This is the protocol of updated our previously guideline named “A rapid advice guideline for the diagnosis and treatment of 2019 novel coronavirus (2019-nCoV) infected pneumonia (standard version)”. This protocol included guideline methodology, target users, target population, conflict of interest policy, evidence searching, review and assessment, grading of evidence and recommendations development of recommendations, and updating plan. We also attached three appendices for readers: list of clinical questions, searching strategies, survey questionnaire of conflict of interest.
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Evidence-based Chinese expert recommendations on drug prevention,diagnosis, treatment, and discharge management of covid-19 a protocol
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References
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2.WHO. Coronavirus disease 2019 (COVID-19) Situation Report-97[EB/OL]. (2020-04-27)[Assess on 2020-04-27]. https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200426-sitrep-97-covid-19.pdf?sfvrsn=d1c3e800_6.
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附录1 指南结构及临床问题
Appendix 1 Structure of guideline and clinical questions
一、药物预防(Prophylactic drug treatments)
(1) 哪些药物可以进行普通人群COVID-19的预防以减少SARS-CoV-2的感染?(Which kind of Traditional Chinese Medicine (TCM) agents can prevent COVID-19 in pre-exposure population to reduce SARS-CoV-2 infection?)
(2) 哪些中医药(Traditional Chinese Medicine, TCM)疗法可以进行普通人群COVID-19的预防以减少SARS-CoV-2的感染?(Which kind of Traditional Chinese Medicine (TCM) agents can prevent COVID-19 in pre-exposure population to reduce SARS-CoV-2 infection?)
(3) 哪些药物可以进行接触或照顾COVID-19确诊患者后的预防以减少SARS-CoV-2的感染?(Which kind of agents can prevent COVID-19 in post-exposure population (who contacted or took care of patients with COVID-19) to reduce SARS-CoV-2 infection?)
(4) 哪些中医药(Traditional Chinese Medicine, TCM)疗法可以进行接触或护理COVID-19确诊患者后的预防以减少SARS-CoV-2的感染?(Which kind of TCM agents can prevent COVID-19 in post-exposure population (who contacted or took care of patients with COVID-19) to reduce SARS-CoV-2 infection?)
二、诊断(Diagnosis)
(1) COVID-19病人的临床表现有哪些?(What are the clinical manifestations of COVID-19 patients?)
(2) 实验室检测结果在COVID-19诊断与预后的价值如何?(What is the value of hematological testing in the diagnosis and prognosis of COVID-19?)
(3) 进行呼吸道核酸检测的时,下呼吸道检测相比上呼吸道检测是不是有更高的阳性检测率?(Is there a higher positive detection rate in lower respiratory tract specimens than that in upper respiratory tract specimens when performing reverse transcription-polymerase chain reaction (RT-PCR)?)
(4) 除RT-PCR外,IgM和IgG抗体检测可以用来诊断COVID-19?(Should IgM and IgG antibody test be used for the diagnosis of COVID-19 in addition to RT-PCR?)
(5) 是不是CT检测可以作为核酸检测的重要补充?(Should chest computed tomography (CT) be an important supplement to nucleic acid test?)
(6) COVID-19病人CT影像学特征是什么?(What are the CT imaging manifestations of COVID-19 patients?)
(7) COVID-19无症状感染者的CT影像学表现有哪些?(What are the CT features of asymptomatic infections with COVID-19?)
三、治疗(Treatment)
1 抗病毒药物治疗(Antiviral therapy)
(1)洛匹那韦/利托那韦治疗COVID-19是否可以改善患者的临床结局?(Should lopinavir-ritonavir be used to treat patients with COVID-19 to improve clinical outcomes?)
(2)阿比多尔治疗COVID-19是否可以改善患者的临床结局?(Should arbidol be used to treat patients with COVID-19 to improve clinical outcomes?)
(3)法匹拉韦治疗COVID-19是否可以改善患者的临床结局?(Should favipiravir be used to treat patients with COVID-19 to improve clinical outcomes?)
(4)瑞德西韦治疗COVID-19是否可以改善患者的临床结局?(Should remdesivir be used to treat COVID-19 patients to improve clinical outcomes?)
(5)羟氯喹或氯喹治疗COVID-19是否可以改善患者的临床结局?(Should hydroxychloroquine (HCQ) be used to treat COVID-19 patients to improve clinical outcomes?)
(6) 干扰素治疗COVID-19 是否可以改善患者的临床结局?(Should interferon be used to treat patients with COVID-19 to improve clinical outcomes?)
(7)抗病毒药物联合治疗COVID-19是否可以改善患者的临床结局?(Could a combination of antiviral drugs be used to treat patients with COVID-19 to improve clinical outcomes?)
2 免疫治疗(Immunomodulatory therapy)
(1)白介素-6抑制剂治疗COVID-19是否可以改善患者的临床结局?(Should Interleukin-6 inhibitors be used to treat COVID-19 patients to improve clinical outcomes?)
(2)白介素-1抑制剂治疗COVID-19是否可以改善患者的临床结局?(Should Interleukin-1 inhibitors be used to treat COVID-19 patients to improve clinical outcomes?)
3 TCM疗法(TCM treatment)
(1)清肺排毒汤治疗COVID-19是否可以改善患者的临床结局?(Should Qingfei Paidu Decoction (TCM) be used to treat patients with COVID-19 to improve clinical outcomes?)
(2)连花清瘟胶囊治疗COVID-19是否可以改善患者的临床结局?(Should Lianhua Qingwen Granules/Capsules (TCM) be used to treat patients with COVID-19 to improve clinical outcomes?)
4 重症及危重症病人治疗(Treatment for severe and critical cases)
(1)糖皮质激素治疗COVID-19是否可以改善患者的临床结局?(Should glucocorticoid be used to treat COVID-19 patients to improve clinical outcomes?)
(2)血液净化治疗重型、危重型COVID-19患者是否可以改善患者的临床结局?(Should blood purification be used to treat COVID-19 patients to improve clinical outcomes?)
(3)康复者血浆治疗COVID-19是否可以改善患者的临床结局?(Should convalescent plasma be used to treat COVID-19 patients to improve clinical outcomes?)
(4)肺移植治疗晚期阶段的重症及危重症患者是否可以改善患者的临床结局?(Should lung transplantation be used to treat COVID-19 patients in end-stage patients to improve clinical outcomes?)
(5)有创通气与无创通气的选用指征是什么?(What are the indications for COVID-19 patients to use invasive or noninvasive ventilation?)
(6)ECMO使用的适应证是什么?(What are the indications for COVID-19 patients to use extracorporeal membrane oxygenation?)
四、出院(Discharge)
(1) COVID-19病人的出院标准如何设定?(What are the discharge criteria for COVID-19 patients?)
(2) 出院后RT-PCR监测如何进行?(Is the RT-PCR test needed to monitor COVID-19 patient after discharge?)
(3) 出院复阳患者的影像学表现如何?(What are the imaging findings of patients where RT-PCR shows positive recovery from COVID-19?)
(4) 出院复阳患者如何进行管理?(What is the management plan in patients whose RT-PCR shows SARS-CoV-2 positive after discharge?)
附录2 文献检索策略
Appendix 2 Literature retrieval strategy
一、原始研究检索
1 诊断部分
1.1 临床表现
#1 "severe acute respiratory syndrome coronavirus 2"[Supplementary Concept] OR COVID-19[Supplementary Concept]
#2 "severe acute respiratory syndrome coronavirus 2"[Title/Abstract] OR SARS-COV-2[Title/Abstract] OR COVID-19[Title/Abstract] OR COVID19[Title/Abstract] OR "The 2019 coronavirus"[Title/Abstract] OR "2019 coronavirus"[Title/Abstract] OR "2019 novel coronavirus"[Title/Abstract] OR 2019-nCoV[Title/Abstract] OR "Novel coronavirus pneumonia"[Title/Abstract] OR NCP[Title/Abstract] OR "coronavirus disease"[Title/Abstract] OR "coronavirus disease-19"[Title/Abstract] OR "coronavirus disease 2019"[Title/Abstract] OR "Corona Virus Disease 2019"[Title/Abstract] OR HCoV-19[Title/Abstract] OR SARS2[Title/Abstract]
#3 #1 OR #2
#4 "Signs and Symptoms"[MeSH Terms] OR Fever[MeSH Terms] OR Cough[MeSH Terms] OR Fatigue[MeSH Terms] OR Dyspnea[MeSH Terms] OR Myalgia[MeSH Terms]
#5 "Signs and Symptoms"[Title/Abstract] OR Fever[Title/Abstract] OR "muscle pain"[Title/Abstract] OR Cough[Title/Abstract] OR Fatigue[Title/Abstract] OR Dyspnea[Title/Abstract] OR Myalgia[Title/Abstract] OR "clinical manifestation"[Title/Abstract] OR "clinical manifestations"[Title/Abstract] OR "clinical feature"[Title/Abstract] OR "clinical features"[Title/Abstract] OR "clinical characteristics"[Title/Abstract] OR "clinical symptoms"[Title/Abstract] OR "clinical characters"[Title/Abstract] OR "clinical character"[Title/Abstract] OR "clinical finding"[Title/Abstract] OR "clinical findings"[Title/Abstract] OR "clinical presentation"[Title/Abstract] OR "clinical presentations"[Title/Abstract] OR "clinical signs"[Title/Abstract] OR "difficult breathing"[Title/Abstract] OR "muscular soreness"[Title/Abstract] OR anhelation[Title/Abstract] OR "muscle aches"[Title/Abstract] OR "muscle pain"[Title/Abstract]
#6 #4 OR #5
#7 #3 AND #6
1.2 影像学检查
#1 #2 同上
#3 #1 OR #2
#4 "diagnostic imaging"[MeSH Terms] OR "Tomography, X-Ray Computed"[MeSH Terms] OR "Computed Tomography"[MeSH Terms]
#5 "imaging examination"[Title/Abstract] OR "imaging examinations"[Title/Abstract] OR "radiological imaging"[Title/Abstract] OR "radiological imagings"[Title/Abstract] OR "imaging procedure"[Title/Abstract] OR "imaging procedures"[Title/Abstract] OR "imaging finding"[Title/Abstract] OR "imaging findings"[Title/Abstract] OR "diagnostic imaging"[Title/Abstract] OR "diagnostic imaging"[Title/Abstract] OR "CT"[Title/Abstract] OR "Computed Tomography"[Title/Abstract] OR "computer assisted tomography"[Title/Abstract] OR "radiological finding"[Title/Abstract] OR "radiological findings"[Title/Abstract] OR "X ray"[Title/Abstract] OR " X-Ray"[Title/Abstract] OR "chest fluoroscopy"[Title/Abstract]
#6 #4 OR #5
#7 #3 AND #6
1.3 实验室检测
#1 #2 同上
#3 #1 OR #2
#4 "Clinical Laboratory Techniques"[MeSH Terms] OR "Immunoglobulin M"[MeSH Terms] OR "Reverse Transcriptase Polymerase Chain Reaction"[MeSH Terms] OR "Immunoglobulin G"[MeSH Terms]
#5 "laboratory"[Title/Abstract] OR "lab"[Title/Abstract] OR "Immunoglobulin M"[Title/Abstract] OR "Immunoglobulin G"[Title/Abstract] OR "Reverse Transcriptase Polymerase Chain Reaction"[Title/Abstract] OR "leukocyte count"[Title/Abstract] OR "lymphocyte count"[Title/Abstract] OR "platelet count"[Title/Abstract] OR "prothrombin time"[Title/Abstract] OR sodium[Title/Abstract] OR "lactate dehydrogenases"[Title/Abstract] OR "C-reactive protein"[Title/Abstract] OR CRP[Title/Abstract] OR IgM[Title/Abstract] OR IgG[Title/Abstract] OR "white blood cell count"[Title/Abstract] OR WBC[Title/Abstract] OR ALT[Title/Abstract] OR "neutrophil count"[Title/Abstract] OR D-dimer[Title/Abstract] OR "alanine aminotransferase"[Title/Abstract] OR "aspartate aminotransferase"[Title/Abstract] OR AST[Title/Abstract] OR potassium[Title/Abstract] OR creatinine[Title/Abstract] OR Cr[Title/Abstract] OR procalcitonin[Title/Abstract] OR PCT[Title/Abstract] OR "polymerase chain reaction"[Title/Abstract] OR PCR[Title/Abstract] OR "reverse transcriptase PCR"[Title/Abstract] OR "transcriptase PCR"[Title/Abstract] OR RT-PCR[Title/Abstract]
#6 #4 OR #5
#7 #3 AND #6
2 治疗部分
2.1 免疫治疗
#1 #2 同上
#3 #1 OR #2
#4 immunotherapy[MeSH Terms] OR "Interleukin 1 Receptor Antagonist Protein"[MeSH Terms] OR tocilizumab[Supplementary Concept] OR sarilumab[Supplementary Concept] OR siltuximab[Supplementary Concept]
#5 immunotherapy[Title/Abstract] OR "monoclonal antibod*"[Title/Abstract] OR "monoclonal antibod*"[Title/Abstract] OR "Interleukin-1 Inhibitor"[Title/Abstract] OR "IL1 Febrile Inhibitor"[Title/Abstract] OR "IL-1 Inhibitor"[Title/Abstract] OR IL-1Ra[Title/Abstract] OR Anakinra[Title/Abstract] OR Kineret[Title/Abstract] OR Antril[Title/Abstract] OR "IFNγ-blocking antibody"[Title/Abstract] OR "Interleukin-6 Inhibitor"[Title/Abstract] OR IL-6R[Title/Abstract] OR tocilizumab[Title/Abstract] OR atlizumab[Title/Abstract] OR Actemra[Title/Abstract] OR roactemra[Title/Abstract] OR sarilumab[Title/Abstract] OR Kevzara[Title/Abstract] OR siltuximab[Title/Abstract] OR Sylvant[Title/Abstract] OR "monoclonal antibody CNTO328"[Title/Abstract] OR meplazumab[Title/Abstract]
#6 #4 OR #5
#7 #3 AND #6
2.2 激素治疗
#1 #2 同上
#3 #1 OR #2
#4 glucocorticoids[MeSH Terms] OR Methylprednisolone[MeSH Terms] OR Dexamethasone[MeSH Terms] OR Hydrocortisone[MeSH Terms] OR ciclesonide[Supplementary Concept]
#5 Glucocorticoid[Title/Abstract] OR "Glucocorticoid Effect"[Title/Abstract] OR Corticosteroid [Title/Abstract] OR Methylprednisolone[Title/Abstract] OR Urbason[Title/Abstract] OR Medrol[Title/Abstract] OR Dexamethasone[Title/Abstract] OR Methylfluorprednisolone[Title/Abstract] OR Hydrocortisone[Title/Abstract] OR Cortisol[Title/Abstract] OR "Glucorticoid Effects"[Title/Abstract] OR "Effects, Glucorticoid"[Title/Abstract] OR Ciclesonide[Title/Abstract] OR Alvesco[Title/Abstract] OR Omnaris[Title/Abstract]
#6 #4 OR #5
#7 #3 AND #6
2.3 抗病毒治疗
#1 #2 同上
#3 #1 OR #2
#4 "Antiviral Agents"[MeSH Terms] OR arbidol[Supplementary Concept] OR "lopinavir-ritonavir drug combination"[MeSH Terms] OR remdesivir[Supplementary Concept] OR favipiravir[Supplementary Concept] OR "Interferon beta-1b"[MeSH Terms] OR Interferons[MeSH Terms] OR "Interferon Type I"[MeSH Terms] OR "Interferon-beta"[MeSH Terms] OR "Interferon-alpha"[MeSH Terms] OR "Interferon-gamma"[MeSH Terms] OR "Interferon alpha-2"[MeSH Terms]
#5 Lopinavir[Title/Abstract] OR Ritonavir[Title/Abstract] OR "lopinavir-ritonavir drug combination"[Title/Abstract] OR arbidol[Title/Abstract] OR arbidole[Title/Abstract] OR remdesivir[Title/Abstract] OR GS-5734[Title/Abstract] OR favipiravir[Title/Abstract] OR avigan[Title/Abstract] OR "Interferon Type I"[Title/Abstract] OR Interferon[Title/Abstract] OR "Interferon-beta"[Title/Abstract] OR "Interferon-alpha"[Title/Abstract] OR "Interferon-gamma"[Title/Abstract] OR "Interferon alpha-2"[Title/Abstract] OR "Interferon beta-1b"[Title/Abstract] OR "antiviral agents"[Title/Abstract] OR "antiviral agent"[Title/Abstract] OR "antiviral drug"[Title/Abstract] OR "antiviral drugs"[Title/Abstract]
#6 #4 OR #5
#7 #3 AND #6
2.4 其他可能的特异性药物-磷酸氯喹/羟氯喹
#1 #2 同上
#3 #1 OR #2
#4 Chloroquine OR Aralen OR hydroxychloroquine OR chloroquine phosphate
#5 #3 AND #4
2.5 传统中药疗法
#1 #2 同上
#3 #1 OR #2
#4 "Medicine, Chinese Traditional"[MeSH Terms]
#5 "Qingfei Paidu Decoction"[Title/Abstract] OR TCM[Title/Abstract] OR "Qingfei Paidu Soup"[Title/Abstract] OR "Lianhua Qingwen Capsule"[Title/Abstract] OR "Chinese medicine soup"[Title/Abstract] OR "Traditional Chinese Medicine"[Title/Abstract] OR "the combination of Chinese and Western medicine"[Title/Abstract] OR "Chinese patent medicine"[Title/Abstract] OR "Chinese medicine decoction"[Title/Abstract] OR "Medicine, ChineseTraditional"[Title/Abstract] OR "Chinese Medicine"[Title/Abstract] OR "Chinese medicine preparation"[Title/Abstract] OR "Chinese medicine injection"[Title/Abstract]
#6 #4 OR #5
#7 #3 AND #6
3 重症病人治疗
3.1 血液净化治疗
#1 #2 同上
#3 #1 OR #2
#4 hemoperfusion[MeSHTerms]
#5 hemofiltration[Title/Abstract] OR hemodialysis[Title/Abstract] OR "blood purification"[Title/Abstract] OR hemoperfusion[Title/Abstract]
#6 #4 OR #5
#7 #3 AND #6
3.2 治愈者血浆治疗
#1 #2 同上
#3 #1 OR #2
#4 "Convalescent plasma"[Title/Abstract] OR "plasma from survivors"[Title/Abstract] OR "plasma therapy"[Title/Abstract]
#5 #3 AND #4
3.3 有创通气与无创通气的选用指征
#1 #2 同上
#3 #1 OR #2
#4 "Noninvasive Ventilation"[MeSH Terms] OR "Intermittent Positive-Pressure Ventilation"[MeSH Terms]
#5 NIV[Title/Abstract] OR NPPV[Title/Abstract] OR CPAP[Title/Abstract] OR BiPAP[Title/Abstract] OR PSV[Title/Abstract] OR IPPV[Title/Abstract] OR "invasive ventilation"[Title/Abstract] OR "Noninvasive Ventilation"[Title/Abstract] OR "Inspiratory Positive Pressure Ventilation"[Title/Abstract]
#6 #4 OR #5
#7 #3 AND #6
3.4 ECMO的使用及撤机指征
#1 #2 同上
#3 #1 OR #2
#4 "Extracorporeal Membrane Oxygenation"[MeSH Terms]
#5 ECMO OR ECLS OR "extracorporeal life support" OR "Extracorporeal Membrane Oxygenation"
#6 #4 OR #5
#7 #3 AND #6
3.5 肺移植
#1 #2 同上
#3 #1 OR #2
#4 "Lung Transplantation"[Mesh]
#5 Lung Transplantation[Title/Abstract]
#6 # 4 OR #5
#7 #3 AND #6
4 出院标准及出院后管理
#1 #2 同上
#3 #1 OR #2
#4 "Patient Discharge"[MeSH Terms]
#5 discharge OR discharged
#6 #4 OR #5
#7 #3 AND #6
二、指南或共识的检索
#1 #2 同上
#3 #1 OR #2
#4 "Guidelines as Topic"[MeSH Terms] OR "Guidelines as Topics"[Title/Abstract] OR "Practice Guidelines as Topic"[MeSH Terms] OR Guideline[Publication Type] OR "Health Planning Guidelines"[MeSH Terms] OR "Practice Guideline"[Publication Type] OR Consensus[MeSH Terms]
#5 guideline*[Title/Abstract] OR guidance*[Title/Abstract] OR recommendation*[Title/Abstract] OR "Practice Guidelines"[Title/Abstract] OR CPG*[Title/Abstract] OR consensus[Title/Abstract]
#6 #4 OR #5
#7 #3 AND #6
三、系统评价或Meta分析的检索
#1 #2 同上
#3 #1 OR #2
#4 "meta-analysis as topic"[MeSH Terms] OR "meta-analysis"[Publication Type] OR "systematic reviews as topic"[MeSH Terms] OR "systematic review"[Publication Type]
#5 "meta-analysis"[Title/Abstract] OR "meta-analyses"[Title/Abstract] OR "systematic review"[Title/Abstract] OR "systematic reviews"[Title/Abstract] OR " systematic review and meta-analysis"[Title/Abstract]
#6 #4 OR #5
#7 #3 AND #6
附录3 利益冲突调查表
Appendix 3 Conflict of interest questionnaire
《新型冠状病毒肺炎药物预防、诊断、治疗与出院管理临床指南》利益冲突调查表
● 所有指南指导委员会、指南共识专家组、指南制定工作组和指南外审组的专家必须声明所有潜在的利益冲突(如:所有影响或可能影响专家客观性和独立性的利益)。
● 您必须在这张利益声明表上声明所有和本部指南主题相关的任何商业的、专业的或其他方面的利益冲突,和所有可能被本部指南成果影响的利益。
请您复制“√”在选择的“是”或者“否”选项旁。如果您选择了“是”,请您同时将“√”复制到您选择的相关企业或者公司名字后面,如上海捷诺公司√,如果没有您相关的企业或公司,请补充至其他企业或公司名后的横线上。
如果您目前正在参与或主持的COVID-19相关研究,请于下框填写项目名称。
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