英夫利西单抗注射剂治疗强直性脊柱炎的临床研究

发布时间：2018-12-24 10:18

【摘要】：目的观察英夫利西单抗治疗强直性脊柱炎的临床疗效及安全性。方法将76例强直性脊柱炎患者随机分为对照组38例和试验组38例。对照组予以来氟米特20 mg,qd+柳氮磺胺吡啶每次1 g,bid+甲氨蝶呤10 mg,每周1次;试验组在对照组治疗的基础上,静脉滴注4 mg·kg~(-1)英夫利西单抗,第1,2,5周,然后每隔8周进行一次用药治疗,共用药6次。2组患者均治疗30周。观察2组患者治疗前后C反应蛋白、红细胞沉降率、疼痛程度、晨僵时间及B细胞亚群变化情况,比较2组患者的临床疗效和药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为92.11%(35/38例)和71.05%(27/38例),差异有统计学意义(P0.05)。治疗后,试验组和对照组的C反应蛋白分别为(13.24±2.43),(22.35±4.22)mg·L~(-1);红细胞沉降率分别为(15.21±4.22),(28.32±5.22)mm·h~(-1);疼痛程度分别为(1.32±0.31),(2.68±0.65)分;晨僵时间分别为(17.34±3.52),(23.54±4.87)min;CD19~+CD24~(int)CD38~(int)成熟B细胞分别为(23.22±3.11)%,(34.32±5.14)%;CD19~+CD24~(hi)CD~(38-)记忆性B细胞分别为(45.22±7.43)%,(38.13±4.74)%,差异均有统计学意义(P0.05)。2组发生的药物不良反应以皮疹、恶心、呼吸道感染为主,且试验组和对照组的药物不良反应发生率分别为10.53%和7.89%,差异无统计学意义(P0.05)。结论英夫利西单抗治疗强直性脊柱炎的临床疗效显著,能有效地改善外周血中B细胞亚群及骨质情况,且不增加药物不良反应的发生率。
[Abstract]:Objective to observe the efficacy and safety of infleximab in the treatment of ankylosing spondylitis. Methods 76 patients with ankylosing spondylitis were randomly divided into control group (n = 38) and experimental group (n = 38). The control group was treated with leflunomide for 20 mg,qd and methotrexate for 10 mg, once a week. On the basis of the treatment in the control group, 4 mg kg~ (-1) Infritemizumab was injected intravenously for 5 weeks and then treated every 8 weeks for 6 times. All the patients in both groups were treated for 30 weeks. The changes of C-reactive protein, erythrocyte sedimentation rate, pain degree, morning stiffness time and B cell subgroup were observed before and after treatment, and the clinical efficacy and adverse drug reactions were compared between the two groups. Results after treatment, the total effective rates of the experimental group and the control group were 92.11% (35 / 38 cases) and 71.05% (27 / 38 cases), respectively. The difference was statistically significant (P0.05). After treatment, the C-reactive protein of the experimental group and the control group were (13.24 卤2.43), (22.35 卤4.22) mg L ~ (-1), the erythrocyte sedimentation rate was (15.21 卤4.22), () 28.32 卤5.22 mm h-1, respectively. The degree of pain was (1.32 卤0.31), (, 2.68 卤0.65) and the time of morning stiffness was (17.34 卤3.52), (, 23.54 卤4.87) min;, respectively. The mature B cells of CD19~ CD24~ (int) CD38~ (int) were (23.22 卤3.11)% and (34.32 卤5.14)%, respectively. CD19~ CD24~ (hi) CD~ (38-) memory B cells were (45.22 卤7.43)%, (38.13 卤4.74)%, respectively. The difference was statistically significant (P0.05). The incidence of adverse drug reactions in the experimental group and the control group was 10.53% and 7.89 respectively, with no significant difference (P0.05). Conclusion Infritemab is effective in the treatment of ankylosing spondylitis, it can effectively improve the B cell subsets and bone mass in peripheral blood, and does not increase the incidence of adverse drug reactions in patients with ankylosing spondylitis.
【作者单位】：诸暨市人民医院内分泌科;湖州市中心医院内分泌科;
【基金】：浙江省医药卫生科技计划基金资助项目(2014KYB264)
【分类号】：R593.23

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