硒酸酯多糖对化疗患者免疫功能调节作用的临床试验

Randomized Double-blind Placebo-controlled Phase ⅡClinical Trial of κ-selenocarrageenan in Cancer Chemotherapy Patients

目的：确定硒酸酯多糖对化疗患者免疫功能的调节作用。方法：采用随机分组双盲临床试验，观察化疗患者口服硒酸酯多糖（κ－ 硒卡拉胶）（治疗组）与安慰剂（对照组）对免疫功能的影响。结果：治疗组患者Ｔ４ 细胞百分比从疗前２７９±７４ 升至３８１ ±１０８（ Ｐ＜００５），Ｔ４／Ｔ８ 比值从０９２±０２３ 升至１２７±０５０（ Ｐ＜ ００１） ，而对照组Ｔ４ 、Ｔ８ 细胞及Ｔ４／Ｔ８ 比值无明显变化。治疗组患者巨噬细胞吞噬率从２４５ ±１９４ 升至３１９ ±１５３（ Ｐ＜ ００１） ，对照组则从２５４ ±１５４ 降至２１６±２２３（ Ｐ＜ ００１） 。两组患者ＮＫ 细胞活性、Ｉｇ 含量、近期疗效及毒性反应似无显著差异。结论：硒酸酯多糖是一种安全有效的免疫调节剂。

To evaluate the clinical usefulness of κ-selenocarrageenan (Se-C) in immunomodulation, a total of 42 patients were enrolled in a randomized, double-blind, placebo-controlled phase II clinical trial Of them 26 patients were given oral administration of 100mg Se-C capsule and 16 patients were given oral administration of placebo once a day for two consecutive weeks and was repeatedly administered in the subsequent cycle in the same manner Immune functions were assessed after six weeks The results showed that the percentage of T 4 cells was increased from 27 9±7 4 to 38 1±10 8 ( P <0 05) and T 4/T 8 ratio was increased from 0 92±0 23 to 1 27±0 50 ( P <0 01) in treatment group Percentage of phagocytosis of macrophages was increased from 24 5±19 4 to 31 9±15 3 ( P <0 01) in treatment group and decreased from 25 4±15 4 to 21 6±22 3 ( P <0 01) in control group NK cell activity, Ig contents, response rate and adverse effects were comparable in both groups Conclusion: Se-C is an effective immunomodulatory agent