目的 探讨骨疏康颗粒联合盐酸雷洛昔芬片治疗绝经后骨质疏松症的临床疗效。方法 选取2021年1月—2022年12月在漯河市郾城区中医院就诊的120例骨质疏松症患者，按照随机数字表法将120例患者分为对照组和治疗组，每组各60例。对照组患者口服盐酸雷洛昔芬片，1片/次，1次/d。治疗组患者在对照组治疗的基础上餐后温水冲服骨疏康颗粒，1袋/次，3次/d。两组患者连续治疗3个月。观察两组的临床疗效，比较两组自觉疼痛程度、股骨近端、桡尺骨的骨密度和血清骨钙素（BGP）、Ⅰ型胶原C末端肽（CTX-1）、Ⅰ型前胶原氨基末端肽（PINP）、转化生长因子-β₁（TGF-β₁）、白细胞介素-6（IL-6）、胰岛素样生长因子1（IGF-1）水平。结果 治疗后，治疗组患者的总有效率95.00%比对照组的83.33%更高（P＜0.05）。治疗后，两组数字疼痛强度量表（NRS）评分明显降低（P＜0.05），且治疗组患者NRS评分较对照组更低（P＜0.05）。治疗后，治疗组股骨近端、桡尺骨的骨密度明显高于治疗前（P＜0.05），且治疗组股骨近端、桡尺骨的骨密度明显高于对照组（P＜0.05）。治疗后，两组的血清BGP、CTX-1水平低于治疗前，血清PINP水平高于治疗前（P＜0.05）；治疗组的血清BGP、CTX-1水平低于对照组，血清PINP水平高于对照组（P＜0.05）。治疗后，两组的血清TGF-β₁、IL-6水平低于治疗前，血清IGF-1水平高于治疗前（P＜0.05）；治疗后，治疗组的血清TGF-β₁、IL-6水平低于对照组，血清IGF-1水平高于对照组，差异有统计学意义（P＜0.05）。结论 骨疏康颗粒联合盐酸雷洛昔芬片可提高骨质疏松症的疗效，有助于降低患者疼痛程度，提高骨密度，改善骨代谢水平，且安全性良好。

Objective To investigate the clinical effect of Gushukang Granules combined with Raloxifene Hydrochloride Tablets in treatment of postmenopausal osteoporosis. Methods Patients (120 cases) with postmenopausal osteoporosis in Luohe Yancheng District Hospital of Traditional Chinese Medicine from January 2021 to December 2022 were randomly divided into control and treatment groups, and each group had 60 cases. Patients in the control group were po administered with Raloxifene Hydrochloride Tablets, 1 tablet/time, once daily. Patients in the treatment group were po administered with Gushukang Granules after meals on the basis of the control group, 1 bag/time, three times daily. Patients in two groups were treated for 3 months. After treatment, the clinical efficacies were evaluated, and the perceived pain level, the bone density of proximal femur and radioulna, and the serum levels of BGP, CTX-1, PINP, TGF-β₁, IL-6, and IGF-1 in two groups were compared. Results After treatment, the total effective rate of 95.00% in the treatment group was higher than 83.33% in the control group (P <0.05). After treatment, the NRS scores of two groups were significantly decreased (P <0.05), and the NRS scores of the treatment group were lower than those of the control group (P <0.05). After treatment, the bone density of the proximal femur and radioulna in the treatment group was significantly higher than before treatment (P < 0.05), and the bone density of the proximal femur and radioulna in the treatment group was significantly higher than that in the control group (P < 0.05). After treatment, the serum levels of BGP and CTX-1 in two groups were lower than before treatment, but the serum levels of PINP were higher than before treatment (P < 0.05). The serum levels of BGP and CTX-1 in the treatment group were lower than those in the control group, but the serum levels of PINP were higher than those in the control group (P < 0.05). After treatment, the serum levels of TGF-β₁ and IL-6 in two groups were lower than before treatment, bute the serum levels of IGF-1 were higher than before treatment (P < 0.05). After treatment, the serum levels of TGF-β₁ and IL-6 in the treatment group were lower than those in the control group, but the serum levels of IGF-1 were higher than those in the control group, with a statistically significant difference (P < 0.05). Conclusion Gushukang Granules combined with Raloxifene Hydrochloride Tablets can improve the efficacy of postmenopausal osteoporosis, help to reduce the pain degree of patients, increase bone density, improve bone metabolism level, with good safety.

R984

河南省医学科技攻关计划项目（LHGJ20210965）