VILANO Group, Fundación Cardiovascular de Colombia, Floridablanca, Colombia.
Am J Trop Med Hyg. 2010 Jul;83(1):97-101. doi: 10.4269/ajtmh.2010.09-0287.
A topical nanofiber nitric oxide (NO) releasing patch ( approximately 3.5 mumol NO/cm(2)/day for 20 days, NOP) was compared with intramuscular meglumine antimoniate (Glucantime, 20 mg/kg/day for 20 days) for the treatment of cutaneous leishmaniasis (CL) caused by Leishmania (V.) panamensis in Santander and Tolima, Colombia. A double-blind, randomized, placebo-controlled, clinical trial was conducted to determine whether the NOP is as effective as Glucantime for the treatment of CL. Patients were randomly assigned to Glucantime and placebo patches or NOP and placebo of Glucantime. The cure rates after a 3-month follow-up were 94.8% for the group that received Glucantime compared with 37.1% in the NOP group. Despite the lower efficacy of the NOP versus Glucantime, a significantly lower frequency of non-serious adverse events and a reduced variation in serum markers were observed in patients treated with NOP. Treatment of CL with NOP resulted in a lower effectiveness compared with Glucantime; however, the low frequency of adverse events and the facility of topic administration justify the development of new generations of NOP systems for the treatment of CL.
一种局部纳米纤维一氧化氮（NO）释放贴剂（每天约释放 3.5umol NO/cm²，持续 20 天，NOP）与肌内注射葡萄糖酸锑钠（Glucantime，每天 20mg/kg，持续 20 天）治疗哥伦比亚桑坦德省和托利马省由 Leishmania（V.）panamensis 引起的皮肤利什曼病（CL）进行了比较。一项双盲、随机、安慰剂对照的临床试验旨在确定 NOP 是否与 Glucantime 一样有效治疗 CL。患者被随机分配到接受 Glucantime 和安慰剂贴剂或 NOP 和安慰剂 Glucantime 的组。3 个月随访后的治愈率分别为接受 Glucantime 治疗的组为 94.8%，而 NOP 组为 37.1%。尽管 NOP 与 Glucantime 相比疗效较低，但接受 NOP 治疗的患者观察到非严重不良事件的频率明显较低，血清标志物的变化减少。与 Glucantime 相比，使用 NOP 治疗 CL 的效果较低；然而，不良反应的低频率和局部给药的便利性证明了开发新一代 NOP 系统来治疗 CL 的合理性。
