Rothenberger Meghan K, Mutuluuza C Kityo, Ssali F, Jasurda Jake, Schmidt Thomas, Schacker Timothy W, Beilman Greg J, Chipman Jeffrey G
1 University of Minnesota , Minneapolis, Minnesota.
Surg Infect (Larchmt). 2015 Feb;16(1):68-71. doi: 10.1089/sur.2013.179. Epub 2015 Feb 4.
Lymph nodes and gut-associated lymphatic tissue are important reservoirs of the human immunodeficiency virus (HIV). Little is known about these reservoirs in different geographic populations. We report the surgical outcomes of excisional lymph node and anorectal mucosal biopsies performed internationally and describe the lessons learned.
Patients were recruited through the Joint Clinical Research Center (JCRC) in Kampala, Uganda, where procedures were performed. Studies were approved by the Institutional Review Boards of the JCRC and the University of Minnesota. Instruments and supplies were shipped to Uganda and prepared onsite. Drugs and skin preparations were purchased locally. Lymph nodes were removed through 1-3 cm incisions with ligatures on lymphovascular pedicles. Incisions were closed with subcuticular sutures and epidermal tape. Two to four pieces of anorectal mucosa were obtained through anoscopes using biopsy forceps.
One hundred thirty-eight lymph node biopsies and 98 anorectal mucosal biopsies were performed on 71 patients. Forty-one patients were HIV-positive. Many patients had multiple procedures. Two minor complications resulted: One hematoma and one lymphocele. Despite the cost of travel and lodging, cost per biopsy was lower in Uganda compared with the United States.
Invasive clinical research can be performed with minimal morbidity in emerging nations with outcomes similar to those found in the United States, but with lower cost.
淋巴结和肠道相关淋巴组织是人类免疫缺陷病毒(HIV)的重要储存库。对于不同地理区域人群中的这些储存库,我们了解甚少。我们报告了在国际上进行的切除性淋巴结活检和肛门直肠黏膜活检的手术结果,并描述了从中吸取的经验教训。
通过乌干达坎帕拉的联合临床研究中心(JCRC)招募患者,在该中心进行手术操作。研究获得了JCRC和明尼苏达大学机构审查委员会的批准。仪器和用品被运往乌干达并在现场准备。药物和皮肤制剂在当地购买。通过1 - 3厘米的切口切除淋巴结,并对淋巴管蒂进行结扎。切口用皮下缝线和表皮胶带缝合。通过肛门镜使用活检钳获取2至4块肛门直肠黏膜。
对71名患者进行了138次淋巴结活检和98次肛门直肠黏膜活检。41名患者为HIV阳性。许多患者接受了多次手术。出现了2例轻微并发症:1例血肿和1例淋巴囊肿。尽管有差旅费和住宿费,但乌干达每次活检的成本低于美国。
在新兴国家可以进行侵入性临床研究,发病率极低,结果与美国相似,但成本更低。