复方骨肽注射液联合唑来膦酸治疗胸腰椎骨质疏松性骨折的临床研究

Clinical study on Compound Ossotide Injection combined with zoledronic acid in treatment of osteoporotic fracture of thoracolumbar vertebra

目的探讨复方骨肽注射液联合唑来膦酸治疗胸腰椎骨质疏松性骨折的临床效果。方法选取林州市人民医院2015年5月—2017年10月收治的胸腰椎骨质疏松性骨折患者152例,随机分成对照组(76例)与治疗组(76例)。对照组静脉滴注唑来膦酸注射液,5 mg加入生理盐水100 m L,1次/3周,连续治疗4次。治疗组在对照组基础上静脉滴注复方骨肽注射液,10 m L加入生理盐水250 m L,1次/d,连用2周,停药1周为1疗程,共治疗4个疗程。评价两组患者临床疗效,同时比较治疗前后两组患者疼痛视觉模拟评分法(VAS)、骨密度和骨代谢指标。结果治疗后,对照组和治疗组临床总有效率分别为81.58%、93.42%,两组比较差异有统计学意义(P<0.05)。治疗1、3个月后,两组患者VAS评分均显著下降(P<0.05);且治疗后治疗组患者VAS评分明显低于同期对照组患者(P<0.05)。治疗1、3个月后,治疗组骨密度比治疗前明显增加(P<0.05);治疗3个月后,对照组骨密度明显增加(P<0.05);治疗3个月后,治疗组患者骨密度均明显高于同期对照组(P<0.05)。治疗后,两组血清骨钙素(BGP)、骨碱性磷酸酶(BALP)水平较治疗前均明显上升(P<0.05);且治疗组比对照组上升更显著(P<0.05)。结论复方骨肽注射液联合唑来膦酸治疗胸腰椎骨质疏松性骨折可有效缓解患者的疼痛程度,提高骨密度,改善骨代谢。

Objective To investigate the clinical effect of Compound Ossotide Injection combined with zoledronic acid in treatment of osteoporotic fracture of thoracolumbar vertebra. Methods Patients（152 cases） with osteoporotic fracture of thoracolumbar vertebra in Linzhou People＇s Hospital from May 2015 to October 2017 were randomly divided into control（76 cases） and treatment（76 cases） groups. Patients in the control group were iv administered with Zoledronic Acid Injection, 5 mg added into normal saline 100 m L, once every 3 weeks. Patients in the treatment group were iv administered with Compound Ossotide Injection on the basis of the control group, 10 m L added into normal saline 250 m L, once daily, Continuous use for 2 weeks and 1 week of drug withdrawal was as 1 course of treatment. Patients in two groups were treated for 4 treatment courses. After treatment, the clinical efficacy was evaluated, and the VAS scores, the bone density, and the bone metabolism indicators in two groups before and after treatment were compared. Results After treatment, the clinical efficacy in the control and treatment groups were 81.58% and 93.42%, respectively, and there were differences between two groups（P〈0.05）. After treatment for 1 and 3 months, the VAS scores in two groups were significantly decreased（P〈0.05）, and the VAS scores in the treatment group after treatment were significantly lower than that in the control group over the same period（P〈0.05）. After treatment for 1 and 3 months, the bone density in the treatment group was significantly increased（P〈0.05）. After treatment for 3 months, the bone density in the control group was significantly increased（P〈0.05）. After treatment for 3 months, the bone density in the treatment group was significantly higher than that in the control group over the same period（P〈0.05）. After treatment, the serum BGP and BALP levels in two groups were significantly increased（P〈0.05）, and the bone metabolism indicators in the treatment group after treatment were significantly higher than those in the control group（P〈0.05）. Conclusion Compound Ossotide Injection combined with zoledronic acid in treatment of osteoporotic fracture of thoracolumbar vertebra can effectively relieve the pain, increase the bone mineral density and ameliorate bone metabolism.