Chinese General Practice ›› 2022, Vol. 25 ›› Issue (17): 2071-2081.DOI: 10.12114/j.issn.1007-9572.2022.0204

Special Issue: 中医最新文章合集 睡眠研究最新文章合集 安全用药最新文章合集 睡眠问题专题研究

• Focus·Sleep Disorders & Problems • Previous Articles     Next Articles

Analysis on the Status of Evaluation Indicators of Clinical Randomized Controlled Trials on Sleep Apnea Hypopnea Syndrome Treated by Traditional Chinese Medicine in Recent 6 Years

  

  1. The First Affiliated Hospital of Henan University of Traditional Chinese Medicine/Henan University of Traditional Chinese Medicine/Provincial and Ministerial Collaborative Innovation Center for the Prevention and Treatment of Respiratory Diseases/Henan Provincial Key Laboratory of Traditional Chinese Medicine in the Prevention and Treatment of Respiratory Diseases, Zhengzhou 450000, China
  • Received:2022-01-26 Revised:2022-04-11 Published:2022-06-15 Online:2022-04-14
  • Contact: Zhiwan WANG
  • About author:
    TIAN W W, WANG Z W. Analysis on the status of evaluation indicators of clinical randomized controlled trials on sleep apnea hypopnea syndrome treated by traditional Chinese medicine in recent 6 years[J]. Chinese General Practice, 2022, 25 (17) : 2071-2081.

近六年中医药治疗阻塞性睡眠呼吸暂停低通气综合征的临床随机对照试验评价指标现状分析

  

  1. 450000 河南省郑州市,河南中医药大学第一附属医院 河南中医药大学 呼吸疾病中医药防治省部共建协同创新中心 河南省中医药防治呼吸病重点实验室
  • 通讯作者: 王至婉
  • 作者简介:
    田望望,王至婉.近六年中医药治疗阻塞性睡眠呼吸暂停低通气综合征的临床随机对照试验评价指标现状分析[J].中国全科医学,2022,25(17):2071-2081.[www.chinagp.net] 作者贡献:田望望进行文章的构思与设计,研究的实施与可行性分析,数据处理、论文撰写、结果的分析,对文章整体负责、监督管理,负责论文的修订;王至婉负责文章的质量控制及审校。
  • 基金资助:
    国家重点研发计划项目--慢性阻塞性肺疾病气虚证的辨证标准研究(2017YFC1700103); 国家自然科学基金面上项目--以COPD气虚证为示范的基础证候量化诊断的关键技术研究(81973791)

Abstract:

Background

Obstructive sleep apnea hypopnea syndrome (OSAHS) is a common disorder. At present, there are great differences in evaluation indicators of clinical randomized controlled trials (RCTs) on OSAHS treated by traditional Chinese medicine (TCM ) . Therefore, it is of great significance to further explore the evaluation indicators of clinical RCTs of OSAHS.

Objective

To analyze the evaluation indicators of clinical RCTs on OSAHS treated by TCM, in order to provide reference for the selection of appropriate Chinese medicine for the treatment of OSAHS in RCTs outcome indicators.

Methods

The RCTs in the TCM treatment of OSAHS were retrieved from CNKI, WanFang Data, VIP, CBM, PubMed and other data bases from 2015-01-01 to 2021-10-20. The basic characteristics of the collected literature included the first author, sample size, gender, age, course of disease, intervention measures, TCM syndrome type, course of treatment, and outcome indicators. According to the functional attributes, the evaluation indicators were divided into TCM syndrome, physical and chemical indicators, life quality indicators, long-term prognosis indicators, safety events indicators, and Western medicine signs indicators. The quality of the included literature was evaluated using a systematic bias risk assessment tool recommended by the Cochrane Collaboration, and the literature quality was evaluated using RevMan 5.4 software.

Results

A total of 41 RCTs were included, including 2 971 patients, involving 270 outcomes of 70 indicators, which were classified as TCM syndrome, physical and chemical indicators, safety events indicators, Western medicine signs indicators, and quality of life indicators. Among them, physical and chemical indicators, symptoms and signs indicators are the most, quality of life indicators are less. There are 14 items of 2 kinds of combination indicators, 16 items of 3 kinds of combination indicators and 7 items of 4 kinds of combination indicators. The measurement time ranged from 7 days to 6 months, and the most was 1 month (15 RCTs, 36.59%) , followed by 3 months (11 RCTs, 31.70%) .

Conclusion

At present, there are large differences in evaluation indicators of TCM treatment of OSAHS, relatively insufficient attention on TCM syndrome score, poor attention on quality of life indicators, no unified standard for evaluation indicators, large span of measurement time points, and no long-term prognostic indexes.

Key words: Sleep apnea syndromes, Sleep apnea, obstructive, Traditional Chinese medicine therapy, Randomized controlled trial, Evaluation index

摘要:

背景

阻塞性睡眠呼吸暂停低通气综合征(OSAHS)是一种临床常见的疾病。目前关于中医药治疗OSAHS的临床随机对照试验(RCTs)评价指标存在巨大差异,因此进一步探索OSAHS相关临床RCTs的评价指标有重要意义。

目的

分析近6年文献中中医药治疗OSAHS临床RCTs的评价指标,为选择合适的中医药治疗OSAHS的临床RCTs结局指标提供参考。

方法

检索中国知网(CNKI)、万方数据知识服务平台(WanFang Data)、维普网(VIP)、中国生物医学文献数据库(CBM)、PubMed等数据库中关于中医药治疗OSAHS的临床RCTs,检索时间为2015-01-01至2021-10-20。收集文献的基本特征,包括第一作者、样本量、性别、年龄、病程、干预措施、中医证型、疗程、结局指标。按照评价指标的功能属性分为中医症状/体征、理化指标、生活质量、远期预后、安全事件、症状体征。使用Cochrane协作网推荐的偏倚风险评估工具评价纳入文献的偏倚风险,使用RevMan 5.4软件评价文献质量。

结果

共纳入41项RCTs,包括2 971例患者,涉及70个评价指标,总使用频次270次,归属于中医症状/体征、理化指标、安全事件、症状体征、生活质量,其中理化指标、症状体征较多,生存质量较少。2种组合指标14项,3种组合指标16项,4种组合指标7项。测量时点分布在7 d~6个月,测量时点最多为1个月(15项RCTs,占36.59%),其次是3个月(11项RCTs,占31.70%)。

结论

目前中医药治疗OSAHS临床RCTs的评价指标差异大、对中医证候评分关注相对不足,对生活质量指标关注度欠佳,评价指标无统一标准,测量时点跨度大,无远期预后。

关键词: 睡眠呼吸暂停综合征, 睡眠呼吸暂停, 阻塞性, 中医药疗法, 随机对照试验, 评价指标