国产氟嗪酸抗麻风的临床和实验研究　

Activity of Home-made Ofloxacin Against M. leprae in Mice and its Clinical Trial in Multibacillary Leprosy

于免疫正常小鼠双后足垫感染１．０×１０４条麻风菌７０天后，给予国产氟障酸１５０ｍｇ／ｋｇ每周５次管饲，共６３天。同时设无药组、进口氟嗪酸和利福平治疗组作对照。结果示无药组小鼠麻风菌繁殖良好，国产氟嗪酸治疗组小鼠与进口氟嗪酸和利福平治疗组的一样，直到感染１２个月，所有小鼠足垫均未检出抗酸菌。 １１例新发未治ＢＬ／ＬＬ病人和 ２例氨苯砜长期单疗复发的ＢＬ／ＬＬ病人，以氟嗪酸４００ｍｇ每日１次，每周６次，监服１２周。结果示皮损有明显进步；细菌形态指数疗前平均为１１．８９％，治疗２周时降至２．５９％，治疗４周时降至０％；细菌指数疗前平均为４．２８，疗程结束时降至３．９０。疗程中４例发生Ⅱ型麻风反应，全部患者对药物耐受良好。结果提示国产氟嗪酸抗麻风菌作用与国外的报告相似。该药可作为麻风联合化疗药物之一。

Seventy days after inoculation of 1. 0 × 104 M. leprae to the foot--pads,the mice were treated with home-made ofloxacin 150mg/kg daily by gavage 5 times weekly for 63 days. The results showed that M. leprae multiplied well in the foot--pads of untreated mice,but no growth of M. lepare were found in the foot-pads of the mice treated with home-made ofloxacin, imported ofloxacin or rifampin until 12 months after infection of M. leprae. Eleven newly diagnosed and untreated BL/LL patients and 2 recently relapsed patients after dapsone monotherapy were treated with home--made ofloxacin 400mg daily 6 times weekly for 12 weeks. The results showed that the skin lesions of all patients markedly improved at the end of therapy. The mean morphological index(MI) in skin smear decreased from 11. 89% before therapy to 2. 59% at the end of 2 week treatment,and to 0% at the end of 4 week treatment. The mean bacteriological index(MI) decreased from 4. 28 before therapy to 3. 90 at the end of therapy. During the therapy, 4 patients developed type Ⅱ lepra reaction, but all patients tolerated the drug well. The study showed that the therapeutic effect of home-made ofloxacin is similar to that of imported one as reported in the literature. The home-made ofloxacin can be used in multidrug therapy for leprosy.