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International Journal of Dermatology Feb 2024Radiesse is a filler composed of calcium hydroxylapatite microspheres suspended in a carboxymethylcellulose gel (CaHA/CMC). It has robust rheological properties that... (Review)
Review
Radiesse is a filler composed of calcium hydroxylapatite microspheres suspended in a carboxymethylcellulose gel (CaHA/CMC). It has robust rheological properties that have been associated with its versatility. CaHA/CMC is employed for both on-label indications of filling wrinkles or lines, volumizing, and contouring of areas as well as off-label indications aiming at biostimulation and skin tightening. However, despite the expanding use of CaHA/CMC, overall evidence and recommendations for treatment are currently lacking. This paper aims to provide an up-to-date overview of CaHA/CMC clinical applications, together with a level of evidence of supporting literature, focusing on the face. Based on the data, CaHA/CMC may be considered a safe and effective treatment option for cheeks, jawline, HIV-related facial lipoatrophy, and nasolabial folds. Treatment of marionette lines, chin, pre-jowl, and corner of the mouth also tends to respond with a high degree of efficacy. Despite the recent trend, guidelines, and safety profile of diluted and hyperdiluted Radiesse , no randomized controlled trials have been published.
Topics: Humans; Biocompatible Materials; Calcium; Carboxymethylcellulose Sodium; Cheek; Cosmetic Techniques; Durapatite; Face; Lipodystrophy; Skin Aging
PubMed: 37897174
DOI: 10.1111/ijd.16888 -
Orthopaedic Journal of Sports Medicine Jul 2021Genicular artery embolization (GAE) is an innovative technique that has been investigated as a supplementary treatment method for chronic pain secondary to knee... (Review)
Review
BACKGROUND
Genicular artery embolization (GAE) is an innovative technique that has been investigated as a supplementary treatment method for chronic pain secondary to knee osteoarthritis (OA).
PURPOSE
To evaluate the current evidence on the effectiveness and safety of GAE for OA-related knee pain.
STUDY DESIGN
Systematic review; Level of evidence, 4.
METHODS
A systematic literature search was conducted in the PubMed, Web of Science, EMBASE, and Scopus databases to identify studies related to knee OA treated with GAE. Treatment agents were categorized as Embozene, imipenem/cilastatin, resorbable microspheres, and polyvinyl alcohol. The main outcomes were the mean difference (MD) in pre- and postembolization pain based on the visual analog scale (VAS) or the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores as well as changes in the need for pain medication. Random- and fixed-effects models were applied for data analysis.
RESULTS
Of 379 initially inspected publications, 11 (N = 225 patients; 268 knees) were included in the final review. The quality of the studies was fair in 8 and poor in 3-categorized according to the National Institutes of Health quality assessment tool. Overall, 119, 72, 13, and 21 patients were treated with imipenem/cilastatin, Embozene, resorbable microspheres, and polyvinyl alcohol, respectively. Symptomatic improvement was reported in all studies. The pooled effect size, characterized by MD, showed a significant improvement in the VAS and WOMAC pain scores, with better functional status after GAE. Pre- versus postembolization MDs in VAS scores ranged from 32 within the first week to 58 after a 2-year follow-up (equivalent to 54% and 80% improvement, respectively). There was a similar trend in the overall WOMAC scores, with MDs ranging from 28.4 to 36.8 (about 58% and 85% improvement, respectively). GAE resulted in a decreased need for pain medication for knee OA, with a 27%, 65%, and 73% decline in the number of patients who used opioids, nonsteroidal anti-inflammatory drugs, and intra-articular hyaluronic acid injection, respectively ( < .00001 for all). No significant difference between embolic agents was seen with regard to post-GAE pain reduction. No severe or life-threatening complications were reported.
CONCLUSION
OA treated by GAE using different embolic particles can be considered generally safe, with good efficacy and no reported serious complications.
PubMed: 34350303
DOI: 10.1177/23259671211021356 -
BJU International Mar 2021To systematically review the literature in order to investigate the efficacy and safety of surgical and non-invasive penile enhancement procedures for aesthetic and...
OBJECTIVE
To systematically review the literature in order to investigate the efficacy and safety of surgical and non-invasive penile enhancement procedures for aesthetic and therapeutic purposes.
METHODS
A systematic search for papers investigating penile enhancement procedures was performed using the MEDLINE database. Articles published from January 2010 to December 2019, written in English, including >10 cases, and reporting objective length and/or girth outcomes, were included. Studies without primary data and conference abstracts were excluded. The main outcome measure was objective length and/or girth improvement. The review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement.
RESULTS
Out of 220 unique records, a total of 57 were reviewed. Eighteen studies assessed interventions for penile enhancement in 1764 healthy men complaining of small penis. Thirty-nine studies investigated 2587 men with concomitant pathologies consisting mostly of Peyronie's disease and erectile dysfunction. Twenty-five studies evaluated non-invasive interventions and 32 studies assessed surgical interventions, for a total of 2192 and 2159 men, respectively. Non-invasive interventions, including traction therapies and injection of fillers, were safe and mostly efficacious, whereas surgical interventions were associated with minor complications and mostly increased penile dimensions and/or corrected penile curvature. Overall, the quality of studies was low, and standardized criteria to evaluate and report efficacy and safety of procedures, as well as patient satisfaction, were missing.
CONCLUSION
The quality of the studies on penile enhancement procedures published in the last decade is still low. This prevents us from establishing recommendations based on scientific evidence regarding the efficacy and safety of interventions that are performed to increase the penis size for aesthetic or therapeutic indications.
Topics: Erectile Dysfunction; Humans; Hyaluronic Acid; Male; Microspheres; Organ Size; Patient Satisfaction; Penile Erection; Penile Induration; Penis; Polyesters; Polymethyl Methacrylate; Prostheses and Implants; Traction; Urogenital Surgical Procedures
PubMed: 32575166
DOI: 10.1111/bju.15145 -
Journal of Clinical Periodontology Jun 2023The aim of this systematic review was to evaluate the efficacy of patient-performed or administered adjunctive measures to non-surgical peri-implantitis therapy in terms... (Review)
Review
AIM
The aim of this systematic review was to evaluate the efficacy of patient-performed or administered adjunctive measures to non-surgical peri-implantitis therapy in terms of probing depth (PD) and/or bleeding on probing (BoP) reductions.
MATERIALS AND METHODS
Randomized and controlled clinical trials with at least 6 months of follow-up were searched in three databases. Secondary outcomes included implant loss, disease resolution, recurrence of peri-implantitis, need of re-treatment, changes in marginal bone levels, patient-reported outcomes and adverse effects.
RESULTS
Of 567 titles, 10 publications, reporting 9 investigations, were included. Three types of adjunctive measures were found (local/systemic antimicrobials and probiotics). Four studies evaluated the effects of local antimicrobials (i.e., minocycline microspheres, chlorhexidine chips or a metronidazole + amoxicillin gel), three studies evaluated systemic antimicrobials (either amoxicillin + metronidazole or metronidazole alone) and two studies evaluated probiotics (Lactobacillus reuteri strains). The addition of local antimicrobials led to modest improvements in PD reduction. Systemic antimicrobials showed significantly greater reductions in PD and BoP, especially at initially deep sites (PD > 6 mm). Due to the large heterogeneity among included studies, no meta-analyses were performed.
CONCLUSIONS
Different adjunctive measures in the non-surgical treatment of peri-implantitis have different impact in terms of PD and BoP reductions. Improved PD reductions result after the use of systemic antimicrobials, and to a lesser extent, after the use of local antimicrobials.
Topics: Humans; Peri-Implantitis; Anti-Bacterial Agents; Metronidazole; Minocycline; Amoxicillin; Anti-Infective Agents; Dental Implants
PubMed: 37143407
DOI: 10.1111/jcpe.13821 -
European Journal of Drug Metabolism and... Jul 2022Almost 15 years after the introduction of transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) for hepatocellular carcinoma (HCC) therapy, the mean... (Meta-Analysis)
Meta-Analysis
Systematic Review and Pharmacokinetic Meta-analysis of Doxorubicin Exposure in Transcatheter Arterial Chemoembolization and Doxorubicin-Eluted Beads Chemoembolization for Treatment of Unresectable Hepatocellular Carcinoma.
BACKGROUND
Almost 15 years after the introduction of transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) for hepatocellular carcinoma (HCC) therapy, the mean peak plasma concentration (C) and area under the concentration-time curve (AUC) for doxorubicin have still not been systematically reviewed or meta-analyzed.
OBJECTIVE
To conduct a systematic review and meta-analysis of available data and establish a reference range for C and AUC of doxorubicin DEB-TACE and TACE, as well as explore the potential influence of microspheres' size and type on these parameters.
METHODS
PubMed, EMBASE, and Web of Science were searched from August 1992 through December 2021. Studies measuring exposure parameters among HCC patients treated with doxorubicin DEB-TACE without restriction on language were included. Two independent reviewers extracted and unified data sets for pooled estimate analysis. The quality of the evidence was assessed via the Grading of Recommendations Assessment, Development and Evaluation framework. The ClinPK Statement checklist and Newcastle-Ottawa Scale (NOS) were used to determine the quality of studies.
RESULTS
Out of 666 studies, 246 full-text were reviewed, and 8 studies entered the meta-analysis (120 patients). C and AUC of doxorubicin were 7.52-fold (95% CI 7.65 to 7.42-fold; P < 0.0001) and 1.91-fold (95% CI 1.95 to 1.88-fold; P = 0.0001) lower with DEB-TACE compared to TACE. Significant reduction in pooled standardized mean difference (SMD) of C and AUC was observed with DEB-TACE versus TACE in direct comparison analysis (- 2.93; 95% CI - 3.60 to - 2.26, P < 0.00001, and - 1.73 95% CI - 2.55 to - 0.91, P < 0.0001, respectively). Moreover, in DEB-TACE stratification analysis, small microspheres revealed higher C, AUC and tumor response rate as well as lower complication rate.
LIMITATION
The heterogeneity could not be completely addressed through sensitivity and stratification analysis.
CONCLUSION
This meta-analysis provides exposure parameters of doxorubicin and justifies the advantage of DEB-TACE over TACE in terms of safety for patients with unresectable HCC. This study showed a marked association between the size of microsphere and exposure parameters of doxorubicin supporting the preference for small microspheres in DEB-TACE. The moderate and low quality of evidence is assigned to the C and AUC, respectively.
Topics: Carcinoma, Hepatocellular; Chemoembolization, Therapeutic; Doxorubicin; Humans; Liver Neoplasms; Microspheres
PubMed: 35543895
DOI: 10.1007/s13318-022-00762-z -
AAPS PharmSciTech May 2022Aqueous colloidal dispersions of water-insoluble polymers (APDs) avoid hassles associated with the use of organic solvents and offer processing advantages related to... (Review)
Review
Aqueous colloidal dispersions of water-insoluble polymers (APDs) avoid hassles associated with the use of organic solvents and offer processing advantages related to their low viscosity and short processing times. Therefore, they became the main vehicle for pharmaceutical coating of tablets and multiparticulates, a process commonly employed using pan and fluidized-bed machinery. Another interesting although less common processing approach is co-spray drying APDs with drugs in aqueous systems. It enables the manufacture of capsule- and matrix-type microspheres with controllable size and improved processing characteristics in a single step. These microspheres can be further formulated into different dosage forms. This systematic review is based on published research articles and aims to highlight the applicability and opportunities of co-spray drying drugs with APDs in drug delivery.
Topics: Drug Compounding; Excipients; Polymers; Solubility; Spray Drying; Tablets; Water
PubMed: 35538248
DOI: 10.1208/s12249-022-02293-x -
Journal of Vascular and Interventional... Dec 2022To assess the safety and effectiveness of transarterial radioembolization (TARE) in the treatment of hepatic metastases from pancreatic ductal adenocarcinoma (PDAC). (Review)
Review
PURPOSE
To assess the safety and effectiveness of transarterial radioembolization (TARE) in the treatment of hepatic metastases from pancreatic ductal adenocarcinoma (PDAC).
MATERIALS AND METHODS
A systematic search of the Embase and MEDLINE databases was conducted using keywords and Medical Subject Headings terms related to TARE and hepatic metastases from PDAC. Observational studies and clinical trials reporting overall survival (OS), hepatic progression-free survival (hPFS), or tumor response after TARE were included.
RESULTS
Eight studies, comprising 145 patients with metastatic PDAC, met the inclusion criteria. No randomized controlled trials were identified, and 4 studies were prospective. Forty-four (30.3%) patients underwent previous pancreatic resection, and 66 (45.5%) had extrahepatic metastases at the time of TARE. Most studies (n = 6) used resin microspheres for TARE. The pooled disease control rate was 69.4% at a median of 3 months. The median OS from the time of TARE ranged from 3.7 to 9 months. The median hPFS ranged from 2.4 to 5.2 months. There were 31 Grade 3-4 biochemical toxicities and 4 treatment-related deaths.
CONCLUSIONS
The role of TARE in patients with hepatic metastases from PDAC remains unclear owing to low patient numbers, limited prospective data, and heterogeneity in the study design. Further prospective studies are required to evaluate the role of TARE in carefully selected patients with liver-only metastatic disease.
Topics: Humans; Yttrium Radioisotopes; Adenocarcinoma; Pancreatic Neoplasms; Treatment Outcome; Liver Neoplasms; Embolization, Therapeutic; Carcinoma, Pancreatic Ductal; Carcinoma, Hepatocellular; Retrospective Studies
PubMed: 36084842
DOI: 10.1016/j.jvir.2022.08.031 -
BMC Oral Health Oct 2023Periodontal pockets are characteristic of periodontitis. Scaling and root planing is the gold standard for periodontitis treatment. Additional local antimicrobials are... (Meta-Analysis)
Meta-Analysis
Periodontal pockets are characteristic of periodontitis. Scaling and root planing is the gold standard for periodontitis treatment. Additional local antimicrobials are recommended in patients with a probing depth of ≥ 5 mm. This study aims to determine the effectiveness of chlorhexidine compared to other local antimicrobials in periodontitis. Searches were conducted using the Preferred Reporting Items for Systematic Reviews and Meta Analysis (PRISMA) guidelines. Meta-analysis was performed on studies that met inclusion criteria after risk of bias assessment. Meta-analysis between chlorhexidine chips and other antimicrobials showed a mean difference in probing depth after one month of 0.58 mm (p < 0.00001) whereas after three months the mean difference in probing depth was 0.50 mm (p = 0.001), index plaque 0.01 (p = 0.94) and gingival index - 0.11 mm (p = 0.02). Between chlorhexidine gel and other antimicrobials showed a mean difference in probing depth of 0.40 mm (p = 0.30), plaque index of 0.20 mm (p = 0.0008) and gingival index of -0.04 mm (p = 0.83) after one month. Chlorhexidine chips were more effective on the gingival index than other antimicrobials after three months. The other antimicrobials were more effective than chlorhexidine chips on probing depth after one and three months, and than chlorhexidine gels on plaque index after one month.
Topics: Humans; Chlorhexidine; Root Planing; Anti-Infective Agents, Local; Dental Scaling; Periodontitis; Gels
PubMed: 37899443
DOI: 10.1186/s12903-023-03241-2 -
Biomaterials Science Feb 2023Glioblastoma (GBM) is an aggressive malignant cancer associated with bleak prognosis and high mortality. The current standard of care for GBM is maximum surgical... (Meta-Analysis)
Meta-Analysis Review
Glioblastoma (GBM) is an aggressive malignant cancer associated with bleak prognosis and high mortality. The current standard of care for GBM is maximum surgical resection plus radiotherapy and temozolomide (TMZ) chemotherapy. The blood brain barrier (BBB) remains the main obstacle for chemotherapy and severely limits the choice of therapeutic agents. Local treatment allows drugs to circumvent the BBB and reduces systemic side effects. Despite much research effort, to date, no drug delivery system (DDS) designed to be directly injected into brain tumors has been clinically approved, and a systematic overview of the progress in this field, or lack thereof, is missing. In this review, a systematic search of pre-clinical literature was conducted which resulted in 36 original articles on injectable DDS for local treatment of GBM which met the inclusion criteria. A wide range of injectable DDS have been developed and tested pre-clinically which include nanoparticles, liposomes, microspheres, hydrogels and others. -Analyses of the included studies showed that, overall, local administration of injectable DDS was beneficial to increase the animal's survival time. Finally, this review summarized the therapeutic effect after local treatment and discussed the shortcomings of the experimental setting in studies.
Topics: Animals; Glioblastoma; Temozolomide; Drug Delivery Systems; Brain Neoplasms; Liposomes
PubMed: 36655634
DOI: 10.1039/d2bm01534j -
ClinicoEconomics and Outcomes Research... 2021Quality of life is among the most important considerations in the treatment of hepatocellular carcinoma (HCC), arguably second only to overall survival. Measuring and... (Review)
Review
Effects of Trial Population Selection on Quality of Life and Healthcare Decision-Making: A Systematic Review and Example in the Treatment of Hepatocellular Carcinoma with Radioembolization.
BACKGROUND AND AIMS
Quality of life is among the most important considerations in the treatment of hepatocellular carcinoma (HCC), arguably second only to overall survival. Measuring and modeling patient quality of life is also crucial in the evaluation of the cost-effectiveness of health interventions. In the present study, we aimed to identify cost-utility analyses comparing selective internal radiation therapy (SIRT) with systemic therapy in patients with unresectable HCC and to compare the modeled incremental quality of life differences between the two therapies.
METHODS
A systematic literature review was conducted. PubMed, EMBASE, the Cochrane Library, and health technology assessment agency websites were searched to identify cost-utility studies of SIRT versus systemic therapies in the treatment of HCC. Key characteristics of the studies, modeled populations and incremental quality of life outcomes were extracted from the included studies.
RESULTS
The systematic literature review retrieved 1140 studies, of which four were ultimately included. Hand searches then identified two distinct analyses, and an updated version of one of the four studies identified initially. From these seven studies, 18 analyses were included. Analyses using data from the overall trial populations reported incremental quality-of-life estimates spanning -0.09 to +0.28 quality-adjusted life years (QALYs), with that range expanding to -0.09 to +0.60 QALYs when also considering post hoc sub-group analyses.
CONCLUSION
The wide range of incremental QALYs, with substantial differences between overall trial populations and subgroups, illustrates the impact that the choice of target population may have on the relative quality of life outcomes of the compared interventions, which may in turn affect clinical decision-making. The small differences also highlight both the importance of reporting measures of dispersion around the findings, and the limitations of the incremental cost-effectiveness ratio (ICER) for assessing the relative cost-effectiveness of interventions that are predicted to result in similar quality-of-life outcomes.
PubMed: 34588788
DOI: 10.2147/CEOR.S319857