论文部分内容阅读
目的 通过 5 0 4例恶性肿瘤应用参芪扶正注射液 (简称参芪液 ) ,验证该药的临床疗效及安全性。 方法 随机分为三组比较疗效。参芪加化疗组 (治疗组 ) 2 79例 ,单纯化疗对照组 (化疗组 ) 10 6例 ,单纯参芪组 (参芪组 ) 119例 ,按照新药Ⅲ级临床的观察方案进行严密观察。结果参芪加化疗组对恶性肿瘤癌灶缓解率 (CR +PR)为 32 .3% ,化疗对照组 (CR +PR)为17.2 % ,参芪组 (PR)为 2 .6 % ;治疗组症状改善率 82 .8% ,参芪组为 79.8% ,化疗组 36 .8% ,其中对乏力、食欲、睡眠及呕吐的症状改善更为明显 ,对体重有很好的维护作用 ,三组的体重提高率和稳定以上率分别为 :治疗组 4 7.6 %、90 .3% ,参芪组 4 0 %、87.4 % ,化疗组 7.5 %、4 5 .3% ;对骨髓造血功能也有较好的维护作用 ,治疗组疗后低于 4× 10 9/L者占 6 .8% ,参芪组疗后无低于 4× 10 9/L者 ,而化疗组高达 2 3.6 % ;该药可提高NK细胞和T淋巴细胞亚群的活性 ,能增加巨噬细胞的吞噬功能。未发现对肝、肾功能有损伤作用 ,无静脉炎发生 ,极个别患者有低度发热 ,可自行缓解。 结论 说明该药对肿瘤的癌灶有缓解和稳定作用 ,对临床症状有明显的改善效果 ,可提高患者的生存质量
Objective To evaluate the clinical efficacy and safety of Shenqi Fuzheng Injection (referred to as Shenqi Liquid) by 504 cases of malignant tumors. Methods were randomly divided into three groups for comparative efficacy. There were 2 79 cases in Shenqi plus chemotherapy group (treatment group), 106 cases in chemotherapy alone group (chemotherapy group) and 119 cases in Shenqi group (Shenqi group), which were closely observed according to the grade Ⅲ clinical observation program of new drug. Results The response rate of CR + PR in the Shenqi plus chemotherapy group was 32.3%, in the chemotherapy group (CR + PR) was 17.2%, in the Shenqi group (2.6%), in the treatment group Symptom improvement rate of 82.8%, Shenqi group was 79.8%, chemotherapy group 36.8%, of which fatigue, appetite, sleep and vomiting symptoms improved more significantly on the body weight had a good maintenance, the three groups of Weight gain rate and stable above rates were: the treatment group 4 7.6%, 90.3%, Shenqi group 40%, 87.4%, chemotherapy group 7.5%, 45.3%; also have good bone marrow function The maintenance effect was less than 4 × 10 9 / L in the treatment group and 6.8% in the Shenqi group, while the chemotherapy group was as high as 23.6% NK cell and T lymphocyte subsets activity, can increase phagocytic function of macrophages. Not found on the liver and kidney function damage, no phlebitis occurred, very few patients have low fever, can ease. Conclusions show that the drug on the tumor foci alleviate and stabilize the clinical symptoms of significant improvement, can improve the quality of life of patients