A randomized， double⁃blind， placebo⁃controlled trial of Bushen Qiangdu Qingre Granule in treating ankylosing spondylitis of kidney deficiency and damp⁃heat syndrome

Yi SHEN; Qi ZHU; Dongyi HE; Peng CHENG; Mengru GUO; Ting JIANG; Yang LIU; Hongbai DING; Yang YANG

doi:10.16305/j.1007-1334.2022.2110011

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A randomized， double⁃blind， placebo⁃controlled trial of Bushen Qiangdu Qingre Granule in treating ankylosing spondylitis of kidney deficiency and damp⁃heat syndrome

更新时间：2022-07-09

- A randomized， double⁃blind， placebo⁃controlled trial of Bushen Qiangdu Qingre Granule in treating ankylosing spondylitis of kidney deficiency and damp⁃heat syndrome
- Shanghai Journal of Traditional Chinese Medicine Vol. 56, Issue 4, Pages: 62-67(2022)
- 作者机构：
  
  1.上海中医药大学附属光华医院关节内科（上海 200052）
  2.上海中医药大学研究生院（上海 201203）
  3.上海市中医药研究院中西医结合关节炎研究所（上海 200052）
- 作者简介：
- 基金信息：
- DOI：10.16305/j.1007-1334.2022.2110011
  CLC：
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沈逸,朱琦,何东仪等.补肾强督清热颗粒治疗肾虚湿热型强直性脊柱炎随机、双盲、安慰剂对照临床研究[J].上海中医药杂志,2022,56(04):62-67.

SHEN Yi,ZHU Qi,HE Dongyi,et al.A randomized， double⁃blind， placebo⁃controlled trial of Bushen Qiangdu Qingre Granule in treating ankylosing spondylitis of kidney deficiency and damp⁃heat syndrome[J].Shanghai Journal of Traditional Chinese Medicine,2022,56(04):62-67.
沈逸,朱琦,何东仪等.补肾强督清热颗粒治疗肾虚湿热型强直性脊柱炎随机、双盲、安慰剂对照临床研究[J].上海中医药杂志,2022,56(04):62-67. DOI： 10.16305/j.1007-1334.2022.2110011.

SHEN Yi,ZHU Qi,HE Dongyi,et al.A randomized， double⁃blind， placebo⁃controlled trial of Bushen Qiangdu Qingre Granule in treating ankylosing spondylitis of kidney deficiency and damp⁃heat syndrome[J].Shanghai Journal of Traditional Chinese Medicine,2022,56(04):62-67. DOI： 10.16305/j.1007-1334.2022.2110011.

摘要

目的,2,评价补肾强督清热颗粒治疗肾虚湿热型强直性脊柱炎（AS）的临床疗效及安全性。,方法,2,采用随机、双盲、安慰剂对照临床试验设计，将70例肾虚湿热型AS患者随机分为治疗组和对照组，每组35例。两组均服用非甾体抗炎药，治疗组加用补肾强督清热颗粒，对照组加用模拟中药颗粒剂，两组疗程均为12周。分别于治疗4周、12周比较两组患者的脊柱痛评分、总体评估评分（PGA）、AS疾病活动指数（BASDAI）、AS功能指数（BASFI）、AS疾病活动评分（ASDAS-CRP）、中医证候积分变化情况，并评价其临床疗效和安全性。,结果,2,①共65例患者完成临床试验，其中治疗组32例，对照组33例。②4周时治疗组达到ASAS20和BASDAI50的患者比例高于对照组（,P,<,0.05），12周时治疗组达到ASAS20、ASAS40、ASAS5/6和BASDAI50的患者比例均高于对照组（,P,<,0.05）。③12周时治疗组 ASDAS-CRP 临床改善度优于对照组（,P,<,0.05）；④4周和12周时治疗组中医证候疗效均优于对照组（,P,<,0.05）。⑤治疗4 周与治疗前组内比较，两组的脊柱痛评分、PGA、BASDAI均下降（,P,<,0.05），治疗组的BASFI、ASDAS-CRP、中医证候积分下降（,P,<,0. 05）；治疗4 周组间比较，治疗组的BASDAI、中医证候积分低于对照组（,P,<,0. 05）。治疗12 周与治疗前组内比较，两组的脊柱痛评分、PGA、BASDAI、ASDAS-CRP、中医证候积分均下降（,P,<,0.05），治疗组的BASFI下降（,P,<,0.05）；治疗12周组间比较，治疗组的脊柱痛评分、PGA、BASDAI、ASDAS-CRP、中医证候积分均低于对照组（,P,<,0. 05）。⑥两组患者在治疗期间均未发生严重不良反应。,结论,2,补肾强督清热颗粒治疗肾虚湿热型AS有良好的临床疗效，能有效降低疾病活动度、改善肾虚湿热证候和临床指标，且安全性较好。

Abstract

Objective,2,To evaluate the efficacy and safety of Bushen Qiangdu Qingre Granules in the treatment of kidney deficiency and damp-heat syndrome ankylosing spondylitis （AS） patients.,Methods,2,A randomized double-blind and placebo-controlled clinical trial was carried out in 70 AS patients with kidney deficiency and damp-heat syndrome， who were randomly divided into the treatment group and the control group， with 35 cases in each group. Both groups received NSAIDs. The treatment group was added with Bushen Qiangdu Qingre Granule， and the control group was added with simulated Chinese medicine granule. The course of treatment in both groups was 12 weeks. The spinal pain scores， patient overall assessment （PGA）， Bath AS disease activity index （BASDAI）， Bath AS function index（BASFI）， AS disease activity score （ASDAS-CRP）and TCM syndrome scores between the two groups were compared at 4 and 12 weeks， respectively， to evaluate the clinical efficacy and safety.,Results,2,①A total of 65 patients completed the clinical trial， including 32 cases in the treatment group and 33 cases in the control group. ②After 4 weeks treatment， the proportion of patients who met the ASAS20 and BASDAI 50 standards in the treatment group was higher than that in the control group （,P,<,0.05）. After 12 weeks treatment， the proportion of patients who met the ASAS20，ASAS40， ASAS5/6 and BASDAI 50 standards in the treatment group was higher than that in the control group （,P,<,0. 05）. ③After 12 weeks treatment， the clinical improvement rate of ASDAS-CRP in the treatment group was higher than that in the control group （,P,<,0.05）. ④After 4 and 12 weeks of treatment， the efficacy for TCM syndromes of the treatment group was better than that of the control group （,P,<,0.05）. ⑤Compared with before treatment， the spinal pain score， PGA， BASDAI in two groups both decreased after 4 weeks of treatment（,P,<,0.05）， and BASFI， ASDAS-CRP， TCM syndrome score in the treatment group decreased （,P,<,0.05）；The comparison between groups showed that BASDAI and TCM syndrome score in the treatment group were lower than those in the control group （,P,<,0.05）. After 12 weeks of treatment， compared with before treatment， the spinal pain score， PGA， BASDAI， ASDAS-CRP， TCM syndrome score in two groups decreased （,P,<,0.05）， and BASFI in the treatment group decreased （,P,<,0.05）； The comparison between groups showed that the spinal pain score， PGA， BASDAI， ASDAS-CRP and TCM syndrome score in the treatment group were lower than those in the control group （,P,<,0.05）. ⑥No serious adverse reaction occurred in the two groups during the treatment.,Conclusion,2,Bushen Qiangdu Qingre Granule has good clinical efficacy in the treatment of AS with kidney deficiency and damp-heat syndrome， it can effectively reduce disease activities， improve kidney deficiency and damp-heat syndrome and clinical indicators， with safety.

关键词

强直性脊柱炎肾虚湿热证补肾强督清热颗粒中西医结合疗法

Keywords

ankylosing spondylitiskidney deficiency and damp-heat syndromeBushen Qiangdu Qingre Granuletherapy of integrated Chinese and western medicine

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