参一胶囊治疗肺癌Ⅱ期临床试验总结

Phase II Clinical Trial Report of Treating Lung Cancer with Shen Yi Capsule

目的:观察参一胶囊对原发性非小细胞肺癌化疗的减毒增效作用及不良反应。方法:采用随机对照的方法,应用参一胶囊配合化疗治疗肺癌120例,单纯化疗31例。结果:参一胶囊能提高化疗疗效,肺癌试验组有效率(PR+CR)为33.3%,化疗组为12.9%,两组相比,P<0.05。参一胶囊能改善气虚证的证候和临床症状,试验组对气虚证临床症状改善的有效率明显高于化疗组,P<0.05。NK细胞提高率试验组为54.1%,化疗组9.7%,T细胞亚群检测结果(CD4/CD8)显示,试验组提高率41.7%,化疗组12.9%,两组比较差异显著。参一胶囊能提高患者的生存质量,Karnofsky评分,试验组明显优于对照组,P<0.01。结论:参一胶囊与化疗合并用药对气虚证肿瘤患者有增效减毒作用,能够改善气虚证候,提高免疫功能和生存质量,增加体重,是安全有效的中药一类新药。

Objective:To study the synergic effect with chemotherapy and toxicity of Shen Yi Capsule in treatment of primary non-small cell lung cancer(NSCLC).Methods:One hun-dred and twenty cases of NSCLC treated with Shen Yi Capsule combined with chemotherapy and31cases treated with single chemotherapy were studied by random contrast method.Results:The effective rate(PR+CR)of Shen Yi Capsule group was33.3%while that of the control group was12.9%with significant difference(P<0.05).Furthermore,Shen Yi Capsule could not only ameliorate the deficiency of'Qi '(vital energy)symptom but also enhance the patient 's immune function.There was significant difference in the raise rate of NK cell or subgroup T lympho-cyte and in Karnofsky score between the treated group and control group(P<0.05),and it could elevate the patient 's life quality as well.Conclusion:The reults show that Shen Yi Capsule combined with chemotherapy can enhance the therapeutic effect and detoxify the side effect of chemotherapy so it is a new,safe and effective approach for treatment of NSCLC especially it is beneficial for patients with'Qi 'deficiency.