De Wit S, Dupont B, Cartledge J D, Hawkins D A, Gazzard B G, Clumeck N, Denning D W
Saint-Pierre Hospital, Brussels, Belgium.
AIDS. 1997 May;11(6):759-63. doi: 10.1097/00002030-199706000-00009.
This multicentre study evaluated the clinical efficacy and tolerability of D0870 in treating oropharyngeal candidiasis in HIV-positive patients who had no history of clinical resistance to fluconazole.
Three regimens were evaluated in two phases. In phase I a 50 mg initial dose was followed by 10 mg for 4 days (Group 1). In phase II a 100 mg initial dose was followed by 25 mg for 4 days (Group 2), or 10 mg for 5 days (Group 3).
Clinical cure was obtained in 27 patients of a total of 35 (77%) and six other patients improved (17%). Two patients at the lowest dose failed and both had very low plasma concentration of D0870. No association was found between clinical outcome; minimum inhibitory concentration of D0870 pre-therapy for Candida albicans, maximum recorded plasma D0870 concentration, cfu of culture or CD4 cell count at entry. Overall, 37% of the patients experienced relapse during the 2 weeks post therapy. Tolerance was excellent. Mild adverse events possibly related to the study drug were recorded in five patients.
D0870 demonstrates excellent efficacy at low doses in the treatment of HIV-related OPC and exhibits a favourable safety profile.
本多中心研究评估了D0870对无氟康唑临床耐药史的HIV阳性患者口腔念珠菌病的治疗效果和耐受性。
分两个阶段评估了三种治疗方案。在第一阶段，初始剂量为50mg，随后4天每天10mg（第1组）。在第二阶段，初始剂量为100mg，随后4天每天25mg（第2组），或5天每天10mg（第3组）。
35例患者中27例获得临床治愈（77%），另外6例病情改善（17%）。最低剂量组的2例患者治疗失败，且这2例患者的D0870血药浓度都非常低。临床结局与D0870治疗白色念珠菌的治疗前最低抑菌浓度、记录的最高血药浓度、培养的菌落形成单位或入组时的CD4细胞计数之间未发现关联。总体而言，37%的患者在治疗后2周内复发。耐受性良好。5例患者记录到可能与研究药物相关的轻度不良事件。
D0870在低剂量时对HIV相关口腔念珠菌病显示出优异的疗效，并具有良好的安全性。
