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OBJECTIVES: To investigate potential carcinogenic exposures in military personnel that are implicated in the development of bladder cancer. METHODS: This systematic review aimed to evaluate the association between specific military exposures and bladder cancer risk among veterans. PubMed, Scopus, and Ovid MEDLINE databases were searched in December 2023 for relevant articles. Inclusion criteria comprised retrospective cohort studies, reviews, and observational studies documenting bladder cancer incidence among military populations exposed to specific agents. A total of 25 studies, involving 4,320,262 patients, met the inclusion criteria. Data extraction followed PRISMA guidelines, and a random-effects model was used for data synthesis. RESULTS: The meta-analysis revealed significant associations between exposure to Agent Orange (HR 1.17 [95% CI: 1.01-1.36], p < 0.00001) and depleted uranium (HR 2.13 [95% CI: 1.31-3.48], p = 0.002) with increased bladder cancer risk among veterans. Contaminated drinking water showed a trend towards increased risk (HR 1.25 [95% CI: 0.97-1.61], p = 0.08). CONCLUSION: The findings suggest a possible association between specific military exposures and heightened bladder cancer risk among veterans, emphasizing the necessity for targeted screening protocols and preventive measures. Further research is essential to identify specific carcinogenic agents and prevalence of exposures among veterans, enabling more effective prevention and management strategies.
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AIMS: Patient satisfaction is associated with positive diabetes outcomes. However, there are no identified studies that evaluate both patient- and clinic-level predictors influencing diabetes care satisfaction longitudinally. METHODS: Data from the INtegrating DEPrEssioN and Diabetes treatmENT trial was used to perform the analysis. We used fixed and random effects models to assess whether and how changes in patient-level predictors (treatment assignment, depression symptom severity, systolic blood pressure, body mass index, LDL cholesterol, and haemoglobin A1C) from 0 to 24 months and clinic-level predictors (visit frequency, visit cost, number of specialists, wait time, time spent with healthcare provider, and receiving verbal reminders) measured at 24 months influence diabetes care satisfaction from 0 to 24 months. RESULTS: Model 1 (patient-level predictors) accounted for 7% of the change in diabetes satisfaction and there was a significant negative relationship between change in depressive symptoms and care satisfaction (ß = -0.23, SE = 0.12, p < 0.05). Within Model 1, 2% of the variance was explained by clinic-level predictors. Model 2 included both patient- and clinic-level predictors and accounted for 18% of the change in diabetes care satisfaction. Within Model 2, 9% of the variance was attributed to clinic-level predictors. There was also a cross-level interaction where the change in depression had less of an impact on the change in satisfaction for those who received a verbal reminder (ß = -0.11, SE = 0.21, p = 0.34) compared with those who did not receive a reminder (ß = -0.62, SE = 0.08, p < 0.01). CONCLUSIONS: Increased burden of depressive symptoms influences diabetes care satisfaction. Clinic-level predictors also significantly influence diabetes care satisfaction and can reduce dissatisfaction in primary care, specifically, reminder calls from clinic staff.
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Ultraviolet (UV) radiation is a major contributor to skin aging, cancer, and other detrimental health effects. Sunscreens containing FDA-approved UV filters, like avobenzone, offer protection but suffer from photodegradation and potential phototoxicity. Encapsulation, antioxidants, and photostabilizers are strategies employed to combat these drawbacks. Octocrylene, an organic UV filter, utilizes nanotechnology to enhance sun protection factor (SPF). This review examines recent literature on octocrylene-enriched sunscreens, exploring the interplay between environmental impact, nanotechnological advancements, and clinical trial insights. A critical focus is placed on the environmental consequences of sunscreen use, particularly the potential hazards UV filters pose to marine ecosystems. Research in the Mediterranean Sea suggests bacterial sensitivity to these filters, raising concerns about their integration into the food chain. This review aims to guide researchers in developing effective strategies for photostabilization of UV filters. By combining encapsulation, photostabilizers, and antioxidants, researchers can potentially reduce phototoxic effects and contribute to developing more environmentally friendly sunscreens.
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Sunscreening Agents , Ultraviolet Rays , Sunscreening Agents/chemistry , Sunscreening Agents/toxicity , Humans , Acrylates/chemistry , Nanotechnology , Antioxidants/chemistry , Sun Protection FactorABSTRACT
BACKGROUND: Estimation of the drug and development of the method is a critical aspect of formulation development and a critical factor for analytical scientists. Gefitinib is a poorly soluble anticancer drug. OBJECTIVE: The present research focuses on the topic of the development of innovative quality by design methods for the estimation of gefitinib (GF) from bulk, pharmaceutical tablet formulation, and complex nanoformulations. METHODS: To simplify the estimation of poorly soluble drugs such as GF, response surface methodology (RSM) was adopted with effective leverages to obtain precise computation design space using the Box-Behnken design (BBD) model. The major three mixed-effect independent factors (percentage of buffer, pH of buffer, and flow rate) were screened with three prominent dependent responses (viz., theoretical plate, retention time, and tailing factor) selected for optimal analysis. Furthermore, co-processed steps were employed for the estimation of the analyte from the complex formulation. RESULTS: The RP-HPLC method uses the quality by design (QbD) approach can effectively estimate the analyte concentration of less than 4.5 min. The developed method was economically robust and sensitive and shows a relative standard deviation (RSD, %) of less than 2% for all the selected validation parameters. The estimated design space suggests the highest desirability (R2-0.998) at 60% of buffer in the mobile phase, pH 4.25, and flow rate of 0.7 mL/min. CONCLUSIONS: The QbD approach was used to design and develop the method by understanding the interaction between dependent and independent variables to get the optimum values. The developed method was validated successfully and can be useful for formulation scientists to estimate drug concentration and drug release profiles from complex nanoformulations. HIGHLIGHTS: The analytical approach was designed and quantified using a quality-by-design approach to make the RP-HPLC method more robust and efficient for the estimation of analytes from complex nanoformulations. The method is also useful to eliminate the interfering molecule during estimation by employing co-processing steps. The developed method saves time and cost of solvent and employs QbD as a requirement of recent regulatory concern.
Subject(s)
Gefitinib , Tablets , Chromatography, High Pressure Liquid/methods , Gefitinib/analysis , Gefitinib/chemistry , Antineoplastic Agents/analysis , Antineoplastic Agents/chemistry , Nanoparticles/chemistry , Drug Compounding/methods , Hydrogen-Ion Concentration , Chromatography, Reverse-Phase/methodsABSTRACT
AIMS: Approximately 55% of patients diagnosed with primary or metastatic cancer endure pain directly attributable to the disease. Consequently, it becomes imperative to address pain management through a comparative analysis of stereotactic radiotherapy (SRT) and conventional radiation therapy (CRT), especially in light of the less efficacious improvement achieved solely through pharmacological interventions. MATERIALS AND METHODS: A systematic exploration was undertaken on PubMed, the Cochrane Library, and Elsevier's ScienceDirect databases to identify studies that compare Stereotactic Radiotherapy to Conventional radiation therapy for pain management in individuals with metastatic bone cancer. The analyses were executed utilizing the random-effects model. RESULTS: A cohort of 1152 participants with metastatic bone cancer was analyzed, demonstrating significantly higher complete pain relief in the Stereotactic Radiotherapy group during both early and late follow-up (RR: 1.61; 95% CI: 1.17, 2.23, p-value: 0.004; I2: 0%). Stereotactic Radiotherapy also showed a non-significant increase in the incidence of partial pain relief (RR: 1.07; 95% CI: 0.85, 1.34, p-value: 0.56; I2: 18%). Furthermore, Stereotactic Radiotherapy was associated with a significantly reduced risk of stationary pain throughout follow-up (RR: 0.61; 95%CI: 0.48, 0.76, p-value: <0.0001; I2: 0. The incidence of progressive pain was non-significantly reduced with Stereotactic Radiotherapy during both early and late follow-up (RR: 0.77; 95% CI: 0.50, 1.17, p-value: 0.22; I2: 0%). Secondary outcomes exhibited a non-significant trend favoring Stereotactic Radiotherapy for dysphagia, esophagitis, pain, and radiodermatitis, while a non-significant increase was observed for nausea, fatigue, and vertebral compression fracture. CONCLUSION: In summary, stereotactic radiation therapy (SRT) has improved in achieving complete pain relief while exhibiting a decreased probability of delivering stationary pain compared to conventional radiation therapy (CRT). Nevertheless, it is crucial in future research to address a noteworthy limitation, specifically, the risk of vertebral compression fracture.
Subject(s)
Cancer Pain , Pain Management , Radiosurgery , Humans , Radiosurgery/methods , Cancer Pain/radiotherapy , Cancer Pain/etiology , Pain Management/methods , Bone Neoplasms/radiotherapy , Bone Neoplasms/secondary , Bone Neoplasms/complicationsABSTRACT
Introduction and importance: Primary biliary cholangitis (PBC) is a rare immune-mediated liver disease characterized by the destruction of intrahepatic bile ducts and a positive antimitochondrial antibody (AMA), which is considered a serological hallmark for the diagnosis. Rarely, AMA can be absent/nondetectable in a few cases and is referred to as 'AMA-negative'. Case presentation: The authors present such an uncommon case of AMA-negative PBC in a 39-year-female with Sjogren's syndrome who presented with fatigue, pruritus, and dry eyes. Clinical discussion: Previously published studies state that approximately only about 5% of patients with PBC are 'AMA-negative'. For patients negative for AMA, the diagnosis has to be based on typical pathological features of this disease. Once a diagnosis of PBC is established, regardless of whether it is positive or negative for AMAs, ursodeoxycholic acid is a widely accepted treatment. Conclusion: The presence/absence of AMAs is associated with similar clinical, biochemical, and histopathological characteristics in PBC. The identification of AMAs alone should not impact the diagnosis or treatment of PBC.
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Introduction: Isolated acromion fractures are rare and in that too, orthopaedicians rarely come across open acromial fractures. Hence literature regarding their management, outcome and any associated complications is obscure. In an extensive search for literature related to our case we found very few articles. We hereby report a case of Gustilo IIIA open acromial fracture with associated supraspinatus, deltoid and capsular injury managed with tension band wiring (TBW) and soft tissue repair with 6 month follow up. Case Report: A 21-year-old male was admitted in our hospital for wound of right shoulder with pain and inability to move this arm with a history of direct trauma with sharp object 3 days back. On examination, a wound 15 cm in length on the superior aspect of the right shoulder with its depth extending up to the glenohumeral joint was noted. The glenohumeral joint was exposed with a Gustilo Anderson type IIIA acromion fracture and injury of supraspinatus and capsule with no associated vascular or neurological injury. Wound was thoroughly irrigated and was used to approach the fracture site for repair. Capsule of shoulder was carefully closed with absorbable suture followed by suturing of supraspinatus with non-absorbable suture. Our initial plan to fix the acromial fracture to spinous process of scapula with 2 4 mm cannulated cancellous screw placed orthogonal to fracture site was modified intraoperative due to screw cut out and we went ahead with TBW with 1 screw and 1 Kirschner wire to prevent further fragmentation of the fragment. Wound was healing and healthy. Patient was started on a passive pendular exercises after 4 weeks and active exercises at 6 weeks. Six months postoperatively patient had complete range of shoulder rotation with forward flexion of 80° and abduction possible till 45°. Patient was able to do most of his activities of daily living barring overhead activities. Conclusion: As there are very limited cases of this sort of injury, this case report will cast a light on management options and outcomes of such injuries. We received fair results in our study with good healing and painless functional shoulder joint. However, long term and multi centric studies are required for further information pertaining to such scenarios.
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INTRODUCTION: Prostatic urethral lifts (PUL) provide improvement in urinary symptoms for men with benign prostatic hyperplasia (BPH). The aim of this study is to determine operative factors associated with improvement in urinary symptoms after PUL in men with bothersome BPH. MATERIALS AND METHODS: Men with BPH undergoing PUL at a single, tertiary center were identified from 2019 to 2022. Inclusion criteria included documented prostate volume as well as preoperative and postoperative cystoscopic images of the prostatic urethra. Multivariate regression modeling was performed to determine the predictive factors-including prostate volume, number of implants, and degree of unobstructed prostatic urethral channel-for improvement in International Prostate Symptom Score (IPSS) after PUL. RESULTS: Of the 47 men, the distribution of prostate volume was 1 patient with < 30 grams, 33 patients with 30-79 grams, five patients with 80-100 grams, and six patients with > 100 grams. The mean number of implants used was six implants. The mean preoperative and postoperative IPSS were 23 and 14, respectively. The mean (standard error (SE)) change and percent change in IPSS score following PUL was 14 and 60%, respectively. The mean percent improvement in prostatic urethral channel after anterior clip placements was 67%. On multivariate analysis, larger prostate volume was associated with greater change in IPPS follow surgery (p = 0.0091) while number of implants and percent of prostatic urethral opening were not associated with change in IPSS (p = 0.3094 and p = 0.2249, respectively). CONCLUSION: Men with larger prostates are associated with greater improvement in urinary symptom after PUL regardless of number of implants utilized and degree of prostatic urethral channel opening after prostatic implants.
Subject(s)
Prostate , Prostatic Hyperplasia , Male , Humans , Prostatic Hyperplasia/complications , Prostatic Hyperplasia/surgery , Urethra , Multivariate Analysis , Postoperative PeriodABSTRACT
Despite accumulating evidence implicating noncoding variants in human diseases, unraveling their functionality remains a significant challenge. Systematic annotations of the regulatory landscape and the growth of sequence variant data sets have fueled the development of tools and methods to identify causal noncoding variants and evaluate their regulatory effects. Here, we review the latest advances in the field and discuss potential future research avenues to gain a more in-depth understanding of noncoding regulatory variants.
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Genetic Predisposition to Disease , Genetic Variation , Humans , Genetic Variation/genetics , Genome-Wide Association Study/methods , Polymorphism, Single Nucleotide/geneticsABSTRACT
Amputation is the surgical removal of all or part of a body part. It demands an adjustment in almost every sphere of a person's life in addition to physical disability. An amputee faces problems in almost every psychosocial sphere.1, 2 Along with physical pain in the stump, patients may experience phantom sensations.3-5 Patients may also grieve, feel depressed, and anxious3, 6, 4, 7 or have posttraumatic stress disorder symptoms.8, 9 They may be apprehensive about their future plans and inconclusive regarding life challenges. Grief is one of the most common reactions to amputation,10, 1, 7 but often gets neglected in intensive surgical units.1 Many times, grief reactions are not resolved, turning into complicated grief or prolonged grief, leading to conditions like depression, anxiety, or even suicide. This article is about an attempt to help a patient initiate the grieving process for healthy outcomes.
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Nanotechnology is an emerging applied science delivering crucial human interventions. Biogenic nanoparticles produced from natural sources have received attraction in recent times due to their positive attributes in both health and the environment. It is possible to produce nanoparticles using various microorganisms, plants, and marine sources. The bioreduction mechanism is generally employed for intra/extracellular synthesis of biogenic nanoparticles. Various biogenic sources have tremendous bioreduction potential, and capping agents impart stability. The obtained nanoparticles are typically characterized by conventional physical and chemical analysis techniques. Various process parameters, such as sources, ions, and temperature incubation periods, affect the production process. Unit operations such as filtration, purification, and drying play a role in the scale-up setup. Biogenic nanoparticles have extensive biomedical and healthcare applications. In this review, we summarized various sources, synthetic processes, and biomedical applications of metal nanoparticles produced by biogenic synthesis. We highlighted some of the patented inventions and their applications. The applications range from drug delivery to biosensing in various therapeutics and diagnostics. Although biogenic nanoparticles appear to be superior to their counterparts, the molecular mechanism degradation pathways, kinetics, and biodistribution are often missing in the published literature, and scientists should focus more on these aspects to move them from the bench side to clinics.
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Several developments and research methods are ongoing in drug technology and chemistry research to elicit effectiveness regarding the therapeutic activity of drugs along with photoprotection for their molecular integrity. The detrimental effect of UV light induces damaged cells and DNA, which leads to skin cancer and other phototoxic effects. The application of sunscreen shields to the skin is important, along with recommended UV filters. Avobenzone is widely used as a UVA filter for skin photoprotection in sunscreen formulations. However, keto-enol tautomerism propagates photodegradation into it, which further channelizes the phototoxic and photoirradiation effects, further limiting its use. Several approaches have been used to counter these issues, including encapsulation, antioxidants, photostabilizers, and quenchers. To seek the gold standard approach for photoprotection in photosensitive drugs, combinations of strategies have been implemented to identify effective and safe sunscreen agents. The stringent regulatory guidelines for sunscreen formulations, along with the availability of limited FDA-approved UV filters, have led many researchers to develop perfect photostabilization strategies for available photostable UV filters, such as avobenzone. From this perspective, the objective of the current review is to summarize the recent literature on drug delivery strategies implemented for the photostabilization of avobenzone that could be useful to frame industrially oriented potential strategies on a large scale to circumvent all possible photounstable issues of avobenzone.
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The clinical landscape of Peyronie's disease is everchanging. There has been growing interest in non-invasive therapeutic options that could assist patients with achieving a meaningful reduction in penile curvature without surgical intervention. These therapies are wide-ranging in terms of their mechanisms of action, efficacies, and short- and long-term safety profiles. Recently, an abundance of outcomes literature on longstanding and novel non-surgical treatment modalities has been published. For sexual medicine providers hoping to offer patients the most up-to-date and evidence-based treatments for the management of Peyronie's disease, it can be challenging to gain a thorough understanding of this body of literature. In this clinical management review, the workup and current theories on the pathophysiology of Peyronie's disease are reviewed, and the most recent outcomes data on the currently available non-surgical treatment modalities are presented. With an accurate understanding of the current landscape of Peyronie's disease treatment, sexual health providers will be able to better evaluate and engage in evidence-based shared decision-making with their patients.
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Altered cellular metabolism is a hallmark of cancer pathogenesis and progression; for example, a near-universal feature of cancer is increased metabolic flux through the hexosamine biosynthetic pathway (HBP). This pathway produces uridine diphosphate N-acetylglucosamine (UDP-GlcNAc), a potent oncometabolite that drives multiple facets of cancer progression. In this study, we synthesized and evaluated peracetylated hexosamine analogs designed to reduce flux through the HBP. By screening a panel of analogs in pancreatic cancer and glioblastoma multiform (GBM) cells, we identified Ac4Glc2Bzâa benzyl-modified GlcNAc mimeticâas an antiproliferative cancer drug candidate that down-regulated oncogenic metabolites and reduced GBM cell motility at concentrations non-toxic to non-neoplastic cells. More specifically, the growth inhibitory effects of Ac4Glc2Bz were linked to reduced levels of UDP-GlcNAc and concomitant decreases in protein O-GlcNAc modification in both pancreatic cancer and GBM cells. Targeted metabolomics analysis in GBM cells showed that Ac4Glc2Bz disturbed glucose metabolism, amino acid pools, and nucleotide precursor biosynthesis, consistent with reduced proliferation and other anti-oncogenic properties of this analog. Furthermore, Ac4Glc2Bz reduced the invasion, migration, and stemness of GBM cells. Importantly, normal metabolic functions mediated by UDP-GlcNAc were not disrupted in non-neoplastic cells, including maintenance of endogenous levels of O-GlcNAcylation with no global disruption of N-glycan production. Finally, a pilot in vivo study showed that a potential therapeutic window exists where animals tolerated 5- to 10-fold higher levels of Ac4Glc2Bz than projected for in vivo efficacy. Together, these results establish GlcNAc analogs targeting the HBP through salvage mechanisms as a new therapeutic approach to safely normalize an important facet of aberrant glucose metabolism associated with cancer.
Subject(s)
Antineoplastic Agents , Pancreatic Neoplasms , Animals , Biosynthetic Pathways , Hexosamines/metabolism , Antineoplastic Agents/pharmacology , Glucose/metabolism , Uridine Diphosphate/metabolism , Acetylglucosamine/metabolism , Pancreatic NeoplasmsABSTRACT
OBJECTIVE: To assess the value of preliminary testicular core extraction (TCE) as a tool for determining whether to pursue clinic testicular extraction (cTESE) versus microscopic testicular sperm extraction (mTESE) to minimize both financial burden and procedural complexity. METHODS: All men with non-obstructive azoospermia (NOA) from 2018 to 2022 who underwent clinic TCE were analyzed. Patients who were found to have sperm on initial TCE were recommended cTESE. Patients who did not have sperm on initial TCE were recommended for mTESE. Sensitivity, specificity, positive predictive value, and negative predictive value of TCE were calculated. Cost reductions were determined based on this institution's fees. A nonparametric Wilcoxon test was performed to determine statistical significance between the results of the TCE sperm present and sperm absent groups. RESULTS: Of the 82 NOA patients undergoing TCE, 51 (62.2%) core biopsies were positive for sperm and 31 (37.8%) were negative for sperm. The SRR for 35 men who then underwent cTESE following sperm seen on TCE was 97.1%. The SRR for 8 men who underwent mTESE after no sperm was found on TCE was 75%. The positive predictive value of TCE for successful TESE result is 94.4% for men with NOA. Treatment success rate of TCE and cTESE was 79.1% with a cost reduction of 59.4%. CONCLUSION: TCE is a prognostic tool to guide decision making between cTESE and mTESE and maximize sperm retrieval rate while mitigating financial burden and operative complexity. TCE is important to identify ideal candidates for both procedures to maximize efficacy and safety amongst men with NOA.
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Azoospermia , Male , Humans , Azoospermia/surgery , Sperm Retrieval , Retrospective Studies , Testis/surgery , Testis/pathology , Spermatozoa/pathologyABSTRACT
ETHNOPHARMACOLOGICAL RELEVANCE: Osbeckia nepalensis Hook. f. is an ICMR documented plant well known for its antidiabetic uses among the folk people of Northeast Region of India. In-depth study with scientific substantiation of the plant may uphold the therapeutic potential against the treatment of type 2 diabetes mellitus (T2DM). AIM OF THE STUDY: The present study evaluates the traditionally claimed prophylactic potential of O. nepalensis and its extracts along with the isolated compound taxifolin-3-O-glucoside (TG) against the downregulation of T2DM related hepatic gluconeogenesis through in vitro, in vivo and in silico conditions as a means of ameliorating hyperglycemia. MATERIALS AND METHODS: Antidiabetic potential of O. nepalensis was carried out in both CC1 hepatocytes (in vitro) and STZ-induced diabetic male Wistar rats (in vivo). Enriched bioactive fraction and bioactive molecules were isolated through bioactivity-guided fractionation, yielding two major molecules, taxifolin-3-O-glucoside and quercitin-3-O-rhamnoside. The bioactivity of taxifolin-3-O-glucoside was validated through immunoblotting techniques aided by in silico molecular docking and simulations. RESULTS: Methanolic extract of O. nepalensis and taxifolin-3-O-glucoside (TG) isolated thereof enhanced the uptake of glucose in CC1 hepatocytes and downregulates the gluconeogenic enzymes (G6Pase and PEPCK) and its related transcription factors (FOXO1, HNF4α and PGC1α) through the stimulation of AMPK phosphorylation in in vitro condition. Moreover, in in vivo experiments, the in vitro most active fraction BuSFr1 (consisting of the two active major compounds taxifolin-3-O-glucoside and quercitin-3-O-rhamnoside) exhibited a substantial decrease in elevated blood glucose level and increase the glucose tolerance as well as plasma insulin level. In silico molecular docking and simulations for TG with the protein G6Pase inferred the docking sites and stability and showed taxifolin-3-O-glucoside as more potent and non-toxic as compared to quercitin-3-O-rhamnoside. CONCLUSION: The traditionally claimed antidiabetic effect of O. nepalensis has been proved to be effective in lowering the blood glucose level through in vitro, in vivo and in silico analysis which will pave a way for the development of antidiabetic phytopharmaceutical drugs which can be validated through further clinical studies.
Subject(s)
Diabetes Mellitus, Type 2 , Hypoglycemic Agents , Rats , Animals , Hypoglycemic Agents/pharmacology , Hypoglycemic Agents/therapeutic use , Rats, Wistar , Diabetes Mellitus, Type 2/drug therapy , AMP-Activated Protein Kinases/metabolism , Blood Glucose/metabolism , Glucosides/pharmacology , Glucosides/therapeutic use , Glucosides/metabolism , Molecular Docking Simulation , Hepatocytes , Glucose/metabolism , LiverABSTRACT
Sulfobutylether ß-cyclodextrin (SBE-ß-CD) is a polyanionic cyclic oligosaccharide that contains glucopyranose units forming a torus ring-like structure. SBE-ß-CD is gifted with many favorable properties viz. relatively high solubility (>50 folds compared to ß-CD), improved stability, and biocompatibility that praised SBE-ß-CD as a smart polymer for drug delivery applications. Commercially, SBE-ß-CD is popular by its brand name Captisol®. The present review discusses the structure, properties, and preparation methods of SBE-ß-CD-based inclusion complexes (ICs). Furthermore, we discuss here the preparation and applications of SBE-ß-CD ICs-based nanoparticulate drug delivery systems, which combines the merits of both, ICs (enhanced solubility) and nanoparticles (NPs, targeted therapy). Patents on and FDA-approved Captisol®-enabled products are tabulated in the benefit of readers. The toxicological aspects and current clinical status of SBE-ß-CD or SBE-ß-CD-based products are briefly explained in the present review. In our opinion, the present review would be a pathfinder to allow dissemination of information on SBE-ß-CD.
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Stimuli Responsive Polymers , beta-Cyclodextrins , Biopolymers , Drug Delivery SystemsABSTRACT
BACKGROUND: Postmastectomy breast cancer lymphedema poses an important health threat. Historically, physical therapy was the exclusive treatment option. More recently, lymphedema surgery has revolutionized care. As a first-in-kind, multicenter report, the postmastectomy breast cancer patients' risk factors associated with postlymphedema ablative surgical outcomes were documented. METHODS: Using the New York Statewide Planning and Research Cooperative System database from 2010 to 2018, multivariable models identified the postmastectomy breast cancer lymphedema surgical patients' characteristics associated with major adverse outcomes and mortality. RESULTS: Of 65,543 postmastectomy breast cancer patients, 1,052 lymphedema surgical procedures were performed including 393 (37.4%) direct excisions and 659 (63.6%) liposuctions. Direct excision and liposuction surgical patients had median ages of 58 and 52 years, respectfully (p < 0.001). Although a 30-day operative mortality was rare (0.3%, all direct excisions), major adverse outcomes occurred in 154 patients (28.5% direct excision; 6.4% liposuction; p < 0.0001). Multivariable clinical outcomes model identified that patients with higher Elixhauser's score, renal disease, emergent admissions, and direct excision surgery had higher incidences of adverse outcomes (all p < 0.01). For those patients with 30-day readmissions (n = 60), they were more likely to have undergone direct excision versus liposuction (12.5 vs. 1.7%; p < 0.0001). The important risk factors predictive of future cellulitis/lymphangitis development included diabetes mellitus, Medicaid insurance, renal disease, prior cellulitis/lymphangitis, chronic obstructive pulmonary disease (COPD), and chronic steroid use (all p < 0.01). CONCLUSION: Lymphedema surgery carries a favorable risk profile, but better understanding the "high-risk" patients is critical. As this new era of lymphedema surgery progresses, evaluating the characteristics for adverse postoperative outcomes is an important step in our evolution of knowledge.