目的:观察七味通痹口服液联合甲氨蝶呤治疗强直性脊柱炎(AS)的临床效果。方法:将60例强直性脊柱炎患者随机分为治疗组、对照组各30例。治疗组给予七味通痹口服液和甲氨蝶呤治疗,对照组仅给予甲氨蝶呤。结果:治疗组总有效率93.73%,对照组89.77%,2组比较,差异有显著性意义(P<0.05)。治疗后2组患者健康综合评分(BAS-G)、疾病活动指数(BASDAI)、功能指数(BASFI)、全身痛和脊柱痛Likert四级评分、晨僵时间、医生总体评价均有改善,与治疗前比较,差异有显著性意义(P<0.05)。治疗后2组间比较,差异也均有显著性或非常显著性意义(P<0.05,P<0.01)。颌柄距、指地距、胸廓活动度、Schober征、脊柱活动度、“4”字试验评分2组治疗后组间比较,差异有显著性或非常显著性意义(P<0.05,P<0.01)。血沉(ESR)、C-反应蛋白(CRP)、补体C3、C4 2组治疗后组间比较,差异有显著性或非常显著性意义(P<0.05,P<0.01),治疗组患者的改善更明显。结论:七味通痹口服液联合甲氨蝶呤治疗可以显著减轻AS患者的临床症状、体征,改善实验室检查指标,疗效明显,值得临床进一步推广应用。 Objective: To observe the clinical effect of Qiwei Tongbi oral solution combined with methotrexate on ankylosing spondylitis (AS). Methods: Sixty patients with ankylosing spondylitis were randomly divided into treatment group and control group with 30 cases each. The treatment group was given Qiweitongbi oral solution and methotrexate treatment, the control group only given methotrexate. Results: The total effective rate was 93.73% in the treatment group and 89.77% in the control group. There was significant difference between the two groups (P <0.05). After treatment, BAS-G, BASDA, BASFI, Likert four-class score of general ache and spine pain, morning stiffness time and doctor’s overall evaluation improved, Before comparison, the difference was significant (P <0.05). After treatment, the differences between the two groups were also significant or very significant (P <0.05, P <0.01). The maxillary distance, the mean distance from the floor, the activity of the thorax, the Schober sign, the spine activity, and the score of “4” were significantly different between two groups after treatment (P <0.05, P <0.01). ESR, C-reactive protein (CRP), complement C3, C4 group after treatment, the difference was significant or very significant (P <0.05, P <0.01), the treatment group improved more obvious. Conclusion: The combination of Qiweitongbi oral solution and methotrexate can significantly reduce the clinical symptoms and signs of AS patients and improve the laboratory tests. The curative effect is obvious and it is worth further clinical application.