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采用随机双盲法将６０例癌症病人分为Ａ、Ｂ两组，每组３０例，选择包括一般状态和多项免疫指标等为疗效判定指标。经４周临床实验后，由委托实验单位揭示Ａ、Ｂ组分别为注射用多抗甲素和注射用生理盐水，与临床观察结果一致。按照本试验组统一制订的临床疗效标准，Ａ组总有效率为７６．７％，Ｂ组为３０％。在一般指标评价中，ＰＳ实验后Ａ组较Ｂ组好（Ｐ＜０．０５），Ａ、Ｂ两组没看到体重有意义变化（Ｐ＞０．０５）；ＷＢＣ两组于治疗后都有下降，而Ｂ组下降非常明显（Ｐ＜０．０５），显示了注射用多抗甲素的良好保护作用。在免疫指标中，ＰＰＤ、ＰＨＡ和ＬＴＴ在治疗后Ａ组明显增强（Ｐ＜０．０１），Ｂ组却明显下降（Ｐ＜０．０５）；ＣＤ３、ＣＤ４、ＮＫ在实验后Ａ组亦表现为明显增多（Ｐ＜０．０１），而Ｂ组却明显下降（Ｐ＜０．０５）；ｓＩＬ－２Ｒ于实验后亦出现两种截然相反的结果，Ａ组减少，Ｂ组增多（Ｐ＜０．０１）。总之，所列免疫指标变化表明，注射用多抗甲素有较强的免疫作用。除少许病人表现轻度发烧外，未发现有其他毒副作用。
A total of 60 cancer patients were divided into A and B groups by randomized double-blind method, 30 cases in each group. The indicators of efficacy were selected as general status and multiple immune indexes. After 4 weeks of clinical trials, the experimental unit revealed by the A, B group were injected with multiple anti-A and injection of saline, consistent with clinical observations. According to the clinical efficacy standard unifiedly formulated in this experimental group, the total effective rate in group A was 76.7% and that in group B was 30%. In the general index evaluation, after PS experiment, A group was better than B group (P <0.05), A, B group did not see significant changes in body weight (P> 0.05); WBC in both groups after treatment (P <0.05), which showed a good protective effect of poly-A for injection. In the immune index, PPD, PHA and LTT were significantly increased in group A (P <0.01), but decreased in group B (P <0.05). CD3, CD4 and NK were also observed in group A (P <0.01), but significantly decreased in group B (P <0.05). There were two opposite results after sIL-2R in experimental group, with a decrease in group A and an increase in group B (P < 0.01). In conclusion, the changes in the immunological indices listed indicate that poly-A has a strong immunologic effect. In addition to a small number of patients showed mild fever, no other side effects were found.