【目的】 观察温阳益气法中药联合阿仑膦酸钠维D3治疗老年骨质疏松症（OP）脾肾阳虚证患者的疗效及对骨代谢和血清 炎症因子的影响。【方法】 将2021年10月至2023年10月在无锡市第九人民医院中医骨伤科就诊的110例老年OP脾肾阳虚证 患者随机分为试验组和对照组，每组各55例。对照组给予阿仑膦酸钠维D3治疗，试验组在对照组的基础上给予温阳益气法 中药（包括淫羊藿、黄芪、牡蛎、当归、川牛膝、补骨脂、桑寄生等）治疗，疗程为3个月。观察2组患者治疗前后中医证候 积分、骨密度（BMD）、疼痛视觉模拟量表（VAS）评分、骨代谢指标[β 胶原降解产物（β-CTX）、总 I 型原胶原氨基端延长肽 （PINP）、骨钙素（BGP）]以及血清炎症因子指标[白细胞介素6（IL-6）、肿瘤坏死因子α（TNF-α）]的变化情况，并评价2组患者 的临床疗效。【结果】（1）疗效方面，治疗3个月后，试验组的总有效率为94.55%（52/55），对照组为74.55%（41/55），组间比 较（χ2 检验），试验组的疗效明显优于对照组（P < 0.01）。（2）中医证候积分方面，治疗后，2组患者的腰膝酸软、畏寒肢冷、神 疲倦怠、夜尿频多等中医证候积分均较治疗前降低（P < 0.05），且试验组的降低幅度均明显优于对照组（P < 0.01）。（3）BMD 和疼痛VAS评分方面，治疗后，2组患者的BMD均较治疗前升高（P < 0.05），疼痛VAS评分均较治疗前降低（P < 0.05），且试 验组对BMD的升高幅度及对疼痛VAS评分的降低幅度均明显优于对照组（P < 0.01）。（4）骨代谢指标方面，治疗后，2组患者 的血清 β-CTX、PINP水平均较治疗前降低（P < 0.05），血清 BGP水平均较治疗前升高（P < 0.05），且试验组对血清 β-CTX、 PINP水平的降低幅度及对血清BGP水平的升高幅度均明显优于对照组（P < 0.01）。（5）血清炎症因子方面，治疗后，2组患者 的血清IL-6、TNF-α水平均较治疗前降低（P < 0.05），且试验组的降低幅度均明显优于对照组（P < 0.01）。【结论】 温阳益气法 中药联合阿仑膦酸钠维D3治疗老年OP脾肾阳虚证患者疗效显著，可有效缓解腰腿疼痛等症状，改善骨代谢，提高骨密度， 减轻炎症反应。

Objective To investigate the therapeutic efficacy of Wenyang Yiqi Therapy，the method of warming yang and replenishing qi in traditional Chinese medicine（TCM），combined with Alendronate Sodium Vitamin D3 in the treatment of elderly patients with osteoporosis（OP）of the spleen-kidney yang deficiency syndrome，and to observe its effect on bone metabolism and serum inflammatory factors. Methods A total of 110 cases of elderly patients with OP of spleen-kidney yang deficiency syndrome who admitted to the Department of Orthopedics and Traumatology of Traditional Chinese Medicine of Wuxi Ninth People 􀆳s Hospital from October 2021 to October 2023 were randomly divided into a trial group and a control group，with 55 patients in each group. The two groups were treated with Alendronate Sodium Vitamin D3，and additionally the trial group was treated with Wenyang Yiqi Therapy by using Chinese herbal medicines of Epimedii Folium，Astragali Radix，Ostreae Concha，Angelicae Sinensis Radix，Cyathulae Radix，Psoraleae Fructus，Taxilli Herba，etc. The course of treatment for the two groups covered three months. Before and after treatment，the two groups were observed in the changes of traditional Chinese medicine（TCM）syndrome scores，bone mineral density（BMD），Visual Analogue Scale（VAS）score of pain ，bone metabolism indicators of β-C-terminal telopeptide of type 1 collagen（β-CTX），total procollagen type 1 N-terminal propeptide（PINP）and bone gla-protein（BGP），and serum inflammatory factor indicators of interleukin 6（IL-6）and tumor necrosis factor α（TNF - α）]. After treatment， the clinical efficacy of the two groups of patients was evaluated. Results（1）After three months of treatment，the total effective rate of the trial group was 94.55%（52 / 55）and that of the control group was 74.55%（41 / 55），and the intergroup comparison （tested by chi-square test）showed that the efficacy of the trial group was significantly superior to that of the control group（P < 0.01）.（2）After treatment，the scores of TCM symptoms of soreness and weakness in the waist and knee，aversion of cold with cold limbs，fatigue and tiredness，and nocturnal frequent polyuria in the two groups were decreased compared with those before treatment （P < 0.05）， and the decrease in the trial group was significantly superior to that in the control group（P < 0.01）.（3）After treatment，the BMD of patients in the two groups were increased（P < 0.05）while the pain VAS scores were decreased compared with those before treatment （P < 0.05），and the increase in BMD and the decrease in pain VAS score of the trial group were significantly superior to that of the control group（P < 0.01）.（4）After treatment， the serum levels of bone metabolism indicators of β-CTX and PINP in the two groups were decreased compared with those before treatment（P < 0.05）， and the serum BGP level was increased compared with that before treatment（P < 0.05）. And the decrease of the serum β-CTX and PINP levels as well as the increase of the serum BGP levels in the trial group were significantly superior to that in the control group（P < 0.01）.（5）After treatment，the serum levels of inflammatory factors of IL-6 and TNF-αof patients in the two groups were decreased compared with those before treatment（P < 0.05）， and the decrease in the trial group was significantly superior to that in the control group（P < 0.01）. Conclusion Wenyang Yiqi Therapy combined with Alendronate Sodium Vitamin D3 exerts certain efficacy in the treatment of elderly patients with OP of spleen-kidney yang deficiency syndrome. The combined therapy is effective on alleviating the symptoms such as soreness in the waist and legs，improving bone metabolism，increasing BMD， and inhibiting the inflammatory responses，which will provide evidence for the clinical treatment.

R274.9

国家自然科学基金资助项目（编号：82004433）；无锡市中医药管理局中医药科技项目（编号：ZYKJ201911）