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目的 :通过对恶性肿瘤患者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 3组比较疗效。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病灶缓解率 (CR +PR)为 3 2 .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 3 6.8% ,其中对乏力、食欲、睡眠及呕吐的症状改善更为明显 ,对体重、骨髓造血功能有很好的维护作用。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。结论 :该药对肿瘤的病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 verify the clinical efficacy and safety of Shenqi Fuzheng Injection (referred to as Shenqi) for patients with malignant tumors. Methods: Randomly divided into 3 groups to compare efficacy. According to the clinical observation program of new drug grade III, close observation was conducted. Results: The remission rate (CR +PR) of malignant tumors in Shenqi plus chemotherapy group was 32.3%, that of chemotherapy control group (CR +PR) was 17.2%, that of Shenqi group (PR) was 2.6%; The improvement rate was 82.8% in the group, 79.8% in the Shenqi group, and 3.8% in the chemotherapy group. Among them, symptoms of fatigue, appetite, sleep, and vomiting improved more significantly, and they had a good maintenance effect on body weight and bone marrow hematopoietic function. . The drug can increase the activity of NK cells and T lymphocyte subsets and increase the phagocytic function of macrophages. Conclusion: The drug can relieve and stabilize the lesions of tumors, and has obvious improvement effect on clinical symptoms, which can improve the quality of life of patients.