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1.
Intern Med J ; 53(7): 1218-1223, 2023 07.
Article in English | MEDLINE | ID: mdl-34897942

ABSTRACT

BACKGROUND: Conventional pull-through percutaneous endoscopic gastrostomy (PEG) risks infection and tumour implantation in head and neck cancers. Endoscopically inserted direct gastrostomy has lower rates of complications but is underutilised. AIMS: To describe the endoscopic steps for direct gastrostomy insertion and review our single-centre experience to assess the technical feasibility and safety. METHODS: Patients who underwent endoscopic direct gastrostomy insertion between December 2016 and June 2021 were included. A 24Fr introducer kit for gastrostomy feeding tube (Avanos Healthcare, Australia) was used. Patient and tumour characteristics, procedural data and 30-day outcomes were recorded. RESULTS: Thirty patients underwent direct PEG insertion (mean age 64 years and 24 male). All were planned for or currently undergoing radiotherapy. Twenty-six (87%) of 30 cases were performed under conscious sedation over a median procedure time of 21 min (interquartile range 11 min). No tumour seeding was seen, and one case of PEG-site infection was observed. CONCLUSIONS: Direct PEG is safe and effective and should be considered for patients with aerodigestive tract cancer in need of nutritional support.


Subject(s)
Gastrostomy , Head and Neck Neoplasms , Humans , Male , Middle Aged , Gastrostomy/methods , Nutritional Support , Head and Neck Neoplasms/surgery , Retrospective Studies , Australia/epidemiology
2.
Eur J Vasc Endovasc Surg ; 64(6): 666-683, 2022 12.
Article in English | MEDLINE | ID: mdl-35952907

ABSTRACT

OBJECTIVE: To assess the comparative effectiveness and temporal changes in quality of life (QoL) outcomes after revascularisation, major lower extremity amputation (MLEA), and conservative management (CM) in chronic limb threatening ischaemia (CLTI). DATA SOURCES: MEDLINE, Embase, PsycINFO, CINAHL, and Web of Science. REVIEW METHODS: A systematic review and meta-analysis were performed on QoL measured by any QoL instrument in adult patients with CLTI after open surgery (OS), endovascular intervention (EVI), MLEA, or CM. Randomised controlled trials and prospective observational studies published in any language between 1 January 1990 and 21 May 2021 were included. There was a pre-specified measurement time point of six months. Random effects meta-analysis was conducted on total scores for each QoL instrument. Certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluations approach (PROSPERO registration: CRD42021253953). RESULTS: Fifty-five studies with 8 909 patients were included. There was significant heterogeneity in the methods used to measure QoL, and the study characteristics. In particular, 14 different QoL instruments were used with various combinations of disease specific and generic instruments within each study. A narrative summary is therefore presented. Comparative effectiveness data showed there was reasonable certainty that QoL was similar between OS and EVI at six months. Temporal outcomes suggested small to moderate improvements in QOL six months after OS and EVI compared with baseline. Limited data indicated that QoL can be maintained or slightly improved after MLEA or CM. Treatment effects were overestimated owing to small study effects, selective non-reporting, attrition, and survivorship bias. CONCLUSION: QoL after OS and EVI appears to be similar. Revascularisation may provide modest QoL benefits, while MLEA or CM can maintain QoL. However, certainty of evidence is generally low or very low, and interpretation is hampered by significant heterogeneity. There is a need for a CLTI specific QoL instrument and methodological standardisation in QoL studies.


Subject(s)
Chronic Limb-Threatening Ischemia , Quality of Life , Humans , Amputation, Surgical , Vascular Surgical Procedures , Conservative Treatment , Observational Studies as Topic
3.
Endosc Int Open ; 10(7): E1004-E1013, 2022 Jul.
Article in English | MEDLINE | ID: mdl-35845028

ABSTRACT

Background and aims Artificial intelligence (AI) technology is being evaluated for its potential to improve colonoscopic assessment of inflammatory bowel disease (IBD), particularly with computer-aided image classifiers. This review evaluates the clinical application and diagnostic test accuracy (DTA) of AI algorithms in colonoscopy for IBD. Methods A systematic review was performed on studies evaluating AI in colonoscopy of adult patients with IBD. MEDLINE, Embase, Emcare, PsycINFO, CINAHL, Cochrane Library and Clinicaltrials.gov databases were searched on 28 th April 2021 for English language articles published between January 1, 2000 and April 28, 2021. Risk of bias and applicability were assessed with the Quality Assessment of Diagnostic Accuracy Studies-2 tool. Diagnostic accuracy was presented as median (interquartile range). Results Of 1029 records screened, nine studies with 7813 patients were included for review. AI was used to predict endoscopic and histologic disease activity in ulcerative colitis, and differentiation of Crohn's disease from Behcet's disease and intestinal tuberculosis. DTA of AI algorithms ranged between 52-91 %. The sensitivity and specificity for AI algorithms predicting endoscopic severity of disease were 78 % (range 72-83, interquartile range 5.5) and 91 % (range 86-96, interquartile range 5), respectively. Conclusions AI has been primarily used to assess disease activity in ulcerative colitis. The diagnostic performance is promising and suggests potential for other clinical application of AI in IBD colonoscopy such as dysplasia detection. However, current evidence is limited by retrospective data and models trained on still images only. Future prospective multicenter studies with full-motion videos are needed to replicate the real-world clinical setting.

4.
Gastrointest Endosc ; 96(3): 467-475.e1, 2022 09.
Article in English | MEDLINE | ID: mdl-35413331

ABSTRACT

BACKGROUND AND AIMS: Guidelines on quality of upper GI (UGI) endoscopy have been proposed by the British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE). However, these guidelines have not been evaluated in clinical practice. We aimed to measure the impact of endoscopist education on the quality of gastroscopy based on these guidelines and the association between compliance with guidelines and the detection of clinically significant premalignant pathology such as Barrett's esophagus (BE), esophageal squamous dysplasia, gastric intestinal metaplasia (GIM), and Helicobacter pylori. METHODS: Endoscopists participated in a 1-hour education session on recommended performance measures and endoscopic detection of premalignant pathologies. A controlled before and after study was performed, measuring compliance with guidelines and rates of detection of pathology in control and intervention groups. RESULTS: Over 2 years, 2719 procedures were performed: 1412 in the control group and 1307 in the intervention group. The proportion of procedures complying with guidelines was higher in the intervention group. The use of biopsy sampling protocols (eg, management of precancerous conditions of the stomach, 52% vs 91%; P = .007) and standardized terminology (eg, Forrest classification, 24% vs 68%; P < .001) was significantly higher. Detection of H pylori was higher in the intervention group (5.5% vs 9.8%, P = .003). Minimum inspection time of 7 minutes was associated with detection of BE (7.4% vs 2.0%, P < .001). CONCLUSIONS: A simple endoscopist education session enhanced the quality of UGI endoscopy by improving compliance with BSG and ESGE recommendations and increasing the detection of clinically significant pathology. A minimum inspection time of 7 minutes was associated with increased diagnostic yield and may be a feasible quality indicator for clinical practice.


Subject(s)
Barrett Esophagus , Helicobacter pylori , Precancerous Conditions , Barrett Esophagus/diagnosis , Barrett Esophagus/pathology , Endoscopy, Gastrointestinal/methods , Humans , Metaplasia/diagnosis , Precancerous Conditions/pathology , Prospective Studies
5.
J Clin Gastroenterol ; 56(5): 412-418, 2022.
Article in English | MEDLINE | ID: mdl-34334762

ABSTRACT

GOAL: The aim of this study was to evaluate current practice in gastric ulcer follow-up to establish diagnostic yield and predictors of malignancy. BACKGROUND: Repeat gastroscopy is routinely performed to confirm gastric ulcer healing and exclude malignancy. However, the incidence of malignancy at follow-up endoscopy is low, without consensus regarding case selection and timing. STUDY: New gastric ulcers diagnosed on gastroscopy at 2 institutions in Australia were identified through keyword search of endoscopy reports over a 5-year period (2013 to 2017). Data collected included patient demographics, clinical presentation, and endoscopic and histologic findings from initial and subsequent gastroscopies. RESULTS: Of 795 patients, repeat gastroscopy was performed in 440 (55%). Malignancy was diagnosed in 52 (7%) with 83% identified at initial gastroscopy. Eight cancers were identified at repeat gastroscopy with malignancy yield of 2% (8/440). Three were diagnosed in patients with benign initial ulcer histology (3/286, 1%). One cancer was diagnosed during follow-up in a patient with benign histology but no repeat gastroscopy (1/286, 0.3%). Predictors of benign ulcers were absence of endoscopic suspicion [odds ratio (OR) 0.1 (0.03-0.13), P≤0.005], complete healing on repeat gastroscopy [OR 0.5 (0.34-0.70), P=0.036] and benign initial histology [OR 0.12 (0.43-0.90), P≤0.005]. CONCLUSIONS: Seven percent of new gastric ulcers were malignant with most identified with biopsy on initial gastroscopy. Malignancy yield from follow-up gastroscopy was 2%. Diagnostic yield of endoscopic follow-up may be low in ulcers with benign appearance and adequate histology. However, current practice of repeat gastroscopy is warranted in the absence of patient-based and lesion-based predictors of malignancy.


Subject(s)
Stomach Neoplasms , Stomach Ulcer , Follow-Up Studies , Gastroscopy , Humans , Stomach Neoplasms/pathology , Stomach Ulcer/diagnosis , Ulcer
6.
J Gastroenterol Hepatol ; 36(10): 2813-2818, 2021 Oct.
Article in English | MEDLINE | ID: mdl-34022773

ABSTRACT

BACKGROUND AND AIMS: Endoscopic submucosal dissection (ESD) is the recommended treatment for early gastric cancer (EGC). However, there are challenges in attaining expertise in ESD in countries where the incidence of gastric cancer and proportion diagnosed at an early stage of disease are relatively low. This study aims to establish the proportion of gastric cancer meeting histological criteria for EGC, which may be suitable for ESD, in a Western population. METHODS: Gastric cancers reported to the Victorian Cancer Registry between January 2011 and December 2016 were analyzed. EGC was defined as tumor confined to mucosa (T1a) or submucosa (T1b). Histology reports were analyzed using Japanese and European guidelines to identify potential ESD candidates. Criteria for extended ESD were based on grade of differentiation, tumor depth, lymphovascular and perineural invasion, and ulceration. RESULTS: Twenty percent of 1217 gastric cancers was EGC (237 cases), with detailed histopathology reports suitable for evaluating ESD criteria recorded in 182 cases. Standard and extended ESD criteria were met in 46% (84/182) and 75% (132/182), respectively. Actual treatment of the 237 EGC was endoscopic in 14% (n = 33) and surgery in 86% (n = 204). Endoscopically treated EGCs were more likely to be stage T1a and located in the proximal stomach. CONCLUSIONS: EGCs represented 20% of reported gastric adenocarcinomas with the majority fulfilling criteria for ESD. ESD should be considered in the management algorithm and discussed at tumor board meetings involving interventional endoscopists. To increase utilization of ESD, systems need to be implemented to improve training, accreditation, and access to ESD.


Subject(s)
Adenocarcinoma , Endoscopic Mucosal Resection , Stomach Neoplasms , Gastric Mucosa/surgery , Humans , Retrospective Studies , Stomach Neoplasms/epidemiology , Stomach Neoplasms/surgery , Treatment Outcome
7.
Gastrointest Endosc ; 94(1): 14-21, 2021 07.
Article in English | MEDLINE | ID: mdl-33373645

ABSTRACT

BACKGROUND AND AIMS: Buried Barrett's mucosa is defined as intestinal metaplasia that is "buried" under the normal-appearing squamous epithelium. This can occur in Barrett's esophagus with or without previous endoscopic therapy. Dysplasia and neoplasia within buried Barrett's mucosa have also been reported. However, endoscopic features of buried Barrett's mucosa have not been described. At our tertiary referral center for Barrett's esophagus, several endoscopic features have been observed in patients who were found to have buried Barrett's mucosa on histology. These features are squamous epithelium which is (1) darker pink on white-light and darker brown on narrow-band imaging and/or (2) has a slightly raised or nodular appearance. It was also observed that either of these 2 features is frequently seen adjacent to a Barrett's mucosa island. This study aimed to (1) evaluate the diagnostic accuracy of these endoscopic features, and (2) evaluate the frequency of endoscopically identifiable buried Barrett's mucosa in patients with dysplastic Barrett's esophagus, before and after endoscopic eradication therapy. METHODS: This was a retrospective analysis of a prospectively observed cohort of all cases of dysplastic Barrett's esophagus referred to St Vincent's Hospital, Melbourne. Endoscopy documentation software and histopathology reports of esophageal biopsy and EMR specimens between March 2013 and March 2019 were searched for terms "buried" or "subsquamous" Barrett's mucosa. Endoscopic reports, images, and histopathology reports of suspected buried Barrett's mucosa were then reviewed to apply the endoscopic features and correlate with the histologic diagnosis. RESULTS: In a cohort of 506 patients with dysplastic Barrett's esophagus, 33 (7%) patients (73% male, median age at referral 70.5 years) had buried Barrett's mucosa on histology. Twenty-seven (82%) patients had previous treatment for dysplastic Barrett's esophagus; radiofrequency in 2 (6%), EMR in 4 (12%), and both modalities in 21 (64%). Six (18%) had no previous treatment. Histologically confirmed buried Barrett's mucosa was suspected at endoscopy in 26 patients (79%). Endoscopic features were (1) darker pink or darker brown mucosa underneath squamous epithelium (24%), (2) raised areas underneath squamous mucosa (27%), and both features present concurrently (27%). These features were associated with adjacent islands of Barrett's esophagus in 48%. Forty-four cases of buried Barrett's mucosa were suspected endoscopically, and these were sampled by biopsy (50%) and EMR (50%). Buried Barrett's mucosa was confirmed in 26 cases, with a positive predictive value of endoscopic suspicion of 59%. Eighteen cases of endoscopically suspected buried Barrett's mucosa had no buried Barrett's mucosa on histology; inflammation or reflux was identified in 12 (67%) patients. Dysplasia was identified within buried Barrett's mucosa in 12 (36%) patients; 5 intramucosal adenocarcinoma, 1 high-grade dysplasia, and 6 low-grade dysplasia. Endoscopic features of buried Barrett's mucosa were observed in 11 of 12 cases harboring dysplasia or neoplasia, compared with 15 of 21 cases of buried Barrett's mucosa without dysplasia. CONCLUSIONS: In this retrospective analysis of prospectively observed patients with dysplastic Barrett's esophagus, buried Barrett's mucosa was identified in 7%, including treatment-naive patients. The proposed endoscopic features of buried Barrett's mucosa were seen in 79% of patients with histology confirmed disease. These endoscopic features may predict the presence of buried Barrett's mucosa, which may contain dysplasia or neoplasia. An overlap between the endoscopic features of inflammation, reflux, and buried Barrett's mucosa was observed. Future prospective studies are required to develop and validate endoscopic criteria for identifying buried Barrett's mucosa.


Subject(s)
Barrett Esophagus , Esophageal Neoplasms , Precancerous Conditions , Esophagoscopy , Female , Humans , Male , Mucous Membrane , Prospective Studies , Retrospective Studies
8.
JGH Open ; 4(3): 345-350, 2020 Jun.
Article in English | MEDLINE | ID: mdl-32514435

ABSTRACT

In 1991, Genta and Haggitt described four patients with segmental ischemic colitis caused by idiopathic myointimal hyperplasia in the small mesenteric veins (IMHMV). There are now 33 published cases of IMHMV in the literature; however, this condition is still sufficiently rare that it poses a diagnostic challenge to pathologists and clinicians and is often clinically or histologically confused with inflammatory bowel disease (IBD) or ischemic colitis. IMHMV is characterized by intimal smooth muscle hyperplasia resulting in thickened small and medium-sized mesenteric veins (with arterial sparing). Clinically, it presents with symptoms that mimic IBD, such as bloody diarrhea, abdominal pain, and weight loss. Surgical resection appears to be curative. The present case describes a 63-year-old Vietnamese man with cardiovascular risk factors who was diagnosed with IMHMV after many months of severe symptoms. A review of the current literature follows the case report.

9.
Intern Med J ; 48(9): 1056-1063, 2018 09.
Article in English | MEDLINE | ID: mdl-29468795

ABSTRACT

BACKGROUND: Cirrhosis was previously perceived as a haemorrhagic disease state due to frequent associations with coagulopathy and bleeding. However, the coagulopathy of cirrhosis is complex with defects in both procoagulant and anticoagulant factors. Derangements in common laboratory indices of coagulation do not accurately reflect bleeding risk or protection from thrombotic events. AIMS: To assess the rate of pharmacological prophylaxis for venous thromboembolism (VTE) among hospital inpatients with cirrhosis and analyse factors associated with prophylaxis being inappropriately withheld. METHODS: A retrospective cohort study was performed in a tertiary teaching hospital. Patients included were admitted for greater than 48 h with discharge diagnosis codes corresponding to chronic liver disease and/or cirrhosis. The use of VTE chemoprophylaxis with enoxaparin was assessed in cirrhotic patients and non-cirrhotic controls. Patient data collected included contraindications to prophylaxis, known high-risk varices, international normalised ratio (INR), creatinine, bilirubin, haemoglobin and platelet count. RESULTS: Of 108 patients with cirrhosis eligible for VTE prophylaxis, 61 (56.5%) received prophylaxis compared to 104 (96.3%) non-cirrhotic patients. Platelets and INR were significantly different between those who did and did not receive VTE prophylaxis. On multivariate analysis, platelet count and INR were independent predictors for VTE not being administered. CONCLUSION: The administration of chemoprophylaxis in accordance with the hospital guidelines was suboptimal in patients with cirrhosis. Platelet count and INR were independent predictors of prophylaxis use. Our results suggest persistent misperceptions that prolonged INR and thrombocytopenia predict bleeding risk in cirrhosis.


Subject(s)
Anticoagulants/therapeutic use , Enoxaparin/therapeutic use , Guideline Adherence/statistics & numerical data , Hemorrhage/epidemiology , Liver Cirrhosis/complications , Venous Thromboembolism/prevention & control , Adult , Aged , Aged, 80 and over , Female , Hospitals, Teaching , Humans , International Normalized Ratio , Male , Middle Aged , Multivariate Analysis , Prognosis , Retrospective Studies , Risk Assessment , Tertiary Care Centers
11.
World J Gastroenterol ; 22(39): 8844-8848, 2016 Oct 21.
Article in English | MEDLINE | ID: mdl-27818600

ABSTRACT

Cyclophosphamide is a potent cytotoxic agent used in many clinical settings. The main risks of cyclophosphamide therapy include hematological disorders, infertility, hemorrhagic cystitis and malignancies. Gastrointestinal side effects reported to date are often non-specific and not severe. We present the first case of a fatal small bowel enteritis and pan-colitis which appears to be associated with cyclophosphamide. We aim to raise the readers' awareness of this significant adverse event to facilitate clinical suspicion and early recognition in potential future cases.


Subject(s)
Cyclophosphamide/adverse effects , Enteritis/chemically induced , Enteritis/complications , Antineoplastic Agents/adverse effects , Diagnosis, Differential , Endoscopy , Fatal Outcome , Glomerulonephritis/complications , Glomerulonephritis/drug therapy , Humans , Intestines/physiopathology , Male , Middle Aged , Tomography, X-Ray Computed
12.
Surg Oncol ; 25(3): 281-97, 2016 Sep.
Article in English | MEDLINE | ID: mdl-27566035

ABSTRACT

BACKGROUND: Radical cystectomy and urinary diversion is the treatment of choice for invasive bladder cancer. Quality of life (QOL) is an important outcome of surgery. This review compares the QOL after continent and incontinent urinary diversion in radical cystectomy for patients with primary invasive bladder cancer. METHODS: A systematic review and meta-analysis of clinical studies published after January 2000 was performed according to the PRISMA guidelines. Quality appraisal and data tabulation were performed using pre-determined forms. Data were synthesised by narrative review and random-effects meta-analysis using standardized response means. Heterogeneity and bias was assessed by Tau(2) and I(2) values and Funnel plots. RESULTS: Twenty-nine studies (3754 patients) were included for review. Pooled post-operative FACT and SF-36 scores showed no difference in overall QOL between continent and incontinent diversion (p = 0.31). Subgroup analysis demonstrated greater improvement in physical health for incontinent (p = 0.002) compared to continent diversions, but no differences in mental health (p = 0.35) and social health (p = 0.81). Qualitative analysis showed patients with neobladder had superior emotional function and body image compared to cutaneous diversion. QOL may improve to similar or better levels compared to baseline after 1 year, but data remains scarce. Patients report poor urinary and sexual function after surgery compared the general population. Long-term QOL is unclear. Levels of heterogeneity and bias were low. CONCLUSIONS: QOL after radical cystectomy is comparable after either continent or incontinent urinary diversion. Post-operative QOL may improve, but urinary and sexual dysfunction remains inferior to the general population. Patient choice is key to selection of reconstruction method.


Subject(s)
Cystectomy/methods , Quality of Life , Urinary Bladder Neoplasms/surgery , Humans , Prognosis
13.
Liver Int ; 34(9): 1298-313, 2014 Oct.
Article in English | MEDLINE | ID: mdl-24703371

ABSTRACT

BACKGROUND & AIMS: Liver transplantation is the only curative intervention for terminal liver disease. Accurate long-term quality of life (QOL) data are required in the context of improved surgical outcomes and increasing post-transplant survival. This study reviews the long-term QOL after primary liver transplantation in adult patients surviving 5 or more years after surgery. METHODS: A literature search was conducted on PubMed for all studies matching the eligibility criteria between January 2000 and October 2013. Bibliographies of included studies were also reviewed. Two authors independently performed screening of titles and abstracts. Consensus for studies included for review was achieved by discussion between authors based on predetermined eligibility criteria. Quality appraisal and data tabulation were performed using predetermined forms. Results were synthesized by narrative review. RESULTS: Twenty-three studies (5402 patients) were included. QOL following liver transplantation remains superior to preoperative status up to 20 years post-operatively. More post-operative complications predicted worse QOL scores especially in physical domains. Benefits in functional domains persist long-term with independence in self-care and mobility. Employment rates recover in the short-term but decline after 5 years, and differ significantly between various aetiologies of liver disease. Overall QOL improves to a similar level as the general population, but physical function remains worse. Participation in post-operative physical activity is associated with superior QOL outcomes in liver transplant recipients compared to the general population. QOL improvements are similar compared to lung, kidney and heart transplantation. Heterogeneity between studies precluded quantitative analysis. CONCLUSIONS: Liver transplantation confers specific long-term QOL and functional benefits when compared to preoperative status. This information can assist in providing a more complete estimate of the overall health of liver transplant recipients and the effectiveness of surgery. Guidelines for future studies are provided.


Subject(s)
End Stage Liver Disease/surgery , Liver Transplantation/psychology , Quality of Life/psychology , Adult , Humans , Liver Transplantation/methods , Time Factors , Treatment Outcome
14.
Curr Opin Pediatr ; 24(5): 609-14, 2012 Oct.
Article in English | MEDLINE | ID: mdl-22828183

ABSTRACT

PURPOSE OF REVIEW: Therapeutic options and approaches in inflammatory bowel disease (IBD) continue to evolve. This review will summarize the recent studies of treatment strategies, efficacy, safety and outcome of biological agents in the treatment of children with Crohn's disease and ulcerative colitis. RECENT FINDINGS: Although there has been little recent change in the number of biologicals easily available for the treatment of children, usage has broadened in pediatric IBD and new treatment strategies have emerged. The use of biologicals in refractory pediatric ulcerative colitis is now accepted, with evidence supporting their potential for maintenance therapy. In pediatric Crohn's disease, scheduled treatment regimens have shown superiority to episodic treatment. Although the 'top-down' approach with early use of biologicals produces superior remission rates in adults, there is still little evidence in children. Concomitant immunosuppression appears to reduce immunogenicity and improve therapeutic control, but there are added risks for infection and malignancy. SUMMARY: Biologicals now form an integral part of the treatment algorithm in childhood IBD and their use is likely to increase. Treatment regimens, particularly those involving concomitant immunosuppressants, need to take account of the perceptions of risk.


Subject(s)
Biological Products/therapeutic use , Colitis, Ulcerative/drug therapy , Crohn Disease/drug therapy , Gastrointestinal Agents/therapeutic use , Adalimumab , Adolescent , Antibodies, Monoclonal/therapeutic use , Antibodies, Monoclonal, Humanized/therapeutic use , Child , Child, Preschool , Colitis, Ulcerative/immunology , Colitis, Ulcerative/physiopathology , Crohn Disease/immunology , Crohn Disease/physiopathology , Evidence-Based Medicine , Female , Humans , Infant , Infliximab , Male , Natalizumab , Treatment Outcome , Tumor Necrosis Factor-alpha/antagonists & inhibitors
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