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Objective Tsushima mamushi (Gloydius tsushimaensis) is an endemic species of snake inhabiting only Tsushima Island, a remote Japanese island. We conducted a multicenter, retrospective study of G. tsushimaensis bites for the first time and developed a treatment algorithm that unified treatment on the island and is still in use today. Methods This is a multicenter, retrospective study comparing 72 cases from January 2005 to December 2018, before the introduction of the algorithm, and 12 cases from January 2019 to December 2020, after its introduction. Results There was no significant decrease in the maximum grade of symptoms after the introduction of the algorithm, but there was a decreasing trend (p=0.057). Conversely, the median of the maximum creatinine kinase levels was 343.5 IU/L (interquartile range: 115.5-4,745.5) before the algorithm's introduction and significantly lower (142.5; interquartile range: 111.3-163) after the algorithm's introduction (p=0.042). After the algorithm's introduction, the disseminated intravascular coagulation merger rate and the acute kidney injury incidence both dropped to 0%, from 9.7% and 6.9%, respectively, before the algorithm's introduction. There was no significant difference in the length of hospital stay before versus after the algorithm's introduction. Conclusion This study showed that the treatment algorithm can be safely and quickly applied. The algorithm's effectiveness is expected to be strengthened by the accumulation of more cases in the future.

The purpose of our study is to identify the patterns of vectors in similar/dissimilar pairs of definition sentence created by Word2vec and doec2vec for elaboration of the terminology for Japanese Medical Device Adverse Events. 2-dimension vector space created by t-SNE showed that the pair with true positive located closer in a vector space, especially Doc2vec had a strong tendency. Comparing with Word2vec, Similar vectors in Doc2vec were close and tended to form clusters.

The purpose of our study is to identify the patterns of vectors in similar/dissimilar pairs of definition sentence created by Word2vec and doec2vec for elaboration of the terminology for Japanese Medical Device Adverse Events. 2-dimension vector space created by t-SNE showed that the pair with true positive located closer in a vector space, especially Doc2vec had a strong tendency. Comparing with Word2vec, Similar vectors in Doc2vec were close and tended to form clusters.

Gloydius tsushimaensis is an endemic species inhabiting only Tsushima, a remote Japanese island, and is a distinct species from Gloydius blomhoffii widely distributed throughout mainland Japan and Gloydius brevicaudus and Gloydius ussuriensis which are geographically distributed in South Korea. This is the first multicenter retrospective study of G. tsushimaensis bites in Japan. A study of seventy-two patients who visited the former Izuhara Hospital, the former Naka Tsushima Hospital, Tsushima Hospital, and Kamitsushima Hospital during the fourteen years from January 1, 2005, to December 31, 2018, revealed the typical clinical characteristics of G. tsushimaensis bites. Five out of seventy-two cases (6.9%) showed severe hypofibrinogenemia, in which fibrinogen levels were below 100 mg/dl, which is an unreported clinical finding for G. blomhoffii bites. Generally, when fibrinogen levels are lower than 100 mg/dl, the bleeding risk increases, and it is perilous. Severe hypofibrinogenemia cases did not improve after G. blomhoffii antivenom administration. Additionally, all five cases had disseminated intravascular coagulation, and there were two cases of acute kidney injury and one death. five cases had a median maximum creatine kinase level of 5171 IU/l (Interquartile range: 4992–41,310). Although the mechanism is not precise, coagulation tests showed that the G. tsushimaensis venom contains a thrombin-like enzyme. Based on this research, we created an algorithm for the treatment of G. tsushimaensis bites and unified the treatment methods used on the island.

We aimed to develop a reliable identification algorithm combining diagnostic codes with several treatment factors for inpatients with acute ischemic stroke (AIS) to conduct pharmacoepidemiological studies using the administrative database MID-NET® in Japan.We validated 11 identification algorithms based on 56 different diagnostic codes (International Classification of Diseases, Tenth Revision; ICD-10) using Diagnosis Procedure Combination (DPC) data combined with information on AIS therapeutic procedures added as "AND" condition or "OR" condition. The target population for this study was 366 randomly selected hospitalized patients with possible cases of AIS, defined as relevant ICD-10 codes and diagnostic imaging and prescription or surgical procedure, in three institutions between April 1, 2015 and March 31, 2017. We determined the positive predictive values (PPVs) of these identification algorithms based on comparisons with a gold standard consisting of chart reviews by experienced specialist physicians. Additionally, the sensitivities of them among 166 patients with the possible cases of AIS at a single institution were evaluated.The PPVs were 0.618 (95% confidence interval [CI]: 0.566-0.667) to 0.909 (95% CI: 0.708-0.989) and progressively increased with adding or limiting information on AIS therapeutic procedures as "AND" condition in the identification algorithms. The PPVs for identification algorithms based on diagnostic codes I63.x were 0.8. However, the sensitivities progressively decreased to a maximum of ~0.2 after adding information on AIS therapeutic procedures as "AND" condition.The identification algorithms based on the combination of appropriate ICD-10 diagnostic codes in DPC data and other AIS treatment factors may be useful to studies for AIS at a national level using MID-NET®.

We aimed to analyze the temporal trends in the per capita food (kcal/day/person) and protein (g/day/person) availability at the national level in the Southeast Asian (SEA) countries from 1961 to 2018. To avoid intercountry variations and errors, we used a dataset derived from the FAO’s old and new food balance sheets. We used the joinpoint model and the jump model to analyze the temporal trends. The annual percentage change (APC) was computed for each segment of the trends. Per capita food and protein availability in the SEA countries increased significantly by 0.8% per year (54.0%) and 1.1% per year (85.1%), respectively, from 1961 to 2018. During the 1960s, 1970s, and 1980s the per capita food availability in mainland SEA did not change significantly and was less than 2200 kcal/person/day. Since the early 1990s, food availability increased appreciably in the mainland SEA countries, except for Cambodia, which has experienced the increasing trend from the late 1990s. Distinct from the mainland, maritime SEA countries showed an up–down–up growth trend in their per-capita food availability from 1961 to 2018. Food-availability growth slowed down for Brunei (since the mid-1980s) and Malaysia (since mid-the 1990s) whereas it increased for Indonesia (1.5% per year), Timor-Leste (0.9% per year), and the Philippines (0.8% per year). Per capita protein availability trends in the mainland SEA countries were similar to the countries’ per capita food availability trends. Since the late 1980s, Thailand and since the late 1990s, other mainland SEA countries experienced a significant growth in their per capita protein availability. Since the late 1990s, per capita protein availability in Vietnam increased markedly and reached the highest available amount in the SEA region, following Brunei and Myanmar. Per capita protein availability increased almost continuously among the maritime SEA countries, except for Timor-Leste. Marked inequality did exist between maritime and mainland SEA countries in per capita food-availability growth till the mid-1990s. Considerable increases in per capita food availability have occurred in most of the SEA countries, but growth is inadequate for Timor-Leste and Cambodia.

Purpose To establish a new medical information database network (designated MID-NET® ) to provide real-world data for drug safety assessments in Japan. Methods This network was designed and developed by the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency in collaboration with 23 hospitals from 10 healthcare organizations across Japan. MID-NET® is a distributed and closed network system that connects all collaborative organizations through a central data center. A wide variety of data are available for analyses, including clinical and administrative information. Several coding standards are used to standardize the data stored in MID-NET® to allow the integration of information originating from different hospitals. A rigorous and consistent quality management system was implemented to ensure that MID-NET® data are of high quality and meet Japanese regulatory standards (good post-marketing study practice and related guidelines). Results MID-NET® was successfully established as a reliable and valuable medical information database and was officially launched in April 2018. High data quality with almost 100% consistency was confirmed between original data in hospitals and the data stored in MID-NET® . A major advantage is that approximately 260 clinical laboratory test results are available for analysis. Conclusions MID-NET® is expected to be a major data source for drug safety assessments in Japan. Experiences and best practices established in MID-NET® may provide a model for the future development of similar database networks.

PURPOSE To examine the potential role of Medical Information Database Network (MID-NET® ), a newly established Japanese medical information database network, in postmarketing drug safety assessments through the characterization of its advantages and limitations in five pilot studies. METHODS The pilot studies were designed to address three major objectives in postmarketing drug safety assessments, ie, the examination of actual drug utilization, the impact of safety-related regulatory actions, and drug-associated risks. The five studies were conducted on the following topics: (a) utilization of codeine-containing products and its relationship with respiratory depression, (b) impact of a Dear Healthcare Professional letter on hypocalcemia incidence associated with denosumab (Ranmark® ) use, (c) risk of acute myocardial infarction associated with antidiabetic drug use, (d) risk of glucose metabolism disorders associated with atypical antipsychotic drug use, and (e) prospective monitoring of abnormal laboratory test results during new drug prescriptions. RESULTS The pilot studies were successfully conducted and demonstrated the value of MID-NET® in postmarketing drug safety assessments. In particular, the ability to utilize laboratory test results as objective clinical indicators is a major advantage of this database. Potential limitations include a relatively small sample size and a lack of patient-level data linkages among hospitals. CONCLUSIONS MID-NET® was confirmed to be a valuable database for postmarketing drug safety assessments. The use of laboratory test results to define clinical outcomes may allow more objective and accurate analyses to be conducted. These studies furthered our understanding of the characteristics of MID-NET® , including its advantages and limitations.

Japanese medical device adverse events terminology, published by the Japan Federation of Medical Devices Associations (JFMDA terminology), contains entries for 89 terminology items, with each of the terminology entries created independently. It is necessary to establish and verify the consistency of these terminology entries and map them efficiently and accurately. Therefore, developing an automatic synonym detection tool is an important concern. Such tools for edit distances and distributed representations have achieved good performance in previous studies. The purpose of this study was to identify synonyms in JFMDA terminology and evaluate the accuracy using these algorithms. A total of 125 definition sentence pairs were created from the terminology as baselines. Edit distances (Levenshtein and Jaro–Winkler distance) and distributed representations (Word2vec, fastText, and Doc2vec) were employed for calculating similarities. Receiver operating characteristic analysis was carried out to evaluate the accuracy of synonym detection. A comparison of the accuracies of the algorithms showed that the Jaro–Winkler distance had the highest sensitivity, Doc2vec with DM had the highest specificity, and the Levenshtein distance had the highest value in area under the curve. Edit distances and Doc2vec makes it possible to obtain high accuracy in predicting synonyms in JFMDA terminology.

The purpose of this study is to extract similar term definitions used in the terminology of Japanese medical device adverse events. We employed Levenshtein and Jaro-Winkler distances as edit distances and Skip-gram, continuous-bag of words, and fast text to produce distributed representations in Word2Vec. A comparison of the accuracies of the models showed that Levenshtein distance had higher specificity whereas Skip-gram had higher sensitivity as compared to the other models.

What is known and objective Since its introduction in April 2012, denosumab has been administered to approximately 7,300 patients as of August 2012, and 32 cases of serious hypocalcaemia after denosumab administration, including two deaths, have been reported in Japan. A Dear Healthcare Professional Letter of Rapid Safety Communication ('Blue letter') was released to warn about the risks of hypocalcaemia associated with denosumab. The goal of this study therefore was to measure the impact of regulatory action on denosumab-induced hypocalcaemia in Japan by using an electronic medical information database (MID). Methods We used two different aggregated data sets based on MIDs (data sets one and two). The patients studied were those who were newly prescribed denosumab or zoledronic acid between April 2012 and September 2014. We assessed four indicators: (a) the proportion of patients with calcium supplementation at the initial denosumab treatment, (b) the proportion of patients who underwent a serum calcium test, (c) the average number of serum calcium tests performed and (d) the prevalence of hypocalcaemia. All indices were aggregated by every 3 months. To evaluate the impact of regulatory action, we used difference in difference (DID) analysis. Results and discussion The proportion of patients with calcium supplementation at the initial denosumab treatment increased year by year in both data sets. The average number of serum calcium tests increased year by year in data set two. There was a significant difference in the prevalence of hypocalcaemia in data set two. This suggests that the estimate of impact of the regulatory action may vary according to the database. In DID analysis, however, significant influences of the regulatory action on combination use with a calcium supplement were detected in both data sets. What is new and conclusion There was a significant influence on combination use of denosumab with vitamin D and/or calcium supplement in both data sets. That there was no apparent increase in the prevalence of denosumab-induced hypocalcaemia, suggests that the regulatory action had an impact in the clinical setting studied. Such regulatory actions may play an important role in the promotion of drug safety.

To examine the potential role of Medical Information Database Network (MID-NETThe pilot studies were designed to address three major objectives in postmarketing drug safety assessments, ie, the examination of actual drug utilization, the impact of safety-related regulatory actions, and drug-associated risks. The five studies were conducted on the following topics: (a) utilization of codeine-containing products and its relationship with respiratory depression, (b) impact of a Dear Healthcare Professional letter on hypocalcemia incidence associated with denosumab (RanmarkThe pilot studies were successfully conducted and demonstrated the value of MID-NETMID-NET

Purpose The purpose of this study is to evaluate the accuracy of gastrointestinal (GI) perforation ICD-10 coding in the Diagnosis Procedure Combination (DPC) database and to examine drug exposure risk factors for GI perforation. Methods A total of 100 patients with GI perforation ICD-10 codes were selected randomly from Kagawa University Hospital's DPC database between April 2011 and December 2016. Two experienced specialist physicians independently reviewed the medical records and classified cases as "definite A," "definite B," "probable," or "no GI perforation." The positive predictive values (PPVs) of "definite A/B" cases were calculated after stratification by sex, age, ICD-10 code, and diagnostic information in the DPC data. The number of prescribed drugs with side effects of GI perforation according to historical data was compared between "definite A/B" and "no GI perforation" cases. Results The overall PPV was 47.0% (95% confidence interval [CI], 36.9-57.2). However, the PPVs for the three categories of diagnostic information in the DPC data ("main diagnosis," "diagnosis causing admission," and "most resource-intensive diagnosis") were each more than 70% after excluding inappropriate patients. Additionally, the PPV focused on these three categories was 76.3% (95% CI, 59.8-88.6). Prescribed drugs with side effects of GI perforation were more frequently detected in "definite A/B" cases (P = .028). Conclusions Although the overall PPV for GI perforation based on ICD-10 code was low, our results suggest that the PPV could be improved by appropriate selection of DPC diagnosis category and that use of multiple medications enhances the risk of GI perforation.

An 84-year-old man visited our hospital with epigastralgia.Levels of hepatic and biliary enzymes and CRP were elevated, as detected by a blood test.On a CT scan, a swollen gallbladder with stones was detected.The patient was admitted to the hospital with a diagnosis of Grade I acute cholecystitis.Conservative treatment was continued with antibiotic administration and the patient was discharged from the hospital with improvement on day 6 after admission.Three months later, the patient underwent laparoscopic cholecystectomy.In the gallbladder, a 45×45 mm tumor was found.Upon pathological examination, diffuse proliferation of lymphocyte-like heterotypic cells and subserosal invasion were observed.Immunohistochemistry results were negative for MUM1 and positive for CD10 and Bcl6 markers.A malignant diffuse large B-cell lymphoma was diagnosed.We experienced a case of malignant lymphoma of the gallbladder diagnosed after surgery for acute cholecystitis, which we herein report with literature consideration.

The aim of this study was to to estimate the sample size for the assumed feasibility study of the computer-assisted input support on a clinica trial. More than 1,500 observations were required for the feasibility study with assumed settings. Further study was required for more efficient research design.

A 75-year-old man admitted for left lateral abdominal pain was found to have advanced poorly differentiated gastric adenocarcinoma with abdominal para-aortic and Virchow's lymph node metastases, which was diagnosed to be clinical Stage IV (T3N3H0M1[LYM]). As curative surgery was not deemed possible, we started chemotherapy administration using S-1 (120mg/day)administered orally for 3 weeks and cisplatin(CDDP 100mg/body)administered intravenously on day 8. After 6 courses of chemotherapy, a CT scan showed that all lymph nodes metastases had disappeared, resulting in downstaging to clinical Stage II (T3[SE]N0H0P0M0). Thus, we performed total gastrectomy, lymph node dissection(D2), and splenectomy. Histological findings showed no residual tumor cells in any of the lymph nodes. However, cancer cells remained in the primary gastric lesion. The pathological response to chemotherapy was judged to be Grade 2. The patient has been recurrence-free for 5 years after surgery.

Context Predicting prognosis using noninvasive and objective tools may facilitate end-of-life decisions for terminal cancer patients, their families, and other health care professionals. Objectives To investigate if the shock index (SI), along with decreased level of consciousness (DLOC), is a reliable tool for predicting short-term survival time in terminal cancer patients. Methods A two-part retrospective cohort study was performed on 670 consecutive adult hospice patients. Part 1 of the study was performed to investigate the reliability of SI and DLOC on admission and to make a simple tool for predicting survival time. Part 2 of the study was to validate the tool's reproducibility and analyze the correlation between SI, DLOC, and survival time. Results In Part 1, multivariate Cox proportional hazards analyses for all study patients revealed that SI ≥ 1.0 in patients with DLOC was a significant risk factor of death (hazard ratio 3.08; 95% CI 1.72–5.53; P = 0.000). Generalized additive models confirmed that DLOC patients with SI = 1.0 had 9.58 days of mean survival time (MST). Receiver operating characteristic curve analyses of SI in patients with DLOC revealed that a survival time of less than three days was most reliably predicted. In Part 2, an increase in SI statistically decreased survival time. The upper 95% CIs of the calculated mean survival time for DLOC patients with SI ≥ 1.0 were less than one week. Bootstrap analyses revealed that the 95% CIs of the predicted survival time were 4.54–6.18 days in DLOC patients with SI = 1.0. Conclusion An SI ≥ 1.0 along with DLOC is a highly reliable tool for predicting short-term survival time in terminal cancer patients.