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Toxins Jun 2023Intracavernosal injections of botulinum toxin A (BTX/A ) may be effective for difficult-to-treat erectile dysfunction (ED). This is a retrospective case series study of...
Safety and Effectiveness of Repeated Botulinum Toxin A Intracavernosal Injections in Men with Erectile Dysfunction Unresponsive to Approved Pharmacological Treatments: Real-World Observational Data.
Intracavernosal injections of botulinum toxin A (BTX/A ) may be effective for difficult-to-treat erectile dysfunction (ED). This is a retrospective case series study of the effectiveness of repeated off-label BTX/A (onabotulinumtoxinA 100U, incobotulinumtoxinA 100U or abobotulinumtoxinA 500U) in men with ED and insufficient response to phosphodiesterase type 5 inhibitors (PDE5-Is) or prostaglandinE1 intracavernosal injections (PGE1 ICIs), defined as an International Index of Erectile Function-Erectile Function domain score (IIEF-EF) < 26 on treatment. Further injections were performed on patients' requests, and the files of men who underwent at least two injections were reviewed. The response to BTX/A was defined as the achievement of the minimally clinically important difference in IIEF-EF adjusted to the severity of ED on treatment at baseline. Out of 216 men treated with BTX/A and PDE5-Is or PGE1-ICIs, 92 (42.6%) requested at least a second injection. The median time since the preceding injection was 8.7 months. In total, 85, 44 and 23 men received, respectively, two, three and four BTX/A . The overall response rate was 77.5%: 85.7% in men with mild ED, 79% for moderate ED and 64.3% for severe ED on treatment. The response increased with repeated injections: 67.5%, 87.5% and 94.7%, respectively, after the second, third and fourth injections. Post-injection changes in IIEF-EF were similar across injections. The time from injection to request for a further injection varied little. Four men reported penile pain at the time of injection (1.5% of all injections), and one experienced a burn at the penile crus. Repeated BTX/A injections combined with PDE5-Is or PGE1-ICIs produced an effective and durable response, with acceptable safety.
Topics: Male; Humans; Erectile Dysfunction; Penile Erection; Alprostadil; Retrospective Studies; Botulinum Toxins, Type A; Phosphodiesterase 5 Inhibitors; Treatment Outcome
PubMed: 37368683
DOI: 10.3390/toxins15060382 -
Clinical, Cosmetic and Investigational... 2023Systemic sclerosis is a connective tissue disease characterized by vasculopathy and progressive fibrosis, leading to multiorgan dysfunction. Given the complex and not...
BACKGROUND
Systemic sclerosis is a connective tissue disease characterized by vasculopathy and progressive fibrosis, leading to multiorgan dysfunction. Given the complex and not fully elucidated pathogenesis, biomarkers of rapid disease progression and therapeutic response are lacking. Copeptin, which reflects vasopressin activity in serum, is used in diagnosing or prognosing different cardiometabolic conditions.
OBJECTIVE
The aim of study was to investigate the concentration of copeptin in patients with systemic sclerosis and correlate it with specific clinical symptoms.
PATIENTS AND METHODS
Serum copeptin was measured in patients with systemic sclerosis (34 women and 3 men; mean age 57.6 years) and in healthy individuals (n=30) using commercially available ELISA kits. According to the criteria of LeRoy our systemic sclerosis cohort consisted of 17 patients with limited cutaneous systemic sclerosis (45.9%) and 20 diffuse cutaneous systemic sclerosis patients (54.1%). According to the criteria of LeRoy our systemic sclerosis cohort consisted of 17 patients with limited cutaneous systemic sclerosis (45.9%) and 20 diffuse cutaneous systemic sclerosis patients (54.1%). The median duration of the disease was 10 [4-14] years.
RESULTS
We found significantly higher copeptin concentration in patients with systemic sclerosis (4.21 pmol/L [3.04-5.42]) in comparison to control group (3.40 pmol/L [2.38-3.76], p<0.01). Copeptin significantly correlated with Raynaud's condition score (r=0.801, p<0.05). Patients with "late" capillaroscopic patterns had higher copeptin concentrations (5.37 pmol/L [4.29-8.06]) than patients with "early" (2.43 pmol/L [2.25-3.20], p<0.05) and "active" patterns (3.93 pmol/L [2.92-5.16], p<0.05]). Copeptin was found to be significantly higher in SSc patients with DUs (5.71 pmol/L [IQR 4.85-8.06]) when compared to SSc patients without DUs (3.31 pmol/L, [2.28-4.30], p<0.05). Additionally, copeptin concentration had good diagnostic accuracy in discriminating between patients with and without digital ulcers (AUC=0.863). Alprostadil decreased copeptin concentration from 4.96 [4.02-6.01] to 3.86 pmol/L [3.17-4.63] (p<0.01) after 4-6 cycles of administration.
CONCLUSION
Our findings suggest that copeptin may be a promising biomarker of microcirculation alterations in systemic sclerosis.
PubMed: 37255624
DOI: 10.2147/CCID.S409490 -
Journal of Interventional Cardiology 2023In-stent restenosis (ISR) is a common complication after percutaneous coronary intervention (PCI) surgery for patients with coronary atherosclerotic heart disease (CHD).... (Meta-Analysis)
Meta-Analysis Review
Application of Nanoliposome Alprostadil in the Perioperative Period of Percutaneous Coronary Intervention to Reduce In-Stent Restenosis: A Systematic Review and Meta-Analysis.
BACKGROUND
In-stent restenosis (ISR) is a common complication after percutaneous coronary intervention (PCI) surgery for patients with coronary atherosclerotic heart disease (CHD). Reports indicate alprostadil may reduce ISR, and this study aimed at reviewing and summarizing the effect of nanoliposome alprostadil on ISR by meta-analysis.
METHODS
Articles were searched from databases, and meta-analysis was performed in Review Manager software. Funnel plots were performed to evaluate the publication bias, and sensitivity analysis was performed to determine the robustness of the overall treatment effects.
RESULTS
Initially, 113 articles were identified, and 5 studies of 463 subjects were included for analysis eventually. The primary endpoint, i.e., the occurrence of ISR after PCI, occurred in 11.91% of the alprostadil treatment group (28 from 235 patients) vs. 21.49% of the conventional treatment group (49 from 228 patients) and showed a statistical significance in our pooled data ( = 7.654, =0.006), while there was no statistically significant difference in all of the separate studies. We observed no statistical methodological heterogeneity among the studies (=0.64, ≈ 0%). The pooled odds ratio (OR) of the occurrence of ISR was 49% in a fixed-effect model, and the 95% confidence boundary (95% CI) was 29% to 81%. The funnel plot did not show serious publication bias, and sensitivity analysis showed well robustness of the overall treatment effect. In conclusion, the early application of nanoliposome alprostadil after PCI could effectively reduce the occurrence of ISR, and the overall effect of alprostadil treatment in reducing ISR after PCI was relatively stable.
Topics: Humans; Percutaneous Coronary Intervention; Alprostadil; Coronary Restenosis; Constriction, Pathologic; Perioperative Period; Risk Factors; Coronary Angiography; Treatment Outcome
PubMed: 37251365
DOI: 10.1155/2023/4100197 -
Pakistan Journal of Medical Sciences 2023To analyze the clinical efficacy of alprostadil combined with nimodipine in the treatment of cerebral vasospasm (CVS) after subarachnoid hemorrhage (SAH) in elderly...
OBJECTIVE
To analyze the clinical efficacy of alprostadil combined with nimodipine in the treatment of cerebral vasospasm (CVS) after subarachnoid hemorrhage (SAH) in elderly patients.
METHODS
This is a retrospective study. According to different treatment methods, the elderly 100 patients with CVS after SAH hospitalized in Baoding First Central Hospital from March 2020 to May 2021 were randomly divided into control group and observation group, with 50 patients in each group. The control group was treated with nimodipine, while the observation group was additionally combined with alprostadil. The levels of inflammatory factors and hemorheological indexes were measured before and after treatment. The clinical efficacy was compared and the adverse reactions were observed of the two groups.
RESULTS
The overall clinical efficacy in the observation group (95.00%) was significantly higher than that in the control group (74.00%) (0.05). After treatment, serum tumor necrosis factor-α (TNF-α), interleukin-8 (IL-8), high-sensitivity C-reactive protein (hs-CRP) and hemorheological indexes such as plasma viscosity, whole blood viscosity at high shear, whole blood viscosity at low shear, hematocrit and platelet adhesion decreased significantly compared with those before treatment (0.05), which were more obvious in the observation group (0.05). During treatment, the rate of adverse reactions in the observation group was 12.00%, and that in the control group was 8.00%, without statistically significant difference between the two groups ( 0.05).
CONCLUSION
Alprostadil combined with nimodipine is markedly effective in the treatment of CVS after SAH in elderly patients. It can effectively reduce inflammatory factor levels and improve hemorheological indexes in patients, which is conducive to the repair of neurological function.
PubMed: 37250544
DOI: 10.12669/pjms.39.3.6753 -
Cell Transplantation 2023Fat graft is widely used in plastic and reconstructive surgery. The size of the injectable product, the unpredictable fat resorption rates, and subsequent adverse...
Fat graft is widely used in plastic and reconstructive surgery. The size of the injectable product, the unpredictable fat resorption rates, and subsequent adverse effects make it tricky to inject untreated fat into the dermal layer. Mechanical emulsification of fat tissue, which Tonnard introduced, solves these problems, and the product obtained was called nanofat. Nanofat is widely used in clinical and aesthetic settings to treat facial compartments, hypertrophic and atrophic scars, wrinkle attenuation, skin rejuvenation, and alopecia. Several studies demonstrate that the tissue regeneration effects of nanofat are attributable to its rich content of adipose-derived stem cells. This study aimed to characterize product by investigating morphology, cellular yield, adipose-derived stem cell (ASC) proliferation rate and clonogenic capability, immunophenotyping, and differential potential. The percentage of SEEA3 and CD105 expression was also analyzed to establish the presence of multilineage-differentiating stress-enduring (MUSE) cell. Our results showed that the kit could isolate 3.74 × 10 ± 1.31 × 10 proliferative nucleated cells for milliliter of the treated fat. Nanofat-derived ASC can grow in colonies and show high differentiation capacity into adipocytes, osteocytes, and chondrocytes. Moreover, immunophenotyping analysis revealed the expression of MUSE cell antigen, making this nanofat enriched of pluripotent stem cell, increasing its potential in regenerative medicine. The unique characteristics of MUSE cells give a simple, feasible strategy for treating a variety of diseases.
Topics: Humans; Alprostadil; Cells, Cultured; Adipose Tissue; Mesenchymal Stem Cells; Obesity; Pluripotent Stem Cells; Stem Cell Transplantation
PubMed: 37243545
DOI: 10.1177/09636897231175968 -
Revista de Gastroenterologia de Mexico... 2024Chronic idiopathic constipation (CIC) negatively impacts quality of life and increases healthcare costs. Lubiprostone stimulates the secretion of intestinal fluid, in... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Chronic idiopathic constipation (CIC) negatively impacts quality of life and increases healthcare costs. Lubiprostone stimulates the secretion of intestinal fluid, in turn facilitating the passage of stools and alleviating associated symptoms. Lubiprostone has been available in Mexico since 2018, but its clinical efficacy has not been studied in a Mexican population.
AIM
To evaluate the efficacy of lubiprostone, assessed by changes in spontaneous bowel movement (SBM) frequency after one week of treatment with 24 μg oral lubiprostone (b.i.d.), as well as its safety, over four weeks of treatment.
STUDY
Randomized, double-blind, placebo-controlled study on 211 adults with CIC in Mexico.
RESULTS
The increase in SBM frequency, after one week of treatment, was significantly higher in the lubiprostone group than in the placebo group (mean: 4.9 [SD: 4.45] vs. 3.0 [3.14], p = 0.020). Secondary efficacy endpoints revealed a significantly higher proportion of SBM frequency/week in the lubiprostone group at weeks 2, 3, and 4. There was a better response within 24 h after the first dose with lubiprostone vs. placebo (60.0% vs. 41.5%; OR: 2.08, CI95%: [1.19, 3.62], p = 0.009) and the lubiprostone group also had significant improvement, with respect to straining, stool consistency, abdominal bloating, and Satisfaction Index. The main adverse events were gastrointestinal disorders in 13 (12.4%) lubiprostone-treated subjects and 4 (3.8%) control subjects.
CONCLUSIONS
Our data confirm the efficacy and safety of lubiprostone for the treatment of CIC in a Mexican population. Lubiprostone treatment induces relief from the most bothersome symptoms associated with constipation.
Topics: Adult; Humans; Lubiprostone; Quality of Life; Constipation; Intestines; Treatment Outcome
PubMed: 37225537
DOI: 10.1016/j.rgmxen.2023.05.006 -
Gastroenterology Jun 2023Chronic idiopathic constipation (CIC) is a common disorder associated with significant impairment in quality of life. This clinical practice guideline, jointly developed...
INTRODUCTION
Chronic idiopathic constipation (CIC) is a common disorder associated with significant impairment in quality of life. This clinical practice guideline, jointly developed by the American Gastroenterological Association and the American College of Gastroenterology, aims to inform clinicians and patients by providing evidence-based practice recommendations for the pharmacological treatment of CIC in adults.
METHODS
The American Gastroenterological Association and the American College of Gastroenterology formed a multidisciplinary guideline panel that conducted systematic reviews of the following agents: fiber, osmotic laxatives (polyethylene glycol, magnesium oxide, lactulose), stimulant laxatives (bisacodyl, sodium picosulfate, senna), secretagogues (lubiprostone, linaclotide, plecanatide), and serotonin type 4 agonist (prucalopride). The panel prioritized clinical questions and outcomes and used the Grading of Recommendations Assessment, Development, and Evaluation framework to assess the certainty of evidence for each intervention. The Evidence to Decision framework was used to develop clinical recommendations based on the balance between the desirable and undesirable effects, patient values, costs, and health equity considerations.
RESULTS
The panel agreed on 10 recommendations for the pharmacological management of CIC in adults. Based on available evidence, the panel made strong recommendations for the use of polyethylene glycol, sodium picosulfate, linaclotide, plecanatide, and prucalopride for CIC in adults. Conditional recommendations were made for the use of fiber, lactulose, senna, magnesium oxide, and lubiprostone.
DISCUSSION
This document provides a comprehensive outline of the various over-the-counter and prescription pharmacological agents available for the treatment of CIC. The guidelines are meant to provide a framework for approaching the management of CIC; clinical providers should engage in shared decision making based on patient preferences as well as medication cost and availability. Limitations and gaps in the evidence are highlighted to help guide future research opportunities and enhance the care of patients with chronic constipation.
Topics: Adult; Humans; Laxatives; Lubiprostone; Lactulose; Quality of Life; Magnesium Oxide; Gastroenterology; Constipation; Polyethylene Glycols; Sennosides
PubMed: 37211380
DOI: 10.1053/j.gastro.2023.03.214 -
The American Journal of Gastroenterology Jun 2023Chronic idiopathic constipation (CIC) is a common disorder associated with significant impairment in quality of life. This clinical practice guideline, jointly developed...
INTRODUCTION
Chronic idiopathic constipation (CIC) is a common disorder associated with significant impairment in quality of life. This clinical practice guideline, jointly developed by the American Gastroenterological Association and the American College of Gastroenterology, aims to inform clinicians and patients by providing evidence-based practice recommendations for the pharmacological treatment of CIC in adults.
METHODS
The American Gastroenterological Association and the American College of Gastroenterology formed a multidisciplinary guideline panel that conducted systematic reviews of the following agents: fiber, osmotic laxatives (polyethylene glycol, magnesium oxide, lactulose), stimulant laxatives (bisacodyl, sodium picosulfate, senna), secretagogues (lubiprostone, linaclotide, plecanatide), and serotonin type 4 agonist (prucalopride). The panel prioritized clinical questions and outcomes and used the Grading of Recommendations Assessment, Development, and Evaluation framework to assess the certainty of evidence for each intervention. The Evidence to Decision framework was used to develop clinical recommendations based on the balance between the desirable and undesirable effects, patient values, costs, and health equity considerations.
RESULTS
The panel agreed on 10 recommendations for the pharmacological management of CIC in adults. Based on available evidence, the panel made strong recommendations for the use of polyethylene glycol, sodium picosulfate, linaclotide, plecanatide, and prucalopride for CIC in adults. Conditional recommendations were made for the use of fiber, lactulose, senna, magnesium oxide, and lubiprostone.
DISCUSSION
This document provides a comprehensive outline of the various over-the-counter and prescription pharmacological agents available for the treatment of CIC. The guidelines are meant to provide a framework for approaching the management of CIC; clinical providers should engage in shared decision making based on patient preferences as well as medication cost and availability. Limitations and gaps in the evidence are highlighted to help guide future research opportunities and enhance the care of patients with chronic constipation.
Topics: Adult; Humans; Laxatives; Lubiprostone; Lactulose; Quality of Life; Magnesium Oxide; Gastroenterology; Constipation; Polyethylene Glycols; Sennosides
PubMed: 37204227
DOI: 10.14309/ajg.0000000000002227 -
Cureus Mar 2023Intracavernosal injection of Trimix (a combination of phentolamine, papaverine, and alprostadil) is used for the treatment of erectile dysfunction. A rare but serious...
Intracavernosal injection of Trimix (a combination of phentolamine, papaverine, and alprostadil) is used for the treatment of erectile dysfunction. A rare but serious side effect of Trimix is priapism, a persistent erection lasting for more than four hours. Penoscrotal decompression is a newer technique being used to treat refractory and persistent ischemic priapism. Here, we report a unique case of priapism treated with penoscrotal decompression in a patient following an unmeasured injection of Trimix. A 36-year-old male presented to the emergency room complaining of a persistent painful erection over the previous five days following a Trimix injection and illicit methamphetamine use. At bedside, aspiration and irrigation were attempted without any improvement. Phenylephrine injection was contraindicated due to sinus tachycardia. The patient then underwent bilateral penoscrotal decompression on day six post-Trimix injection. The procedure was successful with a resolution of the erection, though some moderate corporal fibrosis was noted. At a 10-day follow-up, the patient reported moderate pain in his penis but had regained complete potency. Misuse of Trimix can cause persistent ischemic priapism. Penoscrotal decompression is a novel technique used to treat persistent ischemic priapism and has been shown to have positive efficacy in the resolution of priapism as well as in salvaging erectile function. To our knowledge, treatment of persistent priapism with penoscrotal decompression after using Trimix has not yet been reported in the literature. Given the rarity of this, our report highlights a unique case that has potential benefit for future practitioners who are faced with this clinical scenario.
PubMed: 37123749
DOI: 10.7759/cureus.36757 -
Frontiers in Medicine 2023To systematically evaluate the clinical efficacy and safety of Shenkang injection (SKI) combined with alprostadil in the treatment of chronic renal failure (CRF).
OBJECTIVE
To systematically evaluate the clinical efficacy and safety of Shenkang injection (SKI) combined with alprostadil in the treatment of chronic renal failure (CRF).
METHOD
Randomized controlled trials (RCTs) of Shenkang injection combined with alprostadil in CRF treatment were investigated by retrieving a total of 7 databases including CNKI, Wanfang database, VIP, CBM, PubMed, Embase and Cochrane Library, with the search time ranging from 2012 to now. Revman 5.2 software was used for data analysis, and Cochrane bias risk tool was used to evaluate the quality of the included literature. The final results were represented by relative risk (RR), mean difference (MD) and 95% confidence interval (95% CI).
RESULTS
A total of 20 RCTs and 1,573 patients were included in this study. Meta-analysis showed that the overall response rate (ORR) of the treatment group was superior to the control group [RR = 0.20, 95% CI (0.16, 0.25), < 0.00001]. Compared with the control group, the treatment group achieved favorable improvement in terms of the creatinine clearance rate (Ccr) [MD = 9.48, 95% CI (8.73, 10.24), < 0.00001], serum creatinine (Scr) [MD = -55.12, 95% CI (-63.42, -46.82), < 0.00001], quantitative urine protein (Upro) [MD = -0.48, 95% CI (-0.53, -0.43), < 0.00001], and blood urea nitrogen (BUN) [MD=-3.73, 95% CI (-4.08, -3.3) 7, < 0.00001]. There was no statistical difference in the incidence of adverse reactions in each group.
CONCLUSION
Currently, Shenkang injection combined with alprostadil has been widely used in clinical treatment of CRF due to the certain effect superior to other methods. However, its specific efficacy and safety need to be further verified through numerous large-scale clinical trials.
PubMed: 37089596
DOI: 10.3389/fmed.2023.982016