经导管封堵术与外科手术治疗室间隔缺损对照试验的Meta分析

Transcatheter closure and surgical repair of ventricular septal defect: a Meta analysis of controlled trial

目的对比经导管封堵术和外科手术治疗室间隔缺损(VSD)的疗效、安全性和经济费用,为临床优化治疗提供参考依据。方法采用Meta分析方法,对国内外有关经导管封堵术和外科手术治疗VSD的临床对比研究进行综合定量分析,采用Rev Man5.2软件进行数据处理,比较两组患者的年龄、体重、VSD大小、住院时间、手术费用等,计算两组患者的性别构成比、成功率、并发症、主要并发症、次要并发症等发生率的相对危险度(RR)及其95%可信区间(CI)。结果符合纳入标准共11篇文献,总样本量2 078例。Meta分析结果显示:经导管封堵组和外科手术组性别构成比、体重差异无统计学意义,经导管封堵组患者的年龄较高,治疗的VSD直径较小,差异有统计学意义(P<0.05)。经导管封堵组的成功率与外科手术组比较,差异无统计学意义(98.3%比98.4%,P=0.99);经导管封堵组总并发症、主要并发症、次要并发症发生率均低于外科手术组,差异有统计学意义(10.29%比25.05%,P<0.000 01)、(0.56%比2.44%,P=0.002)、(9.91%比22.69%,P<0.000 01);经导管封堵组住院时间低于外科手术组,差异有统计学意义[(6.13±2.05)d比(11.08±3.76)d,P<0.000 01];经导管封堵组的手术费用稍高于外科手术组,差异无统计学意义[(17 793.76±2 196.06)元比(16 919.96±2 647.63)元,P=0.36]。结论经导管封堵VSD成功率、手术费用与传统外科手术比较无明显差别,但并发症发生率、住院时间均明显低于外科手术患者,因此随着封堵器的不断改进和完善,在适应证范围内经导管封堵术可作为VSD外科手术治疗的替代方法。

Objective To compare the curative effect, safety and medical expense of transcatheter closure with surgical repair for ventricular septal defect（VSD） in order to provide a basic reference for optimization of clinical treatment. Methods By using Meta analysis method the quantitative analysis of clinical comparison studies between transcatheter closure and surgical treatment for VSD, which were reported both at home and abroad, was conducted. Using Rev Man5.2 software for data processing, the patient＇s age, weight, size of VSD, length of hospital stay, operation expenses were compared between the two groups, and the gender ratio, the success rate, complications and incidence of main complications and secondary complications, the relative risk（RR） and their 95% confidence interval（CI）, etc. were calculated. Results A total of 11 studies including 2 078 cases were enrolled in this study. Meta analysis showed that the weight and gender composition was similar in the two groups, but the age in the transcatheter group was higher than that in the surgical group, the VSD size in the transcatheter group was smaller than that in the surgical group, and the differences were statistically significant. The success rate in the transcatheter group（98.3%） was quite the same as that in the surgical group（98.4%）, the difference was not significant（P = 0.99）. The total complications, main complications and secondary complications in the transcatheter closure group were lower than those in the surgical repair group, and the differences were statistically significant（10.29% vs. 25.05%, P 0.000 01; 0.56% vs. 2.44%, P = 0.002; 9.91% vs.22.69%, P 0.000 01; respectively）. The hospitalization time of the transcatheter closure group was shorter than that of the surgical repair group, and the difference was statistically significant [（6.13 ± 2.05） days vs.（11.08 ± 3.76） days, P 0.000 01 ]. The operation cost of the transcatheter closure group was higher than that of the surgical repair group although the difference was not statistically significant [（17 793.76 ±2 196.06） US dollars vs.（16 919.96 ± 2 647.63） US dollars, P = 0.36]. Conclusion No significant differences in the success rate and medical expense exist between the transcatheter closure therapy and the traditional surgery for the treatment of VSD, but in the transcatheter closure group the incidence of complications is lower, the hospitalizations time is shorter when compared with the traditional surgical group.With the development and improvement of the occluder, transcatheter closure technique may substitute for traditional surgical repair for the treatment of ventricular septal defect.