Coker R J, Viviani M, Gazzard B G, Du Pont B, Pohle H D, Murphy S M, Atouguia J, Champalimaud J L, Harris J R
St Mary's Hospital, London, UK.
AIDS. 1993 Jun;7(6):829-35. doi: 10.1097/00002030-199306000-00011.
To determine the safety and efficacy of liposomal amphotericin B (AmBisome) in the primary treatment of AIDS-associated cryptococcosis.
A Phase II, multicentre, European, non-comparative, open study to assess the use of AmBisome in 23 patients (26 enrolments) with cryptococcosis. Dose requirements, mycological response and toxicity were documented.
Hospital-based HIV units.
Twenty-three HIV-1-seropositive patients.
Drug toxicity, assessed in 25 enrolments, was well-tolerated with little renal, hepatic or haematological toxicity. Eighteen out of 23 (78%) enrolments responded clinically. Nineteen enrolments had cryptococcal meningitis: sterilization of spinal fluid was achieved in 12 out of the 18 (67%) who were mycologically evaluable. Fourteen out of the 19 (74%) responded clinically.
AmBisome is well-tolerated and may be an effective formulation in the treatment of cryptococcosis.
确定脂质体两性霉素B(安必素)在艾滋病相关隐球菌病初始治疗中的安全性和有效性。
一项II期、多中心、欧洲、非对照、开放性研究,评估安必素在23例(26次入组)隐球菌病患者中的应用。记录剂量需求、真菌学反应和毒性。
以医院为基础的HIV科室。
23例HIV-1血清学阳性患者。
在25次入组中评估的药物毒性耐受性良好,几乎没有肾、肝或血液学毒性。23次入组中有18例(78%)临床有反应。19次入组患有隐球菌性脑膜炎:在18例可进行真菌学评估的患者中,有12例(67%)脑脊液除菌。19例中有14例(74%)临床有反应。
安必素耐受性良好,可能是治疗隐球菌病的有效制剂。