来源：风湿病与关节炎,2023,12（7）:20-23.

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（临床研究）

戴莉萍，杨婷婷，张会昌，莫　入，魏雅稚，尹志华，叶志中

　　【摘　要】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。

　　【关键词】　强直性脊柱炎；肿瘤坏死因子抑制剂；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；临床疗效

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

DAI Li-ping,YANG Ting-ting,ZHANG Hui-chang,MO Ru,WEI Ya-zhi,YIN Zhi-hua,YE Zhi-zhong

　　【ABSTRACT】Objective:To observe the clinical efficacy and safety of acupoint injection of recombinant human typeⅡ tumor 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.

　　【Keywords】 ankylosing spondylitis;tumor necrosis factor inhibitors;recombinant human typeⅡtumor necrosis factor receptor antibody fusion protein for injection;acupoint injection;clinical efficacy