补肾强督治偻汤治疗强直性脊柱炎患者的随机对照研究  

Treatment of Ankylosing Spondylitis by Bushen Qiangdu Zhilou Decoction:a Clinical Randomized Controlled Study

作　　者：潘峰[1] 伍嘉琪 何羿婷[1] PAN Feng;WU Jia-qi;HE Yi-ting(Department of Rheumatology,Guangdong Provincial Hospital of Chinese Medicine,Guangzhou,510120)

机构地区：[1]广东省中医院风湿科,广州510120

出　　处：《中国中西医结合杂志》2022年第5期560-567,共8页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：国家中医药管理局课题(No.JDZX2015201)。

摘　　要：目的 评价补肾强督治偻汤治疗肾虚督寒证强直性脊柱炎(AS)的临床疗效及安全性,为后期多中心的随机对照研究提供参考。方法 采用前瞻性、随机对照研究方法,将60例肾虚督寒证AS患者分为试验组32例和对照组28例,采用功能锻炼作为基础治疗。试验组口服补肾强督治偻汤,对照组口服塞来昔布胶囊。比较两组治疗前、治疗后2、6、12、24周基于C反应蛋白(CRP)计算的AS疾病活动度评分(ASDAS-CRP)、CRP、血沉(ESR)、巴氏AS活动指数(BASDAI)、巴氏AS功能指数(BASFI)、巴氏AS度量指数(BASMI)、AS生活质量简表(ASQOL)、健康调查简表(SF36)、AS情绪管理评价(SDS)、患者总体评价(PGA)、疼痛视觉模拟评分(VAS)、X线能量骨密度(BMD)测量、骨代谢三项变化,并评价临床疗效和安全性。结果 与本组治疗前比较,治疗后试验组ASDAS-CRP、BASDAI、BASMI、PGA、VAS、ASQOL均降低,差异均有统计学意义(P<0.05)。两组治疗后ASDASCRP、CRP、ESR、BASFI、BASMI、ASQOL、SF36、SDS、PGA、X线能量BMD、骨代谢三项比较,差异均无统计学意义(P>0.05);治疗后24周,对照组BASDAI、VAS改善情况较试验组更优(P<0.05)。试验组不良反应发生16例,对照组为19例,两组无严重不良反应出现。结论 补肾强督治偻汤治疗肾虚督寒证AS可有效降低患者疾病活动度,改善临床症状,长期用药具有良好的安全性。Objective To evaluate the clinical efficacy and safety of Bushen Qiangdu Zhilou Decoction(BSQDZLD) in the treatment of ankylosing spondylitis(AS) patients with Shen deficiency and Du cold syndrome(SDDCS).Methods A prospective randomized controlled study was conducted.Totally 60 AS patients with SDDCS were assigned to TCM experimental group(32 cases) and Western medicine control group(28 cases).Functional exercise was used as basic treatment.Patients in the experimental group took BSQDZLD,while those in the control group took Celecoxib Capsule.The AS disease activity score based on C-reactive protein(ASDASCRP),C-reactive protein(CRP),erythrocyte sedimentation rate(ESR),Bath ankylosing spondylitis disease activity index(BASDAI),Bath ankylosing spondylitis functional index(BASFI),Bath ankylosing spondylitis metrology index(BASMI),ankylosing spondylitis quality of life scale(ASQOL) and the MOS36-Item Short From Health Survey(SF36),self-rating depression scale(SDS),patient’s global assessment(PGA),pain visual analogue scale(VAS),X-ray energy bone mineral density(BMD) measurement,three items of bone metabolism were compared between the two groups after treatment to evaluate the clinical efficacy and safety.Results Compared with before treatment,BSQDZLD reduced ASDAS-CRP,BASDAI,BASMI,PGA,VAS,and ASQOL,after treatment with significant difference in the experimental group(P<0.05).There were no significant differences in ASDAS-CRP,CRP,ESR,BASFI,BASMI,ASQOL,SF36,SDS,PGA,BMD,and bone metabolism between the two groups after treatment(P>0.05).After 24 weeks treatment,the improvement of BASDAI and VAS in the control group was better than that of the experimental group with significant difference(P<0.05).Adverse reactions occurred in 16 cases of the experimental group and 19 cases in the control group.There were no serious adverse reactions.Conclusion BSQDZLD in the treatment of AS patients with SDDCS effectively reduced disease activity and improved clinical symptoms,with favorable safety in long-term medication.

关 键 词：补肾强督治偻汤 强直性脊柱炎 肾虚督寒证 随机对照研究 

分 类 号：R259[医药卫生—中西医结合]