We thank Dr Chen et al. for their insightful comments on our meta-analysis and appreciate the opportunity to address their concerns. Dr Chen et al. suggested that a difference might exist between the effects of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin-receptor blockers (ARBs) on the COVID-19. However, the limited studies precluded us from performing a subgroup analysis stratified by renin-angiotensin-aldosterone system inhibitors or blockers as described in our study limitations. Recently, several new articles were published, so we re-searched the databases (Pubmed, Embase, medRxiv) and added three articles1-3 (combining with our pervious meta-analysis4) for providing the specific results for a ACEIs or ARBs. As shown in Figure 1, there is no significant difference between ACEIs or ARB in the effect on positive COVID-19, severity and death (P for positive COVID-19 = .76, P for severe COVID-19 = .63, P for death = .47) (Figure 1). Secondly, inflammation certainly plays a crucial role in COVID-19. Another meta-analysis also found that interleukin-6 levels were reduced in the ACEI group COVID-19 from positive patients vs non-ACEIs.5 However, an open-label study did not find a significant improvement of sarilumab (an interleukin-6 blocker) in clinical improvement and mortality in patients with severe COVID-19 compared with the standard of care group.6 Therefore, more trials were needed to clarify its mechanism of ACEIs/ARBs on immune response in COVID-19. The author declares no potential conflict of interest. Data available on request from the authors
Dilated cardiomyopathy (DCM) is the most common type of cardiomyopathy, and it often has a poor outcome. Sex differences in the prognosis of patients with DCM remain controversial. The present meta-analysis aimed to investigate whether sex plays a role in the outcome of patients with DCM and to provide real-world information on these potential sex differences for physicians and patients.
Dear Editor,Acute ischemic stroke (AIS) is a major cause of death and disability worldwide and may have a devastating impact on the quality of life [1]. Most strokes are due to blockage of an artery in the brain by a blood clot that begins in the heart or neck arteries [2].Almost 20 years ago, alteplase (recombinant tissue plasminogen activator, rt-PA), a manufactured thrombolytic drug derived from naturally occurring enzymes that dissolve thrombus as part of the natural clotting cascade, was first shown to improve functional outcome after AIS [3]. It could reduce brain damage from a stroke by restoring the blood flow if given rapidly enough after an AIS. Moreover, intravenous thrombolysis is the current recommended therapy for acute ischemic stroke [4]. Previous systematic reviews and guidelines revealed that thrombolysis with alteplase is beneficial when administered to some patients within 4.5 h after the onset of ischemic stroke [5,6]. However, uncertainties remain about the benefit and risk of intravenous thrombolysis (rt-PA), to older patients or to patients with very severe strokes [7].Interestingly, a new meta-analysis of individual patient data from randomized trials - published in The Lancet - provided clear answers to these uncertainties [7]. The authors' analysis is different from previous pooled analyses [8] of alteplase trials by including patients from the International Stroke Trial (IST-3), which almost doubled the number of patients available. Even more importantly, they included more than 1,700 patients aged 80 years or older (alteplase is restricted to patients younger than 80 years in some European countries [9]).The results of the meta-analysis are persuasive. Additionally, the proportional benefits were similar for patients aged older than 80 years compared with younger patients, and for patients with minor (NIH Stroke Scale, NIHSS, score ≤4) or very severe (NIHSS score ≥22) strokes compared with other patients, although minor or very severe stroke is no common operational diagnosis. However, the effects on disability-free survival of rt-PA administration between 4.5 and 6 h after stroke onset remain uncertain, and caution is warranted in this time window. Similar outcomes have been found in the latest study [10].Recently, in the European Stroke Organisation Conference 2015, Mazya et al. [10] reported that very severe stroke (defined as an NIHSS score >25) should not be a contraindication for rt-PA, and these patients should be treated rapidly and not differently from patients with strokes of lesser severity.To examine whether the use of rt-PA was more dangerous in patients with very severe strokes (NIHSS score >25) compared with patients with moderately severe strokes (NIHSS score 15-25), they conducted the Safe Implementation of Treatments in Stroke (SITS) study to determine the differences among these two groups of patients and to further identify the relationship between intracerebral hemorrhage and stroke severity. The SITS registry included data on 60,000 stroke patients who had received thrombolysis since 2002. Of these, 868 (1.5%) had a stroke with an NIHSS score >25 and 19,995 (35%) had an NIHSS score of 15-25. They found that the symptomatic intracerebral hemorrhage risk appeared lower in the very severe stroke group compared with the moderately severe group when defined by the SITS-MOST criteria (a type 2 parenchymal hemorrhage with deterioration in NIHSS score of >4 points or death). But when defined by European Cooperative Acute Stroke Study/NINDs criteria, the risk trended slightly higher in the very severe group. Moreover, they also observed that a very severe stroke was not independently associated with symptomatic hemorrhage after adjusting the baseline variables between the two groups using logistic regression analysis. They also noted that patients appeared similar in terms of sex, blood pressure, weight, rt-PA dose, comorbidities, risk factors and other medications. Therefore, the authors concluded that these patients with very severe stroke were not very different from those with moderately severe stroke, the pathophysiology and demographics may be fairly similar.In conclusion, based on the current evidence, patients should not be excluded from intravenous thrombolysis only based on the criterion of older age >80 years or very severe strokes (NIHSS >22 or 25).
Objective
To evaluate the methodology, safety and clinical applications of colonic transendoscopic enteral tubing (TET) as a new method of fecal microbiota transplantation (FMT) and colonic administration.
Methods
This prospective study included patients who underwent colonic TET for FMT and(or) colonic administration in the Second Affiliated Hospital of Nanjing Medical University from October 2014 to December 2018. The TET procedure time, success rate, retention time of TET tube, factors influencing TET tube retention, adverse events and satisfaction degree were evaluated.
Results
A total of 257 patients underwent TET, among whom 130 patients (50.6%) for microbiota tronsplantation, 8 patients (3.1%) for colon-drip medication, 118 patients (45.9%) for FMT and colon-drip medication, and 1 patient (0.4%) without treatment after TET. The TET procedure time was 10.0±2.8 min. The number of endoscopic clips used was 3.5±1.0. The success rate of the TET procedure was 100.0% (257/257). The retention time of TET tube for 160 patients maintaining the tube for treatment was 9.3±3.8 days. Multivariate analysis indicated that endoscopic clip type (P=0.001) was an independent influencing factor for the retention time of the tube. A total of 9 patients (3.5%) reported adverse events of mild anus discomfort, 4 patients (1.6%) of mobile inconvenience, 3 (1.2%) of anal pain, 2 (0.8%) of mild abdominal pain, 2 (0.8%) of mild bloating, and 1 (0.4%) of mild anal bleeding. No severe adverse events were observed in this study. The total satisfaction degree on colonic TET was 97.3% (250/257) in all patients.
Conclusion
The colonic TET, a safe and easy-operating endoscopic interventional technology with a high degree of patients satisfaction, can be used for colonic delivering of FMT and medications for various diseases.
Key words:
Colonoscopy; Fecal microbiota transplantation; Enema; Transendoscopic enteral tubing
Objective
To evaluate the methodology, feasibility, safety and efficacy of cap-assisted endoscopic sclerotherapy (CAES) for hemorrhoids.
Methods
Patients with grade Ⅰ to Ⅲ internal hemorrhoids underwent CAES from September 2014 to May 2016. According to the methodology of CAES, reasons for blooding were identified and polypectomy and excision of anal papilla fibroma was performed. Efficacy, intraoperative and postoperative complications and patient satisfaction were evaluated during and after CAES. The follow-up was more than three months.
Results
A total of 48 patients with grade Ⅰ to Ⅲ internal hemorrhoids underwent CAES, including 25(52.1%) patients with grade Ⅰ, 21(43.8%) patients with grade Ⅱ, and 2(4.2%) grade Ⅲ. During the whole procedure of CAES, colon and terminal ileum examination was performed in 48(100.0%) patients, polypectomy was performed in 14(29.2%) patients, excision of anal papilla fibroma was performed in 1(2.1%) patient, excision of external hemorrhoids was performed in 1(2.1%) patient, biopsy for the polyps on dentate line was performed in 2(4.2%) patients, and sclerotherapy for rectal mucosal prolapse was performed in 2(4.2%) patients. No bleeding was observed during and after CAES. Infection occurred in one (2.1%) patient, who recovered with a one-week anti-infective therapy. One (2.1%) patient claimed mild tenesmus within four days after CAES. No complications were observed within the three-month follow-up. All patients (100.0%) were satisfied with this novel procedure.
Conclusion
CAES, as a novel endoscopic sclerotherapy, is a safe and effective endoscopic therapy with high patient satisfaction for internal hemorrhoids.
Key words:
Hemorrhoids; Cap-assisted endoscopic sclerotherapy; Colonoscopy
Background An association among the use of angiotensin-converting-enzyme(ACE) inhibitors and angiotensin-receptor blockers(ARBs) with the clinical outcomes of coronavirus disease 2019 (COVID-19) is unclear. Methods PubMed, EMBASE, and the preprint databases MedRxiv and BioRxiv were searched for relevant studies that assessed the association among inflammation level, application of ACEI/ARB, infection severity and death in patients with COVID-19. Odd risks(OR) and 95% confidence interval (CI) were combined using random-effects or fixed models depending on heterogeneity. Results Eleven studies were included with a total of 33,483 patients. Our review showed ACEI/ARB therapy might be associated with the reduced inflammatory factor (interleukin-6) and elevated level of immune cells(CD3, CD8). Meta-analysis showed no significant increase in the risk of COVID-19 infection(OR:0.95, 95%CI:0.89-1.05) in patients receiving ACEI/ARB therapy, and ACEI/ARB therapy was associated with a decreased risk of severe COVID-19 (OR:0.75, 95%CI: 0.59-0.96) and mortality (OR:0.52, 95%CI: 0.35-0.79). Subgroup analyses showed that, among the general population, application of ACEI/ARB therapy was associated with reduced risks of all-cause death(OR:0.31, 95%CI: 0.13-0.75), and the risk of severe COVID-19(OR:0.79, 95%CI: 0.60-1.05) infection and COVID-19 infection(OR:0.85, 95% CI: 0.66-1.08) were not increased. Among patients with hypertension, the use of an ACEI/ARB was associated with a lower severity of COVID-19(OR:0.73, 95%CI: 0.51-1.03) and lower mortality(OR:0.57, 95%CI: 0.37-0.87), without evidence of an increased risk of COVID-19 infection(OR:1.00, 95%CI: 0.90-1.12). Conclusion On the basis of the available evidence, this is the first meta-analysis showed that, in general population, the use of ACEI/ARB therapy was safe without an increased risk of COVID-19 infection and with a decreasing trend of severe COVID-19 infection and lower mortality. In patients with hypertension, the use of ACEI/ARB therapy should be encouraged, without increased risk of COVID-19 inflection, and better prognosis (a decreasing trends of severe COVID-19 and reduced all-cause death). Overall, ACEI/ARB therapy should be continued in patients who are at risk for, or have COVID-19, either in general population or hypertension patients. Our results need to be interpreted with caution considering the potential for residual confounders, and more well-designed studies that control the clinical confounders are necessary to confirm our findings.
Objective
To evaluate the method of colonic transendoscopic enteral tubing (TET) for ulcerative colitis (UC) as a new colonic interventional delivering in fecal microbiota transplantation (FMT) or medications, and to analyze influencing factors for retention time of TET tube.
Methods
UC patients who underwent colonic TET for FMT and/or colonic administration in the Second Affiliated Hospital of Nanjing Medical University from October 2015 to March 2019 were prospectively enrolled. The TET method, procedure time, success rate, adverse events and satisfaction degree, retention time of TET tube were recorded and their influencing factors were analyzed.
Results
A total of 150 UC patients underwent colonic TET. The TET tubes were used in 126 patients (84.0%) for FMT and medication, 18 patients (12.0%) for FMT, and 5 patients (3.3%) for medication. The mean TET procedure time was (9.6 ± 2.7) min. The success rate of TET procedure was 100%. The median retention time of TET tube was 9 (7.0, 11.0) d in 122 patients with the tube falling out naturally. In patients with large endoscopic clips, the retention time of TET tube was significantly prolonged with the increased number of large clips (n=2~4, P=0.002) . The retention time of TET tube in the large clip group was longer than that in the small clip group, when the number of endoscopic clips used was the same (n=3 or 4, P<0.05) . The type (OR=0.085, 95%CI: 0.020 to 0.354, P=0.001) and number (OR=0.509, 95%CI: 0.294 to 0.881, P=0.016) of endoscopic clips were the influencing factors for the retention time of tube. No severe adverse event was observed during and after TET. The satisfaction degree on colonic TET was 96.0% (144/150) in all the patients.
Conclusions
Colonic TET as a colonic delivering of multiple FMT and frequent colonic medication administration for UC patients is safe and feasible. The retention time of TET tube is related to the type and number of endoscopic clip.
Key words:
Transendoscopic enteral tubing; Fecal microbiota transplantation; Ulcerative colitis; Colonoscopy; Enema
Good’s syndrome (GS) is a rare primary immunodeficiency defined as hypogammaglobulinemia associated with the presence of a thymoma. Patients with GS usually have increased susceptibility to a wide range of infections, and clinical treatment is a challenge for physicians. Fecal microbiota transplantation (FMT), which is a safe strategy for reconstruction of the gut microbiota, has a positive influence on the treatment of refractory infections such as those in patients with GS. We herein report a case involving a 73-year-old woman who had been previously diagnosed with a thymoma. After thymectomy, she complained of respiratory and gastrointestinal symptoms. Her laboratory analysis strongly suggested GS. Infusion of immunoglobulin and albumin was the only treatment of choice until FMT was considered as an alternative therapy. The patient’s manifestations were subsequently relieved, and several FMTs were required to maintain clinical remission. Management of GS remains quite challenging to physicians because of the intricate organ involvement and limited and costly existing therapies. FMT is usually well tolerated by patients, and its cost-effectiveness and safety profile allow it to be considered as an alternative therapy for GS.
Background and objective Stress hyperglycemia is common in critically ill patients and is associated with poor prognosis. Whether this association exists in pulmonary hypertension (PH) patients is unknown. The present cohort study investigated the association of stress hyperglycemia with 90-day all-cause mortality in intensive care unit (ICU) patients with PH. Methods Data of the study population were extracted from the Medical Information Mart for Intensive Care IV (MIMIC-IV) database. A new index, the ratio of admission glucose to HbA1c (GAR), was used to evaluate stress hyperglycemia. The study population was divided into groups according to GAR quartiles (Q1-Q4). The outcome of interest was all-cause mortality within 90 days, which was considered a short-term prognosis. Result A total of 53,569 patients were screened. Ultimately, 414 PH patients were enrolled; 44.2% were male, and 23.2% were admitted to the cardiac ICU. As the GAR increased from Q2 to Q4, the groups had lower creatinine levels, longer ICU stays, and a higher proportion of renal disease. After adjusting for confounding factors such as demographics, vital signs, and comorbidities, an elevated GAR was associated with an increased risk of 90-day mortality. Conclusion Stress hyperglycemia assessed by the GAR was associated with increased 90-day mortality in ICU patients with PH.
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