D, Terence O’Keeffe, MB, Ch
B, MSPH, Kenji Inaba, MD, Eileen Bulger, MD, John B Holcomb, MD, & Bryan A Cotton, MD, MPH
David E Meyer
University of Texas Health Sciences Center & Mc
Govern School of Medicine, Houston, TX
John B Holcomb
University of Texas Health Sciences Center & Mc
Govern School of Medicine & The Center for Translational Injury Research, Houston, TX
Bryan A Cotton
University of Texas Health Sciences Center & Mc
Govern School of Medicine and The Center for Translational Injury Research, Houston, TX
David E Meyer, University of Texas Health Sciences Center và Mc
Govern School of Medicine, Houston, TX;
BACKGROUND
ACS-TQIP Best Practices recommends initial massive transfusion (MT) cooler delivery within 15 minutes of protocol activation, with a goal of 10 minutes. The current study sought lớn examine the impact of timing of first cooler delivery on patient outcomes.
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METHODS
Patients predicted lớn receive MT at 12 level-1 trauma centers were randomized khổng lồ two separate transfusion ratios as described in the PROPPR trial. ABC score or clinician gestalt prediction of MT was used to lớn randomize patients & call for initial study cooler. In this planned sub-analysis, the time to MT protocol activation & time lớn delivery of the initial cooler were evaluated. The impact of these times on mortality và time lớn hemostasis were examined using both Wilcoxon rank sum and linear and logistic regression.
RESULTS
Among 680 patients, the median time from patient arrival to lớn MT protocol activation was 9 minutes with a median time from MT activation điện thoại tư vấn to delivery of first cooler of 8 minutes. An increase in both time khổng lồ MT activation & time to lớn arrival of first cooler were associated with prolonged time lớn achieving hemostasis (coef 1.09, p=0.001 và coef. 1.16, phường < 0.001, respectively). Increased time khổng lồ MT activation and time to arrival of first cooler were associated with increased mortality (OR 1.02, p=0.009 and OR 1.02, p = 0.012, respectively). Controlling for injury severity, physiology, resuscitation intensity, và treatment arm (1:1:1 vs. 1:1:2), increased time to arrival of first cooler was associated with an increased mortality at 24-hours (OR 1.05, phường = 0.035) and 30-days (OR 1.05, phường = 0.016).
CONCLUSIONS
Delays in MT protocol activation và delays in initial cooler arrival were associated with prolonged time to lớn achieve hemostasis and an increase in mortality. Independent of products ratios, every minute from time of MT protocol activation to lớn time of initial cooler arrival increases odds of mortality by 5%.
BACKGROUND
Damage control resuscitation (DCR) has dramatically changed the care of the bleeding patient. Much of the focus of recent research has been on optimizing the ratio of blood sản phẩm administration và minimizing the use of crystalloid.1 However, it is the early and timely delivery of higher balanced ratios of plasma và platelets that allows for the achievement of the ultimate goal of DCR: the rapid restoration of circulating red cells, plasma proteins and platelets, while definitive control of bleeding is achieved. The protocolization of massive transfusion (MT) was developed with DCR and has been associated with decreased mortality, decreased multi-organ failure, và an overall decrease in the amount of sản phẩm transfused.2 In part, this is because MT protocols (MTPs) are associated with a decrease in time lớn the availability of the first blood products.3
The specific timing of the delivery of these blood products, however, has not been examined thoroughly. A 2013 single-center retrospective study evaluated this variable indirectly by comparing 30-day mortality in massive transfusion patients before and after instituting an initiative to maintain a small but frequently resupplied stock of thawed plasma to lớn the emergency department (thereby decreasing the time necessary lớn procure và deliver it).4 That study found that moving thawed plasma to the emergency department (ED) resulted in cutting the time to plasma administration in half and decreased the odds of mortality at 30 days by approximately 60%. Of note, the time khổng lồ first red blood cell transfusion remained the same. This suggests that timing of the administration of other blood products (plasma, platelets) may play as crucial a role as the eventual ratio of products or limiting of crystalloid volumes.
The recent multicenter, prospective, randomized controlled trial from the Pragmatic, Randomized Optimal Platelets and Plasma Ratios (PROPPR) study group sought to evaluate mortality with respect to the ratio of blood products given in massive transfusion.5 The study found that there was a significant decrease in deaths due lớn bleeding in the 1:1:1 group, but the significance of the effect was not observed in overall mortality at 30 days. One possible explanation is that the PROPPR 1:1:2 group outperformed all previously reported data, with previous studies noting mortality rates in excess of 30% when a blood product ratio of 1:1:2 was utilized.6,7,8 In PROPPR, however, the mortality rate in the 1:1:2 group was roughly 20%. It has been suggested that this dramatic improvement in mortality in PROPPR compared to other published research was the result of the rapid and balanced delivery of blood products (i.e., alternating red blood cells, plasma, and platelets as opposed khổng lồ previous descriptions of transfusing six units of red blood cells followed by six units of plasma, then platelets).9 In this planned sub-analysis of the PROPPR dataset, we hypothesized that the timely delivery of blood products lớn the exsanguinating patient, regardless of ratio, would result in decreased mortality.
Study Design
The PROPPR study was a pragmatic phase III, multicenter, randomized trial that compared the effectiveness of two resuscitation strategies for bleeding patients. The study began August 3, 2012 và concluded enrollment December 2, 2013. Patients were randomized khổng lồ receive a ratio of 1:1:1 or 1:1:2 of platelets: plasma: red blood cells during the acute phase of resuscitation.10 The study was approved by the US Food and Drug Administration (FDA) (Investigational New Drug No. 14929), Health Canada, NHLBI and the Department of Defense, as well as each individual site’s institutional đánh giá boards. The PROPPR study used exception from informed consent (21 CFR 50.24), including community consultation with delayed patient or legally authorized representative content.
This represents a sub-analysis of the original PROPPR study, investigating the impact of time to activation of local massive transfusion protocols (MTP) và then time from activation to lớn delivery of the first MTP cooler. These time points were specifically included in the PROPPR protocol for collection và later analysis and were audited throughout the study khổng lồ evaluate compliance with study requirements. Prior khổng lồ starting the study, and as part of site training and verification, each site was evaluated for the ability of its blood bank to randomize, prepare, và deliver the first MTP cooler khổng lồ the bedside within ten minutes, as well as lớn prepare and deliver subsequent coolers on-demand.11 As such, time of arrival, time to lớn MTP activation & time khổng lồ arrival of initial và each subsequent cooler were collected as time points of interest. The content of each MTP cooler was identical between centers, varying only by randomization group (i.e., 1:1:1 vs. 1:1:2). Additionally, the sequence of transfusion was also identical between centers, so as to lớn ensure a rapid and balanced transfusion strategy. Finally, as part of an ongoing unique improvement initiative, the study protocol was evaluated và reevaluated at each site & then refined as necessary to lớn function seamlessly within a center’s specific milieu and to ensure rigorous protocol fidelity.12
Study Population
The PROPPR study was conducted at 12 North American level-1 trauma centers, screening those patients who were severely injured & who met local criteria for highest-level trauma activation. To lớn meet the study’s intended focus on those injured patients who were bleeding at the time of arrival, research team personnel were notified simultaneously with trauma team activation và were present prior to patient arrival. Given the aim of rapidly enrolling those patients with severe hemorrhage, inclusion criteria were as follows: (1) highest-level trauma team activation, (2) estimated age of 15 years or older or weight of 50 kg or greater if age unknown, (3) patient received directly from the injury scene, (4) having received at least one unit of any blood component transfused prior khổng lồ hospital arrival or within 1 hour of admission and (5) predicted by an Assessment of Blood Consumption (ABC) score of 2 or greater or by physician judgment of the need for a massive transfusion (defined as ≥10 U of RBCs within 24 hours).13 Patients were excluded if they: (1) did not receive at least one unit of a blood component within one hour of arrival lớn the hospital or during prehospital transport, (2) were expected khổng lồ die within one hour of ED arrival from a devastating injury, or (3) improved during initial stabilization and did not require further transfusion. A total of 680 patients were enrolled in the original PROPPR study of blood hàng hóa ratios, và all of those patients were included in this planned sub-analysis.
Outcomes và Definitions
The primary outcomes of interest in this sub-analysis were 24-hour & 30-day mortality. Secondary outcomes included time to death, time to lớn hemostasis, and 24-hour blood hàng hóa use. A clinician blinded khổng lồ group assignment và external khổng lồ the trial site adjudicated each death. Time lớn death was measured in both minutes and hours. Anatomic hemostasis in the operating room was defined as an objective assessment by the surgeon indicating that bleeding within the surgical field was controlled và no further hemostatic interventions were anticipated. This was also captured and recorded in minutes and hours. Blood sản phẩm use was noted in units.
To best describe the aggressiveness of transfusion and resuscitation administered by the trauma team, independent of specific product availability và site, we utilized Resuscitation Intensity as a surrogate measurement.14 Resuscitation Intensity is defined as the total amount of product given in the first 30 minutes after patient arrival. Each one liter of crystalloid, one 500 m
L bag/bottle of colloid, one unit of red blood cells, one unit of plasma, và one six-pack (or one apheresis) platelet (= 1 unit) were defined as one Resuscitation Intensity unit. Resuscitation with four or more units of any fluid in the first 30 minutes is significantly associated with mortality as early as six hours.
The time lớn MTP activation was defined as the time from patient arrival until the initial phone điện thoại tư vấn made khổng lồ a site’s Blood bank for activation, captured and recorded in minutes. Time khổng lồ initial MTP cooler arrival was defined as time from MTP activation by phone gọi until cooler arrival at the patient’s bedside, also captured and recorded in minutes.
Statistical Analysis
Continuous data are presented with the 25th và 75th percentile interquartile range (IQR) with comparisons between groups performed by use of the Wilcoxon rank sum (Mann-Whitney U test). Categorical data are reported as proportions and, where appropriate, tested for significance using chi-2 or Fisher exact tests. All statistical tests were 2-tailed. Lớn evaluate the above outcomes, we carefully examined the time to MTP activation và time khổng lồ delivery of the initial cooler. These were specifically chosen to investigate whether (1) early recognition of the need for MT and (2) time to the delivery of MTP products impacted outcomes, regardless of transfused ratios. Initial analysis of the impact of these times on mortality và time khổng lồ hemostasis were performed using Wilcoxon rank sum. This was followed by simple (univariate) linear và logistic regression, then a multivariate regression analysis. The logistic multivariate model was created through first selecting variables a priori based on clinical judgment that the potential confounders may be associated with recognition of bleeding and outcomes related to bleeding and mortality. These were then entered into stepwise regression khổng lồ identify statistically significant variables (p<0.05). While this initial mã sản phẩm included the individual site as a variable in order to lớn evaluate for differences between centers, this was not statistically significant & was not included in the subsequent model. This mã sản phẩm did, however, identify anatomic severity of injury (injury severity score, ISS), physiology on arrival (weighted revised trauma score, w-RTS), resuscitation intensity (RI), and randomization group as significant. These four variables were then entered into a multiple logistic regression model, along with time to lớn MTP activation và time to arrival of initial cooler (entered separately). All analyses were performed using STATA Statistical software (version 12.1; Stata
Corp, College Station, TX).
RESULTS
During the study period, 14,313 highest-level trauma activations occurred at the 12 sites, with 11,185 patients undergoing screening. Among these, 680 patients were enrolled và randomized (338 khổng lồ the 1:1:1 group và 342 lớn the 1:1:2 group). Overall, 80% of patients were male and 64% were white, with a median age of 34 (24, 51). Mechanism of injury was blunt in 53%, with an overall median ISS of 26 (17, 41) & w-RTS of 6.81 (4.09, 7.84). For the study population, 24-hour và 30-day mortality were 14.7% & 24.1%, respectively.
Dichotomizing groups by outcome of 24-hour mortality, TABLE 1 demonstrates the differences between baseline and admission variables. Patients who died within the first 24 hours had greater anatomic injury, more disturbed arrival physiology, & had more intense resuscitation in the first 30 minutes of their arrival.
| Male gender | 77% | 81% | 0.352 |
| Median age in years | 39 (24, 56) | 34 (25, 49) | 0.223 |
| White race | 68% | 63% | 0.336 |
| Blunt mechanism | 62% | 51% | 0.042 |
| Median ISS | 36 (25, 48) | 25 (17, 37) | <0.001 |
| Median w-RTS | 4.09 (3.80, 6.37) | 6.90 (4.09, 7.84) | <0.001 |
| Median Resuscitation Intensity | 6 (4, 9) | 4 (3, 6) | <0.001 |
Medians are expressed with 25th và 75th interquartile range; ISS: injury severity score; w-RTS: weighted revised trauma score
Among the 680 patients enrolled, the median time from patient arrival to MTP activation was 9 minutes (IQR 3, 20). The median time from MTP activation lớn delivery of the first cooler was 8 minutes (IQR 5, 11). An increase in time khổng lồ MTP activation in minutes was associated with prolonged time to achieving hemostasis (coef 1.09, p=0.001). Similarly, increased time in minutes to receipt of first cooler was associated with longer time khổng lồ achieving hemostasis (coef. 1.16, p<0.001). More importantly, both an increased time to lớn MTP activation & time khổng lồ receipt of first MTP cooler were also associated with increased unadjusted mortality (OR 1.02, p=0.009 & OR 1.02, p=0.012, respectively). Neither time khổng lồ MTP activation nor time lớn receipt of initial cooler was associated with 24-hour blood hàng hóa transfusion volumes.
Controlling for injury severity, admission physiology, resuscitation intensity, and treatment arm (1:1:1 vs. 1:1:2), the time to lớn arrival of first cooler was associated with an increased mortality at 24-hours (OR 1.05, p=0.035) & 30-days (OR 1.05, p=0.016) (TABLE 2 & TABLE 3). Controlling for these same variables in a multivariate linear model demonstrated that decreased time to receiving the initial cooler was associated with a marked reduction in time khổng lồ death (coef. −271.029, p=0.023)
| Time to lớn receipt of first cooler (min) | 1.05 | 1.01–1.10 | 0.035 |
| Anatomic injury severity (ISS) | 1.03 | 1.02–1.05 | <0.001 |
| Disturbed arrival physiology (w-RTS) | 0.69 | 0.60–0.81 | <0.001 |
| Randomization group (1:1:2) | 1.69 | 1.01–2.86 | 0.047 |
| Resuscitation Intensity (units) | 1.12 | 0.60–2.05 | 0.719 |
95% C.I.: 95% confidence interval; min: minutes; ISS: injury severity score; w-RTS: weighted revised trauma score
| Time to lớn receipt of first cooler (min) | 1.05 | 1.01–1.09 | 0.016 |
| Anatomic injury severity (ISS) | 1.05 | 1.03–1.06 | <0.001 |
| Disturbed arrival physiology (w-RTS) | 0.61 | 0.53–0.69 | <0.001 |
| Randomization group (1:1:2) | 1.46 | 0.92–2.29 | 0.102 |
| Resuscitation Intensity (units) | 1.03 | 0.60–1.44 | 0.184 |
95% C.I.: 95% confidence interval; min: minutes; ISS: injury severity score; w-RTS: weighted revised trauma score
The above mã sản phẩm controlling for injury severity, admission physiology, resuscitation intensity, & treatment arm (1:1:1 vs. 1:1:2) was repeated lớn evaluate the impact of time lớn MTP activation. Increased time to lớn MTP activation showed a trend, but was not significantly associated with an increase in 24-hour (OR 1.03, p=0.154) & 30-day mortality (OR 1.04, p=0.160). As well, a linear model using these same variables demonstrated that decreased time to MTP activation was associated with a trend towards reduction in time khổng lồ death, but this was not statistically significant (coef. −51.098, p=0.130).
DISCUSSION
The concept of improved outcomes with decreased time khổng lồ the delivery of an intervention is well-described throughout medicine. Acute myocardial infarction patients have decreased mortality with decreased time to reperfusion.15 As a result, hospitals are now graded và ranked based on response times & “STEMI” teams have been developed khổng lồ dramatically reduce “door-to-balloon times” for such patients. Similarly, hospital stroke teams have been developed based on data demonstrating improved neurologic outcomes in ischemic stroke patients with decreased time khổng lồ reperfusion; “door-to-t
PA” times.”16 ICU patients with severe sepsis & septic shock have decreased mortality with decreased time to lớn first antibiotic administration.17 A recent study has also demonstrated decreased mortality in traumatic brain injury (TBI) patients with multifocal hemorrhage that receive early administration of plasma.18
The American College of Surgeons (ACS) Trauma unique Improvement (TQIP) guidelines for MT have recently recommended delivery of the first blood product cooler within 15 minutes of activation, & the delivery of each subsequent cooler within 10 minutes of the request.19 Yet these recommendations were based on expert opinion và not prospectively collected data. The current study, however, found a 5% increase in the odds of mortality with every minute of delay in the administration of blood products from time of MTP activation. This suggests that even the availability of blood within 10–15 minutes may be too long for many critically injured patients. Furthermore, decreasing the time to delivery of blood products may be one of the modifiable risk factors that impacts mortality in the trauma patient.
In order khổng lồ improve the timeliness of blood product delivery, several challenges must be overcome. One challenge is to lớn decrease the time lớn activation of MTP by decreasing the time to lớn physician recognition of the need for blood hàng hóa administration. There are several clear opportunities for improving this variable. One is simply physician awareness that timing of blood administration is of critical importance. Additionally, clinical adjuncts can be used to lớn predict the need for MT. The ABC score, for example, is a rapid bedside clinical scoring system that is 75% sensitive và 86% specific for predicting the need for MT.10 Another challenge is to decrease the physical distance between the blood và the patient. To this end, many trauma centers have transitioned to having a small reserve of thawed/liquid blood products immediately available within the emergency department: The Mayo Clinic (Rochester, MN) has a full MTP cooler at all times within their ED; the R Adams Cowley Shock Trauma Center (Baltimore, MD) maintains an entire MTP refrigerator within their ED; Memorial Hermann- Texas Medical Center also maintains a blood sản phẩm refrigerator within the ED, with RBCs and liquid plasma. Another way khổng lồ significantly decrease the distance (and therefore time khổng lồ administration) of blood products is to lớn make them available in the pre-hospital setting. Memorial Hermann Hospital & the Mayo Clinic, as examples, have maintained red blood cells & plasma on-board every air ambulance since 2011. Blood hàng hóa administration pre-hospital is protocolized, and the administration of any pre-hospital blood products automatically activates the hospital’s MTP. A full MTP cooler is then present at the bedside in the ED prior khổng lồ the arrival of the patient.
Several limitations are apparent in this study. First, while the data regarding time to lớn blood cooler delivery was collected prospectively, và intended for sub-analysis, patients were not randomized by time nor were evaluation of time to activation & time to lớn initial cooler designated primary outcomes. Second, the actual time of administration of the first blood product was not used but rather time lớn arrival of first cooler. While it seems unlikely that MTP would be activated for any trauma patient & blood products not given immediately, this cannot be explicitly stated. Finally, this study may not be easily generalizable. Prior to beginning the PROPPR study, each of the twelve North American Level-1 trauma centers was vetted for its ability lớn provide blood products within the strict, predetermined time criteria. Further, periodic assessments of each center’s ability lớn continue to meet these goals were continued throughout the data acquisition phase. Smaller hospitals with fewer resources may find it more difficult lớn consistently meet stringent time criteria. It is difficult khổng lồ calculate the cost of such an effort, especially when measuring against the value of a life saved. However, research suggests that the protocolization of massive transfusion actually decreases both sản phẩm wastage & costs.20 Further, provision of timely blood products is a benchmark of unique that should be continuously reevaluated at every trauma center. “Door-to-balloon” times are measured for cardiac referral centers; no less should be expected for trauma centers.
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| Nhạc sĩ/ sáng sủa tác: |  | |
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| Các ca sĩ thể hiện: | ||
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Lời bài bác hát Em là dân chơi thường xuyên được update đầy đủ những thông tin về nhạc sĩ, ca sĩ thể hiện, năm sáng tác, mp3 cũng như video video clip (youtube) tại docongtuong.edu.vn.Bạn rất có thể liên hệ cùng với ban quản ngại trị trang web qua phần phản hồi hoặc e-mail để bổ sung cập nhật hoặc chỉnh sửa những thiếu sót về lời bài bác hát hoặc các version hay ngôn ngữ khác (tiếng Việt, giờ Anh, tiềng Hàn Quốc...)Từ khóa kiếm tìm kiếm:Lời bài xích hát Em là dân chơi, Em là dân nghịch Lyrics, loi bai hat Em la dan choi, Em la dan choi Lyric, khuyết danh, Emladanchoi