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作 者:辛明[1] 王金华[2] 周春宇[1] 周柯鑫[1] 植锦兰 李乃卿[1]
机构地区:[1]北京中医药大学东直门医院,北京100700 [2]丽珠集团利民制药厂研究所
出 处:《中国中西医结合杂志》1998年第11期658-661,共4页Chinese Journal of Integrated Traditional and Western Medicine
摘 要:目的 :验证参芪扶正注射液的临床疗效和安全性。方法 :临床随机分 3组 ,化疗加参芪组 (简称治疗组 ,化疗加静脉滴注参芪扶正注射液 ) 99例 ,化疗对照组 (简称化疗组 ,单用化疗 ) 4 5例 ,单纯参芪组 (简称参芪组 ,单用参芪扶正注射液治疗 ) 3 8例。结果 :治疗组缓解率为 2 0 2 % ,有效率为 87 9% ,而化疗组分别为 1 5 6%和 68 9% ,组间比较有显著性差异 (P <0 0 5 ) ;证候和生存质量的改善率 ,治疗组为 78 8%和 42 4% ,参芪组为 73 7%和 68 4% ,而化疗组只有 3 7 8%和 2 6 7% ,组间比较有显著性差异 (P <0 0 5 ) ;体重的维护情况 ,治疗组的增加率和有效率分别是 45 5 %和 90 9% ,化疗组是 1 3 3 %和 40 0 % ,组间比较有显著性差异 (P<0 0 5 ) ;该药对造血系统有较好的保护作用 ,治疗组白细胞治疗后低于 4× 1 0 9/L者占 7 7% ,而化疗组为 2 2 2 % ;参芪扶正注射液可以提高自然杀伤 (NK)细胞、巨噬细胞及T淋巴细胞亚群的活性 ,对心、肝、肾功能无明显损伤 ,也无其他不良反应。结论 :参芪扶正注射液配合化疗对消化道肿瘤癌灶有一定的缓解和稳定作用 ,对气虚患者 ,临床疗效显著 ,用药安全可靠。Objective: To assess the clinical effect and safety of Shenqi Fuzheng Injection (SQFZI) combined with chemotherapy in treating malignant tumor of digestive tract.Methods: One hundred and eighty two patients were randomly divided into 3 groups, the combined therapy group (Group A), the SQFZI group (Group B) and the chemotherapy group (Group C). The remission and stabilization effect on cancer were observed. Results: The remission rate and stabilizing rate of Group A were 20.2% and 87.9%, and those of the Group C were 15.6% and 68.9%, the difference between the two groups was significant, P<0 05. The symptom and living quality improving rate of Group A were 78.8% and 42.4% separately, those of the Group B were 73.7% and 68.4% and of the Group C 37.8% and 26.7% respectively, the inter group differences were significant, P<0 05. The weight gain rate and effective rate of Group A were 45.5% and 90.9%, of Group C were 13.3% and 40.0%, P<0 05. SQFZI showed good protective effect on hematopoietic system, 7.7% patients in Group A with WBC count lower than 4×10 9/L after treatment, while in Group C, the percentage reached 22.2%. Moreover, SQFZI could raise activity of NK cell, macrophage and T lymphcyte subgroups, without any injury on heart, liver and kidney function or other adverse reaction. Conclusion: SQFZI combined with chemotherapy has certain effect of remitting and stablizing on digestive tract tumor, the clinical effect is significant to patients with Qi Deficiency, and is safe and reliable.
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