芪珍胶囊与化疗联合治疗恶性肿瘤的多中心随机对照临床研究

Multi-center randomized controlled clinical study of treating malignant tumor with Qizhen Capsule combined with chemotherapy

目的:观察芪珍胶囊治疗气虚血瘀兼瘀阻化热证恶性肿瘤的疗效及安全性。方法:采用多中心、随机、平行、对照的研究方法,观察气虚血瘀兼瘀阻化热证的非小细胞肺癌、胃癌、乳腺癌患者共472例,分为试验组307例和对照组165例,在化疗期间试验组口服芪珍胶囊,对照组口服贞芪扶正胶囊,21d为1个疗程连续治疗2个疗程后评价疗效。结果:试验组和对照组症状改善有效率分别为86.32%和46.67%(P<0.05)。卡氏(KPS)评分提高率各病种试验组均优于对照组(P<0.05)。CD4/CD8提高率试验组优于对照组(P<0.05)。骨髓抑制两组间无统计学差异。结论:芪珍胶囊与化疗联合治疗气虚血瘀兼瘀阻化热证恶性肿瘤患者,能够改善症状,提高生活质量,调节免疫功能,减轻化疗引起的骨髓抑制。芪珍胶囊药物安全性良好。

Objective： To observe the efficacy and safety of Qizhen Capsule applied in malignant tumors characterized by qi deficiency and blood stasis bring together with beat transformed from blood stasis. Methods： By using multi-center randomized parallel-controlled study, 472 patients respectively with non-small cell lung cancer, stomach cancer, breast cancer characterized by qi deficiency and blood stasis bring together with heat transformed from blood stasis were randomly divided into experimental group （307 cases） and control group （165 cases）. Patients in experimental group received Qizhen Capsule treatment, while patients in control group received Zhenqi Fuzheng Capsule treatment during the chemotherapy period for two course, 21 days as a treatment course, and the curative effect was evaluated. Results： The effective rates of symptoms control in experimental group and control group were 86.32% and 46.67% respectively （P〈0.05）. KPS improvement rates of experimental group was better than that of control group （P〈0.05）. The increasing rate of CD4/CD8 in experimental group was better than that of control group （P〈0.05）. The difference in bone marrow suppression between the two groups was not significant. Conclusion： Qizhen Capsule combined with chemotherapy applied in malignant tumor characterized by qi deficiency and blood stasis bring together with heat transformed from blood stasis could ameliorate adverse symptoms, improve the quality of life, regulate the immunity function, and alleviate chemotherapy-induced bone marrow suppression, with good drug safety.