首都医科大学学报 ›› 2019, Vol. 40 ›› Issue (6): 927-937.doi: 10.3969/j.issn.1006-7795.2019.06.021

• 临床研究 • 上一篇    下一篇

发酵的冬虫夏草菌粉治疗慢性阻塞性肺疾病和间质性肺疾病随机对照试验的质量评价

崔瑷1,2, 曹锐3, 张慧1, 黄莉茹1, 袁雪燕1   

  1. 1. 首都医科大学附属北京朝阳医院呼吸与危重症医学科, 北京 100020;
    2. 首都医科大学临床三系循证医学教研室, 北京 100020;
    3. 首都医科大学附属北京朝阳医院中医科, 北京 100020
  • 收稿日期:2019-08-01 出版日期:2019-11-21 发布日期:2019-12-18
  • 通讯作者: 崔瑷 E-mail:cuiai@ccmu.edu.cn
  • 基金资助:
    重大疑难疾病中西医临床协作试点项目。

Quality evaluation of randomized controlled trials on the effect of fermentative cordycepic fungal powder on chronic obstructive pulmonary disease and interstitial lung diseases

Cui Ai1,2, Cao Rui3, Zhang Hui1, Huang Liru1, Yuan Xueyan1   

  1. 1. Department of Respiratory and Critical Care Medicine, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China;
    2. Evidence-Based Medicine Teaching and Research Office, Clinical Third Department of Capital Medical University, Beijing 100020, China;
    3. Department of Chinese Medicine, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China
  • Received:2019-08-01 Online:2019-11-21 Published:2019-12-18
  • Supported by:
    This study was supported by Pilot Project of Clinical Collaboration of Traditional Chinese Medicine and Western Medicine for Difficult and Complicated Diseases.

摘要: 目的 评价人工冬虫夏草治疗慢性阻塞性肺疾病(chronic obstructive pulmonary disease,COPD)、间质性肺疾病(interstitial lung diseases,ILDs)随机和半随机对照试验的质量。方法 计算机检索PubMed、Cochrane Library、中国生物医学文献数据库、中国知网CNKI数据库、万方数据库和维普中文期刊数据库,收集人工冬虫夏草治疗COPD和ILDs的随机对照试验和半随机对照试验。按照Cochrane协作网推荐的评价方法对纳入的研究进行方法学质量评价,按照随机对照试验报告统一标准(consolidated standards of reporting trials,CONSORT)清单进行研究报告质量评价,按照临床指南对纳入研究的疾病诊断标准、干预措施和严重程度评价及结局指标设定进行专业评价。结果 检索相关文献,入组126篇文献,其中涉及COPD的研究112篇,涉及间质性肺疾病或矽肺合并COPD的研究14篇。入组文献的研究方法学质量(COPD正确率0%~35.7%;ILDs正确率9.1%~18.2%)和报告质量亟待提高。入选文献在诊断的确认(COPD合理率42.3%;ILDs合理率78.6%)、治疗方案设定(COPD合理率28.8%;ILDs合理率14.3%)和疗效评价指标及治疗终点设计(COPD合理率50%;ILDs合理率64.3%)上也有很大缺陷。结论 由于研究质量较差,目前的证据不能证实联合使用发酵的虫草粉对改善COPD和ILDs的疗效有肯定作用,仍需要进一步研究以证实其临床价值。

关键词: 慢性阻塞性肺疾病, 间质性肺疾病, 发酵的冬虫夏草菌粉, 质量评价

Abstract: Objective To evaluate the quality of randomized controlled trials (RCTs) for Fermentative Cordycepic Fungal Powder on chronic obstructive pulmonary disease (COPD) and interstitial lung diseases (ILDs). Methods The electronic databases of Medline via PubMed, Cochrane Library, China Biology Medicine disc (CBM), China National Knowledge Infrastructure(CNKI), WANFANG data base and VIP were searched for human randomized controlled trial (RCT) and quasi-RCT by using the key words Fermentative Cordycepic Fungal Powder, COPD and ILDs. The quality was assessed by using recommended criteria by Cochrane Collaboration. The quality of each report was assessed by using the consolidated standards of reporting trials (CONSORT) checklist. Professional assessment of diagnostic criteria, interventions, and outcome indicator setting were accorded with clinical guidelines. Results Totally 126 were met the inclusion criteria, among them, 112 were related to COPD, and 14 were related to interstitial lung disease or silicosis with COPD. The quality of the research methodology (COPD correction rate 0%-35.7%; ILDs correction rate 9.1%-18.2%) and the quality of the reports of the reports in this group were defective and need to be urgently improved. The selected literature also has great defects in the confirmation of the diagnosis (COPD rational rate 42.3%;ILDs rational rate 78.6%), the setting up of treatment plans (COPD rational rate 28.8%;ILDs rational rate 14.3%), the parameters using to evaluate efficacy (COPD rational rate 50%;ILDs rational rate 64.3%) were also need to be improved. Conclusion The current literatures don't warrant the efficacy of the comprehensive treatment with fenebtable on the improvement of COPD and ILDs for the lack of decentness among current studies, and well-designed researches are needed to determine the aforementioned clinical significance.

Key words: chronic obstructive pulmonary disease, interstitial lung diseases, fermentative cordycepic fungal powder, quality evaluation

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