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.

Application of Child-Turcotte-Pugh Scores in Predicting the Risk of Death for In-hospital Heart Failure Patients / 中国循环杂志

Objective: Heart failure (HF) patients are usually associated with liver function impairment, Child-Turcotte-Pugh (CTP) scores can evaluate liver function, but its effect in HF patients has been unclear. We want to study the application of CTP scores in predicting the risk of death for in-hospital HF patients. Methods: A total of 1180 consecutive in-hospital HF patients were enrolled. According to CTP scores evaluated liver function at admission, the patients were divided into 3 groups: CTP grade A group, n=951, CTP grade B group, n=206 and CTP grade C group, n=23. The endpoint of this study was all-cause death. Results: There were 180 patients died at 1 year follow-up period, the in-hospital and 1 year mortalities were increased with the elevated CTP grades accordingly: for in-hospital mortalities in CTP grade A, B and C groups were (0.8%, 11.7% and 56.5%) respectively, P Conclusion: CTP scores may independently predict the risk of death for in-hospital HF patients, the levels of CTP scores might be used for evaluating the efficacy of in-hospital treatment.

Reference value and clinical correlates of soluble ST2 in healthy community-based Chinese population / 中华心血管病杂志

<p><b>OBJECTIVE</b>This study was designed to investigate the plasma level of soluble ST2 (sST2) and related influencing factors, and establish its reference value in the healthy community-based population in Beijing area of China.</p><p><b>METHODS</b>We measured plasma sST2 level by enzyme-linked immunosorbent assay between March 2012 and August 2012 in 1 334 healthy subjects in communities, including 597 males and 737 females. Empiric and quantile regression methods were used to determine the reference range of plasma sST2. A multiple linear regression model was established to analyze the factors that might affect the level of plasma sST2.</p><p><b>RESULTS</b>Gender is the most important factor affecting the plasma level of sST2 in healthy people. Plasma level of sST2 is significantly higher in men than in women (P < 0.01). Within each age strata, i.e. < 45, 45-54, 55-64, ≥ 65 years old, the plasma levels of sST2 were significantly higher in men than age-matched female (all P < 0.01). Age, body mass index (BMI), systolic blood pressure, diastolic blood pressure, and smoking did not affect plasma sST2 level. Reference range of sST2 was 5.7-53.5 µg/L for men and 4.4-42.4 µg/L for women (95% nonparametric reference interval). The one-side upper 95th percentile value of sST2 to discriminate the cardiovascular disease from healthy state was 47.2 µg/L for men and 37.2 µg/L for women.</p><p><b>CONCLUSIONS</b>This study established the normal reference range of plasma sST2 in healthy community-based population. The major influencing factor of sST2 level in healthy population is gender.</p>

Expression of micro RNA-29a and 133a in myocardium of atrium of per-sistent atrial fibrillation model dog / 中国病理生理杂志

AIM:To investigate the effects of microRNA-29a and 133a expression in the atrium on atrial fibril-lation (AF) and fibrosis.METHODS:Chronic rapid atrial pacing was used to establish the persistent AF dog model , and the sham group was also set up .The cardiac ultrasound measurement was used for determining the cardiac structure size . The Masson 3 color staining were used to evaluate the stage of fibrosis .The expression of microRNA-29a and 133a in the left atrium ( LA) was detected by real-time transcriptase polymerase chain reaction .RESULTS: Compared with before modeling , no statistical difference of atrial dilatation and decreased ejection fraction in the model dogs with persistent AF was observed (P>0.05).Compared with sham group, the degree of fibrosis and collagen volume fraction (CVF) in per-sistent AF model group were increased obviously (P<0.05).The expression of microRNA-29a and 133a were decreased obviously (P<0.01, P<0.05).CONCLUSION:Structural remodeling of the atrium and atrial fibrosis are the essential for development and maintenance of atrial fibrillation .Down-regulation of microRNA-29a and 133a expression may be very important molecular mechanism for atrial structural remodeling in the persistent AF model dogs .