Entecavir versus tenofovir for prevention of hepatitis B virus-associated hepatocellular carcinoma after curative resection: study protocol for a randomized, open-label trial.

BACKGROUND: Entecavir and tenofovir disoproxil fumarate (TDF) are standard first-line treatments to prevent viral reactivation and hepatocellular carcinoma (HCC) in individuals chronically infected with the hepatitis B virus (HBV), but the long-term efficacy of the two drugs remains controversial. Also unclear is whether the drugs are effective at preventing viral reactivation or HCC recurrence after hepatectomy to treat HBV-associated HCC. This trial will compare recurrence-free survival, overall survival, viral indicators and adverse events in the long term between patients with HBV-associated HCC who receive entecavir or TDF after curative resection. METHODS: This study is a randomized, open-label trial. A total of 240 participants will be randomized 1:1 into groups receiving TDF or entecavir monotherapy. The two groups will be compared in terms of recurrence-free and overall survival at 1, 3, and 5 years after surgery; adverse events; virological response; rate of alanine transaminase normalization; and seroreactivity at 24 and 48 weeks after surgery. DISCUSSION: This study will compare long-term survival between patients with HBV-associated HCC who receive TDF or entecavir monotherapy. Numerous outcomes related to prognosis will be analyzed and compared in this study. TRIAL REGISTRATION: ClinicalTrials.gov NCT02650271. Registered on January 7, 2016.

The treatment for multilevel noncontiguous spinal fractures.

We report the outcome of 30 patients with multilevel noncontiguous spinal fractures treated between 2000 and 2005. Ten cases were treated conservatively (group A), eight cases were operated on at only one level (group B), and 12 cases were treated surgically at both levels (group C). All cases were followed up for 14-60 months (mean 32 months). Initial mobilisation with a wheelchair or crutches in group A was 9.2 +/- 1.1 weeks, which was significantly longer than groups B and C with 6.8+/-0.7 weeks and 3.1 +/- 0.4 weeks, respectively. Operative time and blood loss in group C were significantly more than group B. The neurological deficit improved in six cases in group A (60%), six in group B (75%) and eight in group C (80%). Correction of kyphotic deformity was significantly superior in groups C and B at the operated level, and increasing deformity occurred in groups A and B at the non-operated level. From the results we believe that three treatment strategies were suitable for multilevel noncontiguous spinal fractures, and individualised treatment should be used in these patients. In the patients treated surgically, the clinical and radiographic outcomes are much better.