金龙胶囊提高胃癌化疗患者免疫功能的随机对照临床试验

Jinlong Capsule for Improvement of Immunologic Functions in Chemotherapy Patients with Gastric Carcinoma:A Randomized Controlled Trial

目的观察金龙胶囊联合化疗对胃癌患者生活质量和免疫功能的影响。方法采用随机双盲阳性对照研究,将42例经病理组织学确诊的胃癌患者随机分为治疗组(21例)和对照组(21例),采用FOXFOL4或PF方案化疗2个周期。在化疗基础上,治疗组服用金龙胶囊4粒/次,每日3次;对照组口服贞芪扶正胶囊4粒/次,每日3次。所有患者均持续服药42 d。观察两组治疗前后Karnofsky评分、体质量变化及T淋巴细胞亚群和自然杀伤细胞(natural killer,NK)数量的变化。结果治疗组治疗后Karnofsky评分,白细胞分化抗原3阳性(cluster of differentiation 3 positive,CD3+)、白细胞分化抗原4阳性(cluster of differentia-tion 4 positive,CD4+)、白细胞分化抗原8阳性(cluster of differentiation 8 positive,CD8+)T淋巴细胞和NK细胞数量较治疗前均有提高,但差异无统计学意义(P>0.05);对照组治疗后Karnofsky评分较治疗前明显提高(P<0.01)。治疗后治疗组患者体质量、CD4+T细胞和NK细胞数量较对照组提高,差异无统计学意义(P>0.05)。结论金龙胶囊和贞芪扶正胶囊有等效作用,能提高胃癌患者的免疫功能,有助于改善患者生活质量。

Objective To observe the quality of life（QOL） and immunologic functions of gastric carcinoma patients treated with Jinlong Capsule,an extracts from geckos and little multibanded kraits,combined with chemotherapy.Methods A randomized double-blind controlled trial was employed.A total of 42 patients with pathologically confirmed gastric carcinoma were averagely randomized into treatment group and control group.The patients in the two groups were treated with chemotherapy based on FOXFOL4 scheme or PF scheme;additionally,patients in the treatment group were treated with Jinlong Capsule,4 capsules per time,3 times daily,and patients in the control group were treated with Zhenqi Fuzheng Capsule,a patent traditional Chinese medicine,4 capsules per time,three times daily.The treatment course was 42 d in both groups.Before and after treatment,the changes of Karnofsky scores,body weight,T lymphocyte subsets,and natural killer（NK） cells were observed and compared between the two groups.Results The Karnofsky scores,and the proportion of cluster of differentiation 3 positive（CD3＋）,cluster of differentiation 4 positive（CD4＋） and cluster of differentiation 8 positive（CD8＋） T lymphocyte subsets,and the number of NK cells were increased in the treatment group after treatment compared with those before treatment;but there were no statistical difference in above-mentioned indexes（P〉0.05）.In the control group,Karnofsky scores were significantly increased after treatment compared with those before treatment（P〈0.01）.After treatment,the body weight,the proportion of CD4＋ T lymphocyte subsets,and the number of NK cells were increased in the treatment group compared with those in the control group,but the differences were not significant.Conclusion Jinlong Capsule can improve the QOL and immunologic functions in adjuvant treatment for gastric carcinoma,and its effect is similar as that of Zhenqi Fuzheng Capsule.