补肾活血壮骨汤联合西药治疗绝经后骨质疏松症肾虚血瘀证临床研究

Clinical Study on Bushen Huoxue Zhuanggu Decoction Combined with Western Medicine for Postmenopausal Osteoporosis with Kidney Deficiency and Blood Stasis Syndrome

摘要:

目的：观察补肾活血壮骨汤联合西药治疗绝经后骨质疏松症肾虚血瘀证患者的疗效。方法：纳 入2024年1月—2025年4月在浙江中医药大学附属温州市中医院诊治的98例绝经后骨质疏松症肾虚血瘀证患 者，按照随机数字表法分为试验组和对照组各49例。2组均予碳酸钙D3片和地舒单抗注射液治疗，试验组加予 补肾活血壮骨汤治疗。2组均治疗3个月。治疗前后检测2组的骨转换标志物［Ⅰ型胶原羧基端肽β特殊序 列（β-CTX）、总Ⅰ型胶原氨基端延长肽（tP1NP）、骨钙素（OC）］，评估骨痛程度［视觉模拟评分法（VAS） 评分］、中医证候评分，比较2 组的总有效率及不良反应发生率。结果：治疗3 个月后，试验组总有效率 91.84% （45/49），对照组总有效率77.55% （38/49），2 组比较，差异有统计学意义（P＜0.05）。2 组血清 β-CTX、tP1NP浓度均较治疗前下降，OC浓度均较治疗前升高，差异均有统计学意义（P＜0.05）；试验组 血清β-CTX、tP1NP浓度均低于对照组，OC浓度高于对照组，差异均有统计学意义（P＜0.05）。2组VAS评分 均较治疗前降低，试验组VAS评分低于对照组，差异均有统计学意义（P＜0.05）。2组中医证候积分均较治疗 前降低，试验组中医证候积分低于对照组，差异均有统计学意义（P＜0.05）。治疗期间，试验组不良反应发 生率16.33%（8/49），对照组不良反应发生率10.20%（5/49），2组比较，差异无统计学意义（P＞0.05）。结论：采 用补肾活血壮骨汤联合西药治疗绝经后骨质疏松症肾虚血瘀证患者，可提高疗效，有效改善相关中医证候，缓 解骨质疏松性骨痛，改善骨代谢失衡状态，且安全性良好。

Abstract:

Abstract： Objective： To observe the curative effect of Bushen Huoxue Zhuanggu Decoction combined with western medicine on postmenopausal osteoporosis with kidney deficiency and blood stasis syndrome. Methods ： A total of 98 patients with postmenopausal osteoporosis with kidney deficiency and blood stasis syndrome diagnosed and treated in Wenzhou TCM Hospital of Zhejiang Chinese Medical University from January 2024 to April 2025 were included in the study. According to the random number table method， they were divided into the trial group and the control group，with 49 cases in each group. Both groups were treated with Calcium Carbonate and Vitamin D3 Tablets and Denosumab Injection，and the trial group was additionally treated with Bushen Huoxue Zhuanggu Decoction. Both groups were treated for three months. Bone turnover markers [carboxy-terminal peptide of type Ⅰ procollagen（ β-CTX）， total type Ⅰ procollagen N-terminal propeptide （tP1NP），osteocalcin （OC）] were detected before and after treatment in the two groups. The degree of bone pain [Visual Analogue Scale （VAS） scores] and traditional Chinese medicine syndrome scores were evaluated. The total effective rate and the incidence of adverse reactions were compared between the two groups. Results：After three months of treatment，the total effective rate was 91.84%（ 45/49） in the trial group and 77.55% （38/49） in the control group， the difference being significant （P＜0.05）. The concentrations of serum β-CTX and tP1NP in the two groups were decreased when compared with those before treatment，and the concentrations of OC was increased when compared with that before treatment， differences being significant （P＜0.05）； the concentrations of serum β-CTX and tP1NP in the trial group were lower than those in the control group，and the OC concentration was higher than that in the control group，differences being significant （P＜0.05）. The VAS scores in the two groups were decreased when compared with those before treatment，and the VAS score in the trial group was lower than that in the control group， differences being significant （P＜0.05）. The traditional Chinese medicine syndrome scores in the two groups were reduced when compared with those before treatment，and the traditional Chinese medicine syndrome scores in the trial group were lower than those in the control group，differences being significant （P＜0.05）. During treatment，the incidence of adverse reactions was 16.33% （8/49） in the trial group and 10.20% （5/49） in the control group，there being no significance in the difference between the two groups （P＞0.05）. Conclusion：Bushen Huoxue Zhuanggu Decoction combined with western medicine can improve the curative effect on postmeopausal osteoporosis with kidney deficiency and blood stasis syndrome， which can effectively improve the relevant traditional Chinese medicine syndromes，relieve osteoporotic bone pain，and improve bone metabolic imbalance with good safety.