路占忠 刘进子 张旭飞

【摘 要】目的：观察金天格胶囊联合西药治疗强直性脊柱炎伴骨质疏松症患者的临床疗效及安全性。方法：将80例强直性脊柱炎伴骨质疏松症患者随机分为治疗组和对照组，每组40例。对照组给予沙利度胺、醋氯芬酸肠溶胶囊及维D钙咀嚼片治疗，治疗组在对照组的基础上予金天格胶囊治疗。2组疗程均为6个月。观察2组治疗前后骨密度、25羟基维生素D[25-（OH）D]、甲状旁腺激素（PTH）、疼痛视觉模拟评分法（VAS）评分、红细胞沉降率（ESR）、超敏C反应蛋白（hs-CRP）变化情况。结果：治疗后，2组骨密度、25-（OH）D、PTH、VAS评分、ESR、hs-CRP较治疗前均有显著改善（P < 0.05）;且治疗组优于对照组（P < 0.05）。2组均未发现明显不良反应。结论：金天格胶囊联合西药治疗强直性脊柱炎伴骨质疏松症患者具有良好的抗骨质疏松、抗炎镇痛效果，安全性高。

【关键词】 强直性脊柱炎;骨质疏松症;金天格胶囊;沙利度胺;骨密度;安全性;临床疗效

【ABSTRACT】Objective：To observe the clinical efficacy and safety of Jintiange Jiaonang（金天格胶囊）combined with western medicine in the treatment of ankylosing spondylitis with osteoporosis.Methods：Eighty cases of ankylosing spondylitis with osteoporosis were randomly divided into a treatment group and a control group，40 cases in each group.The control group was treated with thalidomide，aceclofenac enteric coated capsules and vitamin D calcium tablets，while the treatment group was treated with Jintiange Jiaonang based on the treatment for the control group.Both groups were treated for 6 months.The changes of BMD，25-（OH）D，PTH，VAS，ESR and hs-CRP were observed before and after treatment.Results：After treatment，BMD，25-（OH）D，PTH，VAS，ESR and hs-CRP of the two groups were significantly improved（P < 0.05），and the treatment group was better than the control group（P < 0.05）.No obvious adverse reactions were found in both groups.Conclusion：Jintiange Jiaonang combined with western medicine in the treatment of ankylosing spondylitis with osteoporosis has good anti-osteoporosis，anti-inflammatory and analgesic effect，with high safety.

【Keywords】 ankylosing spondylitis;osteoporosis;Jintiange Jiaonang（金天格胶囊）;thalidomide;bone mineral density;safety;clinical efficacy

强直性脊柱炎（ankylosing spondylitis，AS）特征性表现是异位骨化，可引起受累部位的活动功能障碍[1]。研究发现，随着AS的病情进展，新骨形成和骨质疏松症（osteoporosis，OP）同时存在，甚至可出现骨折等严重后果[2];且这一现象较为普遍，甚至可达50%～92%[3]。因而，AS伴发OP的治疗需要在疾病早期充分利用好时间窗口，以提高临床疗效及患者生活质量。

中医学认为，AS属“大偻”范畴，本病乃肾督亏虚，复感外邪所致[4]。天然虎骨粉金天格胶囊治疗OP，具有健骨、改善骨代谢的功效，对腰背痛亦有很好的治疗效果。沙利度胺临床上应用于AS的治疗，可抗炎、抗风湿。本研究分析金天格胶囊联合沙利度胺治疗AS伴OP的临床疗效及安全性。

1 临床资料

1.1 一般资料 选取2017年3月至2020年5月

在石家莊市第三医院就诊的AS伴OP患者80例，按照随机数字法（非盲法）分为治疗组和对照组，每组40例。……