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匡昱林, 欧梁, 匡建军, 戎宽, 孙绍裘.金刚丸联合骨化三醇治疗肾阳亏虚型老年骨质疏松症的临床研究[J].湖南中医药大学学报英文版,2024,44(5):822-827.[Click to copy
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| 金刚丸联合骨化三醇治疗肾阳亏虚型老年骨质疏松症的临床研究 |
| 匡昱林,欧梁,匡建军,戎宽,孙绍裘 |
| (湖南中医药大学, 湖南 长沙 410208;湖南中医药大学第二附属医院, 湖南 长沙 410005;湖南省中医药研究院, 湖南 长沙 410008) |
| 摘要: |
| 目的 探讨金刚丸联合骨化三醇治疗肾阳亏虚型老年骨质疏松症的临床疗效及安全性。方法 选取湖南省中医药研究院附属医院门诊接受治疗的72名肾阳亏虚型骨质疏松的老年患者，采用分层随机化方法随机分为对照组（骨化三醇治疗）和治疗组（金刚丸联合骨化三醇治疗），每组36例。治疗持续8周。比较两组患者的临床疗效、视觉模拟评分法（visual analogue scale，VAS）评分、骨密度、骨代谢指标、成骨相关基因水平、炎症因子水平、生活质量、中医证候积分和安全性。结果 治疗组总有效率为91.7%，高于对照组的69.4%（P<0.05）；与对照组比较，治疗组VAS评分显著降低（P<0.05），全髋、腰椎及股骨颈骨密度均增加（P<0.05），治疗组骨形态发生蛋白2（bone morphogenetic protein 2，BMP2）RNA表达水平、骨碱性磷酸酶（bone alkaline phosphatase，BALP）、骨钙素（osteocalcin, BGLAP）水平、健康状况调查问卷（36-item short-form，SF-36）评分升高（P<0.05），抗酒石酸酸性磷酸酶5b（tartrate-resistant acid phosphatase 5b，TRACP-5b）水平、miR-133aRNA表达水平、肿瘤坏死因子-α（tumor necrosis factor-α，TNF-α）水平、白细胞介素-6（interleukin-6，IL-6）水平及中医临床症状评分降低（P<0.05）。结论 金刚丸联合骨化三醇可能通过上调BALP、BGLAP、BMP2，下调TRACP-5b、miR-133a、TNF-α及IL-6，改善患者骨密度、骨代谢、炎症状态及生活质量，能有效显著提高“肾阳亏虚证”肾阳亏虚型老年骨质疏松症患者的治疗效果。 |
| 关键词: 老年骨质疏松症 肾阳亏虚证 金刚丸 骨化三醇 临床疗效 视觉模拟评分法 |
| DOI：10.3969/j.issn.1674－070X.2024.05.015 |
| Received:March 13, 2024 |
| 基金项目:中国博士后科学基金面上项目（2023M731070）；湖南省临床医疗技术创新引导项目（2021SK51301）；湖南中医药大学研究生创新课题立项项目（2022CX41）。 |
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| Clinical study of Jingang Pill combined with calcitriol in treating elderly osteoporosis with kidney-yang deficiency pattern |
| KUANG Yulin, OU Liang, KUANG Jianjun, RONG Kuan, SUN Shaoqiu |
| (Hunan University of Chinese Medicine, Changsha, Hunan 410208, China;The Second Hospital of Hunan University of Chinese Medicine, Changsha, Hunan 410005, China;Hunan Academy of Chinese Medicine, Changsha, Hunan 410008, China) |
| Abstract: |
| Objective To investigate the clinical efficacy and safety of Jingang Pill combined with calcitriol in treating elderly osteoporosis with kidney-yang deficiency pattern. Methods A total of 72 elderly patients with kidney-yang deficiency osteoporosis treated in the outpatient department of the Hospital of Hunan Academy of Chinese Medicine were randomized into control group (treated by calcitriol) and treatment group (treated by Jingang Pill combined with calcitriol) by stratified randomization method, with 36 participants in each group. The treatment lasted for 8 weeks. The clinical efficacy, visual analogue scale (VAS) scores, bone mineral density, bone metabolism index, osteogenesis-related gene levels, inflammatory factor levels, quality of life, and TCM pattern scores and safety were compared between the two groups. Results The overall efficacy rate in the treatment group was 91.7%, significantly higher than 69.4% in the control group (P<0.05); compared with the control group, VAS score in the treatment group decreased (P<0.05); bone mineral density in the whole hip, lumbar spine, and femoral neck increased (P<0.05); bone morphogenetic protein 2(BMP2)RNA expression level, bone alkaline phosphatase (BALP) osteocalcin (BGLAP) content, and scores of health status questionnaire (36-item short-form, SF-36) increased (P<0.05); levels of tartrate-resistant acid phosphatase 5b (TRACP-5b), miR-133aRNA expression level, serum tumor necrosis factor-α (TNF-α), and interleukin-6 (IL-6), and TCM pattern scores all decreased (P<0.05). Conclusion Jingang Pill combined with calcitriol may improve bone mineral density, bone metabolism, inflammatory status, and quality of life by up-regulating BGLAP, miR-133a, and down-regulating TRACP-5b, BMP2, TNF-α, and IL-6 levels, thereby effectively improving the treatment efficacy of elderly osteoporosis with kidney-yang deficiency pattern. |
| Key words: elderly osteoporosis kidney-yang deficiency pattern Jingang Pill calcitriol clinical efficacy visual analogue scale |
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