【目的】 分析自拟补肾潜阳汤联合阿仑膦酸钠维D3治疗骨质疏松症（osteoporosis，OP）的疗效及其对骨代谢和氧化三甲 胺（TMAO）-核因子 κB（NF-κB）/活化 T细胞核因子 c1（NFATc1）通路的影响。【方法】 将 2021年 1月至 2023年 1月在台州市中 西医结合医院就诊的102例脾肾阳虚型OP患者按随机数字表法随机分为观察组和西药组，每组各51例。西药组给予阿仑膦 酸钠维 D3治疗，观察组在西药组的基础上给予自拟补肾潜阳汤治疗，疗程为 12周。观察 2组患者治疗前后中医证候积分、 Oswestry功能障碍指数（ODI）评分、疼痛程度视觉模拟量表（VAS）评分、骨代谢指标及TMAO-NF-κB/NFATc1通路相关因子 水平的变化情况，评价 2 组患者的临床疗效和用药安全性。【结果】（1）治疗 12 周后，观察组的总有效率为 96.08%（49/51）， 西药组为 78.43%（40/51），组间比较（χ2检验），观察组的疗效明显优于西药组（P < 0.01）。（2）治疗后，2组患者的腰背冷痛、 酸软乏力、少气懒言、头昏目眩等中医证候积分均较治疗前降低（P < 0.05），且观察组的降低幅度均明显优于西药组（P < 0.01）。（3）治疗后，2组患者的ODI评分和疼痛程度VAS评分均较治疗前降低（P < 0.05），且观察组的降低幅度均明显优于西 药组（P < 0.01）。（4）治疗后，2组患者的血清骨钙素（BGP）水平均较治疗前升高（P < 0.05），血清总Ⅰ型原胶原氨基端延长肽 （PINP）、β胶原降解产物（β-CTX）水平均较治疗前降低（P < 0.05），且观察组对血清BGP水平的升高幅度及对血清PINP、β-CTX 水平的降低幅度均明显优于西药组（P < 0.01）。（5）治疗后，2 组患者的血清 TMAO、NF-κB、NFATc1 水平均较治疗前降低 （P < 0.05），且观察组的降低幅度均明显优于西药组（P < 0.01）。（6）观察组的不良反应总发生率为 5.88%（3/51），西药组为 9.80%（5/51），组间比较，差异无统计学意义（P > 0.05）。【结论】 自拟补肾潜阳汤联合阿仑膦酸钠维D3治疗脾肾阳虚型OP患 者疗效确切，可有效缓解腰背冷痛等症状，减轻功能障碍程度，改善骨代谢，抑制血清 TMAO、NF-κB、NFATc1高表达， 且未引发严重不良反应，具有较高的安全性。

Objective To analyze the efficacy of self-formulated Bushen Qianyang Decoction combined with alendronate sodium and vitamin D3 in treating osteoporosis（OP）and to observe its effect on bone metabolism and trimethylamine oxide（TMAO）- nuclear factor κB（NF - κB）/activated T nuclear factor c1（NFATc1）pathway. Methods A total of 102 cases of patients with OP of spleen and kidney yang deficiency type who admitted to Taizhou Hospital of Integrated Traditional Chinese and Western Medicine from January 2021 to January 2023 were randomly divided into an observation group and a western medicine group according to the random number table method，51 cases in each group. The western medicine group was treated with alendronate sodium and vitamin D， and the observation group was treated with self-formulated Bushen Qianyang Decoction on the basis of treatment for the western medicine group，and the course of treatment covered for 12 weeks. The changes of traditional Chinese medicine（TCM）syndrome score， Oswestry Disability Index（ODI）score， pain visual analogue scale（VAS） score，bone metabolism indicators，and levels of TMAO-NF-κB/NFATc1 pathway related factors before and after treatment in the two groups were observed. Moreover，the clinical efficacy and medication safety of the two groups were evaluated. Results（1）After 12 weeks of treatment， the total effective rate of the observation group was 96.08%（49/51），and that of the western medicine group was 78.43%（40/51）. The intergroup comparison（tested by chi-square test）showed that the efficacy of the observation group was significantly superior to that of the western medicine group（P < 0.01）.（2）After treatment，the two groups presented the decreased scores of TCM symptoms such as cold pain in the lower back，soreness and fatigue，shortness of breath and reluctance to talk，vertigo and dizziness when compared with those before treatment（P < 0.05），and the decrease of TCM syndrome scores in the observation group was significantly superior to that in the western medicine group（P < 0.01）.（3）After treatment， the ODI scores and pain VAS scores of patients in the two groups were decreased when compared with those before treatment（P < 0.05），and the decrease in the observation group was significantly superior to that in the western medicine group（P < 0.01）.（4）After treatment，the serum osteocalcium（BGP）level in the two groups of patients was increased when compared with that before treatment（P < 0.05），and the serum total procollagen type 1 intact N（amino）-terminal propeptide（PINP）and β-collagen degradation product（β-CTX）levels were decreased when compared with those before treatment（P < 0.05），and the increase of the serum BGP level and the decrease of the serum PINP and β-CTX levels in the observation group were significantly superior to those in the western medicine group（P < 0.01）.（5）After treatment，the levels of serum TMAO，NF-κB，and NFATc1 in the two groups of patients were all decreased when compared with those before treatment（P < 0.05），and the decrease of the above indicators in the observation group was significantly superior to that in the western medicine group（P < 0.01）. （6）The total incidence of adverse reactions in the observation group was 5.88%（3/51）and that in the western medicine group was 9.80%（5/51），and the intergroup comparison showed that the difference was not statistically significant between the two groups（P > 0.05）. Conclusion Self-formulated Bushen Qianyang Decoction combined with alendronate sodium and vitamin D3 exerts certain efficacy in treating OP patients with spleen and kidney yang deficiency type，which can effectively alleviate the symptoms such as cold pain in the lower back，alleviate the degree of dysfunction，improve bone metabolism，and inhibit the high-expressed TMAO，NF-κB，and NFATc1 in the serum. Moreover，the combined therapy does not cause serious adverse reactions，with high safety.

R274.9

国家自然科学基金项目（编号：82004433）；浙江省温岭市科技计划项目（编号：2019S0180036）