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 prepare C-phycocyanin nanoparticles （CPC-NPs） and evaluate the in vitro mechanism of CPC- NPs on acute lung injury induced by lipopolysaccharide （LPS） combined with seawater. METHODS Ion crosslinking method was used to prepare CPC-NPs using CPC as the drug， carboxymethyl chitosan （CMCS） as the carrier， and CaCl2 as the crosslinking agent. The basic characterization of CPC-NPs was carried out. Mouse alveolar type Ⅱ epithelial cells MLE-12 and macrophages RAW264.7 were divided into 7 groups： normal group （Con group）， model group （Mod group）， blank NPs group， CPC-NPs 30， 60， 120 and 240 μg/mL groups. Except for the Con group， all other groups were treated with a combination of 10 μg/mL LPS and 25% seawater for 6 hours. After modeling， each treatment group was treated with corresponding drugs for 24 hours. The levels of malondialdehyde （MDA）， total antioxidant capacity （T-AOC）， superoxide dismutase （SOD）， catalase （CAT）， and glutathione peroxidase （GSH-Px） in MLE-12 cells， as well as the expression levels of B-cell lymphoma-2 （Bcl-2）， Bcl-2 associated X protein （Bax）， caspase-3 protein and mRNA， CAT and glutathione S-transferase （GST） mRNA were determined. The levels of interleukin- 1β （IL-1β）， tumor necrosis factor-α （TNF-α） and IL-6 in RAW264.7 cells， as well as the expression levels of NOD-like receptor thermal protein domain associated protein 3 （NLRP3）， cleaved caspase-1 protein， and mRNA expressions of IL-1β，TNF-α， IL-6 and inducible nitric oxide synthase （iNOS） were all detected. RESULTS The prepared CPC-NPs had particle size of （675.69±64.58） nm， Zeta potential of （－20.11± E-mail：zhangleifang1986@163.com 0.98） mV， polydispersity coefficient of 0.455±0.010 （n＝3）；entrapment efficiency of 35.60%， and drug loading of 16.13%；CPC-NPs had regular spherical shapes， where the drug could be sustainably released for more than 30 hours. Compared with Mod group， the levels of T-AOC， SOD， CAT （excluding the 30 μg/mL group of CPC-NPs） and GSH-Px， mRNA expressions of CAT and GST， as well as the Bcl-2/Bax protein ratio and mRNA ratio were significantly increased in MLE-12 cells of different concentration groups of CPC-NPs， while MDA levels and caspase-3 protein and mRNA expression were significantly reduced （P＜0.01 or P＜0.05）. Compared with Mod group， the levels of IL-1β， TNF-α and IL-6， NLRP3 and cleaved-caspase-1 protein expressions， as well as the mRNA expressions of IL-1β， TNF-α， IL-6 and iNOS in RAW264.7 cells of different concentration groups of CPC-NPs were significantly reduced （P＜0.01 or P＜0.05）. CONCLUSIONS CPC-NPs with lung targeting and sustained release property were prepared successfully， which can alleviate acute lung injury induced by LPS combined with seawater through antioxidant stress， inhibiting cell apoptosis and inflammatory response.

Objective To observe the accuracy of the five-level adult emergency triage system (FLAETS) in determining the severity of critically ill patients,and to analyze the factors that influenced the accuracy of the triage.Methods The triage information of patients admitted to Huashan North Hospital Affiliated to Fudan University between 1 year before and 1 year (started in July 2014) after the implementation of the FLAETS were retrospective analyzed.The patients who triaged by FLAETS (from September 2014 to August 2015) were served as observational group,and those manual triaged by modified early warning score (MEWS,from July 2013 to June 2014) were set as control group.The patients with triage of Ⅰ,Ⅱ,and Ⅲ levels were enrolled (fatal,critical,urgent),and the triage results of emergency physicians-in-chief on duty were set as gold standard.The gender,age,triage level,the proportion of over-triage,the proportion of under-triage,and mortality were compared between two groups.The reasons for the overtriage and under-triage were analyzed.The accuracy of FLAETS in determining severity of critically ill patients was calculated.Results 18449 patients were enrolled in observational group,and 720,1641 and 16088 patients were triaged as level Ⅰ,level ⅡⅡ,level Ⅲ respectively;17 378 patients were triaged as critically ill patients according to gold standard,and level Ⅰ,level Ⅱ,level Ⅲ were 637,1476 and 15 265 patients respectively.6 352 patients were enrolled in control group,and level Ⅰ,level Ⅱ,level Ⅲ were 204,771 and 5 377 patients respectively;6002 patients were triaged as critically ill patients according to gold standard,and level Ⅰ,level Ⅱ,level Ⅲ were 308,836 and 4 858 patients respectively.There were no statistically significant differences in gender and age between two groups (both P ＞ 0.05).Compared with the control group,the proportion of over-triage of level Ⅲ was significantly lowered [8.3％ (1 329/16088) vs.12.5％ (674/5 377),P ＜ 0.01],the proportion of under-triage of level Ⅱ and level Ⅲ was significantly lowered [level Ⅱ:0.6％ (9/1 641) vs.7.0％ (54/771),level Ⅲ:0.4％ (63/16088) vs.4.7％ (254/5 377),both P ＜ 0.01].The success rate of resuscitation in observation group was significantly higher than that of control group [80.70％ (619/767) vs.75.23％ (410/545),P =0.020],and the mortality was significantly lowered [1.11％ (193/17 378) vs.2.35％ (141/6002),P =0.037].Over-triages were mainly found in patients with chronic obstructive pulmonary disease (COPD),hypertension and the main complaint of chest tightness,shortness of breath,and under-triages were mainly found in patients with the multiple organ dysfunction in the elder,atypical heart disease and pneumothorax.The accuracy rates of level Ⅰ,level Ⅱ and level Ⅲ in observation group (99.37％,97.42％ and 89.58％) were significantly higher than those of the control group (97.51％,92.54％,and 80.16％,all P ＜ 0.01).Conclusion The FLAETS in determining severity of critically ill patients were objective and reliable,which enable the nurse to better handle the relationship of the emergency and the ordinary,the severe and the mild,the priority and the non-priority,which made the patients received timely and effective treatment.

ObjectiveTo identify the finding of functional MRI(fMRI) during active and passive fingers moving in hemipegic patients after stroke.Methods23 stroke patients with hemipegia were asked to actively moving their fingers and then passively moving with others' help.MSEPI technique was performed with planar parallel AC-PC.During each scan series,they were asked to perform repetitive finger-thumb opposition movement in the same period of active and rest.All the scanning data was transferred to a workstation and dealt with statistical method.Some patients examined fMRI again after rehabilitation.ResultsfMRI showed normal in the healthy side,with the decrease or displacement in the affected side of motor cortex area.Motor cortex area in the affected side would be recovered after rehabilitation.ConclusionfMRI can be used to evaluate the difference between active and passive moving motor cortex,and help to judge the prognosis of the patients with motor functional disorder.

OBJECTIVE:To prepare anti-microbicide contraceptive gel and establish its quality control method. METHODS: The gel was prepared with octoxynol and policresulen as main ingredients and HPMC as matrix. The content of octoxynol in the gel was determined by HPLC,and the content of policresulen in the gel was determined by titration method. RESULTS:Prepared gel was well-proportioned and of good viscidity and its identification and test were up to the standard. The linear rang of octoxynol was 250～1 500 mg?L-1(r=0.999 6)with an average recovery of 100.84%(RSD=0.74%,n=9). The average labeled amount of policresulen was 106.64%(n=3). CONCLUSION:This preparation is feasible and stable in quality,and the quality control method is simple and accurate.