Objective: Pharmaceutical manufacturers conduct drug use-results surveys (DUSs) for drug reexamination applications in Japan. However, most DUSs are single-cohort studies to confirm drug safety; therefore little information is obtained from a DUS for safety comparison with other drugs. Integrating DUS data is a novel method to compare drug safety profiles among drugs. This study examined the usefulness of integrating DUS data.
Design: Active surveillance
Methods: We integrated DUS data obtained from two DUSs of antihypertensive drugs-a calcium channel blocker (CCB), azelnidipine (CalblockR), and an angiotensin-receptor blocker (ARB), olmesartan medoxomil (OlmetecR)-with similar study protocols. Both studies were conducted by the same pharmaceuticalcompany. Matching patients using propensity scores, we examined whether the DUS results could be applied to pharmacoepidemiology data resources for hypothesis strengthening. Safety outcomes included vasodilation-related events, which are typical adverse drug reactions (ADRs) to CCB. The incidence of safety outcomes was compared by conditional logistic regression models. Two definitions for safetuoutcomes were employed: definition 1, physician-reported adverse events; and definition 2, physicianreported ADRs.
Results: In a total of 7196 patients included in the analysis, the propensity-matched patients were well balanced. Most safety outcomes were detected in the CCB group including a significant increase in vasodilation-related events (odds ratio for definition 1 versus ARB group, 1.75; 95% confidence interval,1.01-3.03).
Conclusion: Integrated DUS data collated by pharmaceutical manufacturers following clear criteria are potentially useful to commence pharmacoepidemiology studies designed to strengthen hypotheses.

BACKGROUND/AIMS: Although mucosal healing (MH) has been considered a treatment goal for patients with ulcerative colitis (UC), the risk factors predictive of relapse in patients who achieve MH are unknown. Because the platelet count has been shown to be a marker of inflammation in inflammatory bowel diseases, this study aimed to assess whether the platelet count could predict relapse in UC patients with MH. METHODS: A prospective observational study was performed. UC patients with MH were consecutively enrolled in the study and monitored for at least 2 years or until relapse. The correlation between the incidence of relapse and the platelet count at the time of study enrollment was examined. RESULTS: In total, 43 patients were enrolled, and 14 patients (33%) relapsed. The median platelet count at the time of enrollment in the patients who relapsed significantly differed from that in the patients who did not relapse (27.2×104/μL vs 23.8×104/μL, respectively; p=0.016). A platelet count >25.0×104/μL was a significant risk factor for relapse based on a multivariate analysis (hazard ratio, 4.85; 95% confidence interval, 1.07 to 25.28), and according to the Kaplan-Meier analysis, this cutoff could identify patients susceptible to relapse (p=0.041, log-rank test). CONCLUSIONS: The platelet count could be used as a predictor of relapse in UC patients with MH.
Blood Platelets* ; Colitis ; Colitis, Ulcerative* ; Humans ; Incidence ; Inflammation ; Inflammatory Bowel Diseases ; Kaplan-Meier Estimate ; Multivariate Analysis ; Observational Study ; Platelet Count* ; Prospective Studies ; Recurrence* ; Risk Factors ; Ulcer*

BACKGROUND/AIMS: Both fecal immunochemical test (FIT) and fecal calprotectin (Fcal) results are useful biomarkers for ulcerative colitis (UC). However, the situations in which each marker should be used are largely unknown. METHODS: A total of 110 colonoscopy intervals of UC patients were assessed, and correlations between changes in colonoscopic findings and changes in the two aforementioned fecal markers were examined. RESULTS: Among patients with mucosal healing (MH) and negative FIT or Fcal results at the initial colonoscopy, FIT and Fcal findings exhibited accuracies of 93% (38/41) and 79% (26/33), respectively, for predicting the results of the subsequent examination. Among the 24 patients who showed endoscopic activity at the precedent colonoscopy and MH at the subsequent examination, positive-to-negative conversion of FIT and Fcal findings at the subsequent examination was observed in 92% (12/13) and 62% (8/13) of patients, respectively. Among the 43 patients who showed endoscopic activity at both the precedent and subsequent examinations, Fcal findings reflected the change in endoscopic activity better than FIT results (r=0.59, p<0.0001 vs r=0.30, p=0.054). CONCLUSIONS: The FIT is useful for confirming MH and the occurrence of relapse. In contrast, Fcal is useful for monitoring the mucosal status of patients with active inflammation.
Biomarkers ; Colitis ; Colitis, Ulcerative* ; Colonoscopy ; Humans ; Inflammation ; Leukocyte L1 Antigen Complex* ; Recurrence ; Ulcer*

A 3-month alcoholism rehabilitation program at psychiatric hospitals is common in Japan for patients with alcohol use disorder (AUD). However, many AUD patients are often hospitalized for the treatment of digestive disorders due to alcohol-related liver diseases and pancreatitis. In this sense, AUD patients need to be better supported by professionals and departments in general hospitals. Here we analyzed the problems in alcohol-related medical care in Japan and examined the measures to be taken at general hospitals.

Health support activities for residents were held three times during a period from June, 2016 to November, 2017. The residents registered in order to participate through 11 community pharmacies. Participant’s blood pressure values were measured at the venue of health support activities by pharmacists. The blood pressure values in 66 of the 106 participants were analyzed, excluding 40 participants receiving medical treatment. The rate of participants with hypertension, systolic blood pressure (SBP)≧140 mmHg or diastolic blood pressure (DBP)≧90 mmHg, was 32% (21／66). Of those with hypertension, 43% (9／21) had hypertension of a high risk level, SBP≧160 mmHg or DBP≧100 mmHg. Pharmacists provided lifestyle counseling and encouraged them to make changes in order to achieve tighter blood pressure control. The data of their blood pressure values were provided to community pharmacies for continuing support of their blood pressure control. With the pharmacist’s support, the median value of blood pressure of participants who had hypertension decreased in the second event. In addition, 50% (3／6) of participants who attended the second event with hypertension of high risk level, visited the hospital for a consultation with a doctor after getting pharmacist’s advice. These results indicate that greater access to community pharmacists improved blood pressure control of residents with hypertension. However, there were many residents who consider it difficult to use pharmacies without a prescription. Hence, friendly relationship to residents on their utilizing pharmacies is needed for providing them lifestyle counseling such as preventing hypertension by pharmacists.

The questionnaire was distributed to caregivers regarding their management for home medication therapy. The purpose of this questionnaire was to clarify the role of community pharmacists in city “Z”, Hiroshima in supporting this activity. The results were compared among seven administrative zones. The percentage of caregivers who had routinely administered medications to dependent patients was 81%. Of these, the percentage of caregivers who had encountered difficulty in medication administration to dependent patients was 66%. Only 13% of these caregivers had sought assistance from pharmacists in dealing with issues they faced in the administration of medications. The percentage of caregivers who had easy access to pharmacists was 44%. The percentage of caregivers who received pharmacist-initiated information about patients was 23%. Among the 7 administrative zones in city “Z”, the 2 zones (H-zones) with the highest percentage of elderly citizens, 38.7%, were compared with the other 2 zones (L-zones) with the lowest percentage of elderly citizens, 25.7%, regarding medication management by caregivers. It was observed that the frequency of missing side effects or crushing medicines by caregivers was higher in H-zones as compared to L-zones. The results of this research suggest that close cooperation between pharmacists and caregivers improves the quality of medication therapy management. In an aging society, pharmacist intervention could be very beneficial to providing support and information that would improve the quality of patients’ medication therapy.

The questionnaire was distributed to caregivers regarding their management for home medication therapy. The purpose of this questionnaire was to clarify the role of community pharmacists in city “Z”, Hiroshima in supporting this activity. The results were compared among seven administrative zones. The percentage of caregivers who had routinely administered medications to dependent patients was 81%. Of these, the percentage of caregivers who had encountered difficulty in medication administration to dependent patients was 66%. Only 13% of these caregivers had sought assistance from pharmacists in dealing with issues they faced in the administration of medications. The percentage of caregivers who had easy access to pharmacists was 44%. The percentage of caregivers who received pharmacist-initiated information about patients was 23%. Among the 7 administrative zones in city “Z”, the 2 zones (H-zones) with the highest percentage of elderly citizens, 38.7%, were compared with the other 2 zones (L-zones) with the lowest percentage of elderly citizens, 25.7%, regarding medication management by caregivers. It was observed that the frequency of missing side effects or crushing medicines by caregivers was higher in H-zones as compared to L-zones. The results of this research suggest that close cooperation between pharmacists and caregivers improves the quality of medication therapy management. In an aging society, pharmacist intervention could be very beneficial to providing support and information that would improve the quality of patients’ medication therapy.

Background: Cell blocks (CBs) from pleural fluid are frequently used in the practice of respiratory medicine, but there have been few reports on the use of CBs from forceps and brush washing fluid in bronchoscopy for pathological diagnosis. We retrospectively analyzed the usefulness of CBs from forceps and brush washing fluid. 　Patients and Methods: Patients who underwent bronchoscopy and had CBs made from forceps and brush washing fluid in bronchoscopy at our institution between June 2016 and May 2021 were included. Cases in which additional information was obtained from CBs were reviewed in detail. 　Results: In total, 138 patients had CBs made from forceps and brush washing fluid in bronchoscopy during the study period. EBUS-GS (endobronchial ultrasound-guide sheath) was used for 102 of these patients. The final diagnosis was lung cancer in 114 cases, infection disease in 10 cases, metastatic lung tumor in 8 cases, lymphoproliferative disease in 2 cases, sarcoidosis in 1 case, and organizing pneumonia in 1 case. There were 13 cases with additional information obtained from CBs, all of which were cases of malignant tumors. 　Conclusions: CBs from forceps and brush washing fluid in bronchoscopy were useful for pathological diagnosis in some cases.

As a screening tool for detecting latent pre-locomotive syndrome (latent pre-LS) in women over the age of 40, measuring handgrip strength with a cut-off value of 26 kg was proposed in a previous report. However, this screening method missed 22% of latent pre-LS. It would be beneficial to screen almost persons with latent pre-LS in community pharmacies. In this study, it was investigated whether screening using the combination of measuring handgrip strength and the questionnaire, “Loco-check,” which was proposed by the Japanese Orthopaedic Association, improved the detection of latent pre-LS in the same group mentioned above. Combining only one of the “Loco-check” questions, “I cannot put on a pair of socks while standing on one leg,” with the measurement of handgrip strength with the cut-off value of 26 kg, the detection of latent pre-LS was increased to 90.2%. The odds ratio was 9.72 in logistic regression analysis. Using the combination of the measurement of handgrip strength and the response to one question is both rapid and convenient. Therefore, in this study, this screening combination is proposed to be a useful tool in community pharmacies for detecting early latent pre-LS.

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is useful for diagnosing mediastinal lymph node lesions. Cell blocks prepared from the needle washing fluid and flow cytometry of tissue samples are helpful in making the diagnosis, but the combination of both examinations is not routinely performed. A 77-year-old woman with fever, dyspnea, and anorexia was admitted to our hospital. Computed tomography showed enlarged mediastinal lymph nodes with calcification and left ureteral calculus; however, no focus of infection was identified. We suspected lymph node tuberculosis or malignant lymphoma, and EBUS-TBNA was performed to evaluate the mediastinal lymph node lesions. Because a cell block prepared from the needle rinse fluid was suspicious for malignant lymphoma, we changed the puncture needle from 22 G to 19 G and performed a second EBUS-TBNA. Diffuse large B-cell lymphoma (DLBCL) was diagnosed based on the results of flow cytometry of the EBUS-TBNA samples. Here we report this case of DLBCL in which mediastinal lymph node tuberculosis was suspected and cell block preparation and flow cytometry using EBUS-TBNA specimens were useful for the diagnosis.