Raffanti S P, Schaffner W, Federspiel C F, Blackwell R B, Ching O A, Kühne F W
Dept. of Medicine, Vanderbilt School of Medicine, Nashville, TN 37232-2637, USA.
Infection. 1998 Jul-Aug;26(4):202-7. doi: 10.1007/BF02962364.
A randomized, double-blind trial compared treatment with the immune modulator WF10 (ten patients) and placebo (nine patients) administered in cycles over 3 months among individuals with advanced AIDS. There were no notable clinical adverse events; changes in hematologic and chemistry values were comparable in the two groups. In both groups, median HIV-RNA PCR values remained stable. Immunologic variables showed a consistent tendency to increase in the WF10 group and to decrease in the control group, with significant differences between groups for median WBC, lymphocyte, CD19, and CD35 values. Ten infections occurred in the control group, four of which were Pneumocystis carinii pneumonia (PCP), and three in the WF10 group none of which was PCP. Five patients in the control group were hospitalized during the trial for a total of 53 days; no patients in the WF10 group were hospitalized. Over a subsequent 9-months follow-up, six patients from the control group and one from the WF10 group died. These results indicate that WF10 administration appears safe, may enhance immunologic function, and unlike other macrophage-activating cytokines does not increase HIV expression in this patient population. Further studies of WF10 in larger patient populations are warranted.
一项随机双盲试验比较了免疫调节剂WF10（10名患者）和安慰剂（9名患者）对晚期艾滋病患者进行为期3个月的周期性治疗效果。未出现明显的临床不良事件；两组血液学和化学指标变化相当。两组中，HIV-RNA PCR值中位数均保持稳定。免疫指标显示，WF10组呈持续上升趋势，而对照组呈下降趋势，两组间白细胞、淋巴细胞、CD19和CD35值中位数存在显著差异。对照组发生10次感染，其中4次为卡氏肺孢子虫肺炎（PCP），WF10组发生3次感染，均非PCP。对照组有5名患者在试验期间住院，共53天；WF10组无患者住院。在随后9个月的随访中，对照组有6名患者死亡，WF10组有1名患者死亡。这些结果表明，使用WF10似乎是安全的，可能增强免疫功能，并且与其他巨噬细胞激活细胞因子不同，在该患者群体中不会增加HIV表达。有必要在更多患者群体中对WF10进行进一步研究。
