Hay C R, Ludlam C A, Lowe G D, Mayne E E, Lee R J, Prescott R J, Lee C A
University Department of Haematology, Manchester Royal Infirmary.
Br J Haematol. 1998 Jun;101(4):632-7. doi: 10.1046/j.1365-2141.1998.00753.x.
The CD4 count has been reported to decline less rapidly in HIV-infected haemophiliacs treated with monoclonally purified factor VIII concentrates than in those using intermediate-purity concentrates. No survival advantage has been demonstrated for this effect, and it is unclear whether this effect occurs with all high-purity concentrates. Two cohorts of patients with severe haemophilia A and HIV treated with either ion-exchange-purified or monoclonally-purified concentrates were compared. The CD4 count, survival, AIDS-defining illnesses, CDC category and anti-retroviral therapy were recorded at 6-monthly intervals for 3 years following the change from intermediate to high-purity factor VIII. 116 patients were recruited, 37 of whom were treated with an ion-exchange purified factor VIII concentrate at three centres, mean (SD) age 31.1 (12.2) years, and 79 were treated with monoclonally purified factor VIII concentrate at two centres, mean (SD) age 29.8 (11.2) years. At the start of the study the median CD4 count was (monoclonal v ion-exchange) 0.30 v 0.16 x 10(9)/l. The CD4 count declined in both arms to a median of (monoclonal v ion-exchange) 0.16 v 0.08 x 10(9)/l at the final visit. Analysis of the (CD4 count)(1/2) over time, using a random coefficients model, found that the mean (SE) rates of decline were not statistically significantly different in the two treatment groups (monoclonal v ion exchange: -0.050 (0.008) v -0.034 (0.011) (CD4 count)(1/2) per year, P = 0.24). No statistically significant difference in survival (log-rank test: P = 0.33) was found. There was no difference in the proportion of individuals experiencing one or more AIDS-defining illnesses (P = 0.32) or in the proportion progressing to CDC category IV (P = 0.28) during the study. The CD4 count declined during the study at a rate similar to that previously reported in patients treated with intermediate-purity factor VIII concentrate, and there was no evidence of any difference between the two treatment groups.
据报道，与使用中间纯度浓缩物的HIV感染血友病患者相比，接受单克隆纯化因子VIII浓缩物治疗的患者CD4细胞计数下降速度较慢。尚未证明这种效应具有生存优势，并且尚不清楚所有高纯度浓缩物是否都会出现这种效应。比较了两组患有严重甲型血友病和HIV的患者，他们分别接受离子交换纯化或单克隆纯化的浓缩物治疗。在从中间纯度因子VIII转换为高纯度因子VIII后的3年中，每6个月记录一次CD4细胞计数、生存率、艾滋病定义疾病、疾病控制中心（CDC）分类和抗逆转录病毒治疗情况。共招募了116名患者，其中37名在三个中心接受离子交换纯化因子VIII浓缩物治疗，平均（标准差）年龄31.1（12.2）岁，79名在两个中心接受单克隆纯化因子VIII浓缩物治疗，平均（标准差）年龄29.8（11.2）岁。研究开始时，CD4细胞计数中位数为（单克隆与离子交换）0.30对0.16×10⁹/L。在最后一次随访时，两组的CD4细胞计数均下降至中位数（单克隆与离子交换）0.16对0.08×10⁹/L。使用随机系数模型对随时间变化的（CD4细胞计数）¹/²进行分析，发现两个治疗组的平均（标准误）下降率无统计学显著差异（单克隆与离子交换：每年-0.050（0.008）对-0.034（0.011）（CD4细胞计数）¹/²，P = 0.24）。未发现生存率有统计学显著差异（对数秩检验：P = 0.33）。在研究期间，经历一种或多种艾滋病定义疾病的个体比例（P = 0.32）或进展到疾病控制中心IV类的比例（P = 0.28）没有差异。在研究期间，CD4细胞计数下降的速度与先前报道的接受中间纯度因子VIII浓缩物治疗的患者相似，并且没有证据表明两个治疗组之间存在任何差异。
