Background:To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex ? in Chinese patients with premenopausal breast cancer. Methods:From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex ? every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results:A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex ?. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex ?. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex ? group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion:LY01005 is as effective as Zoladex ? in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.

Objective To investigate the labeling of dialysis-related information in the instructions of drugs for systemic use in patients with end-stage renal disease undergoing hemodialysis,and to provide reference for further standardization and im-provement of drug instructions.Methods Collected the information on pharmacokinetics and drug dose adjustment in hemodi-alysis patients with end-stage renal disease from the instructions of chemicals and biologics used systemically in XuanWu hospital's formulary from January to March 2023.Classified and compared the labeling rates of the corresponding information of the originally developed drugs and generic drugs,imported drugs and domestic drugs;Drugs eliminated by non-renal route,or with mo-lecular weight≥5 000,or binding rate of plasma protein ≥ 60％,or drug distribution volume＞360L were classified as"non-dialysis group",and other drugs were classified as"dialysis group",compared the labeling rate of corresponding information of drugs in"dialysis group"and"non-dialysis group";and compared the labeling rate and content with relevant information in Lexicomp and Micromedex.Results Among the 930 drug instructions,the labeling rates of drug dialysis clearance,drug adjustment,and ex-plicit drug adjustment plan were 16.67％,25.16％,and 24.52％.There was no significant difference in the labeling rate of dialysis-related information between original and generic drugs,and imported and domestic drugs.There was a significant difference in the labeling rate of dialysis-related information between the"dialyzable group"and the"non-dialyzable group"(P＜0.01).The differ-ence in the labeling rate of dialysis related information between the investigated drug instructions and the corresponding drugs in Lexicomp or Micromedex was statistically significant(P＜0.01).Conclusion Attention should be paid to the lack of informa-tion and unclear labeling of hemodialysis patients with end-stage renal disease in the drug instructions by relevant departments.

Objective To investigate the labeling of dialysis-related information in the instructions of drugs for systemic use in patients with end-stage renal disease undergoing hemodialysis,and to provide reference for further standardization and im-provement of drug instructions.Methods Collected the information on pharmacokinetics and drug dose adjustment in hemodi-alysis patients with end-stage renal disease from the instructions of chemicals and biologics used systemically in XuanWu hospital's formulary from January to March 2023.Classified and compared the labeling rates of the corresponding information of the originally developed drugs and generic drugs,imported drugs and domestic drugs;Drugs eliminated by non-renal route,or with mo-lecular weight≥5 000,or binding rate of plasma protein ≥ 60％,or drug distribution volume＞360L were classified as"non-dialysis group",and other drugs were classified as"dialysis group",compared the labeling rate of corresponding information of drugs in"dialysis group"and"non-dialysis group";and compared the labeling rate and content with relevant information in Lexicomp and Micromedex.Results Among the 930 drug instructions,the labeling rates of drug dialysis clearance,drug adjustment,and ex-plicit drug adjustment plan were 16.67％,25.16％,and 24.52％.There was no significant difference in the labeling rate of dialysis-related information between original and generic drugs,and imported and domestic drugs.There was a significant difference in the labeling rate of dialysis-related information between the"dialyzable group"and the"non-dialyzable group"(P＜0.01).The differ-ence in the labeling rate of dialysis related information between the investigated drug instructions and the corresponding drugs in Lexicomp or Micromedex was statistically significant(P＜0.01).Conclusion Attention should be paid to the lack of informa-tion and unclear labeling of hemodialysis patients with end-stage renal disease in the drug instructions by relevant departments.

Background:To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex ? in Chinese patients with premenopausal breast cancer. Methods:From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex ? every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results:A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex ?. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex ?. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex ? group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion:LY01005 is as effective as Zoladex ? in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.

ObjectiveTo review the effect of response interruption and redirection intervention on vocal stereotypy in children with autism spectrum disorder (ASD). MethodsLiteratures on response interruption and redirection intervention for vocal stereotypy in children with ASD were retrieved from databases of EBSCO, PubMed, Web of Science, CNKI, and Wanfang data. The information of the literatures was extracted to conduct a scoping review. ResultsA total of 16 English literatures were included. All researches employed a single-subject time series study design. A total of 41 children with ASD were involved. Significant differences were found in levels of basic verbal functioning of children with ASD. Vocal stereotypy was characterized by both verbal and nonverbal forms. Most of the reviewed researches used experimental functional assessment to analyze the function of vocal stereotypy. In most cases, the function of vocal stereotypy was automatic reinforcement. Iwata et al.'s paradigm was dominantly adopted in performing experimental functional assessment across researches. Other related paradigms developed based on Iwata et al.'s paradigm to make operating process more concise were also used for experimental functional assessment in reviewed researches. Response disruption and redirection was often conducted in individualized setting, with a few researches conducted in special education classes. The time and frequency of interventions varied widely across subjects due to the levels of impairment in vocal stereotypy and other behaviors. According to a comparison of the effects of traditional response interruption and redirection and its morphing procedures, it was found that changing the content of the redirection task, reducing the number of redirection tasks, and varying the duration of execution did not impact the improvement of vocal stereotypy. Based on the comparisons of response interruption and redirection with matched stimuli, response cost, verbal manipulation training, and medication, it was found that both response interruption and redirection and other methods (except for medication) could reduce vocal stereotypy and promote the emergence of appropriate behaviors in children with ASD. Combining response interruption and redirection with other techniques, such as stimulus matching and response costs, yielded more favorable improvement of vocal stereotypy in children with ASD. ConclusionASD children with vocal stereotypy show different levels of functional language, and vocal stereotypy is generally characterized by both verbal and nonverbal formats. The function of vocal stereotypy is mostly automatic reinforcement. Response interruption and redirection as a behavioral intervention is mostly conducted in individualized setting, and the time and frequency of interventions depend on the levels of vocal stereotypy and other behaviors problems. Changing the content and number of redirection instructions does not significantly influence the improvement of vocal stereotypy in children with ASD. Other intervention methods such as matching stimulus and response cost are able to reduce vocal stereotypy in children with ASD, but response interruption and redirection used in conjunction with these methods show more favorable improvements. Response interruption and redirection interventions can not only reduce vocal stereotypy in children with ASD, but also increase appropriate vocalizations, task engagement and command obedience.

Objective:To investigate the status of frailty and activities of daily living (ADL) in maintenance hemodialysis (MHD) patients, and to explore the effect of frailty phenotype on ADL.Methods:The patients who underwent MHD in Kidney Disease Center of the First Affiliated Hospital from March 2019 to March 2020 were enrolled in this study. The demographic and laboratorial data were collected by cross-sectional survey method. Fried frailty phenotype scale and ADL scale were used to evaluate the frailty and ADL, respectively. The differences of basic data and different frailty phenotypes between the normal function group and the function decline group were compared in terms of ADL, physical self-maintenance ability and instrumental ADL ability. Pearson correlation analysis was used to analyze the correlation between frailty and ADL, and binary logistic regression analysis was used to analyze the influencing factors of ADL.Results:A total of 676 MHD patients were included in this study, including 434 males (64.2%) and 242 females (35.8%). The age was (59.2±19.4) years old, and the median dialysis age was 59.0 (25.3, 110.0) months. There were 159 frailty patients (23.5%), 230 pre-frailty patients (34.0%), and 287 non-frailty patients (42.5%). The ADL was decreased in 163 patients (24.1%), including 131 patients (19.4%) with decreased physical self-maintenance ability and 161 patients (23.8%) with decreased instrumental ADL ability. Pearson correlation analysis showed that the frailty score was positively correlated with total ADL score ( r=0.728, P<0.001), physical self-maintenance ability score ( r=0.669, P<0.001) and instrumental ADL ability score ( r=0.729, P<0.001). Binary logistic regression analysis results showed that older age and lower physical activity, fatigue, slowed steps and lower grip strength in the frailty phenotypes were the independent influencing factors of ADL, physical self-maintenance ability and instrumental ADL ability (all P<0.05). Conclusions:The prevalence of frailty is 23.5% in MHD patients, and 24.1% of MHD patients have decreased ADL. Elder age and lower physical activity, fatigue, reduced step counts, and lower grip strength in frailty phenotypes are the independent influencing factors for poor ADL, poor physical self-maintenance ability and poor instrumental ADL ability.

Objective To analyze the changes of primary disease and demography of patients with end-stage renal disease (ESRD) who started dialysis between 2008 and 2013 in Zhejiang province, in order to provide statistical support for the improvement of dialysis quality.Methods The study retrospectively reviewed all the incident ESRD patients on dialysis registered in Zhejiang Dialysis Quality Control Center from 2008 to 2013.Their demographics and primary cause were investigated.Stratified analysis based on dialysis modality, duration and age were conducted.Results A total of 26 310 incident ESRD patients who started dialysis between 2008 and 2013 in Zhejiang were selected, among which 14 886 cases were male and 11 424 cases were female (male: female: 1.30: 1).The study gave priority to patients aged 45 and above (73.9％), with an average age of (55.7± 16.1) years.The top primary disease was chronic glomerulonephritis (51.3％), followed by diabetic nephropathy (17.3％) and hypertensive nephrosclerosis (6.4％).From 2008 to 2013, the incidence of dialysis was 46.3, 60.1, 71.2, 85.8, 104.1, and 119.9 per million population respectively.The average age of patients was increased year by year, from 52.4, 53.3, 54.8, 56.0, 56.9, to 57.6 years.The share of peritoneal dialysis, as well as the promotion of diabetic nephropathy in primary disease was on the rise.With the increase of age, the proportion of primary diseases such as diabetic nephropathy and hypertension nephrnsclerosis was increased.Conclusions In Zhejiang province, incident dialysis patients increase annually.More males than females are on dialysis.The average age and proportion of peritoneal dialysis are rising.The leading cause is chronic glomerulonephritis, but the incidence of diabetic nephropathy is on the increase, which requires attention.

OBJECTIVETo evaluate the efficacy and safety of pylorus-preserving pancreatico-duodenectomy(PPPD) in the treatment of periampullary adenocarcinoma by using Meta-analysis.

METHODSFrom January 1, 1980 to November 8, 2013, the articles of randomized controlled trials (RCTs) about PPPD versus PD in the treatment of periampullary adenocarcinoma were collected from Cochrane Libriary, Embase, PubMed, Ovid, Web of science and CBM etc. The methodological quality of the included studies was evaluated according to Cochrane system review valuator handbook of risk of bias standards. Meta-analysis was performed by RevMan 5.2 software.

RESULTSSeven RCTs were enrolled in the meta-analysis. Compared to PD group, PPPD group was associated with significantly less intraoperative blood loss (MD=-200.10, 95% CI:-400.66 to 0.46, P=0.05), shorter operation time (MD=-46.55, 95% CI:-91.02 to -2.07, P=0.04), and less postoperative blood transfusion (MD=-0.89, 95% CI:-1.59 to -0.19, P=0.01). There were no significant differences between the PPPD and PD group in pancreatic fistula, biliary fistula, intestinal fistula, abdominal abscess, postoperative bleeding, wound infection, relaparotomy, mortality and survival rate(all P>0.05).

CONCLUSIONSPPPD in the treatment of the periampullary adenocarcinoma is safe and effective with similar survival of PD surgery. PPPD can reduce operative time, intraoperative blood loss, transfusion and does not increase the surgery complications as compared to PD.

Adenocarcinoma ; Ampulla of Vater ; Duodenal Neoplasms ; Humans ; Intestinal Fistula ; Operative Time ; Pancreatic Fistula ; Pancreatic Neoplasms ; Pancreaticoduodenectomy ; Pylorus ; Randomized Controlled Trials as Topic ; Survival Rate

Objective To evaluate the efficacy and safety of pylorus-preserving pancreatico-duodenectomy (PPPD) in the treatment of periampullary adenocarcinoma by using Meta-analysis. Methods From January 1, 1980 to November 8, 2013, the articles of randomized controlled trials (RCTs) about PPPD versus PD in the treatment of periampullary adenocarcinoma were collected from Cochrane Libriary, Embase, PubMed, Ovid, Web of science and CBM etc. The methodological quality of the included studies was evaluated according to Cochrane system review valuator handbook of risk of bias standards. Meta-analysis was performed by RevMan 5.2 software. Results Seven RCTs were enrolled in the meta-analysis. Compared to PD group, PPPD group was associated with significantly less intraoperative blood loss (MD=-200.10, 95% CI:-400.66 to 0.46, P=0.05), shorter operation time (MD=-46.55, 95%CI:-91.02 to -2.07, P=0.04), and less postoperative blood transfusion (MD=-0.89, 95% CI:-1.59 to -0.19, P=0.01). There were no significant differences between the PPPD and PD group in pancreatic fistula, biliary fistula, intestinal fistula, abdominal abscess, postoperative bleeding, wound infection, relaparotomy, mortality and survival rate (all P>0.05). Conclusions PPPD in the treatment of the periampullary adenocarcinoma is safe and effective with similar survival of PD surgery. PPPD can reduce operative time, intraoperative blood loss, transfusion and does not increase the surgery complications as compared to PD.

Objective To evaluate the efficacy and safety of pylorus-preserving pancreatico-duodenectomy (PPPD) in the treatment of periampullary adenocarcinoma by using Meta-analysis. Methods From January 1, 1980 to November 8, 2013, the articles of randomized controlled trials (RCTs) about PPPD versus PD in the treatment of periampullary adenocarcinoma were collected from Cochrane Libriary, Embase, PubMed, Ovid, Web of science and CBM etc. The methodological quality of the included studies was evaluated according to Cochrane system review valuator handbook of risk of bias standards. Meta-analysis was performed by RevMan 5.2 software. Results Seven RCTs were enrolled in the meta-analysis. Compared to PD group, PPPD group was associated with significantly less intraoperative blood loss (MD=-200.10, 95% CI:-400.66 to 0.46, P=0.05), shorter operation time (MD=-46.55, 95%CI:-91.02 to -2.07, P=0.04), and less postoperative blood transfusion (MD=-0.89, 95% CI:-1.59 to -0.19, P=0.01). There were no significant differences between the PPPD and PD group in pancreatic fistula, biliary fistula, intestinal fistula, abdominal abscess, postoperative bleeding, wound infection, relaparotomy, mortality and survival rate (all P>0.05). Conclusions PPPD in the treatment of the periampullary adenocarcinoma is safe and effective with similar survival of PD surgery. PPPD can reduce operative time, intraoperative blood loss, transfusion and does not increase the surgery complications as compared to PD.