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1.
Orthop Res Rev ; 13: 255-273, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34880685

RESUMO

Osteoarthritis (OA) is a significant cause of disability. Considering the increasing diffusion of the viscosupplementation (VS) with hyaluronic acid (HA), the International Symposium Intra Articular Treatment (ISIAT) appointed a Technical Expert Panel (TEP) to identify the criteria for successful VS with a specific HA in OA; this through a systematic literature review (SLR), performed following the PRISMA guidelines interrogating Medline, Embase, Cochrane Library, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Grey Matters and American College of Rheumatology (ACR/EULAR) databases and the opinion of international experts. The research included only studies on adults and humans without limitations of language or time of publication. Researchers extracted both quantitative and qualitative data from each study. Mixed Methods Appraisal Tool (MMAT) was used to perform quality analysis for the level of evidence. The SLR retrieved 385 papers, 25 of which were suitable for the analysis. The TEP focused on the different formulations of the product Sinovial® [HA 0.8%, HA 1.6%, HA 2%, 800-1200 kDa, HA 3.2% (1400-2100 kDa/65-110 kDa)]. The choice was due to the vast amount of evidence available. The TEP weighed the evidence in two rounds of a Delphi survey; the results, and any disagreement, were discussed in a final session. Three domains were considered: 1) the patients' characteristics associated with the best results; 2) the contraindications and the conditions linked to increased risk of failure; 3) the clinical conditions in which VS is considered appropriate. The TEP concluded that VS with HA is safe and effective in the treatment of knee and hip OA of grades I to III and that it is possible to undertake VS in other situations (eg grade IV Kellgren-Lawrence - KL); a comprehensive examination of the patient should be performed before the procedure.

2.
Artigo em Inglês | MEDLINE | ID: mdl-34769816

RESUMO

Multiple chemical sensitivity (MCS) is a multisystem, recurrent, environmental disorder that flares in response to different exposures (i.e., pesticides, solvents, toxic metals and molds) under the threshold limit value (TLV) calculated for age and gender in the general population. MCS is a syndrome characterized by cutaneous, allergic, gastrointestinal, rheumatological, endocrinological, cardiological and neurological signs and symptoms. We performed a systematic review of the literature to summarize the current clinical and therapeutic evidence and then oriented an eDelphi consensus. Four main research domains were identified (diagnosis, treatment, hospitalization and emergency) and discussed by 10 experts and an MCS patient. Thus, the first Italian MCS consensus had the double aim: (a) to improve MCS knowledge among healthcare workers and patients by standardizing the clinical and therapeutic management to MCS patients; and (b) to improve and shed light on MCS misconceptions not supported by evidence-based medicine (EBM).


Assuntos
Hipersensibilidade , Sensibilidade Química Múltipla , Consenso , Humanos , Itália/epidemiologia , Sensibilidade Química Múltipla/diagnóstico , Sensibilidade Química Múltipla/epidemiologia , Sensibilidade Química Múltipla/terapia , Solventes
3.
Artigo em Inglês | MEDLINE | ID: mdl-34639683

RESUMO

Axillary web syndrome (AWS) is defined as a visible and palpable network of cords in the skin of the axillary cavity that are tensed by shoulder abduction following surgery for breast cancer, causing significant functional limits of the ipsilateral upper limb (UL) and pain. The purpose of this narrative review is to discuss rehabilitation approaches for greater efficacy with respect to pain and novel suggestions. AWS is a frequent complication of axillary lymphadenectomy that necessitates a thorough follow-up in the medium to long term. Physiotherapy is effective in the treatment of functional limb deficits, the management of pain, and the treatment of upper limb disability. The best management approach involves the use of soft tissue techniques to slow the natural course of the syndrome, in association with therapeutic exercises for functional recovery and muscle strengthening. AWS is linked secondary lymphedema, requiring integration with manual lymphatic drainage. The physiotherapy management of AWS is currently fragmented, and insufficient information is available on the nature of the disease. Thus, randomized and controlled studies that compare rehabilitation approaches in AWS are desirable, including the possibility of using mesotherapy in the treatment of axillary and upper limb pain.


Assuntos
Neoplasias da Mama , Linfedema , Axila , Neoplasias da Mama/cirurgia , Feminino , Humanos , Excisão de Linfonodo/efeitos adversos , Linfedema/etiologia , Linfedema/terapia , Dor , Complicações Pós-Operatórias
4.
Cartilage ; : 19476035211053827, 2021 Oct 25.
Artigo em Inglês | MEDLINE | ID: mdl-34696623

RESUMO

OBJECTIVES: This work studied if and how current clinical practice agrees with European Viscosupplementation Consensus Group (EUROVISCO) recommendations and how this agreement might be different according to physician's specialization. In addition, this work aimed to identify key decision factors that practitioners consider in their decision to retreat or not a patient with hyaluronic acid viscosupplementation. METHODS: Practitioners have been invited by e-mail to participate in an online exercise on viscosupplementation retreatment. They received a fictional patient case at random among a set of predefined fictional cases. The platform asked the practitioner if he/she would retreat the patient with viscosupplementation or not. To take a decision, the practitioner could select questions among a list of predefined questions. Among them, some were related to criteria used in the EUROVISCO decision tree and others served as confounding factors. RESULTS: A total of 506 practitioners participated to the exercise, of which 399 gave their decision about the case assigned to them by the platform. The observed agreement between practitioner decisions and EUROVISCO recommendations was 58.89 ± 4.95% (95% confidence interval [CI]). Overall, the decision to retreat was taken in 47.87% of the cases, while the EUROVISCO guidelines follow-up would have led to 55.89% retreatment for the same cases (P = 0.03). CONCLUSIONS: In current practice, physicians tended to reinject their patients less than recommended, although EUROVISCO guidelines for viscosupplementation retreatment consider decision criteria that clearly correspond to those of practitioners in real life. These include the patients' willingness to be treated or the patients' perception of the effectiveness of the treatment.

5.
Ann Ist Super Sanita ; 57(3): 244-248, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34554119

RESUMO

INTRODUCTION AND AIM: Biologic treatment - particularly with the anti-TNF molecules - is frequently used in clinical practice to treat the severe form for both chronic rheumatic diseases and inflammatory bowel diseases. The immunosuppression induced by biologic therapies increases the risk of infections, including tuberculosis, as well as hepatitis B virus (HBV) reactivation may occur in inactive carriers or occult HBV infection (OBI) subjects during biologic therapy. This study aimed to update data on HBV prevalence and reactivation in patients receiving biologic therapy for either chronic rheumatic diseases or IBD, and to describe their management in clinical practice. MATERIALS AND METHODS: This study was performed in 6 Italian centers (3 Rheumatology Units and 3 Gastroenterology Units). Clinical, biochemical and virological data, as well as follow up information, were recorded and analyzed. RESULTS: 984 patients were considered, including 817 with rheumatic disease and 167 with IBD. A total of 43 showed HBV infection (38 OBI and 5 carriers) accounting for a prevalence of 4%. Among OBI patients, 1 (2.6%) case of HBV reactivation occurred in a male patient with Crohn disease. Among the 5 HBV carriers, two patients (1 with spondyloarthritis and 1 with rheumatoid arthritis) did not received HBV antiviral therapy, and both experienced flare of hepatitis at 47 and 49 months following biologic therapy starting. DISCUSSION: Data of our study highlight that guidelines on management of HBV patients treated with biologic therapies should be still implemented in clinical practice when considering that, although infrequent, HBV reactivation could be potentially life-threatening.

6.
Rheumatol Ther ; 8(4): 1617-1636, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34462887

RESUMO

INTRODUCTION: The objective of this study was to compare a single intra-articular injection of an innovative high and low molecular weight hyaluronic acid formulation (HA-HL) versus placebo in treating moderate-to-severe symptomatic knee osteoarthritis. METHODS: Subjects with primary osteoarthritis knee pain (Kellgren and Lawrence grade 2-3) were randomly assigned to intra-articular HA-HL or placebo in a prospective, double-blind, 24-week study. The primary outcome variable was change from screening to week 24 of a Visual Analogue Scale (VAS) pain score. Secondary outcomes included Lequesne's algofunctional index, EuroQol 5-Dimension Questionnaire, 5-level version (EQ-5D-5L), Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) response and rescue medication usage. RESULTS: In a total of 692 randomized patients, a rapid decrease was observed in mean VAS pain score from baseline to week 1 (26 ± 24 mm in the HA-HL group vs. 23 ± 23 mm in the placebo group); pain intensity continued to decrease during 24 weeks of follow-up, reaching a mean change from baseline of 35 ± 28 mm vs. 32 ± 27 mm at week 24. Mixed model analysis demonstrated statistically significant differences between groups in favor of the HA-HL group at weeks 1, 6, 12, and 24. HA-HL was also more effective than placebo in improving Lequesne's algofunctional index, OMERACT-OARSI response, and health-related quality of life. The use of rescue medication (paracetamol 500 mg tablets; ≤ 6 per day) was lower in the HA-HL group. Both treatments were similarly well tolerated. CONCLUSIONS: A single intra-articular injection of an innovative high and low molecular weight hyaluronic acid formulation (HA-HL) is effective in providing fast, sustained, and clinically relevant reductions in pain, functional limitation, and health-related quality of life that were apparent at 1 week after the intra-articular injection and maintained throughout the 24-week follow-up in subjects with painful knee osteoarthritis, with a good safety profile. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03200288.

7.
Drug Des Devel Ther ; 15: 3041-3047, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34285471

RESUMO

Mesotherapy (local intradermal therapy, LIT) is a technique used to slowly spread drugs in tissues underlying the site of injection to prolong the pharmacological effect with respect to intramuscular injection. Recommendations for proper medical use of this technique have been made for pain medicine and rehabilitation, chronic venous disease, sport medicine, musculoskeletal disorders, several dermatological conditions, skin ageing, and immune-prophylaxis. Although mesotherapy is considered a valid technique, unresolved questions remain, which should be answered to standardize methodology and dosing regimen as well as to define the right indications in clinical practice. New randomized controlled trials are needed to test single products (dose, frequency of administration, efficacy and safety). Even infiltration of substances for dermo-cosmetic purposes must be guided by safety and efficacy tests before being proposed by mesotherapy. In this article, we put forth a preclinical and clinical research plan and a health technology assessment as a call to action by doctors, researchers and scientific societies to aid national health authorities in considering mesotherapy for prevention, treatment and rehabilitation paths.

8.
Ther Clin Risk Manag ; 17: 507-530, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34093017

RESUMO

The aim of this document is to provide a set of indications on the national best practice management of knee osteoarthritis based on an analysis of the existing literature and the contribution of experts in the field. During the first phase of the project, in agreement with the multidisciplinary panel of experts, the main guidelines on the topic were selected. Each guideline was assessed through the AGREEII system to identify their strong/weak points and a summary of the recommendations contained in the various documents was drawn up. The panel drew up a list of therapeutic options to be included in the document and some of these topics were selected for in-depth analysis and review. The search strategy for the required literature reviews was constructed using the PICOS approach. The results obtained from the literature reviews, the in-depth analyses conducted by the members of the scientific societies involved and the analysis of the existing guidelines enabled an initial draft of the consensus document to be elaborated. This document was examined at the consensus conference held on 28 May 2019, in the presence of a multidisciplinary group consisting of members of the various scientific societies involved. Single recommendations were discussed in work groups with a view to combining the indications given by the literature examined with the experience of the specialists involved. The recommendations discussed were then put to the vote in a plenary assembly. The final document contains 26 practice recommendations which leading specialists involved in the management of knee OA in Italy agree upon.

9.
Ther Adv Musculoskelet Dis ; 13: 1759720X211018605, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34104232

RESUMO

Viscosupplementation (VS) is a symptomatic treatment for knee and other joint osteoarthritis (OA). Despite a long history of use, conflicting opinions remain on the best clinical indications and the most appropriate patients to be treated with intra-articular hyaluronic acid (IA-HA), the optimal dosing regimen and the modalities of retreatment. A multidisciplinary committee of European experts on OA (EUROVISCO) was constituted to formulate recommendations, aimed at helping physicians in the decision-making and the optimal achievement of VS. Before each session members were tasked to collate an exhaustive literature review. Level of evidence and strength of recommendation were based on the level of agreement for each item according to the Delphi method. In 2015, a consensus position was proposed for 24 statements. Among those that obtained a consensual agreement, the working group stressed that VS is effective in mild/moderate knee OA but is not an alternative to surgery in advanced OA, and that dosing regimen must be supported by controlled trials. In 2018, two decision algorithms for the retreatment with IA-HA in knee OA were published. Among the key recommendations, the experts recommended to re-treat every year patients with high risk of OA progression, even if not symptomatic. In 2020, EUROVISCO published two sets of recommendations for the design of clinical trials on the disease-modifying effect of VS and for optimizing the results of VS. The working group underlined that an accurate analysis of radiological features and symptoms and a careful clinical examination may improve the chances of success of VS, as well as good technique of injection and the use of imaging guidance. Based on the exhaustive analysis of the literature and their own clinical experience, the EUROVISCO experts offer a wide range of recommendations intended to help practitioners, particularly in certain cases where the specific characteristics of the patients make the therapeutic decision difficult.

10.
Risk Manag Healthc Policy ; 14: 2079-2087, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34045909

RESUMO

This narrative review is the final output of an initiative of the SIM (Italian Society of Mesotherapy). A narrative review of scientific literature on the efficacy of fractional intradermal vaccination in comparison with full doses has been conducted for the following pathogens: influenza virus, rabies virus, poliovirus (PV), hepatitis B virus (HBV), hepatitis A virus (HAV), diphtheria-tetanus-pertussis bacterias (DTP), human papillomavirus (HPV), Japanese encephalitis virus (JE), meningococcus, varicella zoster virus (VZV) and yellow fever virus. The findings suggest that the use of the intradermal route represents a valid strategy in terms of efficacy and efficiency for influenza, rabies and HBV vaccines. Some systematic reviews on influenza vaccines suggest the absence of a substantial difference between immunogenicity induced by a fractional ID dose of up to 20% and the IM dose in healthy adults, elderly, immunocompromised patients and children. Clinical studies of remaining vaccines against other pathogens (HAV, DTP bacterias, JE, meningococcal disease, VZV, and yellow fever virus) are scarce, but promising. In the context of a COVID-19 vaccine shortage, countries should investigate if a fractional dosing scheme may help to save doses and achieve herd immunity quickly. SIM urges the scientific community and health authorities to investigate the potentiality of fractionate intradermal administration in anti-COVID-19 vaccination.

11.
Pain Res Manag ; 2021: 6623651, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34012496

RESUMO

Objective: This study aimed to validate Italian versions of Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale and Pain DETECT questionnaire (PD-Q) and evaluate the ability of these questionnaires to discriminate between nociceptive and neuropathic pain. Design: Multicenter prospective validation cohort study. Subjects and Setting. One hundred patients were included with a diagnosis formulated by a specialist in outpatient settings (50 affected by knee osteoarthritis as nociceptive pain and 50 affected by trigeminal or postherpetic neuralgia as neuropathic pain). Methods: The Italian versions of both questionnaires according to Italian cultural characteristics were performed according to the following steps: (1) translation of the questionnaires from English into Italian; (2) review by a bilingual individual for consistency; (3) proposed version after a mail round between experts; (4) backward translation; (5) comparison with the original English version by the experts; (6) approved version of the questionnaires. One hundred patients were enrolled and completed the two questionnaires administered by a specialist or blinded nursing staff, at the baseline and after 24/48 hours. Internal consistency, stability, validity, and discriminative power were analyzed. Results: Statistically significant differences were reported about the ability of both questionnaires to discriminate between patients affected by neuropathic or nociceptive pain. Internal consistency for the Italian version of the LANSS was 0.76, and for PD-Q, it was 0.80, assessed by Cronbach's α; LANSS showed a good test-retest reliability with an ICC of 0.76, and PD-Q showed a high test-retest reliability with an ICC of 0.96. For interrater reliability, there was a concordance rate of 83.3% between reference diagnosis and LANSS (Cohen's kappa = 0.67, CI 95% 0.52-0.75). Conclusions: This study validated the Italian versions of LANSS and PD-Q as reliable instruments with good psychometric characteristics, for pain evaluation, discriminating between nociceptive and neuropathic pain. Our findings were similar to those observed in the original study. Furthermore, we have reported the test-retest reliability for both questionnaires, not addressed in original validation studies.


Assuntos
Comparação Transcultural , Neuralgia/diagnóstico , Dor Nociceptiva/diagnóstico , Medição da Dor/instrumentação , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Itália , Masculino , Pessoa de Meia-Idade , Medição da Dor/estatística & dados numéricos , Estudos Prospectivos , Inquéritos e Questionários , Traduções , Adulto Jovem
12.
Ther Adv Musculoskelet Dis ; 13: 1759720X211002682, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33854570

RESUMO

Introduction: For patients with rheumatoid arthritis (RA) with an inadequate response to tumor necrosis factor inhibitors (TNFi), main options include cycling onto a different TNFi or switching to a biologic/targeted synthetic disease-modifying antirheumatic drug with a different mechanism of action (MOA). This network meta-analysis (NMA) assessed comparative clinical efficacy of cycling versus switching. Methods: We conducted a literature search in MEDLINE, Embase, and Cochrane Library. Outcomes included proportion of patients with 20%, 50%, or 70% response to American College of Rheumatology criteria (ACR20/ACR50/ACR70 response), Disease Activity Score in 28 joints (DAS28) score below 2.6 or between 2.6 and 3.2, mean change in DAS28 score, mean reduction in and proportion of patients achieving a clinically meaningful reduction (⩾0.22) in Health Assessment Questionnaire score, number of serious adverse events (AEs), and withdrawals for any reason/due to AEs/lack of treatment efficacy. To account for the wide range of study populations and designs, we developed three models to conduct the NMA: fixed-effect, random-effects, and hierarchical Bayesian. PROSPERO ID: CRD42019122993. Results: We identified nine randomized controlled trials and 16 observational studies. The fixed-effect model suggested a 0.99 probability that switch was the better strategy for increasing odds of a clinically meaningful improvement in ACR50 [odds ratio (OR): 1.35 (95% credible interval (CI): 0.96-1.81)]. The fixed-effect model also suggested that switch was associated with lower rates of withdrawal for any reasons [OR: 0.53 (95% CI: 0.40-0.68)]. The random-effects and hierarchical Bayesian models suggested additional uncertainty as they considered more variability than the fixed-effect model. Discussion: Results suggest that switching to a drug with a different MOA is more effective and associated with lower rates of withdrawal than cycling to a different TNFi after failure of first-line TNFi. Further trials that directly compare cycling with switching are warranted to better assess comparative efficacy. Plain language summary: Assessment of the effectiveness of different drug treatment strategies in patients with rheumatoid arthritis: an analysis of the published literature Rheumatoid arthritis (RA) is a chronic disease in which inflammation affects joints along with the entire body; this may cause significant pain, joint damage, physical disability, a decreased quality of life, and an increased risk of death.Tumor necrosis factor inhibitors (TNFis) are a common choice as first-line drugs to treat RA. Although they are effective in many patients, therapy with a TNFi is not successful within the first year of treatment in approximately one-third of patients due to either a lack of efficacy or safety issues.When TNFi therapy is unsuccessful, the options are to "cycle" to another TNFi or to "switch" to another drug with a different mechanism of action (MOA). Further studies are needed to help doctors decide the best treatment strategy for their patients when treatment with an initial TNFi fails.This study analyzed 25 published studies in which patients were either "cycled" to another TNFi or "switched" to a drug with a different MOA after unsuccessful treatment with an initial TNFi.The results showed that "switching" to a drug with a different MOA was a better treatment strategy than "cycling" to another TNFi; "switching" increased the chance of clinically meaningful improvement in disease status and lowered the chance of having to stop treatment for any reason.

13.
Ther Clin Risk Manag ; 16: 953-968, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33116545

RESUMO

Background: Low back pain (LBP) is one of the most common spine diseases and represents the most frequent cause of absence from work in developed countries. Approximately 40% of chronic LBP is related to discogenic origin. The goal of the study is producing a review of literature to describe analytically the techniques of intradiscal injections. Methods: PubMed database was searched for clinical studies with the different key terms: "intradiscal", "injection", "steroid" "procedures", "techniques", "CT", "MRI", "fluoroscopy", "fluoroscopic", "guidance", "ozone", "ultrasound", "images". Only studies written in English, French, or Italian in which the intradiscal injection represents the main procedure for the low back discopathy treatment on humans were considered. We excluded the articles that do not mention this procedure; those which indicated that the intradiscal injection had happened accidentally during other treatments; those reporting the patient's pain was determined by other causes than the discopathy (facet joint syndrome, tumor, spondylodiscitis). Results: Thirty-one articles dated from 1969 to 2018 met the criteria. The examined population was 6843 subjects, 52.3% male and 47.7% female, with a mean age of 45.9±10.1 years. The techniques are highly variable in terms of procedure: different operators, needle guidance, injection sites, drugs, tilt angle of the needle). Conclusion: The efficacy and the safety of the intradiscal procedures are not easily comparable due to different types of studies and their limited number. Further studies are needed to standardize the intradiscal injection technique/procedure to improve safety, repeatability and effectiveness, and last but not least to reduce peri- and postoperative care and health-care costs.

14.
Nanomaterials (Basel) ; 10(6)2020 May 31.
Artigo em Inglês | MEDLINE | ID: mdl-32486448

RESUMO

Different polysaccharides-namely dextran, carboxymethyl dextran, alginate, and hyaluronic acid-were compared for the synthesis of nanoporous microsponges particles (NMPs) obtained from a one-pot self-precipitation/cross-linking process. The morphologies and sizes of the NMPs were evaluated comparatively with respect to polymer-to-polymer and cross-linker solvents (water-based vs. DMSO). We found that the radial distribution of the polymer in the near-spherical NMPs was found to peak either at the core or in the corona of the particle, depending both on the specific polymer or the solvent used for the formation of NMPs. The NMP porosity and the swelling capability were evaluated via scanning electron microscopy (SEM). The degradation study indicated that after 10 h incubation with a reducing agent, approximately 80% of the NMPs were disassembled into soluble polysaccharide chains. The adsorption and release capacity of each type of NMP were evaluated using fluorescently labeled bovine serum albumin and lysozyme as model proteins, highlighting a release time typically much longer than the corresponding adsorption time. The dependence of the adsorption-release performance on pH was demonstrated as well. Confocal microscopy images allowed us to probe the different distribution of labeled proteins inside the NMP. The safety and non-cytotoxicity of NMPs were evaluated after incubation with fibroblast 3T3 cells and showed that all types of NMPs did not adversely affect the cell viability for concentrations up to 2.25 µg/mL and an exposure time up to 120 h. Confocal microscopy imaging revealed also the effective interaction between NMPs and fibroblast 3T3 cells. Overall, this study describes a rapid, versatile, and facile approach for preparing a universal non-toxic, nanoporous carrier for protein delivery under physiological conditions.

15.
ScientificWorldJournal ; 2020: 3542848, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32577099

RESUMO

Intradermal therapy, known as mesotherapy, is a technique used to inject a drug into the surface layer of the skin. In particular, it involves the use of a short needle to deposit the drug in the dermis. The intradermal microdeposit modulates the drug's kinetics, slowing absorption and prolonging the local mechanism of action. It is successfully applied in the treatment of some forms of localized pain syndromes and other local clinical conditions. It could be suggested when a systemic drug-sparing effect is useful, when other therapies have failed (or cannot be used), and when it can synergize with other pharmacological or nonpharmacological therapies. Despite the lack of randomized clinical trials in some fields of application, a general consensus is also reached in nonpharmacological mechanism of action, the technique execution modalities, the scientific rationale to apply it in some indications, and the usefulness of the informed consent. The Italian Mesotherapy Society proposes this position paper to apply intradermal therapy based on scientific evidence and no longer on personal bias.


Assuntos
Analgésicos/administração & dosagem , Derme/metabolismo , Mesoterapia/métodos , Dor/prevenção & controle , Absorção Cutânea , Analgésicos/farmacocinética , Animais , Previsões , Humanos , Injeções Intradérmicas , Itália , Mesoterapia/instrumentação , Mesoterapia/tendências , Guias de Prática Clínica como Assunto , Resultado do Tratamento
16.
Expert Opin Drug Deliv ; 17(9): 1213-1226, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32543240

RESUMO

INTRODUCTION: Management of Osteoarthritis (OA) still is a challenge for clinicians. Taking into account a multidisciplinary approach including pharmacological and non-pharmacological treatments, intra-articular (IA) injection could be considered as an effective local therapy. Areas covered This review provides a new perspective of IA treatment going beyond current available IA agents. We describe novel biological targets for developing new IA agents and innovative modalities of delivery systems. Additional topics include predictors of response for a better choice of IA agents for each patient, diagnostic and prognostic role of biomarkers, accuracy of IA injection, and cost-effectiveness of IA injection. Expert opinion IA treatments seem to be very promising for the management of OA. Identifying clinical and biochemical predictive factors could drive clinician to the appropriate therapeutic approach. To date, there is a gap regarding the benefit of IA treatments in the 'real practice' once they have been adopted. However, considering these promising effects of IA approach, several open questions remain not clarified.


Assuntos
Osteoartrite/tratamento farmacológico , Análise Custo-Benefício , Humanos , Ácido Hialurônico/administração & dosagem , Injeções Intra-Articulares
17.
Orthop Res Rev ; 12: 19-26, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32184679

RESUMO

Purpose: The use of ultrasound (US) guidance has allowed hip osteoarthritis to be treated with intra-articular (IA) injections. HYMOVIS ONE (HYADD4-G) is a new hyaluronic acid (HA) derivative product with unusual characteristics, and it has been used with good results in knee osteoarthritis (OA). This study assessed the efficacy and safety of a single HYMOVIS ONE injection in patients affected by symptomatic hip OA. Patients and Methods: This post-marketing cohort study assessed data from the ANTIAGE Register. Inclusion criteria were age ≥40 years, symptomatic hip OA (Kellgren-Lawrence grade I-III) of ≥1-year duration, and ≥12 months follow-up. All patients received a single HYMOVIS ONE (32 mg/4 mL) injection at baseline. Values for 10-cm visual analogue scale (VAS) pain scores, the Lequesne index, and nonsteroidal anti-inflammatory drug (NSAID) consumption were evaluated at 6 and 12 months. Adverse events were also recorded. Results: The included patients (n = 198) consisted of 42.5% women, with a mean (± SD) age at baseline of 62 (± 14.2) years and a mean (± SD) body mass index of 26.3 (± 2.5). The mean (SD) Lequesne index and VAS pain scores at baseline were 11.5 (± 4.6) and 6.4 cm (± 2.2), respectively. All groups exhibited statistically significant reductions at all time points compared to baseline. At 12 months, the VAS pain score was reduced by 17.2%, the Lequesne index by 33.7%, and NSAID consumption by 41.7%. Conclusion: Our study supports the clinical efficacy and safety of a single HYMOVIS ONE injection for managing symptoms in patients with hip OA, confirming previous data on the use of HYMOVIS as a background therapy in the management of knee osteoarthritis.

18.
Drugs R D ; 20(1): 39-45, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32078147

RESUMO

BACKGROUND AND OBJECTIVE: Clodronate is a nitrogen-free bisphosphonate that is widely and effectively used in the treatment of many osteo-metabolic disorders. The objective of our study was to evaluate the effectiveness of clodronate in reducing pain and bone marrow edema in knee osteoarthritis. METHODS: In total, 74 patients were included in the study. Group 1 received intramuscular clodronate 200 mg daily for 15 days and then once weekly for the next 11.5 months; group 2 received intramuscular clodronate 200 mg daily for 15 days and then once weekly for the next 2.5 months. Visual analog scale (VAS) scores were recorded at baseline (T0) and after 30 days (T1), 3 months (T2), 6 months (T3), 9 months (T4), and 12 months (end of study; T5). We also evaluated functional status and use of paracetamol (T0, T1, T2, T3, T4, and T5) and changes in Whole Organ Magnetic Resonance Imaging Score (WORMS; T0, T2, and T5). RESULTS: Both groups had a statistically significant reduction in VAS score until 3 months. Group 1 then experienced further VAS reductions, whereas VAS scores for group 2 progressively increased. Pain, stiffness, and physical function also showed the same trend, as did bone marrow edema extension, which was evaluated with WORMS. CONCLUSION: Our study indicates that intramuscular administration of a therapeutic dose of clodronate followed by a maintenance dose is effective in the management of symptomatic knee osteoarthritis, improving functional outcomes and reducing pain and bone marrow edema. Prolonged treatment increases the long-term efficacy of clodronate compared with the shorter schedule.


Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Ácido Clodrônico/uso terapêutico , Osteoartrite do Joelho/tratamento farmacológico , Dor/tratamento farmacológico , Idoso , Conservadores da Densidade Óssea/administração & dosagem , Ácido Clodrônico/administração & dosagem , Relação Dose-Resposta a Droga , Feminino , Humanos , Masculino , Osteoartrite do Joelho/diagnóstico por imagem , Dor/diagnóstico por imagem , Medição da Dor , Fatores de Tempo , Resultado do Tratamento
19.
Cartilage ; 11(1): 47-59, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-29926748

RESUMO

OBJECTIVES: The 3 aims of the work were to identify population subgroups that can benefit the most from viscosupplementation (VS), to provide recommendations on injection techniques, and to discuss VS appropriateness in clinical situations that are commonplace in daily practice. METHODS: The task force members voted on their degree of agreement on 27 statements, 36 recommendations, and 22 clinical scenarios using a 9-point scale. The strength of agreement/appropriateness/recommendation (SOA/SOR) was classified as strong if the median agreement score was ≥8. The level of consensus (LOC) was also obtained. RESULTS: Among the assumed predictors for VS failure, obesity, radiographic severity, large synovial fluid effusion, severe patellofemoral involvement, major malalignment, and gross joint instability received a large majority of agreements. The lateral mid-patellar approach was recommended for knee injection. Imaging guidance was unanimously recommended for hip and ankle. Agreement was achieved to strictly respect the dosing regimen proven by controlled trials. There was agreement for treating with VS patients with mild to moderate knee and hip OA, with normal weight or moderate overweight, insufficiently improved by first-line therapies, or who do not wish get oral treatment or who have contraindications to pain killers. The group considered the patient's wishes as a key element in therapeutic decision making. CONCLUSION: Based on literature data and clinical experience, the EUROVISCO group proposed a set of recommendations for optimizing the results of VS, aimed to help practitioners, especially in some cases in which the patients' specificities make the therapeutic decision difficult.


Assuntos
Ácido Hialurônico/administração & dosagem , Osteoartrite/tratamento farmacológico , Guias de Prática Clínica como Assunto , Viscossuplementação/normas , Viscossuplementos/administração & dosagem , Comitês Consultivos , Tomada de Decisão Clínica , Consenso , Europa (Continente) , Humanos , Resultado do Tratamento , Viscossuplementação/métodos
20.
Cartilage ; 11(1): 60-70, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-29972025

RESUMO

OBJECTIVES: Hyaluronic acid viscosupplementation is a commonly used intra-articular treatment for osteoarthritis (OA). Some recent preclinical and clinical trials have demonstrated a potential for its disease-modifying effects. The goal of this expert opinion, consensus-driven exercise is to provide guidelines for the design and conduct of clinical trials assessing the disease-modifying effect of viscosupplementation in the knee. METHODS: The EUROVISCO group constitutes 10 members who had expertise in clinical research methodology in the field of OA and viscosupplementation. They initially drafted issues through an iterative process and had to vote on their degree of agreement on these recommendations. The scores were pooled to generate a median agreement score for each recommendation. RESULTS: The document includes 31 recommendations regarding study population, imaging, clinical and biological assessment of disease-modifying effects of viscosupplementation. Agreements were reached on some recommendations. In particular, the experts reached unanimous agreement on double-blind study design, imaging primary outcomes, time interval between 2 radiographs, x-ray procedure standardization, and the combined use of imaging and biological markers. The group did not recommend the use of ultrasonography, computed tomography (CT) scan and CT arthrography as a tool for OA diagnosis or to assess progression over time. CONCLUSION: In summary, the working group identified 31 recommendations that represent the current best practices regarding clinical trials that target the assessment of viscosupplementation disease-modifying effects in patients with knee OA. These recommendations integrate new imaging technologies and soluble biomarkers.


Assuntos
Monitoramento de Medicamentos/métodos , Ácido Hialurônico/administração & dosagem , Osteoartrite do Joelho/tratamento farmacológico , Viscossuplementação/métodos , Viscossuplementos/administração & dosagem , Comitês Consultivos , Idoso , Idoso de 80 Anos ou mais , Biomarcadores/análise , Feminino , Humanos , Articulação do Joelho/efeitos dos fármacos , Masculino , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
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