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| The literature research of clinical trial design and evaluation of allergic rhinitis drugs in children |
| Hits 870 Download times 755 Received:February 26, 2021 |
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| DOI
10.11656/j.issn.1672-1519.2021.07.12 |
| Key Words
allergic rhinitis;children;traditional Chinese medicine;randomized controlled trial;clinical trail design |
| Author Name | Affiliation | E-mail | | CUI Qian | Department of Pediatrics, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300193, China | | | HU Siyuan | Department of Pediatrics, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300193, China | husiyuan1963@sina.com | | CAI Qiuhan | Department of Pediatrics, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300193, China | | | LI Ruiben | Department of Pediatrics, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300193, China | | | GUO Shengxuan | Department of Pediatrics, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300193, China | |
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| Abstract
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| [Objective] To study the design elements of clinical randomized controlled trials in children with allergic rhinitis (AR),so as to provide reference and guidance for the standardized design of clinical trials of traditional Chinese medicine combined with disease and syndrome,,and improve the feasibility of comparing the results of different trials.[Methods] Through literature research,we searched Chinese and English databases of China National Knowledge Infrastructure (CNKI),China Science and Technology Journal Database (VIP),Wanfang Database (WF),PubMed,EMBASE and Web of Science for randomized controlled trials (RCT) of AR in children. We extracted,analyzed and summarized the literatures that met the inclusion criteria,and extracted the main technical elements for the design and evaluation of clinical trials of AR in children.[Results] A total of 2 735 articles were retrieved and 18 articles were included,including 5 in Chinese and 13 in English. In all studies,no matter short-term or long-term treatment,the clinical orientation was to relieve nasal symptoms.The overall design of the trial was randomized;There were 12 studies (66.67%) with double-blind and 8 studies (44.44%) with sample size estimation. There were clear diagnostic criteria of Western medicine,inclusion criteria and exclusion criteria. The intervention measures included intranasal corticosteroids and antihistamines (5 items,27.78%),combined traditional Chinese and Western medicine and sublingual immunotherapy (3 items,16.67%),oral corticosteroids and antihistamines (1 item,5.56%) and nasal cellulose powder (1 item,5.56%). There were 10 placebo-controlled drugs (55.57%),6 positive drug controlled drugs (33.33%) and 2 three arm trial designs (11.11%). The lead-in period of 8 items (44.44%) was 3 days to 3 weeks;The course of treatment ranged from 1 week to 1 year,mainly from 2 to 4 weeks. Among them,the patients with combined treatment of traditional Chinese medicine and Western medicine,nasal local treatment and antihistamines as intervention measures mostly lasted for 2 to 4 weeks,while the patients with systemic treatment as intervention measures could last as long as 1 year or even longer.The main efficacy indicators were as follows:5 items (27.78%) of comprehensive efficacy of AR symptoms and signs,12 items (66.67%) of symptom/disease severity assessment,and the rest 1 item (5.56%) of asymptomatic days percentage;The assessment tools used included TNSS 4 items (22.22%),RTSS and TSS 2 items (11.11%),T4SS,NSS,TSSC,DSS 1 item (5.56%),or 3TNSS,4TNSS,TOSS 1 item (5.56%).[Conclusion] The literatures included in this study are of high quality and complete information. The research results cover the main technical elements of clinical trial design and evaluation of AR drugs in childrenunder the mode of combination of disease and syndrome,,which has high reference valueand reference value. It provides a literature basis for the development of the standardization project of Chinese society of traditional Chinese Medicine "technical guide for clinical trial design and evaluation of Chinese medicine in children with allergic rhinitis". |
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