Background/Aims: The objectives of this real-world study were to determine 1-year persistence with vedolizumab in patients with ulcerative colitis and to evaluate factors contributing to loss of response. Methods: In this multicenter, retrospective, observational chart review, patients with moderately to severely active ulcerative colitis who received ≥ 1 dose of vedolizumab in clinical practice at 16 tertiary hospitals in Japan (from December 2018 through February 2020) were enrolled. Results: Persistence with vedolizumab was 64.5% (n = 370); the median follow-up time was 53.2 weeks. Discontinuation due to loss of response among initial clinical remitters was reported in 12.5% (35/281) of patients. Multivariate analysis showed that concomitant use of tacrolimus (odds ratio [OR], 2.76; 95% confidence interval [CI], 1.00–7.62; P= 0.050) and shorter disease duration (OR for median duration ≥ 7.8 years vs. < 7.8 years, 0.33; 95% CI, 0.13–0.82; P= 0.017) were associated with discontinuation due to loss of response. Loss of response was not associated with prior use of anti-tumor necrosis factor alpha therapy, age at the time of treatment, disease severity, or concomitant corticosteroids or immunomodulators. Of the 25 patients with disease duration < 1 year, 32.0% discontinued due to loss of response. Conclusions Persistence with vedolizumab was consistent with previous reports. Use of tacrolimus and shorter disease duration were the main predictors of decreased persistence.

Objective: This study aimed to clarify the characteristics of the patients who had hip osteoarthritis (hip OA) of more than K-L grade 3 and did not need total hip replacement (THR) two years after the diagnosis.Methods: Twenty-four patients who were followed up for at least 2 years were included and classified into surgical and non-surgical groups depending on the need for THR. Pain (rest pain, motion pain, gait pain), hip range of motion, performance tests (time up and go test (TUG), 10 m gait speed, 2-step test, one-leg standing time, chair standing-5 (CS-5)), and Japanese Orthopaedic Association Hip-Disease Evaluation Questionnaire (JHEQ) were evaluated at the initial visit.Results: Rest pain was significantly lower in non-surgical group compared to surgical group (p<0.01). JHEQ pain score (p<0.01), motor score (p=0.03), and mental health score (p<0.01) were significantly higher in non-surgery group than those in surgery group.Conclusion: Even if you have end-stage hip OA, those with low rest pain and a high JHEQ score at the time of initial diagnosis may be able to live for two years without undergoing surgery. In patients with hip OA of more than K-L grade 3, low rest pain and a high JHEQ score at the initial visit were associated with avoiding THR for two years.

The development of new treatments for gynecological malignancies has been conducted mainly through collaborative international phase III trials led by the United States and Europe. The survival outcomes of many gynecological malignancies have greatly improved as a result. Recent large-scale genome-wide association studies have revealed that drug efficacy and adverse event profiles are not always uniform. Thus, it is important to validate new treatment options in each country to safely and efficiently provide newly developed treatment options to patients with gynecological malignancies. The Japanese Gynecologic Oncology Group (JGOG) is conducting 5 cohort studies (JGOG 3026, 3027, 3028, 3030, and 3031) to establish real-world data (RWD) of poly(ADP-ribose) polymerase (PARP) inhibitor use in patients with advanced or recurrent epithelial ovarian cancer. The RWD constructed will be used to provide newly developed PARP inhibitors for women with advanced or recurrent ovarian cancer in a safer and more efficient manner as well as to develop further treatment options. In 2022, The JGOG, Korean Gynecologic Oncology Group, Chinese Gynecologic Cancer Society, and Taiwanese Gynecologic Oncology Group established the East Asian Gynecologic Oncology Trial Group to collaborate with East Asian countries in clinical research on gynecologic malignancies and disseminate new knowledge on gynecologic malignancies from Asia. The JGOG will conduct a collaborative integrated analysis of the RWD generated from Asian countries and disseminate real-world clinical knowledge regarding new treatment options that have been clinically implemented.

Prevention, early diagnosis, and early treatment of skeletal-related events (SREs) are important in the treatment of potential or current cases of bone metastasis. In August 2020, our hospital established the bone metastasis team and the bone metastasis board (BMB) started actively engaging in activities aimed at improving the outcome of bone metastasis. We retrospectively examined whether a combined modality therapy started in the diagnosis of bone metastases could prevent the onset of SREs and whether it could prolong survival and improve activities of daily living. The 75 advanced cancer patients who underwent BMB at our hospital from August 1, 2020 to July 31, 2022 were divided into two groups according to when BMB performed before and after SREs for comparative analysis. Numerical Rating Scale improved, however Performance Status did not improve in both groups, and there was no difference in survival between the both groups (15.3 vs. 9.0 months, HR: 0.74, 95%; CI: 0.42–1.29, p=0.29). In conclusion, patients who suffered from SREs from the time of bone metastasis diagnosis were treated early. However, the incidence of SREs after BMB in our hospital was 22.6%, and it is necessary to actively work to prevent SREs in the future.

Background: Poly (adenosine diphosphate)-ribose polymerase (PARP) inhibitors for tumors with homologous recombination deficiency (HRD), including pathogenic mutations in BRCA1/2, have been developed. Genomic analysis revealed that about 20% of uterine leiomyosarcoma (uLMS) have HRD, including 7.5%–10% of BRCA1/2 alterations and 4%–6% of carcinomas of the uterine corpus, and 2.5%–4% of the uterine cervix have alterations of BRCA1/2. Preclinical and clinical case reports suggest that PARP inhibitors may be effective against those targets. The Japanese Gynecologic Oncology Group (JGOG) is now planning to conduct a new investigator-initiated clinical trial, JGOG2052. Methods JGOG2052 is a single-arm, open-label, multi-center, phase 2 clinical trial to evaluate the efficacy and safety of niraparib monotherapy for a recurrent or persistent rare fraction of gynecologic malignancies with BRCA1/2 mutations except for ovarian cancers. We will independently consider the effect of niraparib for uLMS or other gynecologic malignancies with BRCA1/2 mutations (cohort A, C) and HRD positive uLMS without BRCA1/2 mutations (cohort B). Participants must have 1–3 lines of previous chemotherapy and at least one measurable lesion according to RECIST (v.1.1). Niraparib will be orally administered once a day until lesion exacerbation or unacceptable adverse events occur. Efficacy will be evaluated by imaging through an additional computed tomography scan every 8 weeks. Safety will be measured weekly in cycle 1 and every 4 weeks after cycle 2 by blood tests and physical examinations. The sample size is 16–20 in each of cohort A and B, and 31 in cohort C. Primary endpoint is the objective response rate.

Objective: There is little information on the effectiveness and safety of health foods for pregnant women. The purpose of this study was to analyze the risk of health food to pregnant women and fetuses from pharmaceutical interventions and clarify the problems for standardization of pharmaceutical management and guidance.Methods: Among 243 pregnant inpatients who received consultations from our pharmacists, 61 subjects were taking health food products were recruited from May 2015 to April 2017. We developed novel guidelines for the use of health food products for pregnant women, and used the guidelines to provide pharmaceutical interventions. Results of these interventions were reviewed retrospectively to identify issues associated with pharmaceutical management of the use of health food products.Results: Among 61 subjects, 10 (16%) received a total of 11 interventions for the use of health food products. Suggestions to discontinue the use of health food products were accepted by 9 subjects (82%). The majority of interventions (n=7, 64%) were related to therapeutic disadvantages of health food products, such as “bleeding complications during childbirth” and “interaction with other medicines”. Information on the number of weeks of pregnancy, drug history, and treatment status were used to trigger and determine appropriate pharmaceutical interventions.Conclusion: From the intervention cases, the potential disadvantages associated with the use of health foods were confirmed, and the risk status of pregnant women and fetuses associated with the use of health foods was clarified. It is necessary to intervene before embarking on using health foods, to make judgements based on risk assessment considering the number of weeks of pregnancy and patient background, and to provide accurate information to pregnant women. We anticipate that future studies will provide additional insights into the effects of health food intake on pregnant women, and that support systems for pregnant women will be established by medical professionals.

The Japanese Society of Hepato-Biliary-Pancreatic Surgery launched the clinical practice guidelines for the management of biliary tract cancers (cholangiocarcinoma, gallbladder cancer, and ampullary cancer) in 2007, then published the 2nd version in 2014. In this 3rd version, clinical questions (CQs) were proposed on six topics. The recommendation, grade for recommendation, and statement for each CQ were discussed and finalized by an evidence-based approach. Recommendations were graded as grade 1 (strong) or grade 2 (weak) according to the concepts of the grading of recommendations assessment, development, and evaluation system. The 31 CQs covered the six topics: (1) prophylactic treatment, (2) diagnosis, (3) biliary drainage, (4) surgical treatment, (5) chemotherapy, and (6) radiation therapy. In the 31 CQs, 14 recommendations were rated strong and 14 recommendations weak. The remaining three CQs had no recommendation. Each CQ includes a statement of how the recommendations were graded. This latest guideline provides recommendations for important clinical aspects based on evidence. Future collaboration with the cancer registry will be key for assessing the guidelines and establishing new evidence.

We are planning a study focused on the gathering of clinical data for the purpose of formalizing diagnostic logic at 6 institutions specialized in Kampo-based medical examinations. However, during the planning stage, it has been recognized that there are a large number of Kampo formulas to be studied, and differences among faculties and individuals exist regarding how to identify each Kampo formula, methods of gathering findings, and the evaluation of efficacy. Here we report the solution proposal reached after building consensus among all participating faculties on these issues. After raising the issues, conferences were held for each of them, until a unanimous consensus was obtained. As a result, the following conclusions were reached. Thirty-three Kampo formulas were selected as targets for the formalization of diagnostic logic. In addition, the range of dosage forms, crude drug ingredients, and permissible dosages for each Kampo formula were determined. Regarding clinical findings for these Kampo medicines, the items to be collected and evaluation criteria were also established. The criteria for evaluating the validity and safety of each Kampo medicine were decided, together with the grading and timing of evaluation. We hope that our solution proposal reached after building consensus becomes the basis for Kampo research in the future.

BACKGROUND: The effects of prenatal exposure to toxic elements on birth outcomes and child development have been an area of concern. This study aimed to assess the profile of prenatal exposure to toxic elements, arsenic (As), bismuth (Bi), cadmium (Cd), mercury (total mercury (THg), methylmercury (MHg), inorganic mercury (IHg)), lead (Pb), antimony (Sb) and tin (Sn), and essential trace elements, copper (Cu), selenium (Se) and zinc (Zn), using the maternal blood, cord blood and placenta in the Tohoku Study of Child Development of Japan (N = 594-650). METHODS: Inductively coupled plasma mass spectrometry was used to determine the concentrations of these elements (except mercury). Levels of THg and MeHg were measured using cold vapour atomic absorption spectrophotometry and a gas chromatograph-electron capture detector, respectively. RESULTS: Median concentrations (25th-75th) of As, Cd, Pb, Sb, Sn and THg in the maternal blood were 4.06 (2.68-6.81), 1.18 (0.74-1.79), 10.8 (8.65-13.5), 0.2 (0.06-0.40) and 0.2 (0.1-0.38) ng mL and 5.42 (3.89-7.59) ng g, respectively. Median concentrations (25th-75th) of As, Cd, Pb, Sb, Sn and THg in the cord blood were 3.68 (2.58-5.25), 0.53 (0.10-1.25), 9.89 (8.02-12.5), 0.39 (0.06-0.92) and 0.2 (0.2-0.38) ng mL and 9.96 (7.05-13.8) ng g, respectively. CONCLUSIONS THg and Sb levels in the cord blood were twofold higher than those in the maternal blood. Cord blood to maternal blood ratios for As, Cd and Sb widely varied between individuals. To understand the effects of prenatal exposure, further research regarding the variations of placental transfer of elements is necessary.
Adult ; Female ; Fetal Blood ; chemistry ; Humans ; Japan ; Maternal Exposure ; statistics & numerical data ; Maternal-Fetal Exchange ; Metals ; blood ; Placenta ; chemistry ; Pregnancy ; blood ; Trace Elements ; blood ; Urban Health