Preliminary study on the development of a system dynamics model: the case of EVAHEART

The Japanese medical device industry’s stagnation over the years can be attributed to the uncertainty related to device development. The purpose of this study is to identify the major factors that impact development. We studied the ventricular assist device EVAHEART through interviews with the persons involved and created a development model using system dynamics. There are at least six stages in the device development process, including interactions with academia and the government. Through a simulation and comparison to Novacor, it was determined that the satisfaction of academia leads to government action in the subsequent measures. Our trial simulation of EVAHEART suggests that it has the potential to clarify unclear relationships in the development of devices.     

Evaluation of bioartificial renal tubule device prepared with human renal proximal tubular epithelial cells cultured in serum-free medium

Bioartificial renal tubule devices (BTD) use cell therapy to improve conditions commonly observed in recipients of artificial kidneys for treatment of kidney diseases. We previously reported significant improvement of the condition of acute kidney injury (AKI) animals after treatment with BTD prepared with lifespan-extended human renal proximal tubular cells (hRPTEC). However, a major obstacle to use of BTD for patients is their biological safety, because hRPTEC are cultured in medium containing fetal calf serum. To establish the biological safety of BTD, we prepared BTD with lifespan-extended hRPTEC cultured in a newly developed serum-free medium and compared these with BTD prepared with hRPTEC cultured in serum-containing conventional medium. Lifespan-extended hRPTEC cultured in serum-free medium (hRPTEC-SFM) can proliferate similar to hRPTEC cultured in serum-containing conventional medium (hRPTEC-CM). Comparison of leakage and of reabsorption of small molecules for BTD prepared with hRPTEC-SFM (BTD-SFM) with those for our previous BTD prepared with hRPTEC-CM (BTD-CM) showed transportation in these two types of BTD was almost identical. When AKI goats were treated with BTD-SFM for 26 h, increase of survival time and reduction of cytokine expression in blood cells were almost same as for AKI goats treated with BTD-CM. Quantification of the expression of some genes of hRPTEC in BTD revealed significant changes during BTD treatment for AKI goats. In conclusion, lifespan-extended hRPTEC-SFM work as well as hRPTEC-CM, and the biological safety of BTD for patients could be elevated without loss of function by preparation from hRPTEC-SFM.     

Effects of progressive muscular relaxation and stretching exercises combination on blood pressure among farmers in rural areas of Indonesia: a randomized study

Objective: Maintaining blood pressure (BP) could improve the quality of life among farmers in agricultural health. The study aims to evaluate the effects of progressive muscular relaxation and stretching exercises (SEs) for BP in farmer subjects in rural areas.Methods: A randomized controlled design was applied for this study. We performed a method, which is the combination of progressive muscle relaxation (PMR) and SEs for participants (30 in the control group and 60 in the intervention group). The intervention group self-practiced PMR and SEs through a video that providing instructions for 15 min. PMR practiced before going to sleeping in the night,and SEs practiced before going to farms in the morning per day for 3-months. Wilcoxon signed-rank test was performed to measure the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP) as one pre- and post-test comparison of baseline and 3 months data in control and intervention groups.Results: There were no significant differences between SBP and DBP pre- and post-test in control group (P > 0.050). Meanwhile, there were significant differences in reducing SBP (M = 126.67; SD = 18.07; 95％ CI = 120–147.5 mmHg) and DBP (M = 80.67; SD = 6.91;95％ CI = 80–90 mmHg) pre- and post-test combination of PMR and SEs in intervention group (P < 0.001). After 3-months of followup data, number type SBP and DBP still remained at the same levels of baseline and 3-month data in control group. While, there was an increased number of normal and prehypertension for SBP and DBP (10％ vs. 10％ and 20％ vs. 31.6％) and reduced of hypertension stage I for SBP and DBP (30％ vs. 41.6％).Conclusions: This pilot study demonstrated effectively to reduce SBP and DBP among farmers using the combination of PMR and SEs in the agricultural health setting.     

Laparoscopy-assisted repair with Ventralex ST Hernia Patch for a small subcostal hernia: A case report

A 55-year-old woman with a history of right hepatic lobectomy via a Benz incision presented for evaluation of a new abdominal bulge in the right upper quadrant. We diagnosed an incisional hernia, but because we could neither reduce the hernia contents nor locate the orifice, we performed a laparoscopic evaluation. Laparoscopy revealed subcostal herniation of the greater omentum via a 2-cm defect on the caudal side of the right ribs, which we repaired using a Ventralex ST Hernia Patch. Laparoscopic placement of this mesh with straps allowed for reliable deployment, fixation, and confirmation of defect closure, including the cranial aspect—often a major challenge in subcostal hernia repair.     

Efficacy,safety, and pharmacokinetics of oral valganciclovir in patients with congenital cytomegalovirus infection

ObjectivesValganciclovir (VGCV) has been shown to improve sensorineural hearing loss (SNHL) and neurological outcomes in patients with neonatal symptomatic congenital cytomegalovirus (cCMV) infection. However, reports on the pharmacokinetics, efficacy and safety of oral VGCV are limited. The aim of this study is to evaluate the pharmacokinetics of VGCV for use in the treatment of cCMV.MethodsThis was a single-center, retrospective observational study conducted at Saitama Children's Medical Center in Japan between 2012 and 2017. CMV DNA copy number, maximum plasma VGCV concentration (Cmax), and adverse events (ADEs) during treatment were evaluated.ResultsA total of 26 patients with cCMV who received VGCV were included in this study. The median age at VGCV initiation was 9.5 months (range 0–46). Twenty-one patients (81%) had SNHL at baseline. Of these, five patients (19%) presented with improved SNHL, and none experienced worsened SNHL during treatment. The mean VGCV Cmax was 3.5 μg/mL (range 2–5.3), with no significant variation among individual values, and the values were maintained during treatment. Furthermore, there were no correlations between the Cmax values and age, sex, SNHL improvement or ADEs. Neutropenia (<1000/mm³) was observed in six patients (23%); however, no serious ADEs occurred.ConclusionsVGCV prevented the progression of SNHL without serious ADEs due to its stable pharmacokinetics. This study provides safety and tolerability of VGCV for the treatment of cCMV patients.     

The optimal trough-guided monitoring of vancomycin in children: Systematic review and meta-analyses

We carried out a systematic review and meta-analysis exploring the relationship between vancomycin (VCM) trough concentrations and its effectiveness and nephrotoxicity in pediatric patients. We conducted our analysis using MEDLINE, Web of Sciences, and Cochrane Register of Controlled Trials as electronic databases (June 29, 2019). Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated. We identified 16 studies that were eligible for the meta-analysis. A total of 351 and 3,266 patients were included in the analysis for effectiveness and nephrotoxicity, respectively. Pediatric MRSA infection patients with VCM trough concentrations ≥ 10 μg/mL had significantly lower treatment failure rates (OR 0.54, 95% CI 0.30–0.96). The incidence of nephrotoxicity was significantly higher in trough concentrations ≥ 15 μg/mL than when they were < 15 μg/mL (OR 3.02, 95% CI 2.08–4.38). We identified the optimal VCM trough concentrations associated with effectiveness and nephrotoxicity in pediatric patients with MRSA infection. Further prospective studies are needed to find optimal dosing and monitoring strategy on VCM in pediatric population.     

Evaluation of four commercial severe acute respiratory coronavirus 2 antibody tests

IntroductionNumerous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serological tests exists commercially; however, their performance using clinical samples is limited. Although insufficient to detect SARS-CoV-2 in the early phase of infection, antibody assays can be of great use for surveillance studies or for some coronavirus disease 2019 (COVID-19) patients presenting late to the hospital.MethodsThis study evaluated the sensitivity and specificity of four commercial SARS-CoV-2 lateral flow antibody tests using 213 serum specimens from 90 PCR-positive confirmed COVID-19 patients. Of 59 negative control sera, 50 were obtained from patients with other respiratory infectious diseases before COVID-19 pandemic began while nine were from patients infected with other respiratory viruses, including two seasonal coronaviruses.ResultsThe varied sensitivities for the four commercial kits were 70.9%, 65.3%, 45.1%, and 65.7% for BioMedomics, Autobio Diagnostics, Genbody, and KURABO, respectively, between sick days 1 and 155 in COVID-19 patients. The sensitivities of the four tests gradually increased over time after infection before sick day 5 (15.0%, 12.5%, 15.0%, and 20.0%); from sick day 11–15 (95.7%, 87.2%, 53.2%, and 89.4%); and after sick day 20 (100%, 100%, 68.6%, and 96.1%), respectively. For severe illness, the sensitivities were quite high in the late phase after sick day 15. The specificities were over 96% for all four tests. No cross-reaction due to other pathogens, including seasonal coronaviruses, was observed.ConclusionsOur results demonstrated the large differences in the antibody test performances. This ought to be considered when performing surveillance analysis.     

Role of endoscopic ultrasound for gallbladder disease

Journal of Medical Ultrasonics - Endoscopic ultrasonography (EUS) has excellent spatial resolution and allows more detailed examination than abdominal ultrasonography (US) in terms of qualitative...     

A Single Case of Single-Port Access Laparoscopic Appendectomy During the Puerperium

Laparoscopic appendectomy is now widely practiced for the treatment of acute appendicitis. As result of increased demand for minimally invasive surgery, single-incision access was introduced and is being performed in various abdominal surgeries. Conventional laparoscopic appendectomy (LA) is gradually being performed in pregnant women. A 33-year-old woman was referred to our department at 39 weeks and 1 day of gestation due to abdominal pain. She was aware of her gastroepiploic pain even after the delivery. Though it was past 2 days, she was not recovering from right lower abdominal pain, so she was transferred to the Department of Gynecology at our hospital on the same day. Although an antibiotic was administered, the right abdominal pain did not improve, and she was referred to our department from the Department of Gynecology. We performed single-port LA (SP-LA). The total operation time was 63 minutes, and the estimated blood loss was 0 mL. She was discharged with no complications on postoperative day 7. We report our initial experience with single-port LA (SP-LA) using the glove technique for treatment of acute appendicitis in a postpartum woman. SP-LA using the glove technique was performed successfully during the puerperium without prolongation of operation time. This approach is less invasive, offers a much better cosmetic result than with conventional methods, and can be performed safely and at low cost.Key words: PLA (single-port laparoscopic appendectomy), PuerperiumThe advantages of laparoscopic appendectomy (LA) over open appendectomy (OA) are widely known and include decreased pain, shorter convalescence, and earlier return to work. Especially, LA is advantageous for treating acute appendicitis in pregnant women. Because the appendix of a pregnant woman is shifted from its normal position, OA may leave a larger operative scar than normal. In recent years, efforts of laparoscopic surgeons have resulted in a reduction in both the diameter of the access ports and the number of ports needed.¹ In addition, natural orifice transluminal endoscopic surgery (NOTES) is being developed as another form of minimally invasive surgery.² As a part of this process, the single-incision laparoscopic surgery (SILS) technique is presently being developed for various laparoscopic surgeries.³ SILS is a virtually scarless technique in which the single-port access site is hidden in the umbilicus. We think that the primary advantage of single-port laparoscopic appendectomy (SP-LA) is the superior cosmetic result compared with multi-port access LA. We report a very rare case in which SP-LA was performed to treat acute appendicitis during the puerperium. This approach is less invasive, offers a much better cosmetic result than with conventional methods, and can be performed safely and at low cost.