强督活络I号协定方结合皮下注射治疗强直性脊柱炎临床研究

The Clinical Research into Ankylosing Spondylitis Treated with Agreed No. 1 Prescription for Strengthening Governor Vessel and Activating Meridians in Combination with Recombinant human type II Tumor Necrosis Factor Receptor-FC Fusion Protein Injection in

目的:观察强督活络I号协定方联合重组人II型肿瘤坏死因子受体-抗体融合蛋白注射剂皮下注射治疗强直性脊柱炎的临床疗效。方法:选择2013年5月—2015年1月本院诊治的强直性脊柱炎患者114例为研究对象,随机分为对照组和观察组各57例。对照组患者采用重组人II型肿瘤坏死因子受体-抗体融合蛋白注射剂皮下注射,每次25 mg,每周2次;观察组在对照组治疗的基础上采用强督活络I号协定方内服,日1剂,两组均连续治疗3个月。观察两组患者治疗前后脊柱功能的变化,检测炎性因子肿瘤坏死因子(TNF-α)、超敏C反应蛋白(hs-CRP)、白细胞介素-6(IL-6)、基质金属蛋白酶(MMP-9)、基质金属蛋白酶组织抑制因子(TIMP-1)水平变化,比较临床疗效。结果:对照组有效率为75.4%,明显低于观察组的91.2%,差异有统计学意义(χ2=5.116,P=0.042<0.05);观察组患者的脊柱功能较对照组患者改善更突显,其脊柱活动度、胸廓活动度评分较治疗前及对照组明显升高,而功能指数(BASFI)、疾病活动指数(BASDAI)与治疗前及对照组比较则下降,差异有统计学意义(P<0.05);两组患者炎性因子水平与治疗前相比有所降低,观察组患者经治疗后的TNF-α、hs-CRP、IL-6水平与对照组患者相比降低幅度明显,差异有统计学意义(P<0.05);两组患者的MMP-9、TIMP-1浓度较治疗前有所下降,观察组患者与对照组水平相比明显更低,差异有统计学意义(P<0.05)。结论:强督活络I号协定方联合重组人II型肿瘤坏死因子受体-抗体融合蛋白注射剂皮下注射利于提高强直性脊柱炎患者的脊柱功能,疗效显著。

Objective： To observe the clinical curative effect of Agreed No. 1 Prescription for Strengthening Governor Vessel and Activating Meridians in combination with recombinant human type II tumor necrosis factor receptor-FC fusion protein injection in subcutaneous injection on ankylosing spondylitis（ AS）. Methods： One hundred and fourteen patients with AS who were treated in our hospital between May of 2013 and Jan. of 2015 were chosen as the research objects,and randomly divided into the control group and the observation group,with 57 cases in each group. The ones in the control group were given recombinant human type II tumor necrosis factor receptor-FC fusion protein injection in subcutaneous injection,25 mg each time,and twice each week,while the ones in the observation group were given ANPSGVAM,one dose each day. Both groups were treated for 3 months continuously.Then the changes of spinal functions before and after the treatment of the two groups were observed; Their changes of levels of TNF-α,hs-CRP,IL-6,MMP-9,and TIMP-1 before and after the treatment were detected; And their clinical curative effects were compared. Results： The effective rate of the control group was 75. 4%,which was obviously lower than that（ 91. 2%） of the observation group; And the difference between them had statistical significance（ χ2= 5. 116,P = 0. 042 0. 05）. The improved degree of the spinal function of the observation group was more remarkable than that of the control group. Its spinal mobility score and thoracal mobility score were increased more obviously compared with before the treatment and the control group,while its BASFI and BASDAI were reduced more obviously compared with before the treatment and the control group; And the differences between them were statistically significant（ P〈0. 05）. After the treatment,inflammatory factors levels of the two groups were reduced; The reduced degrees of TNF-α,hs-CRP and IL-6 level of the observation group were more obvious than those of the control group; And the differences between them were statistically significant（ P〈0. 05）. MMP-9 and TIMP-1 density of the two groups were reduced compared with before the treatment; The reduced degrees of the observation group were more obvious than those of the control group; And the differences between them were statistically significant（ P〈0. 05）. Conclusion： ANPSGVAM in combination with recombinant human type II tumor necrosis factor receptor-FC fusion protein injection in subcutaneous injection on has remarkable clinical curative effect on AS,and can improve the patients＇ spinal function.