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.

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.

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.

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 .

Abstract

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.

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.

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.

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.

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.

Abstract

BACKGROUND As Asian populations, Chinese have a lower rate of high-risk gene mutations in venous thrombosis. Therefore, individual patient risk assessment, rather than a "blanket policy", is considered the best thromboembolism prophylaxis for Chinese. The purpose of this study was to evaluate the effectiveness and safety of selective thromboembolism prophylaxis compared with conventional thromboembolism prophylaxis by risk stratification with thromboelastography (TEG) after joint arthroplasty in Chinese. METHODS Between August 2016 to August 2017, Chinese patients who underwent hip or knee arthroplasty were randomly divided into a selective anticoagulation group (SAG) and a conventional anticoagulation group (CAG). Participants and outcome assessors were blinded. In the SAG, an anticoagulant was used when TEG indicated hypercoagulability; while in the CAG, an anticoagulant was regularly used until one month after surgery. Outcome evaluation included effectiveness (defined as the incidence of VTE), and safety (defined as the incidence of bleeding events, poor wound healing, blood loss, and infection). RESULTS A total of 197 patients (79 in the SAG and 118 in the CAG) were included in the study. There was 1 case of deep vein thrombosis (DVT) in the SAG and 2 cases of DVT in the CAG, but there was no significant difference between the two groups. Hidden blood loss in the SAG was 707.4±539.8 mL and hidden blood loss in the CAG was 617±565.0 mL, respectively (P>0.05). No significant difference was observed in perioperative blood loss between the SAG and the CAG (1,024.9±597.9 and 1,139.3±620.9 mL, respectively). Volume of blood transfusion was 92.4±270.2 mL in the SAG and 224.6±416.3 mL in the CAG, respectively, while rate of transfusion was 13.9% in the SAG and 33.9% in the CAG, respectively, which were significantly different between the two groups (P<0.05). CONCLUSIONS In Chinese patients who underwent hip or knee arthroplasty, the efficacy of selective anticoagulation using TEG in risk stratification was comparable to that of conventional anticoagulation. Furthermore, the safety of selective anticoagulant prophylaxis was superior to that of conventional anticoagulant prophylaxis.