Ministry Of Health, Labour And Welfare Research Articles

Low billing rates for pediatric sedation fee on magnetic resonance imaging.

The 2018 revision of social insurance in Japan allows additional fees to be calculated for pediatric magnetic resonance imaging (MRI) that must be performed under sedation. The number and trend of actual claims since this revision was established is unknown. The aim of this study to investigate the use of the additional fees and any regional differences in the use. To analyze the claims of additional fees for pediatric sedated MRI after the fiscal year (FY) 2018, the actual claims in inpatient and outpatient practice was analyzed using publicly-available data from the Ministry of Health, Labour and Welfare (MHLW). We analyzed the calculation rate for all MRI scans. Annual changes in the actual number and calculation rate were analyzed. The ratio of the number of additional fees to the overall number of pediatric radiological procedures was used to examine the geographic disparity. The number of calculations from FY 2018 to FY 2020 was available. In FY 2020, only 1347 additional fees were calculated, corresponding to 0.35% of the total number of MRI scans. The number of fees showed a decreasing trend. Most cases were in the 0-4 year age group; however, there were a few cases in the 10-14 year age group without such a decrease. The relative number of calculations by prefecture showed an up to 14-fold disparity. The requirements for sedation for pediatric MRI are strict, but they are not fully utilized. Measures such as relaxing the requirements for the fee are needed to make MRI-related sedation safer.

An adolescent and young adult (AYA) cancer education initiative aimed at healthcare students in Japan.

The focus on cancer in adolescents and young adults (AYA) has increased in recent years. We participated in an event called AYA week 2021 as part of a research project of the Ministry of Health, Labour and Welfare (MHLW) and conducted a fact-finding survey to collect information for raising public awareness of AYA-generation cancers and to improve support for AYA-generation cancer patients. A 25-item questionnaire survey was conducted through requests sent to the deans of medical schools and presidents of related universities across Japan and by advertising on social networking sites and friendship networks. Furthermore, the effects of a lecture given by three cancer survivors on their cancer experience were examined. A total of 1288 healthcare students participated. The most common age group was between 20 and 24years, with the majority being medical students (83%). The AYA cancer-educated population had more knowledge about AYA-generation cancers than the overall group. At present, very few people are familiar with AYA-generation cancers (30.5%), which highlights the importance of school education. There were 163 participants who attended the lecture given by the cancer survivors, of whom 108 completed the questionnaire. The results showed high participant satisfaction related to the lecture given by cancer survivors, suggesting that such lectures could help educate and raise awareness about AYA-generation cancers. The knowledge survey and lecture given by cancer survivors had educational effects. Many healthcare students responded positively, suggesting the efficacy of these types of initiatives.

Treatment-resistant idiopathic multicentric Castleman disease with thrombocytopenia, anasarca, fever, reticulin fibrosis, renal dysfunction, and organomegaly managed with Janus kinase inhibitors: A case report

Thrombocytopenia, anasarca, fever, reticulin fibrosis, renal dysfunction, and organomegaly (TAFRO) syndrome are nonmalignant but life-threatening systemic inflammatory disorders. However, many patients are refractory to treatment, resulting in significant morbidity and mortality. Additionally, established treatment options are unavailable. Therefore, we present 2 cases of adults with the iMCD-TAFRO syndrome refractory to initial treatment but responded to Janus kinase (JAK) inhibitors with ruxolitinib. The report reveals that these rare adult cases of the refractory and treatment-resistant iMCD-TAFRO syndrome can be treated using JAK inhibitors. Case 1 is a 36-year-old previously healthy male patient who presented with fever and general fatigue for 2 weeks. Case 2 is a 42-year-old previously healthy female patient who presented with fever and general fatigue. The diagnosis met the 2015 criteria for TAFRO syndrome, as determined by All Japan TAFRO Syndrome Research Group in the Research Program for Intractable Disease by the Ministry of Health, Labor and Welfare (MHLW) Japan. Treatment with tocilizumab and several immunosuppressants were ineffective. So, we performed ruxolitinib. Each patient received ruxolitinib, the general condition improved, and CRP levels decreased. These cases showed that ruxolitinib was effective for treatment-resistant/ refractory TAFRO syndrome. Further prospective studies are needed on using ruxolitinib with a small number of cases.

An in-hospital relapse case of an elderly COVID-19 patient on steroids

During a pandemic like the novel coronavirus infection 2019 (COVID-19), the availability of inpatient beds is always a major issue. Thus, it is extremely important to release patients from isolation efficiently in order to maintain stable bed operations. However, in clinical practice, patients may develop fever again, before or after the timing specified by the Ministry of Health, Labor and Welfare (MHLW) for lifting isolation, and hence it may be difficult to determine whether the fever is due to a delay in recovery or due to relapse. The diagnosis of relapse is based primarily on the recurrence of symptoms consistent with COVID-19 and a positive PCR result, but few reports have focused on comparing the patterns of variation in two or more blood test findings over the course of the disease. In the present study, we study a case of relapse in an elderly patient on immunosuppressive drugs. Understanding the unique patterns of variability between baseline blood test values and acute infection test values in each individual patient may serve as an adjunctive tool to help diagnose COVID-19 relapse.

PP94 Exploring The Relationship Between Price And Outcome Of The Health-Economic Assessment In Japan

IntroductionThis study reviewed all publicly available Japanese cost-effectiveness appraisals delivered by the Center for Outcomes Research and Economic Evaluation for Health (C2H) from the national institute of public health (NIPH) and analyzed the relationship between the outcomes of the health-economic assessments and the final price adjustment decisions made by the Ministry of Health, Labour and Welfare (MHLW).MethodsData were extracted from all official health-economic assessments published by C2H website for the analysis. The extractions were structured based on the following items: indication, assessment methodology, appropriate comparators, health-economic outcomes, and key uncertainties identified by C2H. The analysis was performed on 29th November 2021. A threshold of 5 million JPY per Quality Adjusted Life Year gained (JPY/QALY) was used for the incremental cost-effectiveness ratio (ICER) analysis cut-off.ResultsUp to the time of this analysis, six health-economic assessments had been conducted for five products: three assessments performed cost-effectiveness analysis, one performed cost-minimization analysis and two performed cost-effectiveness and cost-minimization analysis for different comparators and different patient subgroups respectively. Among the five assessments’ reported ICER values, four of them are under the 5 million JPY/QALY threshold, ranging from 328,585 JPY/QALY to 483,056 JPY/QALY. However, price adjustments were still implemented on three out of the four products which were deemed to be cost-effective, ranging from -0.5 percent to -4.3 percent (mean: -3.0%). For the only product deemed to be not cost-effective, a price adjustment of -4.3 percent was implemented.ConclusionsA price discount could be implemented regardless of whether the ICER value falls under the 5 million JPY/QALY threshold. However, a lower magnitude of price discount is likely to be applied by MHLW for more cost effective treatments. The outcome of this analysis may be limited by the small sample size and continuous monitoring of further HTA publications in Japan is needed.

C-CAT: The National Datacenter for Cancer Genomic Medicine in Japan.

Since June 2019, under the umbrella of the national health insurance system, Japan has started cancer genomic medicine (CGM) with comprehensive genomic profiling (CGP) tests. The Ministry of Health, Labour and Welfare (MHLW) of Japan constructed a network of CGM hospitals (a total of 233 institutes as of July 1, 2022) and established the Center for Cancer Genomics and Advanced Therapeutics (C-CAT), the national datacenter for CGM. Clinical information and genomic data from the CGP tests are securely transferred to C-CAT, which then generates "C-CAT Findings" reports containing information of clinical annotation and matched clinical trials based on the CGP data. As of June 30, 2022, a total of 36,340 datapoints of clinical/genomic information are aggregated in C-CAT, and the number is expected to increase swiftly. The data are now open for sharing with not only the CGM hospitals but also other academic institutions and industries.

First Approval of Generic Mometasone Furoate Nasal Suspension Spray in Japan: Similarities and Differences Between Japan and the USA.

The Ministry of Health, Labour and Welfare (MHLW) in Japan approved the first generic version of Nasonex in February 2018. The Pharmaceuticals and Medical Devices Agency requires in vitro, pharmacokinetic, and pharmacodynamic or clinical endpoint data to approve generic nasal spray drug products. However, the MHLW has not published basic principle for approving nasal generic drug products. Therefore, this article summarizes the data used for the approval of the first generic Nasonex based on publicly available data. Additionally, we compare the bioequivalence evaluations regarding the human studies based on the generic version of Nasonex between Japan and the USA.

Medical Image Sharing in Japan.

This paper reports the history, background including politics, current status of Japan’s health imaging study and other information sharing. Its realization was slow until the Ministry of Health, Labour and Welfare (MHLW) started paying digital image storage at the same rate as films in 2008. Information sharing was initiated in early 2010s, which was before vendors became ready for Integrating the Healthcare Enterprise (IHE) cross-enterprise document sharing (XDS), with the result that most of 34 large regional sharing systems are in non-standardized protocol. One standardized example is the Hamamatsu area where inexpensive online PDI (portable data for imaging) was introduced.

Change of HPV vaccination rates in Japan: the effect of individual notifications implemented by local governments.

In Japan, in June 2013, The Ministry of Health, Labor and Welfare (MHLW) decided to temporarily suspend its official recommendation for the participation of girls in the national immunization program. The HPV vaccination rate in Japan soon declined to below 1%. In October 2020, the MHLW notified that the municipalities could and should begin to individually notify girls and their parents targeted for routine vaccination. We have examined how that type of individual notification has affected the number of vaccinations. From 12municipalities (with a combined total population of approximately 4.06 million), we collected vaccination data for all girls who attended grades 6 through 10 from April 2019 to March 2021. We analyzed the number of initial-round vaccinations that occurred by month and the timing and the subjects of the individual notifications. The annual vaccination rate for tenth-grade students in 2020 in the six municipalities that had implemented individual notification was 9.46% (342/3618), which was significantly higher than the rate of 3.22% (54/1676) in the three municipalities that had not implemented individual notification (p < 0.001). On the other hand, the annual vaccination rate for the sixth to ninth-grade students in 2020 in the six municipalities that had implemented individual notification was not significantly (p = 0.56) higher than the rate in the three municipalities that did not: 1.43% (197/13,785) versus 1.33% (83/6260), respectively. This study clearly demonstrates the importance of providing information for routine vaccination directly to the targets and their parents.

Overview of Vaccine Regulations in European Union and Japan

In this article we identified the important considerations, in particular , on the preclinical assessments that would allow vaccines to proceed to clinical trials, and the differences on the regulatory pathway for the marketing authorization in each region like National procedure, Decentralized procedures, Centralized procedure, Mutual Recognition Procedure (MRP) monitored by European Medicines Agency (EMA) in Europe , Pharmaceuticals and Medical Devices Agency (PMDA) in relation with Ministry of Health, Labour and Welfare (MHLW) (determines if a proposed study meets the regulatory filing requirements in Japan), The various different types of vaccine regulations was studied with its approval , and development procedure are discussed.

Clinical and genetic features of sitosterolemia in Japan

Background and aimClinical manifestations and genetic backgrounds of Japanese patients with sitosterolemia have been unclear. Materials and methodsWe searched PubMed for studies using the keywords “sitosterolemia” or “phytosterolemia” and “Japan”. Moreover, we added information from the members of the Committee on Primary Dyslipidemia under the Research Program on Rare and Intractable Disease of the Ministry of Health, Labour and Welfare (MHLW) of Japan. ResultsWe identified 36 patients with sitosterolemia caused by biallelic pathogenic mutations in the ATP-binding cassette subfamily G member 5 (ABCG5) or ATP-binding cassette subfamily G member 8 (ABCG8) from 31 families in Japan. The diagnosed age ranged from 0 to 64 years (median 13 years). The median sitosterol and LDL cholesterol levels were 100 μg/ml (IQR: 50–183), and 193 mg/dl (IQR: 108–295), respectively. All the patients exhibited cutaneous and/or tendon xanthomas, up to 9 (25%) patients exhibited premature coronary artery disease, 5 (16%) patients exhibited arthritis, and 8 (22%) patients exhibited blood abnormalities. Ezetimibe was administered to all the patients, including infantile cases, while statins, colestimide, evolocumab, probucol, and LDL apheresis were also used. ConclusionWe are providing a demographic overview of the clinical and genetic backgrounds of Japanese patients with sitosterolemia.

Depressive and anxiety symptoms among Japanese cancer survivors: Japan cancer survivorship research project

BackgroundThis study aimed to clarify predictors of depressive symptoms and anxiety symptoms after cancer diagnosis among Japanese cancer survivors (CSs).MethodsAs part of a Japanese cancer survivorship research project commissioned by the Ministry of Health, Labour and Welfare (MHLW) of Japan, we conducted a web-based nationwide survey of CSs in 2018. We analyzed the risk factors for depressive and anxiety symptoms, as measured by the Hospital Anxiety and Depression Scale Japanese version (HADS).ResultsOf 1,234 Japanese CSs, mean score of HADS-depression and HADS-anxiety were 4.08 and 4.78, respectively. At the time of the study, the number of CSs with symptoms of depression and anxiety were 111 (9.0%) and 269 (21.8%), respectively. After multivariable analysis, CSs ≥ 60 years old (reference: ≤ 39 years old, odds ratios (OR): 0.39, 95%CI: 0.17–0.90) and those ≥ 10 years from cancer diagnosis (reference: 0–4 years, OR: 0.55, 95%CI: 0.32–0.96) had lower odds for depressive symptoms. And CSs ≥ 60 years old (reference: ≤ 39 years old, OR: 0.27, 95%CI: 0.15–0.49) and those ≥ 10 years from cancer diagnosis (reference: 0–4 years, OR: 0.62, 95%CI: 0.42–0.90) also had lower odds for anxiety symptoms. CSs who received chemotherapy (OR: 1.56, 95%CI: 1.10–2.20) had higher odds for anxiety symptoms.ConclusionsBased on manifestation of symptoms, CSs who were younger, closer to the time of cancer diagnosis, had advanced-staged cancer, or received chemotherapy may be at higher risk for depressive or anxiety symptoms. Those CSs who have higher risk for depression and anxiety symptoms, should be followed-up more carefully for better cancer survivorship, by medical professionals, companies, and society.

Japanese Regulatory Framework and Approach for Genome-edited Foods Based on Latest Scientific Findings.

The food supply system is facing important challenges and its sustainability has to be considered. Genome-editing technology, which accelerates the development of new variety, could be used to achieve sustainable development goals, thereby protecting the environment and ensuring the stable production of food for an increasing global population. The most widely used genome-editing tool, CRISPR/Cas9, is easy to use, affordable, and versatile. Foods produced by genome-editing technologies have been developed worldwide to create novel traits. In the first half of the review, the latest scientific findings on genome-editing technologies are summarized, and the technical challenge in genome sequence analysis are clarified. CRISPR/Cas9 has versatile alternative techniques, such as base editor and prime editor. Genome sequencing technology has developed rapidly in recent years. However, it is still difficult to detect large deletions and structural variations. Long-read sequencing technology would solve this challenge. In the second part, regulatory framework and approach for genome-edited foods is introduced. The four government ministries, including the Ministry of Environment, the Ministry of Agriculture, Forestry and Fisheries, and the Ministry of Health, Labour and Welfare (MHLW), started to discuss how the regulation should be implemented in 2019. The SDN-1 technique is excluded from the current genetically modified organism (GMO) regulation. The Japanese regulatory framework includes pre-submission consultation and submission of notification form. In the last part of this review, transparency of regulatory framework and consumer confidence were described. Since maintaining consumer trust is vital, transparency of regulatory framework is a key to consumers. The information of notification process on approved genome-edited foods is made public immediately. This review will help regulators build regulatory frameworks, and lead to harmonization of the framework between the countries.

Focusing Points on FSCJ’s Guideline Recently Established: Risk Assessment of Food Contact Materials

In Japan, the Positive List (PL) system was introduced (Enforcement: June 1, 2020) in the regulative field of Food Apparatus, Containers, and Packaging (ACP) by the recent amendment of the Food Sanitation Act. Under this situation, continuous requests for the risk assessments from the Ministry of Health, Labour and Welfare (MHLW) to the Food Safety Commission of Japan (FSCJ) will be expected. To enhance fairness and transparency and to clarify the data required for the risk assessment, the FSCJ established its “Guidelines for the Risk Assessment of Food Apparatus, Containers, and Packaging” on May 28, 2019. The Guidelines apply to new Food Contact Materials or Substances (FCMs) after enforcement of the PL system (June 1, 2020). The subject material is synthetic resins, because the PL system was first introduced to them in Japan. In general, the substances that are migrated from ACP are not intended to migrate into foods, and their technological effects on foods are not expected. It can be supposed that the migration of these substances is generally very limited. Therefore, as adopted in the USA and the EU, the Guidelines also adopt the tiered approach for the toxicological data requirement that depend on the estimated migration levels (Tier of Dietary Concentration (Tier of DC)) on the subject substance. The greater the exposure to the substance through migration, the more toxicity test results will be needed. The risk assessment steps by the tiered approach in the Guidelines are (1) migration assessment, (2) toxicity assessment, (3) exposure assessment, and (4) risk characterization. These steps are aimed to harmonize with the general 4 steps of risk assessments: hazard identification, hazard characterization, exposure assessment, and risk characterization. In this review, we will introduce the overview of the Guidelines and details of the above 4 steps.

The efficacy of human papillomavirus vaccination in young Japanese girls: the interim results of the OCEAN study

ABSTRACT Human papillomavirus (HPV) vaccine has been used to prevent chronic HPV infection, which accounts for cervical cancer. Japanese Ministry of Health, Labor and Welfare (MHLW) conducted an HPV vaccination campaign in 2010 and the Obstetrical Gynecological Society of Osaka initiated a multicenter, prospective cohort study in Osaka, Japan – OCEAN (Osaka Clinical resEArch of HPV vacciNe) study – to investigate the oncogenic HPV prevalence and the long-term protection rate of HPV vaccine. A total of 2814 participants were enrolled on their visit for HPV vaccination between 12 and 18 years old. Among them, 102 participants received HPV/Pap co-test as primary cancer screening at the age of 20–21. We compared the prevalence in two groups (the vaccinated and the unvaccinated group). HPV infection ratio was significantly lower in the vaccinated group compared to the unvaccinated (12.9% vs. 19.7%; p = .04). In particular, HPV 16 and 18 were not detected in the vaccinated group, while 4.9% of participants in the unvaccinated group were infected (p = .001), suggesting that vaccination provided effective protection against high-risk types of HPV. The cross-protection effect of HPV vaccines was also observed against HPV 31, 45, and 52. Although HPV vaccines were not contributed to the reduction of cervical intraepithelial neoplasia 1 (CIN) (p = .28), CIN2 or worse was not observed in vaccinated group. Our research showed that at the age of 20–21, HPV vaccine inhibited the infection of high-risk HPV and had impacted on the development to CIN2 or worse in Japan.

Prospective Registry Study of Primary Dyslipidemia (PROLIPID): Rationale and Study Design.

Introduction: Primary dyslipidemias are inherited disorders in plasma lipoprotein metabolism that lead to serious cardiovascular and other complications. The Japanese Ministry of Health, Labor and Welfare (MHLW) covers medical expenses, under the Research Program on Rare and Intractable Diseases, for homozygous familial hypercholesterolemia (FH), familial chylomicronemia, sitosterolemia, cerebrotendinous xanthomatosis, lecithin:cholesterol acyltransferase deficiency, Tangier disease, and abetalipoproteinemia. Apolipoprotein A1 deficiency, heterozygous FH, and type III hyperlipoproteinemia are covered by the MHLW Pediatric Chronic Disease Program. Heterozygous FH and type III hyperlipoproteinemia are also important for their relatively common prevalence and, accordingly, high impact on Japanese public health by significant contribution to the overall prevalence of cardiovascular diseases. Therefore, a systemic survey of these diseases is mandatory to estimate their actual situation, such as prevalence, clinical manifestations, and prognoses among the Japanese population. The impact of these rare and intractable diseases on cardiovascular and other complications will likely be higher among Japanese people than other ethnicities because the general Japanese population has many cardioprotective aspects. The current study intends to conduct a multicenter registry of these diseases to assess their demographics and clinical features comprehensively. Methods and Analysis: The Prospective Registry Study of Primary Dyslipidemia is a registry-based prospective, observational, multicenter cohort study in Japan, enrolling patients who fulfill the Japanese clinical criteria of the primary dyslipidemias listed above, from 26 participating institutes from August 2015 to March 2023. A total of 1,000 patients will be enrolled in the study and followed for 10 years. Clinical parameters are collected, including physical and laboratory findings, genetic analysis, drugs, lifestyle management, and clinical events, especially cardiovascular events. The primary endpoint of this study is the new onset of cardiovascular disease and acute pancreatitis, and the secondary endpoint is death from any causes. Ethics and Dissemination: This study complies with the Declaration of Helsinki, the Ethical Guidelines for Medical and Health Research Involving Human Subjects, and all other applicable laws and guidelines in Japan. The institutional review boards have approved this study protocol at all participating institutes. The final results are to be published at appropriate international conferences and in peer-reviewed journals.

Concepts and Challenges of Afterschool Program Quality in Japan

This study examines concepts surrounding the quality of afterschool programs in Japan and related challenges using qualitative and quantitative methods. A content analysis of government guidelines for afterschool programs provided by the Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Education, Culture, Sports, Science and Technology (MEXT) is conducted, and the differences in the concepts of afterschool program quality (APQ) between them are explored. Second, using government statistics, the author looks at the current situation and systems of instructional features meant to improve quality. Third, the characteristics of the human resource development system of MEXT and MHLW for APQ are clarified using the social capital theory.

A View on 20 Years of Antimicrobial Resistance in Japan by Two National Surveillance Systems: The National Epidemiological Surveillance of Infectious Diseases and Japan Nosocomial Infections Surveillance.

The Ministry of Health, Labour and Welfare (MHLW) of Japan has conducted two national surveillance systems for approximately 20 years to monitor antimicrobial resistance (AMR) in bacteria: the National Epidemiological Surveillance of Infectious Diseases (NESID) and the Japan Nosocomial Infections Surveillance (JANIS). Data accumulated for 20 years by these two surveillance systems have helped depict the epidemiology of the representative AMR bacteria in Japan chronologically. The epidemiology of methicillin-resistant Staphylococcus aureus teaches us that once AMR bacteria have established their high endemicity, controlling such AMR bacteria requires time and is challenging. On the other hand, the epidemiology that multidrug-resistant Acinetobacter sp. exhibits when a strict containment policy for AMR bacteria was introduced in the early phase of its emergence and spread reveals that it is possible to control it. Detailed epidemiology provided by these two different national surveillance systems in Japan enabled us to set up the goal for controlling each AMR bacteria at the hospital level to the prefecture/national level. It is the public health authorities’ responsibility to maintain a good surveillance system for AMR bacteria and share the data and findings with healthcare professionals and academicians.

NEONATAL FOLLOW-UP OF BABY BORN DERIVED FROM A TWO PRONUCLEI PLUS ONE MICRO PN OOCYTE FOLLOWING INTRACYTOPLASMIC SPERM INJECTION

A micro PN is very small and can be overlooked when observed under a microscope. Furthermore, it is difficult to see when it overlaps with the normal nucleus. Out of 5,026 oocytes derived by intracytoplasmic sperm injection, 0.7% showed micro PN. After performing chromosome and ploidy analysis on embryos that have grown to blastocysts, micro PN-derived balanced-diploid blastocysts have been transferred into three patients and childbirth has been reported in two patients. (Capalbo et al, Fertility and Sterility, 2017) However, there are no reported cases of developmental follow-up of babies born from micro PN oocytes. Therefore, we report on the neonatal follow-up of baby born derived from a two pronuclei plus one micro PN oocyte. Patient seeking infertility treatment in a well-established private IVF clinic. The birth weight and the height and weight at one and a half and three years old of one case in which a micro-PN-derived blastocyst was transferred were compared with the results of the 2010 Infant Physical Growth Survey by the Ministry of Health, Labor and Welfare (MHLW) of Japan. The patient was a nulliparous woman and treatment started at the age of 31. Therapy started in August 2009, and AIH was performed 6 times in total upto February 2011, but pregnancy was unsuccessful. After that, 19 oocytes were collected by controlled ovarian stimulation in April 2014. As a result of insemination of the collected oocytes, microPN (size: 9 μm) appeared in one of the ICSI-derived embryos, which was about one-third the size of the male and female pronuclei. Afterwards singleton vitrified-warmed embryo transfer in hormone replacement cycle was performed twice by July 2014. As a result of transferring micro PN-derived blastocyst (Gardner’s score 3AB) at the time of the second embryo transfer, a girl was born by Caesarean section at 38 weeks, and the weight was 3.02 kg, which was within the normal range of the growth curve of data from children in MHLW database. The height at one and a half years was 74.8 cm and the weight was 9.45 kg, which was within the normal range of the growth curve of the children by MHLW. At the age of three, she was 87 cm tall and weighed 13 kg. The height was slightly below the growth curve, but there were no other abnormalities in the child. Follow up from birth to age 3 years did not report any abnormalities or severe growth retardation in the infant.

Clinical characteristics of patients with polyarteritis nodosa based on a nationwide database in Japan.

This study aimed to clarify the epidemiological and clinical features and treatment of patients with polyarteritis nodosa (PAN) in Japan. We used the database of the Ministry of Health, Labour and Welfare (MHLW) of Japan in 2013 and 2014. We analysed 121 patients who were antineutrophil cytoplasmic antibodies negative among the patients certified as PAN according to the MHLW diagnostic criteria. The analysis included 60 males and 61 females, with a mean age of 52.9 ± 21.0 years. As a general manifestation, fever was observed in 53.7%. Regarding organ involvement, skin manifestations (82.6%), joint and muscle manifestations (75.2%), and neuropsychiatric manifestations (50.4%) were common. Male patients had a higher proportion of mononeuritis multiplex involving motor neuropathy than female patients. Elderly patients had a higher proportion of general and respiratory manifestations. Glucocorticoids were used for treatment in all patients, and 19.0% underwent methylprednisolone pulse. Concomitant immunosuppressants were used in 25.6%, one-third of whom received cyclophosphamide. Methylprednisolone pulse and cyclophosphamide were mostly used in patients with life-threatening organ involvement. PAN developed in middle-aged people and led to numerous clinical manifestations. The common manifestations varied with age, and treatment was determined based on the type of organ involvement and disease severity.