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目的 评价自拟扶正减毒消瘤散对乳腺癌术后化疗患者不良反应和生存状态的影响,并探讨其机制.方法 用随机数字表法将132例乳腺癌术后患者分为研究组和对照组,每组各66例.对照组采用术后常规化疗,研究组在此基础上服用扶正减毒消瘤散6个月.检测外周血WBC、T细胞亚群CD4和CD8,记录治疗中出现的主要不良反应,随访了解生存状况.结果 首个治疗周期的第7天、第14天的WBC值逐渐下降,第21天有所升高,且研究组各时点的WBC均高于对照组.分组因素(F=53.333,P=0.000)和时间因素(F=304.643,P=0.000)对WBC的影响均有统计学意义.研究组和对照组恶心呕吐发生率分别是80.30%和92.42%, χ2=4.117,P=0.042,脱发发生率分别是48.49%和69.70%, χ2=6.142,P =0.013,电解质紊乱发生率分别是24.24%和45.46%,χ2=6.540,P=0.011.治疗6个月时,2组的CD4、CD8和CD4/CD8值均较治疗前降低(P<0.05),且对照组CD4和CD4/CD8降低幅度甚于研究组(P<0.05).研究组和对照组60个月累计生存率分别为84. 3% (95% CI:75. 28% ~93. 32%)和77. 60% (95% CI:67. 21% ~87.99%),χ2=0.918,P=0.338.结论 扶正解毒消瘤散可减少乳腺癌术后化疗患者的毒副作用,改善机体免疫状况.“,”Objective To evaluate the effects of Fuzheng Jiandu Xiaoliu Powder on adverse reactions and survival of patients with chemotherapy after breast cancer surgery,and to explore its possible mechanisms. Methods 132 postoperative patient of breast cancer were randomly divided into study group(n=66)and control group(n=66). The control group was given routine chemotherapy.While the study group was given Fuzheng Jiandu Xiaoliu Powder besides routine chemotherapy for 6 monthes. Peripheral blood WBC, T cell subsets CD4 and CD8 were detected.The main adverse reactions were recorded during treat-ment.The survival status were followed up. Results WBC of 7th day and 14th day decreased gradually in the first treatment cycle,while it increased on 21th day. And the WBC of the study group were higher than control group at each time point. The influence of grouping factor (F=53.333,P =0.000) and time factor(F=304.643,P=0.000) on WBC was statistically significant. (2)The incidence of nausea and vomiting with in the studyboth groups and the control group were 80.30% and 92.42%,χ2=4.117, P=0.042,the incidence of alopecia were 48.49% and 69.70%,χ2=6.142,P=0.013,electrolyte dis-order incidence rate were 24.24% and 45.46%,χ2=6.540. The values of CD4,CD8 and CD4/CD8 in both groups at the time of the 6th month were all lower than which before the treatment,P<0.05. CD4 and CD4/CD8 in the control group were lower than study group,P <0.05. The 60 months-cumulative survival rates of the study group was 84.3% (95% CI:75.28% ~93.32%),while the control group was 77.60% (95% CI:67.21% ~87.99%), χ2=0.918,P =0.338. Conclusion Traditional Chinese medicine could reduce the toxicity and improve immune status of patients with chemotherapy after the breast cancer surgery.