应用金天格胶囊治疗骨质疏松症的Meta分析
Meta-analysis of the application of Jintiange capsule in the treatment of osteoporosis
  
DOI:10.3969/j.issn.1006-7108.2020.01.009
中文关键词:  金天格胶囊  人工虎骨  骨质疏松  骨密度  临床试验  Meta分析
英文关键词:Jintiange capsule  artificial tiger bone  osteoporosis  bone mineral density  clinical trial  meta-analysis
基金项目:中国博士后科学基金(2015M571245)
作者单位
俞桂松1 曾森炎1 董玉鹏1 季卫锋2* 马镇川2 1.浙江中医药大学浙江 杭州 310053 2.浙江省中医院浙江 杭州 310006 
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中文摘要:
      目的 系统评价金天格胶囊治疗骨质疏松症(osteoporosis,OP)的临床疗效。方法 检索建库至2018年9月的Cochrane图书馆、Springer Link、EMBASE、PubMed、中国生物医学文献数据库、万方数据库、中国知网数据库、维普中文期刊数据库,并手工检索相关期刊。收集金天格胶囊治疗OP的随机对照实验,筛选出合格的文章,采用Cochrane风险偏倚评估工具和Jadad量表评估纳入文献的研究质量。采用Cochrane协作网提供的RevMan 5.3软件进行Meta分析。结果 共检索出161篇文献,经筛选最终纳入15篇随机对照研究的文献,共涉及1957例患者,所纳入文献质量偏低,采用随机数字表进行分组的仅3篇文献,采用计算机随机进行分组的文献有1篇,1篇文献说明了安全性评价结果,纳入的所有文献均未说明随机分配方案的隐藏方法、病例脱落情况、也未交代是否采用盲法、样本量估算方法及随访情况,Jadad评分≤2分。纳入的15篇文献均进行了干预组与对照组间的临床疗效有效率的比较,各研究结果之间具有同质性(I2=0%,P=0.88)。治疗组的有效率高于对照组[Z=9.64,P<0.01;OR=4.61,95%CI(3.38,6.30)]。漏斗图表明试验研究散布在竖线的两边,分布比较均匀,未有发表偏倚。结论 金天格胶囊单独使用或联合其他疗法均能有效缓解OP患者的临床症状。因为本次研究纳入的研究质量及病例数量的局限性,上述结论尚需要更多高质量的随机对照实验进一步验证。
英文摘要:
      Objective To evaluate the clinical efficacy of Jintiange Capsule in the treatment of Osteoporosis (OP). Methods Cochrane Library, Springer Link, EMBASE, PubMed, China Biomedical Literature Database (CBM), Wanfang Database, China Knowledge Network Database (CNKI), and VIP Chinese Journal Database (VIP) were searched from the construction of the database to September 2018. Some related journals were manually retrieved. Randomized controlled trials concerning Jintiange capsule for the treatment of OP were collected. Qualified articles were screened and the quality of the included literature was assessed using the Cochrane Risk Bias Evaluation Tool and the Jadad Scale. Meta analysis was performed using RevMan 5.3 software provided by the Cochrane Collaboration. Results A total of 161 articles were retrieved, and 15 randomized controlled studies were included in the screening. A total of 1957 patients were involved. The quality of the included literatures was low. Only 3 papers were grouped by random number table using computer randomization. There was 1 paper grouped, and 1 document described the results of safety evaluation. All the literatures included did not explain the hidden methods of randomized allocation, case shedding, or whether blind method, sample size estimation method and follow-up were used. The Jadad score was ≤ 2 points. All the 15 literatures were compared with the clinical efficacy between the intervention group and the control group. The results were homogeneous (I2=0%,P=0.88). The effective rate in the treatment group was higher than that in the control group [Z=9.64, P<0.01; OR=4.61, 95% CI (3.38, 6.30)]. The funnel plot showed that the experimental studies were distributed on both sides of the vertical line, the distribution was relatively uniform, and there was no publication bias. Conclusion Jintiange capsule alone or in combination with other therapies can effectively alleviate the clinical symptoms of OP patients. Due to the limitations of the quality of the study and the number of cases included in this study, the above conclusions require further high-quality randomized controlled trials to further validate.
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