Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial / 中华医学杂志(英文版)

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.

A model for predicting the probability of poor outcome at 3 months after intravenous thrombolysis for elderly patients with acute cerebral infarction / 中华老年医学杂志

Objective:To explore independent predictors for poor outcome at 3 months in elderly patients with acute cerebral infarction(ACI)treated with intravenous thrombolysis(IVT), and to develop a nomogram-based predictive model.Methods:This was a retrospective cohort study.Clinical, laboratory and imaging data of 346 elderly patients with ACI treated with IVT from January 2016 to April 2021 in our hospital were collected.Poor outcome was defined as a modified Rankin Scale(mRS)score >2 at 3 months after the stroke.Logistic regression analysis was used to screen for independent factors predicting poor outcome in elderly ACI patients treated with IVT, and a corresponding nomogram model was developed using the R software.The ROC curve, calibration plots and decision curve analysis were used to evaluate discrimination, calibration and clinical application value of the nomogram model.Results:Among 346 candidates, 109 developed a poor outcome, representing a rate of 31.5%.Logistic regression analysis showed that symptomatic hemorrhagic transformation( OR=15.647, 95% CI: 8.913-27.454), stroke severity(moderate stroke, OR=3.322, 95% CI: 1.414-7.811; moderate-severe stroke, OR=8.169, 95% CI: 4.102-16.258; severe stroke, OR=9.653, 95% CI: 5.440-17.121), stroke-associated pneumonia( OR=2.239, 95% CI: 1.134-4.420), and heart failure( OR=2.758, 95% CI: 1.424-5.336)were independent predictors for poor outcome at 3 months in elderly ACI patients treated with intravenous thrombolysis(all P<0.05). With the area under curve(AUC-ROC)value at 0.85(95% CI: 0.80-0.89), the nomogram model, which was composed of the above four predictors, demonstrated good discrimination.On the calibration plot, the mean absolute error was 0.020, indicating that the model had good calibration.Decision curve analysis revealed that the model had good clinical application value. Conclusions:The nomogram model composed of symptomatic hemorrhagic transformation, stroke severity, stroke-associated pneumonia and heart failure may predict poor outcome at 3 months in elderly ACI patients treated with IVT, with high prediction accuracy and high clinical application value.

Role of 1,25(OH)2 vitamin D3 and vitamin D receptor in chronic kidney kiseases / 国际儿科学杂志

1,25 (OH)2 D vitamin3 is the activated form of vitamin D in human body.Mediated by specific vitamin D receptor, 1,25(OH) 2 vitamin D3 plays an important role in many physiological and pathological process.In recent years, researches have shown that 1,25 (OH) 2 vitamin D3 can protect podocytes, inhibit the proliferation of mesenteric cells, regulate the apoptosis of mesenteric cells, anti-inflammation, and have negative effect in rennin-angiotensin system, so as to protect the renal function.This paper reviews the progress of the effect of 1,25(OH)2 vitamin D3 and vitamin D receptor in chronic renal disease.

Observation of the curative effect of traditional Chinese medicine direction inductive therapeutical instrument combined with golden bifid in the treatment of infantile diarrhea / 中国基层医药

Objective To explore the effect of traditional Chinese medicine direction inductive therapeutical instrument combined with golden bifid in the treatment of infantile diarrhea .Methods 188 infants aged from 1 month to 3 years who suffered from acute diarrhea were randomly divided into the treatment group and the control group ,94 cases in each group .All the patients were treated with continued diet ,prevention and correct water and electrolyte bal-ance and other treatment ,the treatment group received traditional Chinese medicine direction inductive therapeutical instrument combined with oral golden bifid based on the above treatment .The time of temperature returned to normal , stop vomiting and diarrhea and stool frequency were recorded and analyzed .Results The time of symptoms disap-peared,obvious effective rate and total effective rate of the treatment group were better than those of the control group . Conclusion It is safe and effective to treat infantile diarrhea by traditional Chinese medicine direction inductive therapeutical instrument combined with golden bifid .

Effects of electrode on epileptogenic focus potential and expressions of the beta subunit of ATP synthase in rats with penicillin-induced epilepsy / 生物医学工程学杂志

The changed process of bioenergy and the effects of electrode interfering on penicillin-induced epileptic brains in epileptic seizures rats were investigated. Fifty Sprague-Dawley (SD) rats were randomly divided into 4 groups, i. e. normal saline control group (group A), penicillin model group (group B), metal electrode interfere group (group C) and insulated electrode interfere group (group D). The epileptogenic potential and the expressions of the beta subunit of-ATP synthase( ATP5B) in hippocampal neurons were measured. The epileptogenic foucus potential and expressions of ATP5B in hippocampus neurons showed that the trend increased at first and decreased implantation of later, and the implantation of metal electrodes decreased the epileptogenic foucus potential at corresponding time point, but had no effect on the expressions of ATP5B. The change of epileptogenic focus potential was reduced by implantation of metal electrode, possibly due to the alteration of corrosponding bioenergy metabolism which had participated in the process of epileptic seizure.