补肾中药联合rh TNFR：Fc对治疗强直性脊柱炎继发骨质疏松的临床评价

目的观察治疗前后骨代谢标志物、影像学及血清OPG/RANKL的变化,评价补肾中药联合重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白（rh TNFR：Fc）治疗强直性脊柱炎（AS）继发骨质疏松（OP）的临床疗效。方法将60例AS患者随机分为两组,治疗1组（30例）以补肾中药加rh TNFR：Fc治疗,治疗2组（30例）采用rh TNFR：Fc治疗,两组疗程均为24周。观察指标包括治疗前后骨钙素（OC）、C-端肽（CTX）、NF-κB受体活化因子配体（RANKL）及骨保护素（OPG）的水平;并对治疗前后的骶髂关节、髋关节X线影像进行Bath AS放射学评分（BASRI）。结果 （1）骨代谢标志物：在治疗24周后两组与各自治疗前比较,血清OC均显著增加,CTX均显著下降（P〈0.05）;治疗后两组间比较,治疗1组比治疗2组血清OC显著增加,CTX显著下降（P〈0.05）。（2）影像BASRI评分：两组患者的骶髂关节评分（BASRI-SIJ）和髋关节评分（BASRI-h）在两组间及自身治疗前后比较均无显著差异（P〉0.05）。（3）血清OPG、RANKL水平：两组在治疗24周后与各自治疗前比较血清OPG均显著升高（P〈0.05）,RANKL均显著下降（P〈0.05）,OPG/RANKL比值均显著升高（P〈0.05）;治疗后两组间比较,治疗1组比治疗2组OPG显著升高（P〈0.05）,RANKL显著下降（P〈0.05）,OPG/RANKL比值显著升高（P〈0.05）。结论 rh TNFR：Fc治疗可通过调节骨代谢及OPG系统,有效阻止骶髂关节及髋关节的骨破坏;补肾中药联合rh TNFR：Fc治疗AS继发OP,影响骨代谢及血清OPG/RANKL水平更显著（P〈0.05）,阻止AS患者出现的骨质破坏,是治疗AS的较佳方案。

Bushen Chinase herbs joint rh TNFR:Fc clinical evaluation of the treatment of ankylosing spondylitis secondary osteoporosis

Objective To observe the changes of treatment before and after bone metabolism markers,imaging and serum OPG/ RANKL,to evaluate the effect of Bushen Chinese herbs combined with recombinant human type II tumor necrosis factor receptor-antibody fusion protein（rh TNFR： Fc） treatment of ankylosing spondylitis（AS） secondary osteoporosis（OP）.Methods 60 AS patients were randomly divided into 2 groups： the therapy group（30 cases） treated with Chinese frational medicine and rh TNFR：Fc,the control group（30 cases） were treated with rh TNFR：Fc only.Serum samples from the patients were obtained at baseline and 24 weeks after treatment.Disease activity indexes and serum levels of Osteocalcin（OC）,C-terminal telopeptides（CTX）,receptor activator of nuclear factor-κB ligand（RANKL）,and osteoprotegerin（OPG） were measured before and after treatment respectively. And the X-ray images of patient＇s pelvis were graded based on BASRI before and after treatment.Results After 24 weeks of treatment,the clinical efficacy indexes mproved obviously in patients of both groups（P0.05）.（1）Serum levels of OC increased obviously（P0.05）,while serum levels of CTX decreased obviously（P0.05） in the two groups after 24 weeks.Between two groups, serum levels of OC and CTX were significantly（P0.05）after 24 weeks of treatment.（2）BASRI：Improvement of BASRI-SIJ and BASRI-h were not significant（P0.05） after 24 weeks and improvement in two groups.Between two groups,changes of BASRI-SIJ and BASRI-h were not significant（P0.05）.（3）Serum levels of OPG and RANKL：Serum levels of OPG were significantly elevated（P0.05） and serum levels of RANKL were significantly decreased after treatment at week 24（P0.05）,in two groups.Between two groups,serum levels of RANKL/OPG were significantly（P0.05）after 24 weeks of treatment.Conclusion rhTNFR：Fc treatment may adjust the bone metabolism and the OPG system,and have the impediment shinbone qia joint and the coxa bone destruction;Invigorates Bushen Chinese herbs to unite rh TNFR：Fc to treat AS to continue sends OP,can affect the bone metabolism and the blood serum OPG/RANKL level which is more remarkable（P0.05）,prevent ossein destruction when patient appears,therefore it may be the good plan for AS.