Investigation of the treatment potential of carbon-ion radiation therapy in pelvic recurrence of rectal cancer.
A phase 1/2 dose escalation study was performed. One hundred eighty patients (186 ...lesions) with locally recurrent rectal cancer were treated with carbon-ion radiation therapy (CIRT) (phase 1/2: 37 and 143 patients, respectively). The relapse locations were 71 in the presacral region, 82 in the pelvic sidewalls, 28 in the perineum, and 5 near the colorectal anastomosis. A 16-fraction in 4 weeks dose regimen was used, with total dose ranging from 67.2 to 73.6 Gy(RBE); RBE-weighted absorbed dose: 4.2 to 4.6 Gy(RBE)/fraction.
During phase 1, the highest total dose, 73.6 Gy(RBE), resulted in no grade >3 acute reactions in the 13 patients treated at that dose. Dose escalation was halted at this level, and this dose was used for phase 2, with no other grade >3 acute reactions observed. At 5 years, the local control and survival rates at 73.6 Gy(RBE) were 88% (95% confidence interval CI, 80%-93%) and 59% (95% CI, 50%-68%), respectively.
Carbon-ion radiation therapy may be a safe and effective treatment option for locally recurrent rectal cancer and may serve as an alternative to surgery.
Follow-up study of a retrospective chart review conducted among 566 consecutive HD patients with 613 limbs electively undergoing infrainguinal revascularization to treat CLI at Nagoya Kyoritsu ...Hospital (Nagoya, Japan) and Matsunami General Hospital (Kasamatsu, Japan). ...we conducted propensity score adjustment to minimize the characteristics differences, but there may still be residual confounding, especially in that the definition of CLI might potentially be misclassified because we only referenced Fontaine classification on the chart review.
Abstract Background Cilostazol has been reported to prevent atherosclerotic events in the general population. However, data have been limited whether there are beneficial effects of cilostazol use on ...long-term clinical outcomes after endovascular therapy in hemodialysis (HD) patients with peripheral artery disease (PAD). Methods and results This study consisted of 595 HD patients undergoing endovascular therapy for a clinical diagnosis of PAD. They were divided into two groups: patients receiving 100 mg cilostazol twice daily in conjunction with standard therapy ( n = 249 patients, cilostazol group) and those not administered cilostazol ( n = 346 patients, control group). A propensity score analysis was performed to adjust for baseline differences between the two groups. The propensity score-adjusted 10-year event-free survival rate from major adverse cardiovascular events (MACE) was significantly higher in the cilostazol group than in the control group 58.6% vs. 43.7%, hazard ratio (HR) 0.57; 95% confidence interval (CI) 0.41–0.79; p = 0.0010. Notably, the adjusted stroke-free rate was significantly higher in the cilostazol group than in the control group (81.6% vs. 74.7%; HR = 0.48; 95% CI, 0.25–0.92, p = 0.028). Even after adjusting for other confounders, treatment with cilostazol was an independent predictor for prevention of MACE and stroke ( p = 0.0028 and p = 0.039, respectively). Conclusions Cilostazol administration improves long-term clinical outcomes including prevention of MACE and stroke after endovascular therapy in HD patients with PAD.
Background We undertook a multicenter cohort observational study to investigate the frequency and type of subsequent vascular events after an ischemic stroke and to compare the rates of vascular ...events between patients with and without hyperlipidemia. Methods This nationwide study was conducted in 19 hospitals participating in the Japan Standard Stroke Registry Study. We enrolled ischemic stroke patients, including those with a transient ischemic attack, who had not experienced any vascular events before enrollment after their ischemic stroke events. Each subject was observed prospectively from September 1, 2003, to October 1, 2005, or until a primary end point or death. Primary end points included subsequent fatal or nonfatal vascular events: stroke, angina pectoris, acute myocardial infarction, aortic aneurysm, or arteriosclerosis obliterans. Results A total of 449 patients (mean age, 67.6 years; 64.8% men) were enrolled in this study. Of the 41 vascular events observed during follow-up, 40 were stroke. The median observation period was 568 days. We found that patients with hyperlipidemia had a significantly higher rate of vascular events compared with those without hyperlipidemia according to the Kaplan–Meier method and the log-rank test ( P = .013). Hyperlipidemia significantly increased the risk of vascular events (hazard ratio, 2.169 1.125-4.312; P = .021) according to the Cox proportional hazard model after adjusting for confounding factors (age, sex, days from ischemic stroke until enrollment, smoking habits, and daily drinking habits). Conclusions This study demonstrated that stroke was the most common subsequent vascular event after ischemic stroke; the study also indicated that hyperlipidemia could be a risk factor for subsequent vascular events after ischemic stroke.
The aim of this study was to understand the income and employment status of patients at the start of and during follow-up after palliative radiation therapy for bone metastasis.
From December 2020 to ...March 2021, a prospective multi-institutional observational study was conducted to investigate income and employment of patients at the start of administration of radiation therapy for bone metastasis and at 2 and 6 months after treatment. Of 333 patients referred to radiation therapy for bone metastasis, 101 were not registered, mainly because of their poor general condition, and another 8 were excluded from the follow-up analysis owing to ineligibility.
In 224 patients analyzed, 108 had retired for reasons unrelated to cancer, 43 had retired for reasons related to cancer, 31 were taking leave, and 2 had lost their jobs at the time of registration. The number of patients who were in the working group was 40 (30 with no change in income and 10 with decreased income) at registration, 35 at 2 months, and 24 at 6 months. Younger patients (P = 0), patients with better performance status (P = 0), patients who were ambulatory (P = .008), and patients with lower scores on a numerical rating scale of pain (P = 0) were significantly more likely to be in the working group at registration. There were 9 patients who experienced improvements in their working status or income at least once in the follow-up after radiation therapy.
The majority of patients with bone metastasis were not working at the start of or after radiation therapy, but the number of patients who were working was not negligible. Radiation oncologists should be aware of the working status of patients and provide appropriate support for each patient. The benefit of radiation therapy to support patients continuing their work and returning to work should be investigated further in prospective studies.
Abstract Background It has been reported that pomegranate juice significantly increased the AUC of orally administered carbamazepine in rats, which suggests that pomegranate may inhibit the ...cytochrome P450 3A (CYP3A)–mediated carbamazepine metabolism. Objective The aim of the present study was to clarify the effect of repeated consumption of pomegranate juice on CYP3A activity by assessing the pharmacokinetics of midazolam, a typical CYP3A probe drug, and its metabolites in healthy volunteers. Methods An open-label, randomized, single-center, 2-period crossover study was conducted on healthy Japanese volunteers. Each subject received 200 mL of pomegranate juice twice daily for 2 weeks. On day 14, they were administered 15 μg/kg midazolam orally with either pomegranate juice or water. Plasma concentrations and urinary excretions of midazolam, 1′-hydroxymidazolam, and 4-hydroxymidazolam were determined up to 24 hours using LC/MS/MS and analyzed by a noncompartmental method. Results Sixteen subjects (11 men and 5 women) were enrolled and completed the study. The mean (SD) age was 24.1 (4.8) years (range 22–40), mean body weight was 62.9 (8.8) kg (range 45.6–79.9). Differences in the mean AUC0–∞ were 12.7 (4.4) and 14.2 (6.6) ng/mL/h in pomegranate juice and control groups, respectively (geometric mean ratio: 1.02 95% CI, 0.95–1.09; P = 0.40). Differences in Cmax for midazolam did not reach the level of statistical significance (5.1 1.7 vs 5.0 2.0 ng/mL, geometric mean ratio: 0.95 95% CI, 0.79–1.11; P = 0.68). Excretions of 1′-hydroxymidazolam ( P = 0.34) and 4-hydroxymidazolam ( P = 0.32) were not significantly altered by ingestion of pomegranate juice. Conclusion In this small Japanese adult volunteer population receiving single subtherapeutic doses of midazolam, 2 weeks' consumption of pomegranate juice did not significantly alter the pharmacokinetic profile of midazolam compared with that of the control. Protocol identifier: UMIN000004459.
OBJECTIVES: To assess the prevalence of and risk factors for postintensive care syndrome in family (PICS-F) in the COVID-19 era. DESIGN: A single-center retrospective study using questionnaires and ...telephone calls. SETTING: An ICU at St. Luke’s International Hospital. PATIENTS: Patients who were treated for COVID-19–related acute respiratory distress syndrome between March 23, 2020, and September 30, 2021, and their family members participated. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: PICS-F refers to the psychologic distress such as anxiety, depression, and posttraumatic stress disorder (PTSD) experienced by the patient’s family. The primary outcome was PICS-F occurrence. Furthermore, factors related to PICS-F development were identified using statistical analysis. Of 85 patients with COVID-19 who were admitted to the ICU, 57 family members consented to the study and completed the survey, and 54 family members’ data were analyzed. The median age of family members was 53.5 years, 68.5% were female, and 46.3% were spouses. The median age of patients was 55.5 years, and 83.3% were male. During their ICU stay, 68.5% received invasive mechanical ventilation, 11.1% received venovenous extracorporeal membrane oxygenation, and 11.1% underwent tracheostomy. The median ICU and hospital stays were 7 and 22 days, respectively. Overall PICS-F occurred in 33%. Anxiety, depression, and PTSD occurred in 24%, 26%, and 4% of family members, respectively. The prevalence of all three components of PICS-F was 4%. Multivariable analysis showed that Family Satisfaction with the ICU Survey (FS-ICU) scores were independently associated with PICS-F development (odds ratio, 0.941; 95% CI, 0.891–0.983; p = 0.005). CONCLUSIONS: One-third of family members of COVID-19 patients admitted to the ICU had symptoms of PICS-F. These results suggest that measurement of FS-ICU may be helpful as a predictor of PICS-F development. In addition, increasing the level of ICU care satisfaction of the family members may prevent PICS-F.
Postintensive care syndrome has a strong impact on coronavirus disease 2019 survivors.
Assess the 1-year prevalence of postintensive care syndrome after coronavirus disease 2019.
This was a ...single-center prospective cohort using questionnaires and telephone calls from 4 months to 1 year after ICU discharge. Patients who were treated for coronavirus disease 2019-related acute respiratory distress between March 19, 2020, and April 30, 2020, participated.
Postintensive care syndrome was evaluated according to physical, mental, and cognitive domains. We surveyed the 8-item standardized Short Form questionnaire for assessing physical postintensive care syndrome; the Impact of Event Scale-Revised and the Hospital Anxiety and Depression Scale for assessing mental postintensive care syndrome; and Short-Memory Questionnaire for assessing cognitive postintensive care syndrome. The primary outcome was postintensive care syndrome occurrence of any domain at 1 year. Furthermore, the co-occurrence of the three postintensive care syndrome domains was assessed.
Eighteen patients consented to the study and completed the survey. The median age was 57.5 years, and 78% of the patients were male. Median Acute Physiology and Chronic Health Evaluation-II score was 18. During ICU stay, 78% received invasive mechanical ventilation, and 83% received systemic steroid administration. Early mobilization was implemented in 61%. Delirium occurred in 44%. The median days of ICU and hospital stay were 6 and 23.5, respectively. Overall postintensive care syndrome occurrence was 67%. Physical, mental, and cognitive postintensive care syndrome occurred in 56%, 50%, and 33% of patients, respectively. The co-occurrence of all three domains of postintensive care syndrome was 28%. Age and Acute Physiology and Chronic Health Evaluation-II scores were higher, and systemic steroids were more commonly used in the postintensive care syndrome groups compared with the nonpostintensive care syndrome groups. Chronic symptoms were more common in the postintensive care syndrome groups than the nonpostintensive care syndrome groups.
Patients who suffered critical illness from coronavirus disease 2019 had a high frequency of postintensive care syndrome after 1 year. Long-term follow-up and care should be continuously offered.
Total hip arthroplasty (THA) performed on patients with Perthes-like deformities are technically challenging because of the patient’s abnormal hip anatomy. Patients with Perthes-like deformities are ...at a higher risk of revision, aseptic loosening, nerve injury, and intraoperative fracture after THA, especially if shortening osteotomies are performed. This analysis sought to examine the clinical and radiographic outcomes of a patient cohort with Perthes-like deformities receiving THA with a conical stem, an elevated hip center, and no shortening femoral osteotomy.
Twenty-six patients (27 hips) received THA with MODULUS femoral stems, ceramic or metal femoral heads, and highly cross-linked polyethylene liners between April 2011 and March 2016. All patients were treated at a single center by 4 participating surgeons. Patients completed 2 questionnaires preoperatively and at the final follow-up visit (between 1 and 5 years postoperatively): Harris Hip Score and Japanese Orthopaedic Association Hip-Disease Evaluation Questionnaire. Differences in patient-reported outcome measures (PROM) scores were measured by paired t-tests. Preoperative and postoperative anteroposterior radiographs were analyzed to monitor patient outcomes.
Significant clinical improvements were observed in all individual subcategories of the Harris Hip Score and of the Japanese Orthopaedic Association Hip-Disease Evaluation Questionnaire; the largest magnitude improvements were observed in the subcategory of pain relief for both questionnaires. No complications, including intraoperative and postoperative femoral fractures, nerve palsy, dislocations, or deep venous thrombosis, were observed.
This study found that patients treated with an elevated hip center and low stem-positioning technique using a conical, modular implant system had good clinical outcomes and did not suffer complications at the mean follow-up from surgery of 2.8 years (range: 1-5 years).
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