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 investigate the prevalence and risk factors of primary nocturnal enuresis (PNE) in adolescents, and to explore its psychological effects. 【Methods】 During Sep.2020 and Dec.2020, an epidemiological survey was conducted among 6 408 junior and senior high school students in a region of Henan Province by stratified and cluster random sampling. The survey included general information questionnaire, urinary frequency, urgency, incontinence, recurrent urinary tract infection (RUTI), Enuresis Questionnaire, Self-esteem Scale (SES) and the Pittsburgh Sleep Quality Index (PSQI). 【Results】 A total of 7, 000 questionnaires were distributed and 6 408 (91.54%) were valid. The survey showed that the total prevalence of PNE among adolescents was 2.98%. The prevalence was 4.67% in those aged 12 years and 1.37% in those aged 18 years. The results of Logistic regression analysis showed that male (OR=1.677, P<0.05), overweight (OR=1.842, P<0.05), urgency (OR=1.676, P<0.05), frequency (OR=1.919, P<0.05), incontinence (OR=3.493, P<0.001), RUTI (OR=2.535, P<0.001) and family history (OR=3.005, P<0.001) were related to the risk of PNE. The SES score of PNE patients was lower than that of non-PNE group (z=-3.097, P<0.05), and the PSQI was higher (z=-5.456, P<0.05). 【Conclusion】 The prevalence of PNE is high in adolescents and decreases gradually with age. Male, overweight, frequency, urgency, incontinence, RUTI and family history are risk factors. PNE has a negative impact on self-esteem and sleep quality in adolescents.

Objective: To investigate the proportion of achieving the blood lipid control target and its influencing factors among residents at a high risk of atherosclerotic cardiovascular disease (ASCVD), so as to provide insights into management of blood lipid among residents at a high risk of ASCVD. Methods: Residents at a high risk of ASCVD and at ages of 35 to 70 years were sampled using a multi-stage cluster sampling method from 6 counties (districts) in Shaoxing City from May to July 2021. The residents' demographics, smoking, alcohol consumption and medical history of chronic diseases were collected using questionnaires, the height, weight, waist circumference (WC) and blood pressure were measured, and the total cholesterol (TC), triacylglycerol (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C) and fasting blood glucose were detected. The proportion of blood lipids achieving the control target was analyzed, and factors affecting the proportion of blood lipids achieving the control target were identified using a multivariable logistic regression model. Results: A total of 1 695 individuals at a high risk of ASCVD were enrolled, including 940 men (55.46%) and 755 women (44.54%), with a mean age of (62.56±6.08) years. There were 285 participants that achieved the target of blood lipid control (16.81%). Multivariable logistic regression analysis identified gender (male, OR=1.962, 95%CI: 1.396-2.758), age (OR=1.037, 95%CI: 1.013-1.061), WC (OR=0.979, 95%CI: 0.964-0.995), diastolic blood pressure (OR=0.981, 95%CI: 0.967-0.994), smoking (OR=1.485, 95%CI: 1.034-2.133), alcohol consumption (OR=0.684, 95%CI: 0.498-0.941), hypertension (OR=1.428, 95%CI: 1.006-2.207), administration of hypoglycemic drugs (OR=2.326, 95%CI: 1.720-3.144) as factors affecting the achievement of the target for blood lipid control among residents at a high risk of ASCVD. Conclusions Individuals at a high risk of ASCVD with higher WC, higher diastolic blood pressure and alcohol consumption are less likely to achieve the target for blood lipid control, while male individuals with older age, hypertension and administration of hypogcemic drugs are more likely to achieve the target for blood lipid control.

Objective:To investigate the surgical treatment and prognosis of thoracic esophageal squamous cell carcinoma (ESCC).Methods:The retrospective cohort study was conducted. The clinicopathological data of 2 766 patients with thoracic ESCC who were admitted to Sichuan Cancer Hospital & Institute from January 2010 to December 2017 were collected. There were 2 256 males and 510 females, aged (62±8)years. All patients underwent surgical treatment. Observation indicators: (1) treatment; (2) postoperative complications; (3) postoperative survival. Measurement data with normal distribution were represented as Mean± SD. Measurement data with skewed distribution were represented as M( Q1, Q3). Count data were described as absolute numbers or percentages. The Kaplan-Meier method was used to draw survival curve and calculate survival rate, and the Log-Rank test was used for survival analysis. Result:(1) Treatment. Fifty-two of the 2 766 patients underwent neoadjuvant therapy. There were 1 444 patients undergoing open surgery, including 44 cases conversion to thoracotomy, and there were 1 322 patients undergoing minimally invasive esophagectomy. There were 1 991, 729 and 46 cases with McKeown, Ivor-Lewis and Sweet esophagectomy, respectively. One thousand two hundred and seventy-one of the 2 766 patients underwent postoperative adjuvant therapy. The number of lymph node metastases, the number of lymph node dissected, rate of R 0 resection, operation time of 2 766 patients were 2.1(0,3.0), 22±12, 94.722%(2 620/2 766), (237±66)minutes. (2) Postoperative complications. The overall incidence of postoperative complications was 25.850%(715/2 766). The top two postoperative complications were pneumonia and anastomotic fistula, with incidence rates of 8.604%(238/2766) and 7.484%(207/2766), respectively. One patient may have more than two kinds of postoperative complications. (3) Postoperative survival. The 1-, 3-and 5-year overall survival rates of 2 766 patients were 86.2%, 57.5% and 46.8%, respectively. Further analysis indicated that the 5-year overall survival rates of 510 female patients and 2 256 male patients were 62.0% and 43.3%, respectively, showing a significant difference between them ( χ2=48.94, P<0.05). The 5-year overall survival rates of 693 cases with upper thoracic ESCC, 1 479 cases with middle thoracic ESCC and 594 cases with lower thoracic ESCC were 49.5%, 46.7% and 44.1%, respectively, showing no significant difference among them ( χ2=3.21, P>0.05). The 5-year overall survival rates of 68 cases with stage 0 thoracic ESCC, 259 cases with stage Ⅰ esophageal ESCC, 885 cases with stage Ⅱ thoracic ESCC, 1 222 cases with stage Ⅲ thoracic ESCC, and 332 cases with stage Ⅳ thoracic ESCC were 95.6%, 76.4%, 61.4%, 35.6%, and 14.5%, respectively, showing a significant difference among them ( χ2=500.40, P<0.05). The 5-year overall survival rates of 1 444 patients undergoing open esophagectomy and 1 322 patients undergoing minimally invasive esophagectomy were 42.5% and 51.8%, respectively, showing a significant difference between them ( χ2=31.29, P<0.05). The 5-year overall survival rates of 1 991 cases undergoing McKeown esophagectomy, 729 cases undergoing Ivor-Lewis esophagectomy, and 46 cases undergoing Sweet esophagectomy were 49.5%, 41.2%, and 32.3%, respectively, showing a significant difference among them ( χ2=19.19, P<0.05). Conclusions:Compared with open esophagectomy, minimally invasive esophagectomy brings survival benefits to patients with thoracic esophageal ESCC. Among different esophagectomy methods, the McKeown esophagectomy has also brought survival benefits to patients with esophageal ESCC compared to the Ivor-Lewis esophagectomy and the Sweet esophagectomy.

Objective:To discussed the diagnostic value of magnetic resonance cholangiopancreatography (MRCP), and the use of laparoscopic surgery in management of patients with choledochal cyst with extrahepatic bile duct anomaly.Methods:Of 330 consecutive patients who underwent laparoscopic choledochectomy at Guangzhou Women and Children's Medical Center from January 2010 to September 2018, there were 23 patients with extrahepatic bile duct anomaly. The data of these patients were retrospectively analyzed. There were 4 males and 19 females, with an average age of 3.2 (range 0.3~9.0) years. According to whether the extrahepatic bile duct anomaly was diagnosed by preoperative MRCP, these patients were divided into the preoperative MRCP diagnosis group and the preoperative MRCP undiagnosed group. The impact of MRCP in diagnosing bile duct anomaly to prevent bile duct injury, on operation time, hospital stay and the types of extrahepatic bile duct anomaly on outcomes of laparoscopic treatment were analyzed.Results:All the 23 patients with choledochal cysts complicated by extrahepatic bile duct anomaly were confirmed at surgery. The incidence of extrahepatic bile duct anomaly was 6.97% (23/330). There were 47.8% of type II AHD (11/23); 36.8% of type III AHD (7/23); 4.3% of type IV AHD (1/23); 17.4% (4/23) of the type with communication with accessory bile duct (CABD). The preoperative MRCP diagnosis group consisted of 14 patients, while the preoperative MRCP non-diagnosis group consisted of 9 patients, including 2 patients without MRCP. The diagnostic rate of MRCP in preoperative diagnosis of extrahepatic bile duct anomaly was 66.7%(14/21). The preoperative MRCP undiagnosed group, when compared with the preoperatives MRCP undiagnosed group, had a significantly higher bile duct injury rate [preoperative MRCP diagnosis group 7.1%(1/14), preoperative MRCP non-diagnosis group 55.6%(5/9)], and a significantly longer operation time [preoperative MRCP diagnosis group(232.6±10.0) min, preoperative MRCP undiagnosed group (278.9±22.45)min], (all P<0.05). Laparoscopic surgery was completed in 22 of 23 patients. One patient was converted to open surgery. AHD reconstruction was needed in 11 patients with type II AHD and 1 patient with type IV AHD. Seven patients with type III AHD did not require any surgical intervention for the anomaly. The 4 patients with CABD underwent simple ligation. Postoperative chyloperitoneum developed in 1 patient, who successfully responded to conservative treatment. Postoperative recovery was uneventful in the remaining patients. At a median follow-up of 2 years (range 1 to 5 years), no further complications, including intrahepatic bile duct dilatation and hepatic atrophy were detected. Conclusions:MRCP was effective in preoperative diagnosis of choledochal cysts with extrahepatic bile duct anomaly. It helped to decrease intraoperation injuries to bile duct anomalies. MRCP was also useful in classifying patients with extrahepatic bile duct anomaly to better preoperatively planning of surgical treatment strategies. Laparoscopic surgery could be completed in the majority of these patients with good postoperative results.

Objective:To study the clinical outcomes of children with extrahepatic portal venous obstruction who underwent balloon venoplasties for anastomotic stenosis after Meso-Rex bypass.Methods:The data of 60 patients who underwent Meso-Rex bypass at Guangzhou Women and Children’s Medical Center between October 2014 and November 2018 were retrospectively analyzed. Four patients were shown by transhepatic portal venography to have graft stenosis in the left portal vein anastomosis. There were 2 males and 2 famales, the age of patients were 11 years, 5 years, 5 years and 8 years. Four patients underwent balloon dilation. The pressure, anastomotic diameter and blood flow velocity of the anterior portal vein were compared before and after balloon dilation. The patients were followed-up on the postoperative status.Results:Three of 4 patients who had anastomotic stenosis were successfully treated by balloon venoplasties. On postoperative follow-up for 6 months, the bridging vessels remained unobtrusive and there was no gastrointestinal bleeding. The pressures of the anterior hepatic portal vein before balloon dilation were 19, 15 and 25 mmHg (1 mmHg=0.133 kPa). They were 8, 11 and 20 mmHg after balloon dilation. The preoperative anastomotic diameters were 2.6, 3.0 and 3.0 cm. They were 6.0, 4.5 and 5.5 cm, respectively 6 months after surgery. The preoperative anastomotic blood flow velocities were 138, 107 and 94 cm/s. They were 96, 91 and 90 cm/s, respectively 6 months after surgery. The preoperative three-dimensional CT reconstruction of spleen volumes were 793.24, 192.25, and 318.05 cm 3, respectively. They were 681.84, 190.30, and 310.65 cm 3, respectively 6 months after surgery. In the remaining patient, balloon dilation failed because of the small diameter of the anastomotic stenosis segment. Conclusion:Balloon venoplasties is an optional procedure for patients with anastomotic stenosis after Meso-Rex bypass.

OBJECTIVE：To optimize the microwave processing technology of yellow wine-processed Corydalis yanhusuo . METHODS：The contents of opioid alkaloid ，berberine hydrochloride and tetrahydropalmatine in C. yanhusuo processed with yellow wine were determined by HPLC. The contents of the extracts were determined by hot dipping method. Based on the single factor tests ，using the appearance of yellow wine-processed C. yanhusuo with microwave processing technology ，the contents of extract，opioid alkaloid ，berberine hydrochloride and tetrahydropalmatine as indexes ，with the amount of yellow wine ，wetting time，microwave power and microwaving time as factors ，the processing technology was optimized with orthogonal test combined with comprehensive weighted scoring method ，and then validated and compared with traditional yellow wine-processed C. yanhusuo . RESULTS：The linear ranges of opioid alkaloid ，berberine hydrochloride and tetrahydropalmatine were 0.100-1.500 μg（R2＝0.999 6）， 0.012-0.188 μg（R2＝0.999 5），0.050-0.750 μg（R2＝0.999 8）. RSDs of precision ，stability（12 h）and repeatability tests were all less than 2％ . The recoveries were 99.15％ -100.34％（RSD＝0.54％ ，n＝6），99.52％ -100.78％（RSD＝0.69％ ，n＝6）， 99.26％-99.79％（RSD＝0.28％，n＝6）. The optimum microwave processing technology included that the amount of yellow wine was 4 g（about 20％ of medicinal material amount ），microwave power was 40％，wetting time was 3 hour，processing time was 3 min. The results of three verification tests showed that the contents of extract ，opioid alkaloid ，berberine hydrochloride and tetrahydropalmatine were 15.7％-16.1％，0.061％-0.063％，0.003％-0.004％ and 0.061％-0.063％. The comprehensive scores were 97.916，94.730 and 97.217，and RSD were 0.42％，0.38％，0.46％（n＝3），respectively. Compared with traditional yellow wine processing technology ，there was no significant difference in the contents of opioid alkaloid and other components ，but no scorched spot and crumbs was found in yellow wine-processed C. yanhusuo with microwave processing technology. CONCLUSIONS：Established method for content determination is simple ，accurate，reliable and reproducible ，and can be used for quantitative analysis of active components in yellow wine-processed C. yanhusuo . Optimized microw ave processing technology is stable and feasible ，and can be used for the processing of yellow wine-processed C. yanhusuo .

OBJECTIVE: To investigate the changes of hemorheology and blood lipid index in patients with occupational hand-arm vibration disease(OHAVD). METHODS: A total of 78 patients with OHAVD were selected as the OHAVD group, and 78 workers without hand transmitted vibration exposure were selected as control group by judgment sampling method. The hemorrheology and blood lipid indexes of the two groups were detected. RESULTS: The whole blood viscosities(low-, medium-and high-shear), hematocrit, erythrocyte aggregation index, and abnormal rate of whole blood viscosities(mid-and high-shear) in the OHAVD group were higher in the OHAVD group than that in the control group(P<0.05). The erythrocyte deformability index and erythrocyte electrophoresis index were lower in the OHAVD group than that of the control group(P<0.05). In the vibration-induced white finger(VWF) subgroup of the OHAVD group, the whole blood viscosity(low-, medium-and high-shear), hematocrit were increased(P<0.05), and the abnormal rate of whole blood viscosity(high-shear) was higher(P<0.017) than that of the control group.The whole blood viscosity(medium shear), hematocrit and erythrocyte aggregation index were increased in the non-VWF subgroup than that of the control group(P<0.017). The concentration of low density lipoprotein cholesterol in the OHAVD group and non-VWF subgroup was higher than that in the control group(P<0.05). The whole blood viscosity(low-, medium-and high-shear), hematocrit, erythrocyte deformability index, erythrocyte aggregation index and erythrocyte electrophoresis index were not correlated with the length of service and age in the OHAVD group(P>0.05). CONCLUSION: The changes of hemorheological properties and blood lipids in OHAVD patients may be associated with vibration vascular injury.

Objective: To study the diagnosis and management of choledochal cyst in children with accessory hepatic ducts (AHD). Methods: From November 2013 to June 2018, 14 patients with choledochal cyst with AHD were treated in Guangzhou Women and Children's Medical Center. The patients included 2 males and 12 females, and age ranged from 4 months to 3 years (median 2 years). All patients underwent MRCP before operation, and 2 underwent operative cholangiography through the AHD. Results: Seven patients with choledochal cyst and AHD were demonstrated by preoperative MRCP and intraoperative exploration. One patient was suspected by preoperative MRCP to have AHD which was confirmed by surgical exploration. Preoperative MRCP failed to diagnose, but operative exploration revealed AHD in 6 patients. Anastomosis of the AHD to jejunum was performed laparoscopically in 8 patients and by open surgery in 1 patient. Six patients had the common hepatic duct and the AHD joined together to create a common channel which was then implanted as a single duct into a Roux loop, Three patients had the common hepatic duct and the AHD anastomosed separately to a Roux loop. All the patients recovered well after operation and they were discharged home without any complication. A follow-up which ranged from 0.5 to 5 years showed no jaundice, liver atrophy or liver abscess. Conclusions MRCP was important in the preoperative diagnosis of choledochal cyst with accessory hepatic duct in children. MRCP was difficult in diagnosing type II accessory hepatic ducts. In suspected or undiagnosed cases of AHD, surgical exploration helped to improve the diagnostic accuracy, avoided injury and guided correct surgical decisions. Reconstruction of AHD required joining the AHD to the common hepatic duct, or as a separate duct to jejunal anastomosis to a Roux-y-loop.

OBJECTIVE: To investigate the therapeutic effect of electroacupuncture on peripheral nerve damage induced by 1-bromopropane( 1-BP) exposure.METHODS: A total of 25 specific pathogen free healthy adult male Wistar rats were randomly divided into blank control group( n = 5),model control group( n = 10),and electroacupuncture treatment( EA) group( n = 10).Rats in the blank control group were not exposed to 1-BP and treated with electroacupuncture.The rats in model control group and EA group were placed in a dynamic inhalation exposure cabinet with 1-BP at concentration of 5 000 mg/m~3.The rats were continuously exposed to 1-BP 8 hours per day,5 days a week,for 4 weeks.At the 3 rd day after the end of the exposure,the EA group was treated with electroacupuncture on“Zu sanli”and“Huantiao”points for 4 courses.Each course included 20 minutes each time,once per day for 7 consecutive days.The body weight,the motor nerve conduction velocity( MCV) and sense nerve conduction velocity( SCV) of sciatic nerves on both posterior limbs of the rats were measured.RESULTS: During the course of 1-BP exposure,the rats in the EA and model control group showed reduction of eating,drinking and activities,limited autonomic activities and their hind limbs dragged.The MCV and SCV of posterior limb sciatic nerve of rats in the model control group were slower than that of the control group at the 4 th,6th and 8th week and the 0 week of the same group( P < 0.05).The MCV and SCV of posterior limb sciatic nerve of rats in the EA group improved with the increase of treatment time( P < 0.05),and those at the 6th and 8th weeks of the experiment( corresponding to the 2nd and 4th week after treatment) were faster than that of the model control group at the same time( P < 0.05).The SCV of the posterior limb sciatic nerve in the EA group recovered to normal level 4 weeks after treatment compared with the blank control group( P < 0.05).CONCLUSION: Electroacupuncture treatment can promote the recovery of peripheral nerve damage in rats with 1-BP poisoning.