强骨胶囊治疗骨质疏松症有效性的系统评价和Meta分析

A Meta-analysis and systematic evaluation of the effectiveness of the Qianggu capsules in the treatment of osteoporosis

目的:对强骨胶囊治疗骨质疏松的有效性与安全性进行系统评价。方法:检索主要数据库中截至2022年4月1日的强骨胶囊治疗骨质疏松相关文献,筛选强骨胶囊治疗骨质疏松的随机对照试验,根据设定的纳入和排除标准再次进行文献筛选,提取所需资料。采用Cochrane风险偏倚评估工具评价纳入研究的随机对照试验质量,采用Rev Man5.4软件进行数据整合及Meta分析。结果:共纳入13项随机对照试验研究,总样本量855例,研究质量总体不高。Meta分析结果显示:(1)腰椎骨密度方面,单用强骨胶囊组较对照组骨密度值无显著改善(P6个月疗程=0.05,P3个疗程>0.05)。强骨胶囊加常规干预措施组较常规干预措施组骨密度有显著性改善(P伴有腰椎压缩性骨折<0.000 01,P无腰椎压缩性骨折=0.006);(2)股骨颈骨密度方面,单用强骨胶囊组较对照组中,当疗程为3个月时骨密度值无显著改善(P=0.08),疗程为6个月时骨密度值有显著的改善且差异有统计学意义(P=0.000 7)。强骨胶囊加常规干预措施组较对照组的骨密度有显著改善(P<0.000 01);(3)股骨粗隆骨密度方面,3项研究治疗后试验组股骨粗隆骨密度较对照组有显著性改善(P<0.01),1项研究治疗后试验组股骨粗隆骨密度较对照组无显著性改善(P>0.05);(4) Ward三角骨密度方面,单用强骨胶囊组较对照组骨密度值具有显著改善(P<0.000 01);(5)生化指标方面,强骨胶囊组较对照组能显著提高患者体内骨钙素浓度(P=0.000 2)、对血清碱性磷酸酶浓度具有提高的作用,但差异不具有统计学意义(P=0.33)、在血清钙浓度上单用强骨胶囊组较对照组无显著改变(P=0.22),但联合用药时能显著降低血清钙的浓度(P<0.000 01);(6)临床总有效率方面,试验组治骨质疏松的疗效优于对照组(单用强骨胶囊Vs.常规干预:RR=1.12,95%CI(1.06,1.18),P<0.000 01;强骨胶囊+常规干预Vs.常规干预:RR=1.16,95%CI(1.09,1.24),P<0.000 01)。(7)不良反应方面,所纳入的研究报道均未出现明显的不良反应。结论:基于现有数据分析,强骨胶囊单独使用或联合用药均能有效缓解骨质疏松症患者的临床症状。受限于本次研究纳入的研究质量及病例数量的局限性,研究所得结论尚需更多高质量的随机对照试验进一步验证。

Objective:To evaluate the effectiveness and safety of the Qianggu capsules(强骨胶囊)in the treatment of osteoporosis.Methods:Literature related to the treatment of osteoporosis with the Qianggu capsules was searched from main databases until 1 April 2022.Randomized controlled trials(RCTs)of the Qianggu capsules in the treatment of osteoporosis were screened,andOliteraturewas screened again according to the set inclusion and exclusion criteria to extract the required data.Cochrane risk bias assessment tool was used to evaluate the quality of RCTs in the included studies,and RevMan5.4 software was used for data integration and meta-analysis.Results:A total of 13 RCT studies were included,with a total sample size of 855 cases.The overall quality of the studies was not high.The results of the Meta-analysis showed that:①In terms of lumbar bone mineral density,the BMD in the Qianggu capsules group was not significantly improved compared with the control group(P6 months course=0.05,P3 months course>0.05).The BMD in the Qianggu capsules plus routine intervention group was significantly better than that of the routine intervention group(P with lumbar compression fracture<0.00001,P without lumbar compression fracture=0.006).②In terms of the bone mineral density of the femoral neck,compared with the control group,the BMD in the Qianggu capsules was not significantly improved after 3 months of treatment(P=0.08),but significantly improved after 6 months of treatment with a statistical significance difference(P=0.0007).Compared with the control group,the BMD in the Qianggu capsules plus routine intervention group was significantly improved(P<0.00001).③In terms of the bone mineral density of femur trochanter,the bone mineral density of femur trochanter in the experimental group was significantly improved after treatment in 3 studies compared with the control group(P<0.01),and the bone mineral density of femur trochanter in the experimental group was not significantly improved in 1 study compared with the control group(P>0.05).④In Ward triangle BMD,BMD in the Qianggu capsules group was significantly improved compared with the control group(P<0.00001).⑤In terms of biochemical indicators,the Qianggu capsules group than the control group can significantly improve the patient’s body osteocalcin concentration(P=0.0002),but the function of the concentration of serum alkaline phosphatase is raising with no statistically significant difference(P=0.33),on serum calcium concentration,with the Qianggu capsules group than the control group had no significant change(P=0.22),but the combination can significantly reduce the concentration of serum calcium(P<0.00001).⑥In terms of total clinical effective rate,the efficacy in the experimental group in treating osteoporosis was better than that in the control group(the Qianggu capsules alone Vs.routine intervention:RR=1.12,95%CI(1.06,1.18),P<0.00001.The Qianggu capsules puls routine intervention Vs.routine intervention:RR=1.16,95%CI(1.09,1.24),P<0.00001).⑦In terms of adverse reactions,no obvious adverse reactions were reported in the included studies.Conclusion:Based on the existing data analysis,the Qianggu capsules alone or in combination can effectively relieve the clinical symptoms of Osteoporosis patients.Due to the limitations in the study quality and the number of cases included in this study,the conclusions of this study need to be further verified by more high-quality randomized controlled trials.