Zu Ya-Qi, Li Jing-Hua, Liao Xing, Yu Qi, Li Guo-Xiang, Shi Wen-Yan, Tang Xu-Dong
Institue of Information on Traditional Chinese Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.
Center for Evidence-based Chinese Medicine, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.
Zhongguo Zhong Yao Za Zhi. 2023 Feb;48(4):1116-1123. doi: 10.19540/j.cnki.cjcmm.20220907.502.
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.
为了为功能性胃肠病（FGIDs）的临床决策提供循证医学和决策信息，本研究采用快速卫生技术评估方法，对四种口服中成药治疗FGIDs的疗效、安全性和经济性进行了评估和比较。从数据库建立至2022年5月1日，系统检索了中国知网、万方、维普、中国生物医学文献数据库、EMbase、PubMed、考克兰图书馆和ClinicalTrials.gov中的文献。两名评价者筛选文献、提取数据、评估文献质量，并根据制定的标准进行描述性分析。最终纳入16项研究，均为随机对照试验（RCT）。结果显示，人参健脾片、人参健脾丸、参苓白术颗粒和补中益气颗粒对FGIDs均有一定疗效。人参健脾片治疗FGIDs及持续性腹泻。参苓白术颗粒治疗肠易激综合征腹泻和FGIDs。补中益气颗粒治疗肠易激综合征腹泻、FGIDs及小儿慢性腹泻。人参健脾丸治疗慢性腹泻。这四种口服中成药对FGIDs均有一定疗效且对特定患者有特定优势。与人参健脾片相比，其他中成药临床通用性更高。然而，存在临床研究证据不足、证据质量普遍较低、缺乏药物间比较分析及缺乏学术评价等问题。未来应开展更多高质量的临床研究和经济学研究，为这四种中成药的评价提供更多证据。
