目的 探討淫羊藿總黃酮膠囊聯(lián)合阿侖膦酸鈉治療原發(fā)性骨質(zhì)疏松癥（腎陽虛證）的臨床療效。方法 選擇2023年8月—2023年12月在焦作市人民醫(yī)院和焦作市第二人民醫(yī)院就診的原發(fā)性骨質(zhì)疏松癥（腎陽虛證）患者140例，隨機分為對照組（70例）和治療組（70例）。對照組口服阿侖膦酸鈉片，1片/次，1次/d。在對照組基礎(chǔ)上，治療組患者口服淫羊藿總黃酮膠囊，2粒/次，3次/d。兩組患者均治療6個月。觀察兩組患者臨床療效，比較治療前后兩組患者數(shù)字疼痛強度量表（NRS）評分，腰椎、股骨頸和橈尺骨骨密度，骨代謝指標(biāo)骨鈣素（OC）、Ⅰ型原膠原C-端前肽（PICP）、骨源性堿性磷酸酶（BALP），骨吸收標(biāo)志物包括I型膠原交聯(lián)C-末端肽（CTX）和抗酒石酸酸性磷酸酶（TRACP）水平，及炎癥因子腫瘤壞死因子-α（TNF-α）、白細(xì)胞介素-17（IL-17）和生長分化因子15（GDF15）水平。結(jié)果 治療后，對照組和治療組的總有效率分別為80.00%、92.86%，兩組比較差異具有統(tǒng)計學(xué)意義（P＜0.05）。治療后，兩組患者NRS評分比治療前明顯下降（P＜0.05），且治療后治療組評分降低更顯著（P＜0.05）。治療后，兩組患者腰椎、股骨頸及尺橈骨骨密度及T值均顯著增加（P＜0.05），且治療組骨密度和T值相對于對照組增加更顯著（P＜0.05）。治療后，兩組OC、PICP和BALP水平較治療前顯著升高，而CTX和TRACP則顯著降低（P＜0.05），且治療組這些骨代謝指標(biāo)明顯好于對照組（P＜0.05）。治療后，兩組患者TNF-α、IL-17和GDF15水平均顯著降低（P＜0.05），且治療組患者TNF-α、IL-17和GDF15水平比對照組降低更為顯著（P＜0.05）。結(jié)論 淫羊藿總黃酮膠囊聯(lián)合阿侖膦酸鈉治療原發(fā)性骨質(zhì)疏松癥（腎陽虛證）具有顯著的療效，可能與改善骨代謝及抑制炎癥因子的表達(dá)有關(guān)。

Objective To investigate the clinical efficacy of Epimedium Total Flavonoids Capsules combined with alendronate sodium in treatment of primary osteoporosis (kidney-yang deficiency syndrome). Methods Patients (140 cases) with primary osteoporosis (kidney-yang deficiency syndrome) in Jiaozuo People’s Hospital and Jiaozuo Second People’s Hospital from August 2023 to December 2023 were randomly divided into control (70 cases) and treatment (70 cases) group. Patients in the control group were po administered with Alendronate Sodium Tablets, 1 tablet/time, once daily. Patients in the treatment group were po administered with Epimedium Total Flavonoids Capsules, 2 grains/time, three times daily. Patients in two groups were treated for 6 months. After treatment, the clinical evaluations were evaluated, the NRS scores, bone mineral density of lumbar vertebra, femoral neck and radioulna, T scores of lumbar vertebra, femoral neck and radioulna, the levels of bone metabolism indexes OC, PICP, BALP, CTX and TRACP, and the levels of inflammatory factors TNF-a, IL-17 and GDF15 in two groups before and after treatment were compared. Results After treatment, the total effective rates in the control group and the treatment group were 80.00% and 92.86%, respectively, and the difference between the two groups was statistically significant (P < 0.05). After treatment, the NRS scores in two groups were significantly decreased compared with those before treatment (P < 0.05), and the scores in the treatment group were decreased more significantly (P < 0.05). After treatment, the bone mineral density and T value of the lumbar spine, femoral neck, ulna and radius were significantly increased in two groups (P < 0.05), and the bone mineral density and T value of the treatment group were increased more significantly compared with which in the control group (P < 0.05). After treatment, the levels of OC, PICP and BALP in two groups were significantly increased compared with those before treatment, while CTX and TRACP were significantly decreased (P < 0.05), and these bone metabolism indicators in the treatment group were significantly better than those in the control group (P < 0.05). After treatment, the levels of TNF-α, IL-17 and GDF15 in two groups were significantly reduced (P < 0.05), and the levels of TNF-α, IL-17 and GDF15 in the treatment group were more significantly reduced than those in the control group (P < 0.05). Conclusion Epimedium Total Flavonoids Capsules combined with alendronate sodium had a significant efficacy in treatment of primary osteoporosis (kidney-yang deficiency syndrome), which may be related to improving bone metabolism and inhibiting the expression of inflammatory factors.

R982

河南省醫(yī)學(xué)科技攻關(guān)計劃項目(LHGJ20210927,LHGJ20221011)