Background/Aims: Mirikizumab is a p19-directed anti-interleukin-23 antibody with potential efficacy against ulcerative colitis (UC). We evaluated the efficacy and safety of mirikizumab in a Japanese subpopulation with moderately to severely active UC from the LUCENT-1 and LUCENT-2 studies. Methods: LUCENT-1 and LUCENT-2 were phase 3, randomized, double-blind, placebo-controlled trials of mirikizumab therapy in adults with moderately to severely active UC. LUCENT-1 was a 12-week induction trial where patients were randomized 3:1 to receive intravenous mirikizumab 300 mg or placebo every 4 weeks (Q4W). Patients achieving a clinical response with mirikizumab following the induction study were re-randomized 2:1 to double-blind treatment with either mirikizumab 200 mg or placebo subcutaneously Q4W during the 40-week maintenance study. The primary outcomes were clinical remission at week 12 of LUCENT-1 and week 40 of LUCENT-2. Results: A total of 137 patients enrolled in Japan were randomized to mirikizumab (n = 102) or placebo (n = 35). Compared with placebo, patients who received mirikizumab showed numerically higher clinical remission at week 12 of induction (32.4% [n = 33] vs. 2.9% [n = 1]) and at week 40 of maintenance (48.9% [n = 23] vs. 28.0% [n = 7]). A greater number of patients achieved key secondary endpoints in the mirikizumab group compared with placebo. The frequency of treatment-emergent adverse events was similar across mirikizumab and placebo groups. Efficacy and safety results observed in the Japanese subpopulation were generally consistent with those in the overall population. Conclusions Mirikizumab induction and maintenance treatments were effective in Japanese patients with moderately to severely active UC. No new safety concerns were identified.

In C1–C2 posterior fixation, the C1 lateral mass and C2 pedicle/translaminar screw insertion under spine navigation have been used frequently. To avoid the risk of neurovascular damage in atlantoaxial stabilization, we assessed the safety and effectiveness of a preoperative computed tomography (CT) image-based navigation system with intraoperative independent C1 and C2 vertebral registration. It is ideal when a reference frame can be linked directly to the C1 posterior arch for C1-direct-captured navigation, but there is a mechanical challenge. A new spine clamp-tracker system was implemented recently, which allows reliable C1- and C2- direct-captured navigation in nine patients with traumatic C2 fractures. In this way, there was no misalignment of C1–C2 screws. C1 lateral mass screws were used except for one case, and translaminar screws were primarily used as an anchor for C2. The C1 lateral mass screw locations, which are 19 mm laterally from the C1 posterior arch’s center, are taken to be constant. However, there is one unusual circumstance in which using a C1 laminar hook instead of a C1 lateral mass screw appears to be a beneficial substitute. The increase of surgical accuracy for posterior C1–C2 screw fixation without cost constraints is significantly facilitated by intraoperative C1- and C2-direct-captured navigation with preoperative computed CT images.

A survey was conducted to determine the current status and issues of dysphagia care in hospitals and long-term care facilities in Gifu Prefecture. Responses were obtained from 14 hospitals, 13 welfare facilities for elderly adults requiring long-term care (WFs), and 13 geriatric health services facilities (GHSFs). Dysphagia teams were present at 12 hospitals, 4 WFs, and 8 GHSFs. The teams primarily consisted of general nurses (hospitals = 12, WFs = 4, GHSFs = 8; same order below), certified dysphagia nurses (11, 1, 0), nutritionists (11, 4, 7), speech-languagehearing therapists (11, 0, 5), physicians (7, 2, 4), and pharmacists (7, 0, 0). Facilities that employed certified dysphagia nurses conducted screening for dysphagia, but many hospitals and long-term care facilities did not review patients’ medications to identify medications that could cause dysphagia. In addition, many hospitals did not educate care workers about assisting with eating and swallowing. This demonstrates a need to improve dysphagia-related screening and educational systems for nurses and care workers at hospitals and long-term care facilities.

BACKGROUND/OBJECTIVES: Taste perception is influenced by both nutritional factors and psychological factors. This study was undertaken to measure the 4 basic taste perceptions, nutrient intake, and mental health, and to examine the factors that affect insensitive taste perception in young Japanese women. SUBJECTS/METHODS: Young women in their late teens and twenties were enrolled as subjects. Taste perception was measured by applying the filter-paper disc method over areas of the chorda tympani nerve. Nutritional status was evaluated using brief, self-administered diet history questionnaires. The index of nutritional status was based on the 2015 Japanese dietary reference intakes. Mental health was assessed using the Japanese translation of the Profile of Mood States short version. This study was approved by the ethical committee at Osaka University. RESULTS: The normal taste perception group (four basic tastes [sweet, salty, sour, and bitter] identified as normal taste perception) comprised 55.4% of the subjects, while the abnormal taste perception group (more than 1 abnormal taste perception was perceived, regardless of flavor) comprised 44.6% of the subjects. There were no significant differences in nutrient intake (except manganese) and mental health between the normal and abnormal taste perception groups. Subjects who took 5 mg to less than 7.1 mg zinc per day were at significantly decreased risk of insensitive taste perception compared to subjects who consumed less than 5 mg zinc per day [Regression coefficient 0.831, 95% confidence interval 0.694–0.996]. CONCLUSION: The present results suggest that insensitive taste perception could be associated with zinc deficiency in young women in their late teens and twenties.
Adolescent ; Asian Continental Ancestry Group ; Chorda Tympani Nerve ; Diet ; Female ; Humans ; Mental Health ; Methods ; Nutritional Status ; Psychology ; Recommended Dietary Allowances ; Taste Perception ; Zinc

BACKGROUND: Waldenström Macroglobulinemia (WM) is a rare subtype of indolent B-cell lymphoma, and prospective randomized studies on WM are scarce. The R-CHOP therapy [rituximab (R), cyclophosphamide, hydroxy-doxorubicin, vincristine, and prednisone] is a popular and recommended regimen for primary therapy, prescribed by several treatment guidelines for WM. However, treatment with R-CHOP is accompanied by severe myelosuppression and high rates of peripheral neuropathy. Therefore, we retrospectively evaluated the efficacy and toxicity of half-dose CHOP combined with R as a primary therapy for WM. METHODS: Patients with untreated symptomatic WM, treated at the Disaster Medical Center between April 2011 and September 2016, were retrospectively analyzed after administration of 6 cycles of half-dose R-CHOP for every 3 weeks. The response, median time to response, best response, progression-free survival, overall survival, and toxicities were evaluated. RESULTS: Of the 20 WM patients analyzed, 16 (80%) received half-dose R-CHOP without vincristine, and 13 (65%) responded to the treatment. With a median follow-up duration of 26.3 months, the 2-year progression-free survival and 2-year overall survival rates were 70 and 93.3%, respectively. The median time to response and best response were 6 and 9.9 weeks, respectively. Grade 3/4 leukocytopenia, neutropenia, febrile neutropenia, and Grade 1 peripheral neuropathy developed in 32, 37, 0, and 21% of patients, respectively. CONCLUSION: The half-dose R-CHOP is an effective and well-tolerated primary therapy for WM. To the best of our knowledge, this is the first study reporting the use of a reduced-dose R-CHOP regimen for the primary treatment of WM.
Cyclophosphamide ; Disasters ; Disease-Free Survival ; Febrile Neutropenia ; Follow-Up Studies ; Humans ; Leukopenia ; Lymphoma, B-Cell ; Neutropenia ; Peripheral Nervous System Diseases ; Prospective Studies ; Retrospective Studies ; Rituximab* ; Survival Rate ; Vincristine ; Waldenstrom Macroglobulinemia*

Ibi Welfare Hospital covers a local town that has an aging population, and the development of a community-based integrated care system is an important issue. We have established and are operating a regional integrated NST system to maintain oral nutrition intake essential for daily life and prevention of pneumonia in this area, and here we report on outcomes and future issues. In this study, we investigated the regional integrated NST system (NST outpatient · NST hospitalization · NST visit) and examined dissemination of its service. Data was collected from February 2016 to March 2017. The investigation involved the following: (1) extraction of survey results of latent NST subjects and retrospective investigation of medical records; (2) expansion of NST outpatient services (examinations by surgeons, endoscopic evaluation of swallowing function, blood tests, dental examination, and evaluation by a dietician speech-language-hearing therapist, and return of a joint report created by the individual professionals to the introducing professional); and (3) introduction of NST hospitalization (2-week hospital stay for local inclusion sickbed care, introduction of swallowing passport, initiation of rehabilitation, oral care roundtrip, NST roundtrip, personnel care meetings with home staff, and introduction of visiting speechlanguage-hearing therapist rehabilitation to support home care after discharge). To increase awareness of this system, we visited the local nursing care insurance agency and welfare hospitals and tried to obtain cooperation through transparency. Introducing and initiating this regional integrated NST system “Ibi Model” revealed that the system is greatly needed in our region. We think that it has the potential to become a key supporting tool for the home-based medical care system within the regional comprehensive care system. Further verification is needed to assess real outcome changes such as a decrease in the incidence of pneumonia and improvement in quality of life.

BACKGROUND: Oral food challenge (OFC) tests are conducted in both specialized institutions and general hospitals. We aimed to compare the severity of the conditions of the patients between these 2 types of institutions in order to consider the role of such institutions in society. OBJECTIVE: We evaluated the results of OFC tests for hen's egg, cow's milk, and wheat that were conducted in a specialized institution (Aichi Children's Health and Medical Center [ACHMC], n = 835) and in 4 general hospitals (n = 327) in Aichi prefecture, Japan. METHODS: The symptoms provoked were scored using the total score (TS) of the Anaphylaxis Scoring Aichi scoring system in combination with the total ingested protein dose (Pro) before the appearance of allergic symptoms. RESULTS: The total ingested dose of the challenge-positive patients in ACHMC was significantly less than that in the general hospitals (p < 0.01). The median TS of the provoked symptoms in ACHMC and the general hospitals did not differ to a statistically significant extent in the hen's egg or cow's milk challenges; however, the median TS in ACHMC was significantly lower than that in the general hospitals for the wheat challenge (p = 0.02). The median TS/Pro values in ACHMC were almost identical to the upper 25% of the TS/Pro values in the general hospitals, suggesting that the specialized institution usually managed more severe patients. CONCLUSION: The specialized institution performed OFC tests at a lower threshold dose, but provoked similar TSs to the general hospitals. This evaluation may help in optimizing the distribution of patients to general hospitals and specialized institutions.
Anaphylaxis ; Child Health ; Hospitals, General ; Hospitals, Special ; Humans ; Japan ; Milk ; Ovum ; Severity of Illness Index ; Triticum

A patient, an adultJapanese traveler who had just returned from Thailand, had developed denguehemorrhagic fever (DHF). A primary infection of dengue virus (DENV) wasconfirmed, in particular, DENV serotype 2 (DENV-2) via the detection of the virusgenome, a significant increase in its specific neutralizing antibody and the isolationof DENV-2. DHF is often observed following a secondary infection from another serotypeof dengue virus, particularly in children, but this case was a primaryinfection of DENV. Japan is a non-endemic country of dengue disease. Instead,only Japanese encephalitis (JE) is known to be an endemic flavivirus family. Inthis study, IgG antibody against Japanese encephalitis virus (JEV) was detected.JEV belongs to the family of dengue virus and prevails in Japan, particularly inKyushu. Among many risk factors for the occurrence of DHF, a plausiblecandidate could be a cross-reactive antibody-dependent enhancement (ADE)mechanism by JEV antibody. This indicates that most Japanese travelers, wholive in non-endemic areas of dengue, particularly in Kyushu, should payattention to the occurrence of DHF.

An adult Japanese man who had just returned from Thailand developed dengue hemorrhagic fever (DHF). A primary infection of dengue virus (DENV) was confirmed, specifically DENV serotype 2 (DENV-2), on the basis of the detection of the virus genome, a significant increase in the neutralizing antibody and the isolation of DENV-2. DHF is often observed following a secondary infection from another serotype of dengue virus, particularly in children, but this case was a primary infection of DENV. Japan is a non-endemic country for dengue disease. In fact, only Japanese encephalitis (JE) is known to be a member of the endemic flavivirus family. In this study, IgG antibody against Japanese encephalitis virus (JEV) was detected. JEV belongs to the family of dengue virus and prevails in Japan, particularly Kyushu. Among many risk factors for the occurrence of DHF, a plausible candidate could be a cross-reactive antibody-dependent enhancement (ADE) mechanism caused by JEV antibody. This indicates that most Japanese travelers who living in dengue non-endemic areas, particularly Kyushu, should be aware of the occurrence of DHF.