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 Dilute Pituitrin to Hysteroscopic Surgery / 中国微创外科杂志

Objective To assess the effect of dilute pituitrin solution (0.05 U/ml) on blood loss and distention fluid intravasation during hysteroscopy. Methods From January 2003 to June 2004, 68 women with abnormal uterine hemorrhage undergoing hysteroscopic endometrial resection were randomly divided into treatment and control groups (34 cases in each). In the treatment group, dilute pituitrin solution (0.05 U/ml) was injected into the cervix before dilation of the cervix in preparation for hysteroscopy, while the patients in the control received no pituitrin injection. Results The mean operation time in the treatment group was significantly shorter than that in the control [(32.2?6.0) min vs (35.9?6.8) min; t=-2.379, P=0.020]. The amount of distention fluid infusion in the treatment group was significantly less than that of the control [(2982.1?880.5) ml vs (3461.2?795.8) ml; t=-2.354, P=0.022]. The volume of distention fluid intravasation in the treatment group was significantly less than that of the control [(225.3?81.1) ml vs (319.4?89.2) ml; t=-4.551, P=0.000]. The rate of fluid intravasation was (7.5?1.1)% in the treatment group that was significantly lower than that in the control [(9.2?1.1)%, t=-6.372, P=0.000]. The mean blood loss in the treatment group was significantly less than that of the control [(15.1?4.1) ml vs (24.7?6.6) ml; t=-7.204, P=0.000]. Conclusions Intraoperative administration of dilute pituitrin solution can reduce blood loss, operation time, and the amount of distention fluid infusion and intravasation. As a result, it is useful to avoid post-hysteroscopy complications including TURP syndrome.