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Efficacy of New Hemostatic Techniques in Nonvariceal Gastrointestinal Bleeding: A Systematic Review and Network Meta-analysis
Liu K, Gao L, Bai J, Wang L, Zhu S, Zhao X, Han Y, Liu Z
Journal of digestive diseases. 2023
Abstract
OBJECTIVE This systematic review and network meta-analysis aimed to assess the relative efficacy of currently multiple hemostatic modalities in nonvariceal gastrointestinal bleeding (NVGIB). BACKGROUND Nonvariceal gastrointestinal bleeding is a frequent medical condition with significant mortality and morbidity. There are currently multiple hemostatic modalities, but their relative efficacy is still unknown. METHODS Major databases including PubMed, EMBASE and the Cochrane Library were searched for studies that compared the relative efficacy of different hemostatic techniques for NVGIB (over-the-scope-clip (OTSC), hemostatic powder (HP) and conventional endoscopic treatment (CET)). The 30-day rebleeding rate was the primary outcome. We performed pairwise and network meta-analyses for all treatments. The heterogeneity and transitivity were evaluated. RESULTS Twenty-two studies were included. OTSC and HP + CET showed superior efficacy compared with CET (OTSC vs CET: RR, 0.42 [95% CI, 0.28-0.60]; HP + CET vs CET: RR, 0.40 [95% CI, 0.17-0.87]) while their relative efficacy had not detected any statistically significant difference (OTSC vs HP + CET: RR, 0.95 [95% CI, 0.38-2.31]) in the 30-day rebleeding rate. HP + CET was ranked highest in the network ranking estimate. In addition, the sensitivity analysis showed that it was not robust that OTSC was superior to CET in the short-term rebleeding rate and the initial hemostasis rate. None of the other comparisons found a statistically significant difference. CONCLUSIONS This systematic review and network meta- analysis showed that OTSC and HP + CET significantly reduced 30-day rebleeding rates compared to CET and had similar efficacy. This article is protected by copyright. All rights reserved.
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Fibrin Glue Sac Filling for Preventing Type II Endoleak, Short-Term Outcomes of a Prospective Randomized Controlled Trial
Chen Y, Zhang L, Liu Z, Bi J, Niu F, Zhang X, Lu Q, Dai X
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists. 2023;:15266028231159245
Abstract
OBJECTIVE Type II endoleak (T2EL) worsens the long-term results of endovascular aneurysm repair (EVAR). How to prevent T2ELs remains controversial. This study aimed to evaluate the efficacy and safety of fibrin glue sac filling (FGSF) to prevent T2ELs after EVAR. METHODS A prospective randomized controlled trial was conducted. Patients were randomly divided into group A (standard EVAR + FGSF) and group B (standard EVAR). The follow-up plans included outpatient or telephone consultation at 1 and 3 months and computed tomography (CT) angiography at 6 months, 1 year, and once a year after EVAR. RESULTS A total of 64 abdominal aortic aneurysm (AAA) patients were randomized to the 2 groups. All patients were followed up for more than 6 months. The 2 groups showed similar baseline characteristics. The rate of T2ELs on immediate angiography in group A (9.6%) was significantly lower than that in group B (33.3%, p=0.033). Moreover, the sac area change was significantly reduced in group A at 6 months after EVAR (p=0.021). However, T2EL incidence was similar at the 6-month (p=0.055) and 1-year (p=0.057) follow-ups, and AAA diameter change was also similar at 1 year. There were similar operation times, radiation doses, severe adverse events (SAEs), and reinterventions between the 2 groups. CONCLUSION Fibrin glue sac filling could prevent short-term type II endoleaks and promote AAA shrinkage after 6 months. The FGSF procedure is swift and straightforward; however, patients are at risk of bowel ischemia, especially after previous bowel resections or concomitant superior mesenteric artery (SMA) disease. CLINICAL IMPACT Standard endovascular aneurysm repair (EVAR) couldn't prevent type II endoleak (T2EL). In this study, we found fibrin glue sac filling (FGSF) could prevent T2EL and promote AAA shrinkage in a short term. And the FGSF procedure is easy, it will be a useful supplement to standard EVAR for clinicians. And FGSF might have potential usefulness on ruptured aneurysms, although without direct evidence.Fibrin glue is often used to hemostasis and tissue adhesion in surgical patients and burn patients, we firstly carry out a randomized controlled study and prove that fibrin glue sac filling could prevent T2EL and promote sac remodeling.
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Supplementation with Iron in Pulmonary Arterial Hypertension: Two Randomized Crossover Trials
Howard Lsge, He J, Watson GMJ, Huang L, Wharton J, Luo Q, Kiely DG, Condliffe R, Pepke-Zaba J, Morrell NW, et al
Annals of the American Thoracic Society. 2021
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Abstract
RATIONALE Iron deficiency, in the absence of anaemia, is common in patients with idiopathic and heritable pulmonary arterial hypertension (PAH) and is associated with a worse clinical outcome. Oral iron absorption may be impeded by elevated circulating hepcidin levels. The safety and benefit of parenteral iron replacement in this patient population is unclear. OBJECTIVES To evaluate the safety and efficacy of parenteral iron replacement in pulmonary arterial hypertension. METHODS In two randomised, double blind, placebo-controlled 12 week crossover studies, 39 patients in Europe received a single infusion of ferric carboxymaltose (Ferinject®) 1000 mg (or 15 mg/kg if weight < 66.7Kg) or saline as placebo and 17 patients in China received iron dextran (Cosmofer®) 20 mg iron/kg body weight or saline placebo. All patients had idiopathic or heritable PAH and iron deficiency at entry as defined by: a serum ferritin < 37 µg/l or iron < 10.3 µmol/l or transferrin saturations < 16.4%. RESULTS Both iron treatments were well tolerated and improved iron status. Analysed separately and combined, there was no effect on any measure of exercise capacity (using cardiopulmonary exercise testing or 6 minute walk test) or cardio-pulmonary haemodynamics, as assessed by right heart catheterisation, cardiac magnetic resonance or plasma NT-proBNP, at 12 weeks. CONCLUSION Iron repletion by administration of a slow release iron preparation as a single infusion to PAH patients with iron deficiency without overt anaemia was well tolerated but provided no significant clinical benefit at 12 weeks. Clinical trial registered with ClinicalTrials.gov (NCT01447628).
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The rule of brain hematoma pressure gradient and its influence on hypertensive cerebral hemorrhage operation
Sun G, Fu T, Liu Z, Zhang Y, Chen X, Jin S, Chi F
Scientific reports. 2021;11(1):4599
Abstract
To comparatively study the size of and variation in the 'brain-haematoma' pressure gradient for different surgical methods for hypertensive intracerebral haemorrhage (HICH) and analyse the gradient's influence on surgical procedures and effects of the haemorrhage. Seventy-two patients with HICH treated from 1/2019 to 12/2019 were randomly divided into two groups, namely, the keyhole endoscopy and large trauma craniotomy groups, according to different operative methods. Intraoperative changes in intracranial pressure (ICP) were monitored to calculate intraoperative alterations in the 'brain-haematoma' pressure gradient. Intraoperative characteristics (operative time, bleeding volume, volume of blood transfusion, and haematoma clearance rate) and postoperative characteristics (oedema, postoperative activities of daily living (ADL) scores, mortality rate and rebleeding rate) were compared between the two groups. In the keyhole endoscopy group, ICP decreased slowly; the 'brain-haematoma' pressure gradient was large, averaging 251.1 ± 20.6 mmH(2)O, and slowly decreased. The mean operative time was 83.6 ± 4.3 min, the mean bleeding volume was 181.2 ± 13.6 ml, no blood transfusions were given, the average postoperative haematoma clearance rate was 95.6%, the rate of severe oedema was 10.9%, and the average postoperative ADL score was 85.2%. In the large trauma craniotomy group, ICP rapidly decreased after craniotomy. When the haematoma was removed, the 'brain-haematoma' pressure gradient was small, averaging 132.3 ± 10.5 mmH2O, and slowly decreased. The mean operative time was 232 ± 26.1 min, the mean bleeding volume was 412.6 ± 35.2 ml, the average volume of blood transfusion was 281.3 ± 13.6 ml, and the average postoperative haematoma clearance rate was 82.3%; moreover, the rate of severe oedema was 72.1%, and the average postoperative ADL score was 39.0%. These differences were statistically significant (P < 0.05). Neither the death rate (P > 0.05, 2.7% VS 2.8%) nor rebleeding rate (P > 0.05, 2.7% VS 2.8%) showed any obvious changes. The magnitude and variation in the 'brain-haematoma' pressure gradient for different surgical methods significantly influence surgical procedures and effects of HICH. During keyhole endoscopy surgery, this gradient was relatively large and slowly decreased; the haematoma was therefore easier to remove. Advantages of this approach include a high haematoma clearance rate, decreased bleeding volume, decreased operative time, reduced trauma, decreased postoperative brain oedema and improved postoperative recovery of neurological function.Chinese Clinical Trial Register: ChiCTR1900020655 registration in 12/01/02,019 registration in 28/02/02,020 Number: NCOMMS-20-08,091.
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Effects of carbazochrome sodium sulfonate combined with tranexamic acid on hemostasis and inflammation during perioperative period of total hip arthroplasty: a randomized controlled trial
Luo Y, Releken Y, Yang D, Yue Y, Liu Z, Kang P
Orthopaedics & traumatology, surgery & research : OTSR. 2021;:103092
Abstract
BACKGROUND The hemostatic effect of tranexamic acid (TXA) combined with carbazochrome sodium sulfonate (CSS) in total hip arthroplasty (THA) has not been determined. Therefore we performed a randomized study aiming to evaluate the effects of CSS combined with TXA on perioperative blood loss and inflammatory response of THA. HYPOTHESIS CSS combined with TXA can effectively reduce perioperative blood loss and immune response compared to TXA. MATERIAL AND METHODS This randomized placebo-controlled trial assigned 150 patients undergoing unilateral primary total hip arthroplasty who underwent direct anterior approach surgery to 3 groups: group A received TXA plus topical CSS; group B received TXA only; and group C received placebo. The main outcome was total blood loss. Secondary outcomes included reduction in hemoglobin concentration, coagulation parameters, inflammatory marker levels, perioperative visual analog scale (VAS) pain score, transfusion rates, postoperative hospital stay, and incidence of thromboembolic events. RESULTS Total blood loss in group A (668.84±230.95mL) was lower than in group B (940.96±359.22 mL) and C (1166.52±342.85 mL, p < 0.05). We also found that compared with group B, postoperative hip pain, biomarker level of inflammation, visual analogue score (VAS) pain score in group A were significantly improved. The transfusion rate and unit of group A were significantly lower than group C (8 patients ; 17.5 units), but there was no statistical difference between group A (no transfusion) and group B (2 patients; 4 units). No differences were observed in thromboembolic and other outcomes among the groups. DISCUSSION The combined application of topic CSS and TXA is more effective than TXA alone following THA in regard of reducing total blood loss. In addition, CSS combined with TXA is better than TXA alone in terms of improving postoperative hip pain and reducing the level of inflammatory factors. LEVEL OF EVIDENCE I; randomized controlled study.
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Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19: A Randomized Clinical Trial
Li L, Zhang W, Hu Y, Tong X, Zheng S, Yang J, Kong Y, Ren L, Wei Q, Mei H, et al
Jama. 2020
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Abstract
Importance: Convalescent plasma is a potential therapeutic option for patients with coronavirus disease 2019 (COVID-19), but further data from randomized clinical trials are needed. Objective: To evaluate the efficacy and adverse effects of convalescent plasma therapy for patients with COVID-19. Design, Setting, and Participants: Open-label, multicenter, randomized clinical trial performed in 7 medical centers in Wuhan, China, from February 14, 2020, to April 1, 2020, with final follow-up April 28, 2020. The trial included 103 participants with laboratory-confirmed COVID-19 that was severe (respiratory distress and/or hypoxemia) or life-threatening (shock, organ failure, or requiring mechanical ventilation). The trial was terminated early after 103 of a planned 200 patients were enrolled. Intervention: Convalescent plasma in addition to standard treatment (n = 52) vs standard treatment alone (control) (n = 51), stratified by disease severity. Main Outcomes and Measures: Primary outcome was time to clinical improvement within 28 days, defined as patient discharged alive or reduction of 2 points on a 6-point disease severity scale (ranging from 1 [discharge] to 6 [death]). Secondary outcomes included 28-day mortality, time to discharge, and the rate of viral polymerase chain reaction (PCR) results turned from positive at baseline to negative at up to 72 hours. Results: Of 103 patients who were randomized (median age, 70 years; 60 [58.3%] male), 101 (98.1%) completed the trial. Clinical improvement occurred within 28 days in 51.9% (27/52) of the convalescent plasma group vs 43.1% (22/51) in the control group (difference, 8.8% [95% CI, -10.4% to 28.0%]; hazard ratio [HR], 1.40 [95% CI, 0.79-2.49]; P = .26). Among those with severe disease, the primary outcome occurred in 91.3% (21/23) of the convalescent plasma group vs 68.2% (15/22) of the control group (HR, 2.15 [95% CI, 1.07-4.32]; P = .03); among those with life-threatening disease the primary outcome occurred in 20.7% (6/29) of the convalescent plasma group vs 24.1% (7/29) of the control group (HR, 0.88 [95% CI, 0.30-2.63]; P = .83) (P for interaction = .17). There was no significant difference in 28-day mortality (15.7% vs 24.0%; OR, 0.65 [95% CI, 0.29-1.46]; P = .30) or time from randomization to discharge (51.0% vs 36.0% discharged by day 28; HR, 1.61 [95% CI, 0.88-2.93]; P = .12). Convalescent plasma treatment was associated with a negative conversion rate of viral PCR at 72 hours in 87.2% of the convalescent plasma group vs 37.5% of the control group (OR, 11.39 [95% CI, 3.91-33.18]; P < .001). Two patients in the convalescent plasma group experienced adverse events within hours after transfusion that improved with supportive care. Conclusion and Relevance: Among patients with severe or life-threatening COVID-19, convalescent plasma therapy added to standard treatment, compared with standard treatment alone, did not result in a statistically significant improvement in time to clinical improvement within 28 days. Interpretation is limited by early termination of the trial, which may have been underpowered to detect a clinically important difference. Trial Registration: Chinese Clinical Trial Registry: ChiCTR2000029757.
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Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19
Li L, Zhang W, Hu Y, Tong X, Zheng S, Yang J, Kong Y, Ren L, Wei Q, Mei H, et al
Jama. 2020
Abstract
ImportanceConvalescent plasma is a potential therapeutic option for patients with coronavirus disease 2019 (COVID-19), but further data from randomized clinical trials are needed ObjectiveTo evaluate the efficacy and adverse effects of convalescent plasma therapy for patients with COVID-19 Design, Setting, and ParticipantsOpen-label, multicenter, randomized clinical trial performed in 7 medical centers in Wuhan, China, from February 14, 2020, to April 1, 2020, with final follow-up April 28, 2020 The trial included 103 participants with laboratory-confirmed COVID-19 that was severe (respiratory distress and/or hypoxemia) or life-threatening (shock, organ failure, or requiring mechanical ventilation) The trial was terminated early after 103 of a planned 200 patients were enrolled InterventionConvalescent plasma in addition to standard treatment (n = 52) vs standard treatment alone (control) (n = 51), stratified by disease severity Main Outcomes and MeasuresPrimary outcome was time to clinical improvement within 28 days, defined as patient discharged alive or reduction of 2 points on a 6-point disease severity scale (ranging from 1 [discharge] to 6 [death]) Secondary outcomes included 28-day mortality, time to discharge, and the rate of viral polymerase chain reaction (PCR) results turned from positive at baseline to negative at up to 72 hours ResultsOf 103 patients who were randomized (median age, 70 years;60 [58 3%] male), 101 (98 1%) completed the trial Clinical improvement occurred within 28 days in 51 9% (27/52) of the convalescent plasma group vs 43 1% (22/51) in the control group (difference, 8 8% [95% CI, −10 4% to 28 0%];hazard ratio [HR], 1 40 [95% CI, 0 79-2 49];P = 26) Among those with severe disease, the primary outcome occurred in 91 3% (21/23) of the convalescent plasma group vs 68 2% (15/22) of the control group (HR, 2 15 [95% CI, 1 07-4 32];P = 03);among those with life-threatening disease the primary outcome occurred in 20 7% (6/29) of the convalescent plasma group vs 24 1% (7/29) of the control group (HR, 0 88 [95% CI, 0 30-2 63];P = 83) (Pfor interaction = 17) There was no significant difference in 28-day mortality (15 7% vs 24 0%;OR, 0 65 [95% CI, 0 29-1 46];P = 30) or time from randomization to discharge (51 0% vs 36 0% discharged by day 28;HR, 1 61 [95% CI, 0 88-2 93];P = 12) Convalescent plasma treatment was associated with a negative conversion rate of viral PCR at 72 hours in 87 2% of the convalescent plasma group vs 37 5% of the control group (OR, 11 39 [95% CI, 3 91-33 18];P < 001) Two patients in the convalescent plasma group experienced adverse events within hours after transfusion that improved with supportive care Conclusion and RelevanceAmong patients with severe or life-threatening COVID-19, convalescent plasma therapy added to standard treatment, compared with standard treatment alone, did not result in a statistically significant improvement in time to clinical improvement within 28 days Interpretation is limited by early termination of the trial, which may have been underpowered to detect a clinically important difference Trial RegistrationChinese Clinical Trial Registry:ChiCTR2000029757
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Safety and Efficacy of Eltrombopag and Romiplostim in Myelodysplastic Syndromes: A Systematic Review and Meta-Analysis
Meng F, Chen X, Yu S, Ren X, Liu Z, Fu R, Li L
Frontiers in oncology. 2020;10:582686
Abstract
BACKGROUND AND AIM Many studies indicated that eltrombopag and romiplostim could improve hematopoietic function in patients with myelodysplastic syndromes (MDS), but their toxicity and efficacy were not known. This meta-analysis aimed to investigate the safety and efficacy of eltrombopag and romiplostim in MDS. METHODS A full-scale search strategy was used to search relevant published studies in PubMed, Embase, Web of Science, ClinicalTrials.gov and the Cochrane Library until January 2020 using a random-effects model and the pooled risk ratio (RR) with 95% confidence interval as the effect indicator. Statistical analyses were performed using RevMan 5.3. RESULTS This meta-analysis included eight studies comprising 1047 patients. A lower RR of overall response rate (ORR) (RR: 0.65; 95% CI, 0.47-0.9) and grade ≥3 bleeding events (RR: 0.36; 95% CI, 0.36-0.92) were observed after romiplostim and eltrombopag treatment compared with placebo. The pooled RR for the ORR and grade ≥3 bleeding events were 0.58 (95% CI: 0.41-0.83, P = 0.003) and 0.6 (95% CI: 0.37-0.96, P = 0.03) in eltrombopag, respectively. A lower ORR in intermediate- or high-risk MDS (RR: 0.63; 95% CI: 0.45-0.88, P = 0.006) was observed. No difference in mortality, serious adverse events, platelet transfusion, hematologic improvement, and AML transformation was observed. CONCLUSIONS Thrombopoietin receptor agonists (TPO-RAs) romiplostim and eltrombopag were effective in reducing bleeding events, especially grade ≥3 bleeding events. However, it might reduce the ORR of MDS, especially in eltrombopag treatment group or high-risk MDS group. Due to the limited treatment of MDS and the poor response to the drug, this may be a selection method for MDS combined with fatal bleeding, although further research is needed to confirm the effectiveness of this approach.
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Efficacy and safety of Chinese medicines for vitreous hemorrhage: A protocol for systematic review and meta-analysis
Han M, Liu Z, Nong L, Zi Y, Meng H, Deng Y, Wang ZJ, Jin M
Medicine (Baltimore). 2020;99(19):e20086
Abstract
BACKGROUND Vitreous hemorrhage (VH) is a common ophthalmic disease with a high rate of blindness, which will seriously affect the quality of life of patients and bring great burden to patients' families and society. The treatment for VH contains medical therapy, lasers, and surgery. At present, there is no recognized western medicine with definite curative effect and little side effect for the treatment of VH. In most cases, PRP is not available to treat VH; intravitreal injection or surgical treatment is adopted as the primary therapy. However, in the long-term treatment, the effect of the above-mentioned treatment is not satisfactory, so many patients choose oral Chinese medicines, which has been widely used in China to treat VH. Numerous clinical trials have demonstrated that Chinese medicines can promote the absorption of VH and improve the visual function of patients. The purpose of this review is to evaluate the efficacy and safety of Chinese medicines in the treatment of VH and inform a decision aid for the clinical encounter between patients and clinicians. Besides, it is beneficial to establish a future research agenda. METHODS The systematic review will include all of the randomized controlled trials on the efficacy and safety of Chinese medicines for VH. Nine electronic databases, namely PubMed, Web of Science, EMBASE, the Cochrane Library, Google Scholar, China National Knowledge Infrastructure (CNKI), Wanfang Database, China Science and Technology Journal database (VIP), and CBM, will be searched normatively on the basis of the rule of each database from the inception to August 31, 2019. We will also search registers of clinical trials, potential gray literature, and conference abstracts. There are no limits on language and publication status. The literature screening, data extraction, and quality assessment will be conducted by 2 reviewers independently. The reporting quality and risk of bias will be assessed by other 2 researchers. Standard of curative effect and total treatment efficacy rate were assessed as the primary outcome. The secondary outcomes will include the curative effect of single symptom and sign, the improvement rate of single auxiliary examination, withdrawal and reduction of western medicines in a course of treatment, maintenance of western medicines after the course of treatment, laboratory efficacy indexes. Meta-analysis will be performed using RevMan5.3 software provided by the Cochrane Collaboration. RESULTS This study will provide a comprehensive review based on current evidence of Chinese medicines treatment for VH in several aspects, including standard of curative effect, total treatment efficacy rate, the curative effect of single symptom and sign, the improvement rate of single auxiliary examination, withdrawal and reduction of western medicines in a course of treatment, laboratory efficacy indexes, total treatment efficacy, and safety, among others. CONCLUSION The conclusion of this study will provide evidence to determine whether Chinese medicines are an effective and safe intervention for patients with VH. ETHICS AND DISSEMINATION It is not necessary to obtain ethical approval for this study. The systematic review will be published in a peer-reviewed journal, presented at conferences and will be shared on social media platforms. PROSPERO REGISTRATION NUMBER PROSPERO CRD42020152321.
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Efficacy and safety of tranexamic acid combined with rivaroxaban in primary total knee arthroplasty: a meta-analysis of randomized controlled trials
Meng B, Ma J, Liu Z, Du C, Zhang G
Journal of investigative surgery : the official journal of the Academy of Surgical Research. 2019;:1-10
Abstract
Background: Tranexamic acid (TXA) combined with rivaroxaban (RA) has been widely used in total knee replacement (TKA). This meta-analysis explored the clinical effects of TXA combined with RA on reducing bleeding and preventing venous thrombosis in patients with unilateral TKA.Methods: Five controlled clinical studies that met the inclusion criteria were collected from PubMed, Embase and Cochrane libraries. Fixed effect model and random effect model were used to compare the TXA + RA group with the RA group in 731 patients.Results: Decrease of hemoglobin (Hb), total blood loss, transfusion rate and wound complications of the TXA + RA group is lower than the RA group, the difference was statistically significant (p < 0.05). Deep venous thrombosis (DVT) occurs in the TXA + RA group and the RA group showed no statistically significant difference (p > 0.05). There was no obvious difference of two ways of drug given that intra-articular (IA) and intravenous (IV) effect on Hb decrease, total blood loss, transfusion rate, wound complications, DVT (p > 0.05).Conclusion: The application of TXA combined with RA in the TKA can effectively reduce blood loss without increasing the risk of DVT. However, it should be noted that TXA combined with RA after TKA has a potential increased risk of wound complications.