Abstract

BACKGROUND Selective endoscopic coagulation of a nasal bleeding vessel is an effective means of treating epistaxis. Precisely locating the bleeding site(s) is critical. OBJECTIVE To investigate the utility of combining a negative pressure suction device and endoscope in locating bleeding sites of refractory epistaxis. METHODS A total of 116 patients with refractory epistaxis, who underwent systematic endoscopic exploration under local anesthesia in the absence of identifiable sites of bleeding were randomizely divided into two groups via negative pressure group (NPG) and control group (CG): The negative pressure suction device combined with an endoscope was used to re-explore the epistaxis. Nasal bleeding was induced using this method to help the operator locate the site of epistaxis accurately; the bleeding was then stopped using electrocoagulation with the suction electrode. The CG was treated with endoscopic re-exploration and selective tamponade. RESULTS Compared with the CG, there were statistically significant differences in length of hospital stay, rebleeding, and postoperative pain and complications (all p < .05). CONCLUSION AND SIGNIFICANCE Combining a negative pressure suction device and endoscope was a safe and effective technique for accurately locating bleeding sites in patients with refractory epistaxis.

Abstract

OBJECTIVE To study effect of joint distraction osteogenesis combined with platelet-rich plasma injections on traumatic ankle arthritis (TAA). METHODS 106 patients with TAA admitted to our hospital (from January 2018 to January 2020) were recruited as the study cohort and randomly divided into a surgical group and a combined group. The surgical group was treated with simple joint retraction surgery, and the combined group was treated with platelet-rich plasma injections in addition to the surgery administered to the operation group. After 6 months of treatment, the clinical efficacy of the two groups was evaluated, and the changes in the ankle joint function, the serum related factors, and the quality of life before and at six months after the treatment were observed. The incidences of adverse reactions (ARS) in the two groups were counted to evaluate the treatment safety. RESULTS The total effective rate was 98.11% in the combined group and 77.36% in the operation group. The overall curative effect of the combined group was better than it was in the operation group (P<0.05). After the treatment, the ankle joint movement angles, the joint function, the serum factor levels, and the quality of life of the patients in combined group were better than they were in the operation group (P<0.05). No significant difference was found in the incidence of ARs (P>0.05). CONCLUSION Arthroplasty with platelet-rich plasma injections can improve joint function recovery, inhibit the inflammatory factor expression levels, and enhance TAA patients' quality of life.

Abstract

BACKGROUND Intraventricular hemorrhage (IVH) is a common complication in preterm infants that has poor outcomes, especially in severe cases, and there are currently no widely accepted effective treatments. Erythropoietin has been shown to be neuroprotective in neonatal brain injury. OBJECTIVE The objective of this study was to evaluate the protective effect of repeated low-dose recombinant human erythropoietin (rhEPO) in preterm infants with IVH. METHODS This was a single-blinded prospective randomized controlled trial. Preterm infants ≤ 32 weeks gestational age who were diagnosed with IVH within 72 h after birth were randomized to receive rhEPO 500 IU/kg or placebo (equivalent volume of saline) every other day for 2 weeks. The primary outcome was death or neurological disability assessed at 18 months of corrected age. RESULTS A total of 316 eligible infants were included in the study, with 157 in the rhEPO group and 159 in the placebo group. Although no significant differences in mortality (p = 0.176) or incidence of neurological disability (p = 0.055) separately at 18 months of corrected age were seen between the rhEPO and placebo groups, significantly fewer infants had poor outcomes (death and neurological disability) in the rhEPO group: 14.9 vs. 26.4%; odds ratio (OR) 0.398; 95% confidence interval (CI) 0.199-0.796; p = 0.009. In addition, the incidence of Mental Development Index scores of < 70 was lower in the rhEPO group than in the placebo group: 7.2 vs. 15.3%; OR 0.326; 95% CI 0.122-0.875; p = 0.026. CONCLUSIONS Treatment with repeated low-dose rhEPO improved outcomes in preterm infants with IVH. TRIAL REGISTRATION The study was retrospectively registered on ClinicalTrials.gov on 16 April 2019 (NCT03914690).

Abstract

BACKGROUND Necrotizing enterocolitis (NEC) is one of the most severe complications in very preterm infants, but there are currently no accepted methods to prevent NEC. Studies have shown that erythropoietin (EPO) has the potential to prevent NEC or improve outcomes of preterm NEC. This study aimed to determine whether recombinant human EPO (rhEPO) could protect against NEC in very preterm infants. METHODS The study was a prospective randomized clinical trial performed among four NICU centers. A total of 1327 preterm infants with gestational age ≤ 32 weeks were admitted to the centers, and 42 infants were excluded leaving 1285 eligible infants to be randomized to the rhEPO or control group. Infants in the rhEPO group were given 500 IU/kg rhEPO intravenously every other day for 2 weeks, while the control group was given the same volume of saline. The primary outcome was the incidence of NEC in very preterm infants at 36 weeks of corrected gestational age. RESULTS A total of 1285 infants were analyzed at 36 weeks of corrected age for the incidence of NEC. rhEPO treatment significantly decreased the incidence of NEC (stage I, II and III) (12.0% vs. 17.1%, p = 0.010), especially confirmed NEC (stage II and III) (3.0% vs. 5.4%, p = 0.027). Meanwhile, rhEPO treatment significantly reduced the number of red blood cells transfusion in the confirmed NEC cases (1.2 ± 0.4 vs. 2.7 ± 1.0, p = 0.004). Subgroup analyses showed that rhEPO treatment significantly decreased the incidence of confirmed NEC at gestational age < 28 weeks (p = 0.019), and the incidence of all stages NEC in preterm infants with hemoglobin < 90 g/l (p = 0.000) and 5 min Apgar score > 5 (p = 0.028). CONCLUSION Repeated low-dose rhEPO treatment is beneficial against NEC in very preterm infants. Trial registration The protocol was registered retrospectively at ClinicalTrials.gov (NCT03919500) on April 18, 2019. https://clinicaltrials.gov/ct2/show/NCT03919500.

Abstract

BACKGROUND The survival benefit of early placement of transjugular intrahepatic portosystemic shunts (TIPS) in patients with cirrhosis and acute variceal bleeding is controversial. We aimed to assess whether early TIPS improves survival in patients with advanced cirrhosis and acute variceal bleeding. METHODS We did an investigator-initiated, open-label, randomised controlled trial at an academic hospital in China. Consecutive patients with advanced cirrhosis (Child-Pugh class B or C) and acute variceal bleeding who had been treated with vasoactive drugs plus endoscopic therapy were randomly assigned (2:1) to receive either early TIPS (done within 72 h after initial endoscopy [early TIPS group]) or standard treatment (vasoactive drugs continued to day 5, followed by propranolol plus endoscopic band ligation for the prevention of rebleeding, with TIPS as rescue therapy when needed [control group]). Randomisation was done by web-based randomisation system using a Pocock and Simon's minimisation method with Child-Pugh class (B vs C) and presence or absence of active bleeding as adjustment factors. The primary outcome was transplantation-free survival, analysed in the intention-to-treat population, excluding individuals subsequently found to be ineligible for enrolment. This study is registered with ClinicalTrials.gov, number NCT01370161, and is completed. FINDINGS From June 26, 2011, to Sept 30, 2017, 373 patients were screened and 132 patients were randomly assigned to the early TIPS group (n=86) or to the control group (n=46). After exclusion of three individuals subsequently found to be ineligible for enrolment (two patients in the early TIPS group with non-cirrhotic portal hypertension or hepatocellular carcinoma, and one patient in the control group due to non-cirrhotic portal hypertension), 84 patients in the early TIPS group and 45 patients in the control group were included in the intention-to-treat population. 15 (18%) patients in the early TIPS group and 15 (33%) in the control group died; two (2%) patients in the early TIPS group and one (2%) in the control group underwent liver transplantation. Transplantation-free survival was higher in the early TIPS group than in the control group (hazard ratio 0.50, 95% CI 0.25-0.98; p=0.04). Transplantation-free survival at 6 weeks was 99% (95% CI 97-100) in the early TIPS group compared with 84% (75-96; absolute risk difference 15% [95% CI 5-48]; p=0.02) and at 1 year was 86% (79-94) in the early TIPS group versus 73% (62-88) in the control group (absolute risk difference 13% [95% CI 2-28]; p=0.046). There were no significant differences between the two groups in the incidence of hepatic hydrothorax (two [2%] of 84 patients in the early TIPS group vs one [2%] of 45 in the control group; p=0.96), spontaneous bacterial peritonitis (one [1%] vs three [7%]; p=0.12), hepatic encephalopathy (29 [35%] vs 16 [36%]; p=1.00), hepatorenal syndrome (four [5%] vs six [13%]; p=0.10), and hepatocellular carcinoma (four [5%] vs one [2%]; p=0.68). There was no significant difference in the number of patients who experienced other serious adverse events (ten [12%] vs 11 [24%]; p=0.07) or non-serious adverse events (21 [25%] vs 19 [42%]; p=0.05) between groups. INTERPRETATION Early TIPS with covered stents improved transplantation-free survival in selected patients with advanced cirrhosis and acute variceal bleeding and should therefore be preferred to the current standard of care. FUNDING National Natural Science Foundation of China, National Key Technology R&D Program, Optimized Overall Project of Shaanxi Province, Boost Program of Xijing Hospital.

Abstract

PURPOSE Recent clinical data suggest that terlipressin, a vasopressin analogue, may be more beneficial in septic shock patients than catecholamines. However, terlipressin's effect on mortality is unknown. We set out to ascertain the efficacy and safety of continuous terlipressin infusion compared with norepinephrine (NE) in patients with septic shock. METHODS In this multicentre, randomised, double-blinded trial, patients with septic shock recruited from 21 intensive care units in 11 provinces of China were randomised (1:1) to receive either terlipressin (20-160 microg/h with maximum infusion rate of 4 mg/day) or NE (4-30 microg/min) before open-label vasopressors. The primary endpoint was mortality 28 days after the start of infusion. Primary efficacy endpoint analysis and safety analysis were performed on the data from a modified intention-to-treat population. RESULTS Between 1 January 2013 and 28 February 2016, 617 patients were randomised (312 to the terlipressin group, 305 to the NE group). The modified intention-to-treat population comprised 526 (85.3%) patients (260 in the terlipressin group and 266 in the NE group). There was no significant difference in 28-day mortality rate between the terlipressin group (40%) and the NE group (38%) (odds ratio 0.93 [95% CI 0.55-1.56]; p = 0.80). Change in SOFA score on day 7 was similar between the two groups: - 7 (IQR - 11 to 3) in the terlipressin group and - 6 (IQR - 10 to 5) in the NE group. There was no difference between the groups in the number of days alive and free of vasopressors. Overall, serious adverse events were more common in the terlipressin group than in the NE group (30% vs 12%; p < 0.001). CONCLUSIONS In this multicentre, randomised, double-blinded trial, we observed no difference in mortality between terlipressin and NE infusion in patients with septic shock. Patients in the terlipressin group had a higher number of serious adverse events. TRIAL REGISTRATION This trial is registered at ClinicalTrials.gov: ID NCT01697410.

Abstract

OBJECTIVE To determine the best haemostatic strategy for hysterectomy through a network meta-analysis. METHODS We conducted a systematic literature search of the PubMed, Embase, and Cochrane Library databases and extracted data from randomized controlled trials comparing haemostatic strategies for hysterectomy. Direct comparisons and network meta-analyses were conducted in RevMan and ADDIS. Consistency models were established to identify the differences among different haemostatic strategies, and cumulative probability was used to rank the included strategies. Inconsistencies were also tested using node-splitting models. RESULTS Twenty studies from 16 articles (2 articles contained 3 studies each) comprising 1392 patients were included. Direct meta-analysis showed that the LigaSure (SMD = -1.42 [-2.39, -0.44], P = 0.004), bipolar vessel sealing systems (BVSS) (SMD = -0.35 [-0.66, -0.03], P = 0.03), and pituitrin (SMD = -2.13 [-4.14, -0.13], P = 0.04) applications were effective haemostatic strategies. Based on the network meta-analysis and related subgroup analysis of different surgical procedures, the results showed that the application of pituitrin seemed to be the best haemostatic method for hysterectomy (Rank P = 0.64), especially for vaginal hysterectomy (Rank P = 0.72). The application of LigaSure was the best strategy for abdominal hysterectomy (Rank P = 0.54) but was not effective for laparoscopic hysterectomy (direct comparison with BVSS, MD = -31.39 [-146.61, 83.83], P = 0.59). The node-splitting models test revealed that no significant inconsistencies existed in this research. CONCLUSIONS Pituitrin application seemed to be the most effective haemostatic strategy for hysterectomy and was especially suitable for vaginal hysterectomy. The best method for reducing blood loss in abdominal hysterectomy was the application of LigaSure.