仙灵骨葆联合阿仑磷酸钠治疗原发性骨质疏松症的Meta分析

Meta-analysis of Xianling Gubao Combined with Alendronate in the Treatment of Primary Osteoporosis

目的:系统评价仙灵骨葆联合阿仑磷酸钠治疗原发性骨质疏松症的临床疗效、不良反应及骨代谢生化指标改善情况,从而为老年骨质疏松症的治疗提供参考策略。方法:计算机检索2014年1月-2019年5月中国知网(CNKI)、维普(VIP)、万方及中国生物医学文献数据库(SinoMed)中关于仙灵骨葆联合阿仑磷酸钠治疗原发性骨质疏松症的随机对照实验(RCT)。提取文献,质量评价后Excel整理归纳数据,采用Revman 5.3软件进行Meta分析。结果:共纳入符合条件的13个RCT样本。Revman 5.3软件分析显示,仙灵骨葆联合阿仑膦酸钠(实验组)治疗原发性骨质疏松症的效果明显优于单用阿仑膦酸钠(对照组)[OR=3.42,95%CI(2.52~4.64),P<0.01];两组不良反应结果差异无统计学意义[OR=0.44,95%CI(0.19~1.06),P>0.05];实验组骨密度改善较对照组明显[MD=0.07,95%CI(0.05~0.08),P<0.01]。实验组骨代谢生化指标改善情况明显优于对照组,分别为碱性磷酸酶较对照组降低[MD=-25.76,95%CI(-46.71^-4.80),P<0.05],血磷[MD=0.27,95%CI(0.16~0.38),P<0.01]及血钙[MD=0.33,95%CI(0.06~0.60),P<0.05]较对照组升高。结论:仙灵骨葆联合阿仑磷酸钠较单用阿仑磷酸钠治疗原发性骨质疏松症临床疗效显著,骨密度及骨代谢生化指标改善明显。因纳入的研究存在潜在偏倚,仍需要进一步高质量的RCT进行论证。

Objective To systematically evaluate the clinical efficacy, adverse reactions and improvement of biochemical markers of bone metabolism in the treatment of primary osteoporosis with Xianling Gubao combined with alendronate, so as to provide a reference strategy for the treatment of senile osteoporosis. Methods A randomized controlled trial(RCT) of Xianlinggubao combined with alendronate for the treatment of primary osteoporosis from January 2014 to May 2019 was searched in CNKI, VIP, Wanfang and SinoMed. After the quality evaluation, the data were collected by Excel, and Meta analysis was carried out by Revman 5.3 software. Results A total of 13 eligible RCTs were included. Revman 5.3 software analysis showed that Xianling Gubao combined with alendronate(experimental group) in the treatment of primary osteoporosis was significantly better than alendronate alone(control group) [OR=3.42,95% CI(2.52~4.64), P<0.01]. However, there was no statistical significance between the two groups in adverse reactions [OR=0.44,95% CI(0.19~1.06),P>0.05].The bone mineral density of the experimental group was significantly improved compared with the control group [MD=0.07,95% CI(0.05~0.08), P<0.01]. The improvement of biochemical indicators of bone metabolism in the experimental group was significantly better than that of the control group, including the decrease of alkaline phosphatase [MD=-25.76, 95% CI(-46.71^-4.80), P<0.05] and increase of blood phosphorus [MD=0.27, 95% CI(0.16~0.38), P<0.01] and serum calcium [MD=0.33, 95% CI(0.06~0.60), P<0.05]. Conclusion Compared with alendronate alone, Xianling Gubao combined with alendronate has a significant clinical effect in the treatment of primary osteoporosis, and the improvement of bone mineral density and biochemical indexes of bone metabolism is obvious. Due to the potential bias of the included studies, further high-quality RCTs are still needed to be demonstrated.