Objective: To apply the International Federation of Gynecology and Obstetrics (FIGO) 2018 staging system to all patients who underwent trachelectomy in our previous study and to update the oncologic and obstetric results. Methods: We retrospectively reviewed the medical records of patients in whom abdominal trachelectomy was attempted between June 2005 and September 2021. The FIGO 2018 staging system for cervical cancer was applied to all patients. Results: Abdominal trachelectomy was attempted for 265 patients. Trachelectomy was converted to hysterectomy in 35 patients, and trachelectomy was completed successfully in 230 (conversion rate: 13%). Applying the FIGO 2018 staging system, 40% of the patients who underwent radical trachelectomy had stage IA tumors. Among 71 patients who had tumors measuring ≥2 cm, 8 patients were classified as stage IA1 and 14 as stage IA2. Overall recurrence and mortality rates were 2.2% and 1.3%, respectively. One hundred twelve patients attempted to conceive after trachelectomy; 69 pregnancies were achieved in 46 patients (pregnancy rate: 41%). Twenty-three pregnancies ended in first-trimester miscarriage, and 41 infants were delivered between gestational weeks 23 and 37; 16 were deliveries at term (39%) and 25 were premature deliveries (61%). Conclusion This study suggested that patients judged to be ineligible for trachelectomy and patients receiving overtreatment will continue to appear using the current standard eligibility criteria. With the revisions to the FIGO 2018 staging system, the preoperative eligibility criteria for trachelectomy, which were based on the FIGO 2009 staging system and tumor size, should be changed.

Background/Aims: The safety and effectiveness of adalimumab was demonstrated in a phase 3 trial in Japanese patients with intestinal Behçet’s disease. The aim of this study was to evaluate the long-term safety and effectiveness of adalimumab in Japanese patients with intestinal Behçet’s disease. Methods: This prospective, all-case, post-marketing study was conducted at 254 centers in Japanese patients with intestinal Behçet’s disease receiving adalimumab. The primary endpoint was incidence of adverse drug reactions. Effectiveness endpoints included global improvement rating and change in C-reactive protein levels. Results: Of the 473 registered patients, 462 and 383 included in the safety and effectiveness populations were administered adalimumab for a mean of 515.3 and 579.5 days, respectively. Overall, 395 patients (85.5%) received adalimumab at the recommended dose. Adverse drug reactions and serious adverse drug reactions were reported in 120 (25.97%) and 51 (11.04%) patients, respectively. The incidence of adverse drug reactions was significantly higher in patients with comorbidities (P< 0.0001), patients taking concomitant oral corticosteroids (P< 0.0001), and those not self-administering adalimumab (P= 0.0257). At study end, global improvement rating was “effective” (n = 156, 40.7%) or “markedly effective” (n = 168, 43.9%) in 324 patients (overall effective, 84.6%). Mean C-reactive protein levels (mg/dL) decreased from 1.96 at baseline (n = 324) to 0.58 at week 24 (n = 208) and 0.25 at week 156 (n = 37). Conclusions This large real-world study confirmed the long-term safety and effectiveness of adalimumab in patients with intestinal Behçet’s disease. No new safety concerns were identified. (Clinical trial registration number: NCT01960790)

Background/Aims: The safety and effectiveness of adalimumab was demonstrated in a phase 3 trial in Japanese patients with intestinal Behçet’s disease. The aim of this study was to evaluate the long-term safety and effectiveness of adalimumab in Japanese patients with intestinal Behçet’s disease. Methods: This prospective, all-case, post-marketing study was conducted at 254 centers in Japanese patients with intestinal Behçet’s disease receiving adalimumab. The primary endpoint was incidence of adverse drug reactions. Effectiveness endpoints included global improvement rating and change in C-reactive protein levels. Results: Of the 473 registered patients, 462 and 383 included in the safety and effectiveness populations were administered adalimumab for a mean of 515.3 and 579.5 days, respectively. Overall, 395 patients (85.5%) received adalimumab at the recommended dose. Adverse drug reactions and serious adverse drug reactions were reported in 120 (25.97%) and 51 (11.04%) patients, respectively. The incidence of adverse drug reactions was significantly higher in patients with comorbidities (P< 0.0001), patients taking concomitant oral corticosteroids (P< 0.0001), and those not self-administering adalimumab (P= 0.0257). At study end, global improvement rating was “effective” (n = 156, 40.7%) or “markedly effective” (n = 168, 43.9%) in 324 patients (overall effective, 84.6%). Mean C-reactive protein levels (mg/dL) decreased from 1.96 at baseline (n = 324) to 0.58 at week 24 (n = 208) and 0.25 at week 156 (n = 37). Conclusions This large real-world study confirmed the long-term safety and effectiveness of adalimumab in patients with intestinal Behçet’s disease. No new safety concerns were identified. (Clinical trial registration number: NCT01960790)

This study aimed to estimate the cost-effectiveness of pregabalin treatment for neuropathic pain.
Design:Long-term simulations based on state transition models.
Methods:We examined the cost-effectiveness of pregabalin for treatment of three common peripheral neuropathic pains, postherpetic neuralgia(PHN), painful diabetic peripheral neuropathy(DPN), and radiculopathy, using the incremental cost-effectiveness ratio(ICER). We used quality-adjusted life years(QALYs)as an index of effectiveness, and also estimated medical costs. For PHN and DPN, we constructed state transition models comprising two states, with and without pregabalin treatment, and performed 52-week simulations. The pain scores reported in Japanese phaseIII studies were used to set patients' weekly pain scores. The results of utility surveys conducted overseas were used as utility scores, while values randomly sampled from probability distributions were used to set weekly pain scores and drop-out rates. In base-case analyses, we performed 1000 1st-order Monte Carlo simulations using 1000 values randomly sampled from probability distributions, and calculated QALYs and medical costs for 52 weeks for each group. For radiculopathy, the ICER was calculated from changes in QALYs for 12 weeks reported overseas and medical costs estimated separately for the identical period.
Results:The ICERs for PHN, DPN, and radiculopathy were 1,116,886 Yen/QALY, 1,100,420 Yen/QALY, and 1,095,943 Yen/QALY, respectively, which were well below the upper limits of ICER ranges for treatments considered cost-effective. There were no cases in which ICERs obtained from scenario and sensitivity analyses differed significantly.
Conclusion:Pregabalin was shown to be cost-effective treatment for neuropathic pain.

OBJECTIVEIn this study, we used an intervention approach to examine the effects of physical exercise on elderly people living at home in a rural area.

METHODSTwo regions in a village were randomly assigned as the control and intervention regions. The subjects were 60 years of age or older and were able to carry out their activities of daily living independently. The numbers of subjects were 56 and 81 for the control and intervention regions, respectively. In the control region, lectures on health were provided twice. In the intervention region, instructions on ten types of physical exercise were provided six times during this three-month study. In addition, the subjects in the intervention region were instructed to do, exercises by themselves at home three days per week. The effects were compared by evaluating motor functions in maximum step length, 10-m full-power walking parameters, right knee extension torque, right hip flexion torque, and stepping time on a 40-cm staircase; data were obtained before and after the intervention.

RESULTSAnalysis of covariance (ANCOVA) showed significant improvements in right maximum step length, the mean of the right and left maximum step lengths, and right hip flexion torque in the intervention region.

CONCLUSIONThe three-month physical exercise program improves the motor functions of the elderly.

An 83-year-old man had acute type B aortic dissection combined with a large athelosclerotic abdominal aortic aneurysm (AAA) over 8cm in diameter. The dissection advanced into the wall of the AAA. The patient was treated with strict medical therapy for two months and successfully underwent an early elective abdominal aortic repair concomitant with off-pump aortocoronary bypass grafting. This strategy of meticulous medical management may improve clinical outcome for the acute phase in such rare cases.

Today, well over 160, 000 patients undergo dialysis throughout Japan. The number of patients who are newly required to receive it is increasing year by year. Given that situation, our hospital has annually held a seminar since October 1994 for patients with renal diseases. The purpose is to slow the deterioration of renal function and to delay the introduction of dialysis by encouraging the patients to acquire a habit of taking high calory, low protein food.
This seminar must have help the patients get more knowledgeable about morbidity and learn the benefit of low protein rice-based diet. Now that three years have passed since the opening of the course, we reviewed the outcome, comparing the effects of old and new restrict diets.
A difference began to appear 9-2 months after the lst seminar between the seminar participants and the non-participants (control group) who received guidance only at the outpatient ward. The average rate of decrease in the serum creatine level of those participants who eated lowprotein rice was 0.029 and that of those participants who did not eat the restricted food was 0.166 (p<0.05), compared with 0.262 in the control group. We concluded that the difference is ascribable to the effect of the seminar. We would like to contribute to the well-being of the patients by enriching the content of the seminar and continuing to hold it.