesion revascularization (OR:0 .41 ,95% CI:0 .25-0 .66 ,P=0 .000 2) and the oc‐currence rate of major adverse cardiac events (OR:0 .42 ,95% CI:0 .25-0 .69 ,P=0 .000 8) .But the other aspects in‐cluding final minimal lumen diameter ,total death rate ,death rate due to cardiac causes ,myocardial infarction rate and the occurrence rate of stent thrombosis had no sitnificant differences between SES and PES .Conclusion SES is supe‐rior to PES at least in the aspects of preventing angiographic binary restenosis ,target lesion revascularization and ma‐jor adverse cardiac events in patients with diabetes complicating CHD .