A Literature Study On Clinical Practice Guideline On Traditional Chinese Medicine Alone Or Combined With Antibiotics For Patients With Pelvic Inflammatory Disease

Objective:The formulation of this clinical practice guideline is based on the principle of “evidence-based,consensus-based,and experience-based”.This study uses evidence-based evaluation of Chinese medicine for pelvic inflammatory disease(PID)literature,and selects the safe and effective treatment of pelvic inflammatory disease(PID),and provide evidence-based medical basis for the development of the first draft of the guideline,to guide the rational use of traditional Chinese medicine to treat PID,reducing the unreasonable use of antibiotics,the incidence of antibiotic resistance,and the risk of clinical medication,improving clinical efficacy.Methods:1.Selection,construction and structural treatment of clinical problemsThe research team collected the problems according to the clinical efficacy and existing problems of Chinese medicine treatment of PID,collected and summarized the collected clinical problems,formed a questionnaire,and used the Delphi method to investigate gynecologists.The results are processed,and finally a list of key clinical problems is formed,submitted to the consensus group.After discussion,the formation of PICO is P(patient or problem),I(intervention),C(comparision),O(outcom)form of structural problems.2.Search and filter literatureA literature search strategy is developed based on the structured problem of the PICO form.Two research groups(two in each group)searched the relevant literature of each database by computer.According to the inclusion exclusion criteria,the documents that meet the requirements are screened.The third researcher is responsible for checking and intervening in the objection.3.Evaluation of literature risk biasSelect appropriate risk bias tools to evaluate the literature for the appropriate study type.The systematic review/meta analysis used the AMSTAR scale,the non-randomized clinical trials used the MINORS entry,the observational clinical study(cohort study,case-control study)used the NOS scale,and the randomized controlled trial used the Cochrane risk bias assessment tool.4.Analysis of documentary evidenceExtract and analyze the data included in the study,the interventions and the RCTs with the same outcome indicators,and use Meta-analysis with Review Manager 5.3.At the same time,biased evaluation of the inclusion of ?9 items was included.5.Rating of evidence qualityThe evidence body of the study outcome was ranked using the Grades of Recommendations Assessment,Development and Evaluation(GRADE).Results:1.Selection,construction and structural treatment of clinical problemsAmong the nationwide Chinese and Western medicine gynaecologists,60 gynaecologists were selected for investigation,60 questionnaires were issued,60 questionnaires were recovered,2 duplicates were submitted,and 58 valid questionnaires were collected.After integration,10 clinical issues were identified and the structuring issues in the form of PICO were generated by expert panel discussions.2.Inclusion of literature resultsThe number of documents obtained through the search was 7,907,and the number of documents obtained after the check was 7,234.After reading the title and abstract,6097 were excluded,the 1137 articles were obtained and read.According to the inclusion and discharge standards,56 research papers were finally included.3.Literature bias risk assessment resultsFinally,56 studies were included,including 19 drugs(10 Chinese patent medicines and 9 Chinese medicine prescriptions).According to different research types of the literature,different literature evaluation tools were selected.The results as follows: There were 2 articles in the meta-analysis,AMSTAR The scores were all 9 points;It included 43 RCTs,and the results of the Cochrane Collaboration Risk Assessment Tool: Four RCT papers are high risk of bias,zero RCT Literatures are low risk of bias,thirty-nine RCT papers are unclear risk of bias;It included 5 non-randomized clinical trials,MINORS entry scores were ?18 points;It included 6 observational studies,NOS scales were more than 5 stars.4.Comprehensive analysis of evidenceMeta-analysis of data on five kinds of proprietary Chinese medicines(Jin Gang Teng preparation,Fuyan Kangfu Capsule,Fuyanshu capsule,Huahong preparation and Kangfuyan capsule).The systematic evaluation of the published Fuke Qianjin tablet(capsule)was included and analyzed.The results showed that the clinical efficacy of the six Chinese patent medicines combined with antibiotics in treating PID was better than that of the single antibiotics.The clinical results of the meta-analysis of the six Chinese patent medicines were statistically significant.The funnel plots of the three drugs,such as Huahong preparation,Fuyan Rehabilitation capsule,and Fuke Qianjin capsule(tablet),were slightly asymmetrical,indicating mild publication bias.5.GRADE rating resultsThe quality of evidence was evaluated by GRADEpro software.The results were as follows: no high quality evidence;There are three kinds of TCM treatment methods for medium quality evidence: Jingangteng preparation,Fuke Qianjin capsule(tablet)and Fuyan Kangfu capsule;There are 8 TCM treatments with low quality evidence: Fule Granules,Huahong preparation,Kangfuyan capsule,Fuyanshu capsule,Fuyanxiao capsule,Kangfu Xiaoyan Suppository,Hongteng Decoction and Wu Wei Xiao Du Decoction;There are 8 TCM treatments with very low quality evidence: Yinjia decoction,Yinqiao Hongjiang Jiedu Decoction,Shuangbai powder,Sihuang powder,Ermiao powder,Xianfang huoming yin,Chai zhibai jiang soup and Fukang oral liquid.Conclusion:In this study,the clinical efficacy of PID alone or in combination with antibiotics was confirmed by translating clinical problems into research questions,The research team conducted literature retrieval,screening,risk assessment of bias,evidence analysis,GRADE evidence rating and other evidence-based literature research methods to prove that the clinical efficacy of traditional Chinese medicine single/combined antibiotics in the treatment of PID is better than that of the single antibiotics group.The safety of traditional Chinese medicine single/combined antibiotic in treating PID was higher than that of single antibiotic group.This study provides evidence-based medical research basis for the first draft of the guidelines.