Type III Gustilo-Anderson open fracture does not justify routine prophylactic Gram-negative antibiotic coverage.

Postoperative surgical site infection (SSI) is common in open long bone fractures, so early administration of prophylactic antibiotics is critical to prevent SSI. However, the necessity of initial broad-spectrum coverage for Gram-positive and -negative pathogens remains unclear. The purpose of this study was to clarify the effectiveness of prophylactic broad-spectrum antibiotics in a large, national-wide sample. We reviewed an open fracture database of prospectively collected data from 111 institutions managed by our society. A retrospective cohort study was designed to compare the rates of deep SSI between narrow- and broad-spectrum antibiotics, which were initiated within three hours after injury. A total of 1041 type III fractures were evaluated at three months after injury. Overall deep SSI rates did not differ significantly between the narrow-spectrum group (43/538, 8.0%) and broad-spectrum group (49/503, 9.8%) (p = 0.320). During propensity score-matched analysis, 425 pairs were analyzed. After matching, no significant difference in the SSI rate was seen between the narrow- and broad-spectrum groups, with 42 SSIs (9.9%) and 40 SSIs (9.4%), respectively (p = 0.816). The probability of deep SSI was not reduced by broad-spectrum antibiotics compared with narrow-spectrum antibiotics in type III open long bone fractures.

Three-year outcomes of robotic gastrectomy versus laparoscopic gastrectomy for the treatment of clinical stage I/II gastric cancer: a multi-institutional retrospective comparative study.

BACKGROUND: Oncological benefits of robotic gastrectomy (RG) remain unclear. We aimed to determine and compare the 3-year outcomes of RG and laparoscopic gastrectomy (LG) for the treatment of gastric cancer. METHODS: This was a multi-institutional retrospective study of patients who prospectively underwent RG in a previous study (UMIN000015388) and historical controls who underwent LG. Operable patients with cStage I/II primary gastric cancer were enrolled. The inverse probability of treatment weighting method based on propensity scores was used to balance patient demographic factors and surgeon volume between the RG and LG groups. The primary outcome measure was the 3-year overall survival rate (3yOS). RESULTS: Of the 1,127 patients in the previous study, 326 and 752 patients in the RG and LG groups, respectively, completed the study. The standardized difference of all confounding factors was reduced to 0.09 or less after weighting. In the weighted population, 3yOS was 96.3% and 89.6% in the RG and LG groups, respectively (hazard ratio [HR] 0.34 [0.15, 0.76]; p = 0.009), whereas there was no difference in 3-year recurrence-free survival rate (3yRFS) between the two groups (HR 0.58 [0.32, 1.05]; p = 0.073). Sub-analyses showed that RG improved 3yOS (HR 0.05 [0.01, 0.38]; p = 0.004) and 3yRFS (HR 0.05 [0.01, 0.34]; p = 0.003) in patients with pStage IA disease. Recurrence rates and patterns were similar between the RG and LG groups. RG did not improve the morbidity rate, however, it attenuated some of the adverse events, including anastomotic leakage and intra-abdominal abscess. RG improved estimated blood loss and duration of postoperative hospitalization. CONCLUSION: This study showed surgical and oncological safety of RG for cStage I/II gastric cancer considering the 3-year outcomes, compared with those of LG.

Switching From Pregabalin to Mirogabalin in Patients with Peripheral Neuropathic Pain: A Multi-Center, Prospective, Single-Arm, Open-Label Study (MIROP Study).

INTRODUCTION: Mirogabalin, which is a selective ligand of the α2δ subunit of voltage-gated Ca2+ channels, was recently approved in Japan for peripheral neuropathic pain. The α2δ ligands, including mirogabalin and pregabalin, are associated with significant risk of adverse events (AEs) such as somnolence or dizziness, leading to poor compliance and subsequent inefficacy. Safety and efficacy data for switching patients from pregabalin to mirogabalin are scarce. METHODS: This prospective, single-arm, open-label study involving ten participating centers in Japan recruited patients aged ≥ 20 years with peripheral neuropathic pain [visual analog scale (VAS) score ≥ 40 mm]. Where necessary, patients underwent a 1-week tapering period to reduce their pregabalin dose, after which pregabalin was stopped and mirogabalin dose was increased using a step-wise dose titration. Patients underwent dose increases after the first and second weeks if there were no tolerability issues, followed by the effective doses until the end of the study (4 weeks). The primary endpoint was the incidence of somnolence, dizziness, and peripheral edema; secondary endpoints included changes in VAS score. AEs were monitored for safety. RESULTS: Of 157 patients who provided informed consent, 152 patients were enrolled; 136 (89.5%) patients completed the study. The overall incidences of somnolence, dizziness, and peripheral edema were 41.4, 15.8, and 2.6%, respectively. Most patients (> 70%) experienced mild AEs, and one patient experienced a severe AE (dizziness). Most patients (> 70%) were able to achieve dose titration to an effective dose. Overall mean VAS score significantly decreased (Δ15.7 mm, p < 0.0001) by the end of the study. CONCLUSIONS: Mirogabalin switching from pregabalin is well tolerated and effective in pain management for peripheral neuropathic pain using a step-wise titration. TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCTs031190113).

[Trends in mortality from intractable diseases in Japan, 1972-2004].

PURPOSE: In 1972, the Ministry of Health, Labour and Welfare of Japan defined intractable diseases as those with unknown etiology, no established treatment regimens, and severe sequelae of physical, mental and social difficulties. Since then, the Ministry has promoted scientific research on these diseases and offered financial support to those suffering from their effects. The purpose of the present study was to analyze trends in deaths from the diseases in Japan over the period from 1972-2004. METHODS: For the selected intractable diseases with 100 deaths or more per year, crude (CDR) and direct age-standardized death rates (ADR) were computed using the national underlying-cause-of-death mortality database of Japan based on International Classification of Diseases. Joinpoint regression analysis was applied to identify significant changes in the trends. RESULTS: The CDRs in the latest observed year per 1 million persons/year) for males and females were 25.55 and 25.93, respectively, for Parkinson's disease, 5.41 and 6.92 for aplastic anemia, 0.87 and 3.50 for systemic lupus erythematosus, 2.93 and 2.36 for amyloidosis, 1.40 and 1.54 for polyarteritis nodosa, 1.34 and 1.61 for idiopathic thrombocytopenic purpura, and 1.02 and 0.74 for ulcerative colitis. The respective annual percentage changes (APCs) for males and females during the overall period decreased for ulcerative colitis (-5.2% and -7.5%), aplastic anemia (-3.6% and -3.7%), idiopathic thrombocytopenic purpura (-2.1% and -3.0%), and systemic lupus erythematosus (-0.9% and -2.6%), while the APCs increased for amyloidosis (+3.3% and +3.5%), polyarteritis nodosa (+3.2% and +4.0%), and Parkinson's disease (+0.7% in males alone). With the APCs in the latest trend phase, polyarteritis nodosa and Parkinson's disease in females showed appreciable declines; on the other hand, amyloidosis in males demonstrated the significant increase, and ulcerative colitis in males exhibited an apparent leveling off of the decline. CONCLUSION: The ADRs for most of the intractable diseases have declined significantly in Japan over the last 3 decades. The decline might be attributed in large part to improved diagnosis and treatment because of the lack of effective primary prevention measures. Support for the affected patients and further research on etiology and radical cure of the diseases must be considered necessary.

Creutzfeldt-Jakob disease mortality in Japan, 1979-2004: analysis of national death certificate data.

BACKGROUND: Trend of the mortality rate of Creutzfeldt-Jakob disease (CJD) in Japan is still unclear. This study aimed to estimate annual crude mortality rates due to CJD and examine the CJD mortality trend in Japan during the period of 1979-2004. METHODS: National death certificate data on CJD were used (CJD coded as 046.1 for ICD-9 and A81.0 for ICD-10). Trends in age-standardized mortality rates for CJD were examined by using time series analyses including the joinpoint regression analysis. RESULTS: A total of 1,966 deaths (862 males and 1,104 females) were identified with CJD coded as the underlying-cause-of-death. The annual number of deaths and crude mortality rates peaked in 2004 at 163 (66 for males and 97 for females) deaths and 1.28 (1.06 for males and 1.48 for females) deaths per million population per year, respectively. The age-specific mortality rates rapidly increased with age between 50 and 74 years, especially among females, and sharply declined at 80+ years. Throughout the observed period, there were no significant change points, and the annual percentage changes (95% confidence intervals) were +3.09 (2.18 - 4.02) % for males and +3.90 (2.98-4.83) % and females. The total number of CJD deaths under 50 years of age was 131, and there was found no increase in the annual number of deaths for the past few years in this age group. CONCLUSION: CJD mortality in trend data based on death certificates has significantly increased in Japan during the period of 1979-2004.