A randomized,open-label study comparing low-dose clevudine plus adefovir combination therapy with clevudine monotherapy in naïve chronic hepatitis B patients

Purpose

Clevudine 30 mg showed potent antiviral activity with a marked post-treatment antiviral effect. However, long-term treatment with clevudine monotherapy induced resistance and myopathy in some cases. The objective of this study is to evaluate the preliminary efficacy and safety of the combination of clevudine 20 mg and adefovir compared to clevudine monotherapy.

Methods

Seventy-four patients were randomized to either a combination of clevudine 20 mg and adefovir or clevudine 20 or 30 mg and were treated for 2 years. The viral kinetics for 24 weeks, virological response [VR; hepatitis B virus (HBV) DNA less than 300 copies/ml], and the biochemical response [BR; normal alanine aminotransferase (ALT)] were assessed.

Results

There was no difference in baseline characteristics among the three groups. Viral kinetics study showed no statistically significant difference among them during 24 weeks. The combination group showed 95 % virological response with a statistically significant difference compared to the clevudine 30 mg (67 %) and 20 mg (71 %) groups (p = 0.0376). Biochemical response rates were similar in all groups (78–94 %). No resistance was reported in the combination group, while 20 % of patients treated with clevudine 30 mg or 20 mg reported resistance during 2 years. Muscle-related symptoms such as myalgia (1 in clevudine 30 mg, 1 in the combination group) and muscle weakness (1 in clevudine 30 mg, 2 in clevudine 20 mg) were reported in five patients (7 %); of these, three patients discontinued the study.

Conclusion

We concluded that the combination of clevudine 20 mg and adefovir produced a potent antiviral response together with a good resistance profile compared to clevudine monotherapy at 96 weeks in this pilot study.     

New Insight Into Thermodynamical Stability of Carbamazepine

Carbamazepine (CBZ)—an antiepileptic drug—belongs to Biopharmaceutics Classification System II Class. It has low solubility and consequently limited bioavailability. One of the ways to improve drugs solubility is amorphization of their structure. Herein, cooling CBZ—at different cooling rates—was investigated as a way to obtain glassy, better soluble form. During preliminary differential scanning calorimetry experiments, some peculiar behavior of the examined material, different from those stated in the literature, was observed. Further investigations using differential scanning calorimetry, thermogravimetric analysis, and polarizing optical microscope revealed that decomposition temperature of CBZ is about 30°C lower than previously assumed. Moreover, high-resolution thermogravimetric measurements indicate that some decomposition processes could start even below the temperature reported as the melting point of the form I of CBZ.     

Canalicular adenoma of the palate

ABSTRACT: Canalicular adenomas are uncommon, benign epithelial neoplasm of the salivary glands that usually involve the upper lip and the buccal mucosa of elderly people. Differential diagnosis of the canalicular adenoma versus adenocarcinoma is important because it may result in unjustified radiotherapy or extensive and aggressive surgery. Despite the benign nature of canalicular adenomas, complete surgical removal and a regular clinical follow-up are recommended. The current study describes the diagnostic procedures, surgical management, and follow-up of a canalicular adenoma involving the palate of a 79-year-old man.     

Successful Management of Plastic Bronchitis in a Child Post Fontan: Case Report and Literature Review

Purpose

Plastic bronchitis is the occlusion of the major bronchial airways by a firm, gelatinous mucoid cast. It is a rare condition, which while classically described in asthma and sickle cell disease has greater mortality in patients with congenital heart disease. The management of this disease is obscure given the lack of clinical data regarding treatment therapies.

Methods

We describe a case of an 11-year-old female status after Fontan surgery who presented with respiratory distress secondary to atelectasis of the right lung.

Results

A bronchoscopy was performed demonstrating an obstructing bronchial cast with successful extraction. The plastic bronchitis continued to recur and she was placed on multiple inhaled mucolytics as well as inhaled tissue plasminogen activator with temporary resolution. Further evaluation of the etiology of her casts revealed that she had elevated pulmonary arterial pressures. Repeated bronchoscopic removal of the casts was utilized as well as continuation of the aggressive airway clearance. Ultimately fenestration of her Fontan was performed along with treatment of pulmonary vasodilators sildenafil and bosentan. Although there was improvement of the cast formation, her airway clearance could only be weaned to four times a day therapy with which she was discharged home after a 3-month hospitalization. She continues to remain on this therapy and has not required hospitalization since the initial incident over 1?year ago.

Conclusions

Plastic bronchitis in a patient with Fontan physiology presents a treatment dilemma that may require comprehensive therapy in severe cases such as described.     

The Usefulness of the Ivy Sign on Fluid-Attenuated Intensity Recovery Images in Improved Brain Hemodynamic Changes after Superficial Temporal Artery-Middle Cerebral Artery Anastomosis in Adult Patients with Moyamoya Disease

Objective

MR perfusion and single photon emission computerized tomography (SPECT) are well known imaging studies to evaluate hemodynamic change between prior to and following superficial temporal artery (STA)-middle cerebral artery (MCA) anastomosis in moyamoya disease. But their side effects and invasiveness make discomfort to patients. We evaluated the ivy sign on MR fluid attenuated inversion recovery (FLAIR) images in adult patients with moyamoya disease and compared it with result of SPECT and MR perfusion images.

Methods

We enrolled twelve patients (thirteen cases) who were diagnosed with moyamoya disease and underwent STA-MCA anastomosis at our medical institution during a period ranging from September of 2010 to December of 2012. The presence of the ivy sign on MR FLAIR images was classified as Negative (0), Minimal (1), and Positive (2). Regions were classified into four territories: the anterior cerebral artery (ACA), the anterior MCA, the posterior MCA and the posterior cerebral artery.

Results

Ivy signs on preoperative and postoperative MR FLAIR were improved (8 and 4 in the ACA regions, 13 and 4 in the anterior MCA regions and 19 and 9 in the posterior MCA regions). Like this result, the cerebrovascular reserve (CVR) on SPECT was significantly increased in the sum of CVR in same regions after STA-MCA anastomosis.

Conclusion

After STA-MCA anastomosis, ivy signs were decreased in the cerebral hemisphere. As compared with conventional diagnostic modalities such as SPECT and MR perfusion images, the ivy sign on MR FLAIR is considered as a useful indicator in detecting brain hemodynamic changes between preoperatively and postoperatively in adult moyamoya patients.