WO2023127980A1 - Method for providing information for predicting prognosis of patient with acute respiratory distress syndrome - Google Patents
Method for providing information for predicting prognosis of patient with acute respiratory distress syndrome Download PDFInfo
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- the present invention relates to a method for providing information for predicting the prognosis of patients with acute respiratory distress syndrome.
- ARDS Acute respiratory distress syndrome
- ICU intensive care unit
- the present invention provides an information providing method for predicting the prognosis of patients with acute respiratory distress syndrome.
- a method for providing information for predicting the prognosis of a patient with acute respiratory distress syndrome including the step of determining whether the target patient with acute respiratory distress syndrome is infected with pulmonary mycobacteria.
- the present invention relates to a method for providing information for predicting the prognosis of a patient with acute respiratory distress syndrome, wherein the prognosis of acute respiratory distress syndrome can be predicted simply and accurately by confirming whether or not the target patient with acute respiratory distress syndrome is infected with pulmonary mycobacteria.
- the present invention relates to a method for providing information for predicting the prognosis of patients with acute respiratory distress syndrome.
- the present invention includes a step of determining whether a target patient with acute respiratory distress syndrome is infected with pulmonary mycobacteria.
- the target acute respiratory distress syndrome patient may be a person who has been diagnosed with acute respiratory distress syndrome, has experience of having been diagnosed with acute respiratory distress syndrome, or other people who wish to receive information for predicting the prognosis of acute respiratory distress syndrome.
- the pulmonary mycobacteria may be Mycobacterium tuberculosis or non-tuberculous mycobacteria.
- Whether or not the infection is present may be confirmed using methods and conditions known in the art by means known in the art.
- a positive culture of lung mycobacteria may be found in a sample isolated from a target patient with acute respiratory distress syndrome, or it may be confirmed by PCR (polymerase chain reaction) or other molecular biological methods.
- the sample is not particularly limited as long as it is a respiratory specimen, and may be, for example, sputum.
- the target acute respiratory distress syndrome patient when the target acute respiratory distress syndrome patient is infected with pulmonary mycobacteria, it can be determined that there is a high possibility of dying compared to the control group.
- the control group is patients with acute respiratory distress syndrome who have been diagnosed with acute respiratory distress syndrome or who have experienced acute respiratory distress syndrome, and are not infected with pulmonary mycobacteria.
- Pulmonary tuberculosis was confirmed when culture-positive or TB-PCR was positive in a respiratory specimen obtained before or during ICU admission. Pulmonary NTM infection was diagnosed according to the 2007 ATS/ERS guidelines.
- Baseline characteristics (age, sex, body mass index [BMI]), clinical characteristics including Acute Physiological and Chronic Health Assessment (APACHE) II score, Sequential Organ Failure Assessment (SOFA) score, septic shock, treatment modality, and laboratory test results (White blood cell count, hemoglobin, platelets, red blood cell distribution width, C-reactive protein level, total protein level, albumin level, etc.) were analyzed. Mortality and mortality-related factors were also analyzed.
- APACHE Acute Physiological and Chronic Health Assessment
- SOFA Sequential Organ Failure Assessment
- septic shock Treatment modality
- laboratory test results White blood cell count, hemoglobin, platelets, red blood cell distribution width, C-reactive protein level, total protein level, albumin level, etc.
- Continuous data were expressed as the median of the interquartile range and compared using the Mann-Whitney U test. Discontinuous data were presented as numbers and percentages and were analyzed using the chi-square test or Fisher exact test. Factors associated with 28-day mortality in patients with ARDS were analyzed using a Cox regression hazard model. Factors with a P value ⁇ .1 in univariate analysis and age and sex were considered for multivariate analysis. Differences of P ⁇ .05 were considered statistically significant. All data were analyzed using SPSS software version 18.0 (SPSS Inc, Chicago, IL).
- Table 3 compares the mortality rates of patients with and without pulmonary mycobacterial infection. 28-day, 60-day, ICU and in-hospital mortality were significantly higher in patients with pulmonary mycobacteria infection.
- Table 4 shows univariate and multivariate analyzes of factors associated with 28-day mortality.
- APACHE II and SOFA scores After univariate analysis, APACHE II and SOFA scores, pulmonary mycobacterial infection, serum albumin, partial oxygen pressure/inspiratory oxygen pressure, and use of neuromuscular blockers were included in multivariate analysis.
- Pulmonary mycobacterial infection, high APACHE II and SOFA scores, low serum albumin, low oxygen partial pressure/fractional inspired oxygen ratio, and use of neuromuscular blockers were associated with 28-day mortality.
- Table 5 shows the characteristics of pulmonary mycobacterial infection. Eighteen patients had pulmonary tuberculosis and four had NTM lung infection. Pulmonary mycobacterial infection was confirmed in 72.7% (16/22) of patients before or during ICU admission. Six patients (three pulmonary tuberculosis and three NTM lung infections) were confirmed after death. Smear tests showed positive acid-fast bacteria (AFB) in 63.6% of patients. Caries lesions were observed in the lungs of 31.8% of patients. NTM species could not be identified because all patients with pulmonary NTM infection died before NTM species testing was performed. Anti-mycobacterial treatment was administered to 63.6% of patients and only 1 patient with NTM lung infection without identification of the NTM species received the drug. The 28-day mortality rate was high (81.8%) and all patients with NTM lung infection died.
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Abstract
The present invention relates to a method for providing information for predicting the prognosis of a patient with acute respiratory distress syndrome, with which it is possible to easily and precisely predict the prognosis of acute respiratory distress syndrome by identifying if there is pulmonary mycobacteria infection in a patient, who is the subject, with acute respiratory distress syndrome.
Description
본 발명은 급성 호흡곤란 증후군 환자의 예후 예측을 위한 정보제공 방법에 관한 것이다.The present invention relates to a method for providing information for predicting the prognosis of patients with acute respiratory distress syndrome.
급성 호흡곤란 증후군(ARDS)은 염증에 의해 유발된 비심인성 폐부종을 특징으로 하여 심각한 호흡기 합병증을 유발한다. ARDS는 중환자실(ICU)에서 흔히 발생한다. 최근 연구에 따르면 중환자실에 입원한 환자 10명 중 1명이 기계적 환기를 받는 환자의 약 1/4이 ARDS를 앓고 있다고 보고되었다. 또한 ARDS 환자는 높은 이환율과 사망률을 보인다.Acute respiratory distress syndrome (ARDS) is characterized by inflammation-induced, non-cardiogenic pulmonary edema, leading to severe respiratory complications. ARDS commonly occurs in the intensive care unit (ICU). A recent study reported that approximately 1 in 10 patients admitted to an intensive care unit and 1 in 10 patients receiving mechanical ventilation suffer from ARDS. ARDS patients also show high morbidity and mortality.
이에, ARDS의 발달과 진행 및 임상 결과에 영향을 미치는 주요 인자에 대한 연구가 필요하다.Therefore, it is necessary to study the main factors affecting the development and progression of ARDS and the clinical outcome.
본 발명은 급성 호흡곤란 증후군 환자의 예후 예측을 위한 정보제공방법을 제공한다.The present invention provides an information providing method for predicting the prognosis of patients with acute respiratory distress syndrome.
1. 대상 급성 호흡곤란 증후군 환자의 폐 마이코박테리아(pulmonary mycobacteria) 감염 여부를 확인하는 단계를 포함하는 급성 호흡곤란 증후군 환자의 예후 예측을 위한 정보제공방법.1. A method for providing information for predicting the prognosis of a patient with acute respiratory distress syndrome, including the step of determining whether the target patient with acute respiratory distress syndrome is infected with pulmonary mycobacteria.
2. 위 1에 있어서, 상기 폐 마이코박테리아는 결핵균(Mycobacterium tuberculosis) 또는 비결핵 항상균(non-tuberculous mycobacteria)인, 급성 호흡곤란 증후군 환자의 예후 예측을 위한 정보제공방법.2. The method of providing information for predicting the prognosis of a patient with acute respiratory distress syndrome according to 1 above, wherein the pulmonary mycobacteria are Mycobacterium tuberculosis or non-tuberculous mycobacteria.
3. 위 1에 있어서, 상기 대상 급성 호흡곤란 증후군 환자가 폐 마이코박테리아에 감염된 경우 비교군 대비 사망할 가능성이 높다고 판단하는 급성 호흡곤란 증후군 환자의 예후 예측을 위한 정보제공방법.3. The method of providing information for predicting the prognosis of acute respiratory distress syndrome patients according to 1 above, in which it is determined that the target acute respiratory distress syndrome patients are more likely to die compared to the control group when infected with pulmonary mycobacteria.
본 발명은 급성 호흡곤란 증후군 환자의 예후 예측을 위한 정보제공방법에 관한 것으로, 대상 급성 호흡곤란 증후군 환자의 폐 마이코박테리아(pulmonary mycobacteria) 감염 여부를 확인하여 급성 호흡곤란 증후군의 예후를 간단하고 정확하게 예측할 수 있다.The present invention relates to a method for providing information for predicting the prognosis of a patient with acute respiratory distress syndrome, wherein the prognosis of acute respiratory distress syndrome can be predicted simply and accurately by confirming whether or not the target patient with acute respiratory distress syndrome is infected with pulmonary mycobacteria. can
이하, 본 발명을 상세히 설명한다.Hereinafter, the present invention will be described in detail.
본 발명은 급성 호흡곤란 증후군 환자의 예후 예측을 위한 정보제공방법에 관한 것이다.The present invention relates to a method for providing information for predicting the prognosis of patients with acute respiratory distress syndrome.
본 발명은 대상 급성 호흡곤란 증후군 환자의 폐 마이코박테리아(pulmonary mycobacteria) 감염 여부를 확인하는 단계를 포함한다.The present invention includes a step of determining whether a target patient with acute respiratory distress syndrome is infected with pulmonary mycobacteria.
대상 급성 호흡곤란 증후군 환자는 급성 호흡곤란 증후군 진단을 받거나 급성 호흡곤란 증후군을 진단 받은 경험이 있거나, 그 외 급성 호흡곤란 증후군 예후 예측을 위한 정보를 제공받고자 하는 인간일 수 있다.The target acute respiratory distress syndrome patient may be a person who has been diagnosed with acute respiratory distress syndrome, has experience of having been diagnosed with acute respiratory distress syndrome, or other people who wish to receive information for predicting the prognosis of acute respiratory distress syndrome.
상기 폐 마이코박테리아는 결핵균(Mycobacterium tuberculosis) 또는 비결핵 항상균(non-tuberculous mycobacteria)일 수 있다.The pulmonary mycobacteria may be Mycobacterium tuberculosis or non-tuberculous mycobacteria.
상기 감염 여부는 당 분야에 당 분야에 공지된 방법, 조건으로 공지된 수단을 사용하여 확인하는 것일 수 있다. 예를 들어, 대상 급성 호흡곤란 증후군 환자로부터 분리된 시료에서 폐 마이코박테리아 배양 양성을 보이거나, PCR(polymerase chain reaction)이나 다른 분자생물학적 방법으로 확인할 수 있다.Whether or not the infection is present may be confirmed using methods and conditions known in the art by means known in the art. For example, a positive culture of lung mycobacteria may be found in a sample isolated from a target patient with acute respiratory distress syndrome, or it may be confirmed by PCR (polymerase chain reaction) or other molecular biological methods.
상기 시료는 호흡기 검체라면 특별히 제한되지 않으며, 예를 들어, 객담일 수 있다.The sample is not particularly limited as long as it is a respiratory specimen, and may be, for example, sputum.
본 발명은 대상 급성 호흡곤란 증후군 환자가 폐 마이코박테리아에 감염된 경우 비교군 대비 사망할 가능성이 높다고 판단할 수 있다.According to the present invention, when the target acute respiratory distress syndrome patient is infected with pulmonary mycobacteria, it can be determined that there is a high possibility of dying compared to the control group.
비교군은 급성 호흡곤란 증후군 진단을 받거나 급성 호흡곤란 증후군을 진단 받은 경험이 있는 다른 급성 호흡곤란 증후군 환자로서, 폐 마이코박테리아에 감염되지 않은 환자이다.The control group is patients with acute respiratory distress syndrome who have been diagnosed with acute respiratory distress syndrome or who have experienced acute respiratory distress syndrome, and are not infected with pulmonary mycobacteria.
이하, 본 발명을 구체적으로 설명하기 위해 실시예를 들어 상세하게 설명하기로 한다.Hereinafter, examples will be described in detail to explain the present invention in detail.
재료 및 방법Materials and Methods
1. 대상1. Target
2014년 1월부터 2019년 4월까지 상급종합병원의 13병상 의료 중환자실에서 침습적 기계 환기를 받은 ARDS 환자의 의무기록을 후향적으로 조사하였다. 모든 환자는 ARDS에 대한 베를린 정의 기준을 충족하였다. 이 연구는 경상대학교병원 기관심사위원회(IRB No. 2020-03-022)의 승인을 받았다. 연구는 기관 및/또는 국가 연구 위원회의 윤리 기준과 헬싱키 선언 및 이후 개정된 윤리 기준에 따라 수행되었다.The medical records of ARDS patients who received invasive mechanical ventilation in a 13-bed medical intensive care unit of a tertiary general hospital from January 2014 to April 2019 were retrospectively reviewed. All patients met the Berlin definition criteria for ARDS. This study was approved by the Institutional Review Board of Gyeongsang National University Hospital (IRB No. 2020-03-022). The study was conducted in accordance with the ethical standards of institutional and/or national research committees and the Declaration of Helsinki and its subsequent amendments.
2. 폐 마이코박테리아(pulmonary mycobacteria) 감염의 정의2. Definition of pulmonary mycobacterial infection
ICU 입원 전 또는 입원 중에 얻은 호흡기 검체에서 배양 양성 또는 TB-PCR이 양성인 경우 폐결핵으로 확진되었다. 폐 NTM 감염은 2007ATS/ERS 지침에 따라 진단되었다.Pulmonary tuberculosis was confirmed when culture-positive or TB-PCR was positive in a respiratory specimen obtained before or during ICU admission. Pulmonary NTM infection was diagnosed according to the 2007 ATS/ERS guidelines.
3. 데이터 수집3. Data Collection
기준 특성(나이, 성별, 체질량 지수[BMI]), 급성 생리 및 만성 건강 평가(APACHE) II 점수를 포함한 임상 특성, 순차적 장기 부전 평가(SOFA) 점수, 패혈성 쇼크, 치료 방식 및 실험실 검사 결과(백혈구수, 헤모글로빈, 혈소판, 적혈구 분포폭, C-반응성 단백질 수치, 총 단백질 수치, 알부민 수치 등)을 분석하였다. 사망률과 사망률과 관련된 요인도 분석되었다.Baseline characteristics (age, sex, body mass index [BMI]), clinical characteristics including Acute Physiological and Chronic Health Assessment (APACHE) II score, Sequential Organ Failure Assessment (SOFA) score, septic shock, treatment modality, and laboratory test results ( White blood cell count, hemoglobin, platelets, red blood cell distribution width, C-reactive protein level, total protein level, albumin level, etc.) were analyzed. Mortality and mortality-related factors were also analyzed.
4. 통계 분석4. Statistical analysis
연속 데이터는 사분위수 범위의 중앙값으로 표현되었으며 Mann-Whitney U 테스트를 사용하여 비교되었다. 비연속 데이터는 숫자와 백분율로 표시되었으며 chi-square test 또는 Fisher exact test를 사용하여 분석되었다. ARDS 환자의 28일 사망률과 관련된 요인은 Cox 회귀 위험 모델을 사용하여 분석되었다. 단변량 분석에서 P 값 <.1인 요인과 연령 및 성별은 다변수 분석을 위해 고려되었다. P<.05의 차이는 통계적으로 유의한 것으로 간주되었다. 모든 데이터는 SPSS 소프트웨어 버전 18.0(SPSS Inc, Chicago, IL)을 사용하여 분석되었다.Continuous data were expressed as the median of the interquartile range and compared using the Mann-Whitney U test. Discontinuous data were presented as numbers and percentages and were analyzed using the chi-square test or Fisher exact test. Factors associated with 28-day mortality in patients with ARDS were analyzed using a Cox regression hazard model. Factors with a P value <.1 in univariate analysis and age and sex were considered for multivariate analysis. Differences of P<.05 were considered statistically significant. All data were analyzed using SPSS software version 18.0 (SPSS Inc, Chicago, IL).
결과result
1. 환자의 특성1. Patient characteristics
연구 기간 동안 229명의 ARDS 환자가 중환자실에 입원하였다. 22명의 환자는 폐 마이코박테리아 감염이 있었다(pulmonary tuberculosis 18명, NTM(non-tuberculous Mycobacteria) 4명). 특성의 비교는 표 1과 같다. 환자의 중앙 연령은 72세, 남자가 71%였다. 그룹 간 연령, 성별 및 동반 질환에는 유의한 차이가 없었다. BMI는 폐 마이코박테리아 감염이 있는 환자가 없는 환자보다 유의하게 낮았다. 질병 점수의 중증도와 패혈성 쇼크 및 급성 신장 손상이 발생한 환자의 비율은 그룹 간에 차이가 없었다. 신경근 차단제, 코르티코스테로이드 및 체외 산소화막의 사용도 그룹 간에 차이가 없었다. 실험실 매개변수는 표 2에 나타내었다. 혈청 알부민과 C 반응성 단백질은 폐 마이코박테리아 감염 환자에서 유의하게 낮았다.During the study period, 229 ARDS patients were admitted to the intensive care unit. Twenty-two patients had pulmonary mycobacterial infection (pulmonary tuberculosis in 18 and non-tuberculous mycobacteria (NTM) in 4). A comparison of the characteristics is shown in Table 1. The median age of patients was 72 years, and 71% were male. There were no significant differences in age, gender, and comorbidities between groups. BMI was significantly lower in patients with pulmonary mycobacterial infection than in patients without. There was no difference between groups in the severity of disease scores and the proportion of patients who developed septic shock and acute kidney injury. The use of neuromuscular blockers, corticosteroids, and extracorporeal oxygenated membranes also did not differ between groups. Laboratory parameters are shown in Table 2. Serum albumin and C-reactive protein were significantly lower in patients with pulmonary mycobacteria infection.
2. 폐 마이코박테리아 감염 환자와 그렇지 않은 환자의 사망률 비교2. Comparison of mortality between patients with pulmonary mycobacteria infection and those without
표 3은 폐 마이코박테리아 감염이 있는 환자와 없는 환자의 사망률을 비교한 것이다. 28일, 60일, ICU 및 병원 내 사망률은 폐 마이코박테리아 감염 환자에서 유의하게 더 높았다.Table 3 compares the mortality rates of patients with and without pulmonary mycobacterial infection. 28-day, 60-day, ICU and in-hospital mortality were significantly higher in patients with pulmonary mycobacteria infection.
3. 28일 사망률과 관련된 요인3. Factors associated with 28-day mortality
표 4는 28일 사망률과 관련된 요인에 대한 단변량 및 다변량 분석을 보여준다. 단변수 분석 후 APACHE II 및 SOFA 점수, 폐 마이코박테리아 감염, 혈청 알부민, 산소 분압/흡기 산소 분압, 신경근 차단제 사용이 다변수 분석에 포함된다. 폐 마이코박테리아 감염, 높은 APACHE II 및 SOFA 점수, 낮은 혈청 알부민, 낮은 산소 분압/분획 흡기 산소 비율, 신경근 차단제 사용은 28일 사망률과 관련이 있었다.Table 4 shows univariate and multivariate analyzes of factors associated with 28-day mortality. After univariate analysis, APACHE II and SOFA scores, pulmonary mycobacterial infection, serum albumin, partial oxygen pressure/inspiratory oxygen pressure, and use of neuromuscular blockers were included in multivariate analysis. Pulmonary mycobacterial infection, high APACHE II and SOFA scores, low serum albumin, low oxygen partial pressure/fractional inspired oxygen ratio, and use of neuromuscular blockers were associated with 28-day mortality.
4. 폐 마이코박테리아 감염의 특징4. Characteristics of pulmonary mycobacterial infection
표 5는 폐 마이코박테리아 감염의 특징을 나타낸다. 18명의 환자는 폐결핵이 있었고 4명은 NTM 폐 감염이 있었다. ICU 입원 전 또는 입원 중에 72.7%(16/22)의 환자에서 폐 마이코박테리아 감염이 확인되었다. 사망 후 6명의 환자(3명의 폐결핵 및 3명의 NTM 폐 감염)가 확인되었다. 도말 검사에서 항산균(AFB) 양성이 63.6%의 환자에서 나타났다. 충치 병변은 31.8% 환자의 폐에서 관찰되었다. NTM 종 검사가 수행되기 전에 폐 NTM 감염이 있는 모든 환자가 사망했기 때문에 NTM 종을 식별할 수 없었다. 항-마이코박테리아 치료는 63.6%의 환자에게 투여되었고 NTM 종의 식별 없이 NTM 폐 감염이 있는 1명의 환자만이 약물을 투여받았다. 28일 치사율은 높았고(81.8%) NTM 폐 감염 환자는 모두 사망하였다.Table 5 shows the characteristics of pulmonary mycobacterial infection. Eighteen patients had pulmonary tuberculosis and four had NTM lung infection. Pulmonary mycobacterial infection was confirmed in 72.7% (16/22) of patients before or during ICU admission. Six patients (three pulmonary tuberculosis and three NTM lung infections) were confirmed after death. Smear tests showed positive acid-fast bacteria (AFB) in 63.6% of patients. Caries lesions were observed in the lungs of 31.8% of patients. NTM species could not be identified because all patients with pulmonary NTM infection died before NTM species testing was performed. Anti-mycobacterial treatment was administered to 63.6% of patients and only 1 patient with NTM lung infection without identification of the NTM species received the drug. The 28-day mortality rate was high (81.8%) and all patients with NTM lung infection died.
Claims (3)
- 대상 급성 호흡곤란 증후군 환자의 폐 마이코박테리아(pulmonary mycobacteria) 감염 여부를 확인하는 단계를 포함하는 급성 호흡곤란 증후군 환자의 예후 예측을 위한 정보제공방법.A method of providing information for predicting the prognosis of a patient with acute respiratory distress syndrome, comprising the step of determining whether the target patient with acute respiratory distress syndrome is infected with pulmonary mycobacteria.
- 청구항 1에 있어서, 상기 폐 마이코박테리아는 결핵균(Mycobacterium tuberculosis) 또는 비결핵 항상균(non-tuberculous mycobacteria)인, 급성 호흡곤란 증후군 환자의 예후 예측을 위한 정보제공방법.The method according to claim 1, wherein the pulmonary mycobacteria are Mycobacterium tuberculosis or non-tuberculous mycobacteria.
- 청구항 1에 있어서, 상기 대상 급성 호흡곤란 증후군 환자가 폐 마이코박테리아에 감염된 경우 비교군 대비 사망할 가능성이 높다고 판단하는 급성 호흡곤란 증후군 환자의 예후 예측을 위한 정보제공방법.The method according to claim 1, wherein the method for providing information for predicting the prognosis of patients with acute respiratory distress syndrome is determined to be more likely to die compared to the control group when the target patient with acute respiratory distress syndrome is infected with pulmonary mycobacteria.
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| CN112611877A (en) * | 2020-12-31 | 2021-04-06 | 四川大学华西医院 | Kit for predicting acute respiratory distress syndrome illness and prognosis by using ANGPTL4 |
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| CN113252896A (en) * | 2021-05-13 | 2021-08-13 | 四川大学华西医院 | Kit for predicting acute respiratory distress syndrome prognosis by using ND1 in alveolar lavage fluid |
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