Martinez A, Aviles P, Jimenez E, Caballero J, Gargallo-Viola D
Research Department, Glaxo Wellcome S.A., 28760 Tres Cantos, Madrid, Spain.
Antimicrob Agents Chemother. 2000 Dec;44(12):3389-94. doi: 10.1128/AAC.44.12.3389-3394.2000.
Sordarin derivatives represent a new class of antifungal agents that act as potent inhibitors of fungal protein synthesis and possess a broad spectrum of activity. The in vivo activity of GM193663 and GM237354 was studied in mouse models of disseminated candidiasis and aspergillosis and in a rat model of pneumocystosis. The pharmacokinetic behavior of both sordarin derivatives was studied in mice and rats. In all studies, compounds were administered by the subcutaneous route. After a subcutaneous dose of 50 mg/kg of body weight to mice, the maximum level in serum, area under the concentration-time curve, half-life, and clearance for GM193663 and GM237354 were 51.8 and 23 microg/ml, 79.5 and 46 microg. h/ml, 0.8 and 0.85 h, and 21 and 25 ml/h, respectively. Systemic candidiasis and aspergillosis were established in CD-1 male mice infected with Candida albicans or Aspergillus fumigatus. For systemic candidiasis, compounds were given three times per day for seven consecutive days at 15, 30, 60, or 120 mg/kg/day. GM193663 and GM237354 showed dose-related efficacy against C. albicans, with 50% effective doses, 1 month after infection, of 25.2 and 10.7 mg/kg/dose, respectively. In experimental infections with A. fumigatus, GM237354 was given three times per day at 30, 60, or 120 mg/kg/day for five consecutive days. Animals treated with GM237354 demonstrated irregular responses. The survival of animals treated with GM237354 was 0, 30, and 0% at 30, 60, and 120 mg/kg/day, respectively. The therapeutic efficacy of GM193663 and GM237354 against Pneumocystis carinii was studied in an experimental P. carinii pneumonia (PCP) rat model. After a subcutaneous dose of 10 mg/kg given to rats, the maximum level in serum, area under the concentration-time curve, half-life, and clearance for GM193663 and GM237354 were 6.6 and 7.2 microg/ml, 8.5 and 11.8 microg. h/ml, 0.7 and 0.8 h, and 230 and 133 ml/h, respectively. To induce spontaneous PCP, rats were chronically immunosuppressed with dexamethasone. Infected animals were treated twice daily for 10 days at 0.2, 2, or 10 mg/kg/day. The therapeutic effect was estimated by the reduction in the number of cysts in the lungs of treated versus untreated animals. GM193663 and GM237354 significantly reduced the mean (+/- standard deviation) log number of cysts from 7.6 +/- 0.2 in the untreated group to 4.7 +/- 0.2 and 4.6 +/- 0.1, respectively, when the drugs were administered at a dose of 2 mg/kg/day. The log number of cysts was also reduced in infected animals given lower doses of the compounds (0.2 mg/kg/day). In summary, GM193663 and GM237354 are new sordarin derivatives that may potentially play a major role in the treatment of candidiasis and PCP. Further testing with Aspergillus in other animal models is warranted.
索德菌素衍生物是一类新型抗真菌药物,可作为真菌蛋白质合成的强效抑制剂,具有广泛的活性谱。在播散性念珠菌病和曲霉病的小鼠模型以及肺孢子菌病的大鼠模型中研究了GM193663和GM237354的体内活性。在小鼠和大鼠中研究了这两种索德菌素衍生物的药代动力学行为。在所有研究中,化合物均通过皮下途径给药。给小鼠皮下注射50mg/kg体重的剂量后,GM193663和GM237354在血清中的最高水平、浓度-时间曲线下面积、半衰期和清除率分别为51.8和23μg/ml、79.5和46μg·h/ml、0.8和0.85h以及21和25ml/h。在感染白色念珠菌或烟曲霉的CD-1雄性小鼠中建立了全身性念珠菌病和曲霉病。对于全身性念珠菌病,化合物以15、30、60或120mg/kg/天的剂量连续7天每天给药3次。GM193663和GM237354对白色念珠菌显示出剂量相关的疗效,感染后1个月的50%有效剂量分别为25.2和10.7mg/kg/剂量。在烟曲霉的实验感染中,GM237354以30、60或120mg/kg/天的剂量连续5天每天给药3次。用GM237354治疗的动物表现出不规则的反应。在30、60和120mg/kg/天的剂量下,用GM237354治疗的动物的存活率分别为0、30和0%。在实验性卡氏肺孢子虫肺炎(PCP)大鼠模型中研究了GM193663和GM237354对卡氏肺孢子虫的治疗效果。给大鼠皮下注射10mg/kg的剂量后,GM193663和GM237354在血清中的最高水平、浓度-时间曲线下面积、半衰期和清除率分别为6.6和7.2μg/ml、8.5和11.8μg·h/ml、0.7和0.8h以及230和133ml/h。为了诱导自发性PCP,用 dexamethasone对大鼠进行慢性免疫抑制。感染动物以0.2、2或10mg/kg/天的剂量每天治疗2次,持续10天。通过比较治疗组和未治疗组动物肺中囊肿数量的减少来评估治疗效果。当以2mg/kg/天的剂量给药时,GM193663和GM237354分别将囊肿的平均(±标准差)对数从未治疗组的7.6±0.2显著降低至4.7±0.2和4.6±0.1。给予较低剂量化合物(0.2mg/kg/天)的感染动物的囊肿对数也有所减少。总之,GM193663和GM237354是新的索德菌素衍生物,可能在念珠菌病和PCP的治疗中发挥重要作用。有必要在其他动物模型中对曲霉进行进一步测试。