海南医科大学学报

目的:运用系统评价及Meta分析的方法评估中药复方治疗老年性骨质疏松症的疗效并对其用药进行规律性分析。方法:电子检索CNKI、Wangfang Data、VIP、CBM、PubMed、Embase、Cochrane Library等数据库,纳入以中药复方为干预措施治疗老年性骨质疏松症的临床随机对照试验(RCT)为研究对象,检索时间为数据库建立至2019年10月,由2名研究者独立根据纳排标准筛选文献、提取资料并采用Cochrane 5.1.0偏倚风险评估工具对纳入研究质量进行评价后采RevMan5.3软件进行数据分析。结果:共纳入19篇RCT文献,实验组均采用中药复方治疗,共987例;对照组采用钙剂或非钙剂治疗,共844例;Meta分析显示:实验组患者总有效率(V1.30,95%CI:1.19～1.43,P<0.05)、腰椎骨密度(MD=0.02,95%CI:0.01～0.04,P<0.05)、股骨颈骨密度(MD=0.01,95%CI:0.00～0.02,P<0.05)、VAS评分(MD=-1.04,95%CI:-1.67～0.40,P<0.05)、BMC值(MD=0.06,95%CI:0.01～0.11,P=0.03)、桡骨骨密度(MD=0.04,95%CI:0.03～0.05,P<0.05)、中医证候积分(MD=-6.76,95%CI:-7.94～-5.59,P<0.05)、中医证候疗效率(V1.49,95%CI:1.28～1.73,P<0.05)均具有统计学意义;两组患者ALP(MD=4.72,95%CI:-6～15.44,P=0.39)、雌二醇(MD=10.45,95%CI:-1.75～22.64,P=0.09)、根骨指数(MD=0.01,95%CI:-0.17～0.18,P=0.95)、其他骨密度(MD=0.11,95%CI:-0.01～0.22,P=0.06)、尿钙/尿肌酐(MD=-0.09,95%CI:-0.24～0.06,P=0.24)、血钙(MD=-0.01,95%CI:-0.11～0.09,P=0.83)、血磷(MD=0.03,95%CI:-0.01～0.07,P=0.09)相比较,差异均无统计学意义。所用中药复方中以黄芪为主的补益药频次最高。结论:采用中药复方治疗老年性骨质疏松症有一定疗效,且以补益药为主。

Objective:To evaluate the effectiveness of TCM compound in the treatment of senile osteoporosis and to analyze the regularity of its medication through systematic evaluation and Meta-analysis.Methods:Electronic retrieval of CNKI,Wangfang Data,VIP,CBM,PubMed,Embase,Cochrane Library and other databases were conducted to include the clinical randomized controlled trial(RCT)of TCM compound as intervention measures for the treatment of senile osteoporosis as the study object.The retrieval time was set up until October 2019.The two researchers independently screened the literature according to inclusion criteria,extracted the data,and evaluated the quality of the included studies using Cochrane 5.1.0 bias risk assessment tool,and then used RevMan5.3 software for data analysis.Results:a total of 19 RCT literature were included in the experimental group.In the control group,844 patients were treated with calcium or non-calcium.Meta-analysis showed that total effective rate(V1.30,95% CI:1.19-1.43,P<0.05),lumbar vertebral bone density(MD=0.02,95% CI:0.01-0.04,P<0.05),femoral neck bone density(MD=0.01,95%CI:0.00-0.02,P<0.05),VAS score(MD=-1.04,95%CI:-1.67-0.40,P<0.05),BMC value(MD=0.06,95% CI:0.01-0.11,P=0.03),radial bone density(MD=0.04,95% CI:0.03-0.05,P<0.05),TCM syndrome score(MD=-6.76,95%CI:-7.94--5.59,P<0.05),and TCM syndrome efficacy rate(V1.49,95% CI:1.28-1.73,P<0.05)were all statistically significant.ALP(MD=4.72,95%CI:-6-15.44,P=0.39),estradiol(MD=10.45,95%CI:-1.75-22.64,P=0.09),root bone index(MD=0.01,95%CI:-0.17-0.18,P=0.95),other bone mineral density(MD=0.11,95%CI:-0.01-0.22,P=0.06),urinary calcium/urinary creatinine(MD=-0.09,95% CI:There was no significant difference in serum calcium(MD=-0.01,95% CI:-0.11-0.09,P=0.83),serum phosphorus(MD=0.03,95% CI:-0.01-0.07,P=0.09).Among the Chinese herbal compounds used,astragalus is the most frequently used tonic.Conclusion:traditional Chinese medicine compound is effective in treating senile osteoporosis,and it is mainly used as tonic.