加味安肾汤治疗早中期强直性脊柱炎肾虚督寒证的疗效及对患者血清炎性因子、免疫功能、骨代谢指标的影响

Effect of Modified Anshentang on Serum Inflammatory Factors, Immune Function, Bone Metabolism on Treatment of Patients with Ankylosing Spondylitis in Early and Middle Stages

目的:观察加味安肾汤治疗早中期强直性脊柱炎肾虚督寒证的临床疗效及对患者血清炎性因子、免疫功能、骨代谢指标的影响。方法:120例患者随机分为对照组和观察组,各60例。在甲氨蝶呤治疗基础上,对照组口服补肾舒脊颗粒,观察组口服加味安肾汤,疗程均为8周。观察治疗前后两组临床症状[综合指数积分(BAS-G),巴氏强直性脊柱炎活动指数(BASDAI),加拿大脊柱骨关节研究协会制定的影像学指数(SPARCC),中医证状积分],血清炎性因子[肿瘤坏死因子-α(TNF-α),巨噬细胞移动抑制因子(MIF),白细胞介素-23(IL-23)],免疫功能[免疫球蛋白A(IgA),免疫球蛋白G(IgG),免疫球蛋白M(IgM)],骨代谢指标[骨钙素(BGP),骨形态发生蛋白-2(BMP-2),骨特异性碱性磷酸酶(BALP)]水平变化情况。观察两组临床疗效、不良反应及随访12个月复发率。结果:研究期间对照组脱落4例,观察组脱落2例。观察组总有效率96.55%(56/58),明显高于对照组的80.36%(45/56)(χ^(2)=4.827,P<0.05);观察组随访12个月复发率5.17%(3/58),明显低于对照组的19.64%(11/56)(χ^(2)=5.187,P<0.05)。与对照组治疗后比较,观察组BAS-G,BASDAI,SPARCC,中医证状积分,TNF-α,MIF,IL-23水平明显降低(P<0.05),BGP,BMP-2,BALP,IgA,IgG,IgM水平明显升高(P<0.05)。观察组在研究期间不良反应发生率12.07%(7/58),明显低于对照组的32.14%(18/56)(χ^(2)=4.826,P<0.05)。结论:加味安肾汤可明显改善早中期强直性脊柱炎肾虚督寒证患者的临床症状、血清炎性因子、免疫功能、骨代谢指标,不良反应发生率低。

Objective:This study aims to investigate the clinical efficacy of modified Anshentang on the treatment of ankylosing spondylitis in early and middle stages with kidney deficiency and cold-governing syndrome and its effect on serum inflammatory factors,immune function,and bone metabolism indexes of patients. Method: In this study,120 patients were randomly divided into control group and observation group,60 cases in each group. On the basis of ethotrexate treatment,patients in control group took Bushen Shuji granule orally,while patients in observation group took modified Anshentang orally for 8 weeks. Before and after treatment,patients in two groups were observed for clinical symptoms[ bath ankylosing spondylitis patient global score(BAS-G), bath ankylosing spondylitis disease activity index(BASDAI), spondyloarthritis research consortium of Canada(SPARCC),traditional Chinese medicine symptoms(TCM symptoms)],serum inflammatory factors[ tumor necrosis factor-α(TNF-α),macrophage migration inhibitory factor(MIF),interleukin-23(IL-23)], immune function [ immunoglobulin A(IgA), immunoglobulin G(IgG),immunoglobulin M(IgM)],bone metabolic indicators [osteocalcin(BGP),bone morphogenetic protein-2(BMP-2),bonespecific alkaline phosphatase(BALP)]. The clinical efficacy,adverse reactions and recurrence rates of 12 months in two groups were observed. Result: During the study,4 cases dropped out from control group and 2 cases from observation group. The total effective rate of 96.55%(56/58)in observation group was higher than 80.36%(45/56)in control group(χ^(2)=4.827,P<0.05). The recurrence rate of 5.17%(3/58)in observation group was lower than 19.64%(11/56)in control group(χ^(2)=5.187,P<0.05). Compare with control group after treatment,BAS-G,BASDAI,SPARCC,TCM symptoms,TNF-α,MIF and IL-23 in observation group were significantly decreased(P<0.05), while BGP, BMP-2, BALP, IgA, IgG and IgM were significantly increased(P<0.05). The incidence of adverse reactions was 12.07%(7/58)in observation group,which was lower than 32.14%(18/56)in control group(χ^(2)=4.826,P<0.05). Conclusion: Modified Anshentang is effective in the treatment of ankylosing spondylitis in early and middle stages with kidney deficiency and coldgoverning syndrome,and the incidence of adverse reactions is low.