目的 探讨接骨七厘片联合注射用复方骨肽治疗骨质疏松性骨折的临床疗效。方法 选取2020年1月—2021年12月北京市和平里医院收治的108例骨质疏松性骨折患者，按随机数字表法平均分为对照组和治疗组，每组各54例。对照组静脉滴注注射用复方骨肽，150 mg加入生理盐水250 mL中均匀混合后给药，1次/d，连用2周后停用1周，即以3周为1个疗程，连续治疗4个疗程。治疗组在对照组基础上口服接骨七厘片，5片/次，2次/d，温开水送服，连用12周。评价两组疗效，观察两组主要症状消失时间和骨折临床愈合时间，并比较治疗后两组骨痂骨密度（BMD）值。同时比较治疗前后两组血清骨代谢标志物[I型原胶原N-端前肽（P1NP）、碱性磷酸酶（ALP）、I型胶原交联C末端肽（S-CTX）]以及白细胞介素（IL）-6、核因子κB受体活化因子配基（RANKL）、转化生长因子β1（TGF-β1）和骨硬化蛋白（SOST）水平。结果 治疗组总有效率为94.4%，显著高于对照组81.5%（P<0.05）。治疗后，治疗组骨折部位疼痛、压痛、肿胀的消失时间和骨折临床愈合时间均显著短于对照组（P<0.05）。治疗8、12周后，两组骨痂BMD值均高于治疗4周，治疗组治疗4、8、12周时骨痂BMD值均显著高于对照组同期（P<0.05）。治疗后，两组P1NP、ALP、S-CTX水平均较治疗前显著降低（P<0.05）；且均以治疗组的下降更显著（P<0.05）。与治疗前相比，治疗后两组血清IL-6、RANKL和SOST水平均显著下降，血清TGF-β1水平均显著升高（P<0.05）；且均以治疗组的改善更显著（P<0.05）。结论 接骨七厘片联合注射用复方骨肽治疗骨质疏松性骨折具有确切的临床疗效，能较为安全地加速患者症状恢复，增加BMD，调控骨代谢平衡，促进骨折临床愈合。

Objective To explore the clinical effect of Jiegu Qili Tablets combined with Compound Ossotide for injection in treatment of osteoporotic fracture. Methods A total of 108 patients with osteoporotic fracture admitted to Beijing Heping Li Hospital from January 2020 to December 2021 were selected and evenly divided into control group and treatment group according to the random number table method, with 54 cases in each group. Patients in the control group were iv administered with Compound Ossotide for injection, 150 mg was evenly mixed into normal saline 250 mL and then administered, once daily. After 2 weeks of continuous use, the drug was stopped for 1 week, 3 weeks was as a course of treatment, and they were treated for 4 courses. Patients in the treatment group were po administered with Jiegu Qili Tablets on the basis of the control group, 5 tablets/time, twice daily, for 12 weeks. After treatment, the clinical efficacy was evaluated, the disappearance time of main symptoms and clinical healing time of fracture were observed, and the bone density (BMD) values of the two groups were compared after treatment. At the same time, the serum markers of bone metabolism[type I procollagen N-terminal propeptide (P1NP), alkaline phosphatase (ALP), type I collagen cross-linked C-terminal peptide (S-CTX)], interleukin (IL)-6, nuclear factor κB receptor activator ligand (RANKL), transforming growth factor β1(TGF-β1) and osteoprotegerin (OPN) were compared before and after treatment. Results The total effective rate of the treatment group was 94.4%, significantly higher than that of the control group (81.5%). After treatment, the disappearance time of fracture pain, tenderness and swelling and the clinical healing time of fracture in the treatment group were significantly shorter than those in the control group (P < 0.05). After treatment, the callus BMD values of the two groups at 8 and 12 weeks were higher than those at 4 weeks, and the callus BMD values of the treatment group at 4, 8, and 12 weeks were significantly higher than those of the control group at the same period (P < 0.05). After treatment, the levels of P1NP, ALP, and S-CTX in two groups were significantly decreased compared with those before treatment (P < 0.05). The decrease was more significant in the treatment group (P < 0.05). Compared with before treatment, the serum levels of IL-6, RANKL, and SOST were significantly decreased, and the serum level of TGF-β1 was significantly increased in the two groups after treatment (P < 0.05). The improvement in treatment group was more significant (P < 0.05). Conclusion Jiegu Qili Tablets combined with Compound Ossotide for injection has definite clinical effect in treatment of osteoporotic fracture, and can safely accelerate the recovery of symptoms, increase BMD, which can regulate the balance of bone metabolism and promote the clinical healing of fracture.

R982

中日友好医院横向课题（2021-HX-19）