神经节苷脂预防奥沙利铂周围神经毒性的研究

Protective Effects of Monosialoganglioside on Oxaliplatin-induced Chronic Sensory Neurotoxicity

目的观察神经节苷脂预防奥沙利铂神经毒性的效果。方法 68例接受以奥沙利铂为主方案化疗的患者随机进入试验组(n=38)和对照组(n=30),试验组应用神经节苷脂(40毫克/日,共3天)、对照组应用呋喃硫胺(每次50 mg,每日3次,持续口服)来预防奥沙利铂的神经毒性。观察两组患者化疗后神经毒性的发生情况、化疗疗效和不良反应。结果试验组与对照组患者急性神经毒性发生率分别为5.3%(2/38)和26.7%(8/30),差异有统计学意义(P=0.013)。对照组累积性神经毒性发生率为63.3%(19/30),其中1级有7例、2级有8例、3级有3例、4级有1例;试验组有6例患者出现累积性神经毒性,发生率为15.8%,均为1~2级,较对照组明显降低,且程度减轻。两组患者之间的化疗相关性毒性、化疗总有效率、疾病控制率、中位无进展生存期等差异均无统计学意义。结论神经节苷脂对奥沙利铂所致周围神经毒性有良好的预防作用,且不影响化疗的疗效、不增加治疗相关性不良反应。

Objective To observe the protective effects of monosialoganglioside on oxaliplatin-induced sensory neurotoxicity. Methods Sixty-eight patients receiving oxaliplatin-based chemotherapy were randomly divided into treatment group(n=38, monosialoganglioside, 40 mg/d, 3d) and control group(n=30, fursultiamine, 50 mg, orally bid, three times a day, continuous medication) to prevent oxaliplatin-induced sensory neurotoxicity. The acute and cumulative sensory neurotoxicity, chemotherapeutic effect and adverse reactions in two groups after chemotherapy were assessed. Results The incidence of acute sensory neurotoxicity in monosialoganglioside group was significantly lower than that in control group(5.3% vs. 26.7%, P=0.013). The incidence of cumulative sensory neurotoxicity in control group was 63.3%(19/30), with grade 1-2 in 15 cases, grade 3 in 3 cases and grade 4 in 1 case, signifi cantly higher than that 15.8%(6/38) in monosialoganglioside group, with grade 1-2 in 6 cases. There was no statistically signifi cant difference in chemotherapy-induced adverse reaction, ORR, DCR or mPFS between both groups. Conclusion Monosialoganglioside is an effective neuroprotectant against oxaliplatin-induced sensory neurotoxicity without infl uencing in chemotherapeutic effi cacy or chemotherapy-induced adverse reaction.