| Purpose:This guide follows the principle of "evidence-based,consensus-based,and experience-based".It aims to select Chinese patent medicines for the treatment of pelvic inflammatory disease sequelae with clear clinical positioning,affirmative efficacy,evidence based on evidence-based medicine,and extensive expert consensus.The varieties provide clear guidance for western medicines in the rational use of proprietary Chinese medicines for the treatment of pelvic inflammatory disease sequelae,improve doctors' prescription quality and clinical efficacy of proprietary Chinese medicines,and reduce the risks associated with irrational use.This project will provide evidence-based medical research basis for the development of guidance experts questionnaires and draft guidebooks through clinical investigations,literature search and screening,literature bias risk assessment,comprehensive evidence analysis,GRADE evidence rating,and the formation of evidence registration forms.Methods:1.Clinical issues translated into research issuesThe research team develops a list of original questions according to the scope of the guidelines,uses Delphi's method to investigate,integrates and summarizes important clinical issues,forms a list of key clinical questions,and submits to a consensus panel for discussion of the PICO(Patient Population,Intervention,Control,and Outcomes)model to conduct structured analysis,and translate clinical issues into research questions.2.Literature search and screeningFollow the concept of evidence-based medicine,formulate search strategies,and fully search relevant documents through Chinese databases and foreign language databases.According to the inclusion and exclusion criteria,2 people screened the literature back to back to make the final decision.3.Bibliographic Risk AssessmentThe final inclusion of the literature was categorized according to the type of study and the accepted bias risk assessment tool was used to evaluate the literature study methodology.Meta analysis used the AMSTAR scale,RCT used the ROB scale,nonrandomized clinical trials used MINORS items,and observational clinical studies(cohort studies,case control series)used NOS scale.4.Comprehensive analysis of evidenceBased on statistical principles,quantitative or qualitative analysis of the extracted literature data was performed.Quantitative analysis uses meta-analysis,RCTs with consistent intervention measures and outcome indicators,Meta-analysis using Review Manager 5.3,heterogeneity analysis,sensitivity analysis when necessary,and inclusion of more than 10 studies for publication bias assessment.Qualitative analysis summarizes the characteristics of each clinical study by means of subjects,interventions,results,etc.,and explains the results.5.GRADE Evidence RatingEvidence-based research evidence was graded using the GRADE Evidence Quality Grading Criteria,and was divided into four levels of “high,medium,low,and very low”.Results:1.Clinical Investigation Results1.A total of 19 Chinese and Western medicine gynecologists were selected across the country to investigate the importance of 23 clinical problems.A total of 19 questionnaires were sent out,19 questionnaires were collected,and finally 6 clinical questions were selected.After the structural treatment,they were converted into research questions.2.Literature search and screening resultsTwo people back-to-back search,obtained 8643 articles on the treatment of pelvic inflammatory disease sequelae of Chinese patent medicines,6506 articles were obtained after examination,and 1840 articles after reading articles and abstracts were excluded after reading 4566 articles.Exclusion criteria were checked and 1729 articles were excluded.And according to the 2012 national essential medicine list,the 2015 edition of the Chinese Pharmacopoeia,the 2017 national medical insurance catalog,and the Chinese patent medicine name obtained by electronic search again.Finally,31 kinds of proprietary Chinese medicines were included,and 111 literature studies were conducted.3.Literature bias risk assessment resultsThere was 1 Integrated into Meta-analysis,AMSTAR scale scored 8 points,was a medium-quality literature;There were RCT 89 articles,ROB scale was evaluated as high-risk 64 articles,low-risk 9 articles,risk uncertainty 16 articles;There were non-randomized Of the 12 clinical trials,there were 4 MINORS item scores for 11 points,1 for 13 points,1 for 16 points,5 for 18 points,and 1 for 20 points;for observational studies,There were 2 articles for which the NOS scale was evaluated as 5 stars,and there were 7 articles for 6 stars.4.Comprehensive analysis of evidenceRevman software was used to analyze the outcome indicators.Finally,9 kinds of proprietary Chinese medicines were used for meta-analysis.Forest plots were exported and heterogeneity analysis was performed.Fixed-or random-effect models were used to combine the effects.Sensitivity analysis was performed for serious heterogeneity.The combined effect of the multiple studies included in the meta-analysis of 9 proprietary Chinese medicines was statistically significant.Among them,the Guizhi Fuling capsule(pill)meta-analysis included 30 RCTs,the Gynecological Qianjin Capsule(tablet)meta-analysis included 20 items of RCT,and the inverted funnel plot was derived for publication bias evaluation.Each study was basically symmetrical on both sides of the funnel,indicating that Publishing bias has less influence.5.GRADE Rating ResultsGRADEpro software was used to grade the quantitative studies and qualitative studies included in the study.There was no high-level evidence;There were 7 kinds of Chinese patent medicines for intermediate-level evidence: Gynecological Qianjin capsules(chips),Jingangteng preparations,Kangfuyan capsules,Guizhi Fuling capsules(Pills),Kangfu anti-inflammatory suppository and Jinying capsule,Fuyan Healing Capsules(tablets);low-level evidence of 14 proprietary Chinese medicines: Pot Yanjing Preparations,Huangtengsu Tablets,Fuyanshu Capsules,Anti-fuyan Capsules,Huahong Preparations,Gongyanping Preparations,Puling Panyankang Granules,Fuyanjing Capsules,Jinxiang Capsules,Kunfukang Capsules,Honghua Ruyi Pills,Danhuangquyu Capsules,Analgesic Preparations,Red Tiger Enema Solution;There are 10 kinds of low-level evidence of proprietary Chinese medicines: Fu Yankang Tablets,Fubao Granules,Fule Preparations,Jinji Capsules,Fuyanxiao Capsules,Jinji Huayu Granules,Shaofu Zhuyu Capsules(Pills),Fu Ke Jing Capsule,Female Gold Capsules,Huayu Sanjie Enema Solution.Conclusion:A total of 31 proprietary Chinese medicines for the treatment of pelvic inflammatory disease sequelae were obtained from literature searches.Quantitative and qualitative systematic evaluations found that the clinical efficacy of proprietary Chinese medicines or Chinese patent medicines combined with antibiotics was superior to that of antibiotics,including improving symptoms such as chronic pelvic pain.Improve patient gynecological examination uterus attachment tenderness and other signs to improve the efficacy of TCM syndromes,the incidence of adverse reactions than the antibiotic group.The research team evaluated the systematic evaluation of evidence to obtain intermediate evidence of 7 kinds of proprietary Chinese medicines,low-level evidence of 14 kinds of proprietary Chinese medicines,and extremely low-level evidence of 10 kinds of proprietary Chinese medicines,to provide evidence-based medical research basis for the development of guideline expert questionnaires and draft guidelines. |
PDF Full Text Request