Balanced crystalloids versus saline in critically ill adults with low plasma bicarbonate: A secondary analysis of a clinical trial
Journal of critical care. 2021
PURPOSE We aimed to determine if balanced crystalloids compared with saline improve outcomes in critically ill adults admitted with low plasma bicarbonate. MATERIALS AND METHODS We performed a secondary analysis of the Isotonic Solutions and Major Adverse Renal Events Trial (SMART). We included patients who presented to the Emergency Department with a first measured plasma bicarbonate less than 20 mmol/L. Among these patients, we compared the effect of balanced crystalloid versus saline on the primary outcome of major adverse kidney events within 30 days (MAKE30), defined as a composite of death, new renal-replacement therapy, or persistent renal dysfunction (final inpatient creatinine ≥200% baseline). Secondary outcomes included 30 day in-hospital mortality, receipt of new RRT, persistent renal dysfunction, incident AKI, and vasopressor-free days. RESULTS Among the 2029 patients with an initial plasma bicarbonate concentration < 20 mmol/L, there was no difference in the incidence of MAKE30 between those assigned to balanced crystalloid versus saline (21.8% vs 21.3%; P = 0.93). Secondary outcomes were similar between the balanced crystalloid and saline groups. CONCLUSIONS Among critically ill adults presenting to the Emergency Department, initial plasma bicarbonate concentration does not appear to be a useful marker to guide the selection of balanced crystalloid versus saline.
Clinical Features in Children With Kawasaki Disease Shock Syndrome: A Systematic Review and Meta-Analysis
Frontiers in cardiovascular medicine. 2021;8:736352
Objective: This study aimed to identify the clinical features of Kawasaki disease shock syndrome (KDSS) in children. Methods: The case-control studies of KDSS and KD children up until April 30, 2021 were searched in multiple databases. The qualified research were retrieved by manually reviewing the references. Review Manager 5.3 software was used for statistical analysis. Results: The results showed that there was no significant difference in the incidence of male and female in children with KDSS. Children with KDSS compared with non-shocked KD, there were significant difference in age, duration of fever, white blood cell (WBC) count, percentage of neutrophils (NEUT%), platelet count (PLT), c-reactive protein level (CRP), alanine transaminase concentration (ALT), aspartate transaminase concentration (AST), albumin concentration (ALB), sodium concentration (Na), ejection fraction, and length of hospitalization as well as the incidence of coronary artery dilation, coronary artery aneurysm, left ventricular dysfunction, mitral regurgitation, pericardial effusion, initial diagnosis of KD, intravenous immunoglobulin (IVIG) resistance and receiving second dose of IVIG, vasoactive drugs, hormones, and albumin. In contrast, there was no difference in the hemoglobin concentration, erythrocyte sedimentation rate, and the incidence of conjunctival injection, oropharyngeal change, polymorphous rash, extremity change, and incomplete KD. Conclusion: Current evidence suggested that the children with KDSS had more severe indicators of inflammation and more cardiac abnormalities. These patients were resistant to immunoglobulin treatment and required extra anti-inflammatory treatment. Systematic Review Registration: PROSPERO registration number CRD42021241207.
Neuroimaging Markers of Cerebral Small Vessel Disease on Hemorrhagic Transformation and Functional Outcome After Intravenous Thrombolysis in Patients With Acute Ischemic Stroke: A Systematic Review and Meta-Analysis
Frontiers in aging neuroscience. 2021;13:692942
Objective: The aim of this study was to perform a systematic review and meta-analysis to assess whether cerebral small vessel disease (CSVD) on neuroimaging of patients with acute ischemic stroke (AIS) treated with intravenous thrombolysis (IVT) is associated with an increased risk of hemorrhagic transformation (HT), symptomatic intracranial hemorrhage (sICH), and poor functional outcome (PFO). Methods: A thorough search of several databases was carried out to identify relevant studies up to December 2020. We included studies of patients with AIS and neuroimaging markers of CSVD treated with IVT. The primary outcome was HT, and the secondary outcomes were sICH and 3-month PFO. The quality of the studies involved was evaluated using the Newcastle-Ottawa Scale (NOS). The meta-analysis with the fixed effects model was performed. Results: Twenty-four eligible studies (n = 9,419) were pooled in the meta-analysis. All included studies were regarded as high quality with the NOS scores of at least 6 points. The meta-analysis revealed associations between the presence of CSVD and HT, sICH, and the 3-month PFO after IVT. Compared with no CSVD, the presence of CSVD was associated with an increased risk of HT (OR: 1.81, 95% CI: 1.52-2.16), sICH (OR: 2.42, 95% CI: 1.76-3.33), and 3-month PFO (OR: 2.15, 95% CI: 1.89-2.44). For patients with AIS complicated with CSVD, compared with a CSVD score of 0-1, a CSVD score of 2-4 was associated with an increased risk of HT (OR: 3.10, 95% CI: 1.67-5.77), sICH (OR: 2.86, 95% CI: 1.26-6.49), and 3-month PFO (OR: 4.58, 95% CI: 2.97-7.06). Conclusion: Patients with AIS complicated with neuroimaging markers of CSVD are at increased risk of HT and 3-month PFO after IVT. However, it is still necessary to clarify the exact role of CSVD in the occurrence, development, and prognosis of AIS. Systematic Review Registration: www.ClinicalTrials.gov, identifier CRD4202123 3900.
The effect of butylphthalide injection on the cognitive function and the TLRs/NF-κB pathway in hypertensive intracerebral hemorrhage
American journal of translational research. 2021;13(8):9578-9585
OBJECTIVE This study explored and analyzed the effects of butylphthalide injection on the cognitive function and on the TLRs/NF-κB pathway in hypertensive intracerebral hemorrhage patients. METHODS A total of 115 patients admitted to our hospital with hypertensive intracerebral hemorrhages were recruited as the study cohort and randomly placed in the observation group (n=60) or the control group (n=55). In addition to the routine treatment administered in both groups, the control group was additionally administered oral nimodipine tablets, and the observation group was administered intravenous butylphthalide injections. Both groups were treated continuously for 14 days. Subsequently, the changes in the clinical efficacy, the NIHSS scores, the extremity motor function, the Fugl-Meyer scores, the blood-brain barrier (BBB) and the peripheral blood mononuclear cells (PBMCs), the TLR2, TLR9, and the NF-κB mRNA levels in the two groups before and after the treatment were compared, and any adverse reactions were observed. RESULTS The total effective rate in the observation group was significantly superior to the total effective rate in the control group (P<0.05). The post-treatment NIHSS scores in the two groups were dramatically lower (P<0.05), and the post-treatment scores in the observation group were significantly lower than they were in the control group (P<0.05). The post-treatment cerebral spinal fluid (CSF) albumin and BBB indexes in the two groups were decreased significantly compared to their pre-treatment levels (P<0.05), and the post-treatment indexes in the observation group were significantly lower than the post-treatment indexes in the control group (P<0.05). The post-treatment relative TLR2, TLR9, and NF-κB mRNA expressions in the two groups were apparently lower than their in pre-treatment levels (P<0.05), and the relative expressions in the observation group after the treatment were clearly lower than they were in the control group (P<0.05). CONCLUSION Butylphthalide injection has a high clinical efficacy in treating hypertensive intracerebral hemorrhages. The drug can effectively improve patients' cognitive functions, extremity motor functions, and BBB indexes, and its mechanism may connect with the expressive suppression of the TLRs/NF-κB signaling pathway. The treatment is safe and effective, so it is worthy of clinical promotion.
Clinical efficacy of comprehensive nursing in patients with cerebral hemorrhagic hemiplegia
American journal of translational research. 2021;13(5):5526-5532
OBJECTIVE To explore the clinical efficacy of comprehensive rehabilitation nursing (CRN) intervention in patients with cerebral hemorrhagic hemiplegia (CHH). METHODS A total of 102 patients with CHH admitted to our hospital were selected for the prospective study. The patients were randomly divided into the control group (n=51) and the observation group (n=51) according to the random number table method. Routine nursing was performed in the control group, while CRN was conducted in the observation group. Fugl-Meyer motor function assessment scale, activity of daily living scale (Barthel index), self-rating anxiety scale (SAS), complications and muscle strength improvement (Brunnstrom assessment) were compared between the two groups. RESULTS Compared with those before nursing, Fugl-Meyer score, Barthel index and SAS score in the two groups after nursing were significantly improved (P<0.01). Fugl-Meyer score and Barthel index of the observation group were significantly higher than those of the control group after nursing, while SAS score showed the opposite change (P<0.001). The incidence of complications in the control group was 49.02%, and that in the observation group was 29.41% (P<0.05). The rate of muscle strength improvement in the observation group was 80.39% after nursing, which was significantly higher than that in the control group (60.78%; P<0.05). CONCLUSION CRN intervention has a positive clinical efficacy in patients with CHH. It can enhance motor ability, improve the ability of daily life, amend psychological mood and reduce the incidence of complications.
Comparative Efficacy and Safety of Thrombopoietin Receptor Agonists in Adults With Thrombocytopenia: A Systematic Review and Network Meta-analysis of Randomized Controlled Trial
Frontiers in pharmacology. 2021;12:704093
Thrombopoietin receptor agonists (TPO-RAs) play a crucial role in stimulating thrombopoiesis. However, conventional meta-analyses have shown inconsistent results regarding the efficacy of thrombopoietin receptor agonists versus placebo. Therefore, we performed a network meta-analysis to assess the effects of five TPO-RAs via indirect comparison. For this network meta-analysis, we considered randomized trials that included any of the following interventions: avatrombopag, lusutrombopag, eltrombopag, romiplostim, recombinant human thrombopoietin (rhTPO). We searched the Medline, PubMed, Embase, the Cochrane Library, and Web of Science databases for randomized controlled clinical trials from inception to January 31, 2021. We use randomized controlled clinical trials of TPO-RAs for treatment of immune thrombocytopenia in adults. The primary outcome was the number of patients achieving platelet response which was defined as the achievement of a platelet count of more than 30 or 50 cells × 10(9)/L in the absence of rescue therapy, and the secondary outcome was the therapy-related serious adverse events and incidence of bleeding episodes. To obtain the estimates of efficacy and safety outcomes, we performed a random-effects network meta-analysis. These estimates were presented as odds ratios with 95% confidence intervals. We use surface under the cumulative ranking probabilities to rank the comparative effects and safety of all drugs against the placebo. In total, 2,207 patients were analyzed in 20 clinical trials. All preparations improved the point estimates of platelet response when compared with the placebo. Avatrombopag and lusutrombopag had the best platelet response compared to the placebo, the former had a non-significant advantage compared to the latter [odds ratio (OR) = 1.91 (95% confidence interval: 0.52, 7.05)]. The treatments were better than eltrombopag, romiplostim, rituximab, and rhTPO + rituximab, with corresponding ORs of 3.10 (1.01, 9.51), 9.96 (2.29, 43.29), 33.09 (8.76, 125.02), and 21.31 (3.78, 119.98) for avatrombopag and 1.62 (0.63, 4.17), 5.21 (1.54, 17.62), 17.34 (5.15, 58.36), and 11.16 (2.16, 57.62) for lusutrombopag. Regarding bleeding, the placebo group had the highest probability of bleeding, whereas lusutrombopag had the lowest risk of bleeding when compared to the placebo. Adverse events were slightly higher in patients receiving rituximab than in those receiving placebo or other treatments. Overall, this meta-analysis showed that avatrombopag may yield the highest efficacy because it has the most favorable balance of benefits and acceptability.
Adults with thrombocytopenia (20 studies, n= 2,207).
Thrombopoietin receptor agonists (TPO-RAs): avatrombopag, lusutrombopag, eltrombopag, romiplostim, recombinant human thrombopoietin (rhTPO).
All preparations improved the point estimates of platelet response when compared with the placebo. Avatrombopag and lusutrombopag had the best platelet response compared to the placebo, the former had a non-significant advantage compared to the latter. Regarding bleeding, the placebo group had the highest probability of bleeding, whereas lusutrombopag had the lowest risk of bleeding when compared to the placebo. Adverse events were slightly higher in patients receiving rituximab than in those receiving placebo or other treatments.
Uterine compression suture is an effective mode of treatment of postpartum haemorrhage
Pakistan journal of medical sciences. 2020;36(2):131-135
Objective: To compare the effects of uterine compression suture versus conventional mode of treatment for the management of postpartum haemorrhage after caesarean section. Methods: This study enrolled 84 women with postpartum hemorrhage who were admitted to Binzhou People's Hospital from August 2017 to October 2018 as the research subjects. They were divided into a control group and an observation group according to random number table method, 42 each group. The patients in the control group were treated by conventional treatment, while those in the observation group were treated by uterine compression suture. The hemorrhage, hemostasis, postoperative recovery and frequency of adverse reactions were compared between the two groups. Results: The amount of bleeding in the observation group was less than that in the control group, and the bleeding time was shorter than that in the control group; the differences had statistical significance (P<0.05). The success rate of hemostasis in the observation group was significantly higher than that in the control group, and the ineffective rate of hemostasis was significantly lower than that in the control group (P<0.05); the differences were statistically significant. The cleaning time of lochia, the recovery time of uterus and the recovery time of menstruation in the observation group were significantly shorter than that in the control group (P<0.05); the differences between the two groups were statistically significant (P<0.05). The frequency of adverse reactions in the observation group was significantly lower than that in the control group (P<0.05), and the difference was statistically significant (P<0.05). Conclusion: Uterine compression suture is effective for postpartum hemorrhage of cesarean section, which can effectively reduce postpartum hemorrhage, shorten postpartum hemorrhage time and accelerate the recovery. It is safe and worth clinical promotion.
High-dose dexamethasone plus recombinant human thrombopoietin versus high-dose dexamethasone alone as frontline treatment for newly diagnosed adult primary immune thrombocytopenia:a prospective, multicenter, randomized trial
American journal of hematology. 2020
We conducted a prospective, multicenter, randomized, controlled clinical trial to compare the efficacy and safety of high-dose dexamethasone (HD-DXM) plus recombinant human thrombopoietin (rhTPO) versus HD-DXM alone in newly diagnosed adult immune thrombocytopenia (ITP) patients. Enrolled patients were randomly assigned to receive DXM plus rhTPO or DXM monotherapy. Another 4-day course of DXM was repeated if response was not achieved by day 10 in both arms. One hundred patients in the HD-DXM plus rhTPO arm and 96 patients in the HD-DXM monotherapy arm were included in the full analysis set. HD-DXM plus rhTPO resulted in a higher incidence of initial response (89.0% vs. 66.7%, P < 0.001) and complete response (CR, 75.0% vs. 42.7%, P < 0.001) compared with HD-DXM monotherapy. Response rate at 6 months was also higher in the HD-DXM plus rhTPO arm than that in the HD-DXM monotherapy arm (51.0% vs. 36.5%, P = 0.02; sustained CR: 46.0% vs. 32.3%, P = 0.043). Throughout the follow-up period, the overall duration of response was greater in the HD-DXM plus rhTPO arm compared to the HD-DXM monotherapy arm (P = 0.04), as estimated by the Kaplan-Meier analysis. The study drugs were generally well tolerated. In conclusion, the combination of HD-DXM with rhTPO significantly improved the initial response and yielded favorable SR in newly diagnosed ITP patients, thus could be further validated as a frontline treatment for ITP. This study is registered as clinicaltrials.gov identifier: NCT01734044. This article is protected by copyright. All rights reserved.
The effect of multiple-dose oral versus intravenous tranexamic acid in reducing postoperative blood loss and transfusion rate after adolescent scoliosis surgery: A randomized controlled trial
The spine journal : official journal of the North American Spine Society. 2020
BACKGROUND CONTEXT Tranexamic acid (TXA) is widely used in surgery for adolescent idiopathic scoliosis (AIS) and has been proved to be efficacious in reducing intraoperative blood loss (IBL) and the transfusion rate. However, the routine TXA regimen was intraoperative administration alone, in which the concentration of TXA could not cover the whole process of hyperfibrinolysis. And, its ability to control the massive postoperative blood loss (PBL) may be insufficient. Thus, we promoted a multiple-dose regimen of TXA for patients with AIS who underwent surgical correction. PURPOSE The primary aims were (1) to determine whether the multiple-dose regimen of TXA could reduce PBL and the postoperative transfusion rate, and (2) to compare the efficacy of oral administration with intravenous administration. The secondary aims were (3) to evaluate whether this regimen could alleviate inflammatory response, and (4) to assess the occurrence of drug-related side effects. STUDY DESIGN Prospective, double-blinded, randomized controlled trial PATIENT SAMPLE A total of 108 patients with AIS who underwent posterior scoliosis correction and spinal fusion (PSS) were enrolled in this study. OUTCOME MEASURES The primary parameters were PBL and postoperative transfusion rate. Other parameters such as total blood loss (TBL), maximum hemoglobin (Hb) decrease, volume of drainage, inflammation markers [interleukin-6 (IL-6) and C-reactive protein (CRP)], and occurrence of complications were also collected and compared. Multiple regression analysis was used to examine the variables that affected PBL. METHOD Patients were randomized into three groups. All patients received intravenous TXA 50 mg/kg loading dose and 10 mg/kg/h maintenance dose during surgery. Group A received 1 g oral TXA at 4 h, 10 h, and 16 h postoperatively; group B received 0.5 g intravenous TXA at 6 h, 12 h, and 18 h postoperatively; group C received placebo. RESULTS The mean PBL and postoperative transfusion rate in group A (957.8±378.9 mL, 13.89%) and B (980.3±491.8 mL, 11.11%) were significantly lower than those in group C [1495.9±449.6 mL, mean differences = 538.1 mL, 95% confidence interval (CI), 290.1-786.1 mL, p<0.001; 515.6 mL, 95% CI, 267.6-763.6 mL, p<0.001]; (36.11%, p=0.029, p=0.013). Meanwhile, the mean TBL, maximum Hb decrease, and volume of drainage were also significantly lower in group A and B than in group C. IL-6 and CRP in group A and B were significantly lower than in group C from postoperative days 1 to 3. All these differences were not significant between groups A and B. No drug-related complications were observed in any patient. Multiple regression showed that the application of postoperative TXA and number of screws were significant parameters affecting PBL. CONCLUSION A multiple-dose regimen of TXA, either by oral or intravenous application, could be a safe and effective means of controlling PBL and decreasing the postoperative transfusion rate in patients with AIS who underwent scoliosis surgery. In addition, it could inhibit postoperative inflammatory response.
Combined use of intravenous and topical tranexamic acid efficiently reduces blood loss in patients aged over 60 operated with a 2-level lumbar fusion
Journal of orthopaedic surgery and research. 2020;15(1):339
PURPOSE The current study was conducted to assess the efficacy and safety of the intravenous (IV) administration combined with topical administration of tranexamic acid (TXA)in patients (aged over 60) scheduled for a 2-level lumbar fusion surgery. METHODS Two hundred eighty patients scheduled for a 2-level lumbar fusion surgery were randomized into four groups, including an IV group, a local group, a combined group, and a control group. Patients in the combined group, in the IV group, in the topical group, and in the control group were administrated with 15 mg/kg of IV-TXA + 2 g TXA in local, 15 mg/kg IV-TXA, 2 g TXA in local, and 100 ml IV, respectively. The results of total blood loss (TBL), maximum hemoglobin drop, the transfusion rate, and the number of allogeneic blood units were compared. Deep venous thrombosis (DVT) and pulmonary embolism (PE) events were monitored and recorded. RESULTS The TBL was 635.49 ± 143.60, 892.62 ± 166.85, 901.11 ± 186.25, and 1225.11 ± 186.25 mL for the combined group, the IV group, the topical group, and the control group, respectively (p = 0.015, p = 0.001, respectively). The average maximum hemoglobin drop in the four above groups was 2.18 ± 0.24, 2.80 ± 0.37, 2.40 ± 0.64, and 3.40 ± 1.32 g/dL, respectively. No PE event was reported during the follow-up. Although asymptomatic DVT events were reported by 1, 2, and 2 patients in the combined group, topical group, and control group, respectively, there is no intergroup difference. CONCLUSIONS The combined use of TXA effectively reduced the total blood loss and blood transfusion rate in patients aged over 60 scheduled for a 2-level lumbar fusion, without increasing the incidence of DVT and PE formation.