Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Provisional; 5th Edition Revisions)

Since December 2019, many novel coronavirus patients have been identified in Wuhan, Hubei Province. WIth the spread of the epidemic situation, other areas within and out of the country also identified such cases. This disease, as an infectious acute respiratory disease, has already been assigned as a Class B infectious disease requiring Class A management strategy according to the Law on the Prevention and Control of Infectious Diseases of the People's Republic of China. With the deepened understanding of the disease and with the accumulation of diagnostic and therapeutic experiences, the Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Provisional; 5th Edition) has been revised

as Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Provisional; 5th Edition Revisions).

I. Pathogenic Characteristics

The novel coronavirus belongs to the beta clade of coronavirus. It has an envolope and the particles are globular or ellipsoidal, usually multimorphic. The diameter being 60-140 nm. The genetic characteristics are distinctively different from SARS-CoV or MERS-CoV.

According to the current research, the homology between such virus and a Bat SARS-like Coronavirus (bat-SL-CoVZC45) is higher than 45%. When cultured ex vivo, 2019-nCoV could be spotted in human respiratory epidermal cells within 96 hours, and within 6 days when being cultured in Vero E6 and Huh-7 cell lines.

The knowledge on phyisical and chemical aspects of the virus mainly comes from studies on SARSr-CoV and MERSr-CoV. Such viruses are suspectible to UV and heat. 30 minutes heating at 56 °C, diethyl ether, 75% ethanol, chlorinated bleach, peracetic acid and lipophilic solvents such as chloroform could effectively disinfect the virus, while Chlorhexidine could not.

II. Epidemiological Characteristics

(1) Source of infection.

At present, the source of infection is mainly patients infected by the novel coronavirus. Asymptomatic infected persons could also be the source of infection.

(2) Route of transmission.

The major transmission pathes are respiratory droplet transmission and contact transmission. Other transmission paths such as aerogel or digestive duct transmission are under investigation.

(3) Susceptible populations.

The population is generally susceptible.

III. Clinical Characteristics

(1) Clinical presentation.

Based on current epidemiological investigations, the incubation period is between1-14 days, and is usually between 3-7 days. The primary manifestations are fever, lack of energy, and dry coughing. A small number of patients have accompanying nasal congestion, nasal discharge, sore throat, diarrhea, and other symptoms. 重症患者多在发病一周后出现呼吸困 难和/或低氧血症,严重者快速进展为急性呼吸窘迫综合征、脈 毒症休克、难以纠正代谢性酸中毒和出凝血功能障碍等。 It is worth noting that severe and critical patients may see light or medium fever, or even clear fever, in the course of the illness.

Patients with the mild form of the disease present only as low fever, slight fatigue, and so forth, with no lung inflammation.

从目前收治的病例情况看,多数患者预后良好,少数患者 病情危重。 The prognosis of the elderly and those with chronic underlying diseases is more poor. The symptoms of child cases are relatively mild.

(2) Laboratory examination.

发病早期外周血白细胞总数正常或减少,淋巴细胞计数减少,部分患者可出现肝酶、乳酸脱氢酶(LDH)、肌酶和肌红蛋 白增高;部分危重者可见肌钙蛋白增高。 C-reactive protein (CRP) and erythrocyte sedimentation rate increased in most patients, and procalcitonin was normal. 严重者D-二聚体升高、外 周血淋巴细胞进行性减少。

在鼻咽拭子、痰、下呼吸道分泌物、血液、粪便等标本中 可检测出新型冠状病毒核酸。

(3) Chest Imaging.

In the early stage, there are multiple small patches and interstitial changes, most notably in the outer lung. 进而 发展为双肺多发磨玻璃影、浸润影,严重者可出现肺实变,胸 腔积液少见。

IV. Diagnostic Standards

Provinces other than Hubei:

(1) Suspected cases.

Comprehensively analyze combinations of the following epidemiological history and clinical presentations:

1. Epidemiological history

(1) Within 14 days before the onset of the disease have travel or residence history in Wuhan city and its surrounding areas or other communities with reported within 14 days before the onset of the disease;

(2)发病前14天内与新型冠状病毒感染者(核酸检测阳 性者)有接触史;

(3) Within 14 days prior to onset, had contact with patients who have a fever or respiratory tract symptoms from Wuhan or its surrounding areas, or from other communities reporting cases.

(4) Aggregated onset.

2. Clinical presentation:

(1) Fever and/or respiratory tract symptoms;

(2) having the above-mentioned imaging features of pneumonia;

(3)发病早期白细胞总数正常或降低,或淋巴细胞计数减少。

Where there are any of the epidemiologic history items, and any 2 of the clinical presentions are met. Where there is no clear epidemiological history, and at least 3 of the clinical presentations are met.

(2) Confirmed cases.

Suspected cases have one of the following pathological evidence:

1. 呼吸道标本或血液标本实时荧光RT-PCR检测新型冠状病 毒核酸阳性;
2. 呼吸道标本或血液标本病毒基因测序,与已知的新型冠 状病毒高度同源。

Hubei Province:

(1) Suspected cases. Comprehensively analyze combinations of the following epidemiological history and clinical presentations:

1. Epidemiological history

(1) Within 14 days before the onset of the disease have travel or residence history in Wuhan city and its surrounding areas or other communities with reported within 14 days before the onset of the disease;

(2) Within 14 days prior to symptom onset, having had contact with patients infected with 2019-nCoV (positive nucleic acid test).

(3) Within 14 days prior to onset, had contact with patients who have a fever or respiratory tract symptoms from Wuhan or its surrounding areas, or from other communities reporting cases.

(4) Aggregated onset.

2. Clinical presentation:

(1) Fever and/or respiratory tract symptoms;

(2)发病早期白细胞总数正常或减少,或淋巴细胞计数减少。

有流行病学史中的任何一条或无流行病学史,且同时符合 临床表现中2条。

(2) Clinically confirmed cases.

疑似病例具有肺炎影像学特征者。

(3) Confirmed cases.

临床诊断病例或疑似病例,具备以下病原学证据之一者:

1. 呼吸道标本或血液标本实时荧光RT-PCR检测新型冠状病 毒核酸阳性;

2.呼吸道标本或血液标本病毒基因测序,与已知的新型冠 状病毒高度同源。

V. Clinical Classification

(1) Mild form.

Clinical symptoms are minor, imaging does not show signs of lung inflammation.

(2) Regular form.

Has fever and respiratory tract symptoms, imaging shows visible lung inflammation.

(3) Severe form.

Meeting any of the following:

1. 呼吸窘迫,RR > 30 次/分;
2. In resting state, oxygen saturation is less than 93%;
3. 动脉血氧分压(Pa02)7吸氧浓度(Fi02) < 300mmHg (1mmHg=0.133kPa)

(4) Critical form.

Meeting any of the following criteria:

1. Respiratory failure occurs and mechanical ventilation is required;
2. Shock;
3. other organ failure requiring ICU monitoring;

VI. Differential diagnosis

主要与流感病毒、副流感病毒、腺病毒、呼吸道合胞病毒、 鼻病毒、人偏肺病毒、SARS冠状病毒等其他已知病毒性肺炎鉴别, 与肺炎支原体、衣原体肺炎及细菌性肺炎等鉴别。 此外, 还要与非感染性疾病,如血管炎、皮肌炎和机化性肺炎等鉴别。

VII. Discovery and Reporting of Cases

Provinces other than Hubei:

各级各类医疗机构的医务人员发现符合病例定义的疑似病 例后,应当立即进行隔离治疗,院内专家会诊或主诊医师会诊, 仍考虑疑似病例,在2小时内进行网络直报,并采集标本进行 新型冠状病毒核酸检测,同时在确保转运安全前提下立即将疑似病例转运至定点医院。 与新型冠状病毒感染者有密切接触的 患者,即便常见呼吸道病原检测阳性,也建议及时进行新型冠 状病毒病原学检测。

疑似病例连续两次呼吸道病原核酸检测阴性(采样时间至 少间隔1天),方可排除。

Hubei Province:

各级各类医疗机构的医务人员发现符合病例定义的疑似病 例和临床诊断病例后,应当立即进行隔离治疗,疑似病例和临 床诊断病例要单间隔离,对疑似病例和临床诊断病例要尽快采集标本进行病原学检测。

VIII. Treatment

(1) Determine the place of treatment based on the patients' conditions.

1. 疑似及确诊病例应当在具备有效隔离条件和防护条件的 定点医院隔离治疗,疑似病例应当单人单间隔离治疗,确诊病例可多人收治在同一病室。

2. Critical cases shall be put in ICU treatment as soon as possible.

(2) General treatment.

1. 卧床休息,加强支持治疗,保证充分热量;注意水、电 解质平衡,维持环境稳定;密切监测生命体征、指氧饱和度等。
2. 根据病情监测血常规、尿常规、CRP、生化指标(肝酶、 心肌酶、肾功能等)、凝血功能、动脉血气分析、胸部影像学等。 有条件者可行细胞因子检测。
3. 及时给予有效氧疗措施,包括鼻导管、面罩给氧和经鼻 高流量氧疗。
4. 抗病毒治疗:目前没有确认有效的抗病毒治疗方法。 可 试用a-干扰素雾化吸入(成人每次500 万U或相当剂量,加入 灭菌注射用水 2ml,每日2次)、洛匹那韦/利托那韦(200 mg/50 mg,每粒)每次2粒,每日2次,或可加用利巴韦林(500mg/ 次,每日2至3次静脉输注)。 要注意洛匹那韦/利托那韦相关 腹泻、恶心、呕吐、肝功能损害等不良反应,同时要注意和其 他药物的相互作用。
5. Antibiotic therapies: avoid unjustifiable or inappropriate usage of antibiotics, especially combinatory use of broad-spectrum antibiotics.

(3) Treatment of severe and critical cases.

1. 治疗原则:在对症治疗的基础上,积极防治并发症,治 疗基础疾病,预防继发感染,及时进行器官功能支持。
2. Respiratory support:

(1) 氧疗:重型患者应当接受鼻导管或面罩吸氧,并及时评 估呼吸窘迫和(或)低氧血症是否缓解。

(2) 高流量鼻导管氧疗或无创机械通气;当患者接受标准氧 疗后呼吸窘迫和(或)低氧血症无法缓解时,可考虑使用高流 量鼻导管氧疗或无创通气。 若短时间(1-2 小时)內病情无改善 甚至恶化,应当及时进行气管插管和有创机械通气。

(3) 有创机械通气:采用肺保护性通气策略,即小潮气量 (4-8ml/kg理想体重)和低吸气压力(平台压<30cmH2O)进行 机械通气,以减少呼吸机相关肺损伤。 较多患者存在人机不同 步,应当及时使用镇静以及肌松剂。

(4)挽救治疗:对于严重 ARDS患者,建议进行肺复张。 在人 力资源充足的情况下,每天应当进行 12 小时以上的俯卧位通气。 俯卧位通气效果不佳者,如条件允许,应当尽快考虑体外膜肺 氧合(ECMO)。

3. 循环支持:充分液体复苏的基础上,改善微循环,使用 血管活性药物,必要时进行血流动力学监测。
4. Other treatment measures

可根据患者呼吸困难程度、胸部影像学进展情况,酌情短 期内(3~5日)使用糖皮质激素,建议剂量不超过相当于甲泼尼龙1~2mg/kg/日,应当注意较大剂量糖皮质激素由于免疫抑 制作用,会延缓冠状病毒的清除;可静脉给予血必净 100ml/ 次,每日2次治疗;可使用肠道微生态调节剂,维持肠道微生 态平衡,预防继发细菌感染;可采用恢复期血浆治疗;对有高 炎症反应的危重患者,有条件可以考虑使用体外血液净化技术。

Patients often have anxiety and fear, and psychological counseling should be strengthened.

(4) Chinese Medicine Treatment.

本病属于中医疫病范畴,病因为感受疫戾之气,各地可根 据病情、当地气候特点以及不同体质等情况,参照下列方案进行辨证论治。

1. Period of Medical Observation

Clinical manifestation 1: lack of energy accompanied by gastrointestinal discomfort

推荐中成药:霍香正气胶囊(丸、水、口服液)

Clinical manifestation2: lack of energy accompanied by fever

推荐中成药:金花清感颗粒、连花清瘟胶囊(颗粒)、疏风解毒胶囊(颗粒)、防风通圣丸(颗粒)

2. Clinical treatment period

(1)初期:寒湿郁肺

临床表现:恶寒发热或无热,干咳,咽干,倦怠乏力,胸网,脫痞,或呕恶,便溏。 舌质淡或淡红,苔白腻,脉濡。

推荐处方:苍术15g、陈皮10g、厚朴10g、薰香 10g、草 果6g、生麻黄6g、羌活10g、生姜10g、槟郎 10g

(2)中期:疫毒闭肺

临床表现:身热不退或往来寒热,咳嗽痰少,或有黄痰, 腹胀便秘。 胸闷气促,咳嗽喘憋,动则气喘。 舌质红,苔黄腻 或黄燥,脉滑数。

推荐处方:杏仁10g、生石膏30g、瓜类 30g、生大黄6g(后 下)、生炙麻黄各6g、荸劳子10g、桃仁10g、草果 6g、槟郎 10g、 苍术10g

推荐中成药:喜炎平注射剂,血必净注射剂

(3)重症期:内闭外脱

临床表现:呼吸困难、动辄气喘或需要辅助通气,伴神昏, 烦躁,汗出肢冷,舌质紫暗,苔厚膩或燥,脉浮大无根。

推荐处方:人参15g、黑顺片 10g(先煎)、山茱萸 15g,送 服苏合香丸或安宫牛黄丸

推荐中成药:血必净注射液、参附注射液、生脉注射液

(4)恢复期:肺脾气虚

临床表现:气短、倦怠乏力、纳差呕恶、痞满,大便无力, 便灌不爽,舌淡胖,苔白腻。

推荐处方:法半夏9g、陈皮10g、党参15g、炙黄芪30g、 茯苓15g、藿香10g、砂仁 6g(后下)

IX. Standards for Release from Isolation and Hospital

体温恢复正常3天以上、呼吸道症状明显好转,肺部影像 学显示炎症明显吸收,连续两次呼吸道病原核酸检测阳性(采 样时间间隔至少1天),可解除隔离出院或根据病情转至相应科治疗其他疾病。

十、转运原则 按照我委印发的《新型冠状病毒感染的肺炎病例转运工作方案》(试行)执行。

XI. Prevention and Control of Infection in Medical Establishments

严格按照我委《医疗机构内新型冠状病毒感染预防与控制 技术指南(第一版)》、《新型冠状病毒感染的肺炎防护中常见医 用防护用品使用范围指引(试行)》的要求执行。

抄送:各省、自治区、直辖市应对新型冠状病毒肺炎疫情联防联控机制(领导小组、指挥部)。

General Office of the National Health Commission

Issued on February 8, 2020

Proofread: Qingyang Du