中成药治疗原发性骨质疏松症疗效的系统评价
A systematic review of the efficacy of Chinese patent drugs on primary osteoporosis
  
DOI:10.3969/j.issn.1006-7108.2019.12.027
中文关键词:  中成药  系统评价  原发性骨质疏松
英文关键词:Chinese patent drugs  systematic evaluation  primary osteoporosis
基金项目:国家自然科学基金项目(81473711,81102610);国家中医药行业科研专项(201507006-01)
作者单位
黄委委1 李哲1 郑旭耀1 杨锋2* 1.陕西中医药大学陕西 咸阳712046 2.陕西中医药大学附属医院陕西 咸阳712046 
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中文摘要:
      目的 系统评价中成药治疗原发性骨质疏松症的临床疗效。方法 通过计算机检索EMBASE、PubMed、CNKI、CBM、万方、维普等数据库,人工检索有关于中成药治疗原发性骨质疏松症的随机对照试验(RCTs),文献的纳入和排除以及资料提取均采用统一标准,并对纳入的文献进行质量评估。Meta分析软件运用RevMan5.3版本,对患者服药后整体疗效、腰椎和髋部骨密度(bone mineral density,BMD)、骨钙素(OC)、血钙、碱性磷酸酶、Ⅰ型胶原交联C-末端肽(β-CTX)、Ⅰ型原胶原N-端前肽(PINP)等骨代谢指标进行评价。其中髋部BMD包含Ward三角、股骨颈等部位。结果 本系统评价共纳入41个随机对照临床试验,3个为较高质量,5个为中等质量,其余为低质量。4 084例患者,均为原发性骨质疏松患者,2 114例为治疗组,1 970例为对照组,共计中成药31种。服用中成药组较对照组总体有效率高(P<0.05),部分中成药或中西医结合治疗对提高骨密度,增加血清骨钙素有一定疗效,且能改善β-CTX、PINP水平。而ALP水平、S-Ca水平比较差异无统计学意义(P>0.05)。中成药的副作用在治疗过程中未明显体现。结论 中成药治疗原发性骨质疏松症有一定疗效,然而疗效证据有限,因此,增强评价证据亟需更多高质量研究。
英文摘要:
      Objective To evaluate the clinical efficacy of Chinese patent drugs on primary osteoporosis. Methods The database of EMBASE, PubMed, CNKI, CBM, Wanfang, Weipu, etc., were retrieved by computer, and the randomized controlled trials (RCTs) on the treatment of primary osteoporosis by Chinese patent drug was manually retrieved. The inclusion and exclusion of literature and the extraction of data were all adopted. Uniform standard was applied. The quality of the literature included was evaluated. Rev. Man 5.3 version of meta analysis software was used. Overall efficacy, bone mineral density (BMD) of the lumbar spine and hip, osteocalcin (OC), serum calcium, alkaline phosphatase, type I collagen cross-linked C-terminal peptide (β-CTX), type I collagen N-anterior peptide (PINP), and other bone metabolic indicators were evaluated. BMD of the hip contained Ward triangle and the femoral neck. Results The system evaluation included 41 randomized controlled clinical trials. Among those, 3 were of high quality, 5 were of medium quality, and the rest were of low quality. The 4 084 patients involved were all primary osteoporosis patients, including 2 112 cases in treatment group and 1 970 cases in control group. A total of 31 Chinese patent drugs were used. The total effective rate of Chinese proprietary drug was higher than that of the control group (P<0.05). Some Chinese patent drugs or combined Chinese and Western medicine therapy had a certain effect on increasing BMD and increasing serum bone calcium and the levels of β-CTX and PINP. There was no statistical difference between the ALP level and the S-Ca level (P>0.05). The side effect of Chinese patent drug was not obvious during the treatment process. Conclusion Chinese patent drugs for primary osteoporosis have a certain effect, but the evidence of efficacy is limited. Therefore, more high-quality research is urgently needed to strengthen the evaluation evidence.
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