| Objective:The sequelae of pelvic inflammatory disease(SPID)are mainly manifested as chronic pelvic pain(CPP),infertility,ectopic pregnancy,and recurrent pelvic inflammatory disease,causing great harm to the reproductive and psychological health of women of childbearing age.Nowadays,the clinical practice of Chinese medicine varies from one practitioner to another,and there are no clear guidelines for Western medicine.In order to guide primary care clinicians in the treatment of SPID,reduce the recurrence rate of SPID,and relieve the physical and psychological pain of patients,there is an urgent need to develop clinical guidelines for the diagnosis and treatment of SPID by integrated traditional Chinese and Western medicine.In this study,we systematically searched the literature on the integrated traditional Chinese and Western medicine in the treatment of SPID with reference to the GRADE methodology(The Grading of Recommendations Assessment,Development and Evaluation),formed a system of evidence,selected an integrated traditional Chinese and Western medicine treatment plan supported by evidence-based medical evidence and with a high degree of expert consensus,in order to standardize and promote the clinical treatment of SPID with integrated traditional Chinese and Western medicine.Methods:1 Preparatory Guidelines Working Group:Experts who are well-known and authoritative in China and have rich clinical experience in treating SPID with integrated traditional Chinese and Western medicine were selected to form the guideline steering group,guideline development group,system evaluation group and external review group.At the same time,professionals from the Center for Clinical Evaluation of Traditional Chinese Medicine of the Chinese Academy of Traditional Chinese Medicine were invited to set up a guideline methodology expert group.To ensure the universality of the guidelines,experts in the field of Chinese medicine and Western medicine gynecology were included,with Chinese medicine experts as the mainstay and Western medicine experts as a supplement.2 Guideline Registration:We registered the guideline for the diagnosis and treatment of SPID in integrated traditional Chinese and Western medicine on the International Practice Guideline Registry Platform(IPGRP),and at the same time declared to the Group Standards Office of the Association of Integrated Traditional Chinese and Western Medicine and established a project for the guideline.3 Collection of Clinical Questions:Two rounds of Delphi method expert questionnaire were used to obtain the most concerned clinical issues related to SPID in the current clinical setting.The first round of Delphi method used open-ended questions to collect a wide range of questions nationwide,and the results were summarized and organized before the second round of Delphi method was conducted to evaluate the importance of the questions,and finally 10 clinical questions were selected and deconstructed according to the PICO(population,intervention,comparison,outcome)principles.4 Evidence Retrieval:Evidence from available guidelines(including Chinese medical consultation guidelines and Western medical consultation guidelines),systematic reviews,Meta-analyses,and mesh Meta-analyses were included,and the search databases included Embase,PubMed,Web of Science(WOS),Wanfang,and CNKI;when no available systematic reviews or Meta-analyses were available,randomized controlled trials(randomized controlled trials,RCTs)were included to obtain evidence.The search was conducted from the time of database establishment to September 2022,and updated literature was supplemented in April 2023.The search was limited to Chinese and English publication languages,and the included systematic evaluations and meta-analysis are further traced to their references.5 Systematic Evaluation:For the systematic review and meta-analysis,the AMSTAR 2 scale was used for the risk of bias analysis,and the PRISMA 2020 item list was used to evaluate its quality,for high quality systematic evaluation and Meta-analysis were directly adopted.For RCTs the methodological quality was evaluated using the Cochrane Risk of Bias Assessment Tool and Review Manager 5.4 software.6 Evidence Evaluation:The GRADE systematic methodology was used to evaluate the quality of the body of evidence for the effectiveness and safety of combining Chinese and Western medicine in the treatment of pelvic inflammatory disease sequelae.According to the GRADE methodology,the quality of evidence will be classified into five grades:A,B,C,D,and GPP.After completing the evidence grading,the evidence will be presented through an evidence summary table.7 Formation of expert consensus:After evaluating the evidence and discussing its degree of conformity to the clinical question,the evidence was transformed into recommendations.Make the GRADE decision table,and consensus on recommendations was reached through one round of questionnaires using a modified Delphi method.Results:1 Delphi method:The first round of Delphi method experts were highly professional,with an active level of 100%.The second round Delphi method expert positivity was 92.3%.The mean value(X)of the importance score is greater than 3.5,the full score ratio(K)is greater than 0.25,and the coefficient of variation(CV)is less than 0.25,indicating that these items are very important,and the degree of concentration and coordination of expert opinions are high.The third round Delphi method expert positivity was 100%.A total of 26 entries were listed,the mean value(X)of all entries was greater than 3.5,the coefficient of variation(CV)was less than 0.25,the full score ratio(K)of 21 entries was greater than 0.25,and the full score ratio(K)of 5 entries was less than 0.25,indicating that the combination of Chinese and Western medicine treatment in these entries was important for the treatment of SPID,and the concentration of expert opinions was high,and the coordination of expert opinions was high.2 Clinical Problems:Through Delphi method and literature screening,a total of 18 SPIDrelated key clinical problems were obtained,mainly focusing on the treatment of SPID recurrent PID and chronic pelvic pain with integrated Chinese and Western medicine.For recurrent PID,they were divided into heat toxin incandescence evidence and damp-heat stasis evidence.Each syndrome type is to study the effectiveness of traditional Chinese medicine decoction/traditional Chinese medicine external treatment/traditional Chinese medicine combined with western medicine treatment compared with simple western medicine treatment,with a total of 6 clinical problems.For chronic pelvic pain,it is divided into damp-heat stasis evidence,qi stagnation and blood stasis evidence,cold-damp stagnation evidence,and qi deficiency and blood stasis evidence.Each syndrome type is to study the effectiveness of traditional Chinese medicine decoction/traditional Chinese medicine external treatment/traditional Chinese medicine combined with western medicine treatment compared with simple western medicine treatment,with a total of 12 clinical problems.3 Recommendation:For the treatment of PID recurrent attacks during the attack period,the combination of Wuwei Disinfection Drink and Dahuang Mudan Tang with antibiotics is more effective in the selection of traditional Chinese medicine decoction for the syndrome of heat and toxin excess.Based on B-level evidence,it is strongly recommended with a consensus of 97.83%;The application of Xianfang Huoming Yin combined with coix seed and winter melon seed combined with antibiotics for the treatment of dampness heat stasis syndrome is more effective than the simple use of antibiotics.Based on B-level evidence,it is strongly recommended with a consensus of 93.48%.In terms of the selection of external treatment methods,the application of Dahuang Mudan Tang retention enema combined with antibiotics for the syndrome of excessive heat toxin is more effective than the simple use of antibiotics.Based on B-level evidence,it is strongly recommended with a consensus of 58.70%;The effectiveness of using Xianfang Huoming Yin retention enema combined with antibiotics for the treatment of heat toxin burning syndrome is better than that of using antibiotics alone.Based on B-level evidence,it is weakly recommended,with a consensus of 84.78%;The effectiveness of acupuncture and moxibustion combined with antibiotic treatment for each syndrome type is better than that of antibiotic treatment alone.Based on Level B evidence,it is strongly recommended,with a consensus of 78.26%.In the selection of traditional Chinese patent medicines and simple preparations,the efficacy of Fule Granule combined with antibiotics in the treatment of heat toxic exuberance syndrome is better than that of antibiotics alone.Based on Level B evidence,it is strongly recommended,with a consensus of 84.78%;The effectiveness of using gynecological Qianjin tablets combined with antibiotics for the treatment of dampness heat stasis syndrome is superior to using antibiotics alone.Based on A-level evidence,it is strongly recommended with a consensus of 84.78%;The effectiveness of using Huahong tablets/capsules/granules combined with antibiotics for the treatment of dampness heat stasis syndrome is better than that of using antibiotics alone.Based on B-level evidence,it is strongly recommended with a consensus of 84.78%;The effectiveness of using Fuyanxiao Capsules combined with antibiotics for the treatment of dampness heat stasis syndrome is better than that of using antibiotics alone.Based on B-level evidence,it is strongly recommended with a consensus of 84.78%;The effectiveness of Kangfuyan Capsules combined with antibiotics in the treatment of dampness heat stasis syndrome is superior to that of antibiotics alone.Based on A-level evidence,it is strongly recommended with a consensus of 84.78%;The effectiveness of using Kangfu Xiaoyan Suppository combined with antibiotics for the treatment of dampness heat stasis syndrome is better than that of using antibiotics alone.Based on A-level evidence,it is strongly recommended with a consensus of 91.30%.For the treatment of chronic pelvic pain,in terms of the selection of traditional Chinese medicine decoction,the effectiveness of using Yinjia Pill plus or minus combination with antibiotics for dampness heat stasis syndrome is better than that of using antibiotics alone.Based on B-level evidence,it is strongly recommended,with a consensus of 71.74%;The effectiveness of using Xuefu Zhuyu Tang with modified combination antibiotics for the treatment of Qi stagnation and blood stasis syndrome is better than that of using antibiotics alone.Based on B-level evidence,it is strongly recommended with a consensus of 71.74%;The application of Shaofu Zhuyu Tang combined with Guizhi Fuling Pill and modified combination of antibiotics in the treatment of cold dampness and stasis syndrome is more effective than the simple use of antibiotics.Based on B-level evidence,it is strongly recommended with a consensus of 71.74%;The effectiveness of the application of Lichong decoction in the treatment of Qi deficiency and blood stasis syndrome is superior to the simple use of antibiotics.Based on B-level evidence,it is strongly recommended,with a consensus of 71.74%.In terms of the selection of external treatment methods,the application of Dahuang Mudan Tang retention enema combined with antibiotics for dampness heat stasis syndrome is more effective than the simple use of antibiotics.Based on B-level evidence,weak recommendation,with a consensus of 69.57%;The effectiveness of retention enema with Yiren Patrinia Sauce Hongteng Tang in the treatment of Qi stagnation and blood stasis syndrome is superior to that of simple antibiotic treatment.Based on B-level evidence,it is weakly recommended,with a consensus of 69.57%;The effectiveness of acupuncture and moxibustion treatment for each syndrome type is better than that of western medicine treatment alone.Based on Level B evidence,it is strongly recommended,with a consensus of 78.26%.In the selection of traditional Chinese patent medicines and simple preparations,the efficacy of Kangfuyan capsule combined with antibiotics in the treatment of damp heat and blood stasis syndrome is better than that of antibiotics alone.Based on Level B evidence,it is strongly recommended,with a consensus of 84.78%;The effectiveness of using Jinying Capsules combined with antibiotics for the treatment of dampness heat stasis syndrome is better than that of using antibiotics alone.Based on B-level evidence,it is weakly recommended,with a consensus of 60.87%;The effectiveness of Danbai Granules combined with antibiotics in the treatment of dampness heat stasis syndrome is superior to that of antibiotics alone.Based on B-level evidence,it is strongly recommended with a consensus of 91.30%;The effectiveness of using Kangfu Xiaoyan Suppository combined with antibiotics for the treatment of dampness heat stasis syndrome is superior to that of using antibiotics alone.Based on B-level evidence,it is strongly recommended with a consensus of 91.30%;The effectiveness of using Huayu Sanjie enema combined with antibiotics for the treatment of dampness heat stasis syndrome is better than that of using antibiotics alone.Based on B-level evidence,it is strongly recommended with a consensus of 91.30%;The effectiveness of using Kunfukang capsules/tablets combined with antibiotics for the treatment of Qi stagnation and blood stasis syndrome is superior to that of using antibiotics alone.Based on B-level evidence,weak recommendation,consensus rate of 73.91%;The effectiveness of using Zhitong Huazheng Capsule combined with antibiotics for the treatment of Qi deficiency and blood stasis syndrome is better than that of using antibiotics alone.Based on B-level evidence,it is strongly recommended with a consensus of 56.52%;The effectiveness of using Guizhi Fuling Capsules combined with antibiotics for the treatment of cold dampness and stasis syndrome is superior to using antibiotics alone.Based on A-level evidence,it is strongly recommended,with a consensus of 84.78%.For infertility and ectopic pregnancy caused by sequelae of pelvic inflammatory disease,since there are corresponding guidelines,and surgical treatment is the main treatment,refer to their respective guidelines for diagnosis and treatment.Conclusions:The effectiveness of each SPID-related combined Chinese and Western medical treatment regimen included in this study was superior to the use of Western medicine alone in terms of overall clinical efficiency,laboratory indices,clinical symptoms and signs,and improvement in disease prognosis. |
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