RESUMO
BACKGROUND: Bacterial infections are considered a leading cause of hospitalization and death globally. There is still a need for a rapid and feasible biomarker for bacterial infections. Heparin-binding protein (HBP) was shown to be related to bacterial infections. The objective of the study is to investigate the diagnostic accuracy of HBP in bacterial infections. METHODS: Articles were screened in PubMed, SCOPUS, Web of Science, and Cochrane to recognize eligible studies. We included studies investigating the diagnostic accuracy of HBP and reported the necessary data to construct 2 × 2 tables. A univariate analysis was conducted to determine the pooled sensitivity and specificity, and a bivariate diagnostic random-effects model was used to calculate the optimal cut-off point. RESULTS: The analysis comprised sixteen studies in total. Plasma HBP showed a sensitivity of 0.90 (95% CI: [0.79, 0.96]) and a specificity of 0.87 (95% CI: [0.66, 0.96]) in diagnosing bacterial infections using blood samples. Pooling data from seven studies revealed that HBP in cerebrospinal fluid (CSF) has sensitivity and specificity of 96% (95% CI: [0.85, 0.99]), and 95% (95% CI: [0.89, 0.97]), respectively, for the diagnosis of bacterial meningitis. In urinary tract infections (UTI), urine-HBP was revealed to have a high diagnostic value in discriminating bacterial from non-bacterial UTI infection at a cut-off value of 32.868 ng/ml with sensitivity and specificity of 87%. CONCLUSION: HBP has shown a high diagnostic accuracy of bacterial infections, including UTI and meningitis. Further studies are needed to determine its prognostic value and whether it could guide antibiotic therapy.
Assuntos
Proteínas Sanguíneas , Meningites Bacterianas , Infecções Urinárias , Humanos , Sensibilidade e Especificidade , Infecções Urinárias/diagnóstico , Peptídeos Catiônicos Antimicrobianos , Meningites Bacterianas/diagnósticoRESUMO
BACKGROUND AND AIM: Atrial fibrillation (AF) is the most frequently observed cardiac arrhythmia in clinical settings. Obesity can influence the efficacy of the treatment administered, which requires a larger dose and more time to accomplish therapeutic targets due to altered pathophysiology. Our study aimed to assess the overall efficacy and safety of nonvitamin K antagonist oral anticoagulants (NOACs) versus warfarin in AF patients with morbid obesity (BMI > 40 kg/m2 and/or weight > 120 kg) to prevent complications. METHODS: We conducted a literature search on PubMed, Web of Science, the Cochrane Library, and Scopus till October 2022 for articles addressing the efficacy and safety of NOACs versus warfarin for the treatment of AF in morbidly obese patients. We performed the meta-analysis with RevMan software version 5.4 and Open Meta Analyst. The main outcomes assessed were stroke, major bleeding, and minor bleeding after anticoagulation, as did the history of comorbidities and risk factors in morbidly obese patients. Quality assessment was performed using Cochrane's ROB-2 tool and the Newcastle-Ottawa scale. RESULTS: Regarding major bleeding events, pooled data showed that patients taking NOACs had a significantly lower risk than patients taking warfarin (OR = 0.54, 95% CI: [0.41-0.70]; p < 0.00001). However, for minor bleeding, there was a nonsignificant effect of NOACs on reducing the risk of bleeding (OR = 0.72, 95% CI = 0.47-1.09; p = 0.12), which became highly significant in favor of NOACs after sensitivity analysis (OR = 0.55, 95% CI = 0.49-0.61]; p < 0.00001). There was a significant difference in the incidence of stroke between the NOAC group and the warfarin group (OR = 0.69, 95% CI = 0.60-0.80]; p < 0.00001). According to the results of the single-arm study analysis, the overall effect of all the outcomes was associated with a high risk of disease development in patients receiving NOACs. CONCLUSION: Our meta-analysis showed a favorable effect of NOACs vs warfarin in morbidly obese patients. Some outcomes were not significantly different, which calls for future research to better assess their safety and efficacy in this particular weight group. TRIAL REGISTRATION: The study was registered with PROSPERO under registration number CRD42022362493 on October 2022.
Assuntos
Anticoagulantes , Fibrilação Atrial , Obesidade Mórbida , Humanos , Administração Oral , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/tratamento farmacológico , Hemorragia/induzido quimicamente , Obesidade Mórbida/complicações , Obesidade Mórbida/diagnóstico , Acidente Vascular Cerebral/induzido quimicamente , Acidente Vascular Cerebral/epidemiologia , Resultado do Tratamento , VarfarinaRESUMO
BACKGROUND: Hepatocellular carcinoma (HCC) is the most common type of liver cancer, accounting for 90% of cases worldwide and a significant contributor to cancer-related deaths. This study comprehensively compares the safety and efficacy of laparoscopic liver resection (LLR) versus laparoscopic or percutaneous radiofrequency ablation (LRFA or PRFA) in patients with early and small HCC. METHODS: We systematically searched Cochrane Library, PubMed, Scopus, and Web of Science databases to include studies comparing LLR versus LRFA or PRFA in patients with early HCC meets the Milan criteria (defined as solitary nodule < 5 cm or three nodules ≤ 3 cm with no extrahepatic spread or vascular invasion). Pooled results were examined for overall survival, disease-free survival, recurrence-free survival, local, intrahepatic and extrahepatic recurrence rates, and complications. We conducted subgroup analyses based on the type of RFA. Meta-regression analyzed the association between overall survival, local recurrence, and various factors. The quality of the included studies was assessed using the Newcastle-Ottawa Scale. We analyzed the data using the R (v.4.3.0) programming language and the "meta" package of RStudio software. RESULTS: We included 19 observational studies, compromising 3756 patients. LLR showed higher 5-year overall survival compared to RFA (RR = 1.17, 95% CI [1.06, 1.3], P > 0.01). Our subgroup analysis showed that LLR had higher 5-year survival than PRFA (RR = 1.15, 95% CI [1.02, 1.31], P = 0.03); however, there was no significant difference between LLR and LRFA (RR = 1.26, 95% CI [0.98, 1.63], P = 0.07). LLR was associated with higher disease-free survival) RR = 1.19, 95% CI [1.05, 1.35], P < 0.01; RR = 1.61, 95% CI [1.31, 1.98], P < 0.01(and recurrence-free survival) RR = 1.21, 95% CI [1.09, 1.35], P < 0.01; RR = 1.45, 95% CI [1.15, 1.84], P < 0.01(at 1 and 3 years. LLR was associated with lower local (RR = 0.28, 95% CI [0.16, 0.47], P < 0.01) and intrahepatic recurrence (RR = 0.7, 95% CI [0.5, 0.97], P = 0.03) than RFA. However, complications were significantly higher with LLR (RR = 2.01, 95% CI [1.51, 2.68], P < 0.01). Our meta-regression analysis showed that younger patients had higher risk for local recurrence (P = 0.008), while age wasn't significantly linked to overall survival (P = 0.25). Other covariates like total bilirubin, alpha-fetoprotein levels, and tumor size also showed no significant associations with either overall survival or local recurrence. CONCLUSION: LLR offers improved long-term outcomes and lower recurrence rates than PRFA. However, no significant distinctions were observed between LRFA and LLR in overall survival, recurrence-free survival, and local recurrence. More robust well-designed RCTs are essential to validate our findings.
Assuntos
Carcinoma Hepatocelular , Laparoscopia , Neoplasias Hepáticas , Ablação por Radiofrequência , Humanos , Carcinoma Hepatocelular/cirurgia , Hepatectomia/efeitos adversos , Hepatectomia/métodos , Laparoscopia/efeitos adversos , Laparoscopia/métodos , Neoplasias Hepáticas/cirurgia , Recidiva Local de Neoplasia/epidemiologia , Recidiva Local de Neoplasia/cirurgia , Ablação por Radiofrequência/efeitos adversos , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Many drugs are prescribed in relieving acute migraine attacks, we aim to compare metoclopramide with other antimigraine drugs. METHODS: We searched online databases like PubMed, Cochrane Library, Scopus, and Web of Science till June 2022 for RCTs that compared metoclopramide alone with placebo or active drugs. The main outcomes were the mean change in headache score and complete headache relief. The secondary outcomes were the rescue medications need, side effects, nausea and recurrence rate. We qualitatively reviewed the outcomes. Then, we performed the network meta-analyses (NMAs) when it was possible. which were done by the Frequentist method using the MetaInsight online software. RESULTS: Sixteen studies were included with a total of 1934 patients: 826 received metoclopramide, 302 received placebo, and 806 received other active drugs. Metoclopramide was effective in reducing headache outcomes even for 24 h. The intravenous route was the most chosen route in the included studies and showed significant positive results regarding headache outcomes; however, the best route whether intramuscular, intravenous, or suppository was not compared in the previous studies. Also, both 10 and 20 mg doses of metoclopramide were effective in improving headache outcomes; however, there was no direct comparison between both doses and the 10 mg dose was the most frequently used dosage. In NMA of headache change after 30 min or 1 h, metoclopramide effect came after granisetron, ketorolac, chlorpromazine, and Dexketoprofen trometamol. Only granisetron's effect was significantly higher than metoclopramide's effect which was only significantly higher than placebo and sumatriptan. In headache-free symptoms, only prochlorperazine was non-significantly higher than metoclopramide which was higher than other medications and showed significantly higher effects only with placebo. In rescue medication, metoclopramide's effect was only non-significantly lower than prochlorperazine and chlorpromazine while its effect was higher than other drugs and showed higher significant effects only than placebo and valproate. In the recurrence rate, studies showed no significant difference between metoclopramide and other drugs. Metoclopramide significantly decreased nausea more than the placebo. Regarding side effects, metoclopramide showed a lower incidence of mild side effects than pethidine and chlorpromazine and showed a higher incidence of mild side effects than placebo, dexamethasone, and ketorolac. The reported extrapyramidal symptoms with metoclopramide were dystonia or akathisia. CONCLUSION: A dose of 10 mg IV Metoclopramide was effective in relieving migraine attacks with minimal side effects. Compared to other active drugs, it only showed a lower significant effect compared with granisetron regarding headache change while it showed significantly higher effects only with placebo in both rescue medication needs and headache-free symptoms and valproate in only rescue medication need. Also, it significantly decreased headache scores more than placebo and sumatriptan. However, more studies are needed to support our results.
Assuntos
Metoclopramida , Transtornos de Enxaqueca , Humanos , Metoclopramida/efeitos adversos , Sumatriptana/uso terapêutico , Metanálise em Rede , Proclorperazina/efeitos adversos , Clorpromazina/uso terapêutico , Granisetron/uso terapêutico , Ácido Valproico/uso terapêutico , Cetorolaco/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Transtornos de Enxaqueca/tratamento farmacológico , Transtornos de Enxaqueca/complicações , Náusea/induzido quimicamente , Náusea/tratamento farmacológico , Cefaleia/complicaçõesRESUMO
BACKGROUND: Platelet-rich plasma (PRP) is an autologous platelet concentration recently used in the reproductive field. Studies had conflicting results regarding its effect on pregnancy outcomes. We aimed to solve the debate on the safety and efficacy of PRP in women undergoing assisted reproduction and assess the influence of covariates on the outcomes of PRP infusion. METHODS: We searched PubMed, Scopus, Cochrane, and Web of Science in May 2023. We included randomized and non-randomized clinical trials as well as cohort studies assessing intrauterine PRP in sub fertile women undergoing assisted reproduction (IVF/ICSI). For the quality assessment, We used the Cochrane Risk of Bias Tool 1, the ROBINS-I tool, and the Newcastle-Ottawa Scale. We pooled the data using RevMan version 5.4. RESULTS: The data from 23 studies were pooled. PRP had favorable outcomes compared with the control group on clinical pregnancy rate (RR: 1.84, 95% CI 1.62 to 2.09; P < 0.00001), live birth rate (RR: 1.75, 95% CI: 1.24 to 2.47; P = 0.001), and miscarriages (RR: 0.51, 95% CI: 0.36 to 0.72; P = 0.0002). Women with repeated implantation failure had a significantly improved clinical pregnancy rate (RR: 1.83, 95% CI: 1.49 to 2.24; P < 0.00001), live birth rate (RR:1.83, 95% CI: 1.33 to 2.51; P = 0.002), and miscarriage rate (RR: 0.46, 95% CI: 0.31 to 068; P = 0.0001). CONCLUSION: PRP showed promising results in assisted reproductive techniques. Further large and multicenter RCTs are required to compare the doses of PRP while identifying the specific population with the most benefits from PRP.
Assuntos
Aborto Espontâneo , Infertilidade Feminina , Plasma Rico em Plaquetas , Gravidez , Feminino , Humanos , Nascido Vivo/epidemiologia , Taxa de Gravidez , Técnicas de Reprodução Assistida , Aborto Espontâneo/epidemiologia , Fertilização in vitro/métodos , Estudos Multicêntricos como AssuntoRESUMO
OBJECTIVE: Cesarean Section (CS) is associated with an increased risk of hemorrhage. Many drugs are used to decrease this risk. We aim to compare the combination of ethamsylate and tranexamic acid, oxytocin, and placebo in women undergoing CS. METHODS: We conducted a double-blinded, randomized, placebo-controlled trial between October and December 2020 in four university hospitals in Egypt. The study included all pregnant women in labor without any complications who accepted to participate in the study between October and December 2020. The participants were divided into three groups. The subjects were randomly allocated to receive either oxytocin (30 IU in 500 ml normal saline during cesarean section), combined one gram of tranexamic acid with 250 mg of ethamsylate once before skin incision, or distilled water. Our main outcome was the amount of blood loss during the operation. The secondary outcomes were the need for blood transfusion, hemoglobin and hematocrit changes, hospital stay, operative complications, and the need for a hysterectomy. The one-way ANCOVA test was used to compare the quantitative variables between the three groups while the Chi-square test was used to compare the qualitative variables. Post hoc analysis then was performed to compare the difference between every two groups regarding the quantitative variables. RESULTS: Our study included 300 patients who were divided equally into three groups. Tranexamic acid with ethamsylate showed the least intra-operative blood loss (605.34 ± 158.8 ml) compared to oxytocin (625.26 ± 144.06) and placebo (669.73 ± 170.69), P = 0.015. In post hoc analysis, only tranexamic acid with ethamsylate was effective in decreasing the blood loss compared to placebo (P = 0.013); however, oxytocin did not reduce blood loss compared to saline (P = 0.211) nor to tranexamic acid with ethamsylate (P = 1). Other outcomes and CS complications showed no significant difference between the three groups except for post-operative thrombosis which was significantly higher in the tranexamic and ethamsylate group, P < 0.00001 and the need for a hysterectomy which was significantly increased in the placebo group, P = 0.017. CONCLUSION: The combination of tranexamic acid and ethamsylate was significantly associated with the least amount of blood loss. However, in pairwise comparisons, only tranexamic acid with ethamsylate was significantly better than saline but not with oxytocin. Both oxytocin and tranexamic acid with ethamsylate were equally effective in reducing intra-operative blood loss and the risk of hysterectomy; however, tranexamic acid with ethamsylate increased the risk of thrombotic events. Further research with a larger number of participants is needed. TRIAL REGISTRATION: The study was registered on Pan African Clinical Trials Registry with the following number: PACTR202009736186159 and was approved on 04/09/2020.
Assuntos
Perda Sanguínea Cirúrgica , Cesárea , Etamsilato , Ocitocina , Ácido Tranexâmico , Feminino , Humanos , Gravidez , Perda Sanguínea Cirúrgica/prevenção & controle , Etamsilato/administração & dosagem , Ocitocina/administração & dosagem , Ácido Tranexâmico/administração & dosagem , Terceiro Trimestre da GravidezRESUMO
BACKGROUND: Genitourinary syndrome of menopause (GSM) is a common and disturbing issue in the postmenopausal period. Unlike vasomotor symptoms, it has a progressive trend. Our study aims to evaluate the efficacy and safety of oxytocin gel versus placebo gel in postmenopausal women with GSM. METHODS: A systematic review and meta-analysis synthesizing randomized controlled trials (RCTs) from Web of Science, SCOPUS, PubMed, and Cochrane Central Register of Controlled Trials databases on January 18, 2023. Keywords such as "oxytocin," "intravaginal," "vaginal," "atrophic," and "atrophy" were used. We used Review Manager (RevMan) version 5.4 in our analysis. We used the risk ratio (RR) for dichotomous outcomes and the mean difference (MD) for continuous outcomes; both were presented with the corresponding 95% confidence interval (CI) and were calculated with the Mantel-Haenszel or inverse variance statistical method. Cochrane's Q test and the I2 statistic were used as measures of statistical inconsistency and heterogeneity. The Cochrane Risk of Bias Tool for RCTs was used for the quality assessment of the included studies. RESULTS: Seven studies with 631 patients were included. Regarding the maturation index, there was a statistically insignificant increase in the oxytocin arm (MD = 12.34, 95% CI (-12.52-37.19), P = 0.33). Clinically assessed vaginal atrophy showed a statistically significant reduction in the oxytocin group (RR = 0.32, 95% CI (0.23 - 0.10), P < 0.00001). For dyspareunia, vaginal pH, and histological evaluation of vaginal atrophy, there was a statistically insignificant difference between the two groups (RR = 1.02, 95% CI (0.82-1.27), P = 0.84), (MD = -0.74, 95% CI (-1.58-0.10), P = 0.08), and (MD = -0.38, 95% CI (-0.82-0.06), P = 0.09), respectively. There was no significant difference in the safety profile between the two groups as measured by endometrial thickness (MD = 0.00, 95% CI (-0.23-0.23), P = 0.99). CONCLUSIONS: Although oxytocin has been proposed as a viable alternative to estrogen in the treatment of GSM, our findings show the opposite. Larger, high-quality RCTs are needed to confirm or refute our results. TRIAL REGISTRATION: PROSPERO registration number CRD42022334357.
Assuntos
Dispareunia , Ocitocina , Feminino , Humanos , Ocitocina/uso terapêutico , Pós-Menopausa , Atrofia/tratamento farmacológico , Bases de Dados FactuaisRESUMO
BACKGROUND: Hysteroscopy is a common outpatient procedure but procedural pain limits its use. Music could be used as a pain-relieving intervention. We performed a systematic review and meta-analysis to investigate the effect of music on pain and anxiety during outpatient hysteroscopy. METHODS: Four electronic databases were searched: PubMed, Scopus, Web of Science, and Cochrane Library, from inception to September 2022. We included only the Randomized Controlled Trials (RCTs) that investigated the effect of music on women who underwent outpatient hysteroscopy in reducing pain and anxiety levels compared to no music. We assessed the quality of included RCTs using the risk of bias tool 1 reported in the Cochrane Handbook of Systematic Reviews of Interventions. Data were pooled as the Mean Differences (MDs) with a 95% Confidence Interval (CI) in a random-effects model, using Review Manager 5.3 software. Also, we assessed the evidence of the results using the Grading of Recommendations Assessment, Development and Evaluation (GRADE). RESULTS: Three RCTs (540 women) were included. Music significantly reduced visual analogue scale (VAS) pain scores as well as State-Trait Anxiety Inventory (STAI) scores compared to controls (MD = -1.28; 95% CI [-2.19, -0.36]; P = 0.007) and (MD = -3.91; 95% CI [-6.98, -0.85]; P = 0.01) respectively. Also, the decrease in VAS score for pain was significantly greater in the music group (MD = 1.44; 95% CI [0.44, 2.45]; P = 0.005). However, the change in STAI showed no significant difference between the two groups. The GRADE ratings for all outcomes were very low. CONCLUSION: Music is a potentially promising method for controlling pain for patients undergoing outpatient hysteroscopy; however, its effect in controlling anxiety is controversial.
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Histeroscopia , Musicoterapia , Feminino , Gravidez , Humanos , Musicoterapia/métodos , Pacientes Ambulatoriais , Ansiedade/prevenção & controle , Dor/etiologia , Dor/prevenção & controleRESUMO
OBJECTIVE: Myomectomy is the preferred surgical approach to manage uterine fibroids. However, uterine fibroids are highly vascular tumors and, consequently, extremely susceptible to problems from myomectomy-related hemorrhage. Hence, we aim to compare oxytocin efficacy and safety profile versus tranexamic acid (TA) with ethamsylate for reducing bleeding during myomectomy. METHODS: This randomized, double-blinded multicenter study was performed between 20th August 2020 and 20th October 2020 at El-Galaa Teaching Hospital, El Hussein University Hospital, Al-Azhar University Hospitals of Assiut, and Al-Azhar University Hospitals of Damietta. One hundred and eighty patients were enrolled and divided into three groups: group (1) received an injection of 30 IU of oxytocin in 500 ml of normal saline; group (2) received injections of 1 g of TA, 250 mg of Ethamsylate, and 110 ml of normal saline IV; and group (3) received an injection of 110 ml of normal saline IV just before surgical incision. RESULTS: In 180 premenopausal women, oxytocin and TA with ethamsylate had no significant value in lowering intraoperative blood loss compared with the placebo for abdominal myomectomy (666.25 ± 183.03, 630.72 ± 145.83, and 646.67 ± 168.92, respectively (P = 0.506)). Non-significant trends were observed for a reduction in operation time (P = 0.760), intra/postoperative blood transfusion (P = 0.624), hospital stay (P = 0.986), postoperative fever (P = 0.659), and wound infection (P = 1). CONCLUSION: Oxytocin and TA with ethamsylate had no significant value in lowering intraoperative blood loss compared with the placebo for abdominal myomectomy which opens a new question about the role of the use of the hemostatic drug during myomectomy especially in centers with limited resources and had higher rates. TRIAL REGISTRATION: The study was registered on Pan African Clinical Trials Registry with the following number: PACTR202008739887429 and was approved on 24/08/2020.
Assuntos
Etamsilato , Leiomioma , Ácido Tranexâmico , Miomectomia Uterina , Humanos , Feminino , Ácido Tranexâmico/uso terapêutico , Ocitocina/uso terapêutico , Perda Sanguínea Cirúrgica/prevenção & controle , Solução Salina , Leiomioma/cirurgiaRESUMO
BACKGROUND: Omega-3 may alleviate the severity of coronavirus disease 2019 (COVID-19) by reducing the C-reactive protein (CRP) level, a marker for systemic inflammation. Because the scientific evidence indicating such a role is inconsistent, we aimed to evaluate the effect of Omega-3 on CRP change and CRP level in patients with COVID-19. METHODS: We conducted a comprehensive search on four databases (PubMed, Web of Science, EMBASE, and Scopus). We included all RCTs comparing Omega-3 with a control group regarding their effect on the CRP levels in patients with COVID-19. We used version two of the Cochrane risk of bias assessment tool to appraise the included studies. We extracted data to an online data extraction sheet. The primary outcomes were CRP change from baseline and CRP serum levels. RESULTS: We included four randomized controlled trials (RCTs) with 274 patients in this study. The overall effect estimate favored Omega-3 over the control group in terms of CRP change from baseline (mean difference (MD) =- 2.53, 95% confidence interval (CI): - 4.40, - 0.66) and CRP serum levels at the end of the study (MD =- 6.24, 95% CI: - 11.93, - 0.54). CONCLUSION: Omega-3 showed promising effects on systemic inflammation by reducing CRP levels in COVID-19 patients. Based on this finding, we recommend Omega-3 for COVID-19 patients for its anti-inflammatory actions.
Assuntos
Tratamento Farmacológico da COVID-19 , Ácidos Graxos Ômega-3 , Proteína C-Reativa , Suplementos Nutricionais , Ácidos Graxos Ômega-3/farmacologia , Ácidos Graxos Ômega-3/uso terapêutico , Humanos , Inflamação/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: The food and drug administration approved many drugs to treat diabetes mellitus, but those drugs do not have a noticeable effect on weight management. Recently, glucagon-like peptide 1 agonist known as Cotadutide serve as a potent drug in treating type 2 diabetes by reducing blood glucose levels and body weight indices. This study aimed to explore the safety and efficacy of Cotadutide as a treatment for type 2 diabetes individuals. METHODS: A comprehensive literature search was done on different databases, including PubMed, Scopus, Web of Science, and Cochrane Library to capture all relevant articles using an established search strategy. The inclusion criteria were randomized controlled trials that assessed the safety and efficacy of Cotadutide versus placebo or any anti-diabetes drugs in patients with type 2 diabetes mellitus and a BMI between 22 kg/m2 and 40 kg/m2. We conducted the analysis using Revman software version 5.4. RESULTS: We found 663 relevant articles. From which nine studies were included and subjected to qualitative analysis and eight for quantitative analysis. The pooled effect showed that Cotadutide was better than placebo in reducing body weight (kg) (Mean difference (MD) = 3.31, p < 0.00001), glycated hemoglobin (HbA1c) (MD = 0.68, p > 0.00001), glucose area under the plasma concentration curve (AUC [0-4 h]) (MD = 30.15, p < 0.00001), and fasting plasma glucose over time (mg/dl) (MD = 31.31, p < 0.00001). CONCLUSION: Cotadutide is safe and effective in reducing plasma glucose levels, HbA1c and body weight in individuals with type 2 diabetes. TRIAL REGISTRATION: The study protocol was registered on PROSPERO (CRD: CRD42021257670 ).
Assuntos
Diabetes Mellitus Tipo 2 , Glicemia , Peso Corporal , Diabetes Mellitus Tipo 2/tratamento farmacológico , Humanos , Peptídeos , Preparações Farmacêuticas , Ensaios Clínicos Controlados Aleatórios como Assunto , Estados UnidosRESUMO
PURPOSE: To evaluate the evidence from randomized clinical trials (RCTs) about the effect of music intervention in reducing patients' anxiety during breast biopsy. METHODS: Electronic databases including PubMed, Cochrane Library, Scopus, and Web of Science were searched using the relevant MeSH terms. The inclusion criteria were all RCTs assessing the effect of music therapy versus no music in reducing anxiety during breast biopsy. The extracted outcomes were anxiety and pain during breast biopsy. They were pooled as mean difference (MD) with a 95% confidence interval (CI) in a fixed-effects model, using Review Manager 5.3 software for windows. The quality of included studies was assessed with the Cochrane risk of bias assessment tool (RoB 1.0). Then, the outcomes of our meta-analyses were independently evaluated by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) to know the grade of their evidence. RESULTS: The final analysis included five RCTs. We found a positive effect of music therapy in reducing anxiety levels compared with control group (MD = - 2.11; 95% CI (- 4.16 to - 0.06); p = 0.04). No difference between music and control groups regarding pain associated with breast biopsy (MD = 0.22; 95% CI (- 0.81 to 1.25); p = 0.68). The GRADE rating of our outcomes was low for anxiety levels and very low for pain during the biopsy. CONCLUSIONS: Music therapy could be an effective, simple, non-pharmacological option in relieving anxiety during breast biopsy; however, it had no effect on procedure-associated pain. More large and high-quality studies are needed to confirm our results.
Assuntos
Musicoterapia , Humanos , Musicoterapia/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto , Ansiedade/etiologia , Ansiedade/prevenção & controle , Biópsia/efeitos adversos , Dor/etiologia , Dor/prevenção & controleRESUMO
BACKGROUND: Repeated implantation failure (RIF) is defined as the case whereby the transferred embryos fail to implant after several attempts of In vitro fertilization (IVF) which causes a profound impact on the quality of life and financial burden. Some clinical studies have confirmed that Granulocyte colony-stimulating factor (G-CSF) and human chorionic gonadotropin (HCG) can improve pregnancy outcomes and implantation rates. Hence, our study aims to compare the efficacy of G-CSF and HCG on pregnancy outcomes in RIF women who undergo intra-cytoplasmic sperm injection (ICSI). METHODS: This randomized, single-blinded study was conducted et al.-Azhar University Hospitals, Cairo, Egypt, between 10th October 2020 and 20th December 2020. The study included 100 women aged 20-43 years old undergoing ICSI cycles, with a history of RIF. Patients were divided randomly into two groups: group (1): included 50 patients injected with 500 IU of intrauterine HCG on embryo transfer day, and group (2): Included 50 patients injected with G-CSF on the embryo transfer day. RESULTS: In 100 RIF women, we found a significant improvement in pregnancy outcomes favoring G-CSF over HCG including implantation rate, chemical pregnancy, and clinical pregnancy (P < 0.0001, P = 0.0003, and P = 0.0006, respectively). CONCLUSION: For the first time, we demonstrated a significant improvement in pregnancy outcomes favoring G-CSF over HCG in terms of implantation rate, chemical pregnancy, and clinical pregnancy. TRIAL REGISTRATION: The study was registered on Pan African Clinical Trials Registry with the following number: PACTR202010482774275 and was approved on 2nd October 2020.
Assuntos
Gonadotropina Coriônica , Implantação do Embrião , Fator Estimulador de Colônias de Granulócitos , Injeções de Esperma Intracitoplásmicas , Adulto , Feminino , Humanos , Masculino , Gravidez/efeitos dos fármacos , Adulto Jovem , Aborto Espontâneo/prevenção & controle , Gonadotropina Coriônica/administração & dosagem , Gonadotropina Coriônica/farmacologia , Gonadotropina Coriônica/uso terapêutico , Fator Estimulador de Colônias de Granulócitos/administração & dosagem , Fator Estimulador de Colônias de Granulócitos/farmacologia , Fator Estimulador de Colônias de Granulócitos/uso terapêutico , Qualidade de Vida , Sêmen , Injeções de Esperma Intracitoplásmicas/métodos , Espermatozoides , Fertilização in vitro/métodos , Implantação do Embrião/efeitos dos fármacos , Resultado da Gravidez , Método Simples-Cego , Injeções Intramusculares , Útero/efeitos dos fármacos , Transferência EmbrionáriaRESUMO
BACKGROUND: The main purpose is to investigate the effect of LiCO3 as an add-on therapy with radioactive iodine in increasing the cure and decreasing the T4 level compared to radioactive iodine alone. The primary outcome is the cure rate as defined by the number of hyperthyroid patients who became euthyroid or hypothyroid. The secondary outcome is the T4 level. METHODS: Four databases were searched (PubMed, Scopus, Web of Science, and Cochrane central library). The inclusion criteria were randomized and non-randomized clinical trials of hyperthyroidism patients receiving LiCO3 with radioiodine compared with hyperthyroidism patients receiving radioactive iodine alone. Included studies were appraised with the risk of bias version 2 tool, according to the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0. RESULTS: Nine studies were eligible for inclusion in the study, six randomized control trials and three non-randomized control trials. There were 477 patients in the intervention group and 451 patients in the control group. The cure rate was not significantly different between the two groups, while it was significantly increased with 5000 to 6500 mg optimized cumulative dose of LiCO3 compared with the control group, P = 0.0001. The T4 level showed no significant difference between the two groups, P = 0.13. CONCLUSIONS: LiCO3 adjunct to radioactive iodine did not show significant differences compared with radioactive iodine alone in terms of cure rate or decreasing T4 level. However, the dose of 5000 to 6000 mg of LiCO3 may increase the cure rate.
Assuntos
Quimioterapia Adjuvante/métodos , Hipertireoidismo/terapia , Radioisótopos do Iodo/administração & dosagem , Carbonato de Lítio/administração & dosagem , Humanos , Hipertireoidismo/sangue , Hipertireoidismo/diagnóstico , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Tiroxina/sangue , Resultado do TratamentoRESUMO
In this paper, we study the concomitants of dual generalized order statistics (and consequently generalized order statistics) when the parameters γ1, ,γn are assumed to be pairwise different from Huang-Kotz Farlie-Gumble-Morgenstern bivariate distribution. Some useful recurrence relations between single and product moments of concomitants are obtained. Moreover, Shannon's entropy and the Fisher information number measures are derived. Finally, these measures are extensively studied for some well-known distributions such as exponential, Pareto and power distributions. The main motivation of the study of the concomitants of generalized order statistics (as an important practical kind to order the bivariate data) under this general framework is to enable researchers in different fields of statistics to use some of the important models contained in these generalized order statistics only under this general framework. These extended models are frequently used in the reliability theory, such as the progressive type-II censored order statistics.
RESUMO
We aimed to compare the efficacy of vaginal progesterone versus intramuscular progesterone (IMP) for luteal phase support in assisted reproductive techniques (ART). A comprehensive electronic search of four electronic databases (PubMed, Cochrane Library, Scopus, and ISI Web of Science) was performed from inception till August 2019 for randomized controlled trials (RCTs). We included studies performed different ART with the use of vaginal progesterone versus IMP for luteal phase support. Our primary outcome was clinical pregnancy rate. Our secondary outcomes were ongoing pregnancy, miscarriage, live birth rates, and satisfaction in both groups. 15 RCTs met our inclusion criteria with a total of 5656 patients. Our analysis indicated no significant differences between vaginal progesterone and IMP regarding clinical and ongoing pregnancies (RR = 0.90, 95% CI [0.80, 1.00], p = .06), (RR = 0.90, 95% CI [0.76, 1.06], p = .21), respectively. No significant differences were found between both routes of progesterone in miscarriage (p = .98) and live birth (p = .99). Subgroup analysis between fresh and frozen embryo transfer cycles in above outcomes showed no difference between progesterone routes. Vaginal progesterone was significantly associated with more satisfaction compared to IMP (p < .00001). In conclusion, vaginal progesterone can be used an alternative method for luteal phase support instead of IMP in ART.
Assuntos
Fase Luteal/efeitos dos fármacos , Progesterona/administração & dosagem , Progestinas/administração & dosagem , Técnicas de Reprodução Assistida , Administração Intravaginal , Coeficiente de Natalidade , Feminino , Humanos , Injeções Intramusculares , GravidezRESUMO
BACKGROUND: Sepsis remains a leading cause of death worldwide. In this context, heparin-binding protein (HBP) has emerged as a possible biomarker, drawing significant attention for its diagnostic and prognostic usefulness in septic patients. Despite this advancement, the literature yields conflicting results. This study is intended to critically evaluate the diagnostic and prognostic value of HBP in critically ill septic patients. METHODS: We searched multiple databases, including PubMed, SCOPUS, Web of Science, and EBSCO, to identify relevant studies on April 27, 2023. We included studies investigating sepsis or its severe outcomes that reported HBP levels and the required data to create 2â ×â 2 tables. We used R version 4.2.2 and R Studio to analyze the pooled diagnostic accuracy outcomes. The diagmeta package was utilized to calculate the optimum cutoff value. RESULTS: In our meta-analysis, we incorporated 28 studies including 5508 patients. The analysis revealed that HBP has a sensitivity of 0.71 (95% CI: 0.60; 0.79) and a specificity of 0.68 (95% CI: 0.51; 0.81) in diagnosing sepsis, respectively. HBP demonstrated moderate prognostic accuracy for mortality at a cutoff value of 161.415 ng/mL, with a sensitivity and specificity of 72%, and for severe sepsis outcomes at a cutoff value of 58.907 ng/mL, with a sensitivity and specificity of 71%. CONCLUSION: Our findings indicate a relatively moderate diagnostic and prognostic accuracy of HBP for sepsis. Future studies are required to verify the accuracy of HBP as a biomarker for sepsis.
Assuntos
Biomarcadores , Proteínas Sanguíneas , Sepse , Humanos , Sepse/diagnóstico , Sepse/mortalidade , Sepse/sangue , Prognóstico , Biomarcadores/sangue , Proteínas Sanguíneas/análise , Peptídeos Catiônicos Antimicrobianos/sangue , Sensibilidade e Especificidade , Estado Terminal/mortalidade , Proteínas Citotóxicas Formadoras de PorosRESUMO
BACKGROUND: Aluminum phosphide toxicity is a serious problem in many countries. Unfortunately, there is no specific antidote. N-acetylcysteine has been used in some studies as adjuvant therapy depending on to its antioxidant properties. We hypothesized that IV N-acetylcysteine is effective in reducing mortality rate compared to supportive treatment alone. METHODS: We searched in PubMed, Scopus, Web of Science, and Cochrane Library databases. We only included randomized controlled trials that assessed the efficacy of IV N-acetylcysteine and supportive treatment versus supportive treatment alone in acute aluminum phosphide poisoning. Four investigators independently screened the studies' results and designed the data extraction sheet. The primary and secondary outcomes were mortality and the need for mechanical ventilation rates. Random effects estimators with weights were used to result in the pooled risk ratios. RESULTS: We included four randomized controlled trials with 177 patients. 91 patients were distributed in N-acetylcysteine group and 86 patients in the control group. Mortality rates in N-acetylcysteine group and in the control group were 43.95% 66.27% respectively. There was a statistically significant reduction in mortality rate after leave out test (pooled risk ratio, 0.5; 95% confidence interval, 0.32-0.77). Regarding the need for mechanical ventilation, it was measured only in three RCTs. It was assessed in 67 patients in N-acetylcysteine group and 60 patients in the control group. 24 patients were ventilated in N-acetylcysteine group (35.8%) and 29 patients in the control group (48.3%). But it was statistically nonsignificant (pooled risk ratio, 0.71; 95% confidence interval, 0.48-1.04). CONCLUSION: Our meta-analysis revealed that IV N-acetylcysteine may be effective in reducing mortality of severe aluminum phosphide poisoning cases. TRIAL REGISTRATION: Registration number in Prospero CRD42022375344 on 25 NOVEMBER 2022, retrospectively registered.
Assuntos
Acetilcisteína , Fosfinas , Humanos , Acetilcisteína/uso terapêutico , Antioxidantes , Compostos de AlumínioRESUMO
BACKGROUND AND AIMS: Prader-Willi Syndrome (PWS) is a rare genetic disease. Oxytocin is a neuropeptide hormone that impacts fear, and social recognition. Intranasal administration of oxytocin can be utilized to treat PWS patients. The results of published trials assessing the effects of intranasal oxytocin in PWS are variable. The current systematic review aims to investigate the efficacy of oxytocin in Prader-Willi patients. METHODS: We conducted a systematic literature search on Pubmed, Web of Science, and Scopus from inception to March 2022 for relevant interventional randomized controlled trials (RCTs) reporting the effect of oxytocin in patients with Prader-Willi syndrome. We assessed the quality of included trials using the Cochrane tool risk of bias 1. We performed the meta-analysis with Revman software version 5.4. In addition, we visualized our results using forest plots. We assessed the heterogeneity by using the Chi-square test. RESULTS: Relevant to hyperphagia, the data extracted in three studies comprising 92 patients did not show positive outcomes of oxytocin compared to placebo (MD = 0.18; 95% CI: -0.44, 0.80; P = 0.56). Three studies that included 94 patients revealed no significant effects regarding weight between oxytocin and placebo (MD = 0.30; 95% CI: -0.22, 0.83; P = 0.25). The Aberrant Behaviour Checklist found that group-administered oxytocin improved behaviour compared to their counterpart who received a placebo. CONCLUSION: Oxytocin didn't have significant effects on hyperphagia or weight. To establish the impact of oxytocin in Prader-Willi patients, additional prospective, large-sample randomized controlled trials (RCTs) are needed to avoid controversy.
Assuntos
Ocitocina , Síndrome de Prader-Willi , Humanos , Ocitocina/uso terapêutico , Síndrome de Prader-Willi/tratamento farmacológico , Administração Intranasal , HiperfagiaRESUMO
Polyethylene glycol loxenatide (PEX168) is a novel glucagon-like peptide-1 receptor agonist with a longer half-life developed by modifying the chemical structure of exenatide. This study aims to assess the efficacy and safety of PEX168 and determine the best dose. We searched PubMed, Scopus, Cochrane Library, and Web of Science databases from inception to April 25, 2023, for randomized controlled trials (RCTs) comparing PEX168 therapy alone or in combination with metformin versus other therapies. We used the risk ratio (RR) for dichotomous outcomes and the mean difference (MD) for continuous outcomes, both with 95% confidence intervals (CI). Six RCTs, including 1248 participants, were included. PEX168 added to metformin was significantly better than metformin alone regarding fasting blood glucose (MD = -1.20, 95% CI (-1.78, - 0.62), p < 0.0001), HbA1c (MD = -1.01, 95% CI (-1.48, - 0.53), p < 0.0001), and postprandial glycemia (MD = -1.94, 95% CI (-2.99, - 0.90), p = 0.0003). Similarly, for glycemic control, PEX168 monotherapy was superior to placebo (P < 0.05). No significant effects were noticed in terms of triglycerides, low-density lipoprotein, or high-density lipoprotein (p > 0.05). Body weight was significantly reduced in obese diabetic patients receiving PEX168 compared to the control group (MD = -5.46, 95% CI (-7.90, - 3.01), p < 0.0001) but not in non-obese patients (MD = 0.06, 95% CI (-0.47, 0.59), p = 0.83). People who received PEX168 alone or with metformin showed more common gastrointestinal adverse effects, especially nausea and vomiting (p < 0.05). PEX168 100, 200, and 300 ug monotherapy demonstrated comparable safety and diabetes control to metformin, but when combined with metformin, PEX168 100 and 200 ug showed significant effects on diabetes control; however, only the latter showed a significantly higher incidence of nausea and vomiting (p < 0.05). PEX168 could be a viable option for treating diabetic patients whose metformin control is inadequate or who cannot tolerate metformin. PEX168 at 100 ug in combination with metformin was found to be safe and more effective compared to metformin; however, due to the small number of trials included, these findings should be interpreted with caution, and additional trials are required.