Alrajhi Abdulrahman A, Ibrahim Elfaki A, De Vol Edward B, Khairat Mohammad, Faris Rajab M, Maguire James H
Department of Immunology and Infectious Diseases, Harvard School of Public Health, Brigham and Women's Hospital, Boston, MA, USA.
N Engl J Med. 2002 Mar 21;346(12):891-5. doi: 10.1056/NEJMoa011882.
Whereas certain oral antifungal azoles are well documented to have activity against leishmania, data on the efficacy of fluconazole for leishmaniasis are limited. We conducted a controlled trial in Saudi Arabia of fluconazole for the treatment of cutaneous leishmaniasis caused by Leishmania major.
This randomized, double-blind, placebo-controlled trial assessed the efficacy of oral fluconazole, in a dose of 200 mg daily for six weeks, in the treatment of parasitologically confirmed cutaneous leishmaniasis. The primary outcome measure was the time to the complete healing of all lesions.
A total of 106 patients were assigned to receive fluconazole, and 103 patients were assigned to receive placebo. Follow-up data were available for 80 and 65 patients, respectively. At the three-month follow-up, healing of lesions was complete for 63 of the 80 patients in the fluconazole group (79 percent) and 22 of the 65 patients in the placebo group (34 percent; relative risk of complete healing, 2.33 [95 percent confidence interval, 1.63 to 3.33]). According to an intention-to-treat analysis, the rates of healing were 59 percent and 22 percent, respectively (relative risk, 2.76 [95 percent confidence interval, 1.84 to 4.12]). Sodium stibogluconate was offered to 11 patients in the fluconazole group who returned for follow-up (14 percent) and 33 of those in the placebo group (51 percent) in whom oral treatment was judged to have failed. According to a Kaplan-Meier analysis, the time to healing was shorter for the fluconazole group (median, 8.5 weeks, as compared with 11.2 weeks in the placebo group; P<0.001 by the log-rank test). Side effects were mild and similar in both groups.
A six-week course of oral fluconazole is a safe and useful treatment for cutaneous leishmaniasis caused by L. major.
虽然某些口服抗真菌唑类药物对利什曼原虫的活性已有充分记录，但关于氟康唑治疗利什曼病疗效的数据有限。我们在沙特阿拉伯进行了一项关于氟康唑治疗由硕大利什曼原虫引起的皮肤利什曼病的对照试验。
这项随机、双盲、安慰剂对照试验评估了每日口服200毫克氟康唑，持续六周，用于治疗经寄生虫学确诊的皮肤利什曼病的疗效。主要结局指标是所有病灶完全愈合的时间。
共106例患者被分配接受氟康唑治疗，103例患者被分配接受安慰剂治疗。分别有80例和65例患者有随访数据。在三个月的随访中，氟康唑组80例患者中有63例（79%）病灶完全愈合，安慰剂组65例患者中有22例（34%）；完全愈合的相对风险为2.33（95%置信区间，1.63至3.33）。根据意向性分析，愈合率分别为59%和22%（相对风险，2.76[95%置信区间，1.84至4.12]）。氟康唑组有11例（14%）返回接受随访的患者和安慰剂组中33例（51%）被判定口服治疗失败的患者接受了葡萄糖酸锑钠治疗。根据Kaplan-Meier分析，氟康唑组愈合时间较短（中位数为8.5周，而安慰剂组为11.2周；对数秩检验P<0.001）。两组的副作用均较轻且相似。
为期六周的口服氟康唑疗程是治疗由硕大利什曼原虫引起的皮肤利什曼病的一种安全有效的疗法。
