Efficacy and Safety of Pregabalin for Muscle Cramps in Liver Cirrhosis: A Double-Blind Randomized Controlled Trial

BackgroundMuscle cramp is possibly related to peripheral nerve hyperexcitability (PNH), and one of the most debilitating symptoms frequently encountered in patients with liver cirrhosis. We investigated whether pregabalin, a gamma-aminobutyric acid analogue, can suppress neuronal excitability and reduce muscle cramps in cirrhotic patients.MethodsWe conducted a randomized, double-blind, placebo-controlled trial in which study participants with cirrhosis from a single tertiary center were enrolled. Primary endpoint was the relative change in cramp frequency from the run-in to standard dose treatment phase (4 weeks per each). Secondary endpoints included the responder rate, and the changes in cramp frequency during sleep, pain intensity, health-related quality of life (Liver Disease Quality of Life Instrument, Short Form-36) and electrophysiological measures of PNH.ResultsThis study was terminated early because of insufficient accrual. 80% (n = 56) of the target number of participants (n = 70) were randomized to pregabalin (n = 29) or placebo (n = 27). Median baseline frequency of muscle cramps (interquartile range) was 5.8 (3.5–10) per week in the pregabalin group and 6.5 (4.0–10) in the placebo group (P = 0.970). The primary analysis showed a significant reduction in cramp frequency with pregabalin compared to placebo (−36% vs. 4.5% for the percentage change, P = 0.010). Secondary outcomes did not differ significantly between the two groups. Adverse effects with pregabalin were mainly dizziness and lethargy.ConclusionWith multiple problems emerging from premature termination in mind, the results suggested an acceptable safety profile and favorable effect of pregabalin in reducing muscle cramps compared to placebo in cirrhotic patients.Trial RegistrationClinicalTrials.gov Identifier: {"type":"clinical-trial","attrs":{"text":"NCT01271660","term_id":"NCT01271660"}}NCT01271660     

Prognostic factors of facial nerve function after vestibular schwannoma removal via translabyrinthine approach

Background: Prediction of facial function is a major concern when proposing surgery for patients with vestibular schwannoma (VS).

Aims/objectives: To evaluate postoperative facial function of patients who underwent operation of VS via a translabyrinthine approach (TL), and to analyze factors that influence facial functions.

Material and methods: A total of 91 VS patients, who were operated via a TL approach, between March 1997 and December 2016, were analyzed. Demographics, tumor-related factors, and operative findings were collected. Facial function was assessed according to the House-Brackmann (HB) grading system before surgery, immediately after surgery, and 1-, 3-, 6-months, and 1 year after surgery.

Results: In cases of patients that had a tumor that extended to the CPA, an unsatisfactory facial outcome was noted in 12 (30.0%) patients. FN outcomes after tumor removal depend on tumor size (p?=?.040). Among FN-related factors, only the FN recovery timing was correlated with facial outcomes (p?=?.030). Univariable and multivariable analysis revealed that tumor size and the timing of FN recovery were significant as favorable prognostic factors for good facial outcomes.

Conclusions and significance: Tumor size and the FN recovery timing are significant prognostic factors of facial outcome in VS patients who underwent operations via a TL approach.     

Four-Tier Pathologic Tumor Regression Grading System Predicts the Clinical Outcome in Patients Who Undergo Surgical Resection for Locally Advanced Pancreatic Cancer after Neoadjuvant Chemotherapy

Background/AimsNeoadjuvant chemotherapy is increasingly utilized in patients with borderline or locally advanced pancreatic cancer (LAPC). However, the pathologic evaluation of tumor regression is not routinely performed or well established. We aimed to evaluate the prognostic value of three tumor regression grading systems frequently used in LAPC and to determine the correlation between pathologic and clinical response.MethodsWe included a total of 38 patients with LAPC who were treated with neoadjuvant chemotherapy and subsequent resection. Pathologic tumor regression was graded based on the College of American Pathologists (CAP), Evans, and MD Anderson grading systems.ResultsOne out of 38 patients (2.6%) achieved a pathologic complete response. Unlike other grading systems (Evans, p=0.063; MD Anderson, p=0.110), the CAP grading system was a significant prognostic factor for overall survival (p=0.043). Pathologic N stage (p=0.023), margin status (p=0.044), and radiologic response (p=0.016) correlated with overall survival. In the multivariate analysis, CAP 3 was an independent predictor of shorter overall survival (p=0.026). The CAP grading system correlated with the radiologic response (p=0.007) but not the carbohydrate antigen 19-9 level (p=0.333).ConclusionsThe four-tier CAP pathologic tumor regression grading system predicted the clinical outcome in LAPC patients who underwent resection after neoadjuvant chemotherapy. Therefore, a more comprehensive pathologic evaluation is warranted in these patients.     

Evaluation of Disposal Stability for Cement Solidification of Lime Waste

The Korea Atomic Energy Research Institute (KAERI) obtains UO₂ powder using the ammonium uranyl carbonate (AUC) wet process. Hydrated lime (Ca(OH)₂) is used to neutralize liquid wastes produced from the AUC process, and the resulting byproduct is known as lime waste. The purpose of this study is to determine optimum operating conditions for cementation of radioactive lime waste produced from the AUC process, and to evaluate the structural stability and leaching stability of cement waste form. The waste acceptance criteria (WAC) of a waste disposal facility in Korea were used to evaluate the cement waste form samples. The maximum lime waste content guaranteeing the shape stability of cement waste form was found to be 80 wt.% or less. Considering the economic feasibility and error of the cementation process, the optimum operating conditions were achieved at a lime waste content of 75 wt.% and a water-to-cement (w/c) ratio of 2.0. The compressive strength of cement waste form samples prepared under optimal operating conditions was 61.4, 76.3, and 61.0 kgf/cm² after the thermal cycling test, water immersion test, and irradiation, respectively, satisfying the compressive strength of 35.2 kgf/cm² specified in WAC. A leaching test was performed on the samples, and the leachability indexes (LX) of Cs, Sr, and Co nuclides were 7.63, 8.02, and 10.89, respectively, which are all higher than the acceptance criterion of 6. The results showed that the cement waste forms prepared under optimal operating conditions satisfied the WAC in terms of structural stability and leaching stability. As such, the proposed cement solidification method for lime waste disposal can be effective in solidifying lime waste powder produced during the neutralization of liquid wastes in the AUC process.