The Study Of Clinical Application Guidelines On Chinese Patent Medicine In This Treatment Of Neonatal Jaundice Based On GRADE System

Objective: Develop a Guideline on the clinical application of Chinese patent medicine in the treatment of neonatal jaundice by referring to the current best evidence which followed the principle “Quality of evidence for research is superior to consensus,with expert experience as supplemented” through GRADE system to standardize and promote the application of Chinese patent medicine and improve the clinical effect of neonatal jaundice,reduce the separation of mother and baby and provide humane care.Methods:1.Convene a kick-off meeting to discuss the possible problems in the process of making guidelines,and rank the importance of outcome indicators through questionnaires.2.Search The Chinese and English databases online with the combination of paper materials.The retrieval time was from the database establishment to the end of 2019.1.1.3.Screen the final target literatures according to inclusion and exclusion criteria and form “Literature evidence registration table” and “Literature feature extraction table”.3.Use different items/scales to assess bias for different types of studies:AMSTAR-2 scale/ROB assessment/MINORS items are used for SR(meta analysis)/RCT/non-randomized controlled trials(observational studies)separately.4.Analyze data of literatures with consistency quantitatively by Revman5.3 software.5.Specialist consensus:1)Delphi method: select no less than 30 pediatric/neonatal experts with senior titles or above in all parts of the country,conduct three rounds of questionnaires to them by email,collect the indicators of expert opinion concentration and coordination degree,and vote on the recommendation opinions of proprietary Chinese medicines.2)Consensus conference: Questions unsolved through questionnaires were analyzed and discussed,and finally form a consensus.6.Evaluate the quality of Chinese patent medicine by evidence-based research and expert consensus to form evidence summary tables and recommend the use of Chinese patent medicines from the perspective of Delphi votes,patients' interests and the consideration of decision makers by the GRADE system.Results:1.Evidence-based research:10 kinds of Chinese patent medicine(67 studies)were included into the evidence,of which 41 studies on yinzhihuang preparation(Oral liquid 23,granules 18),9 studies on Qingganlidan Oral liquid,4 studies on Simotang Oral liquid,6 studies on Huangdanyinchen granules,2 studies on Qingkailing infusion,2 studies on Yin Chen wuling syrup,1 study on Xiaoyanlidan tablets,1 study on Huangzhihua Oral liquid,1 study on Ganshule granules.2.Expert consensus: Define the applicable subjects,timing and scope,dominant TCM syndrome,usage and dosage and side effects of Chinese patent medicine in the treatment of neonatal jaundice.3.Quality evaluation: Finally,5 kinds of Chinese patent medicines including Yinzhihuang preparation,Qingganlidan oral liquid,Huangdanyinchen granule,Yinchenwuling syrup and Simotang oral liquid were included in the GRADE system.The quality evaluation results showed that the total evidence of Yinzhihuang preparation/Qingganlidan oral liquid was GRADE C,and the rests were GRADE D.4.Form recommendations: 1)It is strongly recommended to take Yinzhihuang oral liquid alone in reducing the incidence of phototherapy(1B)and combined with phototherapy in reducing the level of serum bilirubin at the end of treatment for the treatment of neonatal jaundice(1C),while recommended weekly in reducing the failure of jaundice resolution and shortening the time of jaundice regression(2C).Besides,it is recommended weekly to take Yinzhihuang oral liquid combined with probiotics for the treatment of neonatal jaundice in reducing the level of serum bilirubin and the failure of jaundice resolution and shortening the time of jaundice regression(2C).The appropriate TCM syndrome type of Yinzhihang oral liquid for neonatal jaundice recommended by specialists is Yang Yellow(heat than wet).2)It is weekly recommended to take Yinzhihuang granules combined with phototherapy for the treatment of neonatal jaundice,which can reduce the level of serum bilirubin at the end of treatment,reduce the efficiency and shorten the time of jaundice regression(2C),TCM syndrome belonging to Yang Yellow(heat than wet).3)It is weekly recommended to take Qingganlidan oral liquid combined with probiotics for the treatment of neonatal jaundice,which can reduce the serum bilirubin level at the end of treatment,increase the average daily decrease rate of bilirubin,and shorten the time of jaundice regression(2C),TCM syndrome belonging to Yang Yellow(Wet than heat).4)It is recommended to take Yinchenwuling syrup for the treatment of neonatal jaundice(IV evidence,Grade D Recommendation),TCM syndrome belonging to Yang Yellow(Wet than heat,difficult urination).5)Huangdan yinchen granules and Simotang oral liquid are not recommended for the treatment of neonatal icterus temporarily(2D).Conclusion: According to the GRADE system and the consensus results,finally Yinzhihuang oral liquid was strongly recommended,Yingzhihuang granules and Qingganlidan oral liquid were weakly recommended,Yinchenwuling syrup was recommended as GRADE D,and Huangdanyinchen granules and Simo tang oral liquid were not recommended for the treatment of neonatal jaundice.