探究补肾祛寒化湿方（由骨碎补、杜仲、川续断、羌活、干姜、薏苡仁、怀牛膝等组成）联合甲氨蝶呤对强直 性脊柱炎（ankylosing spondylitis，AS）肾虚督寒证患者疾病活动度及血清核心结合因子a1（Cbfa1）水平的影响。【方法】将90例 AS肾虚督寒证患者随机分为试验组和对照组，每组各45例。对照组给予甲氨蝶呤治疗，试验组在对照组的基础上加用补肾 祛寒化湿方治疗，疗程为3个月。观察2组患者治疗前后巴氏强直性脊柱炎疾病活动指数（BASDAI）评分、巴氏强直性脊柱炎 功能指数（BASFI）评分和血清Cbfa1、Ⅰ型胶原蛋白C末端肽（CTX-Ⅰ）、Dickkopf1蛋白（DKK1）水平的变化情况，并比较2组 患者的临床疗效和不良反应发生率。【结果】（1）疗效方面，治疗3个月后，试验组的总有效率为97.78%（44/45），对照组为 82.22%（37/45），组间比较（χ2检验），试验组的疗效明显优于对照组，差异有统计学意义（P＜0.05）。（2）疾病活动度方面，治 疗后，2组患者的BASDAI评分和BASFI评分均较治疗前明显降低（P＜0.05），且试验组对BASDAI评分和BASFI评分的降低 幅度均明显优于对照组，差异均有统计学意义（P＜0.01）。（3）血清学指标方面，治疗后，2组患者的血清Cbfa1、CTX-Ⅰ、DKK1 水平均较治疗前降低（P＜0.05），且试验组对血清Cbfa1、CTX-Ⅰ、DKK1水平的降低幅度均明显优于对照组，差异均有统计 学意义（P＜0.01）。（4）不良反应方面，治疗过程中，试验组的不良反应发生率为6.66%（3/45），对照组为11.11%（5/45），2组患 者的不良反应发生率比较，差异无统计学意义（P＞0.05）。【结论】补肾祛寒化湿方联合甲氨蝶呤治疗AS肾虚督寒证患者疗效 确切，能够有效控制患者的疾病活动度，降低血清Cbfa1表达水平。

To investigate the effects of the Bushen Quhan Huashi Prescription（mainly composed of Drynariae Rhizoma，Eucommiae Cortex，Dipsaci Radix ，Notopterygii Rhizoma et Radix，Zingiberis Rhizoma Recens， Coicis Semen， and Achyranthis Bidentatae Radix）in combination with Methotrexate on the disease activity and serum core-binding factor a1（Cbfa1）level of patients with ankylosing spondylitis（AS）of kidney deficiency and governor-vessel cold type. Methods Ninety AS patients with kidney deficiency and governor-vessel cold type were randomly divided into a trial group and a control group，with 45 patients in each group. The control group was given Methotrexate treatment，and the trial group was treated with Bushen Quhan Huashi Prescription on the basis of treatment for the control group. The course of treatment in the two groups lasted for 3 months. The changes of Bath ankylosing spondylitis disease activity index（BASDAI） scores， Bath ankylosing spondylitis function index（BASFI）scores and serum levels of Cbfa1， type I collagen carboxy-terminal peptide（CTX-Ⅰ） and Dickkopf1 protein（DKK1）of the two groups were observed before and after treatment. After treatment，the clinical efficacy and the incidence of adverse effects were compared between the two groups. Results（1）After 3 months of treatment，the total effective rate of the trial group was 97.78%（44/45）and that of the control group was 82.22%（37/45）. The intergroup comparison by chi-square test）showed that the therapeutic efficacy of the trial group was significantly superior to that of the control group， and the difference was statistically significant （P＜0.05）.（2）After treatment，the disease activity scores of BASDAI and BASFI in the two groups of patients were significantly decreased compared with those before treatment（P＜0.05），and the trial group’s reduction of BASDAI scores and BASFI scores were significantly superior to those of the control group， and the differences were statistically significant（P＜0.01）.（3）After treatment，the serum levels of serological indicators of Cbfa1， CTX-Ⅰ，and DKK1 in the two groups were decreased compared with those before treatment（P＜0.05），and the decrease of Cbfa1，CTX-Ⅰ and DKK1 levels in the trial group was significantly superior to that in the control group， the differences being all statistically significant（P＜0.01）.（4）During the treatment，the incidence of adverse reactions in the trial group was 6.66%（3/45）and that in the control group was 11.11%（5/45），and the difference of the incidence of adverse reactions between the two groups was not statistically significant（P＞0.05）. Conclusion Bushen Quhan Huashi Prescription combined with Methotrexate exerts certain effect in treating AS patients with kidney deficiency and governor-vessel cold type，and the therapy can effectively control the disease activity and reduce the level of serum Cbfa1 expression in the patients.

R259.323

上海市卫生健康委员会资助项目（编号：2022QN060）