坚骨胶囊联合常规方案治疗强直性脊柱炎合并骨质疏松的临床观察

目的:观察坚骨胶囊联合常规方案治疗强直性脊柱炎合并骨质疏松的临床疗效和安全性。方法:90例强直性脊柱炎合并骨质疏松患者按随机数字表法均分为对照组、观察一组和观察二组。对照组患者给予柳氮磺吡啶片1.0 g,口服,bid;塞来昔布胶囊0.2 g,口服,bid。观察一组患者在对照组治疗的基础上给予阿伦磷酸钠70 mg,每周1次。观察二组患者在对照组治疗的基础上给予坚骨胶囊1.75 g,口服,tid。3组患者均以4周为1个疗程,共治疗6个疗程。观察3组患者的临床疗效,治疗前后中医症状积分及体征,实验室指标,疾病活动度指标,骨代谢生化指标,各部位骨密度值和足跟骨强度指数及不良反应发生情况。结果:治疗后观察二组患者总有效率>观察一组>对照组,3组比较差异有统计学意义(P<0.05)。治疗后3组患者中医症状积分、枕墙距、指地距、颌柄距、实验室指标、疾病活动度指标、骨钙素(BGP)、I型前胶原羧基末端前肽(PICP)、双氢嘧啶脱氢酶(DPD)、I型胶原羧基端吡啶并啉交联肽(ICTP)均显著低于同组治疗前,且观察一组、观察二组均低于对照组;胸廓活动度、脊柱前弯受限、脊柱活动度、甲状旁腺素(PTH)、骨碱性磷酸酶(BALP)、各部位骨密度值及足跟骨强度指数均显著高于同组治疗前,且观察一组、观察二组均高于对照组,差异均有统计学意义(P<0.05),但观察一组与观察二组比较差异无统计学意义(P>0.05)。3组患者不良反应发生率比较,差异无统计学意义(P>0.05)。结论:坚骨胶囊治疗强直性脊柱炎合并骨质疏松疗效显著,安全性较好。

Clinical Observation of Jiangu Capsule Combined with Conventional Scheme in the Treatment of Ankylos- ing Spondylitis Complicating with Bone Rarefaction

OBJECTIVE： To observe therapeutic efficacy and safety of Jiangu capsule combined with conventional scheme in the treatment for ankylosing spondylitis complicating with bone rarefaction. METHODS： 90 ankylosing spondylitis patients with bone rarefaction were randomly divided into control group, observation group 1 and observation group 2. Control group was given Sulfasalazine tablet 1.0 g orally bid and Celecoxib capsules 0.2 g orally bid. On the basis of control group, observation group 1 was additionally given allen sodium phosphate 70 mg once a week; observation 2 group was given Jiangu capsule 1.75 g orally tid. A treatment course of 3 groups lasted for 4 weeks; and they received 6 courses of treatment. The clinical efficacy, and TCM symp toms score and physical sign, lab indicators, disease activity index, bone metabolic biochemical index, bone density and calcaneus strength index and the incidence of ADR before and after treatment were observed in 3 groups. RESULTS： Total effective rate of 3 groups was in descending order, such as observation group 2〉observation group l〉control group; there was statistical signifi cance among 3 groups （P〈0.05） ; In three groups, the TCM symptoms score, occiput to wall distance, finger to floor distance, mandible to sternum distance, lab indicators, disease activity index, BGP, PICP, DPD and ICTP after treatment were significantly lower than before; and those of observation group 1 and 2 were lower than those of control group; thoracic activity, lordosis re stricted, spinal mobility, PTH, Serum BALP, bone density value and calcaneus strength index after treatment were obviously high er than before; those of observation group 1 and 2 were higher than those of control group; there was statistical significance （P〈 0.05）; but there was no statistical significance between 2 observation groups （P〉0.05）. The incidence of ADR had no statistical significance among 3 groups （P〉0.05）. CONCLUSIONS： Jiangu capsule is effective and safe in combination treatment for osteo porosis complicating with ankylosing spondylitis.