国产经胸壁穿刺诊疗定位系统辅助肺结节穿刺活检的随机对照研究

Clinical value of domestic electromagnetic navigation system for precutaneous transthoracic needle biopsy:a randomized controlled trial

目的·评估国产经胸壁穿刺诊疗定位系统辅助肺结节穿刺活检的应用价值。方法·采用前瞻性随机对照研究,纳入需进行肺结节穿刺活检明确病理诊断的113例患者,按照随机数字表法分组:辅助穿刺组(n=57)采用经胸壁穿刺诊疗定位系统,常规操作组(n=56)采用传统的CT引导下肺穿刺活检。2组操作过程均由低年资医师在高年资医师的监督指导下完成。主要观察和比较2组穿刺耗时、CT扫描次数以及术后并发症。结果·辅助穿刺组操作耗时与常规操作组比较,差异无统计学意义[(26.7±8.0)min vs(25.0±7.8)min,P=0.261)];2组穿刺过程中CT扫描次数比较,差异无统计学意义(4.9±2.7 vs 5.1±2.7,P=0.810);2组术后气胸(15.8%vs 19.6%,P=0.592)和出血(17.5%vs 14.3%,P=0.636)的发生率比较,差异均无统计学意义。结论·经初步研究,国产经胸壁穿刺诊疗定位系统可以安全、有效地辅助临床医师完成肺穿刺活检。

Objective·To evaluate the clinical value of the electromagnetic navigation system for precutaneous transthoracic needle biopsy.Methods·A prospective randomized controlled trial was carried out.One hundred and thirteen patients who needed to have lung nodule biopsy were divided into two groups according to the random number table:the auxiliary puncture group(n=57)adopting the electromagnetic navigation system for precutaneous transthoracic needle biopsy,and the conventional operation group(n=56)adopting the traditional CT-guided transthoracic needle biopsy.The operation process of the two groups was completed by junior doctors under the supervision and guidance of senior doctors.The time of puncture,the number of CT scan,and postoperative complications were observed and compared between the two groups.Results·There was no significant difference in operation time between the auxiliary group and the conventional group[(26.7±8.0)min vs(25.0±7.8)min,P=0.261)].There was no significant difference in the number of CT scan between the two groups(4.9±2.7 vs 5.1±2.7,P=0.810).There was no significant difference in the incidence rate of pneumothorax(15.8%vs 19.6%,P=0.592)and bleeding(17.5%vs 14.3%,P=0.636)between the two groups.Conclusion·The domestic electromagnetic navigation system for precutaneous transthoracic needle biopsy can safely and effectively assist clinicians to complete lung biopsy.