The effect of standard and high dose of rikkunshito on achievement of enteral nutrition target in critically ill patients: a pilot randomized controlled trial.

AIM: Rikkunshito is a traditional Japanese medicine used for delayed gastric emptying in intensive care units in Japan. This study aimed to investigate whether standard- or high-dose rikkunshito can improve the achievement of enteral calorie target among critically ill adults. METHODS: This open-label, single-center, pilot randomized controlled trial was carried out from March 2018 until December 2018 and enrolled critically ill adult patients requiring enteral nutrition by gastric tube for at least 5 days. Patients were randomized into the control group, the standard-dose rikkunshito group (2.5 g three times daily), and the high-dose rikkunshito group (5 g three times daily). Intervention was given for 5 days. The primary outcome measure was the percentage of enteral calorie intake achieved in the target at the fifth day after randomization. RESULTS: The cohort comprised 26 patients; of these, 9, 8, and 9 were included in the control group, the standard-dose group, and the high-dose group, respectively. Twenty-one patients (81%) were included in the primary analysis. The percentage of enteral calorie intake achieved in the target at the fifth day was 59% (interquartile range [IQR], 39-63%), 40% (IQR, 26-61%), and 62% (IQR, 17-83%) in the control, the standard-dose, and the high-dose groups, respectively (P = 0.42). The number of adverse events did not differ significantly between the groups (control group, 4 [44%]; standard-dose group, 3 [38%]; and high-dose group, 4 [44%], P = 1.00). CONCLUSIONS: Standard- or high-dose rikkunshito did not improve the achievement of enteral calorie target in critically ill adults.

Determination of lamotrigine in human plasma using liquid chromatography-tandem mass spectrometry.

AIM: Lamotrigine (LTG) is a widely used anti-epileptic drug that is administered to avoid seizures and to maintain seizure-free status. However, several factors reportedly cause individual differences of plasma LTG levels, and the therapeutic target range of LTG varies between individuals. Thus, to optimize effective doses of LTG, we developed a rapid and simple method for determining plasma LTG concentrations. METHODS: Lamotrigine and the internal standard papaverine were extracted from human plasma using solid-phase extraction. After filtration, 5-µL aliquots of final samples were injected into the liquid chromatography-tandem mass spectrometry instrument and LTG and internal standard were separated using a Cadenza CD-C18 column (100 × 2 mm, 3 µm) with 0.1% formic acid in water/acetonitrile (2/1, v/v). RESULTS: The calibration curve was linear from 0.2 to 5.0 µg/mL, and assessments of recovery, intra- and inter-day precision and accuracy, matrix effects, freeze and thaw stability, and long-term stability demonstrated good reproducibility. Retention times of LTG and internal standard were 1.6 and 2.0 minutes, respectively, and the total run time was 3.5 minutes for each sample. CONCLUSION: We developed a rapid and simple method for determining plasma LTG concentrations. The present novel system could be used to inform LTG dose adjustments for individual patients.

Molecular characterization of Sapovirus detected in a gastroenteritis outbreak at a wedding hall.

Sapovirus (SaV) is an important pathogen of human acute gastroenteritis. A gastroenteritis outbreak occurred at a wedding hall in October 2007 in Ehime Prefecture, Japan. One hundred nine people who had either attended wedding parties or had eaten a box lunch at a conference held at the same hall complained of gastroenteritis symptoms. Among these 109 people, stool specimens from 56 patients were available for pathogen screening, and 20 (35.7%) of these specimens were positive for SaV, of whom 18 showed symptoms. The numbers of cDNA copies of the specimens ranged from 2.36 x 10(6) to 3.03 x 10(10) for symptomatic patients, and 2.19 x 10(6) and 1.18 x 10(9) per gram of stool for two asymptomatic food handlers. The incubation periods of the 18 symptomatic patients ranged from 14.5 to 99.5 hr. Identical nucleotide sequence types of SaV; that is, a single synonymous nucleotide difference (transition) or microheterogeneity, was detected in stool specimens from the symptomatic patients and the asymptomatic food handlers, with the direct nucleotide sequence of approximately 2.3 kb 3' end of the genome. Based on the phylogenetic analysis with the complete capsid nucleotide sequence, these strains were clustered into genogroup IV. This outbreak was thought to be caused by a single source, and underscores the importance of proper hygiene in the environment and/or in food-handling practices to control SaV outbreaks.