扶正健脾汤剂对实体瘤患儿化疗不良反应的作用

Effects of Fuzheng Jianpi(扶正健脾) decoction on adverse reactions to chemotherapy in children with solid tumor

目的探讨扶正健脾汤剂对实体瘤患儿化疗不良反应的作用。方法 2005年1月至2008年1月在北京儿童医院肿瘤外科就诊及住院的实体瘤患儿纳入本研究,按照随机数字表分为化疗药物组(对照组)和化疗药物+扶正健脾汤剂组(治疗组)。扶正健脾汤剂基本方包括17味草药。服药时间为每个化疗周期开始前1 d至化疗周期结束后1周。比较2组患儿化疗6、12个月时的周围血象、不良反应评分以及化疗依从性和化疗完成情况。结果共167例患儿纳入研究。对照组84例,男48例,女36例,平均年龄(3.8±2.6)岁。治疗组83例,男45例,女38例,平均年龄(3.7±2.7)岁。2组患儿肿瘤类型、肿瘤分期和化疗前白细胞计数、血小板计数、血红蛋白浓度差异均无统计学意义(均P>0.05)。化疗6个月时,治疗组患儿白细胞计数和血红蛋白浓度均高于对照组[(4.2±2.0)×109/L比(3.1±1.9)×109/L,P<0.01;(95±20)g/L比(87±15)g/L,P<0.05)],血小板计数与对照组比较差异无统计学意义(P>0.05);化疗12个月时,治疗组患儿3项指标均高于对照组[白细胞计数:(3.8±1.8)×109/L比(3.0±1.6)×109/L,P<0.01;血红蛋白:(87±23)g/L比(80±18)g/L,P<0.05;血小板计数:(170±65)×109/L比(146±51)×109/L,P<0.05]。化疗6、12个月时治疗组患儿呕吐症状明显减轻,活动力及食欲增加,体重增加,与对照组比较,差异均有统计学意义(均P<0.01)。化疗6个月时,治疗组患儿便秘程度轻于同期对照组患儿(P<0.01)。化疗12个月时,治疗组患儿疼痛程度轻于同期对照组(P<0.05)。治疗组患儿化疗依从性优于对照组[86.7%(72/83)比69.0%(58/84),P<0.01)]。治疗组化疗完成率高于对照组[81.9%(68/83)比66.7%(56/84),P<0.05]。结论扶正健脾汤剂可减轻化疗所致不良反应程度,可作为实体瘤患儿化疗的辅助疗法。

Objective To explore the effects of Fuzheng Jianpi decoction on adverse reactions to chemotherapy in children with solid tumor. Methods The children with solid tumor who were in/out-patients in oncological surgery of Beijing Children＇s Hospital during the period from January 2005 to January 2008 were enrolled in the study. The children were divided into the chemotherapy drug group （ the control group） and the chemotherapy drug plus Fuzheng Jianpi decoction group （ the treatment group） by randomized digital table. The decoction contained 17 Chinese herbs. The time of taking the decoction was from the day before beginning of each chemotherapy cycle to one week after the end of chemotherapy. The peripheral blood cell count, scores for adverse reactions, compliance and the situation of chemotherapy completion in the two groups during the sixth and twelfth month of chemotherapy were observed and compared. Results A total of 167 patients were enrolled in the study. The control group （84 cases） comprised 48 boys and 36 girls with average age of （3.8 ±2.6） years. The treatment group （83 cases） comprised 45 boys and 38 girls with average age of （3.7 ± 2. 7 ） years. The differences in tumor types, tumor stages, white blood cell count, platelet count, and hemoglobin concentration before chemotherapy between the two groups were not statistically significant （P 〉 O. 05 for all comparison）. The white blood cell count and hemoglobin concentration in the treatment group were higher than those in the control group [ （ 4.2 -± 2.0 ） × 109/ L vs （3.1 ± 1.9） × 109/L, P 〈 0.01 ; （95 - 20） g/L vs （87 ± 15 ） g/L,P 〈 0.05） , the difference in platelet count between the two groups was not statistically significant （P 〉 0.05） during the sixth month of chemotherapy. Three indexes of children in the treatment group were higher than those in the control group [ white blood cell count ： （ 3.8 ± 1.8 ） × 109/L vs （3.0 ± 1.6） × 109/L, P 〈 0.01 ; hemoglobin concentration： （87 ±-23 ） g/L vs （80 ± 18） g/L, P 〈 0.05 ;platelet count： （ 170 ± 65 ） × 109/L vs （ 146 ± 51 ） × 109/L, P 〈 0.05 ] during the twelfth month of chemotherapy. Compared with the control group, the severity of vomiting was reduced markedly, activities of daily living, appetite and body weight were increased in the treatment group during the sixth month and the twelfth month of chemotherapy, respectively. The differences were statistically significant （ P 〈 0.01 for all comparison）. The severity of constipation in the treatment group was lighter than that in the control group during the sixth month of chemotherapy （P 〈 0.01 ）. The severity of pain in the treatment group was lighter than that in the control group during the twelfth month of chemotherapy （ P 〈 0. 05 ）. The chemotherapy compliance in the treatment group was better than that in the control group [ 86.7% （72/83） vs 69.0% （58/84）, P 〈 0.01 ） ]. The rates of chemotherapy completion in the treatment group was higher than that in the control group [ 81.9% （ 68/83 ） vs 66. 7% （ 56/84）, P 〈 0.051. Conclusion Fuzheng Jianpi decoction can reduce the severity of adverse reactions to chemotherapy and might be used as an adjuvant treatment in children receiving chemotherapy for solid tumor.