Slotman G J, Burchard K W
Arch Surg. 1987 Feb;122(2):147-51. doi: 10.1001/archsurg.1987.01400140029002.
We conducted a prospective, randomized, double-blind, placebo-controlled study to determine whether or not ketoconazole could prevent yeast colonization or invasion in critically ill adult surgical patients. Fifty-seven patients in a surgical intensive care unit (SICU) with three or more clinical risk factors for Candida infection were randomized to receive ketoconazole, 200 mg via the gastrointestinal tract daily (27 patients), or placebo (30 patients). Patients with hepatic dysfunction were excluded. The study was continued for 21 days or until one week after discharge from the SICU, whichever was longer. Stool cultures were obtained every three days and other cultures as indicated clinically. Patients were observed for yeast colonization (sputum, urine, stool, or wound) and invasion (fungemia or deep tissue focus). The incidence of Candida colonization was significantly lower in the ketoconazole group than the placebo group. Invasive yeast sepsis developed in five (17%) of the placebo-treated patients and in no patient in the ketoconazole group, a significant difference. Length of stay in the SICU was significantly lower in the ketoconazole group, as were the basic SICU patient charges. Sixty percent of the patients with invasive fungal sepsis died.
我们开展了一项前瞻性、随机、双盲、安慰剂对照研究，以确定酮康唑能否预防成年重症外科患者的酵母菌定植或侵袭。外科重症监护病房（SICU）中57名具有三种或更多念珠菌感染临床风险因素的患者被随机分组，分别接受每日经胃肠道给予200 mg酮康唑的治疗（27例患者）或安慰剂治疗（30例患者）。肝功能不全患者被排除。研究持续21天，或直至从SICU出院后一周，以时间长者为准。每三天采集一次粪便培养样本，并根据临床指征采集其他样本进行培养。观察患者是否出现酵母菌定植（痰液、尿液、粪便或伤口）和侵袭（真菌血症或深部组织病灶）。酮康唑组念珠菌定植的发生率显著低于安慰剂组。安慰剂治疗的患者中有5例（17%）发生侵袭性酵母菌败血症，酮康唑组无患者发生，差异有统计学意义。酮康唑组在SICU的住院时间显著缩短，SICU的基本患者费用也显著降低。侵袭性真菌败血症患者中有60%死亡。
