中医药治疗消化系统肿瘤术后胃瘫临床研究的文献分析

Literature analysis of clinical study in traditional Chinese Medicine treatment of postsurgical gastroparesis syndrome on digestive system tumors

关键词:  术后胃瘫  消化系统肿瘤  中医药  临床试验  文献研究

Key words:  postoperative gastroparesis  digestive system tumor  traditional Chinese medicine  clinical trial  literature analysis

摘要:

[目的] 分析近 10 年中医药联合常规疗法治疗消化系统肿瘤术后胃瘫的临床研究特征，并评价其方法学质量。[方法] 检索中国知网、万方数据库、维普中文期刊服务平台、中国生物医学文献服务系统、Pubmed、Web ofScience，收集 2013 年 1 月—2022 年 12 月中医药联合常规疗法治疗消化系统肿瘤术后胃瘫的临床研究文献。总结并分析纳入文献的研究类型、诊断标准、干预和对照措施、结局指标等。运用 Cochrane 偏倚风险评估工具等对纳入文献进行方法学质量评价。[结果] 最终纳入 31 篇文献，其中 30 篇为随机对照试验，1 篇为回顾性研究。纳入的随机对照试验（RCT）研究方法学质量整体偏低，27 项（90.00%）研究报告了随机化方案，其中 1 项评价为高风险，仅 3 项（10.00%）研究报告了分配隐藏方案，29 项（96.67%）研究未报告受试者、研究者及结局评价者施盲情况。纳入文献研究对象诊断标准不统一。涉及 33 种干预措施，以中医外治法居多（66.67%）。临床疗效评价指标不规范，仅 2 篇文献区分了主、次要结局指标。[结论] 建议今后研究者提前注册研究方案，完整透明地报告研究方案，严格按照国际标准设计和实施临床方案。期待未来能够出台相关指南或专家共识统一术后胃瘫综合征诊治标准，规范结局指标判定标准，开展中医药相关核心指标集的研究。

Abstract:

[Objective] To evaluate the methodological quality of clinical research on treatment of postsurgical gastroparesis syndrome of digestive system tumors combined with traditional Chinese Medicine （TCM） in recent 10 years，and to analyze the clinical trials characteristics. [Methods] CNKI，Wanfang database，VIP，SinoMed，Pubmed， Web of Science were searched to collect the clinical research literature from January 2013 to December 2022. The methodological quality of the included literature was evaluated by tools as the Cochrane risk of bias assessment tool. The types of studies，diagnostic criteria，interventions and control measures，and outcome measures in the included literature were analyzed. [Results] Totally 31 articles were included，30 were randomized controlled trails and one was retrospective study. The methodological quality of the included Randomized controlled trials（RCTs） was generally low，such as lack of the specific description of randomization protocol，allocation concealment，and blind methods，presence of selective outcome reporting. The diagnostic criteria are not unified，the intervention measures were mainly TCM external treatment，and the clinical efficacy evaluation indicators are not standardized. [Conclusion] Rigorous clinical protocol design should be performed in future studies. It is recommended that researchers should register the study protocol in advance，report the study protocol completely and transparently. The design and implement of the clinical protocol should accordance with international standards. It is expected that relevant guidelines or expert consensus will be issued to unify PGS diagnosis and treatment standards，standardize the judgment criteria of outcome indicators，and carry out research on relevant TCM core indicator set.