| Background:Acute pancreatitis(AP)has been the focus of digestive physicians for many years because of its acute morbidity,complications and high mortality.Severe acute pancreatitis(SAP)is a critical type of pancreatitis.Its mortality is as high as36%-50%.Although the clinicians have been studying unremittingly,the mortality of SAP has not been substantially improved in recent years.Integrated traditional Chinese and Western medicine is the main way to treat SAP at present.However,due to the lack of large sample clinical research and effective evidence-based evidence,TCM has not yet been generally recognized by modern medicine.Objective:This study made the evaluation and analysis of the reports about the literature quality,risk of bias,treatment methods,efficacy and safety,by the use of system evaluation methods of qualitative analysis and quantitative analysis?Which were published and unpublished in recent five years,about the Traditional Chinese medicine for the treatment of SAP in clinical randomized controlled trials.The purpose of this study is to provide evidence-based evidences for the clinical efficacy of Traditional Chinese medicine in the treatment of SAP,and to summarize the effective treatment methods for clinical guidance and promotion.Methods:Initially retrieved the related literature of TCM treatment of SAP on CNKI platform,extracted retrieval words and formulated retrieval strategies,so as to ensure recall rate and accuracy.Based on retrieval strategies,search the CNKI,Wanfang,VIP,CBM,PubMed,Cochrane network,Library Web of Science biomedical database platform of all clinical reports about the TCM treatment of SAP,limited time from January 1,2012 to December31,2017,including journals,conference papers,dissertations and academic reports have been published and registered but not published literature,the main language is Chinese and English.The subjects included in the literature report were people suffering from SAP,and the intervention measures were not limited.A descriptive summary of all related literature was carried out,and meta analysis was carried out for the required randomized controlled trials.According to the fomulated inclusion criteria and exclusion criteria,quality assessment and data extraction form,screened those reports by reading the title,abstract and full text,and manual retrieval the literature references,the qulified documents in Journal,and asked the author abuot whether has unpublished literatures.Then,based on the modified Jadad score and Cochrane system evaluation methods,made the document quality evaluation and bias risk assessment for the final inclusion literatures,and derive the bias risk assessment summary chart.This stage were done by two reviewers.Collected the results of the screening of two evaluators,and the literature on the disagreement was discussed or the third parties were asked to be evaluated until the agreement was reached.The data of four indicators including the total effective rate,mortality rate,abdominal pain relief time and blood amylase recovery time were extracted,and entered into Review Manager 5.3 software.At last,heterogeneity test and combined statistics analysis were conducted,and forest map and funnel plot were derived.Results:There were 2663 articles in Chinese and 251 in English after the searching stage and duplicates elimination stage.According to the inclusion and exclusion criteria,25 articles were included in the literature at last.2 of them were also came from English doucuments.The quality of all the documents was generally poor.17 of 25 articles has the total efficiency for observation indexes,the total heterogeneity test Chi~2=3.44,df=15(P=1.00),I~2=0%,,fixed effect model was used for combining statistic OR test value Z=7.68(P<0.00001);the mortality rate was observed with 4of 25 literatures,heterogeneity test Chi~2=0.47,df=3(P=0.93),I~2=0%,fixed effect model was used for combining statistic OR test value Z=2.80(P=0.005);abdominal pain relief time was observed with 18 references,the total heterogeneity test Tau~2=0.82,Chi~2=621.41,df=17(P<0.00001),I~2=97%,using a random effects model with statistic MD test value Z=8.41(P<0.00001);the recovery time of blood amylase as observation indexes in 4 articles,heterogeneity test Tau~2=1.30,Chi~2=40.99,df=4(P<0.00001),I~2=90%,using a random effects model with statistics the MD test value was Z=6.65(P<0.00001);the combined statistics of the four observation indexes all showed statistical significance.Conclusion:According to the current level of evidences,it can be inferred that with traditional Chinese medicine treatment combined with western medicine in the treatment of SAP is better than pure western medicine treatment,prescription with Dachengqi Decoction,Qingyi Decoction represented with good clinical efficacy,the major intervention measures for oral administration and enema;but as a result of this study provides evidence of lower grade and no clear promotion,it still need a large sample and high quality RCT documents for support.Research registration:This system evaluation has been registered in the PROSPERO database,the registration number is:CRD42018078375. |
PDF Full Text Request