A randomized, placebo-controlled trial of a two-week regimen of aminosidine (paromomycin) ointment for treatment of cutaneous leishmaniasis in Iran

A randomized, placebo-controlled trial of a two-week regimen of aminosidine (paromomycin) ointment for treatment of cutaneous leishmaniasis in Iran
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DOI:
10.4269/ajtmh.1995.53.648
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发表时间:
1995-12-01
影响因子:
3.3
通讯作者:
Olliaro, P
Olliaro, P
中科院分区:
医学4区
文献类型:
--
作者:
Asilian, A;Jalayer, T;Olliaro, P

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在一项随机、双盲、安慰剂对照试验中,对251例伊朗人畜共患皮肤利什曼病患者进行了为期两周的局部氨基苷治疗方案的研究。患者在开始治疗前和治疗后15天(治疗结束)、45天和105天进行临床和寄生虫学评估。氨基苷软膏是安全的,耐受性良好,并产生显着减少的寄生虫阳性涂片的患病率在治疗后第15和105天(但不是第45天)与安慰剂相比。然而,在治疗后的任何阶段都没有明显的临床益处。我们的结论是,这种一天两次,两个星期的氨基苷方案是不足以加速大多数皮肤利什曼病病例的恢复。然而,软膏确实显示出一些明确的证据,寄生虫学的疗效,现在应该研究在更长或更频繁的制度,努力防止寄生虫复发,从而促进临床改善。
The effect of a two-week regimen of topical aminosidine was investigated in a randomized, double-blind, placebo-controlled trial of 251 selected Iranian patients with zoonotic cutaneous leishmaniasis. Patients underwent clinical and parasitologic assessment before and 15 (end of therapy), 45, and 105 days after starting the treatment. Aminosidine ointment was safe and well-tolerated, and produced significant reductions in the prevalence of parasitologically positive smears on days 15 and 105 (but not day 45) after treatment compared with placebo. However, there was no clear clinical benefit at any stage after treatment. We conclude that this twice a day two-week regimen of aminosidine was inadequate to accelerate the recovery of most cases of cutaneous leishmaniasis. However, the ointment did show some clear evidence of parasitologic efficacy and should now be studied in longer or more frequent regimes in an effort to prevent parasitologic relapse and thus promote clinical improvement.