国产电磁导航支气管镜检查定位系统引导经支气管镜肺活检术对肺外周病灶的诊断价值

摘要

目的 评价国产电磁导航支气管镜(electromagnetic navigation bronchoscopy,ENB)检查定位系统引导经支气管镜肺活检术(transbronchial lung biopsy,TBLB)在肺外周病灶诊断中的价值和安全性.方法 收集2014年7月至12月来复旦大学附属中山医院就诊、胸部螺旋CT显示为肺外周病变的患者64例.患者随机分入试验组和对照组,试验组ENB联合X线透视下行TBLB,对照组行X线透视下TBLB.根据外科手术切除病灶的病理检查结果或随诊24个月观察临床治疗反应及病情变化进行最后确诊.同时观察和比较两组病灶的检查时间及术中术后不良事件发生情况.结果 64例患者共70处病灶.两组病灶在患者年龄、性别、病灶大小、病灶部位方面的差异均无统计学意义.试验组肺活检组织病理结果与最终诊断符合率为88.6％,对照组为62.9％,差异有统计学意义(P=0.012).亚组分析显示:病灶长径≤2 cm时,试验组确诊率(66.7％ vs.20.0％)与对照组差异无统计学意义(P=0.266);2 cm＜病灶长径≤3 cm时,两组确诊率差异无统计学意义(100％ vs.81.8％,P=0.485);病灶长径＞3 cm时,两组确诊率差异有统计学意义(94.4％ vs.63.1％,P=0.042).试验组的平均总检查时间为(966±372)s,对照组为(1 040±470)s,差异无统计学意义(P=0.600);试验组寻找病灶所需X线透视时间为(7.0±4.8)s,对照组为(37.0±37.5)s,差异有统计学意义(P=0.008).本研究中未发生气胸、严重出血等不良事件.结论 对于肺外周病灶,与传统X线透视下TBLB相比,国产ENB检查定位系统引导TBLB减少寻找病灶所需X线透视时间、提高病灶组织活检病理诊断正确率,尤其在病灶长径＞3 cm时具有优势,且具有一定的安全性.%Objective To evaluate the diagnostic value and safety of domestic electromagnetic navigation bronchoscopy (ENB) guided transbronchial lung biopsy (TBLB) for peripheral pulmonary lesions.Methods Sixty-four patients with peripheral pulmonary lesions shown by thoracic CT in Zhongshan Hospital,Fudan University between Jul.and Dec.,2014 were collected.The patients were randomly assigned to test group (underwent ENB in combination with X-ray guided TBLB) and control group (underwent X-ray guided TBLB).The final diagnosis was confirmed by pathologic examination of surgically removed lesions or by 24 months clinical follow-up.The operative time as well as the intraoperative and postoperative complications were also recorded.Results Sixty-four patients had 70 peripheral pulmonary lesions.There was no difference in age,sex,the lesion size or location between the two groups.Pathology results showed that the diagnostic yield of test group and control group were 88.6％ and 62.9％,respectively,with statistical significance (P =0.012).Subgroup analysis showed that if the lesion's diameter was ≤2 cm,the diagnosis yield of test group was higher than control group (66.7％ vs.20.0％,P =0.266);if the lesion was ＞2 and ≤3 cm,the diagnosis yield of test group and control group were 100 ％ and 81.8 ％,respectively (P =0.485).But if the lesion was＞3 cm,the diagnostic yield of the 2 group was significantly different (94.4 ％ in test group,63.1％ in control group,P =0.042).Mean operation duration of the 2 group was (966 ± 372)s and (1 040 ± 470) s,respectively,with no statistical difference (P =0.600).However,there was statistical difference between the 2 groups on the X-ray time needed to find the pulmonary lessions [(7.0 ± 4.8)s vs.(37.0 ± 37.5) s,P =0.008).There was no pneumothoraxes and excessive bleeding in patients undergoing ENB.Conclusions Compared with X-ray guide TBLB,ENB guided TBLB for peripheral pulmonary lesions has a certain degree of security,and has superiority in reducing the X-ray time required to find the lesion and improving diagnostic yield especially when the lesion's diameter was ＞3 cm.