[Effect of recombinant human thrombin for hemostasis in liver resection: a randomized controlled phase â ¢ clinical trial].

Objective: To evaluate the hemostatic efficacy, safety and immunogenicity of recombinant human thrombin in the treatment of liver wounds that still ooze after conventional surgical hemostasis. Methods: A multicenter, stratified randomized, double-blind, placebo-controlled phase Ⅲ trial with a planned enrollment of 510 subjects at 33 centers, with a 2∶1 randomization to the thrombin group versus the placebo group. An interim analysis will be conducted after approximately 70% of the subjects have completed the observation period. The primary efficacy endpoint was the rate of hemostasis within 6 minutes at the point of bleeding that could be evaluated. Safety analysis was performed one month after surgery, and the positive rates of anti-drug antibody (ADA) and neutralizing antibody were evaluated. Results: At the interim analysis, a total of 348 subjects had been randomized and received the study drug (215 were male and 133 were female). They were aged 19-69 (52.9±10.9)years. Among them, 232 were in the thrombin group and 116 were in the placebo group, with balanced and comparable demographics and baseline characteristics between the two groups. The hemostasis rate at 6 minutes was 71.6% (95%CI:65.75%-77.36%) in the thrombin group and 44.0% (95%CI: 34.93%-53.00%) in the placebo group, respectively (P<0.001). No grade≥3 drug-related adverse events and no drug-related deaths were reported from the study.No recombinant human thrombin-induced immunologically-enhanced ADA or immunologically-induced ADA was detected after topical use in subjects. Conclusion: Recombinant human thrombin has shown significant hemostatic efficacy and good safety in controlling bleeding during liver resection surgery, while also demonstrating low immunogenicity characteristics.

[Selection and effects of flap/myocutaneous flap repair methods for the defect after perineum tumor resection].

Objective: To explore the selection and effects of flap/myocutaneous flap repair methods for the defect after perineum tumor resection. Methods: From January 2011 to February 2017, 31 patients with vulvar tumor who were admitted to Hunan Cancer Hospital underwent repair of wound after tumor resection with various flaps/myocutaneous flaps. The patients were composed of 5 males and 26 females, aged 39-76 years, with 27 vulvar cancer and 4 Paget's disease in primary diseases. The size of defects after vulvar tumor radical resection ranged from 8.0 cm×4.5 cm to 27.5 cm×24.0 cm. According to the theory of perforasome, the defects were repaired by the external pudendal artery perforator flap, deep inferior epigastric artery perforator flap, rectus abdominis myocutaneous flap, anterolateral thigh flap, internal pudendal artery perforator flap, gracilis myocutaneous flap, and profunda artery perforator flap based on the specific size and location of perineum and groin where the defect was located. According to the blood supply zone of flap, totally 17 local translocation flaps, 18 axial flaps/myocutaneous flaps, and 7 V-Y advancement flaps were resected, with an area of 7.0 cm×4.0 cm to 21.0 cm×13.0 cm. All the flaps/myocutaneous flaps were transferred in pedicled fashion, and the donor sites were closed without tension. The number of flaps/myocutaneous flaps, wound closure, flaps/myocutaneous flaps survival, and follow-up were observed and recorded. Results: Altogether 42 flaps/myocutaneous flaps were harvested in 31 patients. Two flaps/myocutaneous flaps were used in 11 cases for large circular defect repair. All the defects achieved tension-free primary closure. The blood supply of 32 flaps/myocutaneous flaps was good, while insufficient blood supply was noted in the other 10 flaps/myocutaneous flaps. Seventeen flaps/myocutaneous flaps survived smoothly. Wound dehiscence occurred in 5 flaps/myocutaneous flaps 8 to 14 days postoperatively, which was healed with dressing change. Temporary congestion was noted in 7 flaps/myocutaneous flaps 2 to 5 days postoperatively, which recovered without special treatment. Three flaps/myocutaneous flaps had infection 7 to 15 days postoperatively, two of which recovered after dressing change, while the other one had partial necrosis and received debridement and direct closure. Two flaps/myocutaneous flaps were totally necrotic 8 to 15 days postoperatively, which were repaired with pedicled rectus abdominis myocutaneous flap after debridement. Seven flaps/myocutaneous flaps had partial necrosis 7 to 20 days postoperatively and were healed after dressing change. Twenty-four patients were followed up for 9-38 months. The color of flaps/myocutaneous flaps was similar to that of the surrounding skin, the shape of vulva was natural, the movement of hip joint was not limited, the function of micturition and defecation was not affected, and tumor recurrence was noted in 3 patients. Conclusions: For the complicated large defect after perineum tumor resection, the flexible application of different forms of flaps/myocutaneous flaps to repair according to different areas regains the appearance and function. However, there are many complications, so it is necessary to further strengthen the postoperative care.

Shorter hemodialysis duration is a risk factor for the recurrence of urothelial carcinoma of the bladder in patients on maintenance hemodialysis.

PURPOSE: To investigate the association of hemodialysis duration with the recurrence of urothelial carcinoma (UC) of the bladder and overall survival in patients undergoing maintenance hemodialysis (MHD). PATIENTS AND METHODS: 52 bladder cancer patients who underwent MHD at the Xiangya Hospital of The Central South University between 2001 and 2011 were enrolled in the study. The patients were divided into three groups according to hemodialysis duration, and patient mortality and tumor recurrence rates were analyzed. The association of hemodialysis duration with occurrence and recurrence of UC of the bladder was analyzed by Cox regression analysis. Survival was evaluated by the Kaplan-Meier method. RESULTS: Out of 6266 chronic hemodialysis patients, 52 patients had UC of the bladder after the initiation of hemodialysis for 6 months. The mean age at hemodialysis onset was 55 years (IQR 36, 71). The major complaints were painless gross hematuria and urethral bloody discharge. Tumors were generally large and multifocal. The standardized incidence ratio of UC of the bladder was 43.9 compared with general population, and it was higher in women (76.7) and in the age group 61-65 years (186.6). The mean hemodialysis duration before the diagnosis of bladder cancer was 32 months. 30 (57.7 %) patients received hemodialysis no more than 3 years, 10 (19.2 %) patients received hemodialysis between 3 and 6 years, and 12 (23.1 %) patients received hemodialysis for more than 6 years. CONCLUSION: Preoperative shorter hemodialysis duration is a risk factor for the occurrence and recurrence of UC of the bladder in patients undergoing MHD.

Effects of sleep deprivation on human postural control, subjective fatigue assessment and psychomotor performance.

This study aimed to investigate the effects of sleep deprivation on postural control, subjective fatigue assessment and psychomotor performance, and to assess the efficiency of an objective posturographic test as an indicator of mental fatigue. Postural sway using static posturography (Romberg's test), subjective fatigue assessment (Stanford Sleepiness Scale) and psychomotor performance (Sternberg dual-task test) were assessed in 12 subjects before and after 24 h of sustained wakefulness. After sustained wakefulness, the Romberg test parameters of circumference area and rectangle area with the eyes-closed, and standard deviation in the anterior-posterior direction with the eyes-open were significantly higher compared with baseline values (before sustained wakefulness). Subjective fatigue assessment scores were also significantly increased, while psychomotor performance was unchanged. Sleep deprivation can arouse a feeling of fatigue and can affect postural stability, hence an objective posturographic test score may be useful as an indicator of mental fatigue.

[Treatment of intestinal metaplasia and atypical hyperplasia of gastric mucosa with xiao wei yan powder].

UNLABELLED: 138 cases of intestinal metaplasia (IM) and 104 cases of atypical hyperplasia (AH) of the gastric mucosa of chronic gastritis treated with Xiao Wei Yan Powder (XWYP) were reported. The diagnoses were based on the pathological examination of gastric antrum biopsy specimens. The cases were randomly divided into treated group and control group. The XWYP contained Smilax glabrae, Hedyotis diffusae, Taraxacum mongolicum, Caesalpinia sappan, Paeonia alba, Cyperus rotundus, Bletilla striata, Glycyrrhiza uralensis etc., and was prepared in powder form, taken orally 5-7g tid. After 2-4 months of administration, gastroscopic and pathological examinations were repeated. RESULTS: In treated group, the total effective rate of IM was 91.3% and that of the AH was 92.16%, while in control group, they were 21.3% and 14.46% respectively (P < 0.01). It denoated that XWYP had marked therapeutic effects for IM and AH. The animal experiments revealed no toxic effect, so safety guarantee was provided for its clinical application.