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在危地马拉进行的葡萄糖酸锑钠(葡酸锑钠)与局部可控热疗治疗皮肤利什曼病的安慰剂对照临床试验。

Placebo-controlled clinical trial of meglumine antimonate (glucantime) vs. localized controlled heat in the treatment of cutaneous leishmaniasis in Guatemala.

作者信息

Navin T R, Arana B A, Arana F E, de Mérida A M, Castillo A L, Pozuelos J L

机构信息

Division of Parasitic Diseases, Centers for Disease Control, Atlanta, Georgia.

出版信息

Am J Trop Med Hyg. 1990 Jan;42(1):43-50. doi: 10.4269/ajtmh.1990.42.43.

DOI:10.4269/ajtmh.1990.42.43
PMID:2405727
Abstract

Sixty-six Guatemalans with parasitologically proven cutaneous leishmaniasis were randomly and equally divided into 3 treatment groups: those receiving meglumine antimonate (Glucantime), 850 mg antimony/day im for 15 days; those receiving localized controlled heat from a radio-frequency generator, 50 degrees C for 30 sec, 3 treatments at 7 day intervals; and those receiving treatment with a placebo. Of 53 isolates identified, 40 were Leishmania braziliensis braziliensis and 13 were L. mexicana mexicana. Thirteen weeks after beginning treatment, the number of patients from each group with completely healed and parasitologically negative lesions were as follows: meglumine antimonate, 16 (73%); localized heat, 16 (73%); and placebo, 6 (27%). The cure rate for those with infections due to L. b. braziliensis in each group was as follows: meglumine antimonate, 11 out of 14 (79%); controlled heat, 9 out of 14 (64%); and placebo, 0 out of 11.

摘要

66名经寄生虫学证实患有皮肤利什曼病的危地马拉人被随机且平均分为3个治疗组:一组接受葡甲胺锑酸盐(葡糖酸锑钠)治疗,每天850毫克锑,肌肉注射,共15天;一组接受射频发生器产生的局部可控热疗,50摄氏度,持续30秒,每隔7天进行3次治疗;另一组接受安慰剂治疗。在鉴定出的53个分离株中,40个是巴西利什曼原虫巴西亚种,13个是墨西哥利什曼原虫墨西哥亚种。开始治疗13周后,每组中皮损完全愈合且寄生虫学检查呈阴性的患者数量如下:葡甲胺锑酸盐组,16例(73%);局部热疗组,16例(73%);安慰剂组,6例(27%)。每组中由巴西利什曼原虫巴西亚种感染导致患病的患者治愈率如下:葡甲胺锑酸盐组,14例中有11例(79%);可控热疗组,14例中有9例(64%);安慰剂组,11例中0例。

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