[A Study on the Significance of NST Early Intervention for Cancer Patients].

BACKGROUND: Cancer patients are often complicated by weight loss and malnutrition, thus it is important to provide nutritional therapy in parallel with disease treatment. This study examined the significance of early intervention by NST for cancer patients. METHODS: Seventy-five cancer patients out of 281 patients who underwent NST intervention between July 2021 and June 2022 were included. Intervention outcomes, such as energy and protein sufficiency(=intake/target), and final evaluation by a NST nutritionist at the end of the intervention("improvement"/"unchanged"/"disease progression"/ "death"), were compared between patients who received NST intervention within 7 days from admission(Group A)and after 7 days from admission(Group B). RESULTS: Nutritional sufficiency at the end of NST intervention was higher in Group A for both energy and protein, and the proportion of"improvement"was higher in Group A for the final evaluation by a NST nutritionist. Patients' situation(pre-initial treatment/post-chemotherapy/post-surgery/worsening nutritional status during follow-up)was biased between 2 groups, however Group A showed better results for nutritional sufficiency rate and final evaluation in each subgroup of patients' situation. CONCLUSION: Early intervention may improve the effectiveness of NST for cancer patients. It is important to extract subjects and start NST intervention at early timing.

Acetaminophen-induced liver injury at therapeutic doses in a young adult: a case report.

Acetaminophen causes volume-dependent hepatotoxicity; however, hepatotoxicity may also occur with acetaminophen administered at normal doses. We encountered a case of allergic liver damage in a 17-year-old girl receiving acetaminophen at a regular dose. The patient was diagnosed using the Roussel Uclaf Causality Assessment Method (RUCAM) and the diagnostic scale of the Digestive Disease Week Japan 2004 workshop. She tested positive for acetaminophen on a drug-induced lymphocyte stimulation test, and liver biopsy results confirmed the diagnosis of acetaminophen-induced liver injury. Despite administering acetaminophen at normal doses, hepatotoxicity may occur, which warrants further exploration.

Development of a Japanese Scale that Evaluates the Level of Nursing Support Provided to Patients for Decision-Making in Cancer Clinical Trials.

Clinical nurses need learning programs that are useful in nursing support for patients' decision-making (NSPDM) regarding cancer clinical trials (CCTs). The usefulness of the learning program can be evaluated if the practices of NSPDM before and after participation in the learning program can be compared. We developed a scale to measure the level of self-assessed NSPDM regarding participation in a CCT. Thirty-two items of scale were developed in Japanese based on previous literature. Based on the results of a pilot study, items with similar meanings were removed and the validity of the 26 scale items was statistically examined in terms of construct validity and reliability. The study population was clinical nurses and included clinical research nurses. We received 102 valid responses from clinical nurses. Based on the bias of the boxplot distribution and the ceiling and floor effects for the items analysis of the 26-item draft scale, 17 items remained. Exploratory factor analysis (EFA) revealed that the scale consisted of three subscales and 17 items. Regarding fit indices of the model, the goodness-of-fit index (GFI), adjusted GFI (AGFI), comparative fit index (CFI), and root mean square error of application (RMSEA) were 0.775, 0.704, 0.477, and 0.081, respectively. The Cronbach's alpha coefficient for the overall scale was 0.951, with subscales ranging from 0.820 to 0.942. The validity and reliability of this scale were acceptable. This scale may be helpful to evaluate the usefulness of learning programs, i.e., the practice level of NSPDM.

Serum cystatin C and CRP are early predictive biomarkers for emergence of hypoxia in COVID-19.

BACKGROUND: In Japan, during the coronavirus disease 2019 (COVID-19) pandemic, patients with non-hypoxia are recommended to recuperate at home or in pre-hospital facilities. However, it was observed that unexpected hypoxia may occur and become severe subsequently in patients whose symptoms were initially expected to improve naturally. The aim of this study is to validate biomarkers that can predict at an early stage the emergence of hypoxia in COVID-19 patients without hypoxia. METHODS: We retrospectively enrolled 193 patients with COVID-19, excluding patients with hypoxia and severe disease from the onset. Participants were classified into two groups according to the emergence of hypoxia during the clinical course, and the laboratory data were compared to identify biomarkers that could predict early the emergence of hypoxia. RESULTS: The areas under the curve for serum cystatin C (CysC) and C-reactive protein (CRP) levels for the emergence of hypoxia during the clinical course were higher than those for other biomarkers (CysC, 0.84 and CRP, 0.83). Multivariate analysis showed that high serum CysC and CRP levels were associated with the emergence of hypoxia during the clinical course. CONCLUSIONS: Elevated serum CysC and CRP levels were associated with the emergence of hypoxia during the clinical course in COVID-19 patients without hypoxia. These findings may help determine the need for hospitalization in initially non-hypoxic COVID-19 patients.

A case of familial hypocalciuric hypercalcemia type 1 due to CASR p.Pro55Leu mutation.

BACKGROUND: Familial hypocalciuric hypercalcemia (FHH) is a rare autosomal dominant disease, which requires differential diagnosis from relatively common primary hyperparathyroidism (PHPT) in order to avoid unnecessary surgery. CASE PRESENTATION: A 16-year-old female had been followed by the department of psychosomatic medicine at our institution. Throughout the follow-up period, her plasma calcium levels were high, plasma Pi levels were relatively low, and plasma intact PTH was relatively high. She was referred to our department to determine the cause of her hypercalcemia. Her 24 h urinary calcium excretion was as low as 100 mg/day, and calcium creatinine clearance ratio was below 0.01. Moreover, she had a family history of hypercalcemia (proband, her brother, and her father). The genetic testing for her family revealed that she, her brother, and her father were definitively diagnosed with FHH type 1 due to the heterozygous calcium-sensing receptor mutation (NM_00388:4:c.164C > T:p.Pro55Leu). CONCLUSION: We experienced a 16-year-old female with FHH, in whom genetic testing identified the heterozygous calcium-sensing receptor mutation (NM_00388:4:c.164C > T:p.Pro55Leu) as pathogenic, permitting a definitive diagnosis of FHH type 1. The genetic testing for calcium sensing receptor is beneficial to distinguish asymptomatic primary hyperparathyroidism from FHH.

The Effect of Bronchoconstriction by Methacholine Inhalation in a Murine Model of Asthma.

INTRODUCTION: Bronchoconstriction was recently shown to cause airway remodeling and induce allergic airway inflammation in asthma. However, the mechanisms how mechanical stress via bronchoconstriction could induce airway inflammation and remodeling remain unclear. OBJECTIVE: We investigated the effect of bronchoconstriction induced by methacholine inhalation in a murine model of asthma. METHODS: BALB/c female mice were sensitized and challenged with ovalbumin (OVA), followed by treatment with methacholine by a nebulizer twice a day for 7 days. Twenty-four hours after the last methacholine treatment, the bronchoalveolar lavage fluid (BALF) and lung tissues were collected. The BALF was analyzed for total and differential cell counts and cytokine levels. The lung tissues were analyzed for goblet cell metaplasia, thickness of the smooth muscle, and lung fibrosis. The expression of cytokines in the lung was also examined. RESULTS: OVA sensitization and challenge induced infiltration of total cells, macrophages, and eosinophils in the BALF along with goblet cell metaplasia and increased airway smooth muscle hypertrophy. Seven days after the last OVA challenge, untreated mice achieved reduction in airway inflammation, while methacholine maintained the number of BALF total cells, macrophages, and eosinophils. The percentage of goblet cells and the thickness of airway smooth muscle were also maintained by methacholine. Moreover, the treatment of methacholine induced the expression of transforming growth factor (TGF)-ß in the lung. This result indicates that the production of TGF-ß is involved in induction of airway remodeling caused by bronchoconstriction with methacholine. CONCLUSIONS: Repeated bronchoconstriction caused by methacholine inhalation elicited allergic airway inflammation and airway remodeling.

Inhibition of Virus-Induced Cytokine Production from Airway Epithelial Cells by the Late Addition of Budesonide.

BACKGROUND: Viral infection is the main cause of asthma and COPD (chronic obstructive pulmonary disease) exacerbation and accumulate inflammatory cells to airway tissue. We have reported poly I:C, a mimic product of the virus and ligand of toll-like receptor 3 (TLR3), induced inflammatory chemokines from airway epithelial cells and found prior incubation with corticosteroids diminishes the effect of TLR3 activation. In clinical practice, mild asthma is recommended as-needed budesonide (BUD) when symptoms occur following a viral infection, etc. However, many questions still surround BUD's usefulness if taken after a virus has already infected airway tissue. OBJECTIVE: The aim of this study was to investigate the inhibitory effects of BUD on inflammatory cytokines induced by viral infection. Methods: Normal human bronchial epithelial (NHBE) cells were stimulated with poly I:C or infected with human rhinovirus-16 (HRV16) and BUD was added after the initial stimulation. Expression of both thymic stromal lymphopoietin (TSLP) and CCL26/eotaxin-3 was quantified by real-time RT-PCR and enzyme-linked immunosorbent assay (ELISA), respectively. Knockdown study was performed. Results: Pre-or post-incubation with BUD inhibited both poly I:C- and HRV16-induced mRNAs and proteins of both thymic stromal lymphopoietin (TSLP) and CCL26 with significance. Knockdown of the glucocorticoid receptor diminished these effects of BUD. Under the same conditions of BUD's experiment, post-incubation with neither fluticasone propionate nor dexamethasone suppressed expression of both TSLP and CCL26, which induced by poly I:C. CONCLUSION: Post-addition of BUD inhibited the virus-induced TSLP and CCL26 from the airway epithelial cells. These results suggest that inhalation of BUD after viral infection has beneficial effects on asthma. CONCLUSION: Late addition of BUD may benefit among patient with viral infection and type 2 allergic airway disease such as asthma.

Long-term donor quality of life after living donor liver transplantation in Japan.

AIMS: This study examined the long-term quality of life (QOL) of living liver donors (LLDs) in Japan using both generic and LLD-specific instruments. METHODS: The sample comprised 374 LLDs from five university hospitals in Japan who underwent surgery more than a year previously. QOL was evaluated using the Short Form-36 health survey (SF-36) and LLD-QOL scale. RESULTS: SF-36 results indicated that the overall long-term QOL of LLDs was significantly better than the Japanese standard. When comparing by donor factors, LLDs whose recipients were children scored higher for "satisfaction" than those whose recipients were adults on the LLD-QOL scale. LLDs with complications had lower QOL for "scars" and "burden" on the LLD-QOL scale but no differences in SF-36 scores. LLDs with longer hospital stay had lower physical QOL on SF-36 and lower QOL for "scars" and "after-effects" on the LLD-QOL scale. LLDs whose recipients have died showed lower mental QOL on SF-36 and lower "satisfaction" and greater "lack of understanding of donor health" on the LLD-QOL scale. CONCLUSIONS: Our multicenter study clarified the long-term QOL of LLDs and suggested that donors' QOL was related to the donors' and recipients' ages, donor's complications and hospital stay length, and recipient's prognosis.

Close relationship between the short round ligament and the ovarian prolapsed inguinal hernia in female infants.

PURPOSE: The aim of this study was to clarify the relationship between the length of the round ligament and the presence of a patent processus vaginalis (PV) based on the hypothesis that a short round ligament is the cause of ovarian inguinal hernia in female infants. METHODS: Between April 2011 and March 2017, 132 girls underwent laparoscopic surgery for inguinal hernia. Before surgery, the presence of ovarian prolapse was diagnosed. We observed the internal inguinal ring laparoscopically and examined the diameter of the PV orifice as well as the round ligament length. Medical records and video records were reviewed to evaluate PV patency and round ligament length. RESULTS: Seventeen of the 132 cases had an ovarian inguinal hernia; all of them were infants. In all infants, with or without a prolapsed ovary, the round ligament was short, causing the ovary and fallopian tube to be close to the hernia orifice over the pelvic brim. In girls aged over 12 months, the round ligament lengths on the hernia side, contralateral open PV side, and contralateral closed PV side were 33.0 ± 9.3, 36.8 ± 7.5, and 41.4 ± 8.5 mm, respectively. The round ligament length in open PV was significantly shorter than in the closed PV, but the difference was smaller in older patients. CONCLUSION: The round ligament, which is the female gubernaculum in the fetus, was shorter in the open PV than in the closed PV in younger girls. The short round ligament results in the ovarian prolapsed hernia.

Pulmonary function in children with Pectus excavatum and post-operative changes after nuss procedure.

PURPOSE: The aim of this study was to show the difference between the pulmonary function of children with mild or severe types of pectus excavatum (PE) and post-operative changes in their predicted vital capacity (%VC) following Nuss procedure. PATIENTS AND METHODS: One hundred and twenty-four of the 208 children who underwent Nuss procedure for PE between January 2007 and March 2016 were deemed eligible for this study and evaluated retrospectively. A spirometry was performed on these children on four occasions: before operation; pre-bar removal; and 1 month and 1 year after bar removal. Ninety-seven of the children who were more than 7 years of age were divided using the Haller Index (HI) into a mild group (n = 54) and a severe group (n = 43) and compared. The children were also divided into three groups based on their age and their %VC was compared at each follow-up occasion. RESULTS: The severe group showed a significantly lower %VC and peak expiratory flow rate than the mild group. %VC change after bar removal showed significantly lower in group aged 11 or over. 43 of the children had spirometry data recorded 1 year after bar removal which, compared with 1 month after bar removal, showed a significant higher %VC in groups aged of 10 or under. CONCLUSION: Nuss procedure in children aged of 10 or under proved to be an advantage in the post-operative pulmonary function.

Systematic review of school tobacco prevention programs in African countries from 2000 to 2016.

BACKGROUND: The World Bank has reported that global smoking rates declined from 2000 to 2012, with the only exception found in males in Sub-Saharan Africa. Sub-Saharan Africa is considered to be in stage one of the tobacco epidemic continuum. To address this problem, school-based programs for smoking prevention are considered cost-effective and promising. Since tobacco prevention programs are influenced by social competence or customs of each country, tobacco prevention programs that have success in Western countries are not always effective in African countries. Therefore, the current study systematically reviewed relevant literature to examine the effects of these types of programs in African countries. METHOD: Online bibliographic databases and a hand search were used. We included the studies that examined the impact of school-based programs on preventing tobacco use in Africa from 2000 to 2016. RESULTS: Six articles were selected. Four were conducted in South Africa and two were performed in Nigeria. Four programs were systematically incorporated into annual curriculums, targeting 8th to 9th graders, while the other two were temporary programs. All programs were based on the hypothesis that providing knowledge and/or social skills against smoking would be helpful. All studies utilized smoking or polydrug use rates to compare outcomes before/after intervention. There were no significant differences between intervention and control groups in three studies, with the other three demonstrating only partial effectiveness. Additionally, three studies also examined change of knowledge/attitudes towards smoking as an outcome. Two of these showed significant differences between groups. CONCLUSION: All RCTs studies showed no significant change of smoking-rate by the intervention. The effectiveness of intervention was observed only in some sub-group. The cohort studies showed school-based interventions may be effective in improving knowledge and attitudes about smoking. However, they reported no significant change of smoking-rate by the intervention.

Physically triggered Takotsubo cardiomyopathy has a higher in-hospital mortality rate.

BACKGROUND: Takotsubo cardiomyopathy (TC) is a myopathy triggered by severe stressful events. However, little is known about the determinants of in-hospital outcomes. We prospectively determined the effect of different triggers on the prognosis of TC. METHODS AND RESULTS: We enrolled patients who were admitted for suspected acute coronary syndrome (ACS) from January 2008 to December 2015. TC was diagnosed according to the Mayo Clinic diagnosis criteria. The outcome was in-hospital death. Among 1861 consecutive patients with suspected ACS, 82 (4.4%) patients were diagnosed with TC. There were 43 patients (52%) with physical triggers (Physical), 26 (31%) with emotional triggers, and 13 (17%) with no identifiable triggers. The latter two groups were combined and categorized as the Non-physical trigger group. Compared with non-physical triggered TC, patients with physical triggered TC were more likely to have a malignancy (p=0.008), lower blood pressure (p=0.001), lower hemoglobin (p<0.001), higher serum creatinine (p<0.001) and higher norepinephrine levels (p=0.007). During a mean hospital stay of 16±12days, 9 (20.9%) of the Physical and 1 (2.6%) of the Non-physical patients died in-hospital (log-rank p=0.007). After adjusting for the age, gender, trigger, malignancy, and hemoglobin level, being male (hazard ratio 11.9, 95% confidence interval, 2.43-58.5, p=0.002) and having a physical trigger (14.7, 1.19-166, p=0.03) were associated with in-hospital mortality. CONCLUSION: There was a significant difference in in-hospital mortality depending on the trigger type in TC. Being male and having a physical trigger were independent risk factors of in-hospital mortality from TC.

A novel bleb-dependent polysaccharide export system in nitrogen-fixing Azotobacter vinelandii subjected to low nitrogen gas levels.

The alginate biofilm-producing bacterium Azotobacter vinelandii aerobically fixes nitrogen by oxygen-sensitive nitrogenases. Here we investigated the bacterial response to nitrogen/oxygen gas mixtures. A. vinelandii cells were cultured in nitrogen-free minimal media containing gas mixtures differing in their ratios of nitrogen and oxygen. The bacteria did not grow at oxygen concentrations >75% but grew well in the presence of 5% nitrogen/25% oxygen. Growth of wild-type and alginate-deficient strains when cultured with 50% oxygen did not differ substantially, indicating that alginate is not required for the protection of nitrogenases from oxygen damage. In response to decreasing nitrogen levels, A. vinelandii produced greater amounts of alginate, accompanied by the formation of blebs on the cell surface. The encystment of vegetative cells occurred in tandem with the release of blebs and the development of a multilayered exine. Immunoelectron microscopy using anti alginate-antibody revealed that the blebs contained alginate molecules. By contrast, alginate-deficient mutants could not form blebs. Taken together, our data provide evidence for a novel bleb-dependent polysaccharide export system in A. vinelandii that is activated in response to low nitrogen gas levels.

Correlation of asymmetric chest wall deformity and growth in patients with pectus excavatum.

PURPOSE: Pectus excavatum involves wide range of chest wall depression. The degree of depression or asymmetry varies between young and adolescent patients. It has not been clear how the deformity progresses as patients grow. To elucidate the change of asymmetric deformity, preoperative computed tomography (CT) scan was evaluated according to different age groups. METHODS: Preoperative CT scans of 154 patients with pectus excavatum were collected and analyzed using Haller's CT index, asymmetric index and sternal rotation angle. Patients were divided into 5 age groups as follows; group 1: 4-6 y (n=53), group 2: 7-9 y (n=25), group 3: 10-12 y (n=25), group 4: 13-15 y (n=23), group 5: 16-23 y (n=28). The degree of asymmetric chest wall deformity was expressed using sternal rotation angle as follows; symmetrical (-5º to +5º), left-mild (-5º to -15º), right-mild (+5º to +15º), right-moderate (+15º to +25º) and right-severe (over +25º). RESULTS: As the age of patients increased, asymmetric index increased from 1.025±0.065 in group 1 to 1.124±0.111 in group 5 and sternal rotation angle also increased from 6.11±8.61 in group 1 to 15.41±11.98 in group 5. In these two parameters, significant difference was seen between group 1 and 4, group 2 and 4, group 1 and 5 and group 2 and 5. However, average CT index revealed no significant difference in any age groups. In group 1, 83% of patients were classified in symmetrical or left- and right-mild. The incidence of right-moderate plus right-severe was 17% in group 1, 20% in group 2, 40% in group 3, 52.1% in group 4 and 50% in group 5. CONCLUSIONS: The degree of chest depression did not show any change in all age groups. Asymmetric deformity on the right side progressed around the age of 10 to 12. Half of patients over the age of 13 showed moderate or severe asymmetry. These results were suggestive to consider the optimum age for the correction of pectus excavatum.

Optical screening of diabetes mellitus using non-invasive Fourier-transform infrared spectroscopy technique for human lip.

The Fourier-transform mid-infrared spectroscopy (FTIR) technique has not been used for diabetes diagnosis so far in clinical practice. We attempted to predict non-invasively blood hemoglobin A1c (HbA1c) levels by FTIR to enable evaluation and screening for diabetes. Twenty eight patients from age 20s to 80s, 14 males and 14 females, with and without diabetes, were examined in hospital as a pilot study, and their biochemical data were analyzed with infrared (IR) spectral data of the lip surface by FTIR spectroscopy. Some IR peaks of lip surface had significant correlations with blood glucose and HbA1c levels. Among several peaks in the spectra of lip, peaks at around 1300-1400cm(-1) discriminated groups with higher or lower HbA1c levels, suggesting the observation of lip surface advanced glycation end-products with carboxymethyl group. The application of partial least squares (PLS) regression analysis to the correlation between HbA1c levels and lip FTIR spectra resulted in highly significant prediction of HbA1c values for the subjects. Comparison of some IR peaks with predicted HbA1c values served to remove false-negative data effectively. This study with FTIR technique proposed here was effective for screening of diabetes patients with higher HbA1c levels.

Reliability and validity of a new living liver donor quality of life scale.

PURPOSE: To develop a living liver donor (LLD) quality of life (QOL) scale and test its reliability and validity. METHODS: We sent a draft questionnaire comprising 38 questions to 965 LLDs from five hospitals. To evaluate test-retest reliability, the questionnaire was re-sent 2 weeks later to some of the donors from one hospital. RESULTS: Of the 447 (54.5 %) donors who responded, 15 were excluded. Factor analysis of 26 items extracted 7 subscales; namely, damage from the operation, scarring, satisfaction, burden, after-effects, digestive symptoms, and lack of understanding of donor health. We analyzed construct validity on the basis of factor analysis and observed significant correlations among the seven subscales. Criterion-related validity was confirmed by significant correlation with the 36-item Short-Form Health Survey scores. None of the subscales showed unreasonable values. We evaluated the subscale reliability for internal consistency (α = 0.670-0.868, except for "digestive symptoms", α = 0.431) and test-retest reliability (r = 0.749-0.918). The factor "digestive symptoms" needs careful consideration because of low internal consistency. CONCLUSION: The findings of this study confirmed the reliability and validity of the LLD QOL scale, which can be used for quantitatively evaluating the QOL of LLDs.

Beat-to-beat variability of T-wave amplitude for the risk assessment of ventricular tachyarrhythmia in patients without structural heart disease.

AIMS: Increased temporal repolarization lability, assessed by beat-to-beat variability of T-wave amplitude (TAV), has been shown to be associated with ventricular tachyarrhythmia in patients with a variety of clinical conditions. The aim of this study was to test the ability of TAV to identify patients presenting with malignant ventricular arrhythmia and to predict subsequent occurrences. METHODS AND RESULTS: We studied 20 consecutive patients (age 42 ± 15 years, mean ± standard deviation) presenting with ventricular tachyarrhythmia who did not have substantial underlying heart disease and compared them with 40 age- and sex-matched control subjects. The TAV was determined by Holter recording (Ela Medical). Patients with ventricular tachyarrhythmia had a higher maximum value of TAV (max TAV: 38 ± 18 vs. 22 ± 15 µV, P < 0.001) than did the controls. The sensitivity and specificity of max TAV > 22.4 µV for detecting the occurrence of ventricular tachyarrhythmia were 77 and 90%, respectively. During a mean follow-up period of 23 months, three patients had relapses of ventricular tachyarrhythmia. Patients with a recurrence of ventricular tachyarrhythmia had a trend towards a higher max TAV as compared with those who had ventricular tachyarrhythmia but did not relapse (56 ± 23 vs. 36 ± 16 µV, P = 0.061). CONCLUSION: Our results suggest that Holter-derived TAV might be associated with the occurrence and recurrence of ventricular tachyarrhythmia in patients without structural heart disease. Prospective validation will be necessary to assess the potential diagnostic value of the TAV in a large general population.

Primary alveolar bone grafting and gingivoperiosteoplasty or gingivomucoperiosteal flap at the time of 1-stage repair of unilateral cleft lip and palate.

It takes quite a long time to finish treating patients with cleft lip and palate. Usually, lip closure, palate repair, secondary alveolar bone grafting, and secondary repair of lip/nose have been given to patients at appropriate time according to their growth. However, these series of surgical interventions impose a considerable burden on the patients and their families. As for palate repair, it is considered that the earlier the better for the sake of speech, but it should be delayed to approximately 1(1/2) years of age for maxillary growth. However, we have developed a palate repair technique that will hardly result in marked maxillary growth impairment by modifying the Furlow method, so we have become able to perform palate repair between 3 and 10 months after birth. Accordingly, we can perform lip and palate repair simultaneously, which have been performed separately. As we have developed a 1-stage repair of cleft lip and palate including primary alveolar bone grafting from nasal concha and/or hard plate and gingivoperiosteoplasty or gingivomucoperiosteal flap, we report on our technique and treatment outcome.

Preparation of a fast dissolving oral thin film containing dexamethasone: a possible application to antiemesis during cancer chemotherapy.

We prepared fast dissolving oral thin film that contains dexamethasone and base materials, including microcrystalline cellulose, polyethylene glycol, hydroxypropylmethyl cellulose, polysorbate 80 and low-substituted hydroxypropyl cellulose. This preparation showed excellent uniformity and stability, when stored at 40 degrees C and 75% in humidity for up to 24 weeks. The film was disintegrated within 15s after immersion into distilled water. The dissolution test showed that approximately 90% of dexamethasone was dissolved within 5 min. Subsequently, pharmacokinetic properties of dexamethasone were compared in rats with oral administration of 4 mg dexamethasone suspension or topical application of the film preparation containing 4 mg dexamethasone to the oral cavity. Pharmacokinetic parameters were similar between the two groups in which C(max) (h), T(max) (microg/mL), AUC (microg/mL/h) and half-life (h) were 12.7+/-6.6 (mean+/-SD, N=10), 3.4+/-1.4, 93.6+/-37.8 and 1.66+/-0.07, respectively, for oral suspension and 13.3+/-4.0, 3.2+/-1.0, 98.0+/-22.3 and 1.65+/-0.06, respectively, for film preparation. These findings suggest that the fast dissolving oral thin film containing dexamethasone is likely to become one of choices of dexamethasone preparations for antiemesis during cancer chemotherapy.