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用于治疗新大陆皮肤利什曼病的非专利药与品牌五价锑的比较。

Comparison of generic to branded pentavalent antimony for treatment of new world cutaneous leishmaniasis.

作者信息

Soto J, Valda-Rodriquez L, Toledo J, Vera-Navarro L, Luz M, Monasterios-Torrico H, Vega J, Berman J

机构信息

Consorcio de Investigaciones Bioclínicas, Calle 60 A 5-54, Suite 201, Bogota, Colombia.

出版信息

Am J Trop Med Hyg. 2004 Nov;71(5):577-81.

Abstract

The cost of generic pentavalent antimony (generic stibogluconate) is approximately one-sixth that of branded pentavalent antimony (stibogluconate in the form of Pentostam or meglumine antimoniate in the form of Glucantime. We compared generic stibogluconate to Pentostam and Glucantime for the treatment of cutaneous leishmaniasis patients in Bolivia and Colombia. For all 114 patients, the per-protocol cure rates were 83-91% and the intent-to-treat cure rates were 75-83%. The highest values were in the generic stibogluconate group. The incidence of pancreatic enzyme abnormalities was 48-88% and the incidence of liver enzyme abnormalities was 48-87%. The lowest incidences were in the generic stibogluconate group. The efficacy and tolerance of inexpensive generic stibogluconate appears comparable to branded formulations for the treatment of cutaneous leishmaniasis in these endemic regions.

摘要

普通五价锑(普通葡糖酸锑钠)的成本约为品牌五价锑(喷他脒形式的葡糖酸锑钠或葡甲胺锑酸盐形式的葡糖胺锑)的六分之一。我们在玻利维亚和哥伦比亚对普通葡糖酸锑钠与喷他脒及葡糖胺锑进行了比较,用于治疗皮肤利什曼病患者。对于所有114名患者,符合方案的治愈率为83% - 91%,意向性治疗的治愈率为75% - 83%。最高值出现在普通葡糖酸锑钠组。胰腺酶异常的发生率为48% - 88%,肝酶异常的发生率为48% - 87%。最低发生率出现在普通葡糖酸锑钠组。在这些流行地区,廉价的普通葡糖酸锑钠在治疗皮肤利什曼病方面的疗效和耐受性似乎与品牌制剂相当。

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