随机、平行对照评价陶瓷膜室间隔缺损封堵器安全性和有效性

目的:随机、平行对照的临床试验验证先健科技(深圳)有限公司生产的TM陶瓷膜VSD封堵器治疗室间隔缺损的安全性及有效性。方法:根据试验的要求入选术前确诊为室间隔缺损的病人42例,随机分为实验组(A组)和对照组(B组),每组各21例,对A组病人植入CeraTM陶瓷膜VSD封堵器,对B组病人植入普通镍钛合金VSD封堵器,在超声心动图下或X线下观察室间隔缺损大小、位置、形态、类型,选择合适的封堵伞,经输送系统置入封堵器闭合VSD,分别于术前、术后24小时、术后30天、90天及术后180天进行随访,主要随访内容包括临床症状和体征、超声心动图、心电图、胸片、24小时动态心电图检查等。比较这两组患者的即刻手术成功率以及随访过程中终点事件发生率的不同。结果:试验组和对照组的成功率均为100%,残余分流率分别为0和4.8%,试验组的并发症发生率与对照组未见明显差异(P0.005)。结论:试验组与对照组安全性与疗效相当,应用国产陶瓷封堵器是安全、有效的。但由于该项技术是一项新技术,临床试验样本量较少,其安全性和疗效特别是中远期疗效仍需进一步观察。

Evaluation of Safety and Efficiency for CeraTMOccluder of VSD with Randomand Comparison

Objective:Evaluation of safety and efficiency for CeraTM occluder of VSD with random and comparison.Methods:42 cases with final diagnosis of ventricular septal defect according to experiment required were separated two gruops that were test group(A) and control group(B) in average. Patients in test group(A) were implantation of CeraTMVSD occluder and ones in control group(B) were implantation of Ni-Ti alloys VSD occluder. The condition of occluder, such as size, location, shape and type was observed by echocardiogram or X-ray. VSD was occludered by adapted occluder through transfer system. The follows up that included clinical symptoms, echocardiogram, ECG and X-ray were adopted preoperative and postoperative of 24 hours, 30 days, 90 days and 180 days. Comparison of instant operation achievement ratio and incidence of destination events in follows between two groups was adopted.Results:The instant operation achievement ratio between two groups is both 100%. Residual shunt happened between two groups is 0 and 4.8%. Incidence of complication was significantly different(P<.005).Conclusion:Safety and efficiency were equivalent between two groups. However, observation of metaphase and prostecdtive efficacy was also required because it was a newtechniques lack of sample capacities of clinical trials.