scholarly journals Tranexamic Acid in Aneurysmal Subarachnoid Hemorrhage: A Meta-analysis of Randomized Controlled Trials

Author(s):  
Tao Liu ◽  
Huiru Ding ◽  
Renmin Xue

Abstract BackgroundTranexamic acid, as a hemostatic drug, is widely used to treat or prevent excessive blood loss. The efficacy of tranexamic acid in promoting good clinical outcomes, reducing mortality, and the occurrence of adverse events during treatment of aneurysmal subarachnoid hemorrhage remains unclear.MethodsPubMed, Web of Science, Embase, and The Cochrane Library were searched for randomized-controlled trials (from1980 to 2021) following strict inclusion and exclusion criteria. We performed STATA 16.0 and RevMan 5.3 for statistical analysis. Fixed-effect model (M-H method) and effect size RR (95% CI) were used as a pooled measure to combine the heterogeneous data. We also performed post hoc sensitivity analyses and conducted subgroup analyses to evaluate each outcome with low heterogeneity results.ResultsMeta-analysis showed that tranexamic acid was associated with reduced rebleeding(RR 0.72 [0.59, 0.87], p= 0.0008; I2:0%, p = 0.51). Tranexamic acid probably has no effect on good clinical outcome or mortality (RR 0.98 [0.92,1.04], p = 0.51; I2: 0%, p = 0.60; RR 1.01 [0.88,1.15], p=0.91; I2:0%, p = 0.51).TXA was associated with increased hydrocephalus (RR 1.13 [1.02, 1.24], p = 0.02; I2:0%, p = 0.61), DCI (RR 1.70 [1.34, 2.16], p < 0.0001; I2: 0%, p= 0.84) and seizure (RR 1.46 [1.00, 2.14], p= 0.05),The rate for thromboembolic complications were similar in both groups(RR 0.91 [0.63, 1.31], p = 0.62;I2: 0%, p = 0.73). There was significant drug related overall adverse events (RR 1.21 [1.11, 1.32], p < 0.0001; I2: 29%, p = 0.14).ConclusionsIn patients with aneurysmal subarachnoid hemorrhage, these findings indicate that it does not support the routine use of TXA.

2021 ◽  
Author(s):  
Tao Liu ◽  
Lingqin Wu ◽  
Renmin Xue ◽  
Huiru Ding

Abstract Background: Tranexamic acid, as a traditional hemostatic agent, is commonly applied in the treatment or prevention of excessive blood loss. However, the role of tranexamic acid in promoting good clinical outcomes, reducing mortality, and the risk of experiencing adverse events during the therapeutic process of aneurysmal subarachnoid hemorrhage remains unclear.Methods: In strict accordance with the inclusion and exclusion criteria, the Cochrane Library, Embase, Web of Science, and PubMed were retrieved for randomized-controlled trials (from 1980 to 2021). Statistical analysis was performed using STATA 16.0 and RevMan 5.3. In addition, the fixed-effect model (M-H method) and effect size RR (95% CI) were used as a pooled measure to combine the heterogeneous data. We also performed post hoc sensitivity analysis and subgroup analysis to evaluate each outcome with low heterogeneity.Results: Meta-analysis revealed that although tranexamic acid was related to less rebleeding (RR = 0.72; 95% CI 0.59-0.87; P = 0.0008), it might have no effect on good clinical outcome or mortality (RR = 0.98; 95% CI 0.92-1.04; P = 0.51; RR = 1.01; 95% CI 0.88-1.15; P = 0.91). Tranexamic acid was associated with increased hydrocephalus (RR = 1.13; 95% CI 1.02-1.24; P = 0.02), delayed cerebral ischemia (RR = 1.70; 95% CI 1.34-2.16; P < 0.0001) and seizure (RR = 1.46; 95% CI 1.00-2.14; P = 0.05). The incidence of thromboembolic complications was identical in both groups (RR = 0.91; 95% CI 0.63-1.31; P = 0.62), and there were significant drug-related overall adverse events (RR = 1.21; 95% CI 1.11- 1.32; P < 0.0001).Conclusions: These findings indicate that the routine use of TXA is not suggested for patients with aneurysmal subarachnoid hemorrhage.


2022 ◽  
Vol 8 ◽  
Author(s):  
Min Shi ◽  
Chao Yang ◽  
Zu-han Chen ◽  
Ling-fei Xiao ◽  
Wen-yuan Zhao

Tranexamic acid has been shown to reduce rebleeding after aneurysmal subarachnoid hemorrhage; however, whether it can reduce mortality and improve clinical outcomes is controversial. We performed a systematic review and meta-analysis to evaluate the efficacy and safety of the tranexamic acid in aneurysmal subarachnoid hemorrhage. We conducted a comprehensive literature search of PubMed, Embase, Web of Science, and Cochrane Library from inception to March 2021 for randomized controlled trials (RCTs) comparing tranexamic acid and placebo in adults with aneurysmal subarachnoid hemorrhage. The risk of bias was evaluated using the Cochrane Handbook, and the quality of evidence was evaluated using the GRADE approach. This meta-analysis included 13 RCTs, involving 2,888 patients. In patients with aneurysmal subarachnoid hemorrhage tranexamic acid had no significant effect on all-cause mortality (RR = 0.96; 95% CI = 0.84–1.10, p = 0.55, I2 = 44%) or poor functional outcome (RR = 1.04; 95% CI = 0.95–1.15, p = 0.41) compared with the control group. However, risk of rebleeding was significantly lower (RR = 0.59; 95% CI = 0.43–0.80, p = 0.0007, I2 = 53%). There were no significant differences in other adverse events between tranexamic acid and control treatments, including cerebral ischemia (RR = 1.17; 95% CI = 0.95–1.46, p = 0.15, I2 = 53%). At present, routine use of tranexamic acid after subarachnoid hemorrhage cannot be recommended. For a patient with subarachnoid hemorrhage, it is essential to obliterate the aneurysm as early as possible. Additional higher-quality studies are needed to further assess the effect of tranexamic acid on patients with subarachnoid hemorrhage.


2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Jing Yang ◽  
Zongming Wang ◽  
Xilin Zhang

Background. To investigate the efficacy and safety of guselkumab in the treatment of moderate-to-severe plaque psoriasis. Methods. A systematic review was undertaken to identify double-blind randomized controlled trials (RCTs). PubMed, Web of Science, Cochrane Library, EMBASE, and Google Scholar databases were searched before 1 March 2020. The odds ratios (ORs) with 95% confidence interval (CI) were calculated. All analyses were conducted with intention-to-treat basis. A range of sensitivity analyses was undertaken. Results. A total of 7 articles contained 1206 plaque psoriasis patients with guselkumab, 585 patients with placebo, and 1250 patients with adalimumab were included. The results indicated that guselkumab had better efficacy than placebo or adalimumab for Psoriasis Area and Severity Index score reductions from baseline of 75% (PASI 75) (OR=61.37, 95% CI=31.15 to 120.91; OR=3.08, 95% CI=2.35 to 4.06), Investigator’s Global Assessment scores of 0 or 1 (IGA 0/1) (OR=65.75, 95% CI=45.54 to 94.95; OR=2.79, 95% CI=2.17 to 3.59), and Dermatology Life Quality Index scores of 0 or 1 (DLQI 0/1) (OR=29.64, 95% CI=18.80 to 46.73; OR=1.86, 95% CI=1.50 to 2.31). The guselkumab had similar safety with placebo or adalimumab about the incidence of adverse events (AEs) (OR=1.05, 95% CI=0.86 to 1.29; OR=0.97, 95% CI=0.79 to 1.19) and serious adverse events (SAEs) (OR=1.03, 95% CI=0.47 to 2.27; OR=0.91, 95% CI=0.44 to 1.87). Meanwhile, there was no statistically significant association of infections and serious infections compared with the placebo or adalimumab group. The guselkumab was more effective and had the similar tolerance. Conclusion. The guselkumab had excellent efficacy and great safety in moderate-to-severe plaque psoriasis, but long-term safety remained to be determined.


2020 ◽  
Vol 15 (1) ◽  
pp. 34-47 ◽  
Author(s):  
Muhammed Rashid ◽  
Madhan Ramesh ◽  
K. Shamshavali ◽  
Amit Dang ◽  
Himanshu Patel ◽  
...  

Background: Prostate cancer (PCa) is the sixth primary cause of cancer death. However, conflicts are present about the efficacy and safety of Non-steroidal anti-androgens (NSAA) for its treatment. The aim of this study was to assess the efficacy and safety of NSAAs versus any comparator for the treatment of advanced or metastatic PCa (mPCa). Methodology: MEDLINE and the Cochrane Library were searched. References of included studies and clinicaltrials.gov were also searched for relevant studies. Only English language studies after 1990 were considered for review. Randomized controlled trials (RCTs) examining the efficacy and safety of NSAAs as compared with any other comparator including surgery or chemotherapy in mPCa patients were included. The outcomes include efficacy, safety and the tolerability of the treatment. The Cochrane Risk of Bias Assessment Tool was used for quality assessment. Two authors were independently involved in the selection, extraction and quality assessment of included studies and disagreements were resolved by discussion or by consulting a third reviewer. Results: Fifty-eight out of 1307 non-duplicate RCTs with 29154 patients were considered for the review. NSAA showed significantly better progression-free survival [PFS] (Hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.46-0.78; P=0.0001), time to distant metastasis or death [TTD] (HR, 0.80; 95% CI 0.73-0.91; p<0.0001), objective response (Odds ratio [OR], 1.64; 95% CI 1.06-2.54; P=0.03) and clinical benefits (OR, 1.33; 95% CI 1.08-1.63; P=0.006) as compared to the control group. There was no significant difference observed between the groups in terms of overall survival (HR, 0.95; 95%CI, 0.87-1.03; P=0.18) and time to progression (HR, 0.93; 95% CI 0.77-1.11; P=0.43). Treatment-related adverse events were more with the NSAA group, but the discontinuation due to lack of efficacy reason was 43% significantly lesser than the control group in patients with mPCa. Rest of the outcomes were appeared to be non-significant. Conclusion: Treatment with NSAA was appeared to be better efficacious with respect to PFS, TTD, and response rate with considerable adverse events when compared to the control group in patients with metastatic PCa.


2019 ◽  
Vol 142 (3) ◽  
pp. 125-131 ◽  
Author(s):  
Yanping Shao ◽  
Wenda Luo ◽  
Haiyan Xu ◽  
Li Zhang ◽  
Qunyi Guo

Introduction: This systematic review and meta-analysis aims to explore the influence of ferumoxytol versus placebo on iron deficiency anemia. Methods: We search for randomized controlled trials (RCTs) assessing the effect of ferumoxytol on iron deficiency anemia on PubMed, EMbase, Web of science, EBSCO, and Cochrane library databases. This meta-analysis is performed using the random-effects model. Results: Four RCTs are included in the meta-analysis. Compared with the control group for iron deficiency anemia, intravenous ferumoxytol can significantly improve the proportion of patients with a ≥20 g/L hemoglobin (Hb) increase (RR = 18.43; 95% CI = 7.29–46.57; p < 0.00001), the proportion of patients with an Hb level ≥120 g/L (RR = 18.55; 95% CI = 8.66–39.72; p < 0.00001), transferrin saturation (mean difference = 11.08; 95% CI = 9.86–12.31; p < 0.00001) and FACIT-fatigue score (mean difference = 4.60; 95% CI = 3.21–6.00; p < 0.00001), but has no remarkable influence on adverse events (RR = 1.33; 95% CI = 0.84–2.10; p = 0.22), serious adverse events (RR = 1.22; 95% CI = 0.74–2.02; p = 0.44), and death (RR = 0.32; 95% CI = 0.05–1.95; p = 0.22). Conclusions: Intravenous ferumoxytol can provide the important benefits for iron deficiency anemia.


2017 ◽  
Vol 2017 ◽  
pp. 1-13 ◽  
Author(s):  
Zongguo Yang ◽  
Xian Liao ◽  
Yunfei Lu ◽  
Qingnian Xu ◽  
Bozong Tang ◽  
...  

Background and Aims. Traditional Chinese medicine (TCM) therapy for hepatocellular carcinoma remains controversial. This study aimed to evaluate the efficacy and safety of TCM regimens in HCC treatment. Methods. Randomized controlled trials (RCTs) up to June 1, 2016, of the TCM treatment for hepatocellular carcinoma were systematically identified in PubMed, CNKI, Ovid, Embase, Web of Science, Wanfang, VIP, CBM, AMED, and Cochrane Library databases. Results. A total of 1010 and 931 patients in 20 RCTs were randomly treated with add-on TCM therapy and conventional therapy, respectively. The additional use of TCM significantly improved six-month, one-year, two-year, and three-year overall survival rates in HCC cases (RR = 1.3, P=0.01; RR = 1.38, P=0.0008; RR = 1.44, P<0.0001; RR = 1.31, P=0.02, resp.). Add-on TCM therapy significantly increased PR rate and total response rate (tRR) and reduced PD rate compared to those in control group (34.4% versus 26.3%, RR = 1.30, P=0.002; 41.6% versus 31.0%, RR = 1.30, P<0.0001; and 16.6% versus 26.5%, RR = 0.64, P<0.0001, resp.). Additionally, TCM combination therapy significantly increased the quality of life (QOL) improvement rate and reduced adverse events including leukopenia, thrombocytopenia, anemia or erythropenia, liver injury, and gastrointestinal discomfort in HCC patients (all P<0.05). Conclusion. Add-on therapy with TCM could improve overall survival, increase clinical tumor responses, lead to better QOL, and reduce adverse events in hepatocellular carcinoma.


2013 ◽  
Vol 119 (1) ◽  
pp. 180-189 ◽  
Author(s):  
Jian Shen ◽  
Jian-Wei Pan ◽  
Zuo-Xu Fan ◽  
Xiao-Xing Xiong ◽  
Ren-Ya Zhan

Object Clazosentan therapy after aneurysmal subarachnoid hemorrhage (SAH) has been found to be effective in reducing the incidence of vasospasm in randomized controlled trials. However, while vasospasm-related morbidity, including delayed ischemic neurological deficits (DINDs) and delayed cerebral infarctions, was consistently decreased, statistical significance was not demonstrated and outcomes were not affected by clazosentan treatment. The objective of this meta-analysis was to determine whether clazosentan treatment after aneurysmal SAH significantly reduced the incidence of DINDs and delayed cerebral infarctions and improved outcomes. Methods All randomized controlled trials investigating the effect of clazosentan were retrieved via searches with sensitive and specific terms. Six variables were abstracted after the assessment of the methodological quality of the trials. Analyses were performed following the method guidelines of the Cochrane Back Review Group. Results Four randomized, placebo-controlled trials met eligibility criteria, enrolling a total of 2181 patients. The meta-analysis demonstrated a significant decrease in the incidence of DINDs (relative risk [RR] 0.76 [95% CI 0.62–0.92]) and delayed cerebral infarction (RR 0.79 [95% CI 0.63–1.00]) in patients treated with clazosentan after aneurysmal SAH. However, this treatment regimen was not shown to outcomes including functional outcomes measured by Glasgow Outcome Scale-Extended (RR 1.12 [95% CI 0.96–1.30]) or mortality (RR 1.02 [95%CI 0.70–1.49]). Adverse events, including pulmonary complications, anemia, and hypotension, were all significantly increased in patients who received clazosentan therapy. Conclusions The results of the present meta-analysis show that treatment with clazosentan after aneurysmal SAH significantly reduced the incidence of the vasospasm-related DINDs and delayed cerebral infarctions, but did not improve poor neurological outcomes in patients with aneurysmal SAH. Further study is required to elucidate the dissociation between vasospasm-related morbidity and outcomes.


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