ABSTRACT
<p><b>BACKGROUND</b>Gastroesophageal reflux disease (GERD) is one of the most common gastrointestinal complaints. GERD, caused by the reflux of stomach contents into the esophagus, leads to troublesome symptoms such as heartburn and regurgitation. It is classified into two types: erosive esophagitis, characterized by visible esophageal mucosa erosion in endoscopy, and non-erosive reflux disease (NERD). GERD is a chronic and recurrent disease that impairs the quality of life and imposes socioeconomic and therapeutic burdens to both patients and society.</p><p><b>OBJECTIVE</b>Due to the failure of the conventional treatments for GERD and to the traditional use of Amla (Phyllanthus emblica L.), in addition to beneficial effects shown in recent studies, we evaluated the safety and efficacy of Amla tablet for improvement of symptoms of patients with NERD.</p><p><b>DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS</b>We designed a double-arm, randomized, double-blind, placebo-controlled clinical trial. Sixty-eight patients who had classic symptoms of GERD (heartburn, regurgitation and epigastralgia) for at least three months before the start of the trial were randomized in two parallel groups. Patients in the Amla group received two 500 mg Amla tablets twice a day, after meals, for 4 weeks. In the control group, patients received placebo tablets similar to the Amla prescription.</p><p><b>MAIN OUTCOME MEASURES</b>The patients were visited at baseline, and at the end of the 2nd and 4th weeks of intervention; their symptoms were measured on a frequency and severity scale for the symptoms of NERD, according to the quality of life in reflux-associated disease questionnaire.</p><p><b>RESULTS</b>Frequencies of heartburn and regurgitation in both groups of the study were significantly reduced after intervention (P < 0.001). Repeated measures logistic regression analysis showed that, in the Amla group, there was a more significant reduction in regurgitation frequency, heartburn frequency, regurgitation severity and heartburn severity during the study period, compared with the placebo group (P < 0.001).</p><p><b>CONCLUSION</b>This randomized double-blind, placebo-controlled clinical trial demonstrated that Amla could reduce frequencies of heartburn and regurgitation and improve heartburn and regurgitation severity in patients with NERD.</p><p><b>TRIAL REGISTRATION</b>Iranian Registry of Clinical Trials IRCT2016061428469N1.</p>
ABSTRACT
Background: Multistate Markov models are frequently used for analyzing data obtained from longitudinal studies and they are typically appropriate in the study of chronic diseases such as liver cirrhosis. Ascites is the most common major complication of liver cirrhosis. This study was done to examine the importance of ascites complications in the survival analysis of patients with cirrhosis
Materials and Methods: In this longitudinal study, 305 patients with liver cirrhosis who had enrolled in a waiting list for liver transplantation in Imam Khomeini Hospital from May 2008 to May 2009 and had been followed up for at least 7 years, were investigated. To analyze the data and estimation of transition intensities, a 4-state Markov model [state 1: liver cirrhosis [without ascites], state 2: ascites complication, state 3: liver transplantation, and state 4: death] was defined. Finally, data analysis was performed using R statistical software
Results: Of the 305 patients studied, 180 [59%] were male. The mean [+/-standard deviation] age of the patients was 43/14 [ +/- 8/39] years. There were 127 patients with ascites during that period. Estimated transition intensities from liver cirrhosis and ascites state to death state were 0.0419 and 0.1731 per year, respectively, and from ascites state to liver transplantation state was 0.2936 per year. 7-year survival probabilities from cirrhosis and ascites state to death state were estimated 48% and 64%, respectively. Estimated mean sojourn times in cirrhosis and ascites state were 4.0166 and 1.912 years. Serum albumin, bilirubin, and prothrombin levels as well as age, and encephalopathy had a significant effect on the transition intensity from liver cirrhosis state to ascites state [p<0.001]
Conclusion: The result of this study indicates that transition from ascites state to liver transplantation or death state occurs faster than transition from liver cirrhosis state. Especially, accompaniment of ascites and encephalopathy increases the transition intensity to death state
The effect of age, and serum bilirubin and prothrombin levels on the survival of patients is important. As ascites complication has an important role in the prognosis of the survival of patients with cirrhotic, it is suggested that ascites would be considered as an effective factor in prioritization of waiting lists for liver transplantation
ABSTRACT
Tacrolimus, a cornerstone of immunosuppressive therapy in solid organ transplantation, has a narrow therapeutic range with considerable inter-individual and intra-individual pharmacokinetic variability. To date, there is no information on the pharmacokinetics of tacrolimus in Iranian liver transplant recipients. This study was designed to determine pharmacokinetic properties of orally administered tacrolimus in Iranian adult liver transplant recipients. Tacrolimus doses and steady state whole blood trough concentrations as well as patient demographic and clinical data were obtained retrospectively using the 30 included patients' medical records. Pharmacokinetic parameters were estimated by using a nonlinear mixed effect model program [Monolix version 3.1]. Absorption rate constant was fixed at two hours[-1]. Drug apparent clearance [CL/F], apparent volume of distribution [Vd/F], and elimination half life [t1/2 Beta] were calculated. The administered dose of tacrolimus to the patients ranged from 0.02 to 0.14 mg/Kg/day. Tacrolimus blood trough concentrations varied widely within the range of 1.8 to 30 ng/mL. The mean values of CL/F, Vd/F, and t1/2 Beta were found to be 9.3 +/- 0.96 L/h, 101 +/- 29 L, and 7.5 hours, respectively. The pharmacokinetics of tacrolimus was highly variable among our patients. CL/F, Vd/F, and t«? of tacrolimus in this study were comparable to reported values from Italian heart transplant patients but somewhat different from reported ones from other solid organ transplant populations
ABSTRACT
Patients with obstructive sleep apnea [OSA] are at risk of developing the fatty liver as a result of being overweight. Several studies suggest that OSA per se could be a risk factor for liver injury; and ischemic hepatitis with OSA. The OSA is an independent risk factor for Insulin resistance. Therefore, we investigated liver enzymes and insulin resistance in patients with OSA, and compared with controls. Eighty-one consecutive patients with clinical suspicion of OSA were referred to the Sleep Unit of Masih Daneshvary hospital. On the basis of Polysomnography results patients were divided into two groups. The OSA and non-OSA cases, and also patients without OSA were used as internal controls. The Serum levels of liver enzymes were measured in all patients and abdominal ultrasound examination performed for screening the fatty liver and its grading. Insulin resistance was calculated via homeostasis model assessment [HOMA]. The OSA was present in 41 and absent in 40 patients. Age, sex and body mass indices were not significantly different in two groups. The mean of alanine aminotransferase [ALT] was 31.24 +/- 14.05 IU/L in OSA and 29.97 +/- 8.9 IU/L in non-OSA [p= 0.349] and aspartate aminotransferase [AST] was 29.07 +/- 9.6 IU/L in OSA and 26.85 +/- 6.7 IU/L in non-OSA [p= 0.389]. The mean of HOMA was 2.05 +/- 18.2 in OSA and 1.5 +/- 0.54 in non-OSA [p< 0.001]. This study shows that OSA, independent of overweight conditions, is not a risk factor for abnormal liver enzymes. However, the OSA per se seems to be associated with increase in insulin resistance and severity of fatty liver