Eggimann P, Francioli P, Bille J, Schneider R, Wu M M, Chapuis G, Chiolero R, Pannatier A, Schilling J, Geroulanos S, Glauser M P, Calandra T
Department of Internal Medicine, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
Crit Care Med. 1999 Jun;27(6):1066-72. doi: 10.1097/00003246-199906000-00019.
To evaluate the efficacy and safety of intravenous fluconazole for the prevention of intra-abdominal Candida infections in high-risk surgical patients.
Randomized, prospective, double-blind, placebo-controlled study.
Two university-affiliated hospitals in Switzerland.
Forty-nine surgical patients with recurrent gastrointestinal perforations or anastomotic leakages.
Prophylaxis with intravenous fluconazole (400 mg per day) or placebo continued until resolution of the underlying surgical condition.
Patients were evaluated daily, and specimens for culture were obtained three times per week during prophylaxis. The primary study end points were the frequency of and the time to intra-abdominal Candida infections. Secondary end points were the frequency of candidiasis (intra-abdominal and extra-abdominal) and the emergence or persistence of Candida colonization. Among patients who were not colonized at study entry, Candida was isolated from surveillance cultures during prophylaxis in 15% of the patients in the fluconazole group and in 62% of the patients in the placebo group (relative risk, 0.25; 95% confidence interval, 0.07 to 0.96; p = .04). Candida peritonitis occurred in one of 23 patients (4%) who received fluconazole and in seven of 20 patients (35%) who received placebo (relative risk, 0.12; 95% confidence interval, 0.02 to 0.93; p = .02). In addition, one catheter-related Candida albicans sepsis occurred in a fluconazole-treated patient. Thus, overall, candidiasis developed in two fluconazole patients and seven placebo patients (relative risk, 0.25; 95% confidence interval, 0.06 to 1.06; p = .06). C. albicans accounted for 87% of the Candida species isolated before or during prophylaxis, and all C. albicans strains were susceptible to fluconazole. Fluconazole was well tolerated, and adverse events occurred at similar frequencies in both treatment groups.
Fluconazole prophylaxis prevents colonization and invasive intra-abdominal Candida infections in high-risk surgical patients.
评估静脉注射氟康唑预防高危外科手术患者腹腔念珠菌感染的疗效和安全性。
随机、前瞻性、双盲、安慰剂对照研究。
瑞士的两家大学附属医院。
49例有复发性胃肠道穿孔或吻合口漏的外科手术患者。
静脉注射氟康唑（每日400毫克）或安慰剂进行预防，持续至潜在外科病情缓解。
每天对患者进行评估，预防期间每周采集三次培养标本。主要研究终点是腹腔念珠菌感染的频率和发生时间。次要终点是念珠菌病（腹腔内和腹腔外）的频率以及念珠菌定植的出现或持续情况。在研究开始时未定植的患者中，氟康唑组15%的患者在预防期间的监测培养中分离出念珠菌，安慰剂组为62%（相对风险，0.25；95%置信区间，0.07至0.96；p = 0.04）。接受氟康唑治疗的23例患者中有1例（4%）发生念珠菌性腹膜炎，接受安慰剂治疗的20例患者中有7例（35%）发生（相对风险，0.12；95%置信区间，0.02至0.93；p = 0.02）。此外，1例接受氟康唑治疗的患者发生了1例与导管相关的白色念珠菌败血症。因此，总体而言，2例氟康唑治疗患者和7例安慰剂治疗患者发生了念珠菌病（相对风险，0.25；95%置信区间，0.06至1.06；p = 0.06）。白色念珠菌占预防前或预防期间分离出的念珠菌种类的87%，所有白色念珠菌菌株对氟康唑敏感。氟康唑耐受性良好，两个治疗组的不良事件发生频率相似。
氟康唑预防可防止高危外科手术患者发生定植和侵袭性腹腔念珠菌感染。
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