注射用多抗甲素临床验证总结

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。

Clinical summary of polycatinum for injection

Sixty cancer patients were divided into group A and B by random double blind method,each group having 30 cases.General condition and several immune indices were selected as curative criteria.The consigner units pointed out that group A and B used Polyactinum and normal saline both for injection respectively after 4 weeks of clinical test.By the unified clinical curative criteria,the total effective ratio of group A was 76.9%,group B was 30%.In general indices evaluation,group A was better than group B after PS experiment(P<005).WBC of both groups decreased after treatment,but it markedly lowered in group B (P<005).It shows that Polycatinum for injection has good protective action.PPD,PHA and LTT of group A appear strongly increased after treatment (P<001),and that of group B obviously decreased (P<005).CD3,CD4 and NK of group A also significantly increased (P<001), and that of group B markedly decreased (P<005).The results of sIL-2R completely reverse after experiment,that is ,group A decreases,and group B increases (P<001).In short,above immune index changes indicate that Polycainum for injection has better inmmuno-enhancement action,there are no other side effects except a slight fever.