骨松丸联合西药治疗骨质疏松性椎体压缩性骨折后期肝肾不足证临床研究

Clinical Study on Gusong Pills Combined with Western Medicine for Late-Stage Osteoporotic Vertebral Compression Fracture with Liver-Kidney Deficiency Syndrome

摘要:

目的：观察骨松丸联合西药治疗骨质疏松性椎体压缩性骨折（OVCF） 后期肝肾不足证患者的临床 疗效。方法：选择2024年1—12月在湖南省康复医院门诊、住院部治疗的60例OVCF后期肝肾不足证患者为研 究对象，采用随机数字表法分为对照组与观察组各30例。2组均予碳酸钙D3片、阿仑膦酸钠片治疗，观察组加 用骨松丸治疗，2组均治疗12周。比较2组临床疗效，治疗前后评估腰痛视觉模拟评分法（VAS） 评分、腰椎 Oswestry功能障碍指数（ODI） 评分及中医证候评分，检测L1～4及其后方附件结构的骨密度（BMD），记录不良 反应发生情况。结果：治疗12周后，观察组总有效率86.67%（26/30），高于对照组63.33% （19/30），差异有 统计学意义（P＜0.05）。2组VAS评分、ODI评分均随治疗时间的延长呈下降趋势。2组不同时间点的VAS评 分、ODI评分分别整体比较，差异均有统计学意义（P＜0.05）。2组治疗4周后及治疗12 周后的VAS 评分、 ODI 评分均较治疗前降低（P＜0.05）；观察组治疗12 周后的VAS 评分、ODI 评分较治疗4 周后降低（P＜ 0.05）。观察组治疗4周后及治疗12周后的VAS评分、ODI评分均低于同期对照组（P＜0.05）。2组BMD值均随 治疗时间的延长呈上升趋势。2组不同时间点的BMD值分别整体比较，差异均有统计学意义（P＜0.05）。2组 治疗12周后的BMD值均较治疗前降低（P＜0.05）。观察组治疗12周后的BMD值高于对照组（P＜0.05）。2组 治疗12周后的腰部隐痛、腰膝酸软、活动受限、神疲乏力评分均较治疗前降低（P＜0.05），观察组上述4项中 医证候评分均低于对照组（P＜0.05）。2组在治疗期间均未出现严重不良反应。结论：骨松丸联合西药治疗 OVCF后期肝肾不足证患者临床疗效确切，且安全性较好，可有效减轻腰痛，改善腰椎功能、相关中医证候及 BMD。

Abstract:

Abstract： Objective： To observe the clinical effects of Gusong Pills combined with western medicine in the treatment of patients with osteoporotic vertebral compression fracture （OVCF） at the late stage with liver-kidney deficiency syndrome. Methods： A total of 60 patients with late-stage OVCF of liver-kidney deficiency syndrome treated in the outpatient and inpatient departments of Hunan Rehabilitation Hospital from January to December 2024 were selected as the subjects. They were randomly divided into the control group and the observation group via a random number table method，with 30 cases in each group. Both groups received Calcium Carbonate and Vitamin D3 Tablets and Alendronate Sodium Tablets. The observation group additionally received Gusong Pills. The treatment course for both groups was 12 weeks. The clinical effects were compared. The scores of Visual Analogue Scale（ VAS），lumbar Oswestry Disability Index （ODI）， and traditional Chinese medicine （TCM） syndrome scores were evaluated before and after treatment. Bone mineral density（ BMD） of lumbar vertebrae L1~4 and their posterior spinal structures was measured，and adverse reactions were recorded. Results：After 12 weeks of treatment，the total effective rate in the observation group was 86.67% （26/30）， which was higher than 63.33% （19/30） in the control group， the difference being significant （P＜0.05）. The VAS and ODI scores in both groups showed a decreasing trend over the course of treatment. VAS and ODI scores showed statistically significant differences at different time points in both groups （P＜0.05）. VAS and ODI scores in both groups were decreased at 4 weeks and 12 weeks after treatment when compared with those before treatment （P＜0.05）. In the observation group，VAS and ODI scores at 12 weeks after treatment were lower than those at 4 weeks after treatment （P＜0.05）. VAS and ODI scores in the observation group at both 4 and 12 weeks after treatment were lower than those in the control group at the same time points （P＜0.05）. The BMD values in both groups showed an increasing trend over the course of treatment. BMD values showed statistically significant differences at different time points in both groups （P＜0.05）. BMD values in both groups were decreased at 12 weeks after treatment when compared with those before treatment （P＜0.05）， and the BMD in the observation group at 12 weeks after treatment was higher than that in the control group（ P＜0.05）. After 12 weeks of treatment，scores for dull lumbar pain， soreness and weakness of the lumbar region and knees，limited mobility，and mental fatigue and weakness decreased in both groups when compared with those before treatment （P＜0.05），and these TCM syndrome scores in the observation group were lower than those in the control group （P＜0.05）. No serious adverse reactions occurred in either group during treatment. Conclusion：Gusong Pills combined with western medicine shows definite clinical effect and high safety in the treatment of patients with late-stage OVCF of liver-kidney deficiency syndrome. It can effectively relieve back pain， improve lumbar function and related TCM syndromes，and increase BMD.