骨风宁胶囊联合吲哚美辛治疗强直性脊柱炎的临床研究

Clinical study on Gufengning Capsules combined with indomethacin in treatment of ankylosing spondylitis

目的探讨骨风宁胶囊联合吲哚美辛治疗强直性脊柱炎的临床效果。方法选取2019年7月—2020年7月在郑州大学第一附属医院治疗的230例强直性脊柱炎患者为研究对象,随机分为对照组(115例)和治疗组(115例)。对照组口服吲哚美辛肠溶片,50 mg/次,2次/d;治疗组在对照组的基础上口服骨风宁胶囊,3粒/次,3次/d;两组连续治疗15 d。观察两组患者临床疗效,比较治疗前后两组临床症状改善时间、Bath强直脊柱炎功能指数(BASFI)、Bath强直脊柱炎疾病活动指数(BASDAI)、强直性脊柱炎计量学指数(BASMI)、血清白细胞介素-2(IL-2)、IL-4、肿瘤坏死因子-α(TNF-α)和干扰素-γ(IFN-γ)水平及不良反应情况。结果治疗后,治疗组临床总有效率为98.26%,明显高于对照组的86.09%(P<0.05)。治疗后,治疗组腰痛、晨僵、背痛、关节痛改善时间明显短于对照组(P<0.05)。治疗后,两组患者BASFI、BASDAI、BASMI评分明显低于治疗前(P<0.05),且治疗组显著低于对照组(P<0.05)。治疗后,两组患者IL-2、IL-4、TNF-α、IFN-γ水平明显低于治疗前(P<0.05);且治疗组患者显著低于对照组(P<0.05)。治疗组患者药物不良反应总发生率明显低于对照组(P<0.05)。结论骨风宁胶囊联合吲哚美辛肠溶片治疗能够有效的缓解强直性脊柱炎患者主要症状,降低BASFI、BASDAI、BASMI评分和炎症因子水平,疗效显著,安全可靠。

Objective To investigate the clinical study of Gufengning Capsules combined with indomethacin in treatment of ankylosing spondylitis.Methods Patients(230 cases)with ankylosing spondylitis in the First Affiliated Hospital of Zhengzhou University from July 2019 to July 2020 were randomly divided into control(115 cases)and treatment(115 cases)groups.Patients in the control group were po administered with Indometacin Enteric-coated Tablets,50 mg/time,twice daily.Patients in the treatment group were po administered with Gufengning Capsules on the basis of the control group,3 grains/time,three times daily.Patients in two groups were treated for 15 d.After treatment,the clinical efficacy was evaluated,and the improvement time of clinical symptoms,the BASFI,BASDAI,and BASMI scores,the levels of serum inflammatory factors,and adverse reactions in two groups before and after treatment were compared.Results After treatment,the clinical effective rate in the treatment group was 98.26%,which was significantly higher than 86.09%in the control group(P<0.05).After treatment,the improvement time of low back pain,morning stiffness,back pain,and joint pain in the treatment group was significantly shorter than that in the control group(P<0.05).After treatment,the scores of BASFI,BASDAI,and BASMI in the two groups were significantly lower(P<0.05),and which in the treatment group were significantly lower than those in the control group(P<0.05).After treatment,the levels of IL-2,IL-4,TNF-α,and IFN-γin the two groups were significantly lower(P<0.05),and which in the treatment group were significantly lower than those in the control group.The total incidence of adverse drug reactions in the treatment group was significantly lower than that in the control group(P<0.05).Conclusion Gufengning Capsules combined with Indometacin Enteric-coated Tablets can effectively relieve the main symptoms of patients with ankylosing spondylitis,reduce the scores of BASFI,BASDAI,BASMI and inflammatory factors.