4种口服健脾益气类中成药治疗功能性胃肠病的快速卫生技术评估

Rapid health technology assessment of four oral Chinese patent medicines in treatment of functional gastrointestinal disorders

该研究利用快速卫生技术评估对人参健脾片、人参健脾丸、参苓白术颗粒、补中益气颗粒治疗功能性胃肠病(FGIDs)的安全性、有效性、经济性进行评价,以期为FGIDs的临床决策提供循证医学证据及决策依据。系统检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献服务系统(SinoMed)、EMbase、PubMed、Cochrane Library数据库和临床试验注册中心(ClinicalTrials.gov),检索时限均从建库至2022年5月1日。2名评价人员按照预先制定的标准进行文献筛选、数据提取和文献质量评价,并对结果进行描述性分析。最终纳入16篇研究,均为随机对照试验(RCT)。结果显示,人参健脾片、人参健脾丸、参苓白术颗粒、补中益气颗粒对于FGIDs均有一定疗效,人参健脾片可用于治疗功能性胃肠病、迁延性腹泻;参苓白术颗粒可用于治疗腹泻型肠易激综合征、功能性腹泻;补中益气颗粒可用于治疗腹泻型肠易激综合征、功能性腹泻、小儿慢性腹泻;人参健脾丸可用于治疗慢性腹泻。结果表明,4种口服中成药对于FGIDs均有一定疗效,特定疾病人群各有其治疗优势,其中人参健脾片临床普适性更高,但存在临床研究证据不足,证据质量普遍偏低,药物之间缺乏对比分析,经济学评价匮乏等问题。未来应进一步开展更多高质量的临床研究,同时开展经济性研究,以对4种口服中成药的评价提供更多证据支持。

To provide proof of the evidence-based medicine and decision-making information for the clinical decision of functional gastrointestinal disorders(FGIDs), this study evaluated and compared the efficacy, safety, and economy of four oral Chinese patent medicines(CPMs) in the treatment of FGIDs using the method of rapid health technology assessment. The literature was systematically retrieved from CNKI, Wanfang, VIP, SinoMed, EMbase, PubMed, Cochrane Library and ClinicalTrials.gov from the establishment of the databases to May 1, 2022. Two evaluators screened out the literature, extracted data, evaluated the quality of the literature, and descriptively analyzed the results according to the prepared standard. Eventually, 16 studies were included, all of which was rando-mized controlled trial(RCT). The results showed that Renshen Jianpi Tablets, Renshen Jianpi Pills, Shenling Baizhu Granules, and Buzhong Yiqi Granules all had certain effects on the treatment of FGIDs. Renshen Jianpi Tablets treated FGIDs and persistent diarrhea. Shenling Baizhu Granules treated diarrhea with irritable bowel syndrome and FGIDs. Buzhong Yiqi Granules treated diarrhea with irritable bowel syndrome, FGIDs, and chronic diarrhea in children. Renshen Jianpi Pills treated chronic diarrhea. The four oral CPMs all have certain effects on the treatment of FGIDs and have specific advantages for specific patients. Compared with other CPMs, Renshen Jianpi Tablets have higher clinical universality. However, there are problems such as insufficient clinical research evidence, generally low quality of evidence, lack of comparative analysis among medicines, and lack of academic evaluation. More high-quality clinical research and the economic research should be carried out in the future, so as to provide more evidence for the evaluation of the four CPMs.