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1.

Background

Previous reviews of the effectiveness of antibiotic prophylaxis for elective inguinal hernia repair were not conclusive owing to the limited number of patients enrolled in randomized controlled trials (RCTs). However, since new RCTs involving patients undergoing tention-free hernioplasty have been published in recent years, we performed a new meta-analysis to evaluate the effectiveness of antibiotic prophylaxis in the prevention of postoperative complications after this procedure.

Methods

We performed a meta-analysis of RCTs studying the use of antibiotic prophylaxis to prevent postoperative complications in patients undergoing tension-free hernioplasty.

Results

We included 6 RCTs conducted around the world in our analysis. Compared with the control condition, antibiotic prophylaxis was associated with a lower incidence of incision infection (odds ratio [OR] 0.45, 95% confidence interval [CI] 0.26–0.77, p = 0.004). There were no significant differences in risk for incision hematoma (OR 1.57, 95% CI 0.60–4.10, p = 0.35), respiratory infection (OR 1.00, 95% CI 0.17–5.79, p > 0.99) or urinary tract infection (OR 1.81, 95% CI 0.38–8.52, p = 0.45) between the 2 conditions.

Conclusion

Antibiotic prophylaxis use in patients undergoing tension-free hernioplasty decreases the rate of incision infection by 55%.  相似文献   

2.
3.

Purpose

We sought to determine the impact of levosimendan on mortality following cardiac surgery based on large‐scale randomized controlled trials (RCTs).

Methods

We searched PubMed, Web of Science, Cochrane databases, and ClinicalTrials.gov for RCTs published up to December 2017, on levosimendan for patients undergoing cardiac surgery.

Results

A total of 25 RCTs enrolling 2960 patients met the inclusion criteria; data from 15 placebo‐controlled randomized trials were included for meta‐analysis. Pooled analysis showed that the all‐cause mortality rate was 6.4% (71 of 1106) in the levosimendan group and 8.4% (93 of 1108) in the placebo group (odds ratio [OR], 0.76; 95% confidence interval [CI], 0.55‐1.04; P = 0.09). There were no significant differences between the two groups in the rates of myocardial infarction (OR: 0.91; 95% CI, 0.68‐1.21; P = 0.52), serious adverse events (OR: 0.84; 95% CI, 0.66‐1.07; P = 0.17), hypotension (OR: 1.69; 95% CI, 0.94‐3.03; P = 0.08), and low cardiac output syndrome (OR: 0.47; 95% CI, 0.22‐1.02; P = 0.05).

Conclusion

Levosimendan did not result in a reduction in mortality in adult cardiac surgery patients. Well designed, adequately powered, multicenter trials are necessary to determine the role of levosimendan in adult cardiac surgery.  相似文献   

4.

Purpose

The surgical interventions of diverticulitis vary according to its grade and severity. There is a controversy about the best of these different surgical procedures. We aimed to systematically review and meta-analyze randomized controlled trials (RCTs) comparing outcomes and complications between different surgical approaches for acute diverticulitis and its complications.

Methods

Nine electronic databases including PubMed, Scopus, and Web of Science were searched for RCTs comparing different surgical procedures for different grades of diverticulitis. The risk of bias was assessed using the Cochrane Collaboration tool. The protocol was registered in PROSPERO (CRD42015032290).

Results

Outcome data were analyzed from five RCTs comparing laparoscopic sigmoid resection (LSR) (n = 247) versus open sigmoid resection (OSR) (n = 237) for treatment of acute complicated diverticulitis with minimal heterogeneity. There was no significant difference in short-term postoperative overall morbidity (risk ratio (RR) 0.89, 95% confidence interval (CI) 0.61–1.31; P = 0.56) and long-term postoperative major morbidity (RR 0.78, 95% CI 0.46–1.31, P = 0.34). In other six RCTs compared laparoscopic lavage with resection for treatment of perforated diverticulitis with peritonitis, the postoperative mortality rate was non-significant in both short-term (RR 1.55, 95% CI 0.79–3.04; P = 0.21) and long-term (RR 0.67, 95% CI 0.29–1.58; P = 0.36) follow up.

Conclusions

LSR is not superior over OSR regarding postoperative morbidity and mortality for acute symptomatic diverticulitis. Furthermore, laparoscopic lavage was proved to be as safe as resection for perforated diverticulitis with peritonitis. Further RCTs are still needed to make an accurate decision regarding these and other procedures.  相似文献   

5.

Introduction

Early antiretroviral therapy (ART) has improved neurodevelopmental outcomes of HIV‐infected (HIV‐positive) children; however, little is known about the longer term outcomes in infants commencing early ART or whether temporary ART interruption might have long‐term consequences. In the children with HIV early antiretroviral treatment (CHER) trial, HIV‐infected infants ≤12 weeks of age with CD4 ≥25% were randomized to deferred ART (ART‐Def); immediate time‐limited ART for 40 weeks (ART‐40W) or 96 weeks (ART‐96W). ART was restarted in the time‐limited arms for immunologic/clinical progression. Our objective was to compare the neurodevelopmental profiles in all three arms of Cape Town CHER participants.

Methods

A prospective, longitudinal observational study was used. The Griffiths mental development scales (GMDS), which includes six subscales and a global score, were performed at 11, 20, 30, 42 and 60 months, and the Beery‐Buktenica developmental tests for visual motor integration at 60 months. HIV‐exposed uninfected (HEU) and HIV‐unexposed (HU) children were enrolled for comparison. Mixed model repeated measures were used to compare groups over time, using quotients derived from standardized British norms.

Results

In this study, 28 ART‐Def, 35 ART‐40W, 33 ART‐96W CHER children, and 34 HEU and 39 HU controls were enrolled. GMDS scores over five years were similar between the five groups in all subscales except locomotor and general Griffiths (interaction p < 0.001 and p = 0.02 respectively), driven by early lower scores in the ART‐Def arm. At 60 months, scores for all groups were similar in each GMDS scale. However, Beery visual perception scores were significantly lower in HIV‐infected children (mean standard scores: 75.8 ART‐Def, 79.8 ART‐40W, 75.9 ART‐96W) versus 84.4 in HEU and 90.5 in HU (p < 0.01)).

Conclusions

Early locomotor delay in the ART‐Def arm resolved by five years. Neurodevelopmental outcomes at five years in HIV‐infected children on early time‐limited ART were similar to uninfected controls, apart from visual perception where HIV‐infected children scored lower. Poorer visual perception performance warrants further investigation.
  相似文献   

6.
IntroductionThere is a growing population of children who are HIV‐exposed and uninfected (HEU) with the successful expansion of antiretroviral therapy (ART) use in pregnancy. Children who are HEU are at risk of delayed neurodevelopment; however, there is limited research on early brain growth and maturation. We aimed to investigate the effects of in utero exposure to HIV/ART on brain structure of infants who are HEU compared to HIV‐unexposed (HU).MethodsMagnetic resonance imaging using a T2‐weighted sequence was undertaken in a subgroup of infants aged 2–6 weeks enrolled in the Drakenstein Child Health Study birth cohort, South Africa, between 2012 and 2015. Mother–child pairs received antenatal and postnatal HIV testing and ART per local guidelines. We compared subcortical and total grey matter volumes between HEU and HU groups using multivariable linear regression adjusting for infant age, sex, intracranial volume and socio‐economic variables. We further assessed associations between brain volumes with maternal CD4 cell count and ART exposure.ResultsOne hundred forty‐six infants (40 HEU; 106 HU) with high‐resolution images were included in this analysis (mean age 3 weeks; 50.7% male). All infants who were HEU were exposed to ART (88% maternal triple ART). Infants who were HEU had smaller caudate volumes bilaterally (5.4% reduction, p < 0.05) compared to HU infants. There were no group differences in other subcortical volumes (all p > 0.2). Total grey matter volume was also reduced in infants who were HEU (2.1% reduction, p < 0.05). Exploratory analyses showed that low maternal CD4 cell count (<350 cells/mm3) was associated with decreased infant grey matter volumes. There was no relationship between timing of ART exposure and grey matter volumes.ConclusionsLower caudate and total grey matter volumes were found in infants who were HEU compared to HU in the first weeks of life, and maternal immunosuppression was associated with reduced volumes. These findings suggest that antenatal HIV exposure may impact early structural brain development and improved antenatal HIV management may have the potential to optimize neurodevelopmental outcomes of children who are HEU.  相似文献   

7.

Background and Objectives:

Laparoscopic treatment of perforated peptic ulcer (PPU) has been introduced as an alternative procedure to open surgery. It has been postulated that the minimally invasive approach involves less operative stress and results in decreased morbidity and mortality.

Methods:

We conducted a meta-analysis of randomized trials to test this hypothesis. Medline, EMBASE, and the Cochrane Central Register of Randomized Trials databases were searched, with no date or language restrictions.

Results:

Our literature search identified 4 randomized trials, with a cumulative number of 289 patients, that compared the laparoscopic approach with open sutured repair of perforated ulcer. Analysis of outcomes did not favor either approach in terms of morbidity, mortality, and reoperation rate, although odds ratios seemed to consistently support the laparoscopic approach. Results did not determine the comparative efficiency and safety of laparoscopic or open approach for PPU.

Conclusion:

In view of an increased interest in the laparoscopic approach, further randomized trials are considered essential to determine the relative effectiveness of laparoscopic and open repair of PPU.  相似文献   

8.

Introduction

The extraordinarily high incidence of HIV in sub-Saharan Africa led to the search for cofactor infections that could explain the high rates of transmission in the region. Genital inflammation and lesions caused by sexually transmitted infections (STIs) were a probable mechanism, and numerous observational studies indicated several STI cofactors. Nine out of the ten randomized controlled trials (RCTs), however, failed to demonstrate that treating STIs could lower HIV incidence. We evaluate all 10 trials to determine if their design permits the conclusion, widely believed, that STI treatment is ineffective in reducing HIV incidence.

Discussion

Examination of the trials reveals critical methodological problems sufficient to account for statistically insignificant outcomes in nine of the ten trials. Shortcomings of the trials include weak exposure contrast, confounding, non-differential misclassification, contamination and effect modification, all of which consistently bias the results toward the null. In any future STI-HIV trial, ethical considerations will again require weak exposure contrast. The complexity posed by HIV transmission in the genital microbial environment means that any future STI-HIV trial will face confounding, non-differential misclassification and effect modification. As a result, it is unlikely that additional trials would be able to answer the question of whether STI control reduces HIV incidence.

Conclusions

Shortcomings in published RCTs render invalid the conclusion that treating STIs and other cofactor infections is ineffective in HIV prevention. Meta-analyses of observational studies conclude that STIs can raise HIV transmission efficiency two- to fourfold. Health policy is always implemented under uncertainty. Given the known benefits of STI control, the irreparable harm from not treating STIs and the likely decline in HIV incidence resulting from STI control, it is appropriate to expand STI control programmes and to use funds earmarked for HIV prevention to finance those programmes.  相似文献   

9.

Background

Despite many studies comparing on- versus off-pump coronary artery bypass graft (CABG), there is no consensus as to whether one of these techniques offers patients better outcomes.

Methods

We searched PubMed from inception to June 30, 2015, and identified additional studies from bibliographies of meta-analyses and reviews. We identified 42 randomized controlled trials (RCTs) and 31 rigorously adjusted observational studies (controlling for the Society of Thoracic Surgeons-recognized risk factors for mortality) reporting mortality for off-pump versus on-pump CABG at specified time points. Trial data were extracted independently by 2 researchers using a standardized form. Differences in probability of mortality (DPM) were estimated for the RCTs and observational studies separately and combined, for time points ranging from 30 days to 10 years.

Results

RCT-only data showed no significant differences at any time point, whereas observational-only data and the combined analysis showed short-term mortality favored off-pump CABG (n = 1.2 million patients; 36 RCTs, 26 observational studies; DPM [95% confidence interval (CI)], ?44.8% [?45.4%, ?43.8%]) but that at 5 years it was associated with significantly greater mortality (n = 60,405 patients; 3 RCTs, 5 observational studies; DPM [95% CI], 10.0% [5.0%, 15.0%]). At 10 years, only observational data were available, and off-pump CABG showed significantly greater mortality (DPM [95% CI], 14.0% [11.0%, 17.0%]).

Conclusions

Evidence from RCTs showed no differences between the techniques, whereas rigorously adjusted observational studies (with >1.1 million patients) and the combined analysis indicated that off-pump CABG offers lower short-term mortality but poorer long-term survival. These results suggest that, in real-world settings, greater operative safety with off-pump CABG comes at the expense of lasting survival gains.  相似文献   

10.

Background

Fungal infections are still one of the most important issue in liver transplant patients, contributing considerably to both morbidity and mortality. Few studies have been published comparing antifungal protocols for their impact on liver transplant (OLT) patients. The aim of this study was to evaluate the effects of liposomal amphotericin B compared with fluconazole prophylaxis on morbidity and mortality after liver transplantation.

Methods

We evaluated all 44 patients undergoing OLT from January 2006 to January 2009 who were enrolled and randomized to undergo treatment with Amphotericin B (3 mg/kg/d; group A = 25 patients) or fluconazole (800 mg Loading dose and thereafter 400 mg/d according to renal parameters and immunosuppressant trough levels; group B = 18 patients) for at least 7 to 14 days with 12 months follow-up after liver transplantation. A multivariate analysis assessed factors associated with infections and mortality.

Results

Neither antifungal prophylaxis was associated with a fungal episode; however, group A patients experienced fewer bacterial infectious episodes (Mann-Whitney U test P < .05). Furthermore, no renal impairment was observed in either groups. Nonetheless, patients undergoing fluconazole prophylaxis showed significant increases in immunosuppressive trough levels requiring dose adjustment.

Conclusion

We observed comparable results of fluconazole and liposomal amphotericin B to prevent invasive fungal infections throughout 12 months after surgery. The latter drug was associated with fewer bacterial infections after liver transplantation.  相似文献   

11.

Background

The long-term effects of bariatric surgery have yet to be established, and a number of important studies have recently emerged. This systematic review aimed to assess the effects of bariatric surgery on all-cause mortality, cardiovascular events, and cancer compared to non-surgical treatment.

Methods

We searched PubMed, EMBASE, and CENTRAL up to July 13, 2015, and included randomized controlled trials (RCTs) and non-randomized controlled studies comparing bariatric surgery versus non-surgical treatment and reporting data on the three defined outcomes at 1 year or longer. We analyzed RCTs and non-randomized controlled studies, respectively.

Results

Eleven RCTs, 4 non-randomized controlled trials, and 17 cohort studies were included. The randomized evidence suggested substantial uncertainty regarding the effects on all-cause mortality (0/382 vs. 1/287; 7 studies), cancer (OR 0.77, 95 % CI 0.22 to 2.71; 4 studies), and cardiovascular events (no data). The pooled adjusted estimates from non-randomized studies suggested that, compared to the control, the surgical group had lower risk of all-cause mortality (OR 0.55, 95 % CI 0.46 to 0.65; 10 studies), cancer (OR 0.74, 95 % CI 0.65 to 0.85; 2 studies), and cardiovascular events (MI: OR 0.71, 95 % CI 0.54 to 0.94; stroke: OR 0.66, 95 % CI 0.49 to 0.89; and their composite: OR 0.67, 95 % CI 0.54 to 0.83; 1 study).

Conclusions

In conclusion, bariatric surgery could reduce all-cause mortality and probably reduce the risk of any type of cancer. The inference was, however, based on studies with limited methodological rigor. Uncertainty remains regarding the effects on cardiovascular events.
  相似文献   

12.

Background

Meta-analyses in the literature show that enhanced recovery after surgery (ERAS) is associated with lower morbidity rate and shorter hospital stay after elective colorectal surgery. However, a recent Cochrane review did not indicate the ERAS pathway as being the new standard of care due to the limited number of published trials, together with their poor quality. We conducted a meta-analysis of randomized controlled trials (RCTs) to assess the impact of the ERAS pathway on overall morbidity, single postoperative complications, length of hospital stay, and readmission rate following colorectal surgery.

Methods

We searched BioMedCentral, PubMed, Scopus, and the Cochrane Central Register of Controlled Trials (CENTRAL) for RCTs comparing the ERAS pathway to conventional perioperative care. No language restrictions were considered. A quality score was calculated for each trial included.

Results

A total of 2,376 patients in 16 RCTs were included in the analysis. The ERAS pathway was associated with a reduction of overall morbidity [relative ratio (RR) = 0.60, (95 % CI 0.46–0.76)], particularly with respect to nonsurgical complications [RR = 0.40, (95 % CI 0.27–0.61)]. The reduction of surgical complications was not significant [RR = 0.76, (95 % CI 0.54–1.08)]. The ERAS pathway shortened hospital stay (WMD = ?2.28 days [95 % CI –3.09 to –1.47]), without increasing readmission rate.

Conclusions

The ERAS pathway reduced overall morbidity rates and shortened the length of hospital stay, without increasing readmission rates. A significant reduction in nonsurgical complications was evident, while no significant reduction was found for surgical complications.  相似文献   

13.

Background

Children with congenital heart disease (CHD) often require noncardiac surgery. We compared outcomes following open and laparoscopic intraabdominal surgery among children with and without CHD.

Methods

We performed a retrospective cohort study using the 2013–2015 National Surgical Quality Improvement Project-Pediatrics. We matched 45,012 children < 18 years old who underwent laparoscopic surgery to 45,012 children who underwent open surgery. We determined the associations between laparoscopic (versus open) surgery and 30-day mortality, in-hospital mortality, 30-day morbidity, and postoperative length-of-stay.

Results

Among children with minor CHD, laparoscopic surgery was associated with lower 30-day mortality (Odds Ratio [OR] 0.34 [95% Confidence Interval 0.15–0.79]), inhospital mortality (OR 0.42 [0.22–0.81]) and 30-day morbidity (OR 0.61 [0.50–0.73]). As CHD severity increased, this benefit of laparoscopic surgery decreased for 30-day morbidity (ptrend = 0.01) and in-hospital mortality (ptrend = 0.05), but not for 30-day mortality (ptrend = 0.27). Length-of-stay was shorter for laparoscopic approaches for children at cost of higher readmissions. On subgroup analysis, laparoscopy was associated with lower odds of postoperative blood transfusion in all children.

Conclusions

Intraabdominal laparoscopic surgery compared to open surgery is associated with decreased morbidity in patients with no CHD and lower morbidity and mortality in patients with minor CHD, but not in those with more severe CHD.

Level-of-evidence

Level III: Treatment Study.  相似文献   

14.

Background

Renal scarring after acute pyelonephritis (APN) in children is of concern and in the worst cases leads to long-term cardiovascular morbidity. There are reports that vitamin A may alleviate renal damage following APN. We conducted a meta-analysis to investigate the role of vitamin A in the alleviation of renal damage.

Methods

We searched PubMed, EMBASE, the Cochrane Central Register of Controlled trials (CENTRAL, the Cochrane Library) and the Wang Fang database (Chinese) from their inception to February 3, 2015 for randomized controlled trials (RCTs) investigating vitamin A and renal damage. Primary outcome was number of patients/kidneys with renal damage, defined as persistence of photopenic lesions based on technetium-99m dimercaptosuccinic acid renal scintigraphy. We calculated pooled relative risks for renal damage in the vitamin A group.

Results

Four RCTs, involving a total of 248 patients aged 1–144 months (120 in experimental group, 128 in control group), were included in the meta-analysis. Vitamin A was inversely associated with renal damage (relative risk 0.53, 95 % confidence interval 0.43, 0.67) when compared with placebo group after an average follow-up of 5 months.

Conclusions

Current evidence indicates that vitamin A may exert a preventive effect on renal damage in children with APN. However, this finding largely relies on a few studies of low methodological quality, i.e., high risk of selection bias, performance bias and attrition bias. Hence, high-quality and adequately powered RCTs are warranted.
  相似文献   

15.

Introduction

Many children and adolescents living with HIV still present with severe immunosuppression with morbidity and mortality remaining high in those starting antiretroviral therapy (ART) when hospitalized.

Discussion

The major causes of morbidity and mortality in children living with HIV are pneumonia, tuberculosis, bloodstream infections, diarrhoeal disease and severe acute malnutrition. In contrast to adults, cryptococcal meningitis is rare in children under 5 years of age but increases in adolescence. In 2021, the World Health Organizations (WHO) consolidated guidelines for managing HIV disease and rapid ART included recommendations for children and adolescents. In addition, a WHO technical brief released in 2020 highlighted the various interventions that are specifically related to children and adolescents with advanced HIV disease (AHD). We discuss the common clinical presentations of children and adolescents with AHD with a focus on diagnosis, prevention and treatment, highlight some of the challenges in the implementation of the existing package of care, and emphasize the importance of additional research to address the needs of children and adolescents with AHD.

Conclusions

There are limited data informing these recommendations and an urgent need for further research on how to implement optimal strategies to ensure tailored approaches to prevent and treat AHD in children and adolescents. Holistic care that goes beyond a simple choice of ART regimen should be provided to all children and adolescents with AHD.  相似文献   

16.

Introduction

Guidelines in resource-poor settings have progressively included interventions to reduce postnatal HIV transmission through breast milk. In addition to HIV-free survival, infant growth and non-HIV infections should be considered. Determining the effect of these interventions on infant growth and non-HIV infections will inform healthcare decisions about feeding HIV-exposed infants. We synthesize findings from studies comparing breast to formula feeding, early weaning to standard-duration breastfeeding, breastfeeding with extended antiretroviral (ARV) to short-course ARV prophylaxis, and alternative preparations of infant formula to standard formula in HIV-exposed infants, focusing on infant growth and non-HIV infectious morbidity outcomes. The review objectives were to collate and appraise evidence of interventions to reduce postnatal vertical HIV transmission, and to estimate their effect on growth and non-HIV infections from birth to two years of age among HIV-exposed infants.

Methods

We searched PubMed, SCOPUS, and Cochrane CENTRAL Controlled Trials Register. We included randomized trials and prospective cohort studies. Two authors independently extracted data and evaluated risk of bias. Rate ratios and mean differences were used as effect measures for dichotomous and continuous outcomes, respectively. Where pooling was possible, we used fixed-effects meta-analysis to pool results across studies. Quality of evidence was assessed using the GRADE approach.

Results and discussion

Prospective cohort studies comparing breast- versus formula-fed HIV-exposed infants found breastfeeding to be protective against diarrhoea in early life [risk ratio (RR)=0.31; 95% confidence interval (CI)=0.13 to 0.74]. The effect of breastfeeding against diarrhoea [hazard ratio (HR)=0.74; 95% CI=0.57 to 0.97] and respiratory infections (HR=0.65; 95% CI=0.41 to 1.00) was significant through two years of age. The only randomized controlled trial (RCT) available showed that breastfeeding tended to be protective against malnutrition (RR=0.63; 95% CI=0.36 to 1.12). We found no statistically significant differences in the rates of non-HIV infections or malnutrition between breast-fed infants in the extended and short-course ARV prophylaxis groups.

Conclusions

Low to moderate quality evidence suggests breastfeeding may improve growth and non-HIV infection outcomes of HIV-exposed infants. Extended ARV prophylaxis does not appear to increase the risk for HIV-exposed infants for adverse growth or non-HIV infections compared to short-course ARV prophylaxis.  相似文献   

17.

Introduction

Multiple antiretroviral agents have demonstrated efficacy for human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP). As a result, clinical trials of novel agents have transitioned from placebo- to active-controlled designs; however, active-controlled trials do not provide an estimate of efficacy versus no use of PrEP. Counterfactual placebo comparisons using other data sources could be employed to provide this information.

Methods

We compared the active-controlled study (HPTN 084) of injectable cabotegravir (CAB-LA) versus daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) among women from seven countries in Africa to three external, contemporaneous randomized HIV prevention trials from which we constructed counterfactual placebo estimates. We used direct standardization via analysis weights to achieve the same distribution of person-years between the external study and HPTN 084, across strata predictive of HIV risk (country and selected risk covariates). We estimated prevention efficacy against a counterfactual placebo to provide information on the use of CAB-LA and FTC/TDF compared to no intervention. We compared the counterfactual placebo findings for FTC/TDF to previous placebo-controlled trials, adjusted for observed adherence to daily pills.

Results

Distribution of age and baseline prevalence of gonorrhoea and chlamydia were similar among matched counterfactual placebo and observed HPTN 084 arms after standardization. Counterfactual estimates of CAB-LA versus placebo in all three settings showed a consistent risk reduction of 93%–94%, with lower bounds of the confidence intervals above 72%. Observed adherence (quantifiable tenofovir in plasma) in HPTN 084 was 54%–56%, and estimated efficacy of daily oral FTC/TDF against a counterfactual placebo was consistent with a predicted risk reduction of 39%–40% for this level of daily pill use.

Conclusions

Counterfactual placebo rates of HIV acquisition derived from external trial data in similar locations and time can be used to support estimates of placebo-based efficacy of a novel HIV prevention agent. External trial data must be standardized to be representative of the clinical trial cohort testing the novel HIV prevention agent, accounting for confounders.  相似文献   

18.

Background

We investigated prevalence of acute kidney injury (AKI) at hospitalization and its association with in-hospital mortality among Ugandan children hospitalized with common acute infections, and predictors of mortality among AKI children.

Methods

We enrolled 2,055 children hospitalized with primary diagnoses of acute gastroenteritis, malaria, or pneumonia. Serum creatinine, albumin, electrolytes, hemoglobin, and urine protein were obtained on admission. Participants were assessed for AKI based on serum creatinine levels. Demographic and clinical data were obtained using a primary care provider survey and medical chart review. Logistic regression was used to determine predictors of in-hospital mortality.

Results

A total of 278 (13.5 %) of children had AKI on admission; for 76.2 %, AKI was stage 2 (98/278) or stage 3 (114/278) defined as serum creatinine >2- or 3-fold above normal upper limit for age, respectively. AKI prevalence was particularly high in gastroenteritis (28.6 %) and underweight children (20.7 %). Twenty-five percent of children with AKI died during hospitalization, compared to 9.9 % with no AKI (adjusted odds ratio (aOR) 3.5 (95 % CI, 2.2–5.5)). In-hospital mortality risk did not differ by AKI stage. Predictors of in-hospital mortality among AKI children included primary diagnosis of pneumonia, aOR 4.5 (95 % CI, 1.8–11.2); proteinuria, aOR = 2.1 (95 % CI, 1.0–4.9) and positive human immunodeficiency virus (HIV) status, aOR 5.0 (95 % CI, 2.0–12.9).

Conclusions

Among children hospitalized with gastroenteritis, malaria, or pneumonia, AKI at admission was common and associated with high in-hospital mortality.  相似文献   

19.

Background

In the intensive care unit (ICU), stress ulcer prophylaxis with proton pump inhibitors or histamine‐2‐receptor antagonists is standard of care although gastrointestinal bleeding remains uncommon. It remains unknown whether its use is associated with benefits or harms and the quality of evidence supporting the use of stress ulcer prophylaxis has been questioned. Accordingly, the objective of this systematic review was to critically assess the evidence from randomized clinical trials on the benefits and harms of stress ulcer prophylaxis vs. placebo or no prophylaxis in adult ICU patients.

Methods

We will systematically search for randomized clinical trials in major international databases. Two authors will independently screen and select trials for inclusion, extract data and assess the methodological quality using the Cochrane risk of bias tool. Any disagreement will be resolved by consensus. We will perform conventional meta‐analyses using Review Manager, and STATA 15, and we will assess the risk of random errors using Trial Sequential Analysis. Also, we will assess and report the overall quality of evidence for all outcomes according to GRADE.

Discussion

The evidence on the benefits and harms of stress ulcer prophylaxis in adult ICU patients is unclear and an updated systematic review is warranted as new trials have been published. To control risks of systematic and random errors, we will use Cochrane and GRADE methodology and Trial Sequential Analysis. Our ambition with this systematic review is to provide updated, reliable and precise data to better inform decision makers on the use of stress ulcer prophylaxis in adult ICU patients.
  相似文献   

20.

Purpose

This study was designed to determine the most effective peripheral nerve block supplement to standard anesthesia management for hip fracture patients.

Methods

We systematically reviewed randomized controlled trials (RCTs) published from 1990 to 2010 and conducted multiple treatment comparisons using direct and indirect evidence for two outcomes, i.e., acute pain intensity and delirium. We combined trials by type of injection (regardless of time of insertion during the perioperative phase, use of nerve block catheter, local anesthetic type, additives, or duration of treatment).

Results

Twenty-one RCTs comprising 1,422 participants were included. In most cases, the trials were conducted in Europe; they excluded patients with cognitive impairment, and they were unclear or at high risk of bias. The combination of obturator and lateral femoral cutaneous nerve blockade had the highest probability of being the most effective against acute postoperative pain. Fascia iliaca blockade had the highest probability of being the most effective against delirium. There was no difference in outcomes among other nerve blocks.

Conclusion

Not all nerve blocks are equally effective in improving outcomes after hip fracture. Multiple treatment comparison, a tool to compare the effectiveness of multiple treatments simultaneously, provides useful guidance to anesthesia providers seeking effective treatment when faced with a body of RCTs wherein each investigates one treatment. More RCTs comparing multiple nerve blocks in hip fracture are needed.  相似文献   

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