中国骨质疏松杂志

芪黄健脾滋肾颗粒对系统性红斑狼疮患者疾病活动及骨代谢的影响

Effect of Qihuang Jianpizishen Granule on disease activity and bone metabolism in patients with systemic lupus erythematosus

DOI：10.3969/j.issn.1006-7108.2022.11.008

中文关键词: 中医中药系统性红斑狼疮芪黄健脾滋肾颗粒骨代谢疾病活动度

英文关键词:traditional Chinese medicine systemic lupus erythematosus Qihuang Jianpizishen granule bone metabolism disease activity

基金项目:国家自然科学基金项目（81473672，82104782）；安徽省高校协同创新项目（GXXT-2021-085）；安徽省高校自然科学研究基金重点项目（KJ2020A0395）；安徽省红十字基金会中医药传承创新发展项目（2021ZYZD03）；安徽中医药大学研究生科技创新基金项目（2021YB06）

作者	单位
汤忠富程丽丽戈扬徐昌萍黄传兵*	安徽中医药大学第一附属医院，安徽合肥 230031

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中文摘要:

目的观察芪黄健脾滋肾颗粒对系统性红斑狼疮（SLE）患者疾病活动及骨代谢指标的影响。方法将64例女性SLE患者随机分为对照组和观察组各32例，对照组予以醋酸泼尼松片联合阿法骨化醇软胶囊口服，观察组在对照组的基础上加以芪黄健脾滋肾颗粒口服，两组疗程均为12周。观察两组治疗前后SLE疾病活动指数（SLEDAI）、血沉（ESR）、C反应蛋白（CRP）变化，采用酶联免疫吸附法（ELISA）测血清肿瘤坏死因子-α（TNF-α）、白介素-17（IL-17）水平，采用电化学发光免疫分析法测定血清骨钙素（OC）、I型前胶原氨基末端肽（PINP）、血清β胶原降解产物（β-CTX）、甲状旁腺素（PTH）、25羟基维生素D[25(OH)D]水平，采用双能X线骨密度仪测定患者双侧股骨、腰椎( L1~L4)骨密度值，并评价治疗前后两组的临床疗效。结果观察组临床总有效率为93.75 %，显著高于对照组的68.75 %（χ2＝5.026，P＜0.05）。观察组治疗后SLEDAI、ESR、CRP、TNF-α、IL-17均显著低于对照组治疗后（P＜0.01）；对照组治疗后β-CTX、PTH降低（P＜0.05或P＜0.01），25(OH)D升高（P＜0.01），双侧股骨、髋骨骨密度变化不明显（P＞0.05），观察组治疗后双侧股骨、髋骨骨密度高于治疗前（P＜0.05）；观察组治疗后OC、25(OH)D高于对照组（P＜0.05），β-CTX、PTH低于对照组（P＜0.05或P＜0.01）。结论芪黄健脾滋肾颗粒能有效降低SLE疾病活动度，改善患者骨代谢和骨密度，安全性高，值得推广应用。

英文摘要:

Objective To observe the effects of Qihuang Jianpizishen granule on disease activity and bone metabolic indexes in patients with systemic lupus erythematosus (SLE). Methods Sixty-four female SLE patients were randomly divided into a control group and an observation group of 32 patients each, and the control group was given prednisone acetate tablets combined with alfacalcidol soft capsules orally, while the observation group was given Qihuang Jianpizishen Granule orally on the basis of the control group, and the duration of treatment for both groups was 12 weeks. The changes of SLE disease activity index (SLEDAI), blood sedimentation (ESR), C-reactive protein (CRP), serum tumor necrosis factor-α (TNF-α) and interleukin-17 (IL-17) levels were measured by enzyme-linked immunosorbent assay (ELISA), and serum osteocalcin (OC), pre-collagen type I amino acid and terminal peptide (PINP) were measured by electrochemiluminescence immunoassay before and after treatment in both groups. terminal peptide (PINP), serum β-collagen degradation product (β-CTX), parathyroid hormone (PTH) and 25hydroxyvitamin D [25(OH)D] levels were measured by electrochemiluminescence immunoassay, and the bone density values of the femur and lumbar spine ( L1-L4) were measured bilaterally by dual-energy X-ray bone densitometry, and the clinical efficacy of the two groups was evaluated before and after treatment. Results The total clinical efficiency of the observation group was 93.75%, which was significantly higher than 68.75% in the control group (χ2 = 5.026, P < 0.05). SLEDAI, ESR, CRP, TNF-α and IL-17 were significantly lower in the observation group after treatment than in the control group after treatment (P < 0.01); β-CTX and PTH decreased in the control group after treatment (P < 0.05 or P < 0.01), 25(OH)D increased (P < 0.01), and bilateral femur and hip bone mineral density did not change significantly (P > 0.05), while the observation group Bilateral femur and hip bone density were higher after treatment than before treatment (P < 0.05); OC and 25(OH)D were higher in the observation group than in the control group after treatment (P < 0.05), and β-CTX and PTH were lower than in the control group (P < 0.05 or P < 0.01). Conclusion Qihuang JianpiZishen granule can effectively reduce SLE disease activity, improve bone metabolism and bone mineral density of patients, with high safety and worthy of popularization and application.

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