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 develop a ventilation system for the enhaned mobile biosafety level-2(BSL-2)laboratory to control the dispersed aerosol within the laboratory effectively.Methods A ventilation system for the enhanced mobile biosafety level-2 laboratory was designed with the concept of full fresh air ventilation,which realized air supply with 3-stage filtration and constant air volume control,and air exhaust with 1-stage high-efficiency filtration and variable air volume control.The buffer room had the layout of upside air supply and upside exhaust,with the air supply and exhaust equipment integrated into the ceiling;the experimental room had the layout of diagonally upside air supply and diagonally downside exhaust.Computa-tional fluid dynamics(CFD)software was used to analyze the airflow organization,temperature field and velocity field at 0°,30°,45°,60° and 90° air supply angles in order to verify the feasibility of the ventilation system design,and the distributions of aerosol concentration in the experimental room at different air supply angles were simulated to determine the optimal air supply angle.Results Investigations in terms of airflow organization,temperature field,velocity field and aerosol dispersion control showed in case of 60° air supply angel the enhanced mobile BSL-2 laboratory behaved the best and its core indexes all met the requirements of GB 27421-2015 Mobile laboratories—Generalrequirements for biosafety and T/CESC 662-2020 Architectural technical standard for BSL-2 laboratory in medical facilities including the number of air changes,static pressure difference,temperature and humidity,cleanliness and airflow direction.Conclusion Considerations have to be taken on the locations of supply and exhaust outlets,the facility layout and air supply angle when the enhanced mobile BSL-2 laboratory is designed so as to enhance the biosafety of the protective area.[Chinese Medical Equipment Journal,2024,45(7):29-34]

Objective:To explore the application of metagenomic next-generation sequencing (mNGS) in patients with pulmonary infection after failure of empirical treatment.Methods:From September 2021 to November 2023, a total of 64 patients with pulmonary infection who failed to receive empirical treatment in the Ninth People′s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine were retrospectively analyzed, sputum and bronchoalveolar lavage fluid of patients were collected for traditional etiological detection and mNGS detection in alveolar lavage fluid, and the differences between traditional etiological detection methods and mNGS detection methods for pathogen detection in patients with pulmonary infection after failure of empirical treatment were compared.Results:In 64 patients with pulmonary infection after failure of empirical treatment, the positive rate of mNGS microbial detection in alveolar lavage fluid was higher than that of traditional etiological detection: 87.50%(56/64) vs. 57.81%(37/64), and the difference was statistically significant ( P<0.01). The most common microorganisms detected by mNGS were bacterial infections, the main bacteria were Pseudomonas aeruginosa, Klebsiella pneumoniae and Haemophilus paraininfluenzae. The detection rate of mNGS in mixed infection was higher than that of traditional etiological detection: 65.63%(42/64) vs. 15.63%(10/64), χ2 = 33.17, P<0.01. Drug resistance genes were detected by mNGS technique in 18 patients, and a total of 21 kinds of drug resistance genes were detected, 53.13%(34/64) of patients improved after antibiotic adjustment based on mNGS test results. Conclusions:mNGS technology can effectively improve the positive microbial detection rate of patients with pulmonary infection after failure of empirical treatment, and can assist in the evaluation of antimicrobial resistance genes and guide the adjustment of clinical antibiotics, so as to improve the therapeutic effect.

OBJECTIVE: To test the hypothesis that β -glucan enhances protective qi (PQi), an important Chinese medicine (CM) concept which stipulates that a protective force circulates throughout the body surface and works as the first line of defense against "external pernicious influences". METHODS: A total of 138 participants with PQi deficiency (PQD) were randomized to receive β -glucan (200 mg daily) or placebo for 12 weeks. Participants' PQi status was assessed every 2 weeks via conventional diagnosis and a standardized protocol from which a PQD severity and risk score was derived. Indices of participants' immune and general health status were also monitored, including upper respiratory tract infection (URTI), saliva secretory IgA (sIgA), and self-reported measures of physical and mental health (PROMIS). RESULTS: PQi status was not significantly different between the β -glucan and placebo treatment groups at baseline but improved significantly in the β -glucan (vs. placebo) group in a time-dependent manner. The intergroup differences [95% confidence interval (CI)] in severity score (scale: 1-5), risk score (scale: 0-1), and proportion of PQD participants (%) at finish line was 0.49 (0.35-0.62), 0.48 (0.35-0.61), and 0.36 (0.25-0.47), respectively. Additionally, β -glucan improved URTI symptom (scale: 1-9) and PROMIS physical (scale: 16.2-67.7) and mental (scale: 21.2-67.6) scores by a magnitude (95% CI) of 1.0 (0.21-1.86), 5.7 (2.33-9.07), and 3.0 (20.37-6.37), respectively, over placebo. CONCLUSIONS β -glucan ameliorates PQi in PQD individuals. By using stringent evidence-based methodologies, our study demonstrated that Western medicine-derived remedies, such as β -glucan, can be employed to advance CM therapeutics. (ClinicalTrial.Gov registry: NCT03782974).
Adult ; Double-Blind Method ; Humans ; Qi ; Risk Factors ; Self Report ; beta-Glucans/therapeutic use*

Thrombospondin (THBS) 2, as a member of the THBS family, is expressed in a variety of tumor cells and has important significance in the development and metastasis of tumors. In recent years, studies have reported that the specific role of THBS2 in different tumors is different, and it participates in a variety of biological processes, such as cell apoptosis, wound healing, angiogenesis and inflammation. At present, the role of THBS2 in tumorigenesis, development, and prognosis is not completely clear. Exploring the abnormal expression and mechanism of THBS2 in tumors is expected to provide a new method for tumor diagnosis and treatment.

Objective: To explore the potential mechanism of pimecrolimus in airway remodeling of atopic dermatitis (AD) and asthma mice. Methods: Female BALB/c mice were randomly divided into three groups: control group, atopic dermatitis group and pimecrolimus treatment group. The cell in bronchoalveolar lavage fluid (BALF) was calculated by Ray-Jimsa staining. The structural changes in lung tissue and skin tissue were observed by hematoxylin-eosin (HE) staining, and the level of interleukin (IL)-33, IL-5, IL-13 in serum was detected by enzyme-linked immunosorbent assay (ELISA). The expressions of type 1 collagen (Col1) in the airway of mice were detected by RT-PCR and Western blotting. And western blotting was also used to determine the activation of mitogen-activated protein kinase P38 (P38MAPK) and mitogen-and stress-activated protein kinase 1 (MSK1) in the lungs of mice. Results: Compared with those in the control group, the total number of leukocytes in bronchoalveolar lavage fluid (BALF) and the expression levels of IL-33, IL-13 and IL-5 in serum of atopic dermatitis group were significantly higher, and the difference was statistically significant (P < 0.05). In the atopic dermatitis group, the phosphorylation of P38MAPK and MSK1 protein was increased (1.50 ± 0.43 vs. 0.80 ± 0.43, 1.39 ± 0.08 vs. 0.62 ± 0.08) and the expression of Col1 protein and protein (1 vs. 3.20 ± 0.59, 1.40 ± 0.12 vs. 0.13 ± 0.16) was increased, and the difference was statistically significant (P < 0.05). After pimecrolimus treatment, the number of leukocytes in BALF, the levels of IL-33, IL-5 and IL-13 in serum (213.13 ± 11.89, 657.97 ± 86.47, 143.82 ± 33.02), the phosphorylation of P38MAPK and MSK1 protein in lung tissue (0.10 ± 0.04, 0.85 ± 0.05), and the expression of Col1 mRNA and Col1 protein were decreased (0.61 ± 0.22, 0.48 ± 0.08), and the difference was statistically significant (P < 0.05). The edema of lung and skin tissue and the infiltration of inflammatory cells were alleviated. Conclusions Pimecrolimus can alleviate the inflammation and airway remodeling in mice by inhibiting the activation of IL-33 related pathways, thereby reducing the incidence of asthma.

Professor - is the representative inheritor of fire needling therapy. He proposed that the clinical application of fire needling is mainly based on pattern differentiation according to eight priciples, as well as in coordination with the theories of meridians and - organs. He believes that dry eye syndrome can be treated from the aspects of deficiency of liver and kidney, heart deficiency, and and deficiency. Through deeply digging the connotation of ancient classics, and combined his clinical practice using fire needling, professor created a unique therapy that select "Neichengqi"as the main acupoint combined with Xialeidian, Dagukong (EX-UE 5), Xiaogukong (EX-UE 6) and Shaoze (SI 1) in the treatment of dry eye syndrome. In this paper, from the etiology and pathogenesis of dry eye syndrome and therapeutic characteristics of fire needling, the thoughts of syndrome differentiation and characteristics of acupoints selection of professor were analyzed by a typical case, and it is expect to enrich the clinical treatment plan for dry eye syndrome.
Acupuncture Points ; Acupuncture Therapy ; Dry Eye Syndromes ; therapy ; Humans ; Meridians ; Vascular Surgical Procedures