Objective: Treatment of tinea unguium with topical drugs alone is difficult, and medication with oral terbinafine hydrochloride is necessary in many cases.  Since Trychophyton infects the nails in not only men but also women at a reproductive age, the influence on a fetus of the drug ingested during early pregnancy is a matter of concern of many women.  The objective of this study was to investigate the influence of oral terbinafine hydrochloride on fetuses.
Methods: The outcomes were investigated in pregnant women who ingested terbinafine hydrochloride and visited the ‘Outpatient Services for Consultation on Pregnancy and Drugs (Teratology Information Services)’ of Toranomon Hospital, and cases were collected.
Results: Fifteen pregnant women ingested the drug during the organogenic period, in which the teratogenic risk is the highest.  All 15 pregnant women gave birth to healthy babies.
Conclusion: This is the first survey concerning newborns delivered by women who ingested terbinafine hydrochloride during pregnancy in Japan.  All investigated women gave birth to healthy babies, and the incidence of congenital abnormalities did not markedly exceed that in the general population.  Since the number of cases was small, it is necessary to perform a cohort study to investigate details of the safety for fetuses.

Objective: Novel antipsychotic agents less frequently cause extrapyramidal side effects compared to conventional antipsychotic agents, contributing to improvement in the QOL.  Recently, these agents have also been increasingly prescribed to females who may become pregnant.  In Japan, no epidemiological survey regarding the application of novel antipsychotic agents in pregnant women has been published.  In this study, we investigated the influence on fetuses in pregnant women receiving novel antipsychotic agents.
Methods: In pregnant women on novel antipsychotic agents who consulted the Pregnancy and Drug Consultation Outpatient Clinic of Toranomon Hospital, the outcome of pregnancy was confirmed.
Results: Twenty-nine pregnant women took novel antipsychotic agents in the organogenesis phase, in which the risk of teratogenicity is the highest.  The agents consisted of olanzapine in 8 patients, risperidone in 11, quetiapine fumarate in 7, and perospirone hydrochloride hydrate in 4.  The outcomes of pregnancy were full-term delivery in 24 patients, premature delivery in 1, spontaneous abortion in 2, and artificial abortion in 2.  Of the 29 patients, 15 (60%) had continuously taken these agents until delivery.  All 25 neonates were healthy without malformation.
Conclusion: This report describes the first prospective survey in Japan regarding infants delivered by pregnant women receiving novel antipsychotic agents.  All patients delivered healthy neonates; the incidence of congenital anomalies did not exceed that in the general population.  This survey included a small number of patients; cohort studies should be conducted to evaluate the safety in fetuses.

With an increasing number of patients suffering from chronic renal failure, the question of how to prolong the period before starting hemodialysis therapy has been attracting great attention. Kremezin^® and Daio-Kanzo-To, which have been reported to produce good clinical results, were administered to two patients with chronic renal failure in the preservation phase. When the treatment started, renal function tended to deteriorate, and hemodialysis had to be introduced in both patients. We investigated possible causes of this deterioration, and the effect of the combined use of Kremezin^® and Daio-kanzo-To the renal function could not be denied. This combination therapy needs to be studied very carefully.

Background/Aims: Covered self-expandable metallic stents (CMSs) are widely used for malignant distal biliary obstructions (MDBOs) caused by pancreatic carcinoma. This study compared the efficacy and safety of the laser-cut-type and braided-type CMSs. Methods: To palliate MDBOs caused by pancreatic carcinoma, the laser-cut-type CMSs was used from April 2014 to March 2017, and the braided-type CMSs was used from April 2017 to March 2019. The tested self-expandable metallic stents were equipped with different anti-migration systems. Results: In total, 47 patients received CMSs for MDBOs (24 laser-cut type, 23 braided-type). The time to recurrent biliary obstruction (TRBO) was significantly longer in the braided-type CMSs (p=0.0008), and the median time to stent dysfunction or patient death was 141 and 265 days in the laser-cut-type CMSs and braided-type CMSs, respectively (p=0.0023). Stent migration was the major cause of stent dysfunction in both groups, which occurred in 37.5% of the laser-cut-type CMSs and 13.0% of the braidedtype CMSs. There were no differences in the survival duration between the groups. Conclusions The TRBO was significantly longer for the braided-type CMSs with an anti-migration system than for the laser-cuttype. Stent migration tended to be less frequent with the braided-type CMSs than with the laser-cut-type CMSs.

BACKGROUND AND AIMS: We previously reported the comparable efficacy of bi-monthly hepatic arterial infusion chemotherapy (B-HAIC) to that of sorafenib chemotherapy for the treatment of advanced hepatocellular carcinoma (aHCC) in patients with compensated cirrhosis. In this study, we demonstrate the efficacy of B-HAIC in patients with decompensated cirrhosis.METHODS: Forty-five patients with aHCC refractory to transcatheter arterial chemo-embolization (TACE) were treated with B-HAIC and were divided into two groups according to hepatic functional reserve (Child-Pugh grade). Overall survival period, treatment response, and adverse events in each group were analyzed.RESULTS: Efficacy and disease control rates in the Child-Pugh B group (n=24; 21% and 71%, respectively) were not significantly impaired compared the Child-Pugh A group (n=21; 38% and 67%, respectively). Median survival time and survival rate at 12 months in the Child-Pugh B group were 422 days and 58.3%, respectively, whereas those in the Child-Pugh A group were 567 days and 70.8%, respectively. Importantly, the hepatic functional reserve of patients did not worsen in either group during the treatment period. Furthermore, the occurrence rate of adverse events leading to discontinuation of anti-tumor treatment was not significantly increased in the Child-Pugh B group.CONCLUSIONS: Given the preservation of hepatic functional reserve afforded by B-HAIC chemotherapy in patients with decompensated cirrhosis, B-HAIC might be an acceptable alternative strategy for aHCC patients who do not respond to TACE.
Carcinoma, Hepatocellular ; Cisplatin ; Drug Therapy ; Fibrosis ; Humans ; Liver Cirrhosis ; Survival Rate

BACKGROUND/AIMS: L-carnitine not only alleviates hyperammonemia and reduces muscle cramps in patients with liver cirrhosis, but also improves anemia in patients with chronic hepatitis and renal dysfunction. This study prospectively evaluated the preventative efficacy of L-carnitine supplementation against hemolytic anemia during antiviral treatment using ribavirin in patients with hepatitis C virus (HCV)-related chronic liver disease. METHODS: A total of 41 patients with chronic hepatitis were consecutively enrolled in this study. Group A (n=22) received sofosbuvir plus ribavirin for 3 months, whereas group B (n=19) was treated with sofosbuvir, ribavirin, and L-carnitine. Hemoglobin concentration changes, the effects of antiviral treatment, and the health status of patients were analyzed using short form-8 questionnaires. RESULTS: A significantly smaller decrease in hemoglobin concentration was observed in group B compared to group A at every time point. Moreover, the prescribed dose intensity of ribavirin in group B was higher than that of group A, resulting in a higher ratio of sustained virological response (SVR) 24 in group B compared with group A. The physical function of patients in group B was also significantly improved compared to group A at the end of antiviral treatment. CONCLUSIONS: L-carnitine supplementation alleviates ribavirin-induced hemolytic anemia in patients with HCV and helps relieve the physical burden of treatment with ribavirin-containing regimens. These advantages significantly increase the likelihood of achieving SVR.
Anemia ; Anemia, Hemolytic ; Carnitine ; Drug Therapy ; Hepacivirus ; Hepatitis C ; Hepatitis C, Chronic ; Hepatitis ; Hepatitis, Chronic ; Humans ; Hyperammonemia ; Liver Cirrhosis ; Liver Diseases ; Muscle Cramp ; Prospective Studies ; Ribavirin ; Sofosbuvir

Background/Aims: Endoscopic resection (ER) for superficial non-ampullary duodenal epithelial tumors (SNADETs) is challenging. Conventional endoscopic mucosal resection (CEMR) is also problematic due to the anatomical features of the duodenum. We compared the safety and efficacy of underwater endoscopic mucosal resection (UEMR) with those of CEMR through a retrospective analysis. Methods: Altogether, 44 consecutive patients with 46 SNADETs underwent ER (18 CEMR cases and 28 UEMR cases) between January 2016 and October 2019. We investigated the proportions of en bloc resection, R0 resection, complications, resection time, and total procedure time and compared the outcomes of patients from the CEMR group with those of patients from the UEMR group. Results: The median tumor size was 8.0 mm (range, 2.0–20.0 mm). The UEMR group showed a higher proportion of en bloc resection (96.4% vs. 72.2%, p<0.05) and significantly lower median resection time and total procedure time (4 min vs. 9.5 min, p<0.05 and 13 min vs. 19 min, p<0.05; respectively) than the CEMR group. No complications were observed. However, two patients treated with piecemeal resection in the CEMR group had residual tumors. Conclusions UEMR is a feasible therapeutic option for SNADETs. It can be recommended as a standard treatment.

Background/Aims: Endoscopic resection (ER) for superficial non-ampullary duodenal epithelial tumors (SNADETs) is challenging. Conventional endoscopic mucosal resection (CEMR) is also problematic due to the anatomical features of the duodenum. We compared the safety and efficacy of underwater endoscopic mucosal resection (UEMR) with those of CEMR through a retrospective analysis. Methods: Altogether, 44 consecutive patients with 46 SNADETs underwent ER (18 CEMR cases and 28 UEMR cases) between January 2016 and October 2019. We investigated the proportions of en bloc resection, R0 resection, complications, resection time, and total procedure time and compared the outcomes of patients from the CEMR group with those of patients from the UEMR group. Results: The median tumor size was 8.0 mm (range, 2.0–20.0 mm). The UEMR group showed a higher proportion of en bloc resection (96.4% vs. 72.2%, p<0.05) and significantly lower median resection time and total procedure time (4 min vs. 9.5 min, p<0.05 and 13 min vs. 19 min, p<0.05; respectively) than the CEMR group. No complications were observed. However, two patients treated with piecemeal resection in the CEMR group had residual tumors. Conclusions UEMR is a feasible therapeutic option for SNADETs. It can be recommended as a standard treatment.