An Open-label Prospective Noncomparative Clinical Study to Evaluate the Efficacy and Safety of Beliv: An Ayurvedic Medicine in Improving Liver Function

An open-label prospective noncomparative study was conducted to examine the efficacy and safety of Beliv tablet, a polyherbal Ayurvedic medicine, in 30 adult patients suffering from liver disorders. Two tablets were administered daily for 56 days. Patients were evaluated at Day 0, Day 21, Day 42 and at Day 56. The primary end point of the study was a change in liver function test parameters measured by the levels of serum glutamic-oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) and total bilirubin at all assessment points. Results showed a significant reduction in the serum levels of SGOT, SGPT and total bilirubin from baseline to 21 days, 42 days and 56 days. The total icterus symptom score was also significantly reduced from 5.17 ± 2.26 (baseline) to 2.6 ± 1.48, 1.37 ± 1.13 and 0.77 ± 0.73 at Days 21, 42 and 56, respectively. The Subjective Global Assessment (SGA) decreased significantly from 3.33 ± 1.16 (Day 21) to 2.33 ± 1.16 and 1.80 ± 0.76 at Days 42 and 56, respectively. The Physician Global Assessment (PGA) score was also significantly reduced from 3.0 ± 1.02 (Day 21) to 2.07 ± 0.83 and 1.70 ± 0.79 at Days 42 and 56, respectively. A significant reduction in serum creatinine level was observed at Day 56. No adverse effects or serious adverse effects were observed during the study period. The study concluded that Beliv tablet was highly effective for the treatment of liver disorders, as evidenced by the reduction in serum levels of SGOT, SGPT, total bilirubin, icterus symptoms and PGA and SGA scores. No treatment-related side effects were reported by any of the study participants suggesting that it was safe for clinical use in humans for the treatment of liver disorders.

Aneurisma de la aorta abdominal asociado a íctero / Aneurysm of the abdominal aorta associated with icterus

El aneurisma de la aorta abdominal como causa de íctero obstructivo es una situación de excepción en la clínica. El objetivo de esta presentación fue exponer la coexistencia del aneurisma de la aorta abdominal y el íctero. Una asociación muy poco frecuente y de difícil diagnóstico, que coloca al cirujano vascular en la toma de una especial conducta terapéutica. La cuidadosa revisión de los antecedentes patológicos y el análisis del comportamiento clínico del paciente permitieron la solución terapéutica adecuada. Se logró demostrar que el íctero obedecía a una lesión maligna de vías biliares conocida como colangiocarcinoma, que concomitó con la existencia de un aneurisma del V segmento aórtico y no fue el resultado de una compresión extrínseca de la dilatación de la aorta, sobre las vías biliares. La conducta quirúrgica, encaminada a erradicar el íctero y evitar la ruptura aneurismática con resección del aneurisma y colocación de prótesis, no resultó posible por lo avanzado de la lesión tumoral y el grado de metástasis ya establecidos. Solo se realizó resección de la vesícula biliar y seguimiento posterior por oncología(AU)

Abdominal aortic aneurysm as a cause of obstructive icterus is an exceptional situation in the clinic. The aim of this presentation was to expose the coexistence of abdominal aortic aneurysm and icterus. A very rare and difficult to diagnose association, which places the vascular surgeon in a special therapeutic approach. The careful review of the pathological history and the analysis of the patient's clinical behavior allowed the appropriate therapeutic solution. It was possible to demonstrate that the icterus was due to a malignant lesion of the biliary tract known as cholangiocarcinoma, which concomitated with the existence of an aneurysm of the V aortic segment and was not the result of extrinsic compression of the dilatation of the aorta on the biliary tract. The surgical procedure, aimed at eradicating the icterus and avoiding aneurysmal rupture with aneurysm resection and prosthesis placement, was not possible due to the advanced tumor lesion and the degree of metastasis already established. Only gallbladder resection was performed and subsequent follow-up by oncology(AU)

Acute hepatitis induced by a single dose of hydroxychloroquine

Hydroxychloroquine(HCQ)is considered the drug of choice for prophylaxis of COVID-19. It is supposed to be a safe drug. Herein we describe a case where a single dose of HCQ has led to acute toxic hepatitis. A junior of CIMS, Bilaspur while working at surgery department took a single dose of HCQ and suffered from jaundice. This suggests that we cannot label any drug to be safe and should take drug only after proper medical consultation and prescription without which even a single dose can cause hypersensitivity reaction

Unusual presentation of vitamin B12 deficiency in a 3 month old infant: presentation with hemolysis and thrombocytopenia

A 3 month old infant exclusively breast fed presented with vomiting and poor weight gain with purpuric and echymotic patches all over the body. The child also had hyperpigmentation over knuckles and icterus. Laboratory investigations revealed severe dimorphic anemia with thrombocytopenia, elevated bilirubin and LDH levels and severe vitamin B12 deficiency. Following vitamin B12 supplementation there was improvement in well-being including feed tolerance, icterus resolved and in follow up lab studies there was improvement in hemoglobin and platelet counts along with reduced bilirubin levels. Through this case report we want to emphasize the possibility of vitamin B12 deficiency presenting as hemolytic anemia and psuedothrombotic microangiopathy.

Differential diagnoses in 83 dogs with icterus / Diagnósticos diferenciais em 83 cães com icterícia

Icterus (jaundice) is a yellowish pigmentation resulting from the depositing of bilirubin in tissues due to its high plasmatic concentration. The pathogenesis of icterus includes metabolic changes or obstructed bilirubin excretion and it is classified as pre-hepatic, hepatic and post-hepatic. This study aimed to evaluate and classify different causes of icterus in dogs during post mortem examination. These dogs were examined from 2014 to 2017, using macroscopic and histologic exams as well as ancillary tests. Eighty-three dogs were examined macroscopically and microscopically. They were separated into groups of icterus types: 24 (28.9%) dogs had pre-hepatic icterus, 45 (54.2%) had hepatic, 13 (15.7%) pre-hepatic and hepatic and one (1.2%) had post-hepatic icterus. Many factors were identified as a cause of icterus, including infectious agents (51/83), neoplasms (13/83), hepatic degeneration (11/83), chronic hepatic diseases (6/83), and obstructive causes (1/87). Among the infectious causes, leptospirosis, ehrlichiosis and disorders suggestive of septicemia were diagnosed. Neoplasms associated with icterus were cholangiocarcinoma, hemangiosarcoma and lymphoma. Other causes of icterus included degenerative diseases, such as lipidosis and glycogen degeneration. Hepatic fibrosis (cirrhosis) as a chronic disease and cholelithiasis also produced icterus. PCR was performed to confirm leptospirosis and ehrlichiosis. Samples of total DNA were used to amplify a fragment of a gene from Leptospira interrogans and Ehrlichia canis. In some dogs, co-infection of these agents was detected. The classification and identification of icterus etiologies in dogs is very important due to the number of diseases with this alteration, where ante mortem diagnosis is not always easily performed when some of these conditions are present.(AU)

Icterícia é a pigmentação amarelada decorrente da deposição de bilirrubina em tecidos devido à elevada concentração plasmática. A patogênese da icterícia inclui alterações no metabolismo ou na excreção de bilirrubina, sendo classificada em pré-hepática, hepática ou pós-hepática. O objetivo desse estudo foi identificar, avaliar e classificar as causas de icterícia em cães necropsiados de 2014 a 2017, associando as lesões macroscópicas, histológicas e exames complementares. Foram avaliados macro- e microscopicamente 83 cães com diferentes intensidades de icterícia. Os cães foram separados em grupos de acordo com o tipo de icterícia: 24 (28,9%) cães com icterícia pré-hepática, 45 (54,2%) cães com icterícia hepática, 13 (15,7%) com icterícia pré-hepática e hepática e um (1,2%) com icterícia pós-hepática. Foram identificadas várias etiologias associadas à icterícia, dentre elas pode-se destacar, agentes infecciosos (51/83), neoplasmas (13/83), processos degenerativos (11/83), crônicos (6/83) e obstrutivos (1/83). Dentre as causas infecciosas, destacam-se a leptospirose, a erliquiose e as lesões sugestivas de septicemia. Entre os neoplasmas associados com icterícia destacaram-se o colangiocarcinoma, hemangiossarcoma e linfoma. Outras causas de icterícia incluiriam os processos degenerativos como as degenerações gordurosa e glicogênica. Fibrose hepática (cirrose) e colelitíase foram também diagnosticados como causa de icterícia. A PCR foi utilizada para o diagnóstico confirmatório de leptospirose e erliquiose. Amostras de DNA total foram utilizadas para amplificar um fragmento dos genes de Leptospira interrogans e de Ehrlichia canis. Em alguns cães foi detectada co-infecção por estes agentes. A classificação e a identificação das causas de icterícia em cães são relevantes devido ao grande número de doenças que apresentam essa alteração, muitas vezes sem diagnóstico ante mortem.(AU)

Utility of cord blood bilirubin as a predictors of significant neonatal Hyperbilirubinemia in healthy term neonate

Background: Clinical jaundice is evident in more than two-third neonates in their early neonatal life. Early identification of neonates at risk might allow early intervention and prevent complication. Objective of the study was to assess the cord blood bilirubin level as a tool to screen the risk of development of subsequent significant neonatal hyperbilirubinemia in term neonates.Methods: A prospective observational study was conducted over a period of 2 years on 1040 healthy term neonates. Demographic profile, relevant maternal and neonatal information were recorded. Measurement of cord blood bilirubin, blood group/Rh typing and serum bilirubin at the end of 24 & 72 hours was done to predict significant hyperbilirubinemia.Results: Incidence of significant hyperbilirubinemia was 11.53%. Gender, gestational age, mode of delivery and birth weight had no correlation with development of significant jaundice. 800 (76.93%) neonates had cord blood bilirubin level ?3.0mg/dl and 240 (23.07%) neonate had cord blood bilirubin level >3.0mg/dl. Out of 240 (23.07%) neonates with higher cord bilirubin (>3.0 mg/dl), 108 (45%) had significant hyperbilirubinemia at the end of 24 hours with sensitivity 90.00%, specificity 85.65%, positive predictive value 45.00% and negative predictive value 98.50% while 110 (45.83%) neonates were observed with serum bilirubin >17mg/dl at the end of 72 hours with cord blood bilirubin >3mg/dl with sensitivity 91.67%, specificity 84.52% positive predictive value 45.83% and negative predictive value-98.61% and this difference was statistically significant.Conclusions: Neonates with cord blood bilirubin level ?3mg/dl can be safely discharged early whereas neonates with bilirubin >3mg/dl will need close follow up to check for development of subsequent significant jaundice. Hence cord blood bilirubin levels help to determine and predict the possibility of significant jaundice among healthy term neonates.

Information solution for the classification and assessment of specimen quality / 临床检验杂志

Objective@#To establish the information solution for the classification and assessment of specimen quality based on the assembly line. @*Methods@#Before the samples entered into the assembly line, they were took pictures and screened by the image results. For the suspected samples, serum index was detected. Then, the classification criteria of specimen quality were set, and the alarm thresholds of serum indices for each item suitable for our laboratory were established. The results of serum indices were compiled into the corresponding text descriptions and automatically written into the notes of the result reports. The pictures of blood collection tubes were stored in the laboratory information management system (LIMS) and could be accessed at any time for verification. The samples intercepted by the automatic review were further reviewed by manual. @*Results@#The intra-assay coefficients of variation (CV) of serum indices for haemolysis (H), lipaemia (L) and icterus (I) were 0.6%, 0.7% and 1.3%, respectively, indicating that the precision was good. Among 657 770 samples detected by the assembly line, 11.9% of samples were screened out before they entered the assembly line. The detection of serum indices of these samples demonstrated that the samples with haemolysis, lipaemia and icterus accounted for 1.6%, 1.2% and 0.3% of the total samples, respectively. According to the results of the interference experiment, the alarm threshold of hemolytic serum index was set in 11 items, and those of lipaemia and icterus were set in 1 item. @*Conclusion@#By establishing the information solution of specimen quality based on the assembly line, the real-time classification prompting of specimen quality is realized, and the missed detection is avoided, which is helpful to reduce the pre-analysis errors caused by serum quality and simplify the laboratory workflow.

Patrón clínico y epidemiológico de la atresia de vías biliares en Cuba / Clinical and epidemiological pattern of biliary atresia in Cuba

Introducción: La atresia de vías biliares es una colangiopatía infrecuente que se presenta en recién nacidos entre la segunda y cuarta semana de vida. Objetivo: Determinar el patrón clínico-epidemiológico de la atresia de vías biliares en Cuba. Método: Estudio descriptivo en la población con atresia de vías biliares(n= 30) atendida en el Hospital William Soler (enero 2011-diciembre 2015). Se midieron los rasgos clínicos, humorales y variables epidemiológicas con análisis de incidencia (por 1 000 nacidos vivos) y pruebas estadísticas con significación para plt;0,05). Resultados: La incidencia en Cuba es de 0,47x 10 000 nacidos vivos (1: 21 078 nacidos vivos), en Mayabeque, la más alta con 1: 6 784. Todos tuvieron ictericia y 96,7 por ciento coluria. Se presentaron concentraciones elevadas de bilirrubina total (media= 184,9 µmol/L), ligera elevación de alaninoaminotransferasa (media= 201,8 U/L) y aspartatoaminotransferasa (media= 279,5 U/L), mayor aumento en la concentración de gammaglutamiltransferasa (media= 588 U/L) que de fosfatasa alcalina (media=1 557,1 u/L) e incremento del colesterol (6,8 mmol/L) con triglicéridos normales. El 70 por ciento de los sometidos a intervención quirúrgica antes de los 60 días de nacido restablecieron el flujo biliar contra 35,5 por ciento que no lo lograron cuando se intervinieron posteriormente. Conclusiones: La incidencia en la enfermedad en Cuba asciende, sin preferencia de género y es superior en Mayabeque. Son típicas las manifestaciones de ictericia, coluria, hiperbilirrubinemia, hipertransaminasemia ligera, hipercolesterolemia con alteración de gammaglutamiltransferasa más que de la fosfatasa alcalina y restablecimiento del flujo biliar en operados antes de los 60 días de nacido(AU)

Introduction: Biliary atresia is an infrequent colangiopaty that it is present in newborns among the second and the forth weeks of life. Objective: To determine the clinical and epidemiological pattern of biliary atresia in Cuba. Method: Descriptive study in the population presenting biliary atresia (n= 30) attended in William Soler Hospital (from January, 2011 to December, 2015). Clinical and humoral features, and epidemiological variables were measured by an incidence analysis (per 1 000 live births) and statistical tests with significance of p<0,05. Results: Incidence in Cuba is of 0.47 x 10 000 live births (1: 21 078 live births); in Mayabeque province, it is registered the highest incidence 1: 6 784. All the patients presented icterus and 96.7 percent presented choluria. High concentrations of total bilirubine (mean= 184.9 µmol/L), slight increase of alaninoaminotransferasa (mean= 201.8 U/L) and aspartatoaminotransferasa (mean= 27.5 U/L) than in the alcaline fosfatase (mean= 1 557.1 U/L); and cholesterol increase (6.8 mmol/L) with normal triglycerides were present. 70 percent of the patients that underwent surgeries before reaching 60 days of life could reestablish the biliar flow. 35 percent did not achieve this while underwent a surgery after 60 days of life. Conclusions: The incidence of this disease is increasing in Cuba, not having gender preferences and it is higher in Mayabeque province. Manifestations of icterus, choluria, hyperbilirubinemia, light hypertransaminasemia, hypercholesterolemia with gammaglutamiltransferasa alteration higher than alcaline fosfatase, and the reestablishment of the biliary flow in patients being operated before the 60 days of life, are common(AU)

Colestasis: un enfoque actualizado / Cholestasis: an updated approach

Mediante una extensa revisión bibliográfica fue posible profundizar en el tema de las ictericias obstructivas o las colestasis, sobre todo en los aspectos más importantes de su definición, semiogénesis, clasificación, etiopatogenia, manifestaciones clínicas, estudios de laboratorio e imagenológicos, además del diagnóstico, la evolución, el pronóstico y tratamiento, con el objetivo de proporcionar los elementos más novedosos de cada uno de ellos, a través de un enfoque didáctico y una base científica, desde la óptica del internista, para así facilitar conocimientos prácticos acerca del síndrome

It was possible to deepen in the topic of the obstructive icterus or cholestasis by means of an extensive literature review, mainly in the most important aspects of its definition, semiogenesis, classification, etiopathogenesis, clinical manifestations, laboratory and imagenological studies, besides diagnosis, clinical course, prognosis and treatment in this respect, with the objective of providing the most original elements of each of them, through a didactic approach and a scientific base, from the internist's optics, and in this way, to facilitate practical knowledge about the syndrome

Proposal of Modified HIL-indices for Determining Hemolysis, Icterus and Lipemia Interference on the Beckman Coulter AU5800 Automated Platform

BACKGROUND: The amount of interference due to hemolysis, bilirubin, and lipemia can be measured on the AU5800 autoanalyzer (Beckman Coulter, USA) by spectrophotometry. This is reported as semi-quantitative indices, specifically H-index, I-index, and L-index, respectively. In this study, we evaluated the impact of interference using chemistry assays and established the concentration of interfering substances and HIL-index above which analytically significant interference exists, according to CLSI guidelines C56-A and EP7-A2. METHODS: Pooled sera including different concentrations of analytes were prepared and mixed with hemoglobin, bilirubin, or Intralipid. These samples were then tested for 35 clinical chemistry analytes by AU5800 and the bias based on interferent concentrations was computed. The interferent concentration above which significant interference exists was calculated from the 50% within-subject biological variation (desirable analytic goal), and the corresponding index was assigned. RESULTS: Among 35 items evaluated, interference was detected for 12 analytes by hemoglobin, 7 analytes by bilirubin, and 12 analytes by Intralipid. We proposed HIL-index₁ and HIL-index₂ for each analyte according to 2 different medical decision levels. HIL-index₁ and HIL-index₂ were considered more reasonable criteria than the HIL-index from the manufacturer's technical document (HIL-index(TD)). This is because HIL-index(TD) was empirically set to 5% or 10%, and had a wide tolerance range, which was not sufficient to reflect the presence of interference, compared to HIL-index₁ and HIL-index₂. CONCLUSIONS: We have demonstrated hemoglobin, bilirubin, and Intralipid interferences according to CLSI guidelines using the desirable analytic goal. Our results provide applicable information for Beckman Coulter automated chemistry analyzers.

Study of the serum quality controlling method / 国际检验医学杂志

Objective To improve the serum quality controlling level ,in order to regularize and standardize the laboratory processes .Methods Gallery of hemolysis ,lipidemia or icterus serum specimens was established by Roche cobas p612 QSI camera system .The trouble serum specimens were screened out through taking photos of interfere serum and comparing with the gallery . The serum indexes of hemolysis ,lipidemia and icterus were detected respectively as reference information of inspection report .Com‐paring the results of 16 710 specimens detected by system screening and visual judgment ,the accuracy of QSI camera system was verified .Results 195 trouble serum pictures were elected in the gallery .The compliance rates of hemolysis ,lipidemia and icterus se‐rum specimen between QSI camera system and visual judgment were 94 .2% ,87 .4% ,and 60 .9% respectively .Conclusion The QSI camera system can replace visual judgment to screen the trouble serum specimens .

Development of an Integrated Reporting System for Verifying Hemolysis, Icterus, and Lipemia in Clinical Chemistry Results

BACKGROUND: Hemolysis, icterus, and lipemia (HIL) cause preanalytical interference and vary unpredictably with different analytical equipments and measurement methods. We developed an integrated reporting system for verifying HIL status in order to identify the extent of interference by HIL on clinical chemistry results. METHODS: HIL interference data from 30 chemical analytes were provided by the manufacturers and were used to generate a table of clinically relevant interference values that indicated the extent of bias at specific index values (alert index values). The HIL results generated by the Vista 1500 system (Siemens Healthcare Diagnostics, USA), Advia 2400 system (Siemens Healthcare Diagnostics), and Modular DPE system (Roche Diagnostics, Switzerland) were analyzed and displayed on physicians' personal computers. RESULTS: Analytes 11 and 29 among the 30 chemical analytes were affected by interference due to hemolysis, when measured using the Vista and Modular systems, respectively. The hemolysis alert indices for the Vista and Modular systems were 0.1-25.8% and 0.1-64.7%, respectively. The alert indices for icterus and lipemia were <1.4% and 0.7% in the Vista system and 0.7% and 1.0% in the Modular system, respectively. CONCLUSIONS: The HIL alert index values for chemical analytes varied depending on the chemistry analyzer. This integrated HIL reporting system provides an effective screening tool for verifying specimen quality with regard to HIL and simplifies the laboratory workflow.

Comparative Study of Serum Gamma Glutamyltransferase, 5’ Nucleotidase and Alkaline Phosphatase in Icteric and an-Icteric Biliary Disease Patients

Diagnostic enzymology plays a useful role in evaluation of various hepatobiliary diseases and numerous enzymes have been compared in different disorders. Among these, significance of Gamma Glutamyl Transferase and 5’ Nucleotidase over Alkaline Phosphatase has been stressed repeatedly, but mainly in the icteric obstructive biliary disease patients. In this study, these three enzymes were compared not only in the icteric but also the an-icteric biliary disease patients, particularly to look for elevation and significance of these enzymes in the latter group. Methods: The study was conducted on 50 biliary disease patients, who were further divided into an-icteric (32 patients) and icteric (18 patients) subgroups depending on their bilirubin levels. 50 subjects matched for age and sex with the study group were enrolled for the control group. Gamma Glutamyl Transferase, 5’Nucleotidase, Alkaline Phosphatase and bilirubin levels were evaluated in all the patients as well as the control subjects. Results: All three enzymes showed a significant rise in the icteric subgroup (p value < 0.001). However, in the an-icteric subgroup, only Gamma Glutamyl Transferase and 5’Nucleotidase showed a significant rise. The rise was more for Gamma Glutamyl Transferse (1.60 times normal, p < 0.001) as compared to 5’Nucleotidase (1.39 times normal, p < 0.01). Conclusion: Gamma Glutamyl Transferase and 5’Nucleotidase are useful for evaluation of not only obstructive biliary disease patients but also for the patients with biliary disease who are an-icteric, and out of these two, the former is a more valuable diagnostic indicator in such diseases.

Icterícia de íris após rabdomiólise por esforço em um equino / Icterus iris after exertional rhabdomyolysis syndrome in a horse

Neste trabalho, é descrito um caso de icterícia de íris em equino da raça Paint. Ao exame clínico, foram observados tremores, dor muscular, relutância em andar, taquicardia, taquipnéia e icterícia de íris. As concentrações séricas de creatina cinase, aspartato aminotransferase, lactato desidrogenase e bilirrubina indireta estavam marcadamente elevadas. Com base na anamnese, sintomatologia clínica e bioquimica sérica, diagnosticou-se síndrome da rabdomiólise por esforço. Foram instituídos os seguintes tratamentos: terapia analgésica, fluidoterapia e restrição de exercício. Após seis dias, houve a remissão dos sinais clínicos e o retorno da coloração original da íris.

One case of icterus iris diagnosed in an American Paint Horse is described. Stiffness, painful muscle, reluctance to move, elevated respiratory and heart rates, and icterus iris were observed in the clinical examination. Creatine kinase, aspartate aminotransferase, lactate dehydrogenase, alkaline phosphatase, and bilirubin levels were markedly elevated. Exertional rhabdomyolysis syndrome was diagnosed. Analgesic therapy, fluid therapy, and limited exercise were prescribed. After six days there was a remission of clinical signs and return the original color of the iris.

Quality Evaluation on Methodology of Clinical Research of Yinzhihuang Injection in the Treatment of Icteric Virus Hepatitis / 中国药房

OBJECTIVE:To evaluate the quality of the methodology of clinical research on Yinzhihuang injection in the treatment of icteruc virus hepatitis.METHODS:The methodology quality of77pertinent literatures was evaluated and analyzed according to the quality assessment criteria in the evaluation manual of Cochrane Reviewer's Handbook 4.2.2.RESULTS:Only 4 literatures were up to the related standards,2 of which were randomized controlled trials(RCT)and other 2 were semi-randomized controlled trials(CCT).All of the 4 studies were low quality(Grade C)researches,in which the biases on selectivity,practice,measurement and wastage were highly possible.CONCLUSION:More randomized controlled trials of high quality are needed to obtain reliable evidences on Yinzhihuang injection in the treatment of icteric virus hepatitis.