| Objective: Through the systematic evaluation of the main technical factors of pediatric acute bronchitis,it provides reference and basis for the clinical trials of traditional Chinese medicine in this disease,standardized trial design and systematic evaluation.At the same time,it also provides literature support for the development of technical guidelines for clinical trial design and evaluation of TCM for this disease.Methods: According to the retrieval strategy,Embase,Pub Med,Clinical Trials and Cochrane were systematically searched Library,CNKI database,WF Database,CMB database,VIP Database and China Clinical Trial Registry database about randomized controlled clinical trials(RCTS)in pediatric acute bronchitis from 1999 to 2020 in Chinese and English;Document management for all the retrieved literature,remove duplicate documents,according to the set of filtered into and exclusion criteria,requirements included in the literature,western medicine in children with acute bronchitis disease diagnosis standard,children aged < 18 years of age,and intervention measures for Chinese medicine,plant medicine and chemical medicine,improved the Jadad scale score 3 points,or languages into Chinese or English,The risk of bias was analyzed through the Cochrane evaluation manual,and the literatures meeting the above requirements were sorted out and summarized to study the main technical points of clinical trial design and evaluation of pediatric acute bronchitis.Result: A total of 1542 papers were retrieved,and 19 papers were included,including 17 in Chinese and 2 in English.Ten main technical points were extracted:(1)Objective orientation,17 studies(89.47%)were mainly aimed at improving the condition/symptoms,1study(5.26%)was aimed at shortening the course of disease,and 1 study(5.26%)was aimed at improving TCM syndromes;(2)The overall design of the study was randomized.In all studies,14(73.68%)were double-blind,one(5.26%)only mentioned the use of blind,and the other 4(21.05%)did not mention blind design.14(73.68%)positive controls and 5(26.32%)placebo controls were used in all studies.17 multicenter studies(89.47%);Estimated sample size of 4 items(21.05%);There were 15 difference test designs(78.95%),3non-inferiority test designs(15.79%),and 1 excellence test(5.26%).(3)There were 16 western diagnostic criteria(84.21%)in all studies,including 10 items(52.63%)referring to practical Pediatrics and 6 items(31.58%)referring to Pediatrics.Criteria for Diagnosis and Efficacy of Pediatric Diseases,Diagnostic Criteria for Pediatric Diseases,and Clinical Diagnosis and Treatment Guide · Division of Pediatric Internal Medicine(5.26%);Among all the studies,16 items(84.21%)had clearly defined TCM diagnosis and syndrome differentiation standards,6 items(31.58%)referred to TCM Diagnosis and Syndrome Diagnosis and Efficacy Standards(31.58%),3 items(15.79%)referred to TCM Pediatric Diagnosis and Treatment Guidelines(15.79%),and 1 item(5.26%)referred to TCM Pediatric Diagnosis and Efficacy Standards(5.26%).There were 5 items(26.32%)in Pediatrics of Traditional Chinese Medicine,3 items(15.79%)in Guiding Principles for Clinical Research of New Chinese Medicine,and 1 item(5.88%)without indicating the source.(4)In the selection and withdrawal of subjects,all 19 studies were included in the standard design,including 17 items(89.47%)meeting the diagnostic criteria for pediatric acute bronchitis,18items(94.74%)meeting the age range of children,15 items(78.95%)meeting the course of disease,and 8 items(42.10%)meeting the treatment before inclusion.There were 12 informed consents signed(63.16%),and 10(52.63%)defined the severity of the disease,including 5(45.45%)in the temperature range,2(18.18%)in the moderate or above cough symptom,2(18.18%)in the baseline cough score ≥3 and BSS total score ≥5.Symptom and sign score ≥9(9.09%);There were 16 exclusion criteria description items(84.21%),including 16 related standards of target indication(84.21%),3 related standards of experimental drug(38.10%),and 16 exclusion standards of universality(84.21%).There were 7 standard descriptions of abscission(36.84%).(5)Intervention measures: Among the19 studies included,intervention measures included 16 cases of TRADITIONAL Chinese medicine(84.21%),1 case of combined use of traditional Chinese medicine(5.26%)and 2cases of herbal medicine(10.53%).(6)The trial process,19 studies did not set an introduction period,design follow-up study 1(5.26%),follow-up time of 3 to 7 days,in order to observe the recurrence of acute bronchitis in children;The treatment course lasted for 5-7days,mainly for 5 days,including 12 items of 5 days(63.16%),3 items of 6 days(15.79%),and 4 items of 1 week(21.05%).There was 1 item with basic treatment design(5.26%).(7)Effectiveness evaluation: Among 19 studies,13(68.42%)were evaluated by disease response rate/recovery rate,BSS or BPS-PED,and 3(15.79%)were evaluated by cough,expectoration,shortness of breath/wheezing or pulmonary signs.The area under the curve(AUC)of cough symptom integral and time(days)was used as the main evaluation index(5.26%),the effective rate of TCM syndrome was used as the main evaluation index(5.26%),and the time of main symptoms(cough and expectoration)basically disappeared was used as the main evaluation index(5.26%).(8)Safety evaluation: 19 studies were designed with safety indicators,including 15 laboratory safety examination indicators(78.95%)and 6 studies(31.58%)describing vital signs.(9)Of 19 studies,2(10.53%)had description of trial quality control.(10)Among 19 studies,only 2(10.53%)had an ethical approval number.Conclusion: Included in the literature of this study are of good quality,perfect information,in line with the principle of evidence-based medicine,accords with the practice of clinical,highlight the characteristics of traditional Chinese medicine and the results of the study covers the infantile acute bronchitis clinical trial design and evaluation of the main technical elements,is of high reference value,improve the feasibility of clinical trial results comparison,provides literature support system evaluation for the disease. |
PDF Full Text Request