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1.
Tranexamic acid does not significantly lower postoperative bleeding after endoscopic sinus and nasal surgery
Khanwalkar A, Chan E, Roozdar P, Kim D, Ma Y, Hwang PH, Nayak JV, Patel ZM
International forum of allergy & rhinology. 2023
Abstract
BACKGROUND Postoperative epistaxis is a known possibility following endoscopic sinonasal surgery. Tranexamic acid (TXA) has been shown to reduce intraoperative blood loss and improve the visual field. This study evaluates the clinical efficacy of TXA when given at end of surgery to reduce postoperative bleeding. METHODS This randomized, double-blinded placebo-controlled trial was conducted from April to November 2021. Patients scheduled to undergo endoscopic sinus or nasal surgery were randomized to receive an intravenous dose of 1g TXA or saline intraoperatively prior to extubation. A 10-inch visual analog scale (VAS) was used to query patients regarding postoperative bleeding each day for one week. The medical record was examined to determine the need for additional evaluations or interventions for epistaxis. RESULTS 40 patients completed the study. The mean/SD postoperative bleeding VAS for the TXA group on the day of surgery was not significantly different from the saline group (4.82 [2.18] in vs 5.03 [2.14] in, p = 0.8). There were no significant differences between treatment arms on any postoperative day through day 7 (0.67 [1.84] in vs 0.87 [0.99] in, p = 0.7), nor in the reduction in VAS compared to the respective baseline on the day of surgery. There were no significant differences in terms of additional interventions (e.g. additional evaluation in recovery, ED, or clinic, need for packing, or return to OR). CONCLUSION While TXA has previously demonstrated efficacy to reduce intraoperative bleeding during sinonasal surgery, when postoperative bleeding is already minimal at baseline, TXA does not appear to reduce it significantly further. This article is protected by copyright. All rights reserved.
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2.
Comparison of anticoagulation monitoring strategies for adults supported on extracorporeal membrane oxygenation: A systematic review
Sun J, Ma Y, Su W, Miao H, Guo Z, Chen Q, Zhang Y, Ma X, Chen S, Ding R
Heart & lung : the journal of critical care. 2023;61:72-83
Abstract
BACKGROUND Anticoagulation is critical in patients supported on extracorporeal membrane oxygenation (ECMO). The appropriate monitoring strategies for heparin remain unclear. OBJECTIVES This systematic review aimed to compare the accuracy and safety of various monitoring strategies for patients supported on ECMO. METHODS The PubMed and Web of Science databases were searched for articles in March 2023 without restrictions on publication date. Anticoagulation monitoring strategies for adults supported on ECMO were compared across all included studies. The incidence of bleeding, thrombosis, mortality, blood transfusion, correlation between tests and heparin dose, and the discordance between different tests were discussed in the included studies. The risk of bias was assessed using the Newcastle-Ottawa Scale and Cochrane Collaboration's tool. RESULTS Twenty-six studies, including a total of 1,684 patients, met the inclusion criteria. The monitoring of anticoagulation by activated partial thromboplastin time (aPTT) resulted in less blood product transfusion than that by activated clotting time (ACT). Moreover, the monitoring of anticoagulation by anti-factor Xa (Anti-Xa) resulted in a more stable anticoagulation than that by aPTT. Anti-Xa and aPTT correlated with heparin dose better than ACT, and the discordance between different monitoring tests was common. Finally, combined monitoring showed some advantages in reducing mortality and blood product transfusion. CONCLUSION Anti-Xa and aPTT are more suitable for anticoagulation monitoring for patients supported on ECMO than ACT. Thromboelastography and combination strategies are less applied. Most of the studies were retrospective, and their sample sizes were relatively small; thus, more appropriate monitoring strategies and higher quality research are needed.
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3.
Platelet-rich plasma in the treatment of anal fistula: a systematic review and meta-analysis
Wang Y, Rao Q, Ma Y, Li X
International journal of colorectal disease. 2023;38(1):70
Abstract
OBJECTIVE To analyse the safety and effectiveness of platelet-rich plasma (PRP) in anal fistula patients. METHODS Online databases including PubMed, Embase, Cochrane Library, and Web of Science were searched from inception to December 5, 2022, for eligible studies about evaluating the efficacy of platelet-rich plasma (PRP) in treating anal fistula. Literature search, screening, data extraction, and quality assessment were carried out by two independent investigators. The overall cure rate, the complete cure rate, the recurrence rate, and the adverse event rate with their 95% confidence intervals (95% CI) were the primary calculation indexes. Subgroup analyses were conducted primarily according to whether PRP was combined with other treatments. Softwares of MedCalc 18.2 and Review Manager 5.3 were used for meta-analysis. RESULTS A total of 14 studies with 514 patients were included in the meta-analysis. The overall cure rate of 14 studies was 72.11% (95% CI 0.64-0.79). The cure rate of PRP alone was 62.39% (95% CI 0.55-0.69). The combined cure rate of PRP with other treatments was 83.12% (95% CI 0.77-0.88). The cure rate of interventions involving PRP were superior to the cure rate of surgery methods without using PRP significantly in the 4 randomized controlled studies (RR = 1.30, 95% CI 1.10-1.54, p = 0.002). The complete cure rate of the 8 studies was 66.37% (95% CI 0.52-0.79). The recurrence rate of the 12 studies was 14.84% (95% CI 0.08-0.24). The adverse event rate of the 12 studies was 6.31% (95% CI 0.02-0.12). CONCLUSION PRP showed favorable safety and effectiveness in the treatment of anal fistula, especially combined with other treatment procedures.
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4.
Use of platelet-rich plasma for COVID-19 related olfactory loss, a randomized controlled trial
Yan CH, Jang SS, Lin HC, Ma Y, Khanwalker AR, Thai A, Patel ZM
International forum of allergy & rhinology. 2022
Abstract
INTRODUCTION This study evaluated the use of platelet-rich plasma (PRP), an autologous blood product with supraphysiologic concentrations of growth factors, in the treatment of prolonged COVID-19 related smell loss. METHODS This multi-institutional, randomized controlled trial recruited COVID-19 patients with objectively measured smell loss (University of Pennsylvania's Smell Identification Test, UPSIT≤33) between 6-12 months. Subjects were randomized to 3 intranasal injections of either PRP or sterile saline into their olfactory clefts. Primary outcome measure was change in Sniffin' sticks score (TDI) from baseline. Secondary endpoint measures included responder rate (achievement of a clinically significant improvement, ≥5.5 point TDI), change in individual TDI olfaction scores, and change in subjective olfaction via a visual analogue scale. RESULTS 35 subjects were recruited and 26 completed the study. PRP treatment resulted in a 3.67 point (95% CI: 0.05-7.29, p = 0.047) greater improvement in olfaction compared to the placebo group at 3-months and a higher response rate (57.1% versus 8.3%, odds ratio 12.5, 95% exact bootstrap CI 2.2-116.7). There was a greater improvement in smell discrimination following PRP treatment compared to placebo, but no difference in smell identification or threshold. There was no difference in subjective scores between PRP and placebo. No adverse effects were reported. CONCLUSION Olfactory function following COVID-19 can improve spontaneously after 6 months and can improve to a greater extent with PRP injection. This data builds on the promise of PRP to be a safe potential treatment option for patients with COVID-19 smell loss, and larger-powered studies will help further assess efficacy. This article is protected by copyright. All rights reserved.
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5.
Side-effects of carbetocin to prevent postpartum hemorrhage: A systematic review and meta-analysis of randomized controlled trials
Ai W, Zeng Y, Ma Y, Liu L, Fan D, Wu S, Zhang Y
Pharmacology research & perspectives. 2021;9(2):e00745
Abstract
Postpartum hemorrhage (PPH) increases the risk of maternal death worldwide. Heat-stable carbetocin, a long-acting oxytocin analog, is a newer uterotonic agent. Clinicians do not fully understand its side-effects, particularly the unanticipated side-effects. The aim of this study is to investigate the side-effects of carbetocin to PPH. The Cochrane Library, Web of Science, PubMed, Elsevier ScienceDirect, Embase, and ClinicalTrials.gov were searched from the inception to September 2020. Randomized controlled trials (RCTs) that considered pregnant women who received carbetocin before delivery and provided at least one adverse event were included. Statistical analysis included random or fixed-effect meta-analyses using relative risk. Stratified analyses and sensitivity analyses were also performed. Begger's and Egger's test and funnel plots were used to assess the publication bias. Seventeen RCTs involving 32,702 women were included, and all these studies ranked as medium- to high-quality. Twenty-four side-effects were reported. The use of carbetocin had a lower risk of vomiting in intravenously (0.53, 0.30 to 0.93) and cesarean birth (0.51, 0.32 to 0.81) women, and had a slightly higher risk of diarrhea (8.00, 1.02 to 62.79) compared with oxytocin intervention. No significant difference was found among other side-effects. Evidence from our systematic review and meta-analysis of 17 RCTs suggested that the risk of vomiting decreased with carbetocin use in the prevention of PPH after delivery.
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A prognostic score for patients with acute-on-chronic liver failure treated with plasma exchange-centered artificial liver support system
Du L, Ma Y, Zhou S, Chen F, Xu Y, Wang M, Lei X, Feng P, Tang H, Bai L
Scientific reports. 2021;11(1):1469
Abstract
Artificial liver support system (ALSS) therapy is widely used in patients with hepatitis B virus-related acute-on-chronic liver failure (HBV-ACLF). We aimed to develop a predictive score to identify the subgroups who may benefit from plasma exchange (PE)-centered ALSS therapy. A total of 601 patients were retrospectively enrolled and randomly divided into a derivation cohort of 303 patients and a validation cohort of 298 patients for logistic regression analysis, respectively. Five baseline variables, including liver cirrhosis, total bilirubin, international normalized ratio of prothrombin time, infection and hepatic encephalopathy, were found independently associated with 3-month mortality. A predictive PALS model and the simplified PALS score were developed. The predicative value of PALS score (AUROC = 0.818) to 3-month prognosis was as capable as PALS model (AUROC = 0.839), R score (AUROC = 0.824) and Yue-Meng' score (AUROC = 0.810) (all p > 0.05), and superior to CART model (AUROC = 0.760) and MELD score (AUROC = 0.765) (all p < 0.05). The PALS score had significant linear correlation with 3-month mortality (R(2) = 0.970, p = 0.000). PALS score of 0-2 had both sensitivity and negative predictive value of > 90% for 3-month mortality, while PALS score of 6-9 had both specificity and positive predictive value of > 90%. Patients with PALS score of 3-5 who received 3-5 sessions of ALSS therapy had much lower 3-month mortality than those who received 1-2 sessions (32.8% vs. 59.2%, p < 0.05). The more severe patients with PALS score of 6-9 could still benefit from ≥ 6 sessions of ALSS therapy compared to ≤ 2 sessions (63.6% vs. 97.0%, p < 0.05). The PALS score could predict prognosis reliably and conveniently. It could identify the subgroups who could benefit from PE-centered ALSS therapy, and suggest the reasonable sessions.Trial registration: Chinese Clinical Trial Registry, ChiCTR2000032055. Registered 19th April 2020, http://www.chictr.org.cn/showproj.aspx?proj=52471 .
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7.
Application of hepatitis B immunoglobulin in prevention of mother-to-child transmission of chronic hepatitis B in HBsAg- and HBeAg-positive mother
Luo Q, Wang H, Fang JW, Gu ZW, Song DJ, Chen Y, Chen GD, Zhao B, Sun C, Ma Y, et al
Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology. 2021;:1-6
Abstract
The aim of our study was to compare the efficacy of two dosages of hepatitis B immunoglobulin (HBIG) combined with HBV vaccine (HBVac) to prevent mother-to-child transmission (MTCT) of hepatitis B in HBsAg- and HBeAg-positive mother. We enrolled 331 mother-infant pairs with HBsAg- and HBeAg-positive maternal state from the Women's Hospital School of Medicine of Zhejiang University. Newborns were randomly distributed into two groups according to the dosages of HBIG injection: 100 IU and 200 IU. Newborns from both groups were injected with HBVac in the same doses. We compared the immune outcomes between the two groups and explore the influencing factors of immune outcomes through regression analysis. There was no statistically significant relationship between HBsAg serological transmission of newborns and dosages of HBIG in HBsAg- and HBeAg-positive mother (p > .05). The Logistic regression showed that high DNA load is a risk factor for passive-active immunoprophylaxis failure for both 100 IU and 200 IU group, but higher-dosage HBIG is not necessary for higher-viral-load pregnant women with HBsAg- and HBeAg-positive. In conclusion, combined application of HBVac and a single dose of 100 IU HBIG can achieve the ideal MTCT interruption results for HBsAg- and HBeAg-positive pregnant women.IMPACT STATEMENTWhat is already known on this subject? Passive-active immunoprophylaxis is proved to be effective in preventing mother-to-child transmission of hepatitis B. Hepatitis B vaccine combined with 100 IU or 200 IU immunoglobulin is mostly recommended in China.What do the results of this study add? At present, there is still a lack scientific basis for improving existing strategies and measures to prevent mother-to-child transmission of hepatitis B in China.What are the implications of these findings for clinical practice and/or further research? 100 IU and 200 IU immunoglobulin show equivalent blocking effect, and combined use of hepatitis B vaccine and 100 IU immunoglobulin is more cost-effective.
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8.
Platelet-rich plasma injection vs corticosteroid injection for conservative treatment of rotator cuff lesions: A protocol for systematic review and meta-analysis
Wang C, Zhang Z, Ma Y, Liu X, Zhu Q
Medicine. 2021;100(7):e24680
Abstract
BACKGROUND To explore the effectiveness of platelet-rich plasma (PRP) injection regarding functional recovery, pain relief, and range of motion (ROM) of shoulder compared with the corticosteroid injection in patients with rotator cuff lesions treated non-operatively. METHODS An electronic literature search was performed by 2 authors in the PubMed, Embase, Cochrane Library, and Web of Science databases to identify relevant randomized controlled trial (RCTs) that were published up to July 20, 2020. The quality of the included RCTs was evaluated using the approach recommended by the Cochrane Handbook for Systematic Reviews of Interventions. Standardized mean differences (SMDs) or mean differences (MDs) with 95% confidence intervals (CIs) were applied to calculate the pooled effect sizes. RESULTS Six RCTs were included in this systematic review. Meta-analysis revealed that corticosteroid injection yielded statistically significant superior functional recovery (SMD = -0.80; 95% CI, -1.42 to -0.18; P = .01) and pain relief (MD = 1.59; 95% CI, 0.30-2.89; P = .02) compared with PRP injection for rotator cuff lesions during the short-term follow-up period. However, at the medium-term and long-term follow-up, no statistically significant difference was identified between the 2 groups. Regarding the ROM of shoulder, no statistically significant difference was found between the 2 groups during the whole follow-up period. CONCLUSIONS The current clinical evidence revealed short-term efficacy of corticosteroid injection and no significant medium- to long-term difference between corticosteroid and PRP injection in the treatment of rotator cuff lesions. Additional studies with longer follow-ups, larger sample sizes, and more rigorous designs are needed to draw more reliable and accurate conclusions.
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9.
Anticoagulation treatment for patients with coronavirus disease 2019 (COVID-19) and its clinical effectiveness in 2020: A meta-analysis study
Ge J, Ma Y, Wu Z, Jin J, Sun X
Medicine. 2021;100(47):e27861
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Abstract
BACKGROUND To better inform efforts to treat and control the current outbreak with effective anticoagulant treatment strategies for coronavirus disease 2019 patients. METHODS We searched Cochrane Library, Pubmed, EMBASE, MEDLINE, SCIEXPANDED, Web of Science, Google Scholar, CNKI (Chinese Database), WanFang (Chinese Database), CBM (Chinese Database), VIP (Chinese Database) for studies published from November 1, 2019 to October 1, 2020, and we searched references of identified articles. Studies were reviewed for methodological quality. A random-effects model was used to pool results. Heterogeneity was assessed using I2. Publication bias was assessed using funnel plot. RESULTS Fourteen studies involving 7681 patients were included. We meta-analyzed the bleeding, deep vein thrombosis, and pulmonary embolism risk between no anticoagulation and prophylactic anticoagulation, and found no significant difference. The same trend occurred in the comparison between with and without anticoagulation. However, when compared with no anticoagulation, both prophylactic anticoagulation (odd ratio [OR] = 0.80, 95% confidence interval [CI]: 0.69-0.93) and therapeutic anticoagulation (OR = 0.91, 95% CI: 0.80-1.05) had lower risk of mortality. Furthermore, the risk of overall bleeding among patients with therapeutic anticoagulation was 3.11 times (95% CI: 2.29-4.24) than that of patients with prophylactic anticoagulation. On the contrary, therapeutic anticoagulation had lower risk of deep vein thrombosis than prophylactic anticoagulation (OR = 0.34, 95% CI: 0.19-0.63). CONCLUSIONS Among coronavirus disease 2019 patients, preventive and therapeutic anticoagulation were more beneficial than no anticoagulation for reducing mortality rate. The result will inform healthcare providers and public health policy makers in efforts to treat and control the current outbreak.
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Risk stratification with video capsule endoscopy leads to fewer hospital admissions in emergency department patients with low-risk to moderate-risk upper gastrointestinal bleed: A multicenter clinical trial
Meltzer AC, Limkakeng AT Jr, Gentile NT, Freeman JQ, Hall NC, Vargas NM, Fleischer DE, Malik Z, Kallus SJ, Borum ML, et al
Journal of the American College of Emergency Physicians open. 2021;2(5):e12579
Abstract
OBJECTIVE In US emergency departments (EDs), the physician has limited ability to evaluate for common and serious conditions of the gastrointestinal (GI) mucosa such as a bleeding peptic ulcer. Although many bleeding lesions are self-limited, the majority of these patients require emergency hospitalization for upper endoscopy (EGD). We conducted a clinical trial to determine if ED risk stratification with video capsule endoscopy (VCE) reduces hospitalization rates for low-risk to moderate-risk patients with suspected upper GI bleeding. METHODS We conducted a randomized controlled trial at 3 urban academic EDs. Inclusion criteria included signs of upper GI bleeding and a Glasgow Blatchford score <6. Patients were randomly assigned to 1 of the following 2 treatment arms: (1) an experimental arm that included VCE risk stratification and brief ED observation versus (2) a standard care arm that included admission for inpatient EGD. The primary outcome was hospital admission. Patients were followed for 7 and 30 days to assess for rebleeding events and revisits to the hospital. RESULTS The trial was terminated early as a result of low accrual. The trial was also terminated early because of a need to repurpose all staff to respond to the coronavirus disease 2019 pandemic. A total of 24 patients were enrolled in the study. In the experimental group, 2/11 (18.2%) patients were admitted to the hospital, and in the standard of care group, 10/13 (76.9%) patients were admitted to the hospital (P = 0.012). There was no difference in safety on day 7 and day 30 after the index ED visit. CONCLUSIONS VCE is a potential strategy to decrease admissions for upper GI bleeding, though further study with a larger cohort is required before this approach can be recommended.