2025 年第 4 期 第 20 卷

金乌骨通胶囊治疗原发性骨质疏松症的效果及药物经济学评价

Efficacy and pharmacoeconomic evaluation of Jinwugutong capsule in the treatment of primary osteoporosis

作者：孙燕1肖鹏2刘传慧3王志伟2

英文作者：Sun Yan1 Xiao Peng2 Liu Chuanhui3 Wang Zhiwei2

单位：1河南省郑州市骨科医院药学部，郑州450052；2郑州大学第一附属医院创伤骨科，郑州450000；3河南省郑州市骨科医院综合内外科，郑州450052

英文单位：1Department of Pharmacy Zhengzhou Orthopaedic Hospital Henan Province Zhengzhou 450052 China; 2Department of Orthopaedic Trauma the First Affiliated Hospital of Zhengzhou University Zhengzhou 450000 China; 3Department of Medicine and Surgery Zhengzhou Orthopaedic Hospital Henan Province Zhengzhou 450052 China

关键词：骨质疏松症；金乌骨通胶囊；骨代谢标志物；药物经济学

英文关键词：Osteoporosis;Jinwugutongcapsule;Bonemetabolismmarkers;Pharmacoeconomicevaluation

• 摘要：

• 目的 探讨金乌骨通胶囊治疗原发性骨质疏松症的效果并评价药物经济性。方法 选取2022年6月至2023年6月在河南省郑州市骨科医院就诊的200例原发性骨质疏松症患者，按随机数字表法分为对照组和观察组，各100例。对照组给予常规西医治疗，观察组在对照组基础上外加金乌骨通胶囊治疗，2组均治疗24周后评价比较。比较2组治疗前后中医证候积分、腰腿疼痛、日常生活活动能力量表（ADL）评分、骨密度、骨代谢指标变化情况。比较2组不良反应发生情况，分析2组临床疗效差异。评价2组短期内的药物经济性。结果 治疗后4、12、24周，观察组中医证候积分均低于对照组（均P＜0.05）。治疗后，2组疼痛评分、ADL评分均低于治疗前，骨密度高于治疗前，且观察组疼痛评分、ADL评分均低于对照组，骨密度高于对照组（均P＜0.05）。治疗后，2组血清钙、骨钙素、总Ⅰ型胶原氨基端延长肽水平均高于治疗前，血清磷水平低于治疗前，且观察组血清钙、骨钙素、总Ⅰ型胶原氨基端延长肽水平均高于对照组，血清磷水平低于对照组（均P＜0.05）。观察组不良反应发生率低于对照组［2.0%（2/100）比14.0%（14/100）］，差异有统计学意义（P=0.002）。观察组总有效率高于对照组［82.0%（82/100）比73.0%（73/100）］，差异有统计学意义（P=0.004）。对照组成本效果比为132.65，观察组成本效果比为128.04，增量成本效果比为90.72。观察组治疗方案比对照组更具经济性。结论 金乌骨通胶囊治疗原发性骨质疏松症效果较好，可改善中医证候评分，缓解疼痛，改善机体骨代谢，安全可靠，且更具有经济性。

• Objective To investigate the effect of Jinwugutong capsule in the treatment of primary osteoporosis and evaluate the drug economy. Methods A total of 200 patients with primary osteoporosis in Zhengzhou Orthopaedic Hospital, Henan Province from June 2022 to June 2023 were selected. According to the random number table method, they were divided into the control group and the observation group, with 100 cases in each group. The control group was treated with conventional western medicine, and the observation group was treated with Jinwugutong capsule on the basis of the control group. The two groups were evaluated and compared after 24 weeks of treatment. The traditional Chinese medicine syndrome score, low back pain and leg pain, activity of daily living scale (ADL) score, bone mineral density and bone metabolism indexes were compared between the two groups before and after treatment. The incidence of adverse reactions was compared between the two groups, and the differences in clinical efficacy between the two groups were analyzed. The short-term drug economy of the two groups was evaluated. Results At 4, 12 and 24 weeks after treatment, the traditional Chinese medicine syndrome scores of the observation group were lower than those of the control group (all P＜0.05). After treatment, the pain scores and ADL scores of the two groups were lower than those before treatment, and the bone mineral density was higher than that before treatment. The pain scores and ADL scores of the observation group were lower than those of the control group, and the bone mineral density was higher than that of the control group (all P＜0.05). After treatment, the levels of serum calcium, osteocalcin and total N-terminal propeptide of type Ⅰ collagen in the two groups were higher than those before treatment, and the serum phosphorus level was lower than that before treatment. The levels of serum calcium, osteocalcin and total N-terminal propeptide of type Ⅰ collagen in the observation group were higher than those in the control group, and the serum phosphorus level was lower than that in the control group (all P＜0.05). The incidence of adverse reactions in the observation group was lower than that in the control group ［2.0%(2/100) vs 14.0%(14/100)］(P=0.002). The total effective rate of the observation group was higher than that of the control group ［82.0%(82/100) vs 73.0%(73/100)］(P=0.004). The cost-effectiveness ratio of the control group was 132.65, the effectiveness ratio of the observation group was 128.04, and the incremental cost-effectiveness ratio was 90.72. The treatment regimen in the observation group was more economical than that in the control group. Conclusion Jinwugutong capsule is effective in the treatment of primary osteoporosis, which can improve the traditional Chinese medicine syndrome score, relieve pain, improve bone metabolism, and is safe, reliable and more economical.