Efficacy and Safety of Fenofibrate in Uncomplicated Hyperbilirubinemia in Newborn: A Randomized Trial, with a 6-month Follow-up

Author(s):  
Jayendra R. Gohil ◽  
Vishal S. Rathod ◽  
Bhoomika D. Rathod

Objective: To study the effect and safety of Fenofibrate in uncomplicated hyperbilirubinemia in newborn with 6-month follow-up. Materials and Methods: This is a randomized controlled clinical trial conducted in 60 normal term neonates admitted for uncomplicated hyperbilirubinemia in NICU at Sir T G Hospital, Bhavnagar from January 2012 to December 2012. The data included: age, sex, total serum bilirubin (TSB), weight and duration of phototherapy. All neonates enrolled in the study received phototherapy. They were divided in two groups of 30 each: control group A and group B receiving Fenofibrate (100 mg/kg single dose). There was statistically insignificant difference between the parameters of age, sex, weight and TSB between the two groups at hospitalization. Data was analyzed by using appropriate statistical methods. Results: Mean values for total serum bilirubin in Fenofibrate group B at 24 and 48 hours after admission were significantly lower than those for control group A (p<0.0001,  p=0.0001). There was no significant difference in fall of TSB between 24 and 48 hours. The mean duration of phototherapy in Fenofibrate group (44.8h: 24-72h) was significantly shorter than that in control group (55.2 h: 24‐96 h) (P=0.02). There were no side effects of the drug observed during the study and during 6 months follow up period. Conclusion: Fenofibrate as a single 100 mg/kg dose in healthy full term neonates, is effective and a safe drug (till six-month follow-up) for neonatal hyperbilirubinemia, that can decrease the time needed for phototherapy and hence hospitalization. Effect of a single dose seems to wane after 24 hours.

2019 ◽  
Author(s):  
Abolfazl Mahyar ◽  
Shahrokh Mehrpisheh ◽  
Bahman Khajeh ◽  
Parviz Ayazi ◽  
Sonia Oveisi ◽  
...  

Abstract- This study was conducted to determine the effect of purgative Manna and clofibrate on unconjugated hyperbilirubinemia of term neonates. In this randomized clinical trial study, sixty neonates suffering from unconjugated hyperbilirubinemia were evaluated. The neonates were divided into three groups using balanced block randomization. Group A (control group-received only phototherapy), group B (intervention group-received purgative Manna and phototherapy) and group C (intervention group-received clofibrate and phototherapy). After the intervention, the amount of serum bilirubin reduction was compared between groups. There was no significant difference among group A, B, and C in terms of serum bilirubin reduction in 24, 48 and 72 hours after starting the intervention (P>0.05). The hospital stays in the control group was significantly longer than the intervention groups (P<0.05). No side effects were observed related to using purgative Mienna and clofibrate. The present study showed that prescribing of purgative Manna and clofibrate has no effect on reduction of serum bilirubin level in term neonates with unconjugated hyperbilirubinemia. Thus, it seems that the administration of these drugs is not necessary. Further studies in this regard are recommended.


1970 ◽  
Vol 4 (2) ◽  
pp. 71-76
Author(s):  
Nilufa Akhter ◽  
Noorzahan Begum ◽  
Waqar Ahmed Khan

Background: G6PD deficiency is one of the common inherited enzymatic disorder associated with high incidence of severe neonatal hyperbilirubinemia. Objectives: To observe G6PD status in male, term neonates with jaundice and its correlation with serum level of bilirubin. Methods: This cross sectional study was conducted on 90 male, term neonates with jaundice, age ranged from 3 to 12 days (Group B) in the Department of Physiology, Bangabandhu Sheikh Mujib Medical University (BSMMU) between July 2007 to June 2008. On the basis of total serum bilirubin (TSB) level, study group was further divided into B1(TSB <15mg/dl), B2(TSB 15-20mg/dl) and B3 (TSB>20mg/dl). For comparison age and sex matched 30 apparently healthy neonates (Group A) were also included in the study. Erythrocyte G6PD level was measured by Spectrophotometric method by using kit of Randox. Serum bilirubin level was measured by standard laboratory technique. For statistical analysis ANOVA, independent sample "t" test and Pearson's correlation coefficient test were performed as applicable by using SPSS windows version-12. Results: In this study, erythrocyte G6PD levels were significantly lower in moderate (p<0.01) and severe (p<0.001) hyperbilirubinemic group in comparison to that of control group . However, this enzyme level was lower in mild group compared to that of control but the difference was statistically non significant. Again, this enzyme levels were significantly lower in moderate (p<0.05) and severe (p<0.01) group than that of mild group and also between severe and moderate hyperbilirubinemic group (p<0.05). In this study, G6PD enzyme deficient were found in 1(3.33%) and 6(20%) subjects of group B2 and B3 respectively. Though, percentage of the subjects with enzyme deficiency were higher in severe group ( B3 ) compared to that of moderate group( B2 ) but the difference was statistically not significant. However, no enzyme deficient patient were found in control group (A) and mild hyperbilirubinemic group (B1). Serum bilirubin level showed significant (p<0.05) positive (r=+.429) correlation with erythrocyte G6PD level in control group (A). On the other hand, this level was negatively correlated with G6PD enzyme in groups B1 (r= -.127), B2 (r=-.120) and B3 ( r= -.671) but significant negative correlation in group B3 (p<0.01). Conclusion: The results of the study revealed that severity of hyperbilirubinemia depends on degree of G6PD deficiency. Therefore, early detection of this enzymopathy and close surveillance of the affected neonates may be important in reducing the complications of severe hyperbilirubinemia. Key words: Glucose-6-PD, Hyperbilirubinemia, Neonates DOI: 10.3329/jbsp.v4i2.4176 J Bangladesh Soc Physiol. 2009 Dec;4(2): 71-76  


2015 ◽  
Vol 2015 ◽  
pp. 1-7 ◽  
Author(s):  
Zhe Wang ◽  
Li Wang ◽  
Meng-ming Xia ◽  
Wei Sun ◽  
Cheng-ke Huang ◽  
...  

The objective of this work was to investigate the effect of orally administered genistein on the pharmacokinetics of imatinib and N-desmethyl imatinib in rats. Twenty-five healthy male SD (Sprague-Dawley) rats were randomly divided into five groups: A group (control group), B group (multiple dose of 100 mg/kg genistein for consecutive 15 days), C group (multiple dose of 50 mg/kg genistein for consecutive 15 days), D group (a single dose of 100 mg/kg genistein), and E group (a single dose of 50 mg/kg genistein). A single dose of imatinib is administered orally 30 min after administration of genistein (100 mg/kg or 50 mg/kg). The pharmacokinetic parameters of imatinib and N-desmethyl imatinib were calculated by DAS 3.0 software. The multiple dose of 100 mg/kg or 50 mg/kg genistein significantly (P<0.05) decreased theAUC0-tandCmaxof imatinib.AUC0-tand theCmaxof N-desmethyl imatinib were also increased, but without any significant difference. However, the single dose of 100 mg/kg or 50 mg/kg genistein has no effect on the pharmacokinetics of imatinib and N-desmethyl imatinib. Those results indicated that multiple dose of genistein (100 mg/kg or 50 mg/kg) induces the metabolism of imatinib, while single dose of genistein has no effect.


2021 ◽  
Vol 7 (3) ◽  
pp. 134-139
Author(s):  
Pinaki Ranjan Debnath ◽  
Arnab Kumar Saha ◽  
Rashmi D ◽  
Vasu Gautam ◽  
Chetna Khanna ◽  
...  

To compare single dose preoperative antibiotic versus five days antibiotic course in preventing surgical site infection for the pediatric inguinal herniotomy.The present study was conducted on 100 patients of elective inguinal herniotomy from January 2019 to April 2020 and compared on the basis of single dose preoperative antibiotic versus five days antibiotic course. All the patients were evaluated on the 3rd, 7th and 28th post-operative period and instructions were given to the guardians about wound care and to attend for early follow up if any signs & symptoms of wound infection appear.50% of the patients were treated with prophylactic single dose antibiotic, i.e. inj. Ceftriaxone (30 mg/kg/dose) at the time of induction only and rest 50% were treated with inj. Ceftriaxone(30mg/kg/dose) at the time of induction as well as postoperatively at night followed by four days of oral antibiotic with Syr/Tablet. Cephalexin (25mg/kg/day) three times daily for another 4 days.Surgical Site Infection (SSI) in Group-B (4.0%) was higher than that of Group-A (2.0%) on day 3 but it was not significant (p=0.40). There was no significant difference in health status of the patients of the two groups when compared on post-operative day 7 and day 28 (p=0.99, p=0.99 respectively).Implementation of single dose antibiotic prophylaxis regimes tailored to the prevalent organisms in the institution can result in enormous savings, as the study shows significant reduction in hospital stay with no significant increase in incidence of SSI.


2019 ◽  
Vol 6 (4) ◽  
pp. 1029
Author(s):  
Haitham Atif ◽  
Nehad Abdou Zaid ◽  
Abd El-Mieniem Fareed Mohamed ◽  
Yehia Mohamed Alkhateep

Background: Juxta-anastomotic stenosis (JAS) is one of the predominant causes of arteriovenous fistula (AVF) failure, with the reported incidence of 65%, so that technical modification to alter the outflow vein configuration using the modified technique has been applied to prevent JAS and improve AVF maturation. The aim of the study to evaluate the modified technique of end-to-side distal radiocephalic A-V fistula regarding maturation, patency rate and the resultant juxta-anastomotic stenosis.Methods: This prospective study was carried out on 80 patients with end stage renal disease (ESRD) at vascular surgery unit in general surgery department, Menoufia university hospital that prepared for dialysis. 40 patients "intervention group" underwent the modified technique to establish a functioning radiocephalic fistula; the other group (40 patients, control group) had the conventional technique of end to side radiocephalic fistula. Follow up of patients was over 6 months regarding function, patency rate and development of juxta-anastomotic stenosis.Results: There was statistically significant difference between 2 groups regarding primary failure, patency and JAS. Primary failure was detected in 2 patients in group A and in 5 patients in group B (p-value is 0.04). Considering patency rate, after 3 months the ratio between group A and group B was 37:34 with significant P value of 0.02, and after 6 months the ratio was 35:33 with P value of 0.03. Regarding JAS, by the end of follow up period, 4 patients diagnosed with JAS in group A, while group B had 8 patients, with p value of 0.01.Conclusions: Modified technique of end to side anastomosis for primary radio-cephalic fistula creation has better patency rate and low incidence of JAS than conventional method.


2021 ◽  
Vol 16 (1) ◽  
pp. 35-38
Author(s):  
Murshida Mosharref ◽  
Naila Rehnuma ◽  
Nusrat Jahan ◽  
Farzana Zafreen

Introduction: Hyperbilirubinemia is a common problem in the neonatal period. Phototherapy is the most important proposed treatments for hyperbilirubinemia, but several drugs along with phototherapy are used with recent advances. Aim: To see the effect of oral fenofibrate on serum bilirubin level in term neonates with unconjugated hyperbilirubinaemia. Methods: This prospective study was carried out in Combined Military Hospital Cumilla from July 2018 to June 2019. Total 60 term and normal birth weight neonates with neonatal jaundice were enrolled in this study. Jaundiced newborns presenting with infection, G6PD deficiency, conjugated bilirubin >2 mg/dl or >15% of total serum bilirubin (TSB) and congenital anomalies were excluded from this study. These neonates were randomly allocated to the Fenofibrate group (30 cases) and Control group (30 cases). Total serum bilirubin was measured every 24 hours till the end of phototherapy and at the time of discharge. Statistical analysis was done using SPSS 22.0 and p<0.05 was considered significant. Results: There were no significant differences in gender, age, weight, gestational age and type of delivery between two groups. Mean duration of hospital stay were 4.0±0.7 and 5.5±1.4 days in Fenofibrate group and Control group respectively (p<0.001). In Fenofibrate group, TSB was decreased from 17.2 mg/dl to 15.2 mg/dl after 24 hours, to 13.6 mg/dl after 48 hours, and to 10.1 mg/dl at the time of discharge.  In control group, TSB was decreased from 17.0 mg/dl to 16.3 mg/dl after 24 hours, to 15.9 mg/dl after 48 hours, and to 10.3 mg/dl at the time of discharge. Conclusion: Treatment of neonatal unconjugated hyper- bilirubinemia with fenofibrate reduces neonatal bilirubin levels and decreases the need for phototherapy and hospitalization. JAFMC Bangladesh. Vol 15, No 1 (June) 2020: 35-38


2019 ◽  
Vol 32 (1) ◽  
pp. 25-32
Author(s):  
ABM Zafar Sadeque ◽  
AKM Salek ◽  
Md Tariqul Islam Khan ◽  
Badrunnesa Ahmed ◽  
Hasan Habibur Rahman ◽  
...  

Background: De Quervain's disease has been described as an entrapment of the extensor pollicis brevis and abductor pollicis longus tendons in the first dorsal compartment of the wrist is a common cause of wrist and hand pain Treatment of the disease consists of pharmacological & non-pharmacological. The non-pharmacological includes immobilization, therapeutic heat and cold, electrical nerve stimulator, thumb stabilizer splint, postural correction at work and the adjustment of tools and equipment. This randomized clinical trial was performed to find out the effects of UST with NSAIDs and without NSAIDs in the patients of De Quervain’s disease. Methods: This randomized clinical trial was performed in the Department of Physical Medicine and Rehabilitation, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh, over a period of six months. Group A-experimental or interventional group and group B-control group by randomization with the help of lottery. Experimental group was managed by activities of daily living (ADLs) instructions, ultrasound therapy (UST) with non-steroidal anti-inflammatory agents (NSAIDs gel), along with thumb spica splint. Control group B received previous management except non-steroidal anti-inflammatory agents (NSAIDs gel). All patients received therapeutic ultrasound in a same dosage (1 watt/ cm 2/min) for 8 minutes. An evaluation was made at initial visit and two weeks interval for 6 weeks. So, there were three follow up visits and these evaluations were performed by the same investigator. In each visit, measurement of pain intensity and disability level were performed by using visual analogue scale (VAS), Tenderness Index and Patient rated wrist evaluation (PRWE) respectively. All results was recorded systematically. A post intervention result was compared with baseline result by SPSS-20 Results: Out of 60 total patients 60(100%) had Finkelstein test positive. Significant difference between Group A and Group B was found at week 4 and Week 6 follow up (P<0.05) whereas other early follow up was non-significant in VAS analysis (p>0.05). Significant difference between Group A and Group B was found at week 4 and week 6 follow up (P<0.05) regarding change of tenderness and PRWE. Conclusion: Regarding treatment of De Quervain's disease, present study shown that UST with NSAIDs gel reduces the morbidity and relief of pain of patients when in comparison to other conventional treatment. TAJ 2019; 32(1): 25-32


2013 ◽  
Vol 20 (06) ◽  
pp. 909-915
Author(s):  
AMJAD ALI SIDDIQUI ◽  
JAMSHED RAHIM ◽  
ATHAR MAHMOOD ◽  
Jamil Rahim

Introduction: Bladder cancer is the second most common urologic cancer. Approximately 90% are transitional cellcarcinoma among which superficial bladder cancer constitutes about 50-70%. It is usually treated by transurethral resection withadjuvant intravesical instillations of chemotherapy or immunotherapy. Primary problems in superficial bladder cancers are its tendency torecur, about 50-80%, following surgical ablation alone, with progression to muscle invasive disease in 20-25% cases. Intravesicalchemotherapy appears to have major impact on decreasing chances of recurrence of superficial bladder cancer. Objective: To determinethe efficacy of single dose perioperative intravesical mitomycin C in reducing recurrence of superficial bladder tumor. Study Design:Comparative study. Settings: Department of Urology Shaikh Zayed Hospital Lahore. Duration of Study: One year.13-04-2009 to 13-04-2010. Methodology: Patients were divided into two groups randomly by using random numbers i.e. 40 patients in group A and 40 patientsin group B. Group A (40 patients) of bladder tumor received post TURBT single dose Mitomycin-C 40 mg/40ml N/Saline intravesically andGroup B (40 patients) was control group i.e. TURBT alone without Mitomycin-C. Results: The recurrence at first year follow up in bothgroups were showed a significant difference (p<0.05) as shown in Table No V: There were only 10% recurrence in Group A i.e. patientswho had intravesical Mitomycin –C as compared to 55% recurrence in Group B, who did not received postoperative intravesicalMitomycin–C. Conclusions: It is concluded that one perioperative (within 6 hours of TURBT) intravesical instillation of chemotherapysignificantly decreases the risk of recurrence after TURBT in patients with stage Ta T1, single and multiple papillary bladder cancer in lowrisk as well as high risk tumors. One immediate instillation after TUR reduces the recurrence.


Author(s):  
Patil Aniket ◽  
Dindore Pallavi ◽  
Arbar Aziz ◽  
Kadam Avinash ◽  
Saroch Vikas

The quest for excellence in mental and physical health is not new. We find various references and formulations in Ayurvedic classics meant for promoting mental and physical health of a child. Suvarna Prashan is one of the formulations explained in age old Ayurvedic classic Kashyap Samhita. This formulation is very widely used now days as a memory and immune booster for children. But there is very little systematic documented study which can be used to evaluate the efficacy of the formulation. Suvarna Bhasma was prepared in Ayurved Rasayani Pharmacy, Pune. Madhu and Ghrita were collected from KLE Ayurveda Pharmacy, Belgaum. Suvarna Bindu Prashan was prepared in KLE Ayurved pharmacy, Belgaum. It contains Suvarna Bhasma, Ghrita and Madhu. Twenty apparently healthy male and female children with age group of three to four years were ready to sign inform consent form were selected into two groups each. Subjects in Group A received Suvarna Bindu Prashan where as Group B (Control group) did not receive any treatment. Both the groups were observed for six months. Children in Suvarna Bindu Prashan group showed significant reduction in the scores of eating habits, behavior, mood, temperament and scores of event of illness. However there was no significant difference in the score of sleeping habit. There was significant increase in IQ percentage.


Author(s):  
Brij Bhushan Singh ◽  
Shubi Mirja ◽  
Samiya Husain

The purpose of this study was to investigate the effects of yogic practices on cardio-vascular efficiency. Material and methods: Total Forty (40) subject’s boys/girls were selected as the sample of the study through the random sampling and their age ranged between 20 to 25 years from the Department of Physical Education, Aligarh Muslim University, Aligarh. The subjects were divided into two groups comprising 20 subjects in each group, namely group “A” (the experimental group) performs yogic practices (Asanas, Pranayamas and Kriyas) and group “B” (the control group) served as control. Statistical technique: for the assessment of the cardiovascular efficiency through Harvard step test pre and post-test was conducted and t-test was applied for the analysis. Result: revealed that there exist a significant difference between group A and group B, at .05 level of significance. On the basis of the pre and post-test among experimental and control group, experimental group found better than the control group on cardiovascular efficiency and significant result were found in this study.


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