不同剂量利妥昔单抗治疗NMOSD的有效性和安全性比较

Comparison of efficacy and safety of different doses of rituximab in the treatment of NMOSD

目的比较不同剂量利妥昔单抗治疗视神经脊髓炎谱系疾病(NMOSD)的有效性和安全性。方法选取2018年1月至2020年4月我院60例NMOSD患者作为研究对象,按照随机数字表法将其分为对照组和观察组,每组30例。对照组采用常规剂量利妥昔单抗治疗,观察组采用小剂量利妥昔单抗治疗。比较两组的最佳矫正视力、视野、残疾评分、细胞免疫功能指标、复发情况、生活质量评分、肝肾功能指标、不良反应发生情况。结果治疗后,两组的最佳矫正视力、视野缺损度、视野敏感度、残疾评分、CD3^(+)、CD4^(+)/CD8^(+)均较治疗前改善,差异具有统计学意义(P<0.05);治疗后,两组的最佳矫正视力、视野缺损度、视野敏感度、残疾评分、CD3^(+)、CD4^(+)/CD8^(+)比较,差异无统计学意义(P>0.05)。随访6个月,两组的复发率比较,差异无统计学意义(P>0.05)。治疗后,两组的生活质量各项评分比较,差异无统计学意义(P>0.05)。治疗后,两组的AST、ALT、BUN、Scr水平比较,差异无统计学意义(P>0.05)。观察组的不良反应总发生率为6.67%,低于对照组的26.67%,差异具有统计学意义(P<0.05)。结论小剂量利妥昔单抗治疗NMOSD的效果与常规剂量相当,均可有效改善视力和细胞免疫功能,提高生活质量,且复发率较低。但小剂量利妥昔单抗的不良反应总发生率更低,安全性更好。

Objective To compare the efficacy and safety of different doses of rituximab in the treatment of neuromyelitis optica spectrum disorders(NMOSD).Methods A total of 60 patients with NMOSD in our hospital from January 2018 to April 2020 were selected as the research objects.The patients were divided into control group and observation group according to random number table method,with 30 cases in each group.The control group was treated with conventional dose of rituximab,and the observation group was treated with low dose of rituximab.The best corrected visual acuity,visual field,disability score,cellular immune function indexes,recurrence,quality of life score,liver and kidney function indexes and adverse reactions were compared between the two groups.Results After treatment,the best corrected visual acuity,visual field defect,visual field sensitivity,disability score,CD3^(+),CD4^(+)/CD8^(+)of the two groups improved compared with those before treatment,and the differences were statistically significant(P<0.05);after treatment,there were no significant differences in the best corrected visual acuity,visual field defect,visual field sensitivity,disability score,CD3^(+),CD4^(+)/CD8^(+)between the two groups(P>0.05).After 6 months of follow-up,there was no significant difference in the recurrence rate between the two groups(P>0.05).After treatment,there were no significant differences in the quality of life scores between the two groups(P>0.05).After treatment,there were no significant differences in the AST,ALT,BUN and Scr levels between the two groups(P>0.05).The total incidence of adverse reactions in the observation group was 6.67%,which was lower than 26.67%in the control group,and the difference was statistically significant(P<0.05).Conclusion The low dose and conventional dose of rituximab in the treatment of NMOSD have similar effect,both of them can effectively ameliorate vision and cellular immune function,improve quality of life,and have low recurrence rate.However,the total incidence of adverse reactions of low dose of rituximab is lower and the safety is better.