参附注射液治疗乳腺癌术后化疗致白细胞减少的临床疗效及安全性评价

Clinical efficacy and safety of Shenfu injection in the treatment of leukopenia induced by chemotherapy after surgery of breast cancer

目的评价参附注射液治疗乳腺癌术后多西他赛、表柔比星联合环磷酰胺辅助化疗(TEC化疗)致白细胞减少的临床疗效及安全性。方法将106例乳腺癌患者随机分为对照组53例和试验组53例。对照组予以75 mg·m^(-2)多西他赛,静脉输注,第1天+50 mg·m^(-2)表柔比星,静脉输注,第1天+500mg·m^(-2)环磷酰胺静脉输注,第1天,每3周为一个疗程;试验组在对照组的基础上,加用参附注射液50 mL+5%葡萄糖500 mL静脉滴注,每日一次,连续10d,第1~10天为一个疗程。2组患者均接受2个疗程的治疗。比较2组患者的临床疗效、白细胞降低发生率、治疗前后白细胞数和生活质量的改善率,以及不良反应发生情况。结果治疗后,试验组的总有效率为84.91%显著高于对照组69.81%(P<0.05)。治疗7,10 d后,试验组白细胞降低发生率分别为9.43%和11.32%显著低于对照组37.74%和30.19%(P<0.05)。治疗后2组的白细胞数均较治疗前下降,且试验组下降程度明显低于对照组(P<0.05)。治疗后,试验组生活质量的改善率为88.68%显著高于对照组54.72%(P<0.05)。试验组不良反应发生率显著低于对照组(P<0.05)。结论参附注射液治疗化疗致白细胞减少的临床疗效确切,其可提高患者的免疫功能,改善患者的生活质量。

Objective To evaluate the clinical efficacy and safety of Shenfu injection in the treatment of leukopenia induced by chemotherapy docetaxel,epirubicin and cyclophosphamide adjuvant chemotherapy（TEC chemotherapy） after surgery of breast cancer.Methods A total of 106 patients with breast cancer were randomly divided into control group（n =53） and treatment group（n =53）.Control group was received 75 mg·m^（-2） docetaxel,intravenous infusion on day 1 ＋50mg·m^（-2） epirubicin,intravenous infusion on day 1 ＋500 mg·m^（-2） cyclophosphamide,intravenous infusion on day 1,3 weeks for a course.Treatment group was given 50 mL Shenfu injection added 500 mL of 5%glucose intravenous infusion and plus the treatment of control group,1 to10 days for a course.Patients of two groups were received 2 courses of treatment.The clinical efficacy,the incidence of leukopenia,white blood cell count to improve the rate and quality of life before and after treatment,and adverse drug reactions in two groups were compared.Results After treatment,total effective rate in treatment group was significantly higher than that in control group（84.91%vs 69.81%,P〈0.05）.After treatment7,10 d,leukopenia rates in treatment group were 9.43%and 11.32%,significantly lower than 37.74%and 30.19%in control group（P〈0.05）.After treatment,the white blood cell count in the two groups all decreased than those before treatment,and the degree of decline in treatment group was higher than that in control group（P〈0.05）.After treatment,the rate of improvement of quality of life in treatment group was significantly higher than that in control group（88.68%vs 54.72%,P〈0.05）.The incidence of adverse drug reactions in treatment group was significantly lower than that in control group（P〈0.05）.Conclusion Shenfu injection has a definitive clinical efficacy for the treatment of chemotherapy- induced leukopenia,which may improve immune function and the quality of life,worthy of further promotion in clinical practice.