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.

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 evaluate the safety and efficacy of botulinum toxin type A for injection in the treatment of post-stroke upper limb spasticity (dosage was 200 U,or 240 U if combined with thumb spasticity).Methods The study was a multi-center,stratified block randomized,double-blind,placebocontrolled trial.All the qualificd subjects were from 15 clinical centers from September 2014 to February 2016.They were randomized (2∶1) to injections of botulinum toxin type A made in China (200-240 U;n =118) or placebo (n =60) in pivotal phase after informed consent signed.The study was divided into two stages.The pivotal trial phase included a one-week screening,12-week double-blind treatment,followed by an expanded phase which included six-week open-label treatment.The tone of the wrist,finger,thumb flexors was assessed at baseline and at weeks 0,1,4,6,8,12,16 and 18 using Modified Ashworth Scale (MAS),disability in activities of daily living was rated using the Disability Assessment Scale and impaction on pain,muscle tone and deformity was assessed using the Global Assessment Scale.The primary endpoint was the score difference between botulinum toxin type A and placebo groups in the tone of the wrist flexor using MAS at six weeks compared to baseline.Results Muscle tone MAS score in the wrist flexor of botulinum toxin type A and placebo groups at six weeks changed-1.00 (-2.00,-1.00) and 0.00 (-0.50,0.00) respectively from baseline.Botulinum toxin type A was significantly superior to placebo for the primary endpoint (Z =6.618,P ＜ 0.01).The safety measurement showed 10 subjects who received botulinum toxin type A had 13 adverse reactions,with an incidence of 8.47％ (10/118),and three subjects who received placebo had three adverse reactions,with an incidence of 5.00％ (3/60) during the pivotal trial phase.All adverse reactions were mild to moderate,none serious.There was no significant difference in adverse reactions incidence between the botulinum toxin type A and the placebo groups.During the expanded phase three subjects had four adverse reactions and the incidence was 1.95％.All adverse reactions were mild,none serious.Conclusion Botulinum toxin type A was found to be safe and efficacious for the treatment of post-stroke upper limb spasticity.Clinical Trial Registration:China Drug Trials,CTR20131191

Objective To investigate the effect of iodine-125 seed implantation in the treatment of unresectable pancreatic carcinoma.Methods A total of 26 pancreatic carcinoma patients were retrospectively analyzed.Patients undergoing palliative operation in combination with iodine-125 seed implantation.jundice recovery,objective tumor response,pain relieved,clinical benefit response,median survival time and complication were investigated.Results Half of cases with jundice has reduced and totally normal in 3 weeks.Abdominal pain was relieved in 94.7％ patients,average recovery duration was (5.0 ± 1.5) d.18 cases had gastroenterol function disorder (69.2％),gastroparesis in six cases (23％) and average recover time was (16 ± 5.1) d.24 of 26 cases were follow up study,median survival time was (12 ± 5.1) months,objective tumor response was smaller than preoperation in 9,no change in 10 and 5 cases became larger than before.Conclusions Palliative operation in combination with iodine-125 seed implantation is safe and effective in the treatment of unresectable pancreatic carcinoma.

ObjectiveTo discuss the treatment of complications post-pancreticoduedenectomy by reviewing the experiences from 62 cases.MethodsSixty-two cases of pancreticoduedenectomy from March 2001 to April 2011,mean age 59.3 ±4.1 years,were reviewed.All cases were divided into early group 24 cases and recent group (38 cases) by the difference in following aspects:perioperative management,the way of pancreatic bowel anastomosis and material choice,the vessels management,materials using in preventing leakage and bleeding.The differences in leakage,bleeding,infection,the stomach retention,biliary infections,liver abscess and incision infection in two groups were compared.ResultsThe early group showed pancreatic leakage in 10 cases,bleeding in 4 cases,celiac infection in 10 cases,gastric retention in 9 cases,biliary infections in 11 cases,liver abscess in 6 and infection of incision in 7 cases,respectively.Recent groups were in 4,0,0,0,1,2 and 3 cases,respectively.The comparisons showed the complications had reduced significantly in recent group than in the early group (x2 =77.08,P ＜ 0.001 ).ConclusionsMinimally invasive and high quality materials use,strengthening the perioperative management are the effective measures to reduce the postoperative complications.

Objective To study the complications after laparoscopic bile duct exploration.MethodsTwo approaches for bile duct exploration were used in 105 patients: (1) laparoscopic transcystic common bile duct exploration (LTCBDE) was used for patients with gallstones with choledocholithiasis and cystic duct dilation. No T tube was used for drainage, (2) Laparoscopic common bile duct exploration (LCBDE) was used for patients with gallstones with choledocholithiasis but without cystic duct dilation. The common bile duct was sutured primarily without T tube drainage in those patients with a small number of stones. T tube drainage was used in those patients with many stones or severe edema at the lower end of the common bile duct. ResultsWe carried out LTCBDE+ LC in 70 patients and LCBDE+LC in 35 patients, 14 patients had T tube drainage and 21 patients had no T tubes in the latter group of patients. Postoperatively, there were ascites in 17 patients (LTCBDE 6 and LCBDE 11 ), biliary peritonitis in 5 patients (1 LTCBDE and 4 LCBDE), abdominal pain in 13 patients (LTCBDE 4 and LCBDE 9), and fever in 11 patients (LTCBD 3 and LCBDE 8). All the complications responded to conservative treatment. 14 patients in the LCBDE group had residual stones.Choledochoscopy was used to remove the residual stones.There was no pancreatitis. Conclusions Adequate preoperative workup, good clinical judgment and precise treatment skill help to reduce complication rates after operation for gallstones with choledocholithiasis.

Objective To study the application of cyctic duct dilatiion in bile duct exploration through the cystic duct by laparoscope combined with choledochoscope.Methods LC + laparoscopic transcyctic common bile duct exploration were performed in gallstones combined choledocholithiasis in 70 cases.The dilation of cyctic duct was performed by gas-baloon or metal dilator in 39 cases.The dilation of cyctic duct was not performed in 31 cases.Results There was one case of bile leakage and one case of cystic duct damaging in cystic duct dilation group.One case was found bleeding in abdomen postoperation in non-dilation group.Abdominal drainage was(60 ±11)mL and(55 ±8)mL in dilation group and non-dilation group,respectively.Conclusions The dilation of cyctic duct is simple and safe to create the tunnel for common bile duct exploration through the cystic duct by choledochoscope.

AIM: To investigate the expression of heat shock protein 60(HSP60) and Toll-like receptor 4 transduction system in mouse cardiac transplantation. METHODS: The mouse cervical heart transplantation model was established. The animals were divided into control group (the donor and recipient were all C57BL/6 mice) and experimental group (the donor was BALB/c mice and recipient was C57BL/6 mice). The heart and blood were collected for study at 3 d and 7 d. The pathological analysis of the hearts was performed. The levels of cytokines in the serum were determined using ELISA. The expression of HSP60, TLR4, MyD88 and NF-κB in the myocardium was determined by immunohistochemistry and Western blotting. RESULTS: The expression levels of HSP60, TLR4, MyD88 and NF-κB were higher in experimental group than those in control group. Severe rejection was observed in experimental group, whereas no distinct rejection in control group was found. The cytokines (TNF-α, IFN-γ, IL-12) increased significantly in experimental group as compared to those in control group. CONCLUSION: HSP60 increases significantly after heart transplantation, which may activate Toll-like receptor 4 transduction system in a MyD88-dependent pathway and promote allograft rejection. Regulation of HSP60 signal transduction may be a novel way for treating allograft rejection.

Objective To study the morphological changes of the cyctic duct in bile duct stones secondary to choledocholithiasis.Methods The results of imaging examinations before cholecystectomy and biliary exploration with laparoscopy and cholechodoscopy were respectively analyzed in 108 patients.Meanwhile, the cystic duct morphology, diameter and dilatation during the operation were determined to investigate the features of changes in its morphology.Results Gallstones were confirmed in all of the 108 cases by B-model ultrasonography preoperatively.The gallstone was positive in common bile duct in 76 cases.Common bile duct dilatation was seen in 75 cases and cystic duct dilatation in 21.Common bile duct dilatation was found in 81 cases by MRCP and in 45 by CT.Cystic duct dilatation was found in 36 cases by MRCP and in 19 by CT.Cystic duct variety was found in 9 cases by MRCP.Laparoscopic transcyctic common bile duct exploration(LTCBDE)was performed in those patients with short and wide cystic duct.Conclusion MRCP is the effective method for considering the outlooks of the cystic duct in bile duct stones secondary to choledocholithiasis.

Objective To evaluate regional blood flow occlusion (RBFO) in hepatectomy for liver neoplasms. Methods In this study, hepatic tumors were resected under RBFO in 28 cases (RBFO group), and under Springle's technique (control group) in 24 cases. The Child-Pugh classifications of liver function were grade A in all patients. The ligature ribbon was put in liver parenchyma around tumor to block the blood supply before resecting the tumor under guiding of B sounography in RBFO group. Anesthesia time, blood loss and transfusion, hospitalization, change of liver function and complications were compared between the two groups. Results Blood loss, anesthesia time and postoperative hospital stay were (340±92) ml, (98.4±25.0) min, ( 10.2±2.3 ) d in RBFO group and (620±124) ml, ( 135.8±47.5 ) min, (16.5±5.1 ) d, respectively, in control group, differences were all significant between the two groups (P <0.01, t = 9.222,9.328 and 5.875, respectively). On post-op day 2, ALT (U/L) was (378.4±35.2) vs. (539.2±115.4) (t=7.012, P<0.01), TBIL (37.5±11.2) vs. (51.8±29) mmol/L(t=8.818, P<0.01),PT (17.4±2.4) vs. (20.4±2.8) see(t =4.16, P<0.01) in RBFO group and control group, respectively. ALT was (57.1±15.5) vs. (98.1±21.2) U/L(t =8.039),TBIL (25.4±4) vs. (46.3±13) mmol/L(t=8.085),PT (13.2±4.2) vs. (15.7±2.2) see (t=2.621)on post-op day 7 respectively, again the differences were all significant between the two groups (all P<0.01). Conclusion Regional blood flow occlusion is an effective technique to control blood loss during hepatectomy for liver neoplasms.