黄芪注射液防治含奥沙利铂化疗方案所致神经毒性效果的临床观察

Clinical observation of efficacy of Huangqi injection in prevention and treatment of neuroto-xicity induced by oxaliplatin-containing chemotherapy regimen

目的:观察黄芪注射液防治含奥沙利铂化疗方案所致神经毒性的效果。方法:2006年9月至2008年9月胃癌或大肠癌患者40例纳入研究。患者中男23例,女17例,年龄32～75岁,平均年龄60岁,随机分为试验组和对照组,每组20例。所有患者均接受含奥沙利铂化疗方案1个周期,包含奥沙利铂130 mg/m2,第1天,氟尿嘧啶0.5 g,第1～5天,亚叶酸钙0.2 g,第1～5天;试验组加用黄芪注射液30 ml,第1～7天。观察外周神经毒性反应的表现,并测定神经生长因子(NGF)水平。结果:对照组中,发生0级毒性2例,Ⅰ级毒性10例,Ⅱ级毒性6例,Ⅲ级毒性2例;试验组中0级毒性14例,Ⅰ级毒性6例。试验组与对照组神经毒性发生率分别为30%和90%,2组比较差异有统计学意义(P<0.01)。试验组、对照组化疗前NGF值分别为:(167±10)和(204±19)ng/ml,化疗后第2天NGF的值分别为(152±8)和(133±12)ng/ml,对照组化疗后第2天与化疗前比较,NGF值下降明显,2组差异有统计学意义(P<0.01)。结论:黄芪注射液防治含奥沙利铂化疗方案所致神经毒性有一定效果。

Objective： To observe the efficacy of Huangqi injection in prevention and treatment of neurotoxicity induced by oxaliplatin-containing chemotherapy regimen. Methods：From September 2006 to September 2008, 40 patients with stomach or large intestinal cancer were enrolled in the study. The patients comprised 23 men and 17 women with age of 32-75 years （ mean age 60 years） and were randomly divided into two groups： The test group and the control group （20 cases in each group）. All patients were treated with one cycle of a oxaliplatin-containing chemotherapy regimen, which comprised oxaliplatin 130 mg/m^2 on day 1, fluorouracil 0.5 g on days 1-5, and calcium foliate 0.2 g on days 1-5 ; in the test group, 30 ml of Huangqi injection was added to the regimen on days 1-7. The manifestation of peripheral neurotoxic reactions was observed and nerve growth factor levels were measured. Results： The situation of neurotoxicity occurring was as follows： in the control group, 2 patients had grade 0 toxicity, 10 had grade l toxicity, 6 had grade 2 toxicity, and 2 had grade 3 toxicity; in the test group, 14 patients had grade 0 toxicity and 6 had grade 1 toxicity. The incidence rate of neurotoxicity in the test and control groups was 30% and 90%, respectively. The difference was statistically significant （P 〈0.01 ）. In the test and control groups, the nerve growth factor levels were（ 167 ± 10）ng/ml and （204 ± 19）ng/ml before chemotherapy as well as（ 152± 8 ）ng/ml and（ 133 ±12 ）ng/ml 2 days after chemotherapy, respectively. In the control group, the nerve growth factor levels were markedly decreased 2 days after chemotherapy compared with before chemotherapy. The difference between the two groups was statistically significant （P 〈 0.01 ）. Conclusion： Huangqi injection has some degree of efficacy in prevention and treatment of neurotoxicity induced by oxaliplatin-containing chemotherapy regimen.