应用CHOP方案联合日达仙治疗非霍奇金淋巴瘤的临床研究

Randomized comparisonofmulti-center clinical trial of CHOPwith or without thymosin α-1 treatment for low and medium grade non-Hodgkin's lymphoma

目的 采用多中心随机对照临床研究 ,非霍奇金淋巴瘤化疗病人用或不用日达仙对病人免疫功能及对疗效和生活质量提高的作用。方法 参照REAL淋巴瘤病理分类标准 ,随机分为A、B两组 ,采用CHOP方案治疗 ,其中B组病人治疗期间应用日达仙 1 6mg皮下注射 ,每周二次。所有病人须进行不少于 4个周期的化疗 ,以及日达仙须连续给药不少于 15周。结果 本研究根据入组标准共入组病人 3 4例。其中男性 2 1例 ,女性 13例 ,平均年龄 48岁。病理按REAL分型标准低度恶性者 9例 ,中度恶性者 2 0例 ,高度恶性者 2例 ,未定型 3例。A、B两组病人的总有效率 (RR)相近(82 3 5 %vs 88 3 % ) ,统计学差异无显著性 ,但B组病人的完全缓解率明显高于A组病人 (70 6%vs3 5 3 % ) ,差异有显著性统计学意义 (P值 <0 0 5 )。两组病人的体力状况评分KPS(ECOG)在治疗前后没有明显差别。毒副反应无明显差别。所有病人均未见Ⅲ Ⅳ级的毒副反应出现。免疫功能测定A组病人治疗前后CD4/CD8比值改善有统计学差异 ,NK细胞下降差异有显著性 (P <0 0 5 )。B组病人CD3、CD4升高及NK细胞升高明显。结论 CHOP方案联合日达仙可提高非霍奇金淋巴瘤病人的免疫功能 ,提高CD4/CD8比值及NK细胞的数量。

Objective To identify the improvement of the patient’s immunology status and the effectiveness of CHOP regimens with and without Thymosin α 1 for low and medium grade non Hodgkin‘s lymphoma.Methods All patients were randomized into A and B groups treated by classical CHOP with Thymosin α 1 (1 6mg)(Group B)or without (Group A)for at least 4 cycles.Results According to the REAL pathologic typing all the 34 patients (21 males and 13 females,with the average age of 48)were classified as follows:9 of low grade,20 of medium grade,2 of high grade,and 3 of unknown type.The response rate was the same in both groups (82 35% vs 88 3%),but the rate of complete remission of group B was higher than that of group A (70 6% vs 35 3%, P< 0 05).Toxicity in both groups was also the same(nothing significant )with neutrocytopenia as the main findings,and Ⅲ Ⅳ grade toxicity was not observed.Immunoassay before and after treatment showed that CD4/CD8 of group A was on the rise while NK cell count on the decline,which had statistic significance.As for group B,CD3,CD4,CD4/CD8 and NK cell count all increased significantly as compared with those detected before treatment.Conclusion This trial indicates that CHOP combined with Thymosin α 1 for the treatment of non Hodgkin’s lymphoma can improve patient‘s immunity and hence the remission rate.