St Peter Shawn D, Tsao Kuojen, Spilde Troy L, Keckler Scott J, Harrison Christopher, Jackson Mary Ann, Sharp Susan W, Andrews Walter S, Rivard Doug C, Morello Frank P, Holcomb George W, Ostlie Daniel J
Center for Prospective Clinical Trials, Department of Pediatric Surgery, Children's Mercy Hospital, Kansas City, MO 64108, USA.
J Pediatr Surg. 2009 Jan;44(1):106-11; discussion 111. doi: 10.1016/j.jpedsurg.2008.10.018.
Management of empyema has been debated in the literature for decades. Although both primary video-assisted thoracoscopic surgery (VATS) and tube thoracostomy with pleural instillation of fibrinolytics have been shown to result in early resolution when compared to tube thoracostomy alone, there is a lack of comparative data between these modes of management. Therefore, we conducted a prospective, randomized trial comparing VATS to fibrinolytic therapy in children with empyema.
After Institutional Review Board approval, children defined as having empyema by either loculation on imaging or more than 10,000 white blood cells/microL were treated with VATS or fibrinolysis. Based on our retrospective data using length of postoperative hospitalization as the primary end point, a sample size of 36 patients was calculated for an alpha of .5 and a power of 0.8. Fibrinolysis consisted of inserting a 12F chest tube followed by infusion of 4 mg tissue plasminogen activator mixed with 40 mL of normal saline at the time of tube placement followed by 2 subsequent doses 24 hours apart.
At diagnosis, there were no differences between groups in age, weight, degree of oxygen support, white blood cell count, or days of symptoms. The outcome data showed no difference in days of hospitalization after intervention, days of oxygen requirement, days until afebrile, or analgesic requirements. Video-assisted thoracoscopic surgery was associated with significantly higher charges. Three patients (16.6%) in the fibrinolysis group subsequently required VATS for definitive therapy. Two patients in the VATS group required ventilator support after therapy, one of whom required temporary dialysis. No patient in the fibrinolysis group clinically worsened after initiation of therapy.
There are no therapeutic or recovery advantages between VATS and fibrinolysis for the treatment of empyema; however, VATS resulted in significantly greater charges. Fibrinolysis may pose less risk of acute clinical deterioration and should be the first-line therapy for children with empyema.
数十年来,脓胸的治疗方法一直是文献中争论的焦点。虽然与单纯胸腔闭式引流术相比,初次电视辅助胸腔镜手术(VATS)和胸腔闭式引流联合胸膜内注入纤维蛋白溶解剂均已显示可使病情早期缓解,但这些治疗方式之间缺乏对比数据。因此,我们进行了一项前瞻性随机试验,比较VATS与纤维蛋白溶解疗法在儿童脓胸治疗中的效果。
经机构审查委员会批准,通过影像学检查发现有包裹性积液或白细胞计数超过10000/微升而被定义为患有脓胸的儿童接受VATS或纤维蛋白溶解治疗。根据我们以术后住院时间作为主要终点的回顾性数据,计算出样本量为36例患者,α值为0.5,检验效能为0.8。纤维蛋白溶解治疗包括插入一根12F胸管,然后在置管时注入4毫克组织纤溶酶原激活剂与40毫升生理盐水的混合液,随后每隔24小时再给予2次后续剂量。
在诊断时,两组在年龄、体重、氧支持程度、白细胞计数或症状持续天数方面均无差异。结果数据显示,干预后的住院天数、吸氧需求天数、退热天数或镇痛需求方面均无差异。电视辅助胸腔镜手术的费用显著更高。纤维蛋白溶解治疗组中有3例患者(16.6%)随后需要接受VATS进行确定性治疗。VATS组中有2例患者在治疗后需要呼吸机支持,其中1例需要临时透析。纤维蛋白溶解治疗组中没有患者在治疗开始后临床病情恶化。
在治疗脓胸方面,VATS和纤维蛋白溶解疗法在治疗效果或恢复方面没有优势;然而,VATS的费用显著更高。纤维蛋白溶解疗法可能导致急性临床恶化的风险较小,应作为儿童脓胸的一线治疗方法。