目的 探讨壮骨止痛胶囊联合特立帕肽治疗绝经后骨质疏松症的临床疗效。方法 选取2020年1月—2021年10月平煤神马医疗集团总医院收治的126例绝经后骨质疏松症患者，采用随机数字表法将所有患者分为对照组和治疗组，每组各63例。对照组皮下注射特立帕肽注射液，20 μg/次，1次/d，注射部位选择下腹部或大腿。治疗组在对照组基础上口服壮骨止痛胶囊，4粒/次，3次/d。两组疗程均为6个月。观察两组临床疗效；并比较治疗前后两组主要部位骨密度（BMD）值，相关症状评分，原发性骨质疏松症患者生活质量量表（OQOLS）总分及血清骨转换标志物[Ⅰ型前胶原N-端前肽（PINP）、Ⅰ型胶原交联C-末端肽β-降解产物（β-CTX）]和白细胞介素（IL）-33、IL-17、胰岛素样生长因子-1（IGF-1）水平。结果 治疗后，治疗组总有效率为92.1%，显著高于对照组的79.4%（P<0.05）。治疗后，两组腰椎L_1～4、髋部股骨颈、全髋BMD值均显著增加（P<0.05），且治疗后治疗组主要部位BMD值增加更显著（P<0.05）。治疗后，两组腰背疼痛、下肢抽筋、腰膝酸软、步履艰难、持重困难评分均显著降低，OQOLS总分则均显著升高（P<0.05）；且均以治疗组改善更显著（P<0.05）。治疗后，两组血清PINP、β-CTX水平比治疗前均显著上升（P<0.05）；且治疗后，治疗组对血清PINP、β-CTX水平的升高作用较对照组更显著（P<0.05）。治疗后，两组血清IL-33和IGF-1水平均显著上升，血清IL-17水均显著下降（P<0.05）；且治疗组改善更显著（P<0.05）。结论 绝经后骨质疏松症应用壮骨止痛胶囊联合特立帕肽治疗的总体疗效确切，能安全有效地增加患者骨强度，减轻腰背疼痛等症状，提高生活质量，改善体内骨代谢活动，并可进一步上调血中IL-33、IGF-1及下调血中IL-17水平。

Objective To investigate the clinical efficacy of Zhuanggu Zhitong Capsules combined with teriparatide in treatment of postmenopausal osteoporosis. Methods A total of 126 patients with postmenopausal osteoporosis admitted to General Hospital of Pingmei Shenma Group from January 2020 to October 2021 were selected. All patients were divided into control group and treatment group by random number table method, with 63 cases in each group. Patients in the control group were sc administered with Teriparatide Injection, 20 μg/time, once daily, the injection site was chosen as the lower abdomen or thigh. Patients in the treatment group were po administered with Zhuanggu Zhitong Capsules on the basis of the control group, 4 grains/time, three times daily. Patients in two groups were treated for 6 months. After treatment, the clinical efficacy was evaluated. The bone mineral density (BMD) values of the main parts, the related symptom scores, the total score of the quality of life scale (OQOLS), and the serum bone turnover markers[Type I procollagen N-terminal propeptide (PINP), type I collagen cross-linked C-terminal peptide β-degradation product (β-CTX)] and interleukin (IL)-33, IL-17, insulin-like growth factor-1 (IGF-1) level in two groups were compared. Results After treatment, the total effective rate of the treatment group was 92.1%, which was significantly higher than that of the control group (79.4%, P < 0.05). After treatment, BMD values of lumbar L_1-4, hip femoral neck and whole hip were significantly increased in the two groups (P < 0.05), and the BMD values of main parts in the treatment group were increased more significantly after treatment (P < 0.05).After treatment, the scores of low back pain, lower extremity cramps, low back and knee tenderness, difficult walking and difficulty in weight holding were significantly decreased, and the total score of OQOLS was significantly increased in the two groups (P < 0.05). The improvement was more significant in the treatment group (P < 0.05). After treatment, the serum PINP and β-CTX levels of the two groups were significantly increased compared with those before treatment (P < 0.05). After treatment, the increase of serum PINP and β-CTX levels in the treatment group was more significant than that in the control group (P < 0.05). After treatment, the serum levels of IL-33 and IGF-1 in the two groups were significantly increased, and the serum IL-17 water was significantly decreased (P < 0.05). The improvement was more significant in the treatment group (P < 0.05). Conclusion Zhuanggu Zhitong Capsules combined with teriparatide has a definite overall curative effect in the treatment of postmenopausal osteoporosis. It can safely and effectively increase the bone strength of patients, relieve symptoms such as low back pain, improve the life quality, and improve the bone metabolic activity in the body. It can further up-regulate the levels of IL-33 and IGF-1 in blood and down-regulate the levels of IL-17 in blood.

R982

河南省高等学校重点科研项目（21B320035）