生物制剂注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白穴位注射治疗强直性脊柱炎42例临床观察

Clinical Observation on 42 Cases of Ankylosing Spondylitis Treated by Point Injection of Recombinant Human TypeⅡTumor Necrosis Factor Receptor Antibody Fusion Protein for Biological Agent Injection

目的:观察生物制剂注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(强克)穴位注射治疗强直性脊柱炎的临床疗效和安全性。方法:将62例强直性脊柱炎患者分为治疗组42例和对照组20例。治疗组采用生物制剂强克次髎穴穴位注射治疗,每次50 mg,每周1次;对照组使用同等剂次强克常规皮下注射治疗。2组均以12周为1个疗程。观察2组患者治疗前后症状、体征、Bath强直性脊柱炎功能指数(BASFI)、脊柱痛评分、夜间痛评分、总体评分(PGA)、红细胞沉降率(ESR)、C反应蛋白(CRP)及相关不良反应。结果:治疗1周、12周后,与治疗前比较,2组PGA、BASFAI、ESR、CRP均显著下降,差异有统计学意义(P<0.05);且治疗组改善程度优于对照组(P<0.05)。治疗1周后,治疗组达到ACR20、ACR50、ACR70改善的患者分别为36例(85.71%)、28例(66.67%)、18例(42.86%),优于对照组的12例(60.00%)、8例(40.00%)、4例(20.00%)(P<0.05);治疗12周后,治疗组达到ACR20、ACR50、ACR70改善的患者分别为40例(95.24%)、35例(83.33%)、33例(78.57%),优于对照组的15例(75.00%)、11例(55.00%)、10例(50.00%)(P<0.05)。2组不良反应均较轻微,治疗组3例,对照组2例出现注射部位反应。结论:采用生物制剂强克穴位注射治疗强直性脊柱炎患者临床效果显著,优于常规皮下注射,安全性和耐受性好,为中西医结合治疗提供临床经验。

Objective:To observe the clinical efficacy and safety of acupoint injection of recombinant human typeⅡtumor necrosis factor receptor antibody fusion protein(Jonker)for biological agent injection in the treatment of ankylosing spondylitis.Methods:Sixty-two cases of ankylosing spondylitis were divided into a treatment group(42 cases)and a control group(20 cases).The treatment group was treated with biological agent Jonker by acupoint injection of Ciliao(BL32),50 mg per time,once a week.The control group received routine subcutaneous injection of the same dose of Jonker.Both groups were treated for 12 weeks as a course of treatment.The symptoms,signs,Bath ankylosing spondylitis function index(BASFI),spinal pain score,nocturnal pain score,PGA,ESR,CRP and related adverse reactions of the two groups were observed before and after treatment.Results:After 1 week and 12 weeks of treatment,compared with before treatment,PGA,BASFAI,ESR,and CRP in the two groups were significantly reduced,with a statistically significant difference(P<0.05);and the improvement degree of the treatment group was better than that of the control group(P<0.05).After 1 week of treatment,36 patients(85.71%),28 patients(66.67%),and 18 patients(42.86%)in the treatment group achieved improvements in ACR20,ACR50,and ACR70,respectively,which were better than 12 patients(60.00%),8 patients(40.00%),and 4 patients(20.00%)in the control group(P<0.05).After 12 weeks of treatment,the treatment group achieved improvements in ACR20,ACR50,and ACR70 in 40 patients(95.24%),35 patients(83.33%),and 33 patients(78.57%),respectively,which were better than the control group's 15 patients(75.00%),11 patients(55.00%),and 10 patients(50.00%)(P<0.05).Both groups had mild adverse reactions,with 3 cases in the treatment group and 2 cases in the control group experiencing injection site reactions.Conclusion:The treatment of ankylosing spondylitis with point injection of biological agent Jonker has a significant clinical effect,which is better than routine subcutaneous injection,and has good safety and tolerance,providing clinical experience for the treatment of integrated Chinese and western medicine.