Background: This study aimed to determine whether a shorter high-dose rifampicin regimen is non-inferior to the standard 6-month tuberculosis regimen. Methods: This multicenter, randomized, open-label, non-inferiority trial enrolled participants with respiratory specimen positivity by Xpert MTB/RIF assay or Mycobacterium tuberculosis culture without rifampicin-resistance. Participants were randomized at 1:1 to the investigational or control group. The investigational group received high-dose rifampicin (30 mg/kg/day), isoniazid, and pyrazinamide until culture conversion, followed by high-dose rifampicin and isoniazid for 12 weeks. The control group received the standard 6-month regimen. The primary outcome was the rate of unfavorable outcomes at 18 months post-randomization. The non-inferiority margin was set at <6% difference in unfavorable outcomes rates. The study is registered with ClinicalTrials.gov (NCT04485156) Results: Between 4 November 2020 and 3 January 2022, 76 participants were enrolled. Of these, 58 were included in the modified intention-to-treat analysis. Unfavorable outcomes occurred in 10 (31.3%) of 32 in the control group and 10 (38.5%) of 26 in the investigational group. The difference was 7.2% (95% confidence interval, ∞ to 31.9%), failing to prove non-inferiority. Serious adverse events and grade 3 or higher adverse events did not differ between the groups. Conclusion The shorter high-dose rifampicin regimen failed to demonstrate non-inferiority but had an acceptable safety profile.

Background: This study aimed to determine whether a shorter high-dose rifampicin regimen is non-inferior to the standard 6-month tuberculosis regimen. Methods: This multicenter, randomized, open-label, non-inferiority trial enrolled participants with respiratory specimen positivity by Xpert MTB/RIF assay or Mycobacterium tuberculosis culture without rifampicin-resistance. Participants were randomized at 1:1 to the investigational or control group. The investigational group received high-dose rifampicin (30 mg/kg/day), isoniazid, and pyrazinamide until culture conversion, followed by high-dose rifampicin and isoniazid for 12 weeks. The control group received the standard 6-month regimen. The primary outcome was the rate of unfavorable outcomes at 18 months post-randomization. The non-inferiority margin was set at <6% difference in unfavorable outcomes rates. The study is registered with ClinicalTrials.gov (NCT04485156) Results: Between 4 November 2020 and 3 January 2022, 76 participants were enrolled. Of these, 58 were included in the modified intention-to-treat analysis. Unfavorable outcomes occurred in 10 (31.3%) of 32 in the control group and 10 (38.5%) of 26 in the investigational group. The difference was 7.2% (95% confidence interval, ∞ to 31.9%), failing to prove non-inferiority. Serious adverse events and grade 3 or higher adverse events did not differ between the groups. Conclusion The shorter high-dose rifampicin regimen failed to demonstrate non-inferiority but had an acceptable safety profile.

Background: This study aimed to determine whether a shorter high-dose rifampicin regimen is non-inferior to the standard 6-month tuberculosis regimen. Methods: This multicenter, randomized, open-label, non-inferiority trial enrolled participants with respiratory specimen positivity by Xpert MTB/RIF assay or Mycobacterium tuberculosis culture without rifampicin-resistance. Participants were randomized at 1:1 to the investigational or control group. The investigational group received high-dose rifampicin (30 mg/kg/day), isoniazid, and pyrazinamide until culture conversion, followed by high-dose rifampicin and isoniazid for 12 weeks. The control group received the standard 6-month regimen. The primary outcome was the rate of unfavorable outcomes at 18 months post-randomization. The non-inferiority margin was set at <6% difference in unfavorable outcomes rates. The study is registered with ClinicalTrials.gov (NCT04485156) Results: Between 4 November 2020 and 3 January 2022, 76 participants were enrolled. Of these, 58 were included in the modified intention-to-treat analysis. Unfavorable outcomes occurred in 10 (31.3%) of 32 in the control group and 10 (38.5%) of 26 in the investigational group. The difference was 7.2% (95% confidence interval, ∞ to 31.9%), failing to prove non-inferiority. Serious adverse events and grade 3 or higher adverse events did not differ between the groups. Conclusion The shorter high-dose rifampicin regimen failed to demonstrate non-inferiority but had an acceptable safety profile.

Background: This study aimed to determine whether a shorter high-dose rifampicin regimen is non-inferior to the standard 6-month tuberculosis regimen. Methods: This multicenter, randomized, open-label, non-inferiority trial enrolled participants with respiratory specimen positivity by Xpert MTB/RIF assay or Mycobacterium tuberculosis culture without rifampicin-resistance. Participants were randomized at 1:1 to the investigational or control group. The investigational group received high-dose rifampicin (30 mg/kg/day), isoniazid, and pyrazinamide until culture conversion, followed by high-dose rifampicin and isoniazid for 12 weeks. The control group received the standard 6-month regimen. The primary outcome was the rate of unfavorable outcomes at 18 months post-randomization. The non-inferiority margin was set at <6% difference in unfavorable outcomes rates. The study is registered with ClinicalTrials.gov (NCT04485156) Results: Between 4 November 2020 and 3 January 2022, 76 participants were enrolled. Of these, 58 were included in the modified intention-to-treat analysis. Unfavorable outcomes occurred in 10 (31.3%) of 32 in the control group and 10 (38.5%) of 26 in the investigational group. The difference was 7.2% (95% confidence interval, ∞ to 31.9%), failing to prove non-inferiority. Serious adverse events and grade 3 or higher adverse events did not differ between the groups. Conclusion The shorter high-dose rifampicin regimen failed to demonstrate non-inferiority but had an acceptable safety profile.

Background: This study aimed to determine whether a shorter high-dose rifampicin regimen is non-inferior to the standard 6-month tuberculosis regimen. Methods: This multicenter, randomized, open-label, non-inferiority trial enrolled participants with respiratory specimen positivity by Xpert MTB/RIF assay or Mycobacterium tuberculosis culture without rifampicin-resistance. Participants were randomized at 1:1 to the investigational or control group. The investigational group received high-dose rifampicin (30 mg/kg/day), isoniazid, and pyrazinamide until culture conversion, followed by high-dose rifampicin and isoniazid for 12 weeks. The control group received the standard 6-month regimen. The primary outcome was the rate of unfavorable outcomes at 18 months post-randomization. The non-inferiority margin was set at <6% difference in unfavorable outcomes rates. The study is registered with ClinicalTrials.gov (NCT04485156) Results: Between 4 November 2020 and 3 January 2022, 76 participants were enrolled. Of these, 58 were included in the modified intention-to-treat analysis. Unfavorable outcomes occurred in 10 (31.3%) of 32 in the control group and 10 (38.5%) of 26 in the investigational group. The difference was 7.2% (95% confidence interval, ∞ to 31.9%), failing to prove non-inferiority. Serious adverse events and grade 3 or higher adverse events did not differ between the groups. Conclusion The shorter high-dose rifampicin regimen failed to demonstrate non-inferiority but had an acceptable safety profile.

OBJECTIVES: Many of the patients with type 2 diabetes are associated with sleep problems, and the rate of insomnia is known to be higher in the general population. The aims of this study were to know the frequency and clnical characteristics of insomnia, and related variables to insomnia in patients diagnosed with type 2 diabetes. METHODS: For 99 patients from 18 to 80 years of age (65 males and 34 females) with type 2 diabetes, interviews were performed. Total sleep time and sleep latency was evaluated. Insomnia was evaluated using the Korean Version of the Insomnia Severity Index (ISI-K). Severity of depressive symptoms were evaluted using the Korean version of the Hamilton Depression Scale (K-HDRM). According to the cutoff score of 15.5 on the ISI-K, subjects were divided into the group of type 2 diabetics with insomnia (N=34) and those without insomnia (N=65) at first, and then statistically analyzed. RESULTS: TInsomnia could be found in 34.34% of type 2 diabetics. Type 2 diabetics with insomnia had significantly more single or divorced (respectively 11.8%, p<0.05), higher total scores of the K-HDRS (11.76±5.52, p<0.001), shorter total sleep time (5.35±2.00 hours, p<0.001), and longer sleep latency (50.29±33.80 minutes, p<0.001). The all item scores of the ISI-K in type 2 diabetics with insomnia were significantly higher than those in type 2 diabetics without insomnia, that is, total (18.38±2.69), A1 (Initial insomnia) (2.97±0.76), A2 (Middle insomnia) (3.06±0.69), A3 (Terminal insomnia) (2.76±0.61), B (Satisfaction) (3.18±0.72), C (Interference) (2.09±0.97), D (Noticeability) (2.12±1.09) and E (Distress) (2.21±0.81) (respectively p<0.001). Variables associated with insomnia in type 2 diabetics were as following. Age had significant negative correlation with A3 items of the ISI-K (β=−0.241, p<0.05). Total scores of the K-HDRS had significant positive correlation, while total sleep time had significant negative correlation with all items of the ISI-K (respectively p<0.05). Sleep latency had significant positive correlation with total,, A1, B and E item scores of the ISI-K (respectively p<0.05). CONCLUSIONS: Insomnia was found in about 1/3 of type 2 diabetics. According to the presence of insomnia, clinical characteristics including sleep quality as well as quantity seemed to be different. Because depression seemed to be correlated with insomnia, clinicians should pay attention to early detection and intervention of depression among type 2 diabetics
Depression ; Divorce ; Humans ; Male ; Sleep Initiation and Maintenance Disorders

The infection status of Centrocestus armatus metacercariae (CaMc) was broadly surveyed in freshwater fishes from major river systems in the Republic of Korea (Korea) during 2008–2017. A total of 14,977 fishes was caught and examined by the artificial digestion method. CaMc were detected in 3,818 (97.1%) (2,114 Z. platypus: 96.1% and 1,704 Z. temminckii: 98.4%) out of 3,932 Zacco spp. examined and their density was 1,867 (2,109 in Z. platypus and 1,567 in Z. temminckii) per fish infected. The prevalences with CaMc were high, 93.7–100%, in Zacco spp. from all surveyed areas. However, their densities were more or less different by the surveyed areas and fish species. They were most high in Nakdong-gang in Gyeongsangnam-do (4,201 in average), and followed by Geum-gang (2,343), Nakdong-gang in Gyeongsangbuk-do (1,623), Han-gang (1,564), Tamjin-gang and Yeongsan-gang (1,540), streams in the east coast (1,028), Seomjin-gang (488) and Mangyeong-gang (170). In another species of rasborinid fish, Opsariichthys uncirostris amurensis, CaMc were detected in 222 (74.8%) out of 297 ones examined and their density was 278 (1–4,480) per fish infected. CaMc were also detected in total 41 fish species except for the rasborinid fish, Z. platypus, Z. temminckii and O. uncirostris amurensis. Conclusively, it was confirmed that among the 3 species of rasborinid fish, Z. platypus and Z. temminckii are highly prevalent and O. uncirostris amurensis is moderately prevalent with CaMc. Additionally, we could know that variety of fish species act as the second intermediate hosts of C. armatus in Korea.
Digestion ; Fishes ; Fresh Water ; Gyeongsangbuk-do ; Gyeongsangnam-do ; Korea ; Metacercariae ; Methods ; Platypus ; Prevalence ; Republic of Korea ; Rivers ; Water

PURPOSE: Although the standard treatment for patients with locally advanced rectal cancer managed by preoperative chemoradiotherapy (CRT) is a radical resection, local excisions are used in highly-selective cases. Recently, transanal minimally-invasive surgery (TAMIS) has emerged as a feasible technique for local excision of midrectal lesions. We assess the feasibility of using TAMIS to treat patients with locally advanced rectal cancer who showed good response to CRT. METHODS: From October 2010 to June 2013, 35 consecutive patients with rectal cancer managed by using preoperative CRT underwent TAMIS. After a single-incision laparoscopic surgery port had been introduced into the anal canal, a full-thickness local excision with conventional laparoscopic instruments was performed. We retrospectively reviewed a prospectively collected database of these cases. RESULTS: Of the 35 patients analyzed, 18 showed pathologic complete responses and 17 had residual lesions (2 ypTis, 4 ypT1, 9 ypT2, and 2 ypT3); 34 (97.1%) showed clear deep, lateral margins. The median distance of lesions from the anal verge was 5 cm. All procedures were completed laparoscopically, and the median operating time was 84 minutes. No intraoperative events or morbidities were seen in any of the patients, except one with wound dehiscence, who was treated conservatively. The median postoperative hospital stay and follow-up period were 4 days and 36 months, respectively. During the study period, no patients died, but 5 (14.3%) experienced recurrence, including one recurrence at the TAMIS site. CONCLUSION: TAMIS seems to be a feasible, safe modality for treating patients with locally advanced rectal cancer who show good response to preoperative CRT.
Anal Canal ; Chemoradiotherapy* ; Follow-Up Studies ; Humans ; Laparoscopy ; Length of Stay ; Minimally Invasive Surgical Procedures ; Prospective Studies ; Rectal Neoplasms* ; Recurrence ; Retrospective Studies ; Wounds and Injuries

PURPOSE: To investigate patterns of recurrence and oncologic outcomes after recurrence between preoperative and postoperative chemoradiotherapy (CRT). METHODS: Records of patients with stage II or III locally advanced rectal cancer seen between January 2000 and December 2010 were analyzed. The outcomes for patients undergoing preoperative CRT followed by radical resection (n = 466) were compared with outcomes of patients matched for sex, age, and stage who had surgery and then postoperative CRT (n = 466). Recurrence rates and sites, treatment of recurrence, and oncologic outcomes after recurrence were investigated. The rate of sphincter preservation and permanent stoma formation were also evaluated. RESULTS: Recurrence occurred in 124 and 140 patients in the pre- and postoperative CRT groups, respectively. The local and systemic recurrence rates were 3.6% and 20.8%, respectively, in the preoperative CRT group and 3.0% and 25.3%, respectively, in the postoperative CRT group (P = 0.245). Time to recurrence was longer in the postoperative CRT group (19 months vs. 24.2 months, P = 0.029). The overall rates of sphincter preservation (sphincter preservation operation and postoperative permanent stoma formation) did not significantly different between the two groups (P = 0.381). The 5-year overall survival rate after recurrence did not differ between the two groups (25.6% vs. 18.6%, P = 0.051). CONCLUSION: Preoperative and postoperative CRT are both safe and suitable treatment methods for rectal cancer, so the choice can be tailored to the patient's situation.
Case-Control Studies* ; Chemoradiotherapy* ; Colorectal Surgery ; Humans ; Rectal Neoplasms* ; Recurrence ; Survival Rate ; Treatment Outcome

PURPOSE: We compared oncologic outcomes between surgery and radiofrequency ablation (RFA) in patients with metachronous isolated hepatic metastases from colorectal cancer.METHODS: We retrospectively analyzed 123 patients treated with hepatic resection and 82 patients treated with RFA for metachronous hepatic metastases between April 2000 and October 2011. Re-recurrence pattern and 3-year re-recurrence free survival (RFS) rate compared between groups. Factors associated with RFS were evaluated.RESULTS: The patients in the two groups were similar in age, gender, location of primary tumor, disease-free interval to hepatic metastasis, pathological stage of primary disease, number of metastatic lesions. The mean diameter of the biggest hepatic metastatic lesion was significantly larger in the resection group than in the RFA group. The RFS rate after hepatic metastasis treatment was significantly higher in the resection group than in the RFA group (48.6% vs. 33.7%, respectively; P=0.015). Marginal recurrence at the RFA site was observed in 14 of the 82 patients (17.1%). The size and number of metastatic lesions, stage of primary disease, disease-free interval to hepatic metastasis, and modality of treatment were confirmed as re-recurrence-associated factors after hepatic metastasis treatment. Among patients with solitary metastases of ≤3 cm, the RFS rate was not different between the resection and RFA groups (52.4% vs. 53.4%, respectively; P=0.491).CONCLUSION: Surgical resection for metachronous hepatic metastases achieved higher RFS and lower local recurrence rates. However, the RFS rate in patients with a solitary hepatic metastasis of ≤3 cm was similar between the resection and RFA groups.
Catheter Ablation ; Colorectal Neoplasms ; Hepatectomy ; Humans ; Liver ; Neoplasm Metastasis ; Recurrence ; Retrospective Studies