BACKGROUND: An increased prevalence of cleft lip and/or palate (CL/P), a major congenital anomaly, has been observed in the offspring of women with elevated body mass index (BMI) before pregnancy. Likewise, gestational comorbidities, such as hypertension and diabetes mellitus, also increase the risk of CL/P; however, the risk linked to the coexistence of these conditions in women with higher BMI on birth prevalence of CL/P remains unclear. This study focused on the combined effects of a high BMI before pregnancy and gestational comorbidities on the birth prevalence of CL/P. METHODS: Among 98,373 live births from the Japan Environment and Children's Study (JECS), a nationwide birth cohort, 255 mothers of infants with CL/P (74, 112, and 69 infants born with cleft lip, cleft lip and palate, and isolated cleft palate, respectively) were included in the analyses. The association of CL/P birth prevalence with pre-pregnancy BMI and gestational comorbidities (hypertension and diabetes) was examined using multivariate logistic regression analyses after multiple imputations, with adjustments for several maternal (age at delivery, smoking habits, and alcohol intake) and child-related (sex and prevalence of other congenital diseases) variables, obtained through medical record transcriptions and self-reports on JECS transcription forms. RESULTS: Higher prevalence rates of overweight, gestational hypertension, and gestational diabetes mellitus were found in mothers of infants with CL/P (16.1%, 6.3%, and 4.7%, respectively) than in the control group (10.4%, 3.1%, and 3.1%, respectively). The odds ratio [95% confidence interval] for childbirth with CL/P was increased in mothers with high BMI before pregnancy (1.58 [1.11-2.24]). Furthermore, gestational hypertension and diabetes coexisting with high BMI additionally increased the odds ratios for childbirth with CL/P (2.91 [1.28-6.61] and 2.12 [0.87-5.19], respectively). CONCLUSION High maternal BMI, particularly when accompanied by gestational hypertension, was significantly associated with an increased prevalence of childbirth with CL/P.
Humans ; Female ; Cleft Lip/etiology* ; Cleft Palate/etiology* ; Pregnancy ; Japan/epidemiology* ; Prevalence ; Body Mass Index ; Adult ; Male ; Infant, Newborn ; Comorbidity ; Diabetes, Gestational/epidemiology* ; Risk Factors ; Young Adult ; Birth Cohort

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.

Methods: This prospective, single-arm study included 11 patients (eight men; mean age, 62.7 years) with ≥3-months’ chronic pain history due to lumbar disease. Subcutaneous TCZ injections were administered twice, at a 2-week interval. We evaluated low back pain, leg pain, and leg numbness using numeric rating scales and the Oswestry Disability Index (ODI; baseline and 6 months postinjection); serum IL-6 and tumor necrosis factor-α levels (baseline and 1 month postinjection); and clinical adverse events. Results: Intractable symptoms reduced after TCZ administration. Low back pain improved for 6 months. Improvements in leg pain and numbness peaked at 4 and 1 month, respectively. Improvements in ODI were significant at 1 month and peaked at 4 months. Serum IL-6 was increased at 1 month. IL-6 responders (i.e., patients with IL-6 increases >10 pg/mL) showed particularly significant improvements in leg pain at 2 weeks, 1 month, and 2 months compared with nonresponders. We observed no apparent adverse events. Conclusions Systemic TCZ administration improved symptoms effectively for 6 months, with peak improvements at 1–4 months and no adverse events. Changing serum IL-6 levels correlated with leg pain improvements; further studies are warranted to elucidate the mechanistic connections between lumbar disorders and inflammatory cytokines.

Purpose: In this multicenter retrospective observational study, we examined the early effects of romosozumab in patients with severe osteoporosis in terms of time-course changes in bone metabolism marker, improvement in bone density, and adverse effects. Materials and Methods: Patients with severe osteoporosis were included. We investigated the progress of TRACP 5b and P1NP before and 1–2 months after the administration of romosozumab. We also investigated the bone density of lumbar spine, femoral neck, and the entire femur, measured by the DXA method, before and 5–7 months after the administration of romosozumab. Results: A total of 70 patients (7 males and 63 females, age 75.0±3.6 years) participated in this study. Significant improvements in TRACP 5b and P1NP levels were observed before and 1–2 months after romosozumab administration. The average bone density of lumbar spine, femoral neck, and the entire femur were measured before and 5–7 months after romosozumab administration;and a significant increase only observed in the lumbar spine. Conclusion Consistent with the findings of previous clinical studies, romosozumab has both bone formation-enhancing and bone resorption effects (dual effect). In addition, romosozumab also demonstrated improvement in bone density from the early phase after the administration, though the result was only seen in the lumbar spine.

Purpose: In this multicenter retrospective observational study, we examined the early effects of romosozumab in patients with severe osteoporosis in terms of time-course changes in bone metabolism marker, improvement in bone density, and adverse effects. Materials and Methods: Patients with severe osteoporosis were included. We investigated the progress of TRACP 5b and P1NP before and 1–2 months after the administration of romosozumab. We also investigated the bone density of lumbar spine, femoral neck, and the entire femur, measured by the DXA method, before and 5–7 months after the administration of romosozumab. Results: A total of 70 patients (7 males and 63 females, age 75.0±3.6 years) participated in this study. Significant improvements in TRACP 5b and P1NP levels were observed before and 1–2 months after romosozumab administration. The average bone density of lumbar spine, femoral neck, and the entire femur were measured before and 5–7 months after romosozumab administration;and a significant increase only observed in the lumbar spine. Conclusion Consistent with the findings of previous clinical studies, romosozumab has both bone formation-enhancing and bone resorption effects (dual effect). In addition, romosozumab also demonstrated improvement in bone density from the early phase after the administration, though the result was only seen in the lumbar spine.

Background : This study was performed to evaluate surgical outcomes after cardiovascular surgery (including urgent surgery) in patients 85 or older. Methods : A retrospective analysis was performed on 39 patients (mean age, 86.3 years ; age range, 85-90 years) who underwent total arch replacement (n=4), ascending aorta replacement (n=4), descending aorta replacement (n=1), aortic valve replacement (AVR ; n=13), mitral valve replacement or valvuloplasty (n=3), coronary artery bypass grafting (CABG ; n=9), CABG+AVR (n=4), tumor resection (n=1) between June 2008 and December 2012 at Dokkyo Medical University Hospital. Results : Six hospital deaths occurred. One patient died due to bleeding from a ruptured descending thoracic aortic aneurysm, and another patient died due to gastrointestinal perforation from non-occlusive mesenteric ischemia (NOMI) after urgent AVR. The other deaths were related to various complications, including lung cancer, cholecystitis, myocardial infarction, and Takotsubo cardiomyopathy, during the postoperative period. Overall 30-day mortality was 2.6%, hospital mortality was 12.8%, duration of hospital stay after surgery was 41.3 days, duration of intensive care unit (ICU) stay was 3.8 days and ventilator time was 49.1 h. Twenty patients underwent elective surgery, and 19 patients underwent urgent surgery. The two groups had similar preoperative characteristics, except for the number of patients with aortic disease. No significant difference was evident in hospital mortality (26.3% vs. 5%, p=0.065) or 30-day mortality (0% vs. 5.3%, p=0.3) when comparing the two groups. However, the duration of hospital stay (58.9 days vs. 27.5 days, p=0.049), ICU stay (6.74 days vs. 1.05 days, p=0.002) and ventilator time (89.9 h vs. 8.2 h, p=0.006) was significantly longer in the urgent surgery group than in the elective surgery group. Fourteen patients (70%) in the elective surgery group and four patients (21.1%) in the urgent surgery group were able to be discharged from the hospital to their homes within 30 days after surgery. These data demonstrated that cardiovascular surgery in patients 85 years of age or older was associated with satisfactory outcomes, and outcomes associated with elective surgery were even better than those associated with urgent surgery. Conclusions : Therefore, advanced age does not represent a contraindication of conventional cardiovascular surgery. Rather, the decision for surgery should take the patient's preoperative condition, the severity of concurrent medical disease, the wishes of the patient, and the predicted functional outcomes into account.