Comparison of the effectiveness of two topical paromomycin treatments versus meglumine antimoniate for New World cutaneous leishmaniasis
Comparison of the effectiveness of two topical paromomycin treatments versus meglumine antimoniate for New World cutaneous leishmaniasis
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DOI：
10.1016/j.actatropica.2004.03.009
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发表时间：
2004-07-01
期刊：
影响因子：
2.7
通讯作者：
Rodriguez, R
中科院分区：
文献类型：
--
作者：
Armijos, RX;Weigel, MM;Rodriguez, R
这项随机对照研究在120名厄瓜多尔溃疡性病变患者中比较了两种含巴龙霉素的外用制剂与金治疗标准锑酸葡甲胺的疗效和安全性。两种巴龙霉素治疗比较是双盲的。第1组（n = 40）接受溶于软白色石蜡基质中的15%巴龙霉素加12%甲基苯氯铵（PR-MBCL），每天应用两次，持续30天。第2组（n = 40）也用溶于相同石蜡基质的15%巴龙霉素加10%尿素（PR-U）处理30天。第3组（n = 40）根据研究时厄瓜多尔公共卫生部的建议，接受20 mg/kg/天肌内注射锑酸葡胺（MA）10天。MA组完成10天治疗的比例为90%，PR-MBCL组为72.5%（X-2 = 4.0，P = 0.045），PM-U组为75%（X-2 = 3.1，P > 0.05），其治疗方案比MA治疗持续时间长20天。巴龙霉素组和MA组治疗后皮损烧灼感、发红、炎症和疼痛的发生率均高于MA组（P < 0.05）。两个巴龙霉素组治疗相关副作用的发生率相似。治疗开始后6周，80.6%的MA受试者临床治愈，PR-MBCL组为48.3%（X-2 = 6.1，P = 0.014），PM-U组为40%（X-2 = 12.6，P = 0.002）。到12周时，MA组（91.7%）与PM-MBCL组（79.3%）或PM-U组（70%）相比，临床治愈受试者的比例无显著差异（P > 0.05）。与PM-MBCL组（vs 43. 1 +/-14. 4天，t =-3. 7，P = 0. 001）或PR-U组（43. 5 +/- 17天; t =-3. 2，P = 0. 002）相比，12周时临床治愈的MA治疗受试者的平均愈合时间更快（29. 5 +/-12. 2天）。在48周治疗后随访期间，12周时，在15.2%的MA受试者、17.4%的PM-MBCL受试者和10.5%的PM-U受试者中观察到感染再激活，这些受试者被诊断为临床愈合（P > 0.05）。结果表明，虽然溃疡性病变的临床愈合所需的时间较长，局部巴龙霉素可能是一个可接受的治疗选择，在流行地区，葡甲胺锑酸盐是不可用的，是太昂贵或医学禁忌。(C)2004 Elsevier B. V.保留所有权利。
The randomized, controlled study compared the therapeutic efficacy and safety of two paromomycin-containing topical preparations with the gold treatment standard, meglumine antimoniate, and with each other in 120 Ecuadorian patients with ulcerated lesions.. The two paromomycin treatment comparisons were double-blinded. Group 1 (n = 40) received 15% paromomycin plus 12% methylbenzonium chloride (PR-MBCL) dissolved in a soft white paraffin base, applied twice daily for 30 days. Group 2 (n = 40) was also treated for 30 days with 15% paromomycin plus 10% urea (PR-U) dissolved in the same paraffin base. Group 3 (n = 40) received 20 mg/kg/day of IM meglumine antimoniate (MA) for 10 days as per Ecuadorian Ministry of Public Health recommendations at the time of the study. The 10-day treatment was completed by 90% of the MA group compared to 72.5% of the PR-MBCL (X-2 = 4.0, P = 0.045) and 75% of the PM-U (X-2 = 3.1, P > 0.05) groups whose treatment regime lasted 20 days longer than the MA treatment. Post-treatment lesion burning, redness, inflammation, and soreness were more common in the two paromomycin groups compared to MA group (P < 0.05). The frequency of treatment-related side effects in the two paromomycin groups was similar. Six weeks after the start of treatment, 80.6% of MA subjects were clinically cured compared to 48.3% in the PR-MBCL (X-2 = 6.1, P = 0.014) and 40% in the PM-U groups (X-2 = 12.6, P = 0.002). By 12 weeks, the proportion of clinically cured subjects in the MA (91.7%) compared to PM-MBCL (79.3%) or PM-U (70%) groups was not significantly different (P > 0.05). MA-treated subjects clinically cured by 12 weeks had a faster mean healing time (29.5 +/- 12.2 days) compared to those in the PM-MBCL (versus 43.1 +/- 14.4 days, t = -3.7, P = 0.001) or PR-U groups (43.5 +/- 17 days; t = -3.2, P = 0.002). During the 48-week post-treatment follow-up period, infection reactivation was observed in 15.2% of the MA subjects compared to 17.4% in the PM-MBCL and 10.5% PM-U of subjects diagnosed as clinically healed by 12 weeks (P > 0.05). The results suggest that although the time required for the clinical healing of ulcerated lesions takes longer, topical paromomycin may be an acceptable therapeutic alternative in endemic areas where meglumine antimoniate is not available, is too costly or medically contraindicated. (C) 2004 Elsevier B.V. All rights reserved.