ABSTRACT
OBJECTIVE To mine adverse drug event （ADE） signals related to baloxavir marboxil， and to provide reference for clinically safe drug use. METHODS The ADE signals related to baloxavir marboxil from January 1， 2018 to May 31， 2022 in the US FDA adverse event reporting system （FAERS） were mined using the proportional reporting odds ratio （PRR） method. ADE with report number≥3， PRR≥2 and χ2≥4 was defined as a positive signal， and PRR method was used to analyze the ADE signal. RESULTS A total of 1 424 ADE reports with baloxavir marboxil as the main suspected drug were collected， involving 460 ADE signals. The femininity and patient under 18 years old were reported more， the country with the highest number of reports was the United States， and the main indication of drug reported was influenza. A total of 37 ADE positive signals were obtained after PRR calculation and screening exclusion， the first three ADE signals in the list of the reported number were diarrhea， vomiting and immediate hypersensitivity， and the first three ADE signals in the list of PRR value were febrile delirium， ischaemic colitis and hemorrhagic cystitis. Compared with the instructions of baloxavir marboxil， 18 ADE signals had not yet been included， such as abnormal liver function， hematuria， hemorrhagic cystitis， etc. Five new SOCs were involved， such as kidney and urinary system diseases， hepatobiliary system diseases， investigations， nervous system disorders and musculoskeletal and connective tissue disorders. CONCLUSIONS When clinical application of baloxavir marboxil， in addition to the adverse drug reactions mentioned in the drug instructions， attention should be paid to abnormal liver function， hematuria， hemorrhagic cystitis， etc， so as to guarantee the safety of drug use.
ABSTRACT
Objective:To investigate the clinical efficacy of hemoperfusion in the treatment of severe organophosphorus poisoning and its effect on diaphragm function.Methods:Eighty-five patients with severe organophosphorus poisoning who received treatment in Affiliated Huxi Hospital of Jining Medical University (Shanxian Central Hospital), China between January 2018 and January 2020 were included in this study. They were randomly divided into treatment ( n = 43)and control ( n = 42) groups. The control group was given conventional treatment including gastric lavage, catharsis, and application of reactivators and anticholinergic drugs. The treatment group was subjected to three times of hemoperfusion, with an interval of 24 hours between two hemoperfusion interventions based on the conventional treatment used in the control group. Before and after three times of hemoperfusion, serum levels of cholinesterase (CHE), interleukin-6 (IL-6), arterial partial pressure of oxygen (PaO 2), and arterial partial pressure of carbon dioxide (PaCO 2) were measured. The Acute Physiology and Chronic Health Evaluation (APACHE) II score and oxygenation index (OI) in each group were calculated. Right diaphragmatic activity, diaphragmatic thickness at the end of inspiration (DTei) and diaphragmatic thickness at the end of expiration were measured by bedside ultrasound. The diaphragmatic thickening rate (DTF) and diaphragmatic rapid shallow breathing index (D-RSBI) were calculated. Serum CHE and IL-6 levels, OI, diaphragmatic activity, DTF and D-RSBI were compared between the treatment and control groups. The incidence of intermediate syndrome, tracheal intubation rate, 28-day mortality rate, and hospital stay were compared between the two groups. Results:Before hemoperfusion, there were no significant differences in serum levels of CHE and IL-6, OI, right diaphragmatic activity, DTF, and D-RSBI between the treatment and control groups (all P > 0.05). After three times of hemoperfusion, serum IL-6 level and D-RSBI in the treatment group were (37.9 ± 6.2) ng/L and (0.77 ± 0.20) times /min/mm, which were significantly lower than those in the control group [(45.9 ± 5.3) ng/L, (0.90 ± 0.16) times/min/mm ( t = -6.295, -3.382, P < 0.001, P = 0.001)]. Serum CHE level, OI, DE and DTF in the treatment group were (2.29 ± 0.52) kU/L, (264.5 ± 24.3) mmHg, (16.5 ± 1.9) mm, (27.2 ± 4.7) %, respectively, which were significantly higher than those in the control group [(1.96 ± 0.39) kU/L, (252.6 ± 27.2) mmHg, (14.3 ± 1.6) mm, (23.5 ± 4.1) %, t = 3.258, 2.141, 5.598, 3.877, all P < 0.05]. The incidence of intermediate syndrome, tracheal intubation rate, hospital stay in the treatment group were [4.7% (2/43)], [2.3% (1/43)] and [(11.8 ± 1.8) days], respectively, which were significantly lower than those in the control group [23.8% (10/42), 19.0% (8/42) and (12.9 ± 1.8) days, χ2 = 6.432, P = 0.011; χ2 = 6.276, P = 0.012; t = -2.932, P = 0.004]. There was no significant difference in 28-day mortality rate between the two groups ( P > 0.05). Conclusion:Hemoperfusion can improve diaphragmatic function, reduce inflammatory reaction and shorten hospital stay in patients with severe organophosphorus poisoning.
ABSTRACT
Objective To investigate the effect of early activities on risk factors of acute gastrointestinal injury (AGI) in patients with chronic obstructive pulmonary disease (COPD) induced by mechanical ventilation.Methods A total of 118 mechanically ventilated non-diabetic patients with chronic obstructive pulmonary disease who were admitted to our hospital from August 2017 to April 2018 were enrolled in the study.The patients were divided into AGI group (71 cases) and non-AGI group (47 cases) according to the presence or absence of AGI.The examined data were collected in the patients prospectively such as preprocalcitonin (PCT),D-lactic acid,serum albumin (ALB),fasting plasma glucose (FPG),fasting insulin (FINS),and Acute Physiology and Chronic Health Evaluation Ⅱ (APACHE Ⅱ) scores were calculated.The homeostasis model insulin resistance index was used (HOMA-IR) to assess the subjects' insulin resistance.Logistics regression analysis screened for risk factors that affected patients' AGI.The AGI patients were divided into treatment group (36 cases) and control group (35 cases) according to the random number table method.On the basis of the same conventional treatment,the treatment group were received early mobilization.The differences of PCT,D-lactate,FPG,HOMA-IR,APACHE Ⅱ scores,and AGI grades before and after treatment for 3 days were observed for both groups of patients.Results The PCT,D-lactate,FPG,HOMA-IR,and APACHE Ⅱ scores were higher in the AGI group than in the non-AGI group [(2.72 ±0.54)ng/ml vs (1.81 ±0.62)ng/ml;(17.43 ±2.63)mg/ml vs (13.61 ± 1.6)mg/ml;(10.1 ±l.0)mmol/L vs (8.4 ±0.9) mmol/L;(2.4 ±0.5) vs (1.7 ±0.4);(23.8 ±2.9) point vs (21.7 ±4.3)point],and the ALB were lower than non-AGl group [(29.1 ±2.2)g/L vs (30.6 ±3.2)g/L],with statistically significant difference (P ＜ 0.05).Multivariate logistic regression analysis showed that PCT,D-lactic acid,FPG,HOMA-IR,and APACHE Ⅱ scores were risk factors for AGI in mechanically ventilated non-diabetic patients with COPD (regression coefficients were 4.337,1.226,5.106,4.469,0.584 respectively,P ＜0.05).There were no significant difference in PCT,D-lactate,FPG,HOMA-IR,APACHE Ⅱ scores between the treatment group and the control group before treatment (P ＞ 0.05).The PCT,D-lactic acid,FPG,HOMA-IR,and APACHE Ⅱ scores in the treatment group were significantly lower than those in the control group after early treatment [(2.00 ± 0.49) ng/ml vs (2.34 ± 0.34) ng/ml;(15.38 ± 1.71)mg/ml vs (17.38 ±2.88)mg/ml;(8.9 ±0.9)mmol/L vs (9.6 ±0.7)mmol/L;(1.9 ± 0.4) vs (2.2 ± 0.4);(21.0 ± 1.8) point vs (22.2 ± 2.7) point],and AGI severity was reduced (There were 8,18,6,3 and 1 cases of 0,Ⅰ,Ⅱ,Ⅲ,and Ⅳ in the treatment group,and4,12,9,7 and 3 in the control group respectively),with statistically significant differences (P ＜ O.05).Conclusions PCT,Dlactic acid,FPG,HOMA-IR,and APACHE Ⅱ scores were risk factors for AGI in mechanically ventilated non-diabetic patients with COPD.Early mobilization could reduce the level of these risk factors and the severity of AGI.
ABSTRACT
Objective To explore the clinical value of transnasal high volume oxygen therapy in the treatment of patients with acute heart failure.Methods From January 2016 to January 2018,61 cases with acute heart failure in Huxi Hospital Affiliated to Jining Medical College were selected.The patients were randomly divided into control group and treatment group according to the digital table,31 cases in the control group and 30 cases in the treatment group.The two groups were routinely given control of fluid volume,analgesia,strong heart,diuresis,vasodilator,anti-platelet aggregation,camp support and so on.The control group was given conventional oxygen therapy,and the treatment group was treated with high flow oxygen through nose.Before treatment and 12h,24h,48h,72h after treatment,the left ventricular ejection fraction (LVEF),oxygen index (PaO2/FiO2),serum lactic acid (Lac),B type sodium and titanium (BNP) in serum,and the application rate of non-invasive mechanical ventilation and invasive mechanical ventilation in 7d were observed in the two groups.Results Compared with the control group,the LVEF of the treatment group in each time point increased [(35.58 ± 3.64) ％ vs.(37.77 ± 3.76) ％,(37.87 ± 3.58) ％ vs.(40.07 ±3.36)％,(44.94 ±3.19)％ vs.(46.83 ±3.21)％,(47.55 ±3.45％)％ vs.(40.07 ±3.36％)％,t =-2.308,-2.466,-2.316,-2.487,all P ＜ 0.05].The PaO2/FiO2 of the treatment group increased significantly at each time point after treatment [(177.39 ± 10.62) mmHg vs.(184.17 ± 10.49) mmHg,(188.00 ± 11.72) mmHg vs.(198.57 ± 18.47) mmHg,(204.06 ± 17.69) mmHg vs.(221.40 ± 23.80) mmHg,(265.23 ± 34.51) mmHg vs.(290.37 ± 26.72) mmHg,t =-2.507,-2.678,-3.236,-3.174,all P ＜ 0.05].The BNP level of the treatment group decreased significantly at each time point after treatment [(2 462.90 ± 288.00) ng/mL vs.(2 264.53 ± 366.44) ng/mL,(1 646.61 ± 377.19) ng/mL vs.(1 474.07 ± 214.03) ng/mL,(991.94 ± 242.95) ng/mL vs.(811.90 ±258.67) ng/mL,(653.77 ± 147.671) ng/mL vs.(526.47 ± 127.87) ng/mL,t =2.355,2.187,2.803,3.594,all P ＜ 0.05].The Lac level of the treatment group decreased significantly at 12h and 24h after treatment [(5.05 ± 0.69) mmol/L vs.(4.55 ± 0.80) mmol/L,(3.68 ± 0.89) mmol/L vs.(3.13 ± 0.77) mmol/L,t =2.610,2.601,all P ＜ 0.05],but there were no statistically significant differences between the two groups at 48h and 72h after treatment [(1.62 ± 0.65) mmol/L vs.(1.53 ± 0.65) mmol/L,(1.36 ± 0.64) mmol/L vs.(1.26 ± 0.46) mmol/L,all P ＞ 0.05].In the control group and the treatment group,the incidence rates of non-invasive mechanical ventilation in 7d were 35.48％ (11/31),13.33％ (4/30),respetively,the difference was statistically significant (x2 =4.034,P ＜ 0.05).In the control group and the treatment group,the incidence rates of invasive mechanical ventilation in 7d were 12.90％ (4/31),3.33％ (1/30),respetively,the difference was statistically significant (x2 =4.957,P ＜ 0.05).Conclusion Nasal high flow oxygen therapy has better clinical effect on patients with acute heart failure.It is a more active treatment measure,and is worthy of clinical application.
ABSTRACT
Objective To investigate the effect of early mobilization on diaphragmatic function in patients with mechanical ventilation (MV). Methods Sixty chronic obstructive pulmonary disease with acute exacerbation (AECOPD) patients with respiratory failure (RF) and underwent MV admitted to intensive care unit (ICU) of Huxi Affiliated Hospital of Jining Medical College from January 2016 to January 2017 were enrolled. The patients were divided into treatment group (n = 30) and control group (n = 30) by randomly number table method. The two groups were given analgesia, sedation, MV, antibiotics, nutritional support and other treatments. An implementation plan was developed based on the clinical practice of pain, irritability and delirium in adult patients (PAD) with ICU, while the treatment group was given early mobilization (such as joint activity, stand to the bed, 3 times a day). The diaphragmatic thickness at the end of expiration (DTee), diaphragmatic thickness at the end of inspiration (DTei) and diaphragmatic thickening fraction (DTF) were measured by bedside ultrasonography before and 24 hours, 48 hours, 3 days and 5 days after treatment respectively. Results There were no significant differences in the parameters of the diaphragm before treatment between the two groups. In the control group, DTee was gradually decreased at 5 days after treatment and was significantly lower than that before treatment (cm: 0.26±0.06 vs. 0.28±0.08, t = 3.045, 1 = 0.005). While there was no significant change in DTee in the treatment group. There was no significant difference in DTee between the two groups at different time points after treatment. DTei and DTF were significantly increased in the two groups after treatment, and reached the peak value at 48 hours; with the prolonged of MV time, DTei and DTF in the control group at 3 days and 5 days were significantly lower than those at 48 hours [DTei (cm): 0.35±0.07, 0.34±0.07 vs. 0.36±0.08; DTF: (29.29±11.01)%, (28.62±11.97)% vs. (32.48±15.63)%, all 1 < 0.01]; there were no significant changes in the treatment group. DTF in the treatment group at 3 days and 5 days was significantly higher than that in the control groups [(38.53±11.39)% vs. (29.29±11.01)%, (37.27±11.26)% vs. (28.62±11.97)%, both 1 < 0.01]. Conclusion MV can lead to diaphragmatic dysfunction, while early mobilization can delay diaphragmatic atrophy and systolic dysfunction in MV patients.
ABSTRACT
Objective To investigate the effects of sequential blood purification on cardiac function in patients with acute organophosphorus pesticide poisoning (AOPP),and to analyze its application value.Methods Forty-five patients with severe AOPP and toxic myocarditis were researched and randomly divided into two groups.Sequential blood purification included hemoperfusion(HP) and continuous veno-venous hemofiltration (CVVH).In treatment group,23 patients were treated with HP + CVVH on the basis of the conventional therapy.Twenty-two patients of control group received the conventional therapy with HP.The differences of two groups on left ventricular ejection fraction (LVEF) and B-type natriuretic peptide (BNP) were compared before treatment and at 24,48 and 72 h after treatment.Results Before treatment,the levels of LVEF and BNP in treatment group were (47.7 ± 9.8)％ and (511.3 ± 285.3) ng/L,in control group were (47.3 ± 10.2)％ and (535.4 ± 303.9) ng/L,and there were no significant differences (P ＞ 0.05).The levels of LVEF at each time point after treatment in treatment group were significantly higher than those of control group:(52.7 ± 7.3) ％ vs.(47.8 ± 8.4)％,(55.2 ± 5.2)％ vs.(50.6 ± 7.1)％,(60.7 ± 6.3)％ vs.(53.3 ± 5.2)％,and the levels of BNP in treatment group were significantly lower than those of control group:(320.7 ± 181.8) ng/L vs.(496.7 ±268.9) ng/L,(252.7 ±113.8) ng/L vs.(384.3 ±167.5) ng/L,(122.4 ±66.7) ng/L vs.(294.8 ± 121.8) ng/L,there were significant differences between two groups (P＜ 0.05 or ＜ 0.01).In treatment group,the levels of LVEF at 24,48 and 72 h after treatment were significantly increased:(52.7 ± 7.3)％,(55.2 ± 5.2)％,(60.7 ± 6.3)％ vs.(47.7 ± 9.8)％,and the levels of BNP were significantly decreased:(320.7 ± 181.8),(252.7 ± 113.8),(122.4 ±66.7) ng/L vs.(511.3 ±285.3) ng/L,there were significant differences (P ＜ 0.01).In control group,the levels of LVEF and BNP at 24 h after treatment were (47.8 ± 8.4)％ and (496.7 ± 268.9) ng/L,before treatment were (47.3 ± 10.2)％ and (535.4 ± 303.9) ng/L,and there were no significant differences (P ＞ 0.05);the levels of LVEF at 48 and 72 h after treatment were significantly increased:(50.6 ± 7.1)％,(53.3 ± 5.2)％ vs.(47.3 ± 10.2)％,the levels of BNP were significantly decreased:(384.3 ± 167.5),(294.8 ± 121.8) ng/L vs.(535.4 ± 303.9) ng/L,and there were significantl differences (P ＜ 0.05 or ＜ 0.01).Conclusion Sequential blood purification treatment of AOPP can reduce myocardial injury and improve the cardiac function.
ABSTRACT
Objective To explore the relationship between superior vena cava-jugular vein oxygen saturation-differential value (ScVO2-SjVO2) and injury severity and prognosis in patients suffered from severe traumatic brain injury,finding out the chnical value.Methods Forty-three patients with severe tranmatic brain injury were selected and divided into two groups according to Glasgow Coma Scale (GCS) score,19 cases were enrolled in GCS 3-5 scores group;24 cases in GCS 6-8 scores group;20 contemporaneous cases in control group had conscious and without traumatic brain injury.The changes of ScVO2-SjVO2 at 0,12,24,48 h after admission of ICU among the groups were observed.In addition according to the degree of change in ScVO2-SjVO2,12 cases were enrolled in ScVO2-SjVO2 ＜ 0.05 group;14 cases in ScVO2-SjVO2 0.05-0.15 group; 17 cases in ScVO2-SjVO2 ＞ 0.15 group.The GCS score and mortality rate in patients after brain injury 28 d among groups were observed.Results GCS 3-5 scores group compared with control group,ScVO2-SjVO2 reduced significantly at 0,12,24,48 h after admission of ICU (-0.071 ±0.032 vs.0.093 ±0.049,-0.097 ±0.052 vs.0.081 ±0.052,-0.035 ±0.031 vs.0.089 ± 0.059,0.036 ± 0.033 vs.0.081 ± 0.064),there were significant differences (P ＜ 0.01).GCS 6-8 scores group compared with control group,ScVO2-SjVO2 dramatically increased at 0,12,24 h after admission of ICU(0.173 ± 0.043,0.158 ± 0.067,0.123 ± 0.073),there were significant differences (P ＜ 0.01 or ＜ 0.05).ScVO2-SjVO2 ＜0.05 group and ScVO2-SjVO2 ＞0.15 group compared with ScVO2-SjVO2 0.05-0.15group,the mortality rate significantly increased,the mortality rate were 8/12,4/17,1/14,respectively,there were significant differences (P ＜0.01).ScVO2-SjVO2 ＜0.05 group and ScVO2-SjVO2 ＞0.15 group compared with ScVO2-SjVO2 0.05-0.15 group,GCS score decreased significantly[(4.17 ± 1.34),(5.88 ±1.35) scores vs.(6.86 ± 1.35) scores],and there was significant difference (P ＜0.01 or ＜0.05).Conclusions When ScVO2-SjVO2 ＜ 0.05,the difference is negatively related to the deg~e of brain injury.When ScVO2-SjVO2 ＞0.15,the difference is positively related to the degree of brain injury;ScVO2-SjVO2 can assess injury severity objectively in patients who suffered from severe traumatic brain injury,and it also expresses the rate of cerebral oxygen metabolism.It can provide a basis for treatment accurately and timely,and judgment prognosis.
ABSTRACT
Objective To investigate the effects of β-blockers on cardiac protection and hemodynamic in patients with septic shock. Methods A prospective randomized controlled trial was conducted. Forty-one patients with septic shock in accordance with early goal directed treatment and met the target within 6 hours,and admitted to intensive care unit (ICU)of Affiliated Huxi Hospital of Jining Medical College from January 2012 to January 2014 were enrolled. The patients were divided into treatment group (n=21)and control group (n=20)by random number table. The patients in both groups were given the standard treatment,esmolol was giving to patients in treatment group in order to control the heart rate (HR)below 100 bpm within 2 hours,and the patients in control group only received standard treatment. The changes in hemodynamic parameters〔mean arterial pressure(MAP),central venous pressure(CVP), HR,cardiac index(CI),stroke volume index(SVI),systemic vascular resistance(SVRI),global end diastolic volume index(GEDVI)〕,biochemistry metabolic of tissue〔central venous oxygen saturation(ScvO2),lactic acid(Lac)〕,and cardiac markers 〔troponin I (cTnI)〕before and 12,24,48,72 hours after the treatment were recorded. Results①Before treatment,the hemodynamic parameters,tissue metabolism index and cTnI had no significant differences in both groups (all P>0.05).②The hemodynamic parameters after treatment in the control group showed no significant difference compared with that before treatment. HR and CI in the treatment group were gradually declined after treatment,SVRI and GEDVI were gradually increased. There were significant differences in HR,CI,SVRI,and GEDVI between treatment group and control group from 12 hours on〔HR(bpm):93±4 vs. 118±13,CI (L·min-1·m-2):3.3 ±0.8 vs. 4.5 ±0.6,SVRI (kPa·s·L-1·m-2):159.2 ±27.4 vs. 130.5 ±24.2,GEDVI(mL/m2):668 ±148 vs. 588 ±103,P0.05). The ScvO2 was not decreased in both groups.④Compared with before treatment,cTnI in the control group was gradually increased,peaked at 72 hours,and that in the treatment group was gradually increased,peaked at 24 hours and then gradually declined. Compared with control group,the cTnI (μg/L)in the treatment group was decreased significantly at 24,48,72 hours (1.15 ±0.57 vs. 1.74 ±0.77,0.93 ±0.52 vs. 2.15 ±1.23,0.52 ±0.36 vs. 2.39 ±1.17,all P<0.01). Conclusionsβ-blockers (esmolol) can improve cardiac function and myocardial compliance,reduce the myocardial injury in patients with sepsis shock. Although β-blockers can decrease cardiac output,it has no influence on the circulation function and tissue perfusion.