Objective: In many medical institutions in Japan, 10% lidocaine gel is prepared as an in-hospital formulation to treat intractable neuropathic pain. Clinical studies have reported the short-term efficacy of topical lidocaine therapy for neuropathic pain, while there are few reports in real-world practice. To clarify the clinical usage and its usefulness, in this study, we investigated the duration of use, amount, effectiveness, and safety of 10% lidocaine gel.Design: We conducted a retrospective study investigating the actual usage of 10% lidocaine gel using electronic medical records.Methods: This study included 74 patients treated with 10% lidocaine gel in Kyoto University Hospital between July 2019 and January 2022. Information about disease (purpose of use), concomitant medications and other background information of the patients were collected. In addition, the duration of use, amount, adverse events, and discontinuation of 10% lidocaine gel were investigated. Effectiveness was determined by physician interviews and the pain visual analogue scale (VAS).Results: Ten percent lidocaine gel was used primarily to treat postherpetic neuralgia and, in some cases, other types of chronic pain for a median duration of use of 3.2 months (0.03-118.5). Pain relief was achieved in 73.3% of patients according to physician interviews, with a significant decrease in the VAS score. Although adverse events were observed in 12 patients (16.2%), including skin problems (12.2%), paralysis (4.1%), and somnolence (1.4%), eight patients continued to use 10% lidocaine gel after their occurrence. Three patients discontinued it due to adverse events, and their symptoms subsequently improved thereafter.Conclusion: The present results suggest that 10% lidocaine gel is effective and safe even when used for a long-time. Although this is a single-center study, it is the first systematic investigation of real-world usage of an in-hospital formulation of 10% lidocaine gel and is expected to assist clinical practice and drug development.

Objective: To examine the efficacy and safety of an innovative, device-driven abdominal trunk muscle strengthening program, with the ability to measure muscle strength, to treat chronic low back pain (LBP) in elderly participants. Methods: Seven women with non-specific chronic LBP, lasting at least 3 months, were enrolled and treated with the prescribed exercise regimen. Patients participated in a 12-week device-driven exercise program which included abdominal trunk muscle strengthening and 4 types of stretches for the trunk and lower extremities. Primary outcomes were adverse events associated with the exercise program, improvement in abdominal trunk muscle strength, as measured by the device, and improvement in the numerical rating scale (NRS) scores of LBP with the exercise. Secondary outcomes were improvement in the Roland-Morris Disability Questionnaire (RDQ) score and the results of the locomotive syndrome risk test, including the stand-up and two-step tests. Results: There were no reports of increased back pain or new-onset abdominal pain or discomfort during or after the device-driven exercise program. The mean abdominal trunk muscle strength, NRS, RDQ scores, and the stand-up and two-step test scores were significantly improved at the end of the trial compared to baseline. Conclusion No participants experienced adverse events during the 12-week strengthening program, which involved the use of our device and stretching, indicating the program was safe. Further, the program significantly improved various measures of LBP and physical function in elderly participants.

Methods: We retrospectively reviewed 31 ASD patients who underwent multilevel LIF combined with PCO (LIF group, n=14) or multilevel PLIF (PLIF group, n=17) and with a minimum 2-year follow-up. In the comparison between LIF and PLIF groups, their mean age at surgery was 69.4 vs. 61.8 years while the mean follow-up period was 29.2 vs. 59.3 months. We evaluated the transition of pelvic incidence–lumbar lordosis (PI–LL) and disc angle (DA) in the LIF group, in fulcrum backward bending (FBB), after LIF and after posterior spinal fusion (PSF) with PCO. The spinopelvic radiographic parameters were compared between LIF and PLIF groups. Results: Compared with the PLIF group, the LIF group had less blood loss and comparable surgical outcomes with respect to radiographic data, health-related quality of life scores and surgical time. In the LIF group, the mean DA and PI–LL were unchanged after LIF (DA, 5.8°; PI–LL, 15°) compared with the values using FBB (DA, 4.3°; PI–LL, 15°) and improved significantly after PSF with PCO (DA, 8.1°; PI–LL, 0°). Conclusions In the surgical treatment of ASD, multilevel LIF is less invasive than multilevel PLIF and combination of LIF and PCO would be necessary for optimal sagittal correction in patients with rigid deformity.

STUDY DESIGN: Retrospective case series. PURPOSE: To evaluate surgical outcomes and effectiveness of an autogenic rib graft for upper cervical fixation in pediatric patients. OVERVIEW OF LITERATURE: Autogenic bone grafts have long been considered the ‘gold standard’ bone source for posterior cervical fusion in pediatric patients. However, there are some unsolved problems associated with donor-site morbidity and amount of bone grafting. METHODS: We studied five consecutive pediatric patients who underwent atlantoaxial fixation or occipitocervical fixation (OCF) using an autogenic rib graft with at least 2 years of follow-up (mean age, 9.8 years; mean follow-up period, 73.0 months). Two patients underwent OCF without screw-rod constructs and three patients with screw-rod constructs. Autogenic rib grafts were used in all patients. We evaluated the surgical outcomes including radiographic parameter, bony union, and perioperative complications. RESULTS: The atlantoaxial interval (ADI) was corrected from 11.6 to 6.0 mm, and the C1–2 angle was corrected −14.8° to 7.8°. The C2–7 angle was reduced from 31° to 9° spontaneously. Two patients with OCF required revision surgery due to loss of correction. Patients did not experience any complication associated with the donor sites (rib bone grafts). Six months postoperation X-rays clearly showed regeneration of the rib at the donor sites. Bony fusion was achieved in all patients; however, bony fusion occurred more slowly in patients without screw-rod constructs compared with patients with screw-rod constructs. Bone regeneration of the rib was observed in all patients with no complications at the donor site. CONCLUSIONS: Autogenic rib grafts have advantages of potential bone regeneration, high fusion rate, and low donor-site morbidity. In addition, a screw-rod construct provides better bony fusion in pediatric patients with OCF and atlantoaxial fixation.

OBJECTIVE: Rikkunshito, an herbal medicine, is widely prescribed in Japan for the treatment of anorexia and functional dyspepsia, and has been reported to recover reductions in food intake caused by cisplatin. We investigated whether rikkunshito could improve chemotherapy-induced nausea and vomiting (CINV) and anorexia in patients treated with cisplatin. METHODS: Patients with uterine cervical or corpus cancer who were to receive cisplatin (50 mg/m² day 1) and paclitaxel (135 mg/m² day 0) as first-line chemotherapy were randomly assigned to the rikkunshito group receiving oral administration on days 0–13 with standard antiemetics, or the control group receiving antiemetics only. The primary endpoint was the rate of complete control (CC: no emesis, no rescue medication, and no significant nausea) in the overall phase (0–120 hours). Two-tailed p<0.20 was considered significant in the planned analysis. RESULTS: The CC rate in the overall phase was significantly higher in the rikkunshito group than in the control group (57.9% vs. 35.3%, p=0.175), as were the secondary endpoints: the CC rate in the delayed phase (24–120 hours), and the complete response (CR) rates (no emesis and no rescue medication) in the overall and delayed phases (63.2% vs. 35.3%, p=0.095; 84.2% vs. 52.9%, p=0.042; 84.2% vs. 52.9%, p=0.042, respectively), and time to treatment failure (p=0.059). Appetite assessed by visual analogue scale (VAS) appeared to be superior in the rikkunshito group from day 2 through day 6. CONCLUSION: Rikkunshito provided additive effect for the prevention of CINV and anorexia.
Administration, Oral ; Anorexia* ; Antiemetics ; Appetite ; Cisplatin* ; Drug Therapy ; Dyspepsia ; Eating ; Herbal Medicine* ; Humans ; Japan ; Nausea* ; Paclitaxel* ; Time-to-Treatment ; Vomiting*

OBJECTIVE: The aim of this study was to clarify the clinical significance of isolated tumor cells (ITCs) or micrometastasis (MM) in regional lymph nodes in patients with International Federation of Gynecology and Obstetrics (FIGO) stage I to II endometrial cancer. METHODS: In this study, a series of 63 patients with FIGO stage I to II were included, who had at least one of the following risk factors for recurrence: G3 endometrioid/serous/clear cell adenocarcinomas, deep myometrial invasion, cervical involvement, lympho-vascular space invasion, and positive peritoneal cytology. These cases were classified as intermediate-risk endometrial cancer. Ultrastaging by multiple slicing, staining with hematoxylin and eosin and cytokeratin, and microscopic examination was performed on regional lymph nodes that had been diagnosed as negative for metastases. RESULTS: Among 61 patients in whom paraffin-embedded block was available, ITC/MM was identified in nine patients (14.8%). Deep myometrial invasion was significantly associated with ITC/MM (p=0.028). ITC/MM was an independent risk factor for extrapelvic recurrence (hazard ratio, 17.9; 95% confidence interval [CI], 1.4 to 232.2). The 8-year overall survival (OS) and recurrence-free survival (RFS) rates were more than 20% lower in the ITC/MM group than in the node-negative group (OS, 71.4% vs. 91.9%; RFS, 55.6% vs. 84.0%), which were statistically not significant (OS, p=0.074; RFS, p=0.066). Time to recurrence tended to be longer in the ITC/MM group than in the node-negative group (median, 49 months vs. 16.5 months; p=0.080). CONCLUSIONS: It remains unclear whether ITC/MM have an adverse influence on prognosis of intermediate-risk endometrial cancer. A multicenter cooperative study is needed to clarify the clinical significance of ITC/MM.
Adenocarcinoma/pathology/*secondary ; Adult ; Aged ; Aged, 80 and over ; Endometrial Neoplasms/*pathology ; Female ; Follow-Up Studies ; Humans ; Kaplan-Meier Estimate ; Lymph Node Excision ; Lymphatic Metastasis ; Middle Aged ; Myometrium/pathology ; Neoplasm Invasiveness ; Neoplasm Micrometastasis/*pathology ; Neoplasm Recurrence, Local ; Neoplasm Staging ; Prognosis ; Retrospective Studies ; Risk Factors