Surgical vs. Conservative Management for Lobar Intracerebral Hemorrhage, a Meta-Analysis of Randomized Controlled Trials
Frontiers in neurology. 2021;12:742959
BACKGROUND Outcomes regarding the conventional surgical and conservative treatment for the lobar intracerebral hemorrhage (ICH) have not been previously compared. The current meta-analysis was designed to review and compile the evidence regarding the management of patients with lobar intracerebral hemorrhage. METHODS Online electronic databases, including PubMed, Embase, Medline, Cochrane Library, and Google Scholar, were searched for randomized controlled trials (RCTs). Studies were selected on the basis of the inclusion and exclusion criteria. Trials with CT-confirmed lobar intracerebral hemorrhage patients of which treatment regimen was started within 72 h following the stroke were included. Low quality trials were excluded. Death or dependence was defined as primary outcome and death at the end of the follow up was the secondary outcome. RESULTS One hundred five RCTs were screened and 96 articles were excluded on the basis of abstract. Nine articles were assessed for the eligibility and 7 trials were included that involved 1,102 patients. The Odds ratio (OR) for the primary outcome was 0.80 (95% CI, 0.62-1.04, p = 0.09) and for the secondary outcome was 0.79 (95%CI, 0.60-1.03, p = 0.09). CONCLUSION Our findings suggested that surgical treatments did not significantly improve the functional outcome as compared with the conservative medical management for patients with lobar ICH.
Patients with lobar intracerebral haemorrhage (7 studies, n= 1,102).
Surgical treatment, including: endoscopic surgery, open craniotomy, stereotactic aspiration, and endoscopic surgery plus stereotactic aspiration, (n= 552).
Conservative management, including non-surgical or pharmacological (n= 550).
The overall results showed a non-significant trend toward better prognosis in the surgical group (OR 0.80). No significant difference was observed for death at the end of the follow up between surgical and conservative medical management groups.
Balanced crystalloids versus saline in critically ill patients: The PRISMA study of a meta-analysis
OBJECTIVE To compare the safety of balanced crystalloids and saline among critically ill patients in intensive care unit (ICU). METHODS The Medline, EMBASE, Web of Science, Cochrane Library databases were systematically searched from the inception dates to May 17, 2020 in order to identify randomized controlled trials which evaluated the safety of balanced crystalloids and saline in critically ill patients. The primary outcome was major adverse kidney events within 30 days (MAKE30). The second outcomes included 30-day mortality, ICU mortality, In-hospital mortality, ICU length of stay, hospital length of stay, creatinine highest before discharge (mg/dl) and needs for renal replacement therapy (RRT). RESULTS A total of nine randomized controlled trials involving 19,578 critical ill patients fulfilled the inclusion criteria. The outcomes of this meta-analysis showed that balanced crystalloids treatment shared the same risk of MAKE30 with saline treatment among critical ill patients [RR = 0.95; 95%CI, 0.88 to 1.01; Z = 1.64 (P = .102)]. The clinical mortality which included 30-day mortality [RR = 0.92; 95%CI, 0.85 to 1.01; Z = 1.78 (P = .075)], ICU mortality [RR = 0.92; 95%CI, 0.83 to 1.02; Z = 1.67 (P = .094)] and In-hospital mortality [RR = 0.93; 95%CI, 0.71 to 1.21; Z = 0.55 (P = .585)] were similar between balanced crystalloids treatment and saline treatment among critical ill patients. Patients who received balanced crystalloids treatment or saline treatment needed the same length of ICU stay [WMD = 0.00; 95%CI, -0.09 to 0.10; Z = 0.09 (P = .932)] and hospital stay [WMD = 0.59; 95%CI, -0.33 to 1.51; Z = 1.26 (P = .209)]. Critical ill patients who received balanced crystalloids treatment or saline treatment had the same level of creatinine highest before discharge [WMD = 0.01; 95%CI, -0.02 to 0.04; Z = 0.76 (P = .446)] and needs for RRT [RR = 1.04; 95%CI, 0.75 to 1.43; Z = 0.21 (P = .830)]. Similar results were obtained in subgroups of trials stratified according to the age of patients (children or adults). CONCLUSIONS When compared with saline, balanced crystalloids could not reduce the risk of MAKE30, 30-day mortality, ICU mortality and in-hospital mortality, could not reduce the length of ICU stay, length of hospital stay, the level of creatinine highest before discharge and the needs for RRT among critical ill children and adults. Therefore, it was still too early for balanced crystalloids to replace normal saline among critical ill patients.
A multicenter, randomized phase III trial of hetrombopag: a novel thrombopoietin receptor agonist for the treatment of immune thrombocytopenia
Journal of hematology & oncology. 2021;14(1):37
BACKGROUND Hetrombopag, a novel thrombopoietin receptor agonist, has been found in phase I studies to increase platelet counts and reduce bleeding risks in adults with immune thrombocytopenia (ITP). This phase III study aimed to evaluate the efficacy and safety of hetrombopag in ITP patients. METHODS Patients who had not responded to or had relapsed after previous treatment were treated with an initial dosage of once-daily 2.5 or 5 mg hetrombopag (defined as the HETROM-2.5 or HETROM-5 group) or with matching placebo in a randomized, double-blind, 10-week treatment period. Patients who received placebo and completed 10 weeks of treatment switched to receive eltrombopag, and patients treated with hetrombopag in the double-blind period continued hetrombopag during the following open-label 14-week treatment. The primary endpoint was the proportion of responders (defined as those achieving a platelet count of ≥ 50 × 10(9)/L) after 8 weeks of treatment. RESULTS The primary endpoint was achieved by significantly more patients in the HETROM-2.5 (58.9%; odds ratio [OR] 25.97, 95% confidence interval [CI] 9.83-68.63; p < 0.0001) and HETROM-5 (64.3%; OR 32.81, 95% CI 12.39-86.87; p < 0.0001) group than in the Placebo group (5.9%). Hetrombopag was also superior to placebo in achieving a platelet response and in reducing the bleeding risk and use of rescue therapy throughout 8 weeks of treatment. The durable platelet response to hetrombopag was maintained throughout 24 weeks. The most common adverse events were upper respiratory tract infection (42.2%), urinary tract infection (17.1%), immune thrombocytopenic purpura (17.1%) and hematuria (15%) with 24-week hetrombopag treatment. CONCLUSIONS In ITP patients, hetrombopag is efficacious and well tolerated with a manageable safety profile. Trial registration Clinical trials.gov NCT03222843 , registered July 19, 2017, retrospectively registered.
[Evaluation of pharmaceutical prevention and treatment of intensive care unit-acquired weakness: a Meta-analysis]
Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2020;32(3):357-361
OBJECTIVE To evaluate the effect of preventing and treatment of pharmaceuticals on intensive care unit-acquired weakness (ICU-AW) by systematic review. METHODS The randomized controlled trials (RCTs) concerning pharmaceutical prevention and treatment about ICU-AW in SinoMed, CNKI, Wanfang data, PubMed, Cochrane Library, Web of Science, EMbase, and other sources were searched from their foundation to May 30th, 2019. The patients in the intervention group were treated with drugs to prevent or treat ICU-AW; and those in control group were treated with other rehabilitation methods. Data searching, extracting and quality evaluation were assessed by two reviewers independently. Stata 12.0 software was then used for Meta-analysis. Only descriptive analysis was conducted when only one study was enrolled. RESULTS A total of 11 RCTs were enrolled with 1 865 patients in the intervention group and 1 894 in the control group. The results of quality evaluation showed that 4 studies were A-level and 7 studies were B-level, indicating that the overall quality of the enrolled literature was high. Meta-analysis showed that intensive insulin therapy could prevent ICU-AW [relative risk (RR) = 0.761, 95% confidence interval (95%CI) was 0.662-0.876, P = 0.000], but reduced phenylalanine loss (nmolx100 mL(-1)xmin(-1): -3+/-3 vs. -11+/-3, P < 0.05) and glutamine intake (nmolx100 mL(-1)xmin(-1): -97+/-22 vs. -51+/-13, P < 0.05). There was no significant difference in the prevention and treatment of ICU-AW between other drugs (including growth hormone, glutamine, dexmedetomidine, neostigmine, oxandrolone, and intravenous immunoglobulin) and control group. CONCLUSIONS Intensive insulin therapy can prevent ICU-AW, but the risk of hypoglycemia will increase. Other drugs including growth hormone, glutamine, dexmedetomidine, neostigmine, oxandrolone, and intravenous immunoglobulin have no obvious advantages in the prevention and treatment of ICU-AW, so no drug has been recommended to prevent and treat ICU-AW.
Prevention of recurrent miscarriage in women with antiphospholipid syndrome: A systematic review and network meta-analysis
OBJECTIVES To compare and rank currently available pharmacological interventions for the prevention of recurrent miscarriage (RM) in women with antiphospholipid syndrome (APS). METHODS A search was performed using PubMed, Embase, the Cochrane Central Register of Controlled Trials, Web of Science, CNKI, ClinicalTrials.gov, and the UK National Research Register on December 15, 2019. Studies comparing any types of active interventions with placebo/inactive control or another active intervention for the prevention of RM in patients with APS were considered for inclusion. The primary outcomes were efficacy (measured by live birth rate) and acceptability (measured by all-cause discontinuation); secondary outcomes were birthweight, preterm birth, preeclampsia, and intrauterine growth retardation. The protocol of this study was registered with Open Science Framework (DOI: 10.17605/OSF.IO/B9T4E). RESULTS In total, 54 randomized controlled trials (RCTs) comprising 4,957 participants were included. Low-molecular-weight heparin (LMWH) alone, aspirin plus LMWH or unfractionated heparin (UFH), aspirin plus LMWH plus intravenous immunoglobulin (IVIG), aspirin plus LMWH plus IVIG plus prednisone were found to be effective pharmacological interventions for increasing live birth rate (ORs ranging between 2.88 to 11.24). In terms of acceptability, no significant difference was found between treatments. In terms of adverse perinatal outcomes, aspirin alone was associated with a higher risk of preterm birth than aspirin plus LMWH (OR 3.92, 95% CI 1.16 to 16.44) and with lower birthweight than LMWH (SMD -808.76, 95% CI -1596.54 to -5.07). CONCLUSIONS Our findings support the use of low-dose aspirin plus heparin as the first-line treatment for prevention of RM in women with APS, and support the efficacy of hydroxychloroquine, IVIG, and prednisone when added to current treatment regimens. More large-scale, high-quality RCTs are needed to confirm these findings, and new pharmacological options should be further evaluated.
The efficacy of combined intra-articular and intravenous tranexamic acid for blood loss in primary total knee arthroplasty: a meta-analysis
BACKGROUND This meta-analysis aimed to illustrate the efficacy and safety of combined topical and intravenous (IV) tranexamic acid (TXA) for blood loss control in primary total knee arthroplasty (TKA) patients. METHODS In April 2017, a systematic computer-based search was conducted in PubMed, EMBASE, Web of Science, Cochrane Database of Systematic Reviews, and Google database. Data on patients prepared for TKA surgery in studies that compared combined topical and IV TXA versus placebo, topical, or IV TXA alone were retrieved. The primary endpoint was the need for transfusion, total blood loss, hemoglobin drop, and the occurrence of deep venous thrombosis (DVT), pulmonary embolism (PE), and the infection. After testing for publication bias and heterogeneity between studies, data were aggregated for random-effects models when necessary. RESULTS Seven clinical studies were ultimately included in the meta-analysis. Compared with IV TXA and control group, combined TXA was associated with less need for transfusion, blood loss, and hemoglobin drop (P < .05). There was no significant difference between the combined TXA and topical TXA in terms of the need for transfusion, total blood loss, and hemoglobin drop (P > .05). There was no significant difference between the complications (DVT, PE, and infection) between the combined TXA, IV TXA, topical TXA, and control group. CONCLUSIONS Current meta-analysis suggests that the combined IV and topical TXA was superior than IV TXA or control group. There is still need for more studies to identify whether combined TXA was superior than topical TXA alone.