论著

注射用重组人Ⅱ型肿瘤坏死因子受体抗体融合蛋白剂量递减方案与标准剂量维持方案治疗强直性脊柱炎的疗效比较

Comparison of clinical effect between dose reduction scheme for hTNFR:Fc for injection and standard dose maintenance scheme in treatment of ankylosing spondylitis

:12-15
 
目的 观察并比较注射用重组人Ⅱ型肿瘤坏死因子受体抗体融合蛋白(益塞普)剂量递减方案与标准剂量维持方案治疗强直性脊柱炎(AS)的疗效及安全性。方法 选择2015年1月—2016年6月共18个月在我院治疗的80例AS患者为研究对象,随机分为两组,A组40例,给予益塞普递减方案治疗,B组40例,给予益塞普标准剂量维持方案治疗,比较两组的用药疗效及安全性。结果 治疗后,两组的BASDAI、BASFI评分,腰背痛VAS评分,血清CRP、ESR水平均低于治疗前(P<0.05),但两组组间比较未见统计学意义(P>0.05);在治疗期间,A组与B组的不良反应发生率(32.50%、55.00%)及复发率(27.50%、22.50%)比较均无统计学意义(P>0.05);经统计,A组的年平均药物费用为(47 391±4 830)元,少于B组(82 038±5 127)元(P<0.05)。结论 采用益塞普剂量递减方案治疗AS安全有效,能在短时间内控制疾病活动及改善临床症状,且花费更低,患者接受度更高。
Objective To observe and compare the clinical effect and safety of dose reduction scheme for recombinant human tumor necrosis factor receptor antibody fusion protein (hTNFR:Fc,etanercept) for injection and standard dose maintenance scheme in treatment of ankylosing spondylitis (AS). Methods 80 cases of patients with AS and who were treated in our hospital from January 2015 to June 2016 for 18 months were selected as the research objects,and were randomly divided into two groups.The group A of 40 cases were treated with etanercept of degressive scheme therapy,while the group B of 40 cases were treated with etanercept of standard dose maintenance therapy. Then,the clinical effect and safety of drug use of two groups were compared. Results The BASDAI,BASFI score,VAS score of low back pain,serum CRP and ESR levels of two groups after treatment were lower than those before the treatment (P < 0.05),but there was no statistical significance between the two groups (P > 0.05). During the treatment,there was no significant difference in the incidence of adverse reactions (32.50%,55%) and recurrence rate (27.50%,22.50%) between group A and group B (P > 0.05). By statistics,the average annual drug cost in group A was RMB (47 391±4 830) yuan,which was less than that in group B of RMB (82 038±5 127) yuan (P < 0.05). Conclusion The etanercept of degressive scheme therapy in treatment of AS are safe and effective,which may control disease activity and improve clinical symptoms in a short time,and low costs. The patient will receive higher degree of acceptance.
论著

重组人Ⅱ型肿瘤坏死因子受体抗体融合蛋白治疗难治性慢性痛风性关节炎的临床分析

Clinical analysis of recombinant human type Ⅱ tumor necrosis factor receptor-antibody fusion protein in refractory chronic gouty arthritis

:1264-1267
 
目的 评估重组人Ⅱ型肿瘤坏死因子受体抗体融合蛋白(rhTNRF:Fc)治疗难治性慢性痛风性关节炎的临床疗效及安全性。方法 选取2022年1月一2023年12月广州中医药大学顺德医院风湿科门诊收治的46例难治性痛风性关节炎患者,分为观察组和对照组两组,对照组规范使用降尿酸药物治疗,观察组在对照组治疗的基础上联合使用rhTNRF:Fc至少12周,在0、12、24、48周观察两组的血尿酸(sUA)、肿瘤坏死因子-α(TNF-α)、关节肌肉骨骼超声变化、痛风发作例数、肝肾功能等指标。结果 观察组与对照组sUA无明显差别(P>0.05),TNF-α水平明显下降(P<0.05),滑膜炎、关节积液影像表现减少(P<0.05),痛风发作例数明显减少(P<0.05),观察期间肝肾功能正常,无患者因不良反应退出研究。结论 rhTNRF:Fc对难治性慢性痛风性关节炎安全有效。
Objective To explore the efficacy and safety of recombinant human type II tumor necrosis factor receptor-antibody fusion protein(rhTNRF:Fc)in refractory chronic gouty arthritis. Methods From January 2022 to December 2023, 46 cases of refractory chronic gouty arthritis in the Rheumatology Outpatient Department,Shunde Hospital Guangzhou University of Chinese Medicine were selected and divided into an observation group and a control group. The control group received routine treatment,while the observation group received rhTNRF:Fc treatment additionally for at least 12 weeks, two groups of indicators such as serum urine acid(sUA), TNF-α, changes in musculoskeletal ultrasound,number of gout attacks,hepatic and renal function at 0, 12, 24, and 48 weeks were observed. Results There was no significant difference in sUA between the observation group and the control group(P>0. 05), TNF-α significantly decreased(P<0. 05), synovitis and joint effusion imaging manifestations reduced(P<0. 05), number of gout attacks decreased(P<0. 05). During the observation period, liver and kidney function were normal, and no patients withdrew from the study due to adverse reactions. Conclusions Using rhTNRF:Fc is safe and effective in treating refractory chronic gouty arthritis.
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