OBJECTIVE: To investigate the efficacy and safety of the conditioning regimen BeEAM (bendamustine+et-oposide+cytarabine+melphalan) in autologous stem cell transplantation (ASCT) for patients with malignant lymphoma. METHODS: The clinical data of 20 patients with malignant lymphoma who underwent ASCT after conditioning with BeEAM regimen from January 2021 to December 2022 in the First Affiliated Hospital of Bengbu Medical University were collected, and the clinical characteristics before transplantation, conditioning-related toxicity, hematopoietic reconstitution after transplantation, and therapeutic effects were analyzed. 67 patients with malignant lymphoma who did not undergo ASCT during the same period were selected as the control group, and the 1-year progression-free survival (PFS) rate and overall-survival (OS) rate between the ASCT group and the non-ASCT group were compared. RESULTS: 15 cases achieved complete remission (CR) and 5 cases achieved partial remission (PR) before transplantation in ASCT group. During the conditioning process of patients in the ASCT group, 14 cases experienced gastrointestinal adverse reactions, 13 cases experienced neutropenic fever, 10 cases experienced oral mucositis, 2 cases experienced abnormal liver function, and only 1 case experienced acute renal injury. All the adverse reactions resolved after symptomatic treatment. After transplantation, 19 cases achieved hematopoietic reconstitution, and only one case had poor platelet engraftment. The median time of peripheral white blood cell (WBC) engraftment was 9 (9-16) days, and the median time of platelet engraftment was 12 (10-23) days. By the end of follow-up, there were no transplant-related deaths. The 1-year PFS rates in the ASCT group and the non-ASCT group were 94.4% and 68.5%, respectively; The 1-year OS rates were 94.4% and 83.5%, respectively. The median PFS and OS time for both groups were not reached. The PFS in the ASCT group was significantly better than that in the non-ASCT group (P < 0.05), and there was no significant difference in OS between the two groups ( P >0.05). CONCLUSION BeEAM regimen is safe and effective as a conditioning treatment for ASCT in patients with malignant lymphoma, with tolerable adverse reactions, controllable non-hematological toxicity, smooth hematopoietic reconstitution, and considerable short-term efficacy. However, further follow-up is required to evaluate its long-term efficacy.
Humans ; Transplantation Conditioning/methods* ; Transplantation, Autologous ; Hematopoietic Stem Cell Transplantation ; Lymphoma/therapy* ; Cytarabine/therapeutic use* ; Female ; Male ; Melphalan/therapeutic use* ; Adult ; Middle Aged ; Bendamustine Hydrochloride/therapeutic use*

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

OBJECTIVETo study the filtration efficiency of a positive pressure powered air purifying medical protective equipment and the effect of the flow rate on the microenvironment of the equipment.

METHODSThe filtration efficiency of high efficiency particulate air (HEPA) filter was measured with the biologic aerosol of simulating virus (Escherichia coli bacteriophage f(2)). The simulation work was done at the walk rate of 4 km/h in summer. The effect of the flow rate on the oxygen content, the carbon dioxide content, the temperature and the humidity of the microenvironment of the equipment was investigated. The clinical experiments were conducted in three appointed hospital for fighting against SARS.

RESULTSThe HEPA filter could filtrate 99.99% simulating viruses in the air. When the flow rate ranged from 75 to 125 L/min, the microenvironment parameters of the equipment were: the oxygen content was between 19.6% and 20.1% (the physiological safety limit is more than 14.6%); the carbon dioxide content ranged from 0.43% to 0.57% (the physiological safety limit is less than 1.0%); the temperature was between 32.0 degrees C to 32.2 degrees C; the humidity ranged from 49.7% to 59.4% (the physiological safety limit is the temperature 31 degrees C and the humidity 85% or temperature 38 degrees C and humidity 50%). Each microenvironment parameter met the demand of a healthy person under the normal workload. In the clinical experiments, the doctors wearing the equipment who performed the tracheotomy for a SARS patient in a deep coma were not infected.

CONCLUSIONThe medical protective equipment can protect the doctor and nurse in SARS contaminated areas effectively and improve their work conditions.

Air ; analysis ; Air Microbiology ; Carbon Dioxide ; analysis ; Colony Count, Microbial ; Humans ; Humidity ; Occupational Medicine ; instrumentation ; Oxygen ; analysis ; Protective Devices ; Respiratory Protective Devices ; Temperature ; Ventilation