参麦注射液对儿童恶性实体瘤化疗保护作用的临床研究

目的:研究参麦注射液在儿童恶性实体瘤化疗中保护骨髓、降低化疗毒副作用、改善近期疗效、提高生活质量的作用。方法:224例小儿恶性实体肿瘤患儿随机分为对照组及3个剂量梯度试验组共4组,对照组只进行标准化疗,3个试验组除标准化疗外,加用不同剂量(0.50mL/kg、0.75mL/kg及1.00mL/kg)的参麦注射液,每天1次,5d为1个疗程,连用4个疗程后观察试验组及对照组血常规、肝肾心功能和化疗毒副作用、近期疗效、生活质量的差异。结果:3个试验组与对照组之间血常规及肝、肾、心功能和化疗毒副作用比较差异无统计学意义( P均>0.05);试验组1、2与对照组近期疗效比较差异有统计学意义(P均<0.05),试验组3与对照组近期疗效比较差异无统计学意义(P>0.05);试验组1、2、3与对照组生活质量比较差异有统计学意义(P均<0.05)。结论:参麦注射液对恶性实体瘤化疗患儿骨髓、重要器官功能及化疗毒副作用无显著改善,但能促进患儿化疗间期身体恢复,改善生活质量,更能耐受并完成化疗,改善恶性实体肿瘤患儿预后。

Protective Effects of Shenmai Injection in Chemotherapy of Malignant Solid Tumor in Children

Objective: To study the effects of Shenmai injection in protecting bone marrow, reducing side effects of chemotherapy, promoting short-term efficacy and improving quality of life in chemotherapy in children with malignant solid tumor. Methods: Totally 224 children with malignant solid tumor were randomly divided into control group and three dose gradient experimental groups. The control group only received standard chemotherapy. In addition to the standard chemotherapy, the three experimental groups were treated with Shenmai injection of different doses (0.50 mL/kg,0.75 mL/kg and 1.00 mL/kg) for once a day, with a course of treatment for 5 days. After 4 courses of treatment, the differences of blood routine, liver and kidney function and side effects of chemotherapy, short-term efficacy and quality of life were observed in the experimental group and the control group. Results: There was no significant difference between three experimental groups and the control group in blood routine, liver and kidney function and side effects of chemotherapy (P>0.05). There was statistically significant difference in short-term efficacy between the experimental group 1, 2 and the control group (P<0.05), there was no statistically significant difference in short-term efficacy between the experimental group 3 and the control group (P>0.05). There was statistically significant difference in the quality of life between the experimental group 1, 2, and 3 and the control group (P<0.05). Conclusion: Shenmai injection has no significant improvement on the function of bone marrow, vital organs function and side effects of chemotherapy in children treated with chemotherapy, otherwise it can help with the recovery of body during chemotherapy, improve the quality of life, enable to tolerant and complete the chemotherapy, and improve the prognosis of children with malignant solid tumors.