Objective: The drug use-results survey of Metronidazole gel (Rozex® gel 0.75%: hereinafter, this is called “this medicine”) was conducted for the purpose of assessing the safety and effectiveness of this medicine in clinical practice including long-term use. Methods: Patients who initiated treatment with this medicine for sterilization and reduction of odor at cancerous skin ulcer for the first time were registered by the central registration method. The longest period of observation was 1 year. Results: The safety analysis set included 301 patients. The incidence proportion of adverse drug reaction was 3.32% (in 10 of 301 patients), with no serious events. The overall improvement rate was 73.7% (in 205 of 278 patients). At the final observation, the improvement rate of odor by physician's assessment was 80.2% (in 203 of 253 patients) and the improvement rate of patient's satisfaction was 70.1% (in 82 of 117 patients), respectively. Conclusion: The present study demonstrated that this medicine is safe and effective for sterilization and reduction of odor at cancerous skin ulcer, and leads to high treatment satisfaction of patients.

Background/Aims: Crohn’s disease is a chronic disorder; therefore, it is essential to investigate long-term safety and efficacy of treatments. This study assessed the safety and effectiveness of adalimumab for up to 3 years in Japanese patients with Crohn’s disease in real-world settings. Methods: This was a multicenter, single-cohort, observational study of patients with Crohn’s disease. Safety assessments included incidence of adverse drug reactions. Effectiveness assessments included clinical remission, mucosal healing, and Work Productivity and Activity Impairment (WPAI). Results: The safety and effectiveness analysis populations comprised 389 and 310 patients, respectively. Mean (standard deviation) exposure to adalimumab in the safety analysis population was 793.4 (402.8) days, with a 58.1% retention rate. A total of 105 patients (27.0%) and 43 patients (11.1%) experienced adverse drug reactions and serious adverse drug reactions, respectively, with no patient reporting tuberculosis or hepatitis B. Infections and serious infections were reported in 37 patients (9.5%) and 17 patients (4.4%), respectively. Malignancy was reported as an adverse drug reaction in 2 patients (0.5%). Remission rate increased from 37.8% (98/259) at baseline to 73.9% (167/226) at week 4 and remained > 70% over 3 years. Proportion of patients without mucosal ulcerations increased from 2.7% (2/73) at baseline to 42.3% (11/26) between years > 2 to ≤ 3. WPAI improvement started at 4 weeks, with the overall work impairment score improving from 42.7 (n = 102) at baseline to 26.9 (n = 84) at 4 weeks. Conclusions Results from this study confirm the long-term safety and effectiveness of adalimumab treatment in Japanese patients with Crohn’s disease in the real-world setting.

Papua New Guinea (PNG) is one of the Pacific island countries facing a noncommunicable disease (NCD) crisis. Little has been reported about rehabilitation services for them. This study aimed to describe the characteristics of inpatients with the four major NCDs receiving rehabilitation services in PNG: cardiovascular disease (CVD) (divided into cerebrovascular disease and ischaemic heart disease), diabetes, cancer and respiratory disease. We conducted a subanalysis of our previous study. We reviewed the inpatient records of all inpatients (12,241 records, Total group) and those of inpatients receiving rehabilitation services by physical therapy (PT) (350 records, PT group). After extracting the records of patients with NCDs, we investigated the demographic data, diagnostic data and gait function. We calculated the percentages of inpatients’ characteristics and the ratio of the number of inpatients in the PT group to that in the Total group by diagnosis (PT ratio). The final analysis included 442 records in the Total group and 68 records in the PT group. Diagnoses and percentages in the PT group were cerebrovascular disease (65%), diabetes (22%), cancer (9%), respiratory disease (4%) and ischaemic heart disease (0%). The PT ratio was the highest in cerebrovascular disease (0.88), followed by diabetes (0.16) and other diagnosis (≤0.05). The inpatients with cerebrovascular disease and diabetes were more likely to have poor gait function than those with other NCDs. Our findings suggested that the provision of rehabilitation services for inpatients with the four NCDs was limited and biased for specific conditions. For development of rehabilitation services for patients with NCDs in PNG, scaling up the service provision and expanding its scope would be a possible way forward

Objective: Papua New Guinea (PNG) is the largest of the Pacific Island countries that is facing challenges related to the burden of cerebrovascular disease. There are few reports on rehabilitation services for inpatients with cerebrovascular disease, including stroke. This study aimed to examine the provision of rehabilitation services, physical therapy (PT) and service outcomes in PNG. Methods: A sub analysis of our previous retrospective observational study at a single provincial hospital in PNG was conducted in which patient records of all inpatients (Total group, n = 12,241) and those of inpatients receiving rehabilitation services (PT group, n = 350) were reviewed, and the records of inpatients with cerebrovascular disease were extracted for analysis. For descriptive purposes, demographic data, service provision statistics (length of hospital stay and duration and frequency of PT services provided) and gait function were summarized. Results: The final analysis comprised 50 of 12,241 records in the Total group and 34 of 350 records in the PT group. All of these studied patients suffered a stroke. The dominant age in both groups was ≥40 years. The median length of stay in hospital was 9 days in the Total group. The median frequency and duration of PT services were 4 times and 8.5 days, respectively. Of the 34 inpatients in the PT group, 32 (94%) were discharged with poor gait function defined as ‘dependent or no walking function’. Conclusions: The results implied that stroke patients who were discharged with poor gait function and restarted their life in the community would confront significant barriers and challenges in PNG. This first report, to our knowledge, on rehabilitation services for stroke in PNG may provide a reference point for further clinical research.

Lentinula edodes mycelia extract has been reported to maintain and improve immune function and QOL in cancer patients. In this study, the effects of Lentinula edodes mycelia extract on immune function were investigated in 10 healthy volunteers. Ten subjects were administrated Lentinula edodes mycelia extract orally for 20 weeks on average (846 mg / day ), and the immunological function (IFNγ production amount, IL-10 production amount, lymphocyte subset)was evaluated before and after ingestion at Fukuoka Tenjin Southern Clinic. Immune function following ingestion of Lentinula edodes mycelia extract showed a tendency of IFNγ production to increase, IL - 10 to decrease, and IFNγ / IL - 10 production ratio to be improved remarkably. No significant change was observed in lymphocyte subsets such as regulatory T cells before and after ingestion. Adverse events during the intake period were not observed. It was suggested that oral intake of Lentinula edodes mycelia extract has an action to improve the immune function of healthy adults.

BACKGROUND/AIMS: Decreased trough levels of infliximab (TLI) and antibodies to infliximab (ATI) are associated with loss of response (LOR) in Crohn's disease. Two prospective studies were conducted to determine whether TLI or ATI better correlates with LOR (Study 1), and whether TLI could become a predictor of mucosal healing (MH) (Study 2). METHODS: Study 1 was conducted in 108 patients, including those with LOR and remission to compare ATI and TLI in discriminating the 2 conditions based on receiver operating characteristic (ROC) curve analyses. Study 2 involved 35 patients who were evaluated endoscopically. RESULTS: In Study 1, there were no differences between the 2 assays in ROC curve analyses; the TLI cutoff value for LOR was 2.6 µg/mL (sensitivity, 70.9%; specificity, 79.2%), and the ATI cutoff value was 4.9 µg/mL (sensitivity, 65.5%; specificity, 67.9%). The AUROC (area under the ROC curve) of TLI was greater than that of ATI. AUROC was useful for discriminating between the 2 conditions. In Study 2, the TLI was significantly higher in the colonic MH group than in the non-MH group (2.7 µg/mL vs. 0.5 µg/mL, P=0.032). CONCLUSIONS: TLI is better than ATI for clinically diagnosing LOR, and a correlation was observed between TLI and colonic MH.
Antibodies ; Cohort Studies* ; Colon ; Crohn Disease* ; Humans ; Infliximab* ; Prospective Studies* ; ROC Curve ; Sensitivity and Specificity

BACKGROUND/AIMS: Colonic diverticular hemorrhage (DH) was a rare disease until the 1990s, and its incidence has increased rapidly since 2000 in Japan. In recent years, colonic DH has been the most frequent cause of lower gastrointestinal bleeding (LGIB). Nearly all cases of DH are mild, with the bleeding often stopping spontaneously. Some cases, however, require surgery or arterial embolization. In this study, using a cohort at Fukuoka University Chikushi Hospital, we investigated factors associated with severe colonic DH. METHODS: Among patients with LGIB who underwent colonoscopy at our hospital between 1995 and 2013, DH was identified in 273 patients. Among them, 62 patients (22.7%) were defined as having severe colonic DH according to recurrence of bleeding in a short period, and/or the necessity of transfusion, arterial embolization, or surgery. We then evaluated risk factors for severe DH among DH patients in this retrospective cohort. RESULTS: Among the 273 patients with DH, use of non-steroidal anti-inflammatory drugs (NSAIDs) (odds ratio [OR], 2.801; 95% confidence interval [CI], 1.164–6.742), Charlson Risk Index (CRI) ≥2 (OR, 3.336; 95% CI, 1.154–7.353), right-sided colonic DH (OR, 3.873; 95% CI, 1.554–9.653), and symptoms of cerebral hypoperfusion (such as light-headedness, dizziness, or syncope) (OR, 2.926; 95% CI, 1.310–6.535) showed an increased risk of severe DH even after controlling for other factors. CONCLUSIONS: Severe DH occurred in 23% of DH patients, and NSAID use, CRI ≥2, right-sided colonic DH, and symptoms of cerebral hypoperfusion are suggested to be predictors of severe DH.
Anti-Inflammatory Agents, Non-Steroidal ; Cohort Studies ; Colon* ; Colonoscopy ; Dizziness ; Hemorrhage* ; Humans ; Incidence ; Japan ; Rare Diseases ; Recurrence ; Retrospective Studies ; Risk Factors*

BACKGROUND/AIMS: Anti-tumor necrosis factor drugs (anti-TNF) and thiopurines are important treatment options in patients with inflammatory bowel disease (IBD), including during pregnancy. However, there are limited data on the benefit/risk profile of anti-TNF and thiopurines during pregnancy in Asia. The aim of this study was to analyze pregnancy outcomes of female Japanese IBD patients treated with anti-TNF and/or thiopurines. METHODS: This cross-sectional study assessed pregnancy outcomes in 72 women with IBD. Pregnancy outcomes were compared among 31 pregnancies without exposure to infliximab (IFX), adalimumab (ADA), or thiopurines; 24 pregnancies with exposure to anti-TNF treatment (23 IFX, 1 ADA); 7 pregnancies with exposure to thiopurines alone; and 10 pregnancies with exposure to both IFX and thiopurines. RESULTS: Thirty-five of the 41 pregnancies (85.3%) that were exposed to anti-TNF treatment and/or thiopurines resulted in live births after a median gestational period of 38 weeks. Of the 35 live births, 3 involved premature deliveries; 7, low birth weight; and 1, a congenital abnormality. There were 6 spontaneous abortions in pregnancies that were exposed to anti-TNF treatment (17.7%). Pregnancy outcomes among the 4 groups were similar, except for the rate of spontaneous abortions (P =0.037). CONCLUSIONS: Exposure to anti-TNF treatment or thiopurines during pregnancy was not related to a higher incidence of adverse pregnancy outcomes in Japanese IBD patients except for spontaneous abortion.
Adalimumab ; Abortion, Spontaneous ; Asia ; Asian Continental Ancestry Group ; Congenital Abnormalities ; Cross-Sectional Studies ; Female ; Humans ; Incidence ; Infliximab ; Infant, Low Birth Weight ; Infant, Newborn ; Inflammatory Bowel Diseases* ; Japan* ; Live Birth ; Necrosis* ; Pregnancy ; Pregnancy Outcome* ; Pregnancy*

Objective: The purpose of this study was to confirm the effect of feeding Okara fermented by Bacillus coagulans on cecum microflora in rat. Method: Three groups of SD rat of 8 weeks old were used in the experiment. The experimental animals were fed control diet, 2% okara diet, 2% fermented okara diet in each group for two weeks. The experimental diet and water were provided ad libitum. Food intake was measured every day. After 24 hours fast, we performed drawing blood with heparin after the experimental period. After drawing blood, several organs were removed for measuring their weight. In addition, we removed cecum after drawing blood about each three groups and studied their microflora. We also measured about plasma albumin, ALT, AST, ALP, LDH, total cholesterol, triacylglycerol, glucose, and cytokine level. Result: Bifidobacteria of cecum and blood IFN-g levels significantly increased in the fermented okara group. The total cholesterol level in blood significantly decreased. Conclusion: Okara fermented by Bacillus coagulans had an influence on not only intestinal microflora but also the immune system in rat, suggesting that the fermented okara can expect development as functional materials.

A-75-year-old man had refractory late cardiac tamponade after an off-pump coronary artery bypass grafting. He was initially treated by pericardiocentesis with oral nonsteroidal anti-inflammatory drugs, but the treatment failed. Pericardial fenestration was conducted twice for refractory pericardial effusion during his hospitalization. He presented again with recurrence of cardiac tamponade 2 months after the last pericardial fenestration. Therefore, a pleuroperitoneal shunt system was implanted. He recovered well and was discharged without reaccumulation of pericardial effusion.