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 ; COVID-19/drug therapy* ; Humans ; SARS-CoV-2 ; Treatment Outcome

Objective:To explore the value of cardiovascular MR (CMR) T 1 mapping in evaluating myocardial injury in patients recovered from COVID-19. Methods:The clinical and image data of 15 patients with COVID-19 (9 with moderate clinical manifestation, 6 with severe clinical manifestation) who underwent CMR screening at 3 months after being discharged from the Second People′s Hospital of Fuyang City during May 2020 to June 2020 were prospective collected. Fifteen COVID-19 patients were selected as case group, and another 11 healthy volunteers were selected as control group. A standardized CMR protocol included cine, native and enhanced T 1 mapping, late gadolinium enhancement (LGE). Cardiac functional parameters, native T 1 value of left ventricular and extracellular volume fraction (ECV) were measured. One way ANOVA was used to assess the difference between CMR parameters among moderate and severe manifestation groups and control group, and LSD- t was used to assess the difference between the three groups. Results:LGE value was negative in all subjects. ECV values were higher in recovered COVID-19 patients with either moderate (27.9%±2.7%) or severe manifestation (30.0%±3.7%) than control group (23.2±1.9%) ( P<0.05); there was no significant difference of ECV values between recovered COVID-19 patients with moderate and severe manifestation ( P=0.100). There was no difference of native T 1 values and other functional and morphologic parameters of left ventricular and right ventricular among recovered COVID-19 patients with moderate and severe manifestation and control group ( P>0.05). Conclusion:CMR myocardial tissue ECV increase in patients who recovered from COVID-19, suggesting subclinical myocardial injury.

Objective:To analyze the clinical characteristics of patients with novel coronavirus pneumonia (COVID-19) and the factors influencing mild cases developing into severe cases, so as to provide a basis for clinical screening, prevention and treatment of potential severe cases.Methods:Retrospective analysis was performed on the clinical characteristics of 168 cases who were admitted to two tertiary general hospitals in Anhui province and diagnosed with COVID-19 from January 20 to March 4, 2020. According to the classification criteria in the COVID-19 diagnosis and treatment program (trial version 6) issued by the National Health Commission, the mild and common cases were classified as the mild group ( n=137), and the severe and critical cases were classified as the severe group ( n=31). The general data, epidemiological history, clinical manifestations, laboratory examination and imaging indexes of the two groups were compared. Univariate analysis was performed. Then multivariate Logistic regression analysis was conducted on the factors with statistically significant differences in univariate analysis to obtain independent influencing factors of the occurrence of severe COVID-19. Results:Among the 168 COVID-19 patients, 95 were male and 73 were female, with an average age of 42.6±15.8 years old. The mean age of the mild group was younger than that of the severe group (40.5±15.5 vs 51.6 ±14.1, P<0.01). The proportion of patients combined with hypertension (29.0% vs 10.9%), diabetes (25.8% vs 2.2%, P=0.005) and two or more underlying diseases (29.0% vs 4.4%, P=0.006) in the severe group were significantly higher than those in the mild group. In the severe group, the proportion of patients receiving initial treatment in Medical institutions below secondary hospitals was significantly higher than that in the mild group ( P<0.01), and the time between symptom onset and diagnosis was longer [(8.00±3.27) d vs (6.49±3.90) d, P=0.048]. There was no significant difference in the initial symptoms between the mild group and the severe group. However, the body temperature was higher in the severe group [(38.80±0.67)℃ vs (37.9±0.60)℃, P<0.01]. At the time of admission, the lymphocyte percentage of the severe group was significantly lower than that of the mild group [(18.20±9.13)% vs (24.43±10.43)%, P<0.01], while C-reactive protein, interleukin-6 (IL-6), D-dimer, LDH, aspartate and aminotransferase were significantly higher than that of the mild group ( P<0.01). CT imaging showed that 11 (8%) patients in the mild group had lesions confined to a single lobe of the lung, while all patients in the severe group had multi-lobe lesions ( P<0.01). All the 168 COVID-19 patients in this study were cured, and the length of hospital stay in the severe group was significantly longer than that in the mild group [(24.71±7.72) d vs (20.28±7.67) d, P=0.021]. According to multivariate binary Logistic regression analysis, age ( P=0.042), diabetes ( P=0.021), body temperature at admission ( P=0.001), and IL-6 measured at admission ( P=0.008) were independent factors affecting COVID-19 to severe progress. Conclusions:Strengthening the professional knowledge training of primary hospitals is helpful for early diagnosis of COVID-19. Patients with older age, combined with diabetes, high initial fever and significantly increased IL-6 level are more possibly to develop into severe disease. Early identification and prevention should be carried out.

Objective: To evaluate the feasibility and potential value of comprehensive geriatric assessment (CGA) in elderly (≥60 years) patients with newly diagnosed acute myeloid leukemia (AML) in China. Methods: The CGA results of 83 newly diagnosed AML (non-APL) patients from 16 hospitals in Beijing and Tianjin between March 2016 and December 2017 were prospectively collected and analyzed. The clinical data, treatment and follow-up information were also collected. Results: Of 83 newly diagnosed elderly AML patients, 81 patients (97.6%) completed all designated CGA assessment. The median number of impaired scales of the CGA assessment in the studied population was 2(0-6). Sixteen patients (19.3%) showed no impairments according to the geriatric assessment scales implem ented by this study. The distributions of impaired scales were as follows: impairment in ADL, 55.4%; IADL impairment, 42.2%; MNA-SF impairment, 48.2%; cognitive impairment, 15.7%; GDS impairment, 31.7%; HCT-CI impairment, 19.5%, respectively. In patients with "good" ECOG (n=46), the proportion of impairment for each CGA scale ranged from 6.5% to 37.0% and 32 patients (68.9%) had at least one impaired CGA scale. Survival analysis showed that the number of impaired scales of the CGA was significantly correlated with median overall survival (P=0.050). Conclusions CGA was a tool with feasibility for the comprehensive evaluation in elderly AML patients in China. Combined with age and ECOG, CGA may be more comprehensive in assessing patients’ physical condition.

Objective To explore the optimal perioperative nursing program for patients receiving cardiac pacemaker by His bundle pacing or by para-His bundle pacing.Methods A total of 26 patients,who were receiving cardiac pacemaker by His bundle pacing or by para-His bundle pacing,were enrolled in this study.The bundle of cares,used as the nursing intervention measures,was executed in all patients,which included strengthening the professional training for specialist team members,improvement of preoperative intervention,careful intraoperative cooperation,postoperative observation of patient's condition and complications,prevention and health guidance,etc.Results Through the strict implementation of the special bundle of nursing cares,all the 26 patients could well cooperated with surgical procedure,and after the treatment the patients recovered smoothly and achieved the desired results with no occurrence of complications.Conclusion The intervention measures of the bundle of cares are scientific and reasonable.The implementation of the special bundle of nursing cares can promote the professional nursing ability of nurses and ensure the quality of nursing service.

Objective To explore the clinical characteristics and causes of death in patients with acute heart failure at aged 75 and over.Methods The prospective study collected 175 patients with acute heart failure from January 2012 to December 2014.They were divided into ≥75 years old group and＜75 years old group and the general clinical data were recorded.Follow-up was performed mainly by telephone with supplemented hospitalization follow-up and outpatient follow-up.Survival rates were assessed by Kaplan-Meier method.The survival rate difference between the two groups was compared using the log-rank test.Multivariate Cox proportional hazards regression analysis was used to determine the independent risk factors for death.Results The proportions of ischemic heart disease,hypertension and old myocardial infarction were higher in the elderly group than in the young group with a higher proportion of male,diabetes and body mass index in ＜75 years old group.Elderly group had a higher level of left ventricular ejection fraction(LVEF)and a lower level of total cholesterol,triglycerides and low density lipoprotein cholesterol(LDL-C).Kaplan-Meier curves showed that allcause mortality(x2 =4.005,P =0.045) and non-cardiovascular mortality(x2 =4.418,P =0.041) were significantly higher in the elderly group than in the younger group,whereas cardiovascular mortality had no significant difference between the two groups (x2 =0.754,P =0.385).In patients with noncardiovascular mortality,12 cases (63.2％)died of pulmonary infection in elderly group,3 cases(25.0％) died of lung infection in younger group,and the difference was statistically significant between the 2 groups (x2 =4.288,P =0.038).Multivariate Cox proportional hazards regression analysis showed that age≥75 years was an independent predictor for both non-cardiovascular mortality [HR(95％CI):2.71(1.50-6.55),Wald x2 =2.266,P=0.038]and all-cause mortality[HR(95 ％CI):1.75(1.28-3.13),Wald x2 =2.914,P=0.026]in patients with acute heart failure.Conclusions Age ≥75 years is an independent risk factor for all dead patients with acute heart failure and noncardiovascular death,but it is not the independent risk factors for cardiovascular death,which is of great significance to establish a more rational treatment strategy for senile heart failure.

Objective To investigate the clinical efficacy and safety of Ganciclovir combined with interferon-α1 b inhalation for children with infectious mononucleosis(IM).Methods A total of 177 childhood cases of IM were selected,and they were divided into 3 groups,59 cases in each group according to the random number table.Three therapeutic methods were applied in different groups for 5-7 days in different groups:Ganciclovir (group A),Ganciclovir + interferon-α1 b inhalation (group B) and Ganciclovir + interferon-α1b intramuscularly (group C).The time of post-drug recovery from isthmitis,less than 0.05 of heterotypic lymphocytes,shrink of cervical lymph nodes shrink,liver retraction,spleen retraction among groups were compared.The Epstein-Barr virus (EBV)-DNA copy number and T lymphocyte subsets were compared before and after treatment.Adverse reactions were observed in each group.Results Compared with group A,the time to defervescence [(3.20 ± 1.81) d,(3.17 ± 1.76) d vs.(4.01 ± 2.34) d],duration of isthmitis was [(3.15 ± 1.33) d,(3.09 ± 1.37) d vs.(3.98 ± 1.31) d],and the time of heterotypic lymphocytes less than 0.05 [(3.12 ± 1.55) d,(3.10 ± 1.33) d vs.(3.95 ± 1.26) d] in group B and group C,were obvious shorter,and there were significant differences(F =4.150,4.580,4.060,all P ＜ 0.05).EBV-DNA negative conversion rate of group B and group C were higher than that of group A [53 cases(89.8％),52 cases (88.1％) vs.41 cases (69.5％),x2 =10.403,P ＜ 0.05],and the cellular immune function was improved significantly than that of group A after treatment for 7 days [CD3 +:(63.00 ±4.39)％,(62.75 ±4.84)％ vs.(68.70 ± 7.70)％;CD4+:34.08(30.21,41.70)％,33.94(29.17,45.17)％ vs.32.34(28.16,43.53)％;CD8+:30.59 (27.14,40.22)％,30.09(27.54,40.48)％ vs.32.57(28.68,41.17)％;CD4+/CD8+:1.12(1.03,1.31),1.11 (0.99,1.64) vs.0.94 (0.87,1.59),F/x2 =11.020,1.217,1.121,6.728,all P ＜ 0.05].The differences in indexes between B group and C group were not significant,and there was no statistical significance (all P ＞ 0.05).There were 2 cases with fever in the group C,and 2 cases of granulocytopenia in all group.Conclusions Ganciclovir combined with interferon-α1 b inhalation or intramuscular injection is effective and safe in treating children with IM.It can improve clinical symptoms,cellular immune function and EBV-DNA negative conversion rate.Since inhalation is of less side effects and no pain,it can be accepted by children and their parents easily.Therefore,it is recommended that Ganciclovir be used together with interferon-α1 b inhalation in the treatment of children with IM.

Objective: The aim of the study is to validate whether the Recognition Of Stroke In the Emergency Room (ROSIER) scale can be used by general practitioners (GPs) in an emergency medical service (EMS) protocol to transfer stroke patients from primary care center to advanced hospital with acute stroke center. Methods: GPs prospectively performed the ROSIER scale and the Cincinnati Prehospital Stroke Scale (CPSS) on suspected stroke patients as a transfer protocol. All patients were immediately transferred to the Level-II hospital for further treatment. Results: 468 of the 512 suspected stroke patients met the inclusion criteria in this study. The ROSIER scale showed a diagnostic sensitivity of 83.13% (95% confidence intervals [CI] 79.74-86.52%) and specificity of 80.88% (95% CI 77.32- 84.44%). The CPSS showed a diagnostic sensitivity of 78.01% (95% CI 74.26-81.76%) and specificity of 70.59% (95% CI 66.46-74.72%). The Kappa statistic value of the ROSIER scale and the CPSS were 0.601 and 0.454, respectively. The area under the curve (AUC) of ROSIER scale was large than the CPSS (AUC 0.855 vs. 0.791). However, the difference was not significantly different. Conclusions: This study suggest that ROSIER and CPSS could be used in an EMS protocol to transfer stroke patients from a primary care center to an advanced hospital offering thrombolysis service
Stroke

Objective To discuss the benefits of extracorporeal membrane oxygenation (ECMO) applied in the patients with idiopathic pulmonary arterial hypertension during the operation of bilateral sequential single lung transplantation.Methods Fifteen patients with idiopathic pulmonary arterial hypertension received lung transplantation supported with ECMO between Nov.2009 and Sep.2014.ECMO was removed after the transplantation if the oxygenation and hemodynamic were stable,otherwise,ECMO was applied continuously until the situation improved.Results All the operations of 15 patients were accomplished successfully and the ECMO was removed in 3 patients after the operation immediately,while in the other 12 patients,ECMO was applied continuously until the situation improved in ICU.ECMO was applied again in 3 patients when it was necessary.Deep venous thrombosis occurred in one patient.Three patients died after operation and the other 12 patients are alive till now.Conclusion ECMO can be applied safely and effectively in lung transplantations for idiopathic pulmonary arterial hypertension patients.

Objective: To investigate the clinical efficacy and outcome determinants in cardiac arrest patients secondary to acute myocardial infarction treated with extracorporeal membrane oxygenation (ECMO) and percutaneous coronary intervention (PCI). Methods: The clinical data of 27 patients hospitalized from January 2014 to March 2017 in 3 hospitals were retrospectively analyzed. The clinical data of the surviving group (12 cases) and the death group (15 cases) were compared and the outcome determinants were explored. Results: Twenty seven patients were successfully treated with coronary angiography and emergency PCI under ECMO assistance, and the successful procedure rate was 100%. The survival rate was 44.4% (12/27). There was no significant difference in gender, age, body weight, myocardial infarct location, past disease history and smoking status between the two groups (all P>0.05). Traditional cardiopulmonary resuscitation time was significantly longer, the CCU hospitalization time was significantly shorter, the number of diseased vessels was significantly higher, and the prevalence of distribution of blood vessels in left main stem was significantly higher and mean artery pressure at 24 and 48 hours post ECMO was significantly lower in the death group than in survival group (all P<0.05). Multiple logistic regression analysis showed that left anterior descending artery lesion, higher number of lesion vessels, longer traditional cardiopulmonary resuscitation time, longer time interval between cardiac arrest and ECMO placement were related increased risk of death post ECMO and emergency PCI in this patient cohort(OR=1.316, 95%CI 1.217-5.792, P=0.002; OR=1.238, 95%CI 1.107-4.961, P=0.000; OR=1.712, 95%CI 1.136-3.973, P=0.001; OR=1.629, 95%CI 1.132-4.521, P=0.000, respectively), while higher mean artery pressure at 48 hours post ECMO was related with reduced risk of death post ECMO and emergency PCI in this patient cohort(OR=0.672, 95%CI 0.326-0.693, P=0.001). Conclusions ECMO combined with emergency PCI can improve the success rate of traditional cardiopulmonary resuscitation in patients with cardiac arrest secondary to acute myocardial infarction. Left anterior descending artery lesion, number of lesion vessels, traditional cardiopulmonary resuscitation time, time interval between cardiac arrest and ECMO placement and mean artery pressure at 48 hours post ECMO are outcome determinants post ECMO and emergency PCI in this patient cohort.