BACKGROUND: LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer. METHODS: We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels. RESULTS: On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]). CONCLUSION: LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile. TRIAL REGISTRATION ClinicalTrials.gov, NCT04563936.
Humans ; Male ; Antineoplastic Agents, Hormonal/therapeutic use* ; East Asian People ; Gonadotropin-Releasing Hormone/agonists* ; Goserelin/therapeutic use* ; Prostate-Specific Antigen ; Prostatic Neoplasms/drug therapy* ; Testosterone

Objective: To evaluate the effect of traditional Chinese medicine (TCM) on anthracycline-induced car-diotoxicity (AIC) in animal models. Methods: Separate systematic searches for preclinical studies were performed in the PubMed, EMBASE, Web of Science, Chinese National Knowledge Infrastructure, Chinese Biomedical Database, Chinese Sci-entific Journal Database, and Wanfang Data from inception to August 2019. The primary outcomes were echocardiography, serum assays for myocardial enzymograms, histological assessments, and electro-cardiograms. The secondary outcomes mainly included body weight and safety evaluations. The protocol is registered on PROSPERO (CRD42019145819). RevMan (V.5.3) was used for meta-analysis. Results: We identified 10 studies from 9 international scientific publications describing the efficacy of TCM on AIC animal models. All the included studies reported that, compared with animal model without any intervention, TCM significantly improved ventricular function, cardiac biomarkers, electrocardio-graph results, and cardiac fibrosis. Improved survival rates and body mass indices were also observed with TCM. We further pooled the available data from four studies (63 animals) for the meta-analysis and the results showed that, compared with models without any intervention, TCM significantly increased the ejection fraction by 14.13％ (95％ CI, 9.96-18.29) and fraction shortening by 8.66％ (95％ CI, 6.05-11.26). Creatine kinase-MB (SMD = -2.49, 95％ CI: -3.12 to -1.85) and lactate dehydrogenase (SMD =-2.78, 95％ CI:-3.45 to-2.12) were also significantly decreased by TCM. Conclusions: TCM is effective in improving AIC in animal models and has tremendous potential to be translated to treat AIC in clinical practice. Additionally, the systematic review and meta-analysis of an-imal experiments may be valuable in enhancing and guiding animal experiments and promoting the transformation of the results.

Fecal incontinence is a common but refractory anorectal disorder,seriously affecting the quality of life of patients. Although there are many methods for the treatment of fecal incontinence, the efficacy is uncertain and the mechanism of action is not fully clear. This article summarizes several commonly used modeling method of typical fecal incontinence models at home and abroad, and explores in depth, laying the foundation for further studies on fecal incontinence.

Traditional Chinese surgical treatment "suture-dragging" therapy is based on medical thread therapy and tight seton drainage in combination of minimal invasive surgical principle. It can preserve the integrity of anal sphincter musculature involved in fistulous tract or abscess and maintain anal function. This article not only describes in detail about the operation points and mechanisms of "suture-dragging" therapy of anorectal fistula, but also reviews the application and modification of anorectal disease.
Abscess ; Drainage ; Humans ; Rectal Fistula ; Suture Techniques ; Sutures

Objective To investigate the impact of paced QRS duration (pQRSd) on heart function in patients with right ventricular apical pacing. Methods Seventy-six patients with Ⅲ° atrioventricular block received pacemaker treatment were enrolled and randomized into group A (pQRSd < 190 ms, n = 52) and group B(pQRSd≥ 190 ms, n = 24). The concentration of brain natriuretic peptide (BNP),parameters of left atrial diameter (LAD), left ventricular ejection fracetion (LVEF), left ventricular end diastolic diameter (LVEDD), left ventricular end systolic dimension (LVEDD) were measured before operation, at 12 months and 24 months after implanting, respectively. The parameters of echocardiography assay, the concentration of BNP and the incidence of heart failure event after implantation were compared between two groups. Results At 12 months after implanting, LVEF of the patients in the group B decreased significantly compared with that of group A (P < 0.05). However, the echocardiography paramenters and the concentration of BNP were not significantly different between the two groups (P > 0.05). At 24 months after implanting, LAD、LVEDD、LVESD of group B increased significantly compared with those of group A [LAD,( 44.5 ± 6.2) mm vs (41.6 ± 5.1) mm, LVEDD, (52.7 ± 9.3) mm vs (48.2 ± 7.5) mm, LVESD, (37.5 ± 5.6) mm vs (33.8 ± 4.9)mm, each P < 0.05, respectively]. The concentration of BNP of group B increased significantly [(408.2 ± 102.1)ng / L vs (243.7 ± 92.8)ng / L, P < 0.001], and LVEF of the patients in group B decreased significantly compared with those of group A [(46.3 ± 6.8)% vs (51.6 ± 5.2)%, P < 0.001], respectively. No significant difference in the incidence of heart failure event (41.7% vs 26.9%, P > 0.05)between two groups during 24-month follow-up. Conclusion The prolonged paced QRS duration has a detrimental effect on long-term cardiac function during RVA pacing in patients with Ⅲ°atrioventricular block.

ObjectiveTo observe the clinical effect of Kangxiuke apozem in the treatment of severe bum shock.Methods40 patients of severe burn shock were randomly divided into a treatment group and a control group,with 20 patients in each group.All the patients were treated by the same route of counter-shock therapy,and the treatment group was additionally given Kangxiuke apozem (nasal feeding,qd,150 ml/d).Level of blood lactic acid,heart rate and urinary volume were evaluated by time.Main shock symptoms,including restlessness,hydrodipsia,perspiration and coldness,were observed.ResultsThe treatment group was significantly superior to the control group in the amelioration of blood lactic acid,heart rate and urinary volume ( t =10.485、3.219、7.429,P＜ 0.01 ).The symptomatic extinction of restlessness,hydrodipsia,perspiration and coldness in the extremities in the treatment group were significantly superior to those in the control group (x2=10.16、7.37、5.63、4.29,P＜0.05).ConclusionAt the same time of routine counter-shock therapy,thereby prompt burn patients to smoothly go through shock period and decreas late complications.

Objective: This study was to develop an experimental rat model of subcutaneous fistula induced by bacteria infection and treat it with thread-dragging therapy. Methods: A spring-gauze was surgically implanted into 24 male Sprague-Dawley rats' dorsal muscles, respectively, then mixed Staphylococcus aureus and Escherichia coli were injected into the spring-gauze. After 45 d, all the spring-gauzes were removed from the rats under anesthesia. X-ray and ultrasound were performed to assess the fistula tract. Each rat was examined by a fistula probe and four rats were randomly selected for histological assessment. The residual rats were randomly divided into two groups. Group A was treated with thread-dragging therapy, and group B was treated with fistulotomy. The healing time and body weight of the two groups were compared. Results: On the 45th day of the spring-gauze implantation, imaging assessment proved a tract with two openings in all rats and histological results proved that lumen and surrounding granulation tissue with epithelium were similar to the features of fistula in human beings. The mean healing time of rats in group A was shorter than that of the rats in group B (P<0.01). The body weight of rats in group A was heavier than that of the rats in group B on the 7th and 14th day after surgery, respectively (P<0.05). Conclusion: A rat model of subcutaneous fistula induced by mixed Staphylococcus aureus and Escherichia coli infection was successfully established. Traditional Chinese medicine thread-dragging therapy is less invasive and safer than fistulotomy.

Abstract: There were more and more patients suffered from perianal abscess. The patient's condition will become even worse if the patients cannot be treated properly. Selecting proper operation method according to special condition is the key point of increasing curative effect, decreasing suffering and relapse rate and promoting quality of life of patients. The authors summarized operation methods, including abscess incision drainage, radical incision and thread-drawing, and staging incision and thread-drawing, etc. in treating perianal abscess in clinic.

Background: Basic principles of clinical trials of nonpharmacologic treatment are similar to those of pharmacologic treatment, but its some special characteristics should be discussed. Objective: To explore the design characteristics of clinical surgery trial through the example of tunnel thread-drawing therapy for simple anal fistula. Design, setting, participants and interventions: The clinical trial was designed as a prospective, controlled, randomized multicenter trial. The patients came from Longhua Hospital, Yueyang Hospital of Integrated Traditional Chinese and Western medicine, and Affiliated Hospital of Jianxi University of Traditional Chinese Medicine. Stratified random was performed according to the subtype of anal fistula including low and high anal fistula. Full analysis set was applied to analyze the baseline data, and per protocol set was used in efficacy and safety analysis. The intervention was tunnel thread-drawing method. Classical therapy of thread-drawing method was employed as positive control. Main outcome measures: The primary outcomes were course of recovery and cure rate. Quality of life score was used as secondary outcome and anal maximum constriction pressure was considered as safety outcome. Results: Optimal efficiency testing method was used to estimate sample size. A total of 244 subjects were recruited and 236 subjects completed the trial. There was no significant difference in the cure rate of the low and high anal fistula between the treatment group and control group. There was a significant difference in the course of recovery in the patients with low and high anal fistula between treatment group and control group (P<0.01). To the patients with low anal fistula, the course of recovery in the treatment group was (22.26+/-8.67) d, and the course of recovery in the control group was (31.41+/-11.39) d. To the patients with high anal fistula, the course of recovery in the treatment group was (24.73+/-8.15) d, and the course of recovery in the control group was (32.20+/-12.60) d. There was no significant difference in the scores of quality of life in the patients with low anal fistula between the treatment group and control group (P>0.05). The trial showed that the tunnel thread-drawing therapy was significantly more effective than classical method for improving the anal sphincter function and patient satisfaction with treatment in the patients with high anal fistula. However the other items of quality of life in the two groups did not show significant difference. There was no any adverse event report in each group. There was no significant difference in the anal maximum constriction pressure in the treatment group before and after the operation. Conclusion: The trial shows that the tunnel thread-drawing therapy for simple anal fistula can shorten the course of recovery and improve the patients' quality of life. The training about surgical intervention and clinical implementation program is important in clinical surgery trial. Blind is absolutely difficult to implement and placebo cannot be used in this kind of trial.