Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial / 中华医学杂志(英文版)

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.

Design and application of medical institutions′ intelligent medical insurance audit system / 中华医院管理杂志

In recent years, the medical insurance coverage of China has been increased significantly, and the medical insurance policies have been launched continuously, so the traditional manual audit method is unable to support medical institutions to effectively supervise the medical insurance fund. In view of this situation, a tertiary hospital in Beijing had successfully built an intelligent medical insurance audit system for drugs, diagnosis and treatment projects under key supervision, realized the prior audit and in-process control of the illegal use of medical insurance funds, through the establishment of intelligent audit rules, the design of audit trigger points and the interception level of illegal medical orders, and the establishment of a pre-operational preparation system and continuous improvement mechanism. In March 2021, the hospital officially launched the system. After the application of the system, the amount and quantity of outpatient medical insurance refusal from April to September 2021 were 10 587 yuan and 72 respectively, which decreased by 79.21% and 77.50% compared with the same period in 2020. This system effectively improved the quality and efficiency of medical insurance fund supervision.

The efficacy of intravesical instillation of domestic BCG versus epirubicin in the prevention of recurrence of intermediate-risk or high-risk non-muscular invasive bladder cancer and predictive factors of BCG instillation: a randomized, controlled, multi-center clinical trial with 2 years’ follow-up / 中华泌尿外科杂志

Objective:To investigate the 2 years’ efficacy of intravesical instillation of domestic BCG versus epirubicin in the prevention of recurrence of intermediate-risk or high-risk non-muscular invasive bladder cancer and predictive factors of BCG instillation.Methods:From July 2015 to June 2020, 18-75 years old patients with moderate to high-risk non muscle invasive bladder cancer (NMIBC) confirmed by pathological examination were involved. The ECOG score was 0-2. Exclusion criteria included ①immune deficiency or impairment (such as AIDS), using immunosuppressive drugs or radiotherapy, suspected allergic to BCG or epirubicin or excipients of the two drugs, fever or acute infectious diseases including active tuberculosis or receiving anti tuberculosis treatment, with severe chronic cardiovascular and cerebrovascular diseases or chronic kidney disease; ②combined with other urogenital system tumors or other organ tumors; ③combined with muscle invasive bladder urothelial carcinoma (≥T 2); ④undergoing chemotherapy, radiotherapy or immunotherapy within 4 weeks (immediate instillation after surgery not included); ⑤ pregnant or lactating women; ⑥ comfirmed or suspected bladder perforation; ⑦gross hematuria; ⑧cystitis with severe bladder irritation that may affect the evaluation; ⑨participat in other clinical trials within 3 months; ⑩alcohol or drug addiction; ?any risk factors that may increasing the risk of patients. Epirubicin 50 mg was irrigated immediately after the operation(TURBT or laser resection). The patients were randomly divided into BCG15 group, BCG19 group and epirubicin group by the ratio of 2∶2∶1, and the patients were maintained intravescical instillation for 1 year. The recurrence and adverse events of the three groups were compared. Univariate and multivariate analysis was performed to predict the risk factors of BCG irrigated therapy failure. Result:By June 15, 2020, the median follow-up duration was 22.1 months(12.1, 32.3), and there was no statistical difference between the groups ( P=0.9024). There were 274 patients enrolled in BCG19 group, 277 patients enrolled in BCG15 group and 130 patients enrolled in the epirubicin group. The drop-off rate was 16.6%(113 cases)and made no difference between groups( P=0.6222). There were no significant difference in age, gender, BMI, or ECOG score( P>0.05). During the follow-up, 116 cases was detected recurrence or progression. The recurrence rate of the three groups was 14.2% and 14.8% in BCG19 group and BCG15 group, and 27.7% in the epirubicin group. There was no difference in recurrence rate between BCG19 and BCG15 group( P=0.9464). The recurrence rate of BCG19 group was lower than that of the epirubicin group ( P=0.0017). The recurrence rate of BCG15 group was lower than that of the epirubicin group ( P=0.0020). There was no difference in the cumulative recurrence free survival rate between BCG19 and BCG15 group (95% CI0.57-1.46, P=0.7173). The cumulative recurrence free survival rate of BCG 19 group was better than that of the epirubicin group( HR=0.439, 95% CI0.26-0.74, P=0.0006), and the cumulative recurrence free survival rate of BCG15 group was better than that of the epirubicin group ( HR=0.448, 95% CI0.29-0.80, P=0.0021). The total incidence of adverse events in 19 BCG19, BCG15 and epirubicin group were 74.5%, 72.6% and 69.8% respectively. There was no difference in the incidence of adverse events between BCG19 and BCG15 group( P=0.6153). The incidence of adverse events in epirubicin group was lower than that of BCG19( P=0.0051) and BCG15( P=0.0167) groups.There was no significant difference in the incidence of serious adverse events (SAE) among the three groups ( P=0.5064). Log rank test univariate analysis and Cox risk regression model multivariate analysis showed that the history of bladder cancer recurrence( HR=6.397, 95% CI1.95-20.94, P=0.0001)was independent risk factor for BCG irrigation failure. Conclusions:The 2 years’ efficacy of intravesical instillation of domestic BCG is better than than of epirubicin with good tolerance and safety. There is no difference between BCG19 and BCG15 group. BCG doesn’t increase SAE compared with epirubicin. Recurrence status was an independent prognostic factor regarding recurrence-free survival.

Analysis of clinical features of ophthalmic and cerebral artery occlusion after facial cosmetic injection / 中华眼底病杂志

Objective To observe the clinical characteristics of ophthalmic and cerebral artery occlusion after facial cosmetic injection.Methods A retrospective case study. Twenty patients (20 eyes) with ophthalmic and cerebral artery occlusion in Department of Ophtalmology, The Fourth Hospital of Xi'an from February 2014 to December 2016 were enrolled in this study. There were 2 males (2 eyes) and 18 females (18 eyes). They aged from 21 to 41 years, with the mean age of 29.8±1.4 years. The disease courses was ranged from 3.5 hours to 21 days, with the mean of 40 hours. Facial cosmetic injections of all patients were performed at out-of-hospital beauty institutions. The visual impairment was associated with eyelid pain 1 to 10 minutes after injection.There were 12 right eyes and 8 left eyes.The injection materials, 18 patients were hyaluronic acid and 2 patients were autologous fat, respectively. At the injection site, 13 patients were sacral, 4 patients were nasal, and 3 patients were frontal. The concentration and dose of the injected filler were not known. All patients underwent vision, slit lamp microscope, fundus color photography, visual field, FFA, OCT, and brain CT, magnetic resonance angiography (MRA) examination.Results The visual acuity was ranged from no light perception to 1.0. Among the 20 eyes, 3 eyes (15％) were obstructed by simple ophthalmic artery; 5 eyes (25％) were obstructed by ophthalmic artery combined with cerebral artery; 7 eyes (35％) were obstructed by simple retinal artery occlusion (RAO) alone, which including central RAO (CRAO, 4 eyes), hemi-lateral artery obstruction (1 eye) and branch RAO (2 eyes); 1 eye (5％) was CRAO with ciliary artery branch obstruction; 1 eye (5％) was branch artery occlusion with ischemic optic neuropathy; 2 eyes (10％) were CRAO with nasal dorsal artery occlusion; 1 eye (5％) was CRAO, posterior ciliary artery obstruction and right middle cerebral artery occlusion. Among 20 patients, 4 patients (20％) had eye movement disorder and eyelid skin bun; 2 patients (10％) had facial pain and nasal skin ischemic necrosis. MRA revealed 6 patients (30％) of new intracranial ischemic lesions. Among them, 5 patients of hyaluronic acid injection showed asymptomatic small blood vessel embolization; 1 patient of autologous fat injection showed ophthalmary artery occlusion, cerebral artery occlusion, ipsilateral eye blindness, eye movement disorder and contralateral limb hemiplegia.Conclusion Facial cosmetic injection can cause severe iatrogenic complications such as RAO, ciliary artery occlusion, ischemic optic neuropathy, ophthalmic artery occlusion, and cerebral artery occlusion.

Application values of flexible ureteroscope in treatment of retained kidney calculi after percutaneous nephrolithotomy / 中国医师进修杂志

Objective To explore the effect of flexible ureteroscope in treatment of retained kidney calculi after percutaneous nephrolithotomy.Methods Thirty-six patients with retained kidney calculi after percutaneous nephrolithotomy who were treated with flexible ureteroscope were selected,and clinical data of the patients were retrospectively analyzed.Results In the 36 patients,26 patients were through the percutaneous nephroscope channel,and 10 patients were through the ureter channel.Except for 1 patient who stopped the operation because of poor visibility caused by active bleeding in percutaneous nephroscope channel lithotripsy 7 d after percutaneous nephrolithotomy,other patients did not appear severe complication.All the patients were rechecked plain abdominal radiograph the second,seventh and fourteenth day after this operation,and the eradication rates of calculi were 13.9％ (5/36),69.4％ (25/36) and 94.4％ (34/36).Two patients still had less than 0.4 cm retained calculi in lower renal calices and were followed up.Conclusions The retained kidney calculi after percutaneous nephrolithotomy can be effectually treated by flexible ureteroscope,and it can avoid secondary percutaneous nephrolithotomy or multichannel percutaneous nephrolithotomy,and inprove the eradication rate of complex kidney calculi by percutaneous nephrolithotomy.The method is economical,safe,simple and with little injury,and it is the effective supplement protocol of percutaneous nephrolithotomy.

Practice and experiences on reengineering of the settlement business process with Diagnosis Related Groups-prospective payment in the hospital / 中华医院管理杂志

The hospital designed a new business process according to the business process reengineering theory and requirement of Diagnosis Related Groups-prospective payment.This new process has scored good outcomes following adjustment of department functions,staffing and equipment installation,as well as process optimization,and policy explanations.

Analysis of the distribution of cerebral ischemic stroke in different gender by TOAST subtype / 中国医师进修杂志

ObjectiveTo analyze the distribution of cerebral ischemic stroke by TOAST subtype in different gender and provide basis for prevention. MethodsAll of 463 patients with cerebral ischemic stroke from October 2007 October 2009 were involved in this study. Two hundred and seventy-nine patients were male (male group),and 184 patients were female (female group). The distribution of TOAST subtype was analyzed between the two groups. ResultsAccording to TOAST subtype, large artery atherosclerosis (LAA), small artery obstructive (SAO), cardiogenic embolism(CE),stoke of other etiology(SOE) and stoke of undetermined etiology(SUE) subtype was 54 cases( 19.4％ ,54/279), 95 cases(34.1％ ,95/279),33 cases( 11.8％ ,33/279), 9 cases(3.2％ ,9/279) and 88 cases(31.5％ ,88/279) in male group;22 cases ( 12.0％ ,22/184),66 cases (35.9％ ,66/184),35 cases ( 19.0％ ,35/184),6 cases (3.3％ ,6/184) and 55 cases (29.9％ ,55/184) in female group. The percentage of LAA was higher and the percentage of CE was lower in male group than in male group that in female group (P ＜ 0.05 ). ConclusionThedistribution of cerebral ischemic stroke in different gender by TOAST subtype exists difference.

Analysis on running problems in medical insurance real-time settlement in outpatient department / 中华医院管理杂志

Analyze the problems of medical insurance real-time settlement in outpatient department.Explore the situation of stringent management of health medical insurance agencies,accuracy of the information,significant increasing costs that medical insurance agencies refused to pay and severe environment to doctors.And management strategy such as regulating doctors' behavior strictly,upgrading hospital information systems,increasing hospital staff to excavate the hospital potential and publicizing the new policy of medical insurance comprehensively.

Analysis of clinicopathologic features and surgical effects in urachal carcinoma / 中国综合临床

Objective To study the clinicopathologic features and the effects of various surgical methods of urachal carcinoma,to improve the diagnosis and treatment of this disease. Methods The clinicopathologic features,diagnosis, surgical methods and effects of 9 patients diagnosed as urachal carcinoma were analyzed retrospectively. Results Among 9 patients,7 cases were diagnosed as mucinous adenocarcinoma, 1 case as nonclassified adenocarcinoma and 1 case as small cell neuroendocrine carcinoma. According to Sheldon staging system,8 cases were classified into stage Ⅲ A and 1 case into stage Ⅲ C. Eight cased underwent extensive partial cystectomy,whereas the other one underwent regular partial cystectomy. One patient died of multiple bone-metastasis at 3 months after operation, 1 patient received operation again for recurrence at 11 months after operation and 1 patient experienced recurrence in bladder neck and urethra respectively at 15 months and 24 months after operation and receivedTUR-Bt. All of the other 6 patients lived without recurrence and metastasis by follow-up survey of 6 - 42 months. Conclusions Urachal carcinoma is a rare malignant tumor,which has very poor prognosis. Clinicopathologic features recognition is very important for improving the diagnosis of this disease. The long-term disease free survival can be achieved from extensive partial cystectomy.