康妇消炎栓治疗盆腔炎症性疾病临床应用专家共识

Expert consensus statement on Kangfu Xiaoyan Suppository in treatment of pelvic inflammatory in clinical practice

康妇消炎栓临床较为广泛的应用于对妇科炎性疾病的治疗。长期的临床应用和一定量的研究证据均表明康妇消炎栓不仅可以改善女性盆腔炎症性疾病(pelvic inflammatory disease,PID)的临床症状以及降低复发率、改善后遗症,还有较好的安全性和经济性特点。该药作为国家中药保护品种、医保乙类品种,作为直肠给药的中成药外用药,入选2012年中华中医药学会发布的《中医妇科常见病诊疗指南》、2014年版中华医学会妇产科学分会感染性疾病协作组发布的《盆腔炎性疾病诊治规范》和2017年中华中医药学会团体标准《中医药单用/联合抗生素治疗常见感染性疾病临床实践指南-盆腔炎性疾病》。为进一步提高临床医生对该药的认识,更好地指导其临床合理用药,邀请来自中西医妇科领域的临床一线专家研制编撰该专家共识。共识充分考虑临床证据和专家临床经验,通过名义组法,对于有证据支持的临床问题形成推荐意见,对于没有证据支持的临床问题形成共识建议。专家共识意见的形成主要考虑6个方面的因素:证据质量、经济性、疗效、不良反应、病人可接受性以及其他。该共识基于临床研究证据和专家经验,采用简洁明了的体例格式,为该药的临床使用提供了初步的参照,但仍需通过大量的高质量研究提供循证支持,并在未来根据实际应用中随着新的临床问题的出现及循证证据的更新予以修订。

Kangfu Xiaoyan Suppository is widely used in the treatment of gynecological inflammatory diseases.Long-term clinical application and a certain amount of research evidences show that Kangfu Xiaoyan Suppository can alleviate the clinical symptoms of pelvic inflammatory diseases,reduce the recurrence rate,and relieve sequelae,with a better safety and economic characteristics.As a type of nationally protected traditional Chinese medicine and type B medicine included in medical insurance,it has been selected as a Chinese patent medicine for rectal administration.It was included in the Guidelines for diagnosis and treatment of common gynecological diseases of traditional Chinese medicine published by the Chinese Academy of Traditional Chinese Medicine in 2012,the Pelvic inflammatory diseases diagnosis and treatment guidelines issued by the Infectious Diseases Collaborative Group of the Obstetrics and Gynecology Branch of the Chinese Medical Association in 2014,and the group standard of Single use of traditional Chinese medicine/combined antibiot guidelines for clinical practice-pelvic inflammatory diseases of the Chinese Academy of Traditional Chinese Medicine in 2017.To further enhance clinicians’understanding of the drug and better guide its rational clinical use,experts from the field of gynecology of traditional Chinese and Western medicine were invited to develop and compile this expert consensus.This consensus takes full account of clinical evidences and expert clinical experience,and form recommendations for clinical problems based on evidences and consensus recommendations for clinical problems without evidence by nominal grouping method.The expert consensus is mainly formed in the consideration of six factors:quality of evidence,economy,efficacy,adverse reactions,patient acceptability and others.Based on clinical research evidences and expert experience,this consensus provides a preliminary reference for the clinical use of the drug in a concise and clear format.However,evidence-based support is still required in a large number of high-quality studies,and this consensus will be revised in the future according to new clinical problems and the update of evidence-based evidence in practical application.