|
| Literature research on design elements in clinical randomized controlled trials of children with hand-foot-and-mouth disease |
| Hits 536 Download times 340 Received:December 06, 2021 |
| View Full Text View/Add Comment Download reader |
| DOI
10.11656/j.issn.1672-1519.2022.04.09 |
| Key Words
hand,foot and mouth disease (HFMD);children;randomized controlled trial;clinical tricals design |
| Author Name | Affiliation | E-mail | | JIN Li | Pediatric Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300381, China | | | HU Siyuan | Pediatric Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300381, China | husiyuan1963@sina.com | | LI Han | Pediatric Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300381, China | | | LI Xuan | Pediatric Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300381, China | | | GUO Shengxuan | Pediatric Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300381, China | |
|
| Abstract
|
| [Objective] To study the design elements of clinical randomized controlled trial of hand,foot and mouth disease(HFMD) in children,and to provide reference and guidance for the standardized design of clinical trials,furthermore,to improve the feasibility of comparison of different test results.[Methods] Through literature research,we systematic retrieved Chinese and English literatures about HMFD clinical trials (RCTs) in the past 10 years in Chinese and English databases such as CNKI,Wanfang,VIP and PubMed,Cochrane Library databases,and extracted,analyzed and summarized literature that met the inclusion criteria,then abstracted the main technical elements for design and evaluation of clinical trials.[Results] The 1 081 articles were retrieved,14 articles were finally included. The clinical trials of pediatric HFMD were mainly aimed at shortening the heat course,and the second phase/severe indications were also mainly to reduce the occurrence of critical illness. All the tests were designed by random blind method,including 5 double-blind designs (35.71%). The selection of subjects had clear diagnostic criteria or corresponding descriptions,as well as inclusion criteria and exclusion criteria design. The intervention measures included Chinese medicine or Chinese patent medicine(4 items,28.57%),Chinese medicine injection (5 items,35.71%),antiviral drugs (4 items,28.57%),immunosuppressant (1 item,7.14%). The 14 studies had no lead-in period design. The total treatment course were 3~10 days,the general type test is mainly 3~7 days,the severe and severe test mainly were 7~10 days. The 6 (42.86%) studies designed a follow-up period of 3~15 days. The main effectiveness indicators,mostly around fever (8 items, 57.14%),the incidence of critical illness (3 items,21.43%) and skin rash (2 items,14.29%) were evaluated. Secondary indicators included the amount of enterovirus vector or negative conversion rate,hospitalization time,traditional Chinese medicine syndrome score or effect,mortality rate. The safety indicators were based on adverse events or adverse reactions as the main observation outcome (13 items,92.86%). [Conclusion] The quality of the literature included in this study was high,the information was complete. The research results covered the main technical elements of the design and evaluation of clinical trials for pediatric hand,foot and mouth disease,and have high reference value. |
|
|
|
|
|
|
|
