硼替佐米治疗多发性骨髓瘤伴肾功能不全患者的临床研究

Clinical trial of bortezomib in the treatment of patients with multiple myeloma with renal insufficiency

目的评价硼替佐米联合地塞米松、沙利度胺治疗多发性骨髓瘤伴肾功能不全患者的疗效。方法将多发性骨髓瘤伴肾功能不全患者采用随机数字表法分为对照组和试验组。2组均进行常规对症治疗,包括抗炎、补液、营养支持、利尿、水化等,在此基础上,对照组采用200 mg·m^(-2)注射用环磷酰胺、地塞米松注射液20 mg、沙利度胺片(起始剂量50~100 mg·d^(-1),每两周增加剂量50 mg·d^(-1),最大剂量200 mg·d^(-1))进行治疗;试验组在对照组的基础上200 mg·m^(-2)环磷酰胺改为1.3 mg·m^(-2)注射用硼替佐米进行治疗,2组均治疗3个月。比较2组临床疗效、实验室指标、骨代谢指标、炎性因子水平、肾功能及药物不良反应发生情况。结果试验组和对照组分别纳入39例。治疗后,试验组的总有效率为79.49%,对照组为56.41%,差异有统计学意义(P<0.05)。治疗后,试验组和对照组血清β2-微球蛋白(β2-MG)水平分别为(2.15±0.68)和(4.74±1.41)μg·L^(-1),血清N端中段骨钙素(N-MID)水平分别为(18.75±2.47)和(21.42±2.63)ng·mL^(-1),血清C反应蛋白(CRP)水平分别为(8.96±1.22)和(13.27±1.72)mg·L^(-1),血清尿素氮(BUN)水平分别为(4.62±1.27)和(5.77±1.62)mmol·L^(-1),2组上述指标比较,差异均有统计学意义(均P<0.05)。治疗期间,试验组和对照组的总药物不良反应发生率比较,差异无统计学意义(P>0.05)。结论与环磷酰胺、地塞米松、沙利度胺的治疗方案相比,采用硼替佐米、地塞米松、沙利度胺的方案治疗多发性骨髓瘤伴肾功能不全患者具有更好的治疗效果,同时安全性良好。

Objective To evaluate the efficacy of bortezomib combined with dexamethasone and thalidomide in the combined with bortezomib of multiple myeloma patients with renal insufficiency.Methods Patients with multiple myeloma and renal insufficiency were selected as the subjects.They were divided into control group and treatment group by random number table method.Both groups were treated with conventional symptomatic treatment,including anti-inflammatory,fluid rehydration,nutritional support,diuretic,hydration,etc.On the basis of this,the control group was treated with 200 mg·m^(-2)cyclophosphamide for injection,dexamethasone injection 20 mg and thalidomide tablets(initial dose 50-100 mg·d^(-1),increased dose 50 mg·d^(-1)every two weeks,maximum dose 200 mg·d^(-1)).In the treatment group,200 mg·m^(-2)cyclophosphamide was changed to 1.3 mg·m^(-2)bortezomib for injection based on the control group.Both groups were treated for 3 months.The clinical efficacy,laboratory indexes,bone metabolism indexes,inflammatory factor levels,renal function and adverse drug reactions were compared between the two groups.Results The treatment group and the control group were included in 39 patients.After treatment,the total effective rate was 79.49%in the treatment group and 56.41%in the control group,with significant difference between the two groups(P<0.05).After treatment,the level of serumβ2-microglobulin(β2-MG)of the treatment group and the control group were(2.15±0.68)and(4.74±1.41)μg·L^(-1),respectively;the level of serum osteocalcin in the middle of the N terminus(N-MID)were(18.75±2.47)and(21.42±2.63)ng·m L^(-1),respectively;the level of serum C-reactive protein(CRP)were(8.96±1.22)and(13.27±1.72)mg·L^(-1),respectively;the level of serum urea nitrogen(BUN)were(4.62±1.27)and(5.77±1.62)mmol·L^(-1),respectively.There were statistically significant differences in the above indicators between the two groups(all P<0.05).During the treatment period,there was no significant difference in the incidence of total adverse drug reactions between the treatment group and the control group(P>0.05).Conclusion Compared with cyclophosphamide,dexamethasone,thalidomide regimen,bortezomib,dexamethasone,thalidomide regimen in the treatment of multiple myeloma patients with renal insufficiency has better therapeutic effect,and good safety.