目的 探讨阿达木单抗联合美洛昔康治疗强直性脊柱炎的疗效、安全性以及对Th17/Treg平衡状态的影响。方法 选取2022年3月—2024年3月在新乡医学院第一附属医院诊治的强直性脊柱炎患者96例，根据不同的治疗方案将其分为对照组（48例）和治疗组（48例）。对照组每日口服美洛昔康片剂，每次15 mg,1次/d；而治疗组在服用美洛昔康片的基础上，每两周皮下注射一次阿达木单抗注射液，剂量为40 mg/次。两组患者均持续治疗3个月。观察两组患者临床疗效，比较治疗前后两组患者主要临床症状缓解时间，巴氏强直性脊柱炎功能指数（BASFI）、巴氏强直性脊柱炎疾病活动指数（BASDAI）和EASi-QoL评分，辅助性T淋巴细胞17/调节性T淋巴细胞（Th17/Treg）平衡状态，及血清半胱氨酸蛋白酶-1(Caspase-1)、正五聚蛋白3(PTX3)和可溶性肿瘤坏死因子相关凋亡诱导配体（sTRAIL）水平。结果 治疗结束后，对照组与治疗组的总有效率分别是83.33%和95.83%，两组之间的差异在统计学上具有显著性（P<0.05）。治疗结束后，治疗组患者外周关节疼痛、肿胀以及腰骶部疼痛的缓解时间显著短于对照组（P<0.05）。经过治疗，两组患者Th17细胞比例和Th17/Treg比值均显著降低，而Treg细胞比例则明显上升（P<0.05），且治疗组在这些免疫学指标上的改善程度显著优于对照组（P<0.05）。治疗后，两组血清Caspase-1、PTX3和sTRAIL水平较治疗前显著降低（P<0.05），且治疗后治疗组各指标改善显著优于对照组（P<0.05）。结论 阿达木单抗与美洛昔康联合治疗强直性脊柱炎效果显著，不仅能大幅改善患者的躯体功能、疾病活动度及生活质量，还能有效促进Th17/Treg平衡状态的恢复及血清学指标的改善。

Objective To explore the efficacy, safety, and impact on Th17/Treg balance of adalimumab combined with meloxicam in treatment of ankylosing spondylitis. Methods Patients（96 cases） with ankylosing spondylitis in the First Affiliated Hospital of Xinxiang Medical University from March 2022 to March 2024 were divided into control（48 cases） and treatment（48 cases） group based on different treatments. Patients in the control group were po administered with Meloxicam Tablets, 2 tablets/time, once daily. Patients in the treatment group were sc injection administered with Adalimumab Solution for injection, 40 mg/time, once every two weeks. Patients in two groups were treated for 3 months. After treatment, the clinical evaluations were evaluated, the main clinical symptom relief time, the scores of BASFI, BASDAI, and EASi QoL, Th17/Treg balance status, and the levels of serum Caspase-1, PTX3, and sTRAIL in two groups before and after treatment were compared. Results After treatment, the total effective rate of the control group and the treatment group was 83.33% and 95.83%, respectively, and the difference between the two groups was statistically significant（P＜0.05）. After treatment, the relief time of peripheral joint pain, swelling and lumbosacral pain in treatment group was significantly shorter than that in control group（P＜0.05）. After treatment, the proportion of Th17 cells and Th17/Treg ratio were significantly decreased in both groups, but the proportion of Treg cells was significantly increased（P＜0.05）, and the improvement degree of these immunological indicators in the treatment group was significantly better than that in the control group（P＜0.05）. After treatment, the levels of serum Caspase-1, PTX3 and sTRAIL in two groups were significantly decreased compared with those before treatment（P＜0.05）, and the improvement of indexes in treatment group was significantly better than that in control group after treatment（P＜0.05）. Conclusion The combination of adalimumab and meloxicam has a significant therapeutic effect on ankylosing spondylitis. It can not only significantly improve the physical function, disease activity, and quality of life of patients, but also promote the balance of Th17/Treg and the repair of serological indicators.

R914

河南省医学科技攻关计划联合共建项目(LHGJ20210518)