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The Cochrane Database of Systematic... Nov 2016Tuberculosis (TB) of the gastrointestinal tract and any other organ within the abdominal cavity is abdominal TB, and most guidelines recommend the same six-month regimen... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Tuberculosis (TB) of the gastrointestinal tract and any other organ within the abdominal cavity is abdominal TB, and most guidelines recommend the same six-month regimen used for pulmonary TB for people with this diagnosis. However, some physicians are concerned whether a six-month treatment regimen is long enough to prevent relapse of the disease, particularly in people with gastrointestinal TB, which may sometimes cause antituberculous drugs to be poorly absorbed. On the other hand, longer regimens are associated with poor adherence, which could increase relapse, contribute to drug resistance developing, and increase costs to patients and health providers.
OBJECTIVES
To compare six-month versus longer drug regimens to treat people that have abdominal TB.
SEARCH METHODS
We searched the following electronic databases up to 2 September 2016: the Cochrane Infectious Diseases Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Embase (accessed via OvidSP), LILACS, INDMED, and the South Asian Database of Controlled Clinical Trials. We searched the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov for ongoing trials. We also checked article reference lists.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) that compared six-month regimens versus longer regimens that consisted of isoniazid, rifampicin, pyrazinamide, and ethambutol to treat adults and children that had abdominal TB. The primary outcomes were relapse, with a minimum of six-month follow-up after completion of antituberculous treatment (ATT), and clinical cure at the end of ATT.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected trials, extracted data, and assessed the risk of bias in the included trials. For analysis of dichotomous outcomes, we used risk ratios (RR) with 95% confidence intervals (CIs). Where appropriate, we pooled data from the included trials in meta-analyses. We assessed the quality of the evidence using the GRADE approach.
MAIN RESULTS
We included three RCTs, with 328 participants, that compared six-month regimens with nine-month regimens to treat adults with intestinal and peritoneal TB. All trials were conducted in Asia, and excluded people with HIV, those with co-morbidities and those who had received ATT in the previous five years. Antituberculous regimens were based on isoniazid, rifampicin, pyrazinamide, and ethambutol, and these drugs were administered daily or thrice weekly under a directly observed therapy programme. The median duration of follow-up after completion of treatment was between 12 and 39 months.Relapse was uncommon, with two cases among 140 participants treated for six months, and no events among 129 participants treated for nine months. The small number of participants means we do not know whether or not there is a difference in risk of relapse between the two regimens (very low quality evidence). At the end of therapy, there was probably no difference in the proportion of participants that achieved clinical cure between six-month and nine-month regimens (RR 1.02, 95% CI 0.97 to 1.08; 294 participants, 3 trials, moderate quality evidence). For death, there were 2/150 (1.3%) in the six-month group and 4/144 (2.8%) in the nine-month group. All deaths occurred in the first four months of treatment, so was not linked to the duration of treatment in the included trials. Similarly, the number of participants that defaulted from treatment was small in both groups, and there may be no difference between them (RR 0.50, 95% CI 0.10 to 2.59; 294 participants, 3 trials, low quality evidence). Only one trial reported on adherence to treatment, with only one participant allocated to the nine-month regimen presenting poor adherence to treatment. We do not know whether six-month regimens are associated with fewer people experiencing adverse events that lead to treatment interruption (RR 0.53, 95% CI 0.18 to 1.55; 318 participants, 3 trials, very low quality evidence).
AUTHORS' CONCLUSIONS
We found no evidence to suggest that six-month treatment regimens are inadequate for treating people that have intestinal and peritoneal TB, but numbers are small. We did not find any incremental benefits of nine-month regimens regarding relapse at the end of follow-up, or clinical cure at the end of therapy, but our confidence in the relapse estimate is very low because of size of the trials. Further research is required to make confident conclusions regarding the safety of six-month treatment for people with abdominal TB. Larger studies that include HIV-positive people, with long follow-up for detecting relapse with reliability, would help improve our knowledge around this therapeutic question.
Topics: Abdomen; Antitubercular Agents; Drug Administration Schedule; Ethambutol; Humans; Isoniazid; Pyrazinamide; Randomized Controlled Trials as Topic; Recurrence; Rifampin; Time Factors; Tuberculosis, Gastrointestinal
PubMed: 27801499
DOI: 10.1002/14651858.CD012163.pub2 -
International Endodontic Journal Oct 2023Sodium hypochlorite (NaOCl) and ethylenediaminetetraacetic acid (EDTA) and/or calcium hydroxide (Ca(OH) ) are commonly used during root canal treatment. Evaluation of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Sodium hypochlorite (NaOCl) and ethylenediaminetetraacetic acid (EDTA) and/or calcium hydroxide (Ca(OH) ) are commonly used during root canal treatment. Evaluation of their effectiveness regarding clinical and patient-related outcomes requires further understanding.
OBJECTIVES
To assess the effectiveness of root canal irrigation and dressing for the treatment of teeth with apical periodontitis (AP).
METHODS
A search was conducted in the PubMed-MEDLINE, Scopus, EMBASE, Google scholar databases and available repositories, followed by hand searches, until July 2021. Eligibility criteria followed the a priori formulated Population, Intervention, Comparator, Outcomes, Timing, and Study design (PICOTS) framework. Clinical studies restricted to English language were included. The revised Cochrane risk-of-bias tool for randomised trials (RoB 2) was used to assess the quality of included studies. Meta-analyses were performed using the fixed-effect model to obtain Risk Ratio (RR) and 95% Confidence Interval (CI), with sensitivity analysis. Overall quality of evidence of meta-analyses was assessed through the Grading of Recommendations Assessment, Development, and Evaluation tool.
RESULTS
The search identified 1357 records of which six fulfilled the inclusion criteria, providing data for 'irrigation' from 212 teeth and for 'dressings' from 438 teeth. Two studies reported no significant difference regarding the outcome 'pain at 7 days' using 2% chlorhexidine vs. 5.25% NaOCl and EDTA or after using different concentrations of NaOCl (1% vs. 5%). No significant difference was detected between different NaOCl concentrations regarding the reduction of AP. A meta-analysis was possible for the comparison of single-visit (SV) versus multiple-visits including the use of Ca(OH) demonstrating a significant effect in favour of SV (RR: 1.10; 95% CI: 1.03-1.19; p = .007; I = 0). RoB of included studies was moderate to low.
DISCUSSION
The use of Ca(OH) for the treatment of AP may not be beneficial. There is scarce or no evidence fulfilling the proposed PICOTS regarding irrigants and dressings.
CONCLUSIONS
There is moderate certainty that SV treatment is associated with better radiographic evidence of normal periodontal ligament space (strict criteria) compared with the use of Ca(OH) Reduction of AP is comparable after irrigation with 1% and 5% NaOCl, whereas postoperative pain at 7 days for the irrigants assessed is similar.
REGISTRATION
PROSPERO database CRD42021260271.
Topics: Humans; Dental Pulp Cavity; Edetic Acid; Root Canal Therapy; Periapical Periodontitis; Bandages; Root Canal Irrigants
PubMed: 35579074
DOI: 10.1111/iej.13777 -
The International Journal of... Jun 2016Therapeutic drug monitoring (TDM) may improve tuberculosis (TB) treatment outcomes, but there is little evidence to guide TDM in clinical practice. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Therapeutic drug monitoring (TDM) may improve tuberculosis (TB) treatment outcomes, but there is little evidence to guide TDM in clinical practice.
DESIGN
We performed a systematic review and meta-analysis to summarise existing literature on TDM in first-line drugs.
RESULTS
We identified 41 studies that reported 2 h post-dose drug concentrations (C2h) for first-line drugs and 12 studies that reported clinical outcomes. We pooled data by study quality, design, region, dosing modality and patient characteristics. The pooled proportion of subjects with low isoniazid C2h was 0.43 (95%CI 0.32-0.55), 0.67 (95%CI 0.60-0.74) had low rifampicin C2h, 0.27 (95%CI 0.17-0.38) had low ethambutol C2h, and 0.12 (95%CI 0.07-0.19) had low pyrazinamide C2h. Patients with diabetes had a non-significant increase in the proportion of subjects with low C2h levels across all four drugs. Only three of 12 studies that examined clinical outcomes demonstrated an association between low C2h and unsuccessful treatment outcomes.
CONCLUSION
Across a wide variety of studies, a high proportion of patients undergoing first-line anti-tuberculosis treatment had 2 h drug concentrations below the accepted normal threshold. These findings point to a discrepancy between accepted 2 h TDM thresholds and TB drug dosing recommendations.
Topics: Antitubercular Agents; Databases, Factual; Dose-Response Relationship, Drug; Drug Monitoring; Ethambutol; Humans; Isoniazid; Pyrazinamide; Randomized Controlled Trials as Topic; Rifampin; Treatment Outcome; Tuberculosis
PubMed: 27155187
DOI: 10.5588/ijtld.15.0803 -
The Cochrane Database of Systematic... Oct 2023Apnea of prematurity is a common problem in preterm infants that may have significant consequences on their development. Methylxanthines (aminophylline, theophylline,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Apnea of prematurity is a common problem in preterm infants that may have significant consequences on their development. Methylxanthines (aminophylline, theophylline, and caffeine) are effective in the treatment of apnea of prematurity. Doxapram is used as a respiratory stimulant in cases refractory to the methylxanthine treatment.
OBJECTIVES
To evaluate the benefits and harms of doxapram administration on the incidence of apnea and other short-term and longer-term clinical outcomes in preterm infants.
SEARCH METHODS
We used standard, extensive Cochrane search methods. The latest search date was March 2023.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) assessing the role of doxapram in prevention and treatment of apnea of prematurity and prevention of reintubation in preterm infants (less than 37 weeks' gestation). We included studies comparing doxapram with either placebo or methylxanthines as a control group, or when doxapram was used as an adjunct to methylxanthines and compared to methylxanthines alone as a control group. We included studies of doxapram at any dose and route.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Our primary outcomes were clinical apnea, need for positive pressure ventilation after initiation of treatment, failed apnea reduction after two to seven days, and failed extubation (defined as unable to wean from invasive intermittent positive pressure ventilation [IPPV] and extubate or reintubation for IPPV within one week). We used GRADE to assess the certainty of evidence for each outcome.
MAIN RESULTS
We included eight RCTs enrolling 248 infants. Seven studies (214 participants) provided data for meta-analysis. Five studied doxapram for treatment of apnea in preterm infants. Three studied doxapram to prevent reintubation in preterm infants. None studied doxapram in preventing apnea in preterm infants. All studies administered doxapram intravenously as continuous infusions. Two studies used doxapram as an adjunct to aminophylline compared to aminophylline alone and one study as an adjunct to caffeine compared to caffeine alone. When used to treat apnea, compared to no treatment, doxapram may result in a slight reduction in failed apnea reduction (risk ratio [RR] 0.45, 95% confidence interval [CI] 0.20 to 1.05; 1 study, 21 participants; low-certainty evidence). The evidence is very uncertain about the effect of doxapram on need for positive pressure ventilation after initiation of treatment (RR 0.31, 95% CI 0.01 to 6.74; 1 study, 21 participants; very low-certainty evidence). Doxapram may result in little to no difference in side effects causing cessation of therapy (0 events in both groups; risk difference [RD] 0.00, 95% CI -0.17 to 0.17; 1 study, 21 participants; low-certainty evidence). Compared to alternative treatment, the evidence is very uncertain about the effect of doxapram on failed apnea reduction (RR 1.35, 95% CI 0.53 to 3.45; 4 studies, 84 participants; very low-certainty evidence). The evidence is very uncertain about the effect of doxapram on need for positive pressure ventilation after initiation of treatment (RR 2.40, 95% CI 0.11 to 51.32; 2 studies, 37 participants; very-low certainty evidence; note 1 study recorded 0 events in both groups. Thus, the RR and CIs were calculated from 1 study rather than 2). Doxapram may result in little to no difference in side effects causing cessation of therapy (0 events in all groups; RD 0.00, 95% CI -0.15 to 0.15; 37 participants; 2 studies; low-certainty evidence). As adjunct therapy to methylxanthine, the evidence is very uncertain about the effect of doxapram on failed apnea reduction after two to seven days (RR 0.08, 95% CI 0.01 to 1.17; 1 study, 10 participants; very low-certainty evidence). No studies reported on clinical apnea, chronic lung disease at 36 weeks' postmenstrual age (PMA), death at any time during initial hospitalization, long-term neurodevelopmental outcomes in the three comparisons, and need for positive pressure ventilation and side effects when used as adjunct therapy to methylxanthine. In studies to prevent reintubation, when compared to alternative treatment, the evidence is very uncertain about the effect of doxapram on failed extubation (RR 0.43, 95% CI 0.10 to 1.83; 1 study, 25 participants; very low-certainty evidence). As adjunct therapy to methylxanthine, doxapram may result in a slight reduction in 'clinical apnea' after initiation of treatment (RR 0.36, 95% CI 0.13 to 0.98; 1 study, 56 participants; low-certainty evidence). Doxapram may result in little to no difference in failed extubation (RR 0.92, 95% CI 0.52 to 1.62; 1 study, 56 participants; low-certainty evidence). The evidence is very uncertain about the effect of doxapram on side effects causing cessation of therapy (RR 6.42, 95% CI 0.80 to 51.26; 2 studies, 85 participants; very low-certainty evidence). No studies reported need for positive pressure ventilation, chronic lung disease at 36 weeks' PMA, long-term neurodevelopmental outcomes in the three comparisons; failed extubation when compared to no treatment; and clinical apnea, death at any time during initial hospitalization, and side effects when compared to no treatment or alternative treatment. We identified two ongoing studies, one conducted in Germany and one in multiple centers in the Netherlands and Belgium.
AUTHORS' CONCLUSIONS
In treating apnea of prematurity, doxapram may slightly reduce failure in apnea reduction when compared to no treatment and there may be little to no difference in side effects against both no treatment and alternative treatment. The evidence is very uncertain about the need for positive pressure ventilation when compared to no treatment or alternative treatment and about failed apnea reduction when used as alternative or adjunct therapy to methylxanthine. For use to prevent reintubation, doxapram may reduce apnea episodes when administered in adjunct to methylxanthine, but with little to no difference in failed extubation. The evidence is very uncertain about doxapram's effect on death when used as adjunct therapy to methylxanthine and about failed extubation when used as alternative or adjunct therapy to methylxanthine. There is a knowledge gap about the use of doxapram as a therapy to prevent apnea. More studies are needed to clarify the role of doxapram in the treatment of apnea of prematurity, addressing concerns about long-term outcomes. The ongoing studies may provide useful data.
Topics: Infant, Newborn; Humans; Doxapram; Apnea; Caffeine; Aminophylline; Infant, Premature; Lung Diseases
PubMed: 37877431
DOI: 10.1002/14651858.CD014145.pub2 -
European Urology Dec 2016Positron emission tomography (PET) of Ga-labelled prostate-specific membrane antigen (Ga-PSMA) is an emerging imaging modality introduced to assess the burden of... (Meta-Analysis)
Meta-Analysis Review
Sensitivity, Specificity, and Predictors of Positive Ga-Prostate-specific Membrane Antigen Positron Emission Tomography in Advanced Prostate Cancer: A Systematic Review and Meta-analysis.
CONTEXT
Positron emission tomography (PET) of Ga-labelled prostate-specific membrane antigen (Ga-PSMA) is an emerging imaging modality introduced to assess the burden of prostate cancer, typically in biochemically recurrent or advanced disease. Ga-PSMA PET provides the ability to selectively identify and localize metastatic prostate cancer cells and subsequently change patient management. Owing to its limited history, robust sensitivity and specificity data are not available for Ga-PSMA PET-positive scans.
OBJECTIVE
A systematic review and meta-analysis of reported predictors of positive Ga-PSMA PET and corresponding sensitivity and specificity profiles.
EVIDENCE ACQUISITION
We performed critical reviews of MEDLINE, EMBASE, ScienceDirect, Cochrane Library, and Web of Science databases in April 2016 according to the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) statement. Quality was assessed using the Quality Assessment if Diagnostic Accuracy Studies-2 tool. Meta-analysis and meta-regression of proportions were performed using a random-effects model with pre-PET prostate-specific antigen (PSA) levels as the dependent variable. Summary sensitivity and specificity values were obtained by fitting bivariate hierarchical regression models.
EVIDENCE SYNTHESIS
Sixteen articles involving 1309 patients were analysed. The overall percentage of positive Ga-PSMA PET among patients was 40% (95% confidence interval [CI] 19-64%) for primary staging and 76% (95% CI 66-85%) for biochemical recurrence (BCR). Positive Ga-PSMA PET scans for BCR patients increased with pre-PET PSA. For the PSA categories 0-0.2, 0.2-1, 1-2, and >2 ng/ml, 42%, 58%, 76%, and 95% scans, respectively, were positive. Shorter PSA doubling time increased Ga-PSMA PET positivity. On per-patient analysis, the summary sensitivity and specificity were both 86%. On per-lesion analysis, the summary sensitivity and specificity were 80% and 97%, respectively.
CONCLUSIONS
In the setting of BCR prostate cancer, pre-PET PSA predicts the risk of positive Ga-PSMA PET. Pooled data indicate favourable sensitivity and specificity profiles compared to choline-based PET imaging techniques.
PATIENT SUMMARY
Positron emission tomography using Ga-labelled prostate-specific membrane antigen is an emerging radiological technique developed to improve the characterisation of metastatic prostate cancer. We summarised the data available to date and found that this new test provides excellent rates of detection of cancer spread in late-stage prostate cancer.
Topics: Edetic Acid; Gallium Isotopes; Gallium Radioisotopes; Humans; Male; Oligopeptides; Positron-Emission Tomography; Prostatic Neoplasms; Sensitivity and Specificity
PubMed: 27363387
DOI: 10.1016/j.eururo.2016.06.021 -
Journal of the American Heart... Mar 2022Background EDTA is an intravenous chelating agent with high affinity to divalent cations (lead, cadmium, and calcium) that may be beneficial in the treatment of... (Meta-Analysis)
Meta-Analysis Review
Background EDTA is an intravenous chelating agent with high affinity to divalent cations (lead, cadmium, and calcium) that may be beneficial in the treatment of cardiovascular disease (CVD). Although a large randomized clinical trial showed benefit, smaller studies were inconsistent. We conducted a systematic review of published studies to examine the effect of repeated EDTA on clinical outcomes in adults with CVD. Methods and Results We searched 3 databases (MEDLINE, Embase, and Cochrane) from database inception to October 2021 to identify all studies involving EDTA treatment in patients with CVD. Predetermined outcomes included mortality, disease severity, plasma biomarkers of disease chronicity, and quality of life. Twenty-four studies (4 randomized clinical trials, 15 prospective before/after studies, and 5 retrospective case series) assessed the use of repeated EDTA chelation treatment in patients with preexistent CVD. Of these, 17 studies (1 randomized clinical trial) found improvement in their respective outcomes following EDTA treatment. The largest improvements were observed in studies with high prevalence of participants with diabetes and/or severe occlusive arterial disease. A meta-analysis conducted with 4 studies reporting ankle-brachial index indicated an improvement of 0.08 (95% CI, 0.06-0.09) from baseline. Conclusions Overall, 17 studies suggested improved outcomes, 5 reported no statistically significant effect of treatment, and 2 reported no qualitative benefit. Repeated EDTA for CVD treatment may provide more benefit to patients with diabetes and severe peripheral arterial disease. Differences across infusion regimens, including dosage, solution components, and number of infusions, limit comparisons across studies. Additional research is necessary to confirm these findings and to evaluate the potential mediating role of metals. Registration URL: https://www.crd.york.ac.uk/; Unique identifier: CRD42020166505.
Topics: Adult; Cardiovascular Diseases; Chelation Therapy; Edetic Acid; Humans; Prospective Studies; Quality of Life; Randomized Controlled Trials as Topic; Retrospective Studies
PubMed: 35229619
DOI: 10.1161/JAHA.121.024648 -
Alzheimer's & Dementia : the Journal of... May 2021Schizophrenia is a chronic neuropsychiatric brain disorder that has devastating personal impact and rising healthcare costs. Dysregulation of glutamatergic...
Schizophrenia is a chronic neuropsychiatric brain disorder that has devastating personal impact and rising healthcare costs. Dysregulation of glutamatergic neurotransmission has been implicated in the pathobiology of the disease, attributed largely to the hypofunction of the N-methyl-d-aspartate (NMDA) receptor. Currently, there is a major gap in mechanistic analysis as to how endogenous modulators of the NMDA receptors contribute to the onset and progression of the disease. We present a systematic review of the neurobiology and the role of endogenous NMDA receptor antagonists in animal models of schizophrenia, and in patients. We discuss their neurochemical origin, release from neurons and glia with action mechanisms, and functional effects, which might contribute toward the impairment of neuronal processes underlying this complex pathological state. We consider clinical evidence suggesting dysregulations of endogenous NMDA receptor in schizophrenia, and highlight the pressing need in future studies and emerging directions, to restore the NMDA receptor functions for therapeutic benefits.
Topics: Animals; Brain; Disease Models, Animal; Humans; Neurons; Receptors, N-Methyl-D-Aspartate; Schizophrenia
PubMed: 33336545
DOI: 10.1002/alz.12244 -
Indian Journal of Pharmacology 2019Suicide is a public health problem, and the number of paraphenylenediamine (PPD)-containing hair dye poisoning with suicidal intentions is increasing in developing... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Suicide is a public health problem, and the number of paraphenylenediamine (PPD)-containing hair dye poisoning with suicidal intentions is increasing in developing countries. In order to better understand this situation, we aimed to conduct a systematic review and meta-analysis to estimate the prevalence and complications associated with hair dye poisoning in developing countries.
METHODS
We conducted a systematic review of epidemiological studies using MeSh terms and text keywords to identify studies from the inception to March 2016 about hair dye poisoning with suicidal intentions in developing countries. A meta-analysis was used to calculate the pooled prevalence proportion of hair dye poisoning and its major complications. Data extraction, data analysis, and risk of bias assessment were performed.
RESULTS
Thirty-two studies were included in the systematic review and 29 of these studies containing 5,559 subjects covering six countries were included in the meta-analysis. The pooled prevalence proportion of hair dye poisoning with suicidal intentions was 93.5% (95% confidence interval [CI] = 91.6-95.4) with a mortality rate of 14.5% (95% CI = 11.1-17.9). Of these, 73.8% were female, and 26.2% were male (sex ratio: 2.7:1). The occurrence of angioneurotic edema in hair poisoning patients was 67.1% (95% CI = 56.6-77.6), and tracheostomy intervention was considered in 47.9% (95% CI = 22.7-73.2) patients with respiratory distress. Acute renal failure was noticed in 54.7% (95% CI = 34.5-74.9) of the pooled samples and mortality rates were 14.5% (95% CI = 11.1-17.9). The pooled rate of the population studied from Asia and Africa showed 94.6% (95% CI = 92.5-96.7) and 82.9% (95% CI = 70.6-95.3), respectively, ingested hair dye with suicidal intentions. Further, studies carried out in Africa showed slightly higher mortality of 15.1% (95% CI = 6.56-23.7) than the Asians 14.3% (95% CI = 10.5-18.1).
CONCLUSION
This meta-analysis provided clear evidence of the prevalence of hair dye poisoning among individuals with suicidal intentions and had given robust evidence for policy making to curtail emerging PPD-containing hair dye poisoning in developing countries.
Topics: Developing Countries; Female; Hair Dyes; Humans; Male; Phenylenediamines; Prevalence; Suicide, Attempted
PubMed: 31831919
DOI: 10.4103/ijp.IJP_246_17 -
Journal of Nuclear Medicine : Official... Jun 2016Neuroendocrine tumors (NETs) are uncommon tumors with increasing incidence and prevalence. Current reports suggest that (68)Ga-DOTATATE PET/CT imaging improves diagnosis... (Comparative Study)
Comparative Study Meta-Analysis Review
68Ga-DOTATATE Compared with 111In-DTPA-Octreotide and Conventional Imaging for Pulmonary and Gastroenteropancreatic Neuroendocrine Tumors: A Systematic Review and Meta-Analysis.
UNLABELLED
Neuroendocrine tumors (NETs) are uncommon tumors with increasing incidence and prevalence. Current reports suggest that (68)Ga-DOTATATE PET/CT imaging improves diagnosis and staging of NETs compared with (111)In-DTPA-octreotide and conventional imaging. We performed a systematic review of (68)Ga-DOTATATE for safety and efficacy compared with octreotide and conventional imaging to determine whether available evidence supports U.S. Food and Drug Administration approval.
METHODS
Medline, EMBASE, Web of Science, and Cochrane Reviews electronic databases were searched from January 1999 to September 2015. Results were restricted to human studies comparing diagnostic accuracy of (68)Ga-DOTATATE with octreotide or conventional imaging for pulmonary or gastroenteropancreatic NET and for human studies reporting safety/toxicity for (68)Ga-DOTATATE with 10 subjects or more thought to have NETs. Direct communication with corresponding authors was attempted to obtain missing information. Abstracts meeting eligibility criteria were collected by a research librarian and assembled for reviewers; 2 reviewers independently determined whether or not to include each abstract. If either reviewer chose inclusion, the abstract was accepted for review.
RESULTS
Database and bibliography searches yielded 2,479 articles, of which 42 were eligible. Three studies compared the 2 radiopharmaceuticals in the same patient, finding (68)Ga-DOTATATE to be more sensitive than octreotide. Nine studies compared (68)Ga-DOTATATE with conventional imaging. (68)Ga-DOTATATE estimated sensitivity, 90.9% (95% confidence interval, 81.4%-96.4%), and specificity, 90.6% (95% confidence interval, 77.8%-96.1%), were high. Five studies were retained for safety reporting only. Report of harm possibly related to (68)Ga-DOTATATE was rare (6 of 974), and no study reported major toxicity or safety issues.
CONCLUSION
No direct comparison of octreotide and (68)Ga-DOTATATE imaging for diagnosis and staging in an unbiased population of NETs has been published. Available information in the peer-reviewed literature regarding diagnostic efficacy and safety supports the use of (68)Ga-DOTATATE for imaging of NETs where it is available.
Topics: Humans; Intestinal Neoplasms; Lung Neoplasms; Neuroendocrine Tumors; Octreotide; Organometallic Compounds; Pancreatic Neoplasms; Pentetic Acid; Positron Emission Tomography Computed Tomography; Stomach Neoplasms
PubMed: 26769864
DOI: 10.2967/jnumed.115.165803 -
European Radiology Aug 2022The definition of washout in gadoxetate disodium-enhanced MRI (Gd-EOB-MRI) is controversial. The current Liver Imaging Reporting and Data System (LI-RADS) defines... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
The definition of washout in gadoxetate disodium-enhanced MRI (Gd-EOB-MRI) is controversial. The current Liver Imaging Reporting and Data System (LI-RADS) defines washout only in the portal venous phase on Gd-EOB-MRI, leading to low diagnostic sensitivity for HCC. We performed a meta-analysis to compare the diagnostic performance of Gd-EOB-MRI using conventional (cWO) and modified (mWO) definitions of washout.
METHODS
The PubMed and EMBASE databases were searched to identify studies published between January 1, 2010, and August 1, 2021, that compared the diagnostic performance of cWO and mWO for HCC. The mWOs added transition phase (TP) hypointensity (mWO-1), hepatobiliary phase (HBP) hypointensity (mWO-2), or both (mWO-3). The pooled sensitivity and specificity were calculated using a bivariate random-effects model. Study heterogeneity was explored by subgroup analysis and meta-regression analysis.
RESULTS
Ten comparative studies with 2391 patients were included. Compared to cWO, the overall mWO yielded significantly higher sensitivity (71% vs. 81%, p = 0.00) and lower specificity (97% vs. 93%, p = 0.01) for diagnosing HCC. The area under the curve (AUC) was 0.90 and 0.94 for the cWO and mWO, respectively. Regarding the three types of mWOs, mWO-2 showed the highest sensitivity (85%) and specificity (96%) for diagnosing HCC. mWO-2 achieved the highest AUC (0.97), followed by mWO-1 (0.90), and mWO-3 (0.89). Average reviewer experience and scanner field strength were significantly associated with study heterogeneity (p < 0.05).
CONCLUSIONS
Inclusion of TP and HBP hypointensity in the definition of washout improved the sensitivity with slightly lower specificity for diagnosing HCC in LI-RADS.
KEY POINTS
• Compared to the conventional definition of washout, studies using a modified definition had higher sensitivity (71% vs. 81%) but lower specificity (97% vs. 93%) in LI-RADS for the diagnosis of HCC. • Hepatobiliary phase hypointensity may be a preferred alternative washout for HCC diagnosis with the highest area under the curve. • Studies with experienced reviewer or 3.0T MRI showed higher sensitivity and lower specificity for diagnosing HCC when using modified washout (p < 0.05).
Topics: Carcinoma, Hepatocellular; Contrast Media; Gadolinium DTPA; Humans; Liver Neoplasms; Magnetic Resonance Imaging; Retrospective Studies; Sensitivity and Specificity
PubMed: 35267090
DOI: 10.1007/s00330-022-08665-y