目的 探討接骨七厘片聯(lián)合注射用復(fù)方骨肽治療骨質(zhì)疏松性骨折的臨床療效。方法 選取2020年1月—2021年12月北京市和平里醫(yī)院收治的108例骨質(zhì)疏松性骨折患者，按隨機(jī)數(shù)字表法平均分為對(duì)照組和治療組，每組各54例。對(duì)照組靜脈滴注注射用復(fù)方骨肽，150 mg加入生理鹽水250 mL中均勻混合后給藥，1次/d，連用2周后停用1周，即以3周為1個(gè)療程，連續(xù)治療4個(gè)療程。治療組在對(duì)照組基礎(chǔ)上口服接骨七厘片，5片/次，2次/d，溫開(kāi)水送服，連用12周。評(píng)價(jià)兩組療效，觀察兩組主要癥狀消失時(shí)間和骨折臨床愈合時(shí)間，并比較治療后兩組骨痂骨密度（BMD）值。同時(shí)比較治療前后兩組血清骨代謝標(biāo)志物[I型原膠原N-端前肽（P1NP）、堿性磷酸酶（ALP）、I型膠原交聯(lián)C末端肽（S-CTX）]以及白細(xì)胞介素（IL）-6、核因子κB受體活化因子配基（RANKL）、轉(zhuǎn)化生長(zhǎng)因子β1（TGF-β1）和骨硬化蛋白（SOST）水平。結(jié)果 治療組總有效率為94.4%，顯著高于對(duì)照組81.5%（P<0.05）。治療后，治療組骨折部位疼痛、壓痛、腫脹的消失時(shí)間和骨折臨床愈合時(shí)間均顯著短于對(duì)照組（P<0.05）。治療8、12周后，兩組骨痂BMD值均高于治療4周，治療組治療4、8、12周時(shí)骨痂BMD值均顯著高于對(duì)照組同期（P<0.05）。治療后，兩組P1NP、ALP、S-CTX水平均較治療前顯著降低（P<0.05）；且均以治療組的下降更顯著（P<0.05）。與治療前相比，治療后兩組血清IL-6、RANKL和SOST水平均顯著下降，血清TGF-β1水平均顯著升高（P<0.05）；且均以治療組的改善更顯著（P<0.05）。結(jié)論 接骨七厘片聯(lián)合注射用復(fù)方骨肽治療骨質(zhì)疏松性骨折具有確切的臨床療效，能較為安全地加速患者癥狀恢復(fù)，增加BMD，調(diào)控骨代謝平衡，促進(jìn)骨折臨床愈合。

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

中日友好醫(yī)院橫向課題（2021-HX-19）