Safety and efficacy of long-term nasobiliary drainage to treat intractable pruritus in cholestatic liver disease.
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ABSTRACT:
SUBMITTER: Appleby VJ
PROVIDER: S-EPMC5369582 | biostudies-other | 2015 Oct
REPOSITORIES: biostudies-other
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Project description:BACKGROUND AND AIM:Among various symptoms accompanied with chronic liver disease, pruritus affects the quality of life of patients, causing physical and mental stress, and worsens hepatic function. Recently, ?-opioid receptor agonist, nalfurafine hydrochloride was approved to treat central pruritus in patients with liver disease in Japan. This study aimed to assess the long-term efficacy and safety of nalfurafine hydrochloride on pruritus in chronic liver disease patients. METHODS:A patient-reported outcome using questionnaire-based methods was used for 41 liver disease patients with or without pruritus symptoms. Nalfurafine hydrochloride (2.5 ?g/day) was orally administered to 18 patients suffering from pruritus symptoms and whose current treatment was not effective. The same questionnaires and visual analogue scales (VAS) were repeatedly followed up for the patients for the entire follow-up period, and biochemical analyses were performed to evaluate the safety of the treatment. RESULTS:Pruritus completely disappeared in seven of 18 cases, and VAS scores showed a decreasing trend over time from the start of nalfurafine hydrochloride administration in all patients who received the medication. Among 11 patients who were followed up for more than 12 weeks, nine patients showed continuous improvement of symptoms, and this progress was still apparent at ?20 weeks after starting administration (p < 0.0001). The medication was discontinued in four patients because of progression of primary disease, high cost, oral dryness, and anemia. No significant toxicity was observed on the serum biochemical analyses. CONCLUSIONS:Nalfurafine hydrochloride contributed to long-term suppression of pruritus without significant safety problems.
| S-EPMC5467861 | biostudies-literature
Project description:BackgroundPruritus is a symptom of several cholestatic liver diseases (CLDs) that can impair health-related quality of life (HRQoL). Despite evidence-based guideline therapy, managing cholestatic pruritus (CP) remains challenging, thus making the need for newer, more effective therapeutic agents more evident.ObjectiveOur study evaluated the efficacy of existing CP therapies.DesignSystematic review.Data sourcesFrom inception until March 2023, we conducted a comprehensive search of MEDLINE, Cochrane, EMBASE, Scopus, ClinicalTrial.gov, and other sources, including pharmaceutical webpages and conference proceedings published in English that reported on CP interventions.MethodsTwo reviewers independently conducted screening and full-text review of articles with extraction conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. The methodological quality of studies included in our qualitative synthesis was assessed by using the Cochrane ROBINS-I and ROBINS-II tools for interventional studies and the National Heart, Lung, and Blood Institute Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies. The primary outcome assessed in our systematic review was the severity of CP after therapy.ResultsOf 3293 screened articles, 92 studies were eligible for inclusion in the qualitative synthesis. Some patients' HRQoL improved with evidence-based standard therapy. Others, particularly those with severe and refractory CP, often required conversion to or addition of experimental noninvasive (e.g., ondansetron) or extracorporeal liver support to alleviate CP. In addition, studies investigating a newer class drug, the ileal bile acid transporter inhibitor (IBATi), demonstrate its effectiveness in reducing serum bile acid and alleviating CP with sustained improvement noted in patients with the inherited childhood cholestatic disorders - progressive familial intrahepatic cholestasis and Alagille syndrome.ConclusionOur findings consolidate data on the efficacy of guideline-based approaches and newer therapies for CP. While the initial findings are promising, additional clinical trials will be needed to determine the full extent of IBATi's efficacy and potential use in treating other common CLDs. These results provide a foundation for future research and highlight the need for continued investigation into the management and treatment of CLDs.
| S-EPMC10226044 | biostudies-literature
Project description:BACKGROUND: Previously surgical operation was the only accepted treatment for hydatid liver cysts. Recently percutaneous management has become more preferable because of its low morbidity rate and lower cost. PATIENTS AND METHODS: In all, 101 patients harbouring 120 hydatid cysts of the liver were treated by percutaneous drainage between October 1994 and December 1997. Of these cysts, 89 were in the right liver and 31 in the left liver.Thirty-one patients had had previous operations for hydatid disease. All cysts had an anechoic or hypoechoic unilocular appearance on ultrasound scan. The mean dimension of the cysts was 7.5+/-2.9 cm (range 3-10.4 cm). All patients received oral albendazole 10 mg/kg perioperatively. After aspiration under sonographic guidance, cysts were irrigated with 95% ethanol. RESULTS: The amount of cyst fluid aspirated was 220+/-75 ml and the amount of irrigation solution used was 175+/-42 ml. Four patients developed mild fever and three had urticaria. Mean length of hospital stay was 2.1+/-0.7 (range 1-4) days, and patients were followed up for 43-62 months (mean 54+/-5.4 months). Maximal cyst diameter decreased from 7.5+/-2.9 cm to 3.2+/-15 cm (p<0.001). Sonographic examinations revealed high-level heterogeneous echoes in the cyst cavity (heterogeneous echo pattern), while the cyst cavity was completely obliterated by echogenic material (pseudotumour echo pattern). DISCUSSION: Most hydatid cysts of the liver can be managed successfully by a combination of drug therapy and percutaneous drainage.
| S-EPMC2020557 | biostudies-other
Project description:Laparoscopic living donor hepatectomy for transplantation has been well established over the past decade. This study aimed to assess its safety and feasibility in pediatric living donor liver transplantation (LDLT) by comparing the surgical and long-term survival outcomes on both the donor and recipient sides between open and laparoscopic groups. The medical records of 100 patients (≤17 years old) who underwent ABO-compatible LDLT using a left lateral liver graft between May 2008 and June 2016 were analyzed. A total of 31 donors who underwent pure laparoscopic hepatectomy and their corresponding recipients were included in the study; 69 patients who underwent open living donor hepatectomy during the same period were included as a comparison group. To overcome bias from the different distributions of covariables among the patients in the 2 study groups, a 1:1 propensity score matching analysis was performed. The mean follow-up periods were 92.9 and 92.7 months in the open and laparoscopic groups, respectively. The mean postoperative hospital stay of the donors was significantly shorter in the laparoscopic group (8.1 days) than in the open group (10.6 days; P < 0.001). Overall, the surgical complications in the donors and overall survival rate of recipients did not differ between the groups. Our data suggest that the laparoscopic environment was not associated with long-term graft survival during pediatric LDLT. In addition, the laparoscopic approach for the donors did not adversely affect the corresponding recipient's outcome. Laparoscopic left lateral sectionectomy for living donors is a safe, feasible, and reproducible procedure for pediatric liver transplantation.
| S-EPMC8246762 | biostudies-literature
Project description:Local chemodenervation with botulinum toxin (BoNT) injections to relax abnormally contracting muscles has been shown to be an effective and well-tolerated treatment in a variety of movement disorders and other neurological and non-neurological disorders. Despite almost 30 years of therapeutic use, there are only few studies of patients treated with BoNT injections over long period of time. These published data clearly support the conclusion that BoNT not only provides safe and effective symptomatic relief of dystonia but also long-term benefit and possibly even favorably modifying the natural history of this disease. The adverse events associated with chronic, periodic exposure to BoNT injections are generally minor and self-limiting. With the chronic use of BoNT and an expanding list of therapeutic indications, there is a need to carefully examine the existing data on the long-term efficacy and safety of BoNT. In this review we will highlight some of the aspects of long-term effects of BoNT, including efficacy, safety, and immunogenicity.
| S-EPMC3640534 | biostudies-other
Project description:ObjectivePruritus is a common symptom of liver disease, managed with various medications including opioid antagonists like naltrexone. Current literature surrounding the safety and efficacy of naltrexone for cholestatic pruritus is limited. Our objective was to describe naltrexone prescribing practices for cholestatic pruritus.MethodsWe conducted a single-center, retrospective review of inpatients who received naltrexone for cholestatic pruritus. We gathered information on naltrexone dosing, frequency, dose adjustments, duration, elevations in liver function tests (LFTs), and use of additional antipruritic agents.ResultsThirty-nine patients and 122 dosing regimens were included for analysis. Most patients were male (56.4%) with a median age of 6.32 years (range, 0.63-18.89). The median weight-based doses of naltrexone were 1.45 mg/kg/dose (IQR, 0.84-2.81) and 1.86 mg/kg/day (IQR, 0.97-3.37). The median flat doses were 25 mg/dose (IQR, 12.25-50) and 50 mg/day (IQR, 25-50). The median number of additional antipruritic agents used before and after naltrexone initiation was 3 (IQR, 2-4) and 4 (IQR, 3-5), respectively (p < 0.001). The most common elevated LFTs were total bilirubin and alanine aminotransferase (ALT), occurring in 15% of patients.ConclusionsNaltrexone dosing ranged between 1 and 2 mg/kg/dose once or twice daily, with larger weight-based doses prescribed in younger and lower-weight patients. Naltrexone was commonly added as a fourth-line agent and did not lead to discontinuation of other antipruritic therapies. Larger, prospective, controlled studies are needed to assess the safety and efficacy of naltrexone for cholestatic pruritus.
| S-EPMC10731951 | biostudies-literature
Project description:BackgroundA higher-than-usual resistance to standard sedation regimens in COVID-19 patients suffering from acute respiratory distress syndrome (ARDS) has led to the frequent use of the second-line anaesthetic agent ketamine. Simultaneously, an increased incidence of cholangiopathies in mechanically ventilated patients receiving prolonged infusion of high-dose ketamine has been noted. Therefore, the objective of this study was to investigate a potential dose-response relationship between ketamine and bilirubin levels.MethodsPost hoc analysis of a prospective observational cohort of patients suffering from COVID-19-associated ARDS between March 2020 and August 2021. A time-varying, multivariable adjusted, cumulative weighted exposure mixed-effects model was employed to analyse the exposure-effect relationship between ketamine infusion and total bilirubin levels.ResultsTwo-hundred forty-three critically ill patients were included into the analysis. Ketamine was infused to 170 (70%) patients at a rate of 1.4 [0.9-2.0] mg/kg/h for 9 [4-18] days. The mixed-effects model revealed a positively correlated infusion duration-effect as well as dose-effect relationship between ketamine infusion and rising bilirubin levels (p < 0.0001). In comparison, long-term infusion of propofol and sufentanil, even at high doses, was not associated with increasing bilirubin levels (p = 0.421, p = 0.258). Patients having received ketamine infusion had a multivariable adjusted competing risk hazard of developing a cholestatic liver injury during their ICU stay of 3.2 [95% confidence interval, 1.3-7.8] (p = 0.01).ConclusionsA causally plausible, dose-effect relationship between long-term infusion of ketamine and rising total bilirubin levels, as well as an augmented, ketamine-associated, hazard of cholestatic liver injury in critically ill COVID-19 patients could be shown. High-dose ketamine should be refrained from whenever possible for the long-term analgosedation of mechanically ventilated COVID-19 patients.
| S-EPMC9125956 | biostudies-literature
Project description:In this paper, we review the published evidence about the long-term efficacy of the available human papillomavirus (HPV) vaccines and their safety profile. Two prophylactic HPV vaccines - bivalent (bHPV) and quadrivalent (qHPV) - are now available, and vaccination programs are being widely implemented, primarily targeting adolescent girls. Efficacy has been widely demonstrated for both vaccines. Since the risk of HPV exposure potentially persists throughout a woman's sexual life, vaccine duration of protection is critical to overall effectiveness. Interpreting the results of long-term efficacy studies for the two HPV vaccines can be puzzling, due to the heterogeneity of studies, different methods used in the assessment of immunogenicity, histopathological and virological end points, and statistical power issues. Moreover, an immunologic correlate of protection has not yet been established, and it is unknown whether higher antibody levels will really result in a longer duration of protection. Disease prevention remains the most important measure of long-term duration of vaccine efficacy. To date, the longest follow-up of an HPV vaccine has been 9.4 years for the bHPV vaccine. Long-term follow-up for qHPV vaccine goes up to 8 years. The vaccine continues to be immunogenic and well tolerated up to 9 years following vaccination. All randomized controlled clinical trials of the bHPV and the qHPV vaccines provide evidence of an excellent safety profile. The most common complaint reported is pain in the injection site, which is self-limiting and spontaneously resolved. The incidence of systemic adverse events (AEs), serious AEs, and discontinuations due to a serious AE reported in clinical studies are similar between the two vaccines and their control groups. In particular, no increased risk of autoimmune disease has been shown among HPV-vaccinated subjects in long-term observation studies. As these are crucial topics in HPV vaccination, it is important to establish systems for continued monitoring of vaccine immunogenicity, efficacy, and safety over time.
| S-EPMC4262378 | biostudies-literature
Project description:BackgroundUremic pruritus (UP) is a multifactorial problem that contributes to low quality of life in dialysis patients. The long-term influences of UP on dialysis patients are still poorly understood. This study aims to elucidate the contribution of UP to long-term outcomes.Materials and methodWe used the Taiwan National Health Insurance Research Database to conduct this study. Patients on chronic dialysis were included and divided into UP and non-UP groups according to the long-term prescription of antihistamine in the absence of other indications. The outcomes include infection-related hospitalization, catheter-related infection, major adverse cardiac and cerebrovascular events (MACCE) and parathyroidectomy.ResultsAfter propensity score matching, 14,760 patients with UP and 29,520 patients without UP were eligible for analysis. After a mean follow-up of 5 years, we found that infection-related hospitalization, MACCE, catheter-related infection, heart failure and parathyroidectomy were all slightly higher in the UP than non-UP group (hazard ratio: 1.18 [1.16-1.21], 1.05 [1.01-1.09], 1.16 [1.12-1.21], 1.08 [1.01-1.16] and 1.10 [1.01-1.20], respectively). Subgroup analysis revealed that the increased risk of adverse events by UP was generally more apparent in younger patients and patients who underwent peritoneal dialysis.ConclusionUP may be significantly associated with an increased risk of long-term morbidities.
| S-EPMC7588085 | biostudies-literature
Project description:Background and aimsHomozygous familial hypercholesterolaemia (HoFH) is a rare genetic disorder characterized by severely elevated LDL cholesterol (LDL-C) and premature atherosclerotic cardiovascular disease. In the pivotal Phase 3 HoFH trial (NCT03399786), evinacumab significantly decreased LDL-C in patients with HoFH. This study assesses the long-term safety and efficacy of evinacumab in adult and adolescent patients with HoFH.MethodsIn this open-label, single-arm, Phase 3 trial (NCT03409744), patients aged ≥12 years with HoFH who were evinacumab-naïve or had previously received evinacumab in other trials (evinacumab-continue) received intravenous evinacumab 15 mg/kg every 4 weeks with stable lipid-lowering therapy.ResultsA total of 116 patients (adults: n = 102; adolescents: n = 14) were enrolled, of whom 57 (49.1%) were female. Patients were treated for a median (range) duration of 104.3 (28.3-196.3) weeks. Overall, treatment-emergent adverse events (TEAEs) and serious TEAEs were reported in 93 (80.2%) and 27 (23.3%) patients, respectively. Two (1.7%) deaths were reported (neither was considered related to evinacumab). Three (2.6%) patients discontinued due to TEAEs (none were considered related to evinacumab). From baseline to Week 24, evinacumab decreased mean LDL-C by 43.6% [mean (standard deviation, SD), 3.4 (3.2) mmol/L] in the overall population; mean LDL-C reduction in adults and adolescents was 41.7% [mean (SD), 3.2 (3.3) mmol/L] and 55.4% [mean (SD), 4.7 (2.5) mmol/L], respectively.ConclusionsIn this large cohort of patients with HoFH, evinacumab was generally well tolerated and markedly decreased LDL-C irrespective of age and sex. Moreover, the efficacy and safety of evinacumab was sustained over the long term.
| S-EPMC11242450 | biostudies-literature