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目的观察益血生胶囊联合人粒细胞集落刺激因子对妇科肿瘤化疗后白细胞下降的临床疗效,并探讨了其临床使用安全性。方法收集2013年4月—2015年8月周口市中医院治疗的妇科肿瘤化疗后白细胞下降患者124例,使用数字法随机分为对照组和观察组,每组62例。对照组给予人粒细胞集落刺激因子,150μg/d,皮下注射,1次/d,观察组在对照组基础上加用益血生胶囊,4粒/次,口服,3次/d,4周为1疗程。比较两组治疗前后血细胞计数、Spitzer生存质量指数评分量表(Spitzer评分)和癌症康复评价简表(Cares-SF评分)以及治疗期间不良反应发生率的差异。结果两组治疗前白细胞、红细胞和血小板计数均无显著性差异,治疗后两组白细胞、红细胞和血小板计数均出现显著升高(P<0.05、0.01),但观察组对白细胞、红细胞和血小板的升高作用优于对照组(P<0.05)。两组治疗前Spitzer和Cares-SF评分均无显著性差异,治疗后两组Spitzer评分均出现显著升高和Cares-SF评分均出现显著减低(P<0.05、0.01),但观察组对Spitzer评分的升高作用以及Cares-SF评分的减低作用优于对照组(P<0.05)。观察组感染发生率为22.6%(14/62)显著低于对照组的38.7%(24/62)(P<0.05)。对照组人粒细胞集落刺激因子使用(17.24±3.52)支,显著高于观察组的(12.14±2.73)支(P<0.05)。观察组临床治疗不良反应率为8.1%(5/62),显著低于对照组的21.0%(13/62)(P<0.05)。结论益血生胶囊联合人粒细胞集落刺激因子可显著升高妇科肿瘤化疗后白细胞下降患者的血细胞,改善患者临床症状,提高生活质量,临床使用安全。
Objective To observe the clinical efficacy of Yishensheng Capsule combined with human granulocyte-colony-stimulating factor on the leukopenia after gynecological tumor chemotherapy and to discuss its clinical safety. Methods A total of 124 patients with leukopenia after gynecologic oncology treated by Zhoukou Hospital of Traditional Chinese Medicine from April 2013 to August 2015 were randomly divided into control group and observation group with 62 cases in each group. Control group was given human granulocyte colony-stimulating factor, 150μg / d, subcutaneously, once a day. The observation group was given Yixuesheng Capsule on the basis of the control group, 4 capsules / time, orally, 3 times / d for 4 weeks 1 course of treatment. The difference of blood cell count, Spitzer’s quality of life index (Spitzer score) and cancer remission evaluation index (Cares-SF score) between the two groups before and after treatment and the incidence of adverse reactions during the treatment were compared. Results There was no significant difference in leucocyte, erythrocyte and platelet counts before treatment in both groups. After treatment, the counts of white blood cells, erythrocytes and platelets increased significantly in both groups (P <0.05, 0.01). However, in the observation group, the counts of white blood cells, erythrocytes and platelets The effect of raising is better than the control group (P <0.05). Spitzer and Cares-SF scores were not significantly different between the two groups before treatment, Spitzer scores were significantly increased and Cares-SF scores were significantly decreased after treatment (P <0.05, 0.01), but the observation group’s Spitzer score And the effect of Cares-SF score reduction was better than that of the control group (P <0.05). The incidence of infection in observation group was 22.6% (14/62), which was significantly lower than that in control group (38.7%, 24/62) (P <0.05). In the control group, the number of human granulocyte colony stimulating factor (17.24 ± 3.52) was significantly higher than that of the observation group (12.14 ± 2.73) (P <0.05). The adverse reaction rate in the observation group was 8.1% (5/62), which was significantly lower than that in the control group (21.0%, 13/62) (P <0.05). Conclusion Yishen Capsule combined with human granulocyte colony-stimulating factor can significantly increase the blood cells of patients with leukopenia after gynecological tumor chemotherapy, improve the clinical symptoms and improve the quality of life, and the clinical use is safe.