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1.
Evid Based Dent ; 2022 Dec 08.
Article in English | MEDLINE | ID: mdl-36482194

ABSTRACT

Introduction The aim of this systematic review and meta-analysis was to evaluate the effects of maxillary expansion on adults with obstructive sleep apnoea (OSA).Methods Electronic searches up to July 2021 in eight electronic databases were conducted. Study selection, data extraction, risk of bias evaluation using ROBINS-I, quality of evidence assessment using GRADE and meta-analyses were performed.Results The electronic searches yielded 1,007 studies. Following the application of the eligibility criteria, 15 articles were fully read and five studies were included. The studies evaluated the effects of surgically assisted rapid maxillary expansion in adults with OSA. The meta-analysis demonstrated an improvement in Apnoea-Hypopnea Index (AHI) (MD = -9.91, CI = -14.57 to -5.25), Oxygen Desaturation Index (ODI) (MD = -7.95, CI = -12.23 to -3.67), and Epworth Sleepiness Scale (ESS) (MD = -4.40, CI = -6.39 to -2.40). ROBINS-I indicated serious, no information and critical risk of bias for the included studies. The quality of the evidence was very low.Conclusion The findings herein suggest that maxillary expansion could improve OSA in adults in the short term.

2.
Oral Oncol ; 130: 105936, 2022 07.
Article in English | MEDLINE | ID: mdl-35662028

ABSTRACT

The present study is a systematic review of the evaluation of screening programs as a strategy for early detection of oral cancer. The aim of this study was to assess whether screening through visual inspection is able to identify injuries in early stages, to increase survival, and to decrease the incidence and mortality of oral cancer. Studies using visual inspection to screen for oral cancer and potentially malignant lesions in apparently healthy individuals over 18 years without previous diagnosis of the disease were included. The MEDLINE/PubMed, Cochrane databases Library, EMBASE, and LILACS, including manual search and gray literature, were searched through January 2021 with no language or date restrictions. The risk of bias and the methodological quality were evaluated according to the appropriate tool for each study design. The analysis of the results was narrative. Seventeen studies were reviewed that included cohort, accuracy, and randomized clinical trial studies. The tracking type performed was opportunistic and organized in a variety of environments. The age of participants ranged between 18 and 60 years old and, in some programs, only people with risk habits for oral cancer were included. The screeners were healthcare professionals, physicians, and dentists. Two studies reported data on the incidence rate of severe cases and mortality and showed a reduction when patients were at risk for the disease and participated in the program more than once. A limitation of this review was the great variability observed in the estimates of the screening effectiveness among the studies, which made comparisons difficult. If a screening program is continuous and able to ensure the inclusion of high-risk individuals, it can contribute to improvement in survival rates with a change of stage and can have a significant impact on incidence and mortality due to the disease. Registration in the Open Science Framebook (OSF) with the osf.io/zg8nr link.


Subject(s)
Early Detection of Cancer , Mouth Neoplasms , Adolescent , Adult , Health Status , Humans , Mass Screening/methods , Middle Aged , Physical Examination/methods , Randomized Controlled Trials as Topic , Young Adult
3.
Eur J Clin Pharmacol ; 77(12): 1765-1781, 2021 Dec.
Article in English | MEDLINE | ID: mdl-34292359

ABSTRACT

BACKGROUND: The assessment of adherence to warfarin therapy is useful in clinical practice due to its wide variability in dose-response and risks of complications. The aim of this study was to investigate validated instruments used to assess adherence to warfarin therapy. METHODS: Information was collected from the MEDLINE (PubMed), LILACS, EMBASE, and Cochrane Library databases. Search strategies were applied for each database, with no time limit or language restriction. Inclusion criteria consisted of study participants of ≥ 18 years of age, from both sexes, on chronic anticoagulation with warfarin for any indication and the use of validated instruments to assess adherence to warfarin therapy. Exclusion criteria consisted of duplicate articles, narrative or systematic reviews, and meta-analyses, as well as case reports/series and experimental studies involving animals. Two independent reviewers performed the following steps: evaluation of titles/abstracts, selection of studies after full reading, data extraction, and evaluation of potential bias. Discrepancies were resolved by a third reviewer. RESULTS: Overall, 19 articles were selected for this systematic review, including 17 cross-sectional studies, one cohort study, and one quasi-experimental study, published from 2009 to 2019. The validated instruments identified in this review were Morisky Medication Adherence Scale (MMAS), the eight-item Morisky Medication Adherence Scale (MMAS-8), Measurement of Treatment Adherence (MTA), and Brief Medication Questionnaire (BMQ). Only MMAS-8 was tested for reliability, using the internal consistency assessment, with Cronbach's α range 0.56-0.71. CONCLUSIONS: This review highlighted a gap in knowledge regarding the scarcity of validated instruments to assess adherence to warfarin therapy. Limitations were found in instruments that comprised the assessment of the isolated use of medication and the lack of analysis of other relevant therapeutic aspects. Future studies are needed to develop and validate more comprehensive instruments in an attempt to assess adherence to warfarin therapy. PROSPERO: Registration number CRD42019128324.


Subject(s)
Anticoagulants/administration & dosage , Medication Adherence/statistics & numerical data , Self Report/standards , Warfarin/administration & dosage , Anticoagulants/therapeutic use , Humans , Reproducibility of Results , Warfarin/therapeutic use
4.
J Clin Exp Dent ; 12(12): e1196-e1200, 2020 Dec.
Article in English | MEDLINE | ID: mdl-33282142

ABSTRACT

Thrombocytopenia-absent radius (TAR) syndrome is a congenital malformation in which affected individuals present reductions in the number of platelets, hypoplasia, or absence of radial bone unilaterally or bilaterally. Hematologic, skeletal, cardiac (particularly tetralogy of Fallot and septal-atrial defects), and gastrointestinal anomalies are most commonly associated with TAR syndrome. Skeletal changes result in a higher risk of dental and craniofacial trauma in patients with the syndrome. Thus, it is important for the dentist to be aware of the characteristics of TAR syndrome and its clinical management for better care of these patients. The objective of this study is to describe a case report of a 26-year-old patient with TAR syndrome with a history of trauma and root fracture of tooth 11 and alveolar bone ridge. During anamnesis, root fractures requiring the extraction of the 11 tooth, alveolar bone ridge fracture in the adjacent region, and dental trauma were observed. A hematological evaluation and blood and radiological examinations were performed. Osseointegrated implant was performed using the guided surgery and flapless technique, as well as prosthetic rehabilitation in the affected region. This report discusses the importance of careful planning, such as the use of incisions and conservative surgery, techniques for alveolar ridge preservation, gingival manipulation, and prosthesis confection. The patient was attended by a hematologist throughout the treatment. Key words:TAR syndrome, absent radii and thrombocytopenia, dental implants, oral surgery.

5.
J Clin Exp Dent ; 11(11): e1078-e1092, 2019 Nov.
Article in English | MEDLINE | ID: mdl-31700581

ABSTRACT

BACKGROUND: The aim of this systematic review was to evaluate the effects of piezocision in accelerating orthodontic tooth movement (OTM) and its possible adverse effects. MATERIAL AND METHODS: The Databases Medline, Embase, CENTRAL and LILACS were searched until March 2019, for randomized controlled trials (RCTs) and controlled clinical trials (CCTs) that used piezocision associated with orthodontic treatment. A manual search was also performed. The search, studies selection, assessment of risk of bias and data collection were carried out by two independent reviewers. RESULTS: Eleven publications were included in this review (4 CCTs and 7 RCTs). No study presented low risk of bias. Different types of tooth movement were evaluated: lower anterior alignment, en-masse retraction, overall orthodontic treatment and canine distalization. A total of 240 participants were analyzed in the included studies. Seven studies found significant acceleration in the piezocision group, while two studies found no differences. Adverse effects regarding patient's satisfaction, pain perception, or worsening of periodontal parameters were not observed. There was no consensus concerning anchorage loss and root resorption. CONCLUSIONS: The literature does not provide high-quality evidence to confirm that Piezocision results in significant OTM acceleration. Therefore, high-quality RCTs should be conducted to allow reliable conclusions about the effects of piezocision in orthodontics. Key words:Piezosurgery, tooth movement techniques, orthodontics.

6.
Medicine (Baltimore) ; 98(42): e17323, 2019 Oct.
Article in English | MEDLINE | ID: mdl-31626087

ABSTRACT

BACKGROUND: Non-adherence can be highlighted as one of the main contributors to the occurrence of adverse events in patients treated with warfarin. The usefulness of self-reporting measures of drug adherence could be improved by following psychometric properties in the development of the measurement scales. Thus, we aimed to describe the protocol of a systematic literature review designed to investigate and describe validated instruments used to assess adherence to warfarin therapy. METHODS: We will perform a systematic review will include observational and experimental studies involving the use of validated instruments to assess adherence to warfarin therapy. Dimensions of adherence raised by the selected studies will be extracted to be compared. We will systematically search electronic databases including MEDLINE, LILACS, EMBASE, and Cochrane Library using a comprehensive strategy from inception to June 31, 2019. Two reviewers will revise the literature independently using a standardized form and assess the potential bias. After the comparison of results, discrepancies will be solved after the analysis of a third reviewer. RESULT: The development of the present systematic will help to summarize and evaluate the validated instruments that have been previously published to assess adherence to warfarin therapy. CONCLUSION: This review will substantiate the discussion of relevant topics that should be assessed while providing care to patients taking warfarin. This knowledge will enable a comprehensive approach for healthcare professionals to improve treatment outcomes and the design of future investigations. REGISTRATION: The systematic review is registered in the PROSPERO international prospective register of systematic review (PROSPERO# CRD42019128324).


Subject(s)
Anticoagulants/therapeutic use , Medication Adherence , Warfarin/therapeutic use , Administration, Oral , Humans , Systematic Reviews as Topic , Validation Studies as Topic
7.
Eur J Clin Nutr ; 73(11): 1441-1449, 2019 11.
Article in English | MEDLINE | ID: mdl-30154533

ABSTRACT

BACKGROUND/OBJECTIVE: The nutritional risk in hospitalized children and adolescents is a frequent and under-diagnosed reality. There is still no consensus regarding the best nutritional screening method in pediatrics, with StrongKids being one of the existing proposals. A systematic review was performed to evaluate the scientific evidence about StrongKids, with emphasis on the world frequency of nutritional risk, associations of interest in health, validation and reproducibility studies. METHODS: Databases Pubmed, Lilacs, Scielo, ScienceDirect, Web of Science, Scopus and Cochrane Library were searched, using keyword "StrongKids," without limit on the year of publication, in English, Spanish, and Portuguese. RESULTS: From 125 papers initially identified, 22 original were included in analysis. The sample size ranged from 43 to 2874, with a maximum of 44 hospitals. The frequency of nutritional risk (medium or high) ranged from 35.7 to 100%. The nutritional risk was mainly associated with acute and/or chronic malnutrition already installed, lower anthropometric indexes and longer length of hospital stay. The method presented satisfactory inter-rater and intra-rater agreements and was validated in the three studies performed with this proposal. CONCLUSIONS: The prevalence of nutritional risk in hospitalized children and adolescents is high. StrongKids is a valid, easy-to-use, and reproducible method, with significant associations of interest in health.


Subject(s)
Child Nutrition Disorders/epidemiology , Hospitalization/statistics & numerical data , Nutrition Assessment , Nutritional Status/physiology , Child , Humans , Prevalence , Risk Assessment/methods
8.
BioDrugs ; 32(6): 585-606, 2018 Dec.
Article in English | MEDLINE | ID: mdl-30499082

ABSTRACT

BACKGROUND: The last decade has seen the increasing use of biological medicines in combination with chemotherapy containing 5-fluorouracil/oxaliplatin or irinotecan for the treatment of metastatic colorectal cancer (mCRC). These combinations have resulted in increased progression-free survival (PFS) in patients with mCRC; however, there are remaining concerns over the extent of their effect on overall survival (OS). Published studies to date suggest no major differences between the three currently available monoclonal antibodies (MoAbs); however, there are differences in costs. In addition, there is rising litigation in Brazil in order to access these medicines as they are currently not reimbursed. OBJECTIVE: The aim was to investigate the comparative effectiveness and safety of three MoAbs (bevacizumab, cetuximab and panitumumab) associated with fluoropyrimidine-based chemotherapy regimens and compared to fluoropyrimidine-based chemotherapy alone in patients with mCRC, through an updated systematic review and meta-analysis of concurrent or non-concurrent observational cohort studies, to guide authorities and the judiciary. METHOD: A systematic review and meta-analysis was performed based on cohort studies published in databases up to November 2017. Effectiveness measures included OS, PFS, post-progression survival (PPS), Response Evaluation Criteria In Solid Tumors (RECIST), response rate, metastasectomy and safety. The methodological quality of the studies was also evaluated. RESULTS: A total of 21 observational cohort studies were included. There were statistically significant and clinically relevant benefits in patients treated with bevacizumab versus no bevacizumab mainly around OS, PFS, PPS and the metastasectomy rate, but not for the disease control rates. However, there was an increase in treatment-related toxicities and concerns with the heterogeneity of the studies. CONCLUSION: The results pointed to an advantage in favor of bevacizumab for OS, PFS, PPS, and metastasectomy. Although this advantage may be considered clinically modest, bevacizumab represents a hope for increased survival and a chance of metastasectomy for patients with mCRC. However, there are serious adverse events associated with its use, especially severe hypertension and gastrointestinal perforation, that need to be considered.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Colorectal Neoplasms/drug therapy , Cost-Benefit Analysis , Antineoplastic Combined Chemotherapy Protocols/economics , Bevacizumab/economics , Bevacizumab/therapeutic use , Brazil , Cetuximab/economics , Cetuximab/therapeutic use , Colorectal Neoplasms/mortality , Disease-Free Survival , Fees, Pharmaceutical , Fluorouracil/economics , Fluorouracil/therapeutic use , Humans , Hypertension/chemically induced , Hypertension/epidemiology , Incidence , Intestinal Perforation/chemically induced , Intestinal Perforation/epidemiology , Irinotecan/economics , Irinotecan/therapeutic use , Oxaliplatin/economics , Oxaliplatin/therapeutic use , Panitumumab/economics , Panitumumab/therapeutic use , Reimbursement Mechanisms/legislation & jurisprudence , Response Evaluation Criteria in Solid Tumors
9.
PLoS One ; 13(6): e0199446, 2018.
Article in English | MEDLINE | ID: mdl-29928006

ABSTRACT

BACKGROUND: Multiple Sclerosis (MS) is a disease that appreciably impacts on the quality of life of patients and is associated with high expenditure. MS is a chronic multifactorial disease, characterized by inflammation, demyelination and axonal loss. The Brazilian public health system provides pharmacological treatment as well as hospital and outpatient care for patients with relapsing-remitting and secondary progressive multiple sclerosis. However, we are not aware of any previous publications assessing total direct medical costs in patients with a long follow-up within the Brazilian healthcare system. Consequently, the objective is to analyze public spending on patients with MS to guide stakeholders in future investment and disinvestment decisions. METHODS AND FINDINGS: We retrospectively analyzed public Brazilian spending on patients with MS between 2000 and 2015 using the patient-centered registry of all patients in the public health system (SUS) obtained through deterministic-probabilistic record linkage of the Outpatient Information System, Hospital Information System and Mortality Information Systems in Brazil. Descriptive data analysis and a multiple linear regression model was performed to evaluate the associations between the mean annual cost per patient and the clinical and demographic variables. The suitability of the model was verified from a residue analysis and the level of significance adopted was 5%. RESULTS: 28,401 patients were identified and subsequently 23,082 patients were analyzed. The majority of the patients were female (73.3%), lived in the southeast region (58.9%), had a mean age of 36.8 (± 12.2) years and started treatment using one of the interferons beta (78.9%). The total direct medical cost spending in the sixteen years of the follow-up was US $ 2,308,393,465.60, and the mean annual expenditure per patient was US $ 13,544.40 (± 4,607.05). In the best fit model (p <0.001), approximately 40% of the variability of the mean annual cost per patient was explained by the region of residence; medication used (intention to treat); if the patient was a non-exclusive user of medicines, i.e., used SUS for other procedures other than high-cost medicines; year of treatment start; and presence of events (death; Relapse; change of treatment and/or comorbidity). CONCLUSIONS: In the public health system of Brazil, disease modifying therapies currently represent almost all of the total direct costs of multiple sclerosis treatment. Around the world, new and emerging health technologies to treat of MS impose a challenge to health budgets, highlighting the need for cost-effectiveness studies comparing these technologies to those already available. Our regression model may help in this process, and calls attention to the need to access the real world performance of new therapies available in SUS, with the potential for disinvestment and/ or price reductions if needed.


Subject(s)
Health Care Costs , Multiple Sclerosis/drug therapy , Multiple Sclerosis/economics , Adolescent , Adult , Aged , Brazil , Child , Child, Preschool , Female , Follow-Up Studies , Humans , Infant , Infant, Newborn , Linear Models , Male , Middle Aged , Retrospective Studies , Young Adult
10.
JMIR Mhealth Uhealth ; 5(3): e4, 2017 Mar 01.
Article in English | MEDLINE | ID: mdl-28249834

ABSTRACT

BACKGROUND: Diabetes Mellitus (DM) is a chronic disease that is considered a global public health problem. Education and self-monitoring by diabetic patients help to optimize and make possible a satisfactory metabolic control enabling improved management and reduced morbidity and mortality. The global growth in the use of mobile phones makes them a powerful platform to help provide tailored health, delivered conveniently to patients through health apps. OBJECTIVE: The aim of our study was to evaluate the efficacy of mobile apps through a systematic review and meta-analysis to assist DM patients in treatment. METHODS: We conducted searches in the electronic databases MEDLINE (Pubmed), Cochrane Register of Controlled Trials (CENTRAL), and LILACS (Latin American and Caribbean Health Sciences Literature), including manual search in references of publications that included systematic reviews, specialized journals, and gray literature. We considered eligible randomized controlled trials (RCTs) conducted after 2008 with participants of all ages, patients with DM, and users of apps to help manage the disease. The meta-analysis of glycated hemoglobin (HbA1c) was performed in Review Manager software version 5.3. RESULTS: The literature search identified 1236 publications. Of these, 13 studies were included that evaluated 1263 patients. In 6 RCTs, there were a statistical significant reduction (P<.05) of HbA1c at the end of studies in the intervention group. The HbA1c data were evaluated by meta-analysis with the following results (mean difference, MD -0.44; CI: -0.59 to -0.29; P<.001; I²=32%).The evaluation favored the treatment in patients who used apps without significant heterogeneity. CONCLUSIONS: The use of apps by diabetic patients could help improve the control of HbA1c. In addition, the apps seem to strengthen the perception of self-care by contributing better information and health education to patients. Patients also become more self-confident to deal with their diabetes, mainly by reducing their fear of not knowing how to deal with potential hypoglycemic episodes that may occur.

11.
J Comp Eff Res ; 6(2): 165-180, 2017 Mar.
Article in English | MEDLINE | ID: mdl-28084784

ABSTRACT

INTRODUCTION: Dengue virus (DENV) is a serious global health problem. CYD-TDC (Dengvaxia®) was the first vaccine to gain regulatory approval to try and address this problem. AIM: Summarize all available evidence on the immunogenicity, efficacy and safety of the CYD-TDV dengue vaccine. METHOD: Meta-analysis and systematic review. RESULTS: The best and worst immunogenicity results were for DENV4 and DENV1, respectively. Vaccine efficacy of 60% was derived from studies with participants aged 2-16 years old, with DENV4 and DENV2 presenting the best and worst results, respectively. Erythema and swelling were more frequent with CYD-TDV. No differences were detected for systemic adverse events. CONCLUSION: CYD-TDV showed moderate efficacy in children and adolescents. From the immunogenicity results in adults, we can expect satisfactory efficacy from vaccination in this population.


Subject(s)
Dengue Vaccines , Dengue/prevention & control , Adaptive Immunity/immunology , Adolescent , Child , Child, Preschool , Dengue/immunology , Female , Humans , Immunogenicity, Vaccine , Male , Patient Safety , Treatment Outcome
12.
Expert Rev Clin Pharmacol ; 9(9): 1183-94, 2016 Sep.
Article in English | MEDLINE | ID: mdl-27180992

ABSTRACT

INTRODUCTION: Chemotherapy-induced nausea and vomiting are adverse effects responsible for worsening quality of life in cancer patients. To assess the efficacy, safety and effectiveness of serotonin receptor antagonist in cancer patients undergoing chemotherapy, comparing ondansetron with granisetron, dolasetron, tropisetron and palonosetron. AREAS COVERED: Systematic review and meta-analysis. The data were collected using CINAHL; CENTRAL; MEDLINE/PubMed; and LILACS databases; grey literature; and manual search. The methodological quality was assessed using the modified Jadad scale; Cochrane Collaboration's tool for assessing risk of bias in randomized clinical trials and the Newcastle-Ottawa Scale for observational studies. The search was completed in November, 2015. 26 studies were included in the meta-analysis. Ondansetron exhibited similar efficacy than granisetron and tropisetron, as well as greater efficacy than dolasetron for acute vomiting. Palonosetron exhibited greater efficacy than ondansetron for delayed nausea and acute and delayed vomiting. The comparison of granisetron with ondansetron in the cohort studies showed no difference. Expert commentary: In this review, palonosetron had increased efficiency compared with ondansetron, except in the subgroup analysis and acute nausea. Few cohort studies have been published addressing this topic.


Subject(s)
Nausea/drug therapy , Ondansetron/therapeutic use , Vomiting/drug therapy , Antiemetics/adverse effects , Antiemetics/pharmacology , Antiemetics/therapeutic use , Antineoplastic Agents/adverse effects , Antineoplastic Agents/therapeutic use , Humans , Nausea/chemically induced , Neoplasms/drug therapy , Ondansetron/adverse effects , Ondansetron/pharmacology , Quality of Life , Randomized Controlled Trials as Topic , Serotonin 5-HT3 Receptor Agonists/adverse effects , Serotonin 5-HT3 Receptor Agonists/pharmacology , Serotonin 5-HT3 Receptor Agonists/therapeutic use , Vomiting/chemically induced
13.
Article in English | MEDLINE | ID: mdl-26923561

ABSTRACT

This evaluation determines whether published studies to date meet the key characteristics identified for budget impact analyses (BIA) for medicines, accomplished through a systematic review and assessment against identified key characteristics. Studies from 2001-2015 on 'budget impact analysis' with 'drug' interventions were assessed, selected based on their titles/abstracts and full texts, and their characteristics checked according to key criteria. Out of 1,984 studies, 92 were subsequently identified for review. Of these, 95% were published in Europe and the USA. 2012 saw the largest number of publications (16%) with a decline thereafter. 48% met up to 7 out of the 9 key characteristics. Only 22% stated no conflict of interest. The results indicate low adherence to the key characteristics that should be considered for BIAs and strong conflict of interest. This is an issue since BIAs can be of fundamental importance in managing the entry of new medicines including reimbursement decisions.


Subject(s)
Budgets , Pharmaceutical Preparations/economics , Technology Assessment, Biomedical/methods , Conflict of Interest , Humans , Insurance, Pharmaceutical Services , Reimbursement Mechanisms , Technology Assessment, Biomedical/standards
14.
Rev Bras Reumatol ; 54(3): 220-30, 2014.
Article in English, Portuguese | MEDLINE | ID: mdl-25054600

ABSTRACT

INTRODUCTION: Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by systemic joint inflammation that often leads to significant disability. Several effective anti-TNF agents have been used, but some patients have shown an inadequate response. Rituximab is a therapeutic monoclonal antibody indicated in such cases. METHODS: We conducted a systematic review to access efficacy and safety of rituximab in patients with active RA which have or have not been treated with anti-TNF agents before, and to relate outcome with RF and anti-CCP serology. We searched major electronics databases, grey literature and searched for references manually. We used Review Manager(r)5.1 for meta-analysis. RESULTS: We included six RCTs comparing rituximab 1000 mg with placebo. Methotrexate was used by both groups. Treatment with rituximab was more effective in naïve and in anti-TNF treatment failure patients - ACR20/50/70 and EULAR response. We observed lower changes in Total Genant-modified Sharp score, erosion score and joint narrowing scores in the rituximab group, and SF-36, FACIT-T and HAQ-DI scores were also better in this group. There were no differences between groups regarding safety outcomes, with exception of acute injection reactions, which were more common on rituximab group. More RF/anti-CCP seropositive patients achieved ACR20 than RF/anti-CP negative patients in rituximab group. CONCLUSION: Available data support the use of rituximab for the treatment of RA, as it is an effective and safe option for naïve and anti-TNF treatment failure patients. RF and anti-CCP seam to influence treatment results, but this inference needs further research.


Subject(s)
Antirheumatic Agents/therapeutic use , Arthritis, Rheumatoid/drug therapy , Rituximab/therapeutic use , Humans , Treatment Outcome
15.
Pharmaceuticals (Basel) ; 6(10): 1170-94, 2013 Sep 30.
Article in English | MEDLINE | ID: mdl-24275847

ABSTRACT

To evaluate the safety of regimens containing calcineurin inhibitors (CNI), proliferation signal inhibitors (TOR-I) and antimetabolites, we conducted a meta-analysis of randomized clinical trials (RCTs) and observational studies. A total of 4,960 citations were identified in our electronic search and 14 additional articles were identified through hand searching. Forty-eight articles (11,432 participants) from 42 studies (38 RCTs and four cohorts) met the inclusion criteria. Meta-analysis results revealed the following: (i) tacrolimus was associated with an increased risk for diabetes and lower risk of dyslipidemia, compared to cyclosporine; (ii) mycophenolate mofetil (MMF) was associated with increased risk for total infections, abdominal pain, diarrhea and vomiting, compared with azathioprine; (iii) sirolimus was associated with higher risk of anemia, diabetes, dyslipidemia, lymphoceles and withdrawal compared to tacrolimus or cyclosporine, and cyclosporine was associated with an increased risk of CMV infection; (iv) the combination of CNI with antimetabolites was associated with more adverse events than CNI alone; (v) TOR-I was related to more adverse events than MMF. The data observed in this meta-analysis are similar to those describe by others authors; thus, the choice of treatment must be made by the clinical staff based on specific patient characteristics.

16.
Rheumatol Int ; 33(9): 2199-213, 2013 Sep.
Article in English | MEDLINE | ID: mdl-23686218

ABSTRACT

Biological agents directed against tumor necrosis factor (TNF) represent therapeutic options for patients with ankylosing spondylitis with high disease activity despite use of non-steroidal anti-inflammatory drugs. To evaluate the efficacy and safety of the anti-TNF agents infliximab, etanercept, adalimumab, golimumab, and certolizumab for the treatment of ankylosing spondylitis, we performed a systematic review of randomized clinical trials on adult patients with ankylosing spondylitis using articles culled from the EMBASE, MEDLINE, Cochrane Controlled Trials Register and LILACS databases (September/2012), manual literature search, and the gray literature. Study selections and data collection were performed by two independent reviewers, with disagreements solved by a third reviewer. The following outcomes were evaluated: ASAS 20 response, disease activity, physical function, vertebral mobility, adverse events, and withdraws. The meta-analysis was performed using the Review Manager(®) 5.1 software by applying the random effects model. Eighteen studies were included in this review. No study of certolizumab was included. Patients treated with anti-TNF agents were more likely to display an ASAS 20 response after 12/14 weeks (RR 2.21; 95 % CI 1.91; 2.56) and 24 weeks (RR 2.68; 95 % CI 2.06; 3.48) compared with controls, which was also true for several other efficacy outcomes. Meta-analysis of safety outcomes and withdraws did not indicate statistically significant differences between treatment and control groups after 12 or 30 weeks. Adalimumab, infliximab, etanercept, and golimumab can effectively reduce the signs and symptoms of the axial component of ankylosing spondylitis. Safety outcomes deserve further study, especially with respect to long-term follow-ups.


Subject(s)
Spondylitis, Ankylosing/drug therapy , Tumor Necrosis Factor-alpha/antagonists & inhibitors , Adalimumab , Antibodies, Monoclonal/adverse effects , Antibodies, Monoclonal/therapeutic use , Antibodies, Monoclonal, Humanized/adverse effects , Antibodies, Monoclonal, Humanized/therapeutic use , Bias , Certolizumab Pegol , Etanercept , Humans , Immunoglobulin Fab Fragments/adverse effects , Immunoglobulin Fab Fragments/therapeutic use , Immunoglobulin G/adverse effects , Immunoglobulin G/therapeutic use , Polyethylene Glycols/adverse effects , Polyethylene Glycols/therapeutic use , Randomized Controlled Trials as Topic , Receptors, Tumor Necrosis Factor/therapeutic use
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