Squires K E
Outpatient AIDS Clinic, University of Alabama at Birmingham 35294, USA.
AIDS. 1996 Dec;10 Suppl 4:S13-8.
To determine the relative effectiveness of an oral formulation compared to a standard intravenous regimen of ganciclovir in preventing the progression of cytomegalovirus (CMV) retinitis in patients with AIDS.
Two randomized, multicenter 20-week studies of standard intravenous ganciclovir maintenance therapy compared with 3000 mg/day or oral ganciclovir.
Patients randomized to receive intravenous ganciclovir (5 mg/kg per day) or oral ganciclovir (500 mg six times a day), or to receive intravenous ganciclovir (5 mg/kg per day) or one of two regimens of oral ganciclovir (500 mg six times a day or 1000 mg three times/day).
AIDS patients with newly diagnosed CMV retinitis or who had CMV retinitis treated previously with intravenous ganciclovir for more than 4 weeks, but less than 4 months. MAIN OUTCOME AND MEASURE(S): Primary endpoints were times to first progression of retinitis, time to the occurrence of one or more prospectively observed, severe and dose-limiting adverse events, or 20 weeks. Visual assessments every 2 weeks included indirect ophthalmologic examination (funduscopy), photographs (bilateral, full 9- or 12-field photographs), and Snellen visual acuity assessments.
Mean times to progression for intravenous ganciclovir by photographic assessment were 62 days and 66 days, and for oral ganciclovir mean times were 57 days and 54 days. The differences in mean time to progression (oral minus intravenous) was -5 days and -12 days. In the funduscopic assessment, both the mean time to progression and the differences in mean time to progression were longer in both treatment groups. Neutropenia was more common in the intravenous than in the oral ganciclovir treatment groups, but no significant differences were found in other laboratory parameters.
CMV retinitis progression occurs a mean of 5-12 days sooner with oral ganciclovir than with intravenous ganciclovir maintenance treatment. Oral ganciclovir is an effective alternative to intravenous ganciclovir for maintenance therapy of CMV retinitis in patients with AIDS.
确定与更昔洛韦标准静脉给药方案相比，口服制剂在预防艾滋病患者巨细胞病毒（CMV）视网膜炎进展方面的相对有效性。
两项随机、多中心的20周研究，将更昔洛韦标准静脉维持疗法与3000毫克/天的口服更昔洛韦进行比较。
患者被随机分配接受静脉注射更昔洛韦（每天5毫克/千克）或口服更昔洛韦（每天6次，每次500毫克），或者接受静脉注射更昔洛韦（每天5毫克/千克）或两种口服更昔洛韦方案之一（每天6次，每次500毫克或每天3次，每次1000毫克）。
新诊断为CMV视网膜炎的艾滋病患者，或之前接受静脉注射更昔洛韦治疗CMV视网膜炎超过4周但少于4个月的患者。主要结局和衡量指标：主要终点为视网膜炎首次进展的时间、发生一项或多项前瞻性观察到的严重且剂量限制性不良事件的时间或20周。每2周进行的视力评估包括间接眼科检查（眼底镜检查）、拍照（双侧、全9或12视野照片）以及斯内伦视力评估。
通过摄影评估，静脉注射更昔洛韦的平均进展时间为62天和66天，口服更昔洛韦的平均进展时间为57天和54天。进展平均时间的差异（口服减去静脉注射）为-5天和-12天。在眼底镜评估中，两个治疗组的进展平均时间和进展平均时间的差异都更长。中性粒细胞减少症在静脉注射更昔洛韦治疗组比口服更昔洛韦治疗组更常见，但在其他实验室参数方面未发现显著差异。
口服更昔洛韦治疗的CMV视网膜炎进展平均比静脉注射更昔洛韦维持治疗早5 - 12天。口服更昔洛韦是艾滋病患者CMV视网膜炎维持治疗中静脉注射更昔洛韦的有效替代方案。
