1.Effects of dopamine combined with norepinephrine on blood lactic acid and inflammatory factors in elderly patients with severe septic shock
Chinese Journal of Primary Medicine and Pharmacy 2017;24(16):2520-2524
Objective To investigate the effects of dopamine combined with norepinephrine on blood lactate and inflammatory factors in elderly patients with severe septic shock.Methods 120 elderly patients with severe septic shock were randomly divided into control group and observation group,60 cases in each group.The control group was treated with dopamine.The observation group was treated with norepinephrine on the basis of the control group at the same time.The treatment was evaluated 48 h after treatment.The changes of heart rate(HR),mean arterial pressure(MAP),central venous pressure(CVP),blood lactate(Lac),urine output,central venous oxygen saturation(SC-VO2),tumor necrosis factor alpha(TNF-α),C-reactive protein(CRP),serum calcitonin(PCT),cardiac function index(CI),peripheral vascular resistance index(SVRI)and extravascular lung water index(ELVWI)were observed before and after treatment for 48h.Results After treatment,the HR of the patients of the two groups decreased,there was no significant difference between before and after treatment in the control group(t=1.551,P=0.062),HR of the observation group were significantly lower than those of the control group and before treatment,the differences were statistically significant(t=15.847,14.960,all P=0.00).The MAP of the control group and the observation group after treatment were higher than those of before treatment(t=32.949,44.344,all P=0.00),and CVP were higher than before treatment(t=12.620,18.959,all P=0.00),urine volume increased significantly compared with before treatment(t=83.213,94.562,all P=0.00),and SC-VO2 were higher than those of before treatment(t=36.589,42.899,all P=0.00),Lac were lower than before treatment(t=15.653,24.016,all P=0.00).The improve degree of HR,MAP,CVP,Lac,urine volume,SC-VO2 of the observation group were higher than those of the control group(t=14.960,15.267,4.857,7.022,20.395,5.704,all P=0.00).The TNF-α levels of the control group and the observation group were lower than those of before treatment(t=13.300,33.004,all P=0.00),the CRP decreased significantly compared with before treatment(t=24.759,24.756,all P=0.00),the PCT were lower than those of before treatment(t=15.235,26.693,all P=0.00),the TNF-α,CRP and PCT of the observation group were decreased more significantly compared with the control group(t=17.470,6.079,10.550,all P=0.00).The CI of the control group and the observation group was higher than before treatment(t=16.050,34.124,all P=0.00),the SVRI were higher than those of before treatment(t=60.357,68.434,all P=0.00),the ELVWI were lower than those of before treatment(t=4.523,8.013,all P=0.00),the CI,SVRI,ELVWI of the observation group were improved more significantly than those of the control group(t=13.176,12.483,2.100,all P=0.00).Conclusion Dopamine combined with norepinephrine can improve the vital signs of patients with severe septic shock,reduce the concentration of lactate in blood,improve the level of inflammatory factors,and heart index.However,due to the subjective factors such as the size of the subject,the lack of research,the future study can increase the sample size to demonstrate the above speculation.
2.Comparison between enteral nutrition and parenteral nutrition support in aged ventilated patients
Yumin YANG ; Huaping ZHANG ; Tianjun PAN ; Litong JIN ; Chunying YANG ;
Parenteral & Enteral Nutrition 1997;0(03):-
Objectives: To observe the effect of total enteral nutrition (TEN)and total parenteral nutrition (TPN)in aged patients with mechanical ventil ation. Methods: 60 cases of aged patients with mechanical ventilation were randomly divided to TEN group and TPN group.All patients accepted the same amount of calorie and nitrogen. Results: with regard to albumin and hemoglobin levels and nitrogen equilibrium TEN group was superior to parenteral nutrition group ( P 0.05). Conclusions: Enteral nutrition can reduce mechanical ventilation time and lower treatment cost in aged patients.
3.Effects of positive end-expiratory pressure on hemodynamics and intra-abdominal pressure in patients with acute respiratory distress syndrome with and without intra-abdominal hypertension
Tianjun YANG ; Aijun PAN ; Xiaogen TAO ; Bao LIU
Chinese Journal of Emergency Medicine 2014;23(9):1013-1017
Objective To investigate the effects of positive end-expiratory pressure (PEEP) on hemodynamics and intra-abdominal pressure in patients with acute respiratory distress syndrome (ARDS) with normal intra-abdominal pressure (IAP) and intra-abdominal hypertension (IAH) during mechanical ventilation under a incremental PEEP.Methods Eighteen ARDS patients with normal IAP or IAH treated in intensive care unit of Anhui Provincial Hospital were enrolled for study.At different PEEP levels (5,10,15,20 cmH2O),hemodynamic parameters including extravascular lung water index (EVLWI),intrathoracic blood volume index (ITBVI),stroke volume variation (SVV) and IAP were measured with PICCO technology.Results Compared with ARDS patients with normal IAP,the ARDS patients with IAH were characterized by:(1) EVLWI was decreasing under the increment of PEEP,but there was no significant difference between 15 cmH2O and 20 cmH2O (t =0.593,P =0.572).As PEEP was gradually escalated,EWLVI had no significant changes in patients with normal IAP.(2) SVV increased as PEEP was being titrated to higher level in both groups but in normal IAP group such effect was observed till PEEP above 10cmH2O (PEEP5 vs.PEEP10,t=0.326,P=0.752; PEEP,10 vs.PEEP 15,t=-20.032,P< 0.01).(3) There was no statistical difference in ITBVI between two groups at varied levels of PEEP.(4) PEEP could increase IAP levels and had much more profound effects on patients with IAH.Conclusions PEEP is a contributing factor changing IAP.It is necessary to take the level of PEEP into account as IAP variation is interpreted in patients under mechanical ventilation.Different PEEP levels can significantly affect the EVLWI in patients with IAH but not do not in ones with nomal IAP.
4.Phenotype and functions of natural killer cells in septic patients and its clinical significance
Aijun PAN ; Yanru DENG ; Tianjun YANG ; Lei ZHANG ; Min SHAO ; Shusheng ZHOU ; Chunyan WANG ; Bao LIU
Chinese Critical Care Medicine 2014;(11):827-831
Objective To investigate the possible mechanism of natural killer cells(NK cells)in immune dysfunction in sepsis by monitoring the phenotype and function of periphery NK cells in patients with sepsis. Methods A retrospective study was conducted. The patients with systemic inflammatory response syndrome(SIRS,n=59)or sepsis(n=65)admitted to Department of Critical Care Medicine of Anhui Provincial Hospital from August 2011 to August 2013 were enrolled. Blood samples were collected within 48 hours after intensive care unit(ICU)admission,the phenotype and function of periphery NK cells were determined by flow cytometry. Twenty-eight healthy people served as controls. Results The proportion and number of peripheral blood CD3-CD56+NK cells in SIRS and sepsis groups were normal,and no statistical difference was found when compared with those of the healthy control group〔cell proportion:0.102±0.019,0.102±0.108 vs. 0.106±0.018,F=0.018,P=0.982;cell number(×106/L):182.46±65.98, 172.97±63.51 vs. 179.25±60.44,F=0.349,P=0.706〕. It was shown by NK cell degranulation detection that there was no significant difference in the expression of CD107 and interferon-γ(IFN-γ)secretion〔CD107:0.135±0.050,0.140±0.058,0.128±0.070,F=0.583,P=0.560;IFN-γ(kU/L):14.36±4.74,12.49±4.21, 13.45±5.04,F=1.616,P=0.202〕among healthy control group,SIRS group,and sepsis group. It was shown by antibody dependent cytotoxic effect(ADCC)test that there was no difference in the expression of CD107 among healthy control group,SIRS group,and sepsis group(0.574±0.166,0.643±0.165,0.581±0.157,F=0.808,P=0.448). When compared with healthy controls,the secretion of IFN-γwas increased in SIRS patients(kU/L:40.5±13.2 vs. 28.4±9.6,P=0.001),while reduced in sepsis patients(kU/L:19.8±6.7 vs. 28.4±9.6,P<0.01). Compared with SIRS group,only NK cell surface inhibitory receptors CD158e(KIR 3DL1)expression in sepsis group was significantly increased(0.203±0.057 vs. 0.079±0.021,t=15.762,P<0.001),and there were no significant differences in the other phenotype between the two groups. Compared with SIRS group,the IFN-γproduction of the sepsis group was significantly lowered(kU/L:0.280±0.040 vs. 0.310±0.038,t=3.390,P=0.009),and the level of IL-12 was also significantly decreased(ng/L:0.15±0.03 vs. 0.30±0.08,t=32.832,P<0.001). Conclusion It was showed by NK cell phenotype and function assay that the function of NK cells in patients with sepsis was impaired and led to a poor production of IFN-γ. The IFN-γmediated immune dysfunction may be a main reason for the disorder of NK cell function,which laid the foundation of the clinical immune intervention practice to improve to NK cell function.
5.Efficacy and safety of colistimethate sodium in critical patients: anin vitro study by using of Monte Carlo simulation
Aijun PAN ; Qing MEI ; Tianjun YANG ; Xiaolan GAO ; Huaiwei LU ; Ying YE ; Jiabin LI ; Bao LIU
Chinese Critical Care Medicine 2017;29(5):385-389
Objective To evaluate the efficacy and safety of colistimethate sodium (CMS) for the treatment of critical patients infected by pan-drug resistantAcinetobacter baumannii (PDR-AB) or pan-drug resistant Pseudomonas aeruginosa (PDR-PA).Methods 321 isolates of PDR-AB and 204 isolates of PDR-PA from critical patients admitted to 35 intensive care units (ICUs) of grade two or above were collected from the Anhui Antimicrobial Resistance Investigation Net (AHARIN) program from September 2012 to September 2015, while the minimal inhibitory concentrations (MIC) of colistin were determined by the E-test. A series of Monte Carlo simulations was performed for CMS regimens (1 MU q8h, 2 MU q8h, and 3 MU q8h, and MU meant a million of unit), and the probability of achieving a 24-hour area under the drug concentration time curve (AUC24)/MIC ratio > 60 and risk of nephrotoxicity for each dosing regimen was calculated. Each simulation was run over three CLCr ranges: < 60, ≥ 60-90, ≥ 90-120 mL/min. The probability of target attainment (PTA)for the AUC24/MIC ratio was calculated using the partial MIC value, while the cumulative fraction of response (CFR) was determined by integrating each PTA with the MIC distributions, the value greater than or equal to 90% or more than 80% was set as the optimal dosing regimen or suboptimal dosing regimen respectively. The probability of average 24-hour serum concentrations up to 4 mg/L for three dosage regimens was used to predict the risks of nephrotoxicity.Results All 321 isolates of PDR-AB and 204 isolates of PDR-PA were susceptible to colistin, the MIC50/90 against PDR-AB were 0.5mg/L and 1.0 mg/L, and those against PDR-PA were 0.5 mg/L and 1.5 mg/L, respectively. When recommended dose (1 MU q8h) was used for patients with CLCr of < 60 mL/min, high CFR value (89.78% for PDR-AB, 81.06% for PDR-PA) were obtained, but with a high risks of nephrotoxicity (> 32.51%). Moreover, low value of PTA (< 66.56%) was yielded for isolates with MIC of ≥ 1 mg/L. Recommended dose also yielded a low CFR value (56.97%-69.31% for PDR-AB, 44.76%-56.94% for PDR-PA) in patients with CLCr of ≥ 60-120 mL/min. When dose was increased to 2 MU q8h, CFR (77.45%-92.87%) and the risks of nephrotoxicity (< 0.15%) was optimal for patients with CLCr ≥ 60-120 mL/min, but low value of PTA (< 75.36%) was also yielded for isolates with MIC of ≥ 1 mg/L. The most aggressive dose of 3 MU q8h provided high CFR (> 89.24%) even in patients with CLCr ≥ 90-120 mL/min, and PTA was < 76.20% only for isolates with MIC of ≥ 1.5 mg/L, but this dosing scheme was associated with unacceptable risks of nephrotoxicity (> 33.68%).Conclusion Measurement of MIC, individualized CMS therapy and therapeutic drug-level monitoring should be considered to achieve the optimal drug exposure and ensure the safety of CMS.
6.Effect of early rehabilitation physiotherapy on muscle quality and function in critically ill patients
Chunyan ZHU ; Bao LIU ; Tianjun YANG ; Qing MEI ; Aijun PAN ; Dongsheng ZHAO
Chinese Critical Care Medicine 2018;30(6):569-572
Objective To investigate the effect of early rehabilitation physiotherapy on muscle quality and function in critical patients. Methods A prospective randomized controlled study was performed. Adult critically ill patients admitted to intensive care unit (ICU) of Anhui Provincial Hospital from October 1st, 2016 to August 31st, 2017 who had been hospitalized for more than 7 days and had acute physiology and chronic health evaluation Ⅱ(APACHE Ⅱ ) > 8 were enrolled, and they were divided into treatment group and control group according to random number table method. All patients were given routine treatment, and on this basis, the treatment group was given rehabilitation therapy within 24 hours after admission, including limb active / passive activities, respiratory muscle function training and transcutaneous electrical nerve stimulation, etc. Bedside ultrasound was used to measure the area and cross sectional thickness of left rectus femoris muscle and the cross sectional thickness of middle thigh muscle of patients at 1, 4 and 7 days after treatment; at the same time, the muscle strength of sober patients was evaluated by medical research council (MRC) muscle strength evaluation method, and the mechanical ventilation time, ICU hospitalization time and ICU expenses were recorded. Results Forty patients were enrolled in this study, with 20 in each group. Compared with the control group, the difference of left rectus femoris muscle area between 1 day and 4 days, 4 days and 7 days, 1 day and 7 days (cm2: 0.19±0.02 vs. 0.31±0.19, 0.02±0.01 vs. 0.08±0.05, 0.04±0.02 vs. 0.38±0.23), and the difference in left rectus femoris thickness (cm: 0.01±0.01 vs. 0.14±0.13, 0.03±0.03 vs. 0.16±0.14) and the difference in middle thigh muscle thickness (cm: 0.02±0.02 vs. 0.11±0.09, 0.03±0.02 vs. 0.16±0.12) between 1 day and 4 days, 1 day and 7 days in the treatment group were significantly reduced (all P <0.01). The MRC strength score in the treatment group was significantly higher than that of the control group at 7 days (52.06±3.52 vs. 47.94±3.96, P < 0.05). The mechanical ventilation time in the treatment group (n = 15) and the control group (n = 13) were (138.5±34.5) hours and (185.0±40.9) hours, respectively, and the difference between two groups were statistical significance (P < 0.05). Compared with the control group, the incidence rate of ICU acquired muscle weakness (ICUAW) in the treatment group was significantly decreased [5.0% (1/20) vs. 40.0% (8/20), P < 0.05], the length of ICU stay was significantly shortened (days: 17.67±4.91 vs. 22.06±5.94, P < 0.05), and the ICU expenses were significantly reduced (ten thousand yuan: 7.53±2.09 vs. 9.55±1.73, P < 0.05). Conclusion Early rehabilitation physiotherapy can improve the muscle quality and function in critical patients, and decrease the length of ICU stay.
7.The characteristics of laboratory parameters evolution in patients with acute fatty liver of pregnancy and the effect of plasma exchange on those parameters
Tianjun YANG ; Chunyan ZHU ; Xiaoqin FAN ; Aijun PAN ; Bao LIU
Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care 2018;25(6):620-624
Objective To observe the variation tendency of laboratory indexes after delivery in pregnant women with acute fatty liver of pregnancy (AFLP) and the effects of plasma exchange (PE) on the patients prognoses and those parameters. Methods The data of 37 patients with AFLP admitted to the Department of Intensive Care Unit (ICU) of Anhui Provincial Hospital from January 2009 to June 2017 were retrospectively analyzed and the authors tried to clarify the natural course of AFLP; all the selected patients met the Swansea criteria of the AFLP diagnosis. The patients were divided into a PE group (9 cases) and a non-PE group (28 cases) according to whether they were treated with PE or not. At the same time, the effects of PE on liver function and coagulation parameters in the patients were analyzed. Results The most common clinical symptoms of 37 AFLP patients were as follows: nausea and vomiting (21 cases, incidence 56.8%), jaundice (21 cases, 56.8%), upper abdominal pain (14 cases, 37.8%), and more than 90% of patients had more than one symptom. All 37 patients with AFLP had abnormal liver function, their differences in the severity degrees were great, and the level of aspartate aminotransferase (AST) was (271.65±265.90) U/L;the levels of creatinine (SCr) of 72.9% patients (27 cases) were more than 140 mmol/L; the prothrombin times (PT) of 72.97% patients (27 cases) were more than 15 seconds; all patients had received blood product transfusion. Liver function and blood coagulation parameters mostly returned to normal within 1 week after delivery: AST rapidly decreased on the 1 - 2 days after delivery and then continued to decrease; all the cholesterol levels in the two groups decreased to the lowest levels within 3 - 4 days after delivery and then began to rise; the total bilirubin (TBil) levels kept on basically unchanging after delivery; in the patients with levels of platelet counts (PLT) on admission ≥ 150×109/L, on the second day after delivery, their counts returned to approximately 100×109/L, while in patients with PLT < 150×109/L on admission, on the sixth day after delivery, the counts began to slowly increase to about 100×109/L; the patients with fibrinogen (Fib) levels > 1.5 g/L on admission, the levels slightly decreased 2 days before delivery, then gradually recovered and stabilized after delivery, while the patients with Fib < 1.5 g/L, the levels began to rise slowly on the second day after delivery; prothrombin time (PT) and activated partial thromboplastin time (APTT) were basically return to the normal reference ranges on the fifth day after delivery. The PE therapy could significantly improve the patients' laboratory indexes: the levels of AST, TBil, PLT, PT were significant lower immediately and on the second day after PE compared with those levels before the PE [AST (U/L): 197 (114, 383), 116 (65, 311) vs. 239 (125, 430), TBil (μmol/L):109 (67, 126), 125 (103, 178) vs. 164 (99, 198), PLT (×109/L): 96.44±33.10, 89.89±33.03 vs. 126.22±40.83, PT (s): 17.82±5.93, 18.36±3.19 vs. 22.67±8.44, all P < 0.05]. Conclusion After terminating the delivery in time for about one week, the AFLP patients' various indexes may basically return to normal; PE therapy can improve the patients' liver function and coagulation indexes.
8.Incidence and risk factor analysis of deep venous thrombosis in patients with severe traumatic brain injury
Tianjun YANG ; Gang WEI ; ChunYan ZHU ; Aijun PAN
Chinese Critical Care Medicine 2019;31(2):182-186
Objective? To?estimate?the?incidence?and?risk?factors?for?deep?venous?thrombosis?(DVT)?in?patients?with?severe?traumatic?brain?injury?(TBI)?treated?in?the?intensive?care?unit?(ICU).? Methods? 105?patients?with?TBI?admitted?to?the?First?Affiliated?Hospital?of?University?of?Science?and?Technology?of?China?from?January?2016?to??June?2018?were?enrolled?[Glasgow?coma?scale?(GCS)?3-8;?concise?injury?score?for?other?parts≤3].?All?patients?did?not?receive?any?medication?or?physical?measures?to?prevent?DVT?during?hospitalization.?Bilateral?compression?Doppler?ultrasounds?of?the?double?lower?limbs?and?upper?limbs?were?performed?to?clarify?the?occurrence?of?DVT?on?the?first?day?of?admission?and?twice?a?week?until?ICU?discharge?or?the?death?of?patient.?The?examination?was?performed?by?a?senior?ultrasound?doctor.?It?was?defined?as?DVT?as?long?as?any?deep?vein?had?thrombosis.?Patients?were?divided?into?two?groups?according?to?whether?DVT?occurred?or?not?during?hospitalization.?Clinical?data?such?as?body?mass?index?(BMI),?coagulation?index,?platelet?count?(PLT)?and?deep?venous?catheterization?were?obtained?from?the?clinical?chemistry?laboratory?database?and?patient?files.?Logistic?regression?was?used?to?analyze?the?risk?factors?of?DVT.?Binary?Logistic?regression?was?used?to?calculate?the?predictive?probability?of?risk?factors.?The?predictive?value?of?risk?factors?and?predictive?probability?to?the?occurrence?of?DVT?was?analyzed?by?receiver?operating?characteristic?(ROC)?curve.? Results? In?105?patients?with?simple?TBI,?42?patients?developed?DVT?during?hospitalization,?and? the?incidence?of?DVT?was?40%.?Univariate?Logistic?regression?showed?that?high?BMI?[odds?ratio?(OR)?=?1.490,?95%?confidence?interval?(95%CI)?=?1.174-1.891,?P?=?0.001],?high?PLT?(OR?=?1.023,?95%CI =?1.006-1.040,?P =?0.007),?shorten?activated?partial?thromboplastin?time?(APTT;?OR?=?0.913,?95%CI?=?0.853-0.978,?P?=?0.010)?and?catheterization?in?deep?vein?(OR?=?0.114,?95%CI =?0.026-0.493,?P?=?0.004)?were?risk?factors?for?DVT.?It?was?shown?by?multivariate?regression?analysis?that?high?BMI?(OR?=?1.378,?95%CI =?1.411-1.665,?P?=?0.001),?high?PLT?(OR?=?1.017,?95%CI =?1.003-1.032,?P?=?0.020),?low?APTT?(OR =?0.920,?95%CI =?0.860-0.982,?P?=?0.012)?and?catheterization?in?deep?vein??(OR?=?0.113,?95%CI =?0.029-0.443,?P?=?0.002)?were?independent?risk?factors?for?DVT.?The?predictive?probability?formula:?Logit?P?=?-4.673+0.321×BMI-0.083×APTT+0.017×PLT-2.181×catheterization?in?deep?vein.?It?was?shown?by?ROC?curve?analysis?that?high?BMI,?high?PLT,?low?APTT?and?catheterization?in?deep?vein?could?predict?the?occurrence?of?DVT?in?severe?TBI?patients,?and?the?area?under?ROC?curve?(AUC)?was?0.775,?0.709,?0.709?and?0.680,?respectively.?The?AUC?of?prediction?probability?was?0.890,?and?its?sensitivity?and?specificity?were?respectively?increased?to?88.10%?and?85.71%.? Conclusions? The?incidence?of?DVT?was?higher?in?patients?with?simple?severe?TBI.?High?coagulation,?high?BMI,?high?PLT?and?catheterization?in?deep?vein?are?the?independent?risk?factors?for?DVT.
9.Clinical value of Aβ1-42, tau protein and thyroid hormone levels in predicting cognitive impairment after ischemic stroke.
Lei MAO ; Peng LI ; Xiaohan CHEN ; Tianjun MA ; Yixin XU ; Xiao PAN ; Jianhua ZHUANG ; You YIN
Chinese Journal of Nervous and Mental Diseases 2019;45(7):385-389
Objective To investigate the relationship between serum markers β amyloid (Aβ), tau and thyroid hormone levels and post-stroke cognitive impairment (PSCI) in the acute phase of cerebral infarction. Methods A total of 214 patients with acute cerebral infarction were enrolled. The baseline data and serological indicators were collected and the cognitive function of patients was evaluated. All patients were divided into cognitive impairment group and normal group based on follow-up results. The differences of Aβ1-42, tau protein and thyroxine levels between the two groups and their relationship with disease progression were analyzed. The Cox regression analysis and ROC curve were used to compare the above parameters to predict the development of PSCI. Results The total protein level of Tau (210.6 ±98.9 pg/mL) was higher and Aβ1-42 (426.1 ±123.5 pg/mL) and triiodothyronine (T3) (1.43 ±0.57 nmol/L), free thyroxine (FT4) (13.15±2.23 pmol/L) was significantly lower in the cognitive impairment group than in the normal group (P<0.05). Tau protein (r=-0.457), Aβ1-42 (r=0.348), T3 (r=0.211), and FT4 (r=0.306) were all associated with disease progression (P<0.05). Cox regression analysis showed that Aβ1-42 and T3 were important influencing factors in the occurrence of PSCI. The area under the curve of Aβ1-42 combined with T3 was 0.841. The specificity and the sensitivity were 74.8% and 85.3%, respectively, with a diagnostic cutoff value of 0.572. Conclusion Aβ1-42 and T3 levels in the acute phase of cerebral infarction may predict the progression of PSCI.
10.Tocilizumab in patients with moderate or severe COVID-19: a randomized, controlled, open-label, multicenter trial.
Dongsheng WANG ; Binqing FU ; Zhen PENG ; Dongliang YANG ; Mingfeng HAN ; Min LI ; Yun YANG ; Tianjun YANG ; Liangye SUN ; Wei LI ; Wei SHI ; Xin YAO ; Yan MA ; Fei XU ; Xiaojing WANG ; Jun CHEN ; Daqing XIA ; Yubei SUN ; Lin DONG ; Jumei WANG ; Xiaoyu ZHU ; Min ZHANG ; Yonggang ZHOU ; Aijun PAN ; Xiaowen HU ; Xiaodong MEI ; Haiming WEI ; Xiaoling XU
Frontiers of Medicine 2021;15(3):486-494
Tocilizumab has been reported to attenuate the "cytokine storm" in COVID-19 patients. We attempted to verify the effectiveness and safety of tocilizumab therapy in COVID-19 and identify patients most likely to benefit from this treatment. We conducted a randomized, controlled, open-label multicenter trial among COVID-19 patients. The patients were randomly assigned in a 1:1 ratio to receive either tocilizumab in addition to standard care or standard care alone. The cure rate, changes of oxygen saturation and interference, and inflammation biomarkers were observed. Thirty-three patients were randomized to the tocilizumab group, and 32 patients to the control group. The cure rate in the tocilizumab group was higher than that in the control group, but the difference was not statistically significant (94.12% vs. 87.10%, rate difference 95% CI-7.19%-21.23%, P = 0.4133). The improvement in hypoxia for the tocilizumab group was higher from day 4 onward and statistically significant from day 12 (P = 0.0359). In moderate disease patients with bilateral pulmonary lesions, the hypoxia ameliorated earlier after tocilizumab treatment, and less patients (1/12, 8.33%) needed an increase of inhaled oxygen concentration compared with the controls (4/6, 66.67%; rate difference 95% CI-99.17% to-17.50%, P = 0.0217). No severe adverse events occurred. More mild temporary adverse events were recorded in tocilizumab recipients (20/34, 58.82%) than the controls (4/31, 12.90%). Tocilizumab can improve hypoxia without unacceptable side effect profile and significant influences on the time virus load becomes negative. For patients with bilateral pulmonary lesions and elevated IL-6 levels, tocilizumab could be recommended to improve outcome.
Antibodies, Monoclonal, Humanized
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COVID-19/drug therapy*
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Humans
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SARS-CoV-2
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Treatment Outcome