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[摘要]
目的 探讨丹杞颗粒联合唑来膦酸治疗骨质疏松症的有效性与安全性。方法 选取驻马店市中心医院于2016年7月—2017年7月收治的骨质疏松症患者118例,根据入院顺序分成对照组和治疗组,每组各59例。对照组患者静脉滴注唑来膦酸注射液,100 mL/次,1次/年;治疗组在对照组基础上口服丹杞颗粒,1袋/次,2次/d。两组患者均治疗12个月。观察两组患者临床疗效,同时比较治疗前后两组患者Oswestry功能障碍指数和SF-36评分及骨代谢指标水平和不良反应情况。结果 治疗后,对照组和治疗组临床有效率分别为84.75%和96.61%,两组比较差异具有统计学意义(P<0.05)。治疗后,两组患者Oswestry功能障碍指数显著降低(P<0.05),SF-36评分显著升高(P<0.05),且治疗组Oswestry功能障碍指数和SF-36评分情况明显优于对照组(P<0.05)。治疗后,两组患者血清骨源性碱性磷酸酶、β骨胶原交联和骨钙素N端中分子片断水平均显著降低(P<0.05),且治疗组这些骨代谢指标水平明显低于对照组(P<0.05)。治疗期间,对照组患者药物不良反应发生率为18.64%,明显高于治疗组的5.08%,两组比较差异具有统计学意义(P<0.05)。结论 丹杞颗粒联合唑来膦酸治疗骨质疏松症疗效显著,安全性高,具有一定的临床推广应用价值。
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[Abstract]
Objective To investigate the clinical efficacy and safety of Danqi Granules combined with zoledronic acid in treatment of senile osteoporosis. Methods Patients (118 cases) with osteoporosis in Zhumadian Central Hospital from July 2016 to July 2017 were divided into control and treatment groups according to the order of hospitalization, and each group had 59 cases. Patients in the control group were iv administered with Zoledronic Acid Injection, 100 mg/time, once a year. Patients in the treatment group were po administered with Danqi Granules on the basis of the control group, 1 bag/time, twice daily. Patients in two groups were treated for 12 months. After treatment, the clinical efficacy was evaluated, and the Oswestry dysfunction indexes, SF-36 scores, the levels of bone metabolic markers and adverse reactions in two groups before and after treatment were compared. Results After treatment, the clinical efficacy in the control and treatment groups was 84.75% and 96.61% respectively, and there were differences between two groups (P<0.05). After treatment, the Oswestry dysfunction indexes in two groups were significantly decreased (P<0.05), but SF-36 scores were significantly increased (P<0.05). After treatment, the Oswestry dysfunction indexes and SF-36 scores in the treatment group were significantly better than those in the control group (P<0.05). After treatment, the serum bone alkaline phosphatase, beta-collagen crosslinking and N-MID Osteocalcin levels in two groups were significantly decreased (P<0.05), and the levels of bone metabolic markers in the treatment group were significantly lower than those in the control group (P<0.05). During the treatment, the adverse reactions rate in the control group was 18.64%, which was significantly higher than 5.08% in the treatment group, with significant difference between two groups (P<0.05). Conclusion Danqi Granules combined with zoledronic acid has significant curative effect on senile osteoporosis with high safety, which has a certain clinical application value.
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