Koichi Hashimoto

Phase I/IIa trial of fractionated radiotherapy, temozolomide, and autologous formalin-fixed tumor vaccine for newly diagnosed glioblastoma

OBJECT Temozolomide (TMZ) may enhance antitumor immunity in patients with glioblastoma multiforme (GBM). In this paper the authors report on a prospective Phase I/IIa clinical trial of fractionated radiotherapy (FRT) concomitant with TMZ therapy, followed by treatment with autologous formalin-fixed tumor vaccine (AFTV) and TMZ maintenance in patients with newly diagnosed GBM. METHODS Twenty-four patients (age 16-75 years, Karnofsky Performance Scale score ≥ 60% before initiation of FRT) with newly diagnosed GBM received a total dose of 60 Gy of FRT with daily concurrent TMZ. After a 4-week interval, the patients received 3 AFTV injections and the first course of TMZ maintenance chemotherapy for 5 days, followed by multiple courses of TMZ for 5 days in each 28-day cycle. RESULTS This treatment regimen was well tolerated by all patients. The percentage of patients with progression-free survival (PFS) ≥ 24 months was 33%. The median PFS, median overall survival (OS), and the actuarial 2- and 3-year survival rates of the 24 patients were 8.2 months, 22.2 months, 47%, and 38%, respectively. The median PFS in patients with a delayed-type hypersensitivity (DTH) response after the third AFTV injection (DTH-2) of 10 mm or larger surpassed the median length of follow-up for progression-free patients (29.5 months), which was significantly greater than the median PFS in patients with a smaller DTH-2 response. CONCLUSIONS The treatment regimen was well tolerated and resulted in favorable PFS and OS for newly diagnosed GBM patients. Clinical trial registration no.: UMIN000001426 (UMIN clinical trials registry, Japan).

Do dispatcher instructions facilitate bystander-initiated cardiopulmonary resuscitation and improve outcomes in patients with out-of-hospital cardiac arrest? A comparison of family and non-family bystanders

OBJECTIVES Bystander-initiated cardiopulmonary resuscitation (CPR) has been reported to increase the possibility of survival in patients with out-of-hospital cardiopulmonary arrest (OHCA). We evaluated the effects of CPR instructions by emergency medical dispatchers on the frequency of bystander CPR and outcomes, and whether these effects differed between family and non-family bystanders. METHODS We conducted a retrospective cohort study, using Utstein-style records of OHCA taken in a rural area of Japan between January 2004 and December 2009. RESULTS Of the 559 patients with non-traumatic OHCA witnessed by laypeople, 231 (41.3%) were given bystander CPR. More OHCA patients received resuscitation when the OHCA was witnessed by non-family bystanders than when it was witnessed by family members (61.4% vs. 34.2%). The patients with non-family-witnessed OHCA were more likely to be given conventional CPR (chest compression plus rescue breathing) or defibrillation with an AED than were those with family-witnessed OHCA. Dispatcher instructions significantly increased the provision of bystander CPR regardless of who the witnesses were. Neurologically favorable survival was increased by CPR in non-family-witnessed, but not in family-witnessed, OHCA patients. No difference in survival rate was observed between the cases provided with dispatcher instructions and those not provided with the instructions. CONCLUSIONS Dispatcher instructions increased the frequency of bystander CPR, but did not improve the rate of neurologically favorable survival in patients with witnessed OHCA. Efforts to enhance the frequency and quality of resuscitation, especially by family members, are required for dispatcher-assisted CPR.

Comparison of Education-Only versus Group-Based Intervention in Promoting Weight Loss: A Randomised Controlled Trial

Aim: To compare the effectiveness of education-only versus group-based intervention in promoting weight loss. Methods: Between April and October 2009, a 6-month randomised controlled trial was conducted at Mito Kyodo General Hospital in Japan (UMIN000001259). The participants were 188 overweight adults (145 women, 43 men) aged 40–65 years. They were randomly assigned to one of three groups: control, moderate or intensive intervention. A single motivational lecture was provided to all three groups, educational materials (textbooks, notebooks, and a pedometer) to the moderate and intensive intervention groups, and group-based support to the intensive intervention group. Amount of weight loss was the primary outcome measure. Secondary outcome measures were components of metabolic syndrome. Results: Mean ( SD weight loss of participants in the control, moderate and intensive intervention groups was 2.9 ( 4.1, 4.7 ( 4.0 and 7.7 ( 4.1 kg, respectively. Bonferroni post-hoc comparisons revealed all between-group differences to be significant (p < 0.05). Waist circumference decreased in the intensive intervention group more than in the other groups, whereas no significant differences were observed in the other secondary outcome measures. Conclusion: Education-only intervention is a cost-effective method to promote weight loss. Adding group-based intervention further promotes weight loss.

Weight loss maintenance for 2 years after a 6-month randomised controlled trial comparing education-only and group-based support in Japanese adults.

Objective: Our previous study, a 6-month randomised controlled trial, demonstrated that a group-based support promoted weight loss as compared to an education-only intervention. The purpose of this study was to examine weight loss maintenance for 2 years. Methods: Originally, 188 overweight Japanese adults, aged 40-65 years, were randomly assigned to 3 groups: control, education-only or group-based support. After the 6-month intervention, 125 participants in the education-only and the group-based support groups were followed up for 2 years. The primary outcome was the amount of weight lost. The participants were retrospectively grouped into quartiles of percent weight loss for secondary analyses. Results: At the end of follow-up, the amount of weight lost in the education-only and the group-based support groups was the same (3.3 kg). Secondary analyses using data of those who completed the study (n = 100) revealed that the participants in the highest quartile of percent weight loss significantly increased their step counts and moderate-to-vigorous physical activity compared with the lowest quartile. No significant differences were observed in the energy intake among the four groups. Conclusion: The effects of group-based support disappear within 2 years. Increasing physical activity may be a crucial factor for successful maintenance of weight loss.

IV–4 Acceleration of Tibial Open and/or Comminuted Fracture Healing by Low-Intensity Pulsed Ultrasound (LIPUS); A Retrospective Cohort Study

Objective: To investigate the efficacy of LIPUS for fracture healing of tibial open and/or comminuted fracture. Study Design: Retrospective multicenter cohort study. Institute: Thirty-seven hospitals (University hospitals and community teaching hospitals) in Japan. Patients and Methods: A 1-year observational retrospective cohort study was conducted with a consecutive cohort of 343 open and/or comminuted tibial shaft fractures in adults (18 years or older). All patients were treated with an intramedullary nail, a plate and screws, or an external fixator and screws/wires between April 1, 2007 and September 30, 2010. Cases for which LIPUS was applied within 21 days after definitive fixation were defined as the LIPUS group (n = 103); all other patients were in the Non-LIPUS group (n = 240). Five orthopaedic surgeons who did not participate in the treatment of the cases determined the radiographic healing date for each case. Main Outcome: Kaplan-Meier curve between healing periods and cumulative healing rate was plotted. Log-rank examination was performed to evaluate the effectiveness of LIPUS on fracture healing. Results: There were no significant demographic differences between the LIPUS group and the Non-LIPUS group. Median healing time was 143 days for the LIPUS group and 150.5 days for the Non-LIPUS group (P = 0.067). LIPUS was applied as adjuvant therapy in 49 patients in the Non-LIPUS group, after a diagnosis of delayed union and/or nonunion. Eliminating these 49 cases from the Non-LIPUS group, there was no statistically significant difference in healing time between the LIPUS and Non-LIPUS groups (P = 0.855). Subgroup analysis revealed that LIPUS accelerated fracture healing significantly in cases treated by plate fixation (P < 0.001), but not in cases treated by intramedullary nail. Conclusion: LIPUS may have a positive effect on fracture healing for open and/or comminuted tibial shaft fracture, especially for the cases treated by plate fixation.

Comparison of Glucose Concentrations between Flash and Continuous Monitoring Systems in Patients with Diabetes Mellitus

Flash glucose (FGMS) and continuous glucose (CGMS) monitoring systems are becoming increasingly prevalent in clinical practice. We directly compared FGMS (FreeStyle Libre-Pro, FSL-Pro) and CGMS (iPro2) in a patient with diabetes mellitus (T1DM/T2DM = 3/10). Analysis of 7,365 paired values revealed a close correlation between FSL-Pro and iPro2 glucose values (r = 0.93, p 180 mg/dL) compared with normoglycemic values (70-180 mg/dL) (32.0 (19.0-47.0) vs. 23.0 (14.0-31.0) mg/dL, p Disclosure R. Kumagai: None. A. Muramatsu: None. M. Fujii: None. Y. Katakura: None. K. Fujie: None. Y. Nakata: None. K. Hashimoto: None. H. Yagyu: None.

Correction to: Comparison of Education-Only versus Group-Based Intervention in Promoting Weight Loss: A Randomised Controlled Trial

[This corrects the article on p. 387 in vol. 62.].Following the publication of the article Nakata Y, Okada M, Hashimoto K, Harada Y, Sone H, Tanaka K: Comparison of education-only versus group-based intervention in promoting weight loss: a randomised controlled trial. Obes Facts 2011;4:222–228, DOI: 10.1159/000329619 the authors were notified of errors in tables 1 and 2 . The correct versions of the tables were presented below. The corrected results in the two tables were given in bold. We sincerely regret these errors. Received: December 27, 2012 Accepted: January 16, 2013 Published online: March 2, 2013