基于CONSORT拓展声明和STRICTA清单的针刺治疗慢性阻塞性肺疾病随机对照试验的质量评价  

Quality Assessment of Randomized Controlled Trials of Acupuncture for Chronic Obstructive Pulmonary Disease Based on the CONSORT Extended Statement and STRICTA Checklist

作　　者：崔萌萌 徐丹[2] 荆晶[2] 王益德 李风森[2,3] Cui Mengmeng;Xu Dan;Jing Jing;Wang Yide;Li Fengsen(the Fourth Clinical Medical College of Xinjiang Medical University,Urumqi 830000,China;the Fourth Affiliated Hospital of Xinjiang Medical University,Urumqi 830000,China;National famous old Chinese medicine expert inheritance studio,Urumqi 830000,China)

机构地区：[1]新疆医科大学第四临床医学院,乌鲁木齐830000 [2]新疆医科大学第四附属医院,乌鲁木齐830000 [3]全国名老中医药专家传承工作室,乌鲁木齐830000

出　　处：《世界科学技术-中医药现代化》2023年第10期3311-3321,共11页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：国家自然科学基金委员会地区科学基金项目(82060802):赖氨酸琥珀酰修饰在不同脏腑虚损慢阻肺患者线粒体中表达差异及SIRT5调控下的氧化应激机制研究,负责人:徐丹;新疆医科大学研究生创新创业项目(CXCY2022013):基于“肺通调水道”理论探究PKM2琥珀酰化修饰通过抑制巨噬细胞极化调控慢阻肺水液代谢失常的机制,负责人:崔萌萌

摘　　要：目的评价针刺治疗慢性阻塞性肺疾病(Chronic obstructive pulmonary disease,COPD)随机对照试验(Randomized controlled trial,RCT)的方法学、报告质量和干预措施报告质量。方法经计算机系统检索CNKI、Wanfang、VIP、SinoMed、PubMed数据库中,从数据库建立到2023年3月1日收录的针刺治疗慢性阻塞性肺疾病的随机对照试验。由2名研究者独立进行文献检索、相关资料提取等工作,并运用Cochrane系统评价手册的偏倚风险评估工具ROB2、CONSORT拓展声明和STRICTA清单评估报告质量。结果通过既定的纳入排除标准剔除不符合文献后,最终剩余31篇RCT。本研究使用Cochrane网站偏倚风险评估工具ROB2进行RCT的方法学质量评估,结果表明9项研究(29.03%)偏倚风险较高,无低风险偏倚研究。基于非药物随机对照临床试验的CONSORT扩展声明对文献进行报告质量评价,提示在方法、结果、试验方案注册等方面报告率较低。按照STRICTA清单条目评价结果显示多数文献对针刺细节和治疗师背景描述不够详细,但对针刺治疗的合理性报告相对完整。结论目前针刺治疗COPD的随机对照试验报告质量普遍较低,导致证据的论证强度下降,建议今后研究者进行针刺相关研究要严格遵循国际公认的CONSORT声明和STRICTA清单进行试验方案设计和研究结果的报告。Objective To assess the methodology,reporting quality and intervention reporting quality of randomised controlled trials(RCT)of acupuncture for chronic obstructive pulmonary disease(COPD).Methods Randomized controlled trials of acupuncture for the treatment of chronic obstructive pulmonary disease from the establishment of the database to March 1,2023 through computer system search of CNKI,Wanfang,VIP,SinoMed,and PubMed databases.Two researchers independently conducted literature search,relevant data extraction,etc.,and assessed the quality of reports using the bias assessment tools ROB2,CONSORT Extended Statement and STRICTA List of Cochrane Systematic Review Manuals.Results After excluding non-compliant articles through the developed exclusion criteria,31 RCT remained.A methodological assessment of the included RCT according to the Cochrane website bias assessment tool ROB2 showed that 9 studies(29.03%)were at high risk of bias and no studies at low risk of bias.The CONSORT extended statement based on non-drug randomized controlled trials evaluated the quality of the literature,indicating that the reporting rate in terms of methods,results,trial protocol registration,etc.was low.The results of the evaluation according to the entries in the STRICTA list show that most of the literature does not describe the details of acupuncture and the background of the therapist in sufficient detail,but the reasonableness of acupuncture treatment is relatively complete.Conclusion At present,the quality of randomized controlled trials of acupuncture for COPD is generally low,and it is recommended that future researchers strictly follow the internationally recognized CONSORT statement and STRICTA list for trial protocol design and study result reporting.

关 键 词：慢性阻塞性肺疾病 针刺 随机对照试验 CONSORT拓展声明 STRICTA清单 质量评价 

分 类 号：R385.6[医药卫生—医学寄生虫学]