脊得舒丸联合三伏贴治疗肾虚督寒型强直性脊柱炎临床研究
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R593.23

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河南省中医药科学研究专项课题(2019JDZX083)


Clinical Study on Jideshu Pills Combined with Sanfu Paste in Treating Ankylosing Spondylitis with Kidney Deficiency and Du Cold Syndrome
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    摘要:

    目的:观察脊得舒丸联合三伏贴治疗肾虚督寒型强直性脊柱炎(AS) 的临床疗效,以及对骨代谢 和炎症因子的影响。方法:选取2021年6月—2023年6月在河南省中医院治疗的108例肾虚督寒型AS患者,使 用随机数字表法分为研究组与对照组各54例。2组均给予常规西药治疗,对照组在常规西药基础上给予脊得舒 丸治疗,研究组在常规西药基础上给予脊得舒丸联合三伏贴治疗。比较2组临床疗效、骨代谢指标、炎症因 子、急性期反应标志物、中医证候积分、巴氏AS疾病活动指数(BASDAI) 评分、腰骶疼痛视觉模拟评分 法(VAS) 评分及不良反发生率。结果:治疗后,研究组总有效率96.23%(51/53),高于对照组82.35%(42/ 51)(P<0.05)。2组血清骨特异性碱性磷酸酶(BALP)、骨钙素(OC)、Ⅰ型前胶原羧基末端肽(PⅠCP)、 Ⅰ型前胶原氨基末端肽(PⅠNP) 水平均较治疗前升高(P<0.05),研究组上述4 项指标水平均高于对照 组(P<0.05);2组血清25-羟维生素D[25(OH) D]、甲状旁腺激素(PTH) 水平比较,差异均无统计学意 义(P>0.05)。2组血清白细胞介素-6(IL-6)、白细胞介素-17(IL-17)、白细胞介素-23(IL-23)、肿瘤坏死 因子-α(TNF-α)、C-反应蛋白(CRP) 及血沉(ESR) 水平均较治疗前降低(P<0.05),研究组上述6项指标 水平均低于对照组(P<0.05)。2组腰胯疼痛、腰部活动受限、腰膝酸软、喜暖畏寒、神疲乏力积分及中医证 候总分均较治疗前降低(P<0.05),研究组上述5 项中医证候积分及总分均低于对照组(P<0.05)。2 组 BASDAI、VAS评分均较治疗前降低(P<0.05),研究组BASDAI、VAS评分均低于对照组(P<0.05)。研究组 不良反应率13.21%(7/53),与对照组11.76%(6/51),差异无统计学意义(P>0.05)。结论:脊得舒丸联合三 伏贴治疗肾虚督寒型AS,可有效改善骨代谢,减轻炎症反应,缓解症状,临床疗效良好。

    Abstract:

    Abstract: Objective: To observe the clinical efficacy of Jideshu Pills combined with Sanfu Paste in treating ankylosing spondylitis (AS) with kidney deficiency and Du cold syndrome, and to investigate its effects on bone metabolism and inflammatory factors. Methods: A total of 108 AS patients with kidney deficiency and Du cold syndrome treated at Henan Province Hospital of Traditional Chinese Medicine from June 2021 to June 2023 were selected and divided into the study group and the control group by the random number table method,with 54 cases in each group. Both groups received conventional western medicine treatment. The control group received additional Jideshu Pills, while the study group received Jideshu Pills combined with Sanfu Paste. Clinical efficacy, bone metabolism markers, inflammatory factors, acute-phase reactants, traditional Chinese medicine(TCM) syndrome scores,Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores,Visual Analogue Scale (VAS) scores for lumbosacral pain,and the incidence of adverse reactions were compared between the two groups. Results:After treatment,the total effective rate in the study group was 96.23%( 51/53),significantly higher than 82.35%( 42/51) in the control group (P<0.05). Serum levels of bone-specific alkaline phosphatase (BALP), osteocalcin (OC), procollagen type Ⅰ C-terminal propeptide (P Ⅰ CP), and procollagen type Ⅰ N-terminal propeptide (P Ⅰ NP) increased in both groups compared to pretreatment (P<0.05), with the study group showing higher levels than the control group (P<0.05). No significant differences were observed in serum 25-hydroxyvitamin D [25(OH)D] and parathyroid hormone (PTH) levels between the two groups (P>0.05). Serum levels of interleukin-6 (IL-6), interleukin-17 (IL-17),interleukin-23 (IL-23),tumor necrosis factor-α (TNF-α),C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR) decreased in both groups compared to pretreatment (P<0.05), with the study group showing lower levels than the control group (P<0.05). Scores for lumbosacral pain,confinement of lumbar mobility,soreness and weakness of waist and knees,preference for warmth and aversion to cold,fatigue,and total TCM syndrome scores decreased in both groups compared to pretreatment (P<0.05), with the study group showing lower scores than the control group (P<0.05). BASDAI and VAS scores decreased in both groups compared to pretreatment( P<0.05),with the study group showing lower scores than the control group( P<0.05). The incidence of adverse reactions was 13.21% (7/53) in the study group and 11.76% (6/51) in the control group,with no significant difference (P>0.05). Conclusion:Jideshu Pills combined with Sanfu Paste can effectively improve bone metabolism, reduce inflammation responses,alleviate symptoms,and demonstrate good clinical efficacy in treating AS with kidney deficiency and Du cold syndrome.

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陈蕾,周子朋,杨帅.脊得舒丸联合三伏贴治疗肾虚督寒型强直性脊柱炎临床研究[J].新中医,2025,57(12):80-86

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  • 在线发布日期: 2025-06-26
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