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We aim to assess the safety and efficacy of proxalutamide, a novel androgen receptor antagonist, for men with metastatic castration-resistant prostate cancer (mCRPC) in a multicenter, randomized, open-label, phase 2 trial. In our study, the enrolled mCRPC patients were randomized to 100, 200 and 300 mg dose groups at 1:1:1. The primary efficacy endpoint was prostate-specific antigen (PSA) response rate. The secondary endpoints included objective response rate (ORR), disease control rate (DCR) and time to PSA and radiographic progression. Safety and pharmacokinetics were also assessed. Finally, there were 108 patients from 17 centers being enrolled. By week 16, there were 13 (35.1%), 12 (36.4%) and 15 (42.9%) patients with confirmed 50% or greater PSA decline in 100 mg (n = 37), 200 mg (n = 33) and 300 mg (n = 35) groups, respectively. Among the 19 patients with target lesions at study entry, three (15.8%) had a partial response and 12 (63.2%) had stable disease. The ORRs of 20.0%, 22.2%, 0% and DCRs of 80.0%, 88.9%, 60.0% were, respectively, achieved in 100, 200 and 300 mg groups. By the maximum follow-up time of 24 weeks, there were 42.6% and 10.2% of cases experiencing PSA progression and radiographic progression, respectively. Overall, adverse events (AEs) were experienced by 94.4% of patients, most of which were mild or moderate. There were 28 patients experiencing ≥grade 3 AEs. The most common AEs were fatigue (17.6%), anemia (14.8%), elevated AST (14.8%) and ALT (13.0%), decreased appetite (13.0%). These findings preliminarily showed the promising antitumor activity of proxalutamide in patients with mCRPC with a manageable safety profile. The proxalutamide dose of 200 mg daily is recommended for future phase 3 trial (Clinical trial registration no. CTR20170177).  相似文献   
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近年来性早熟的发病率呈逐年升高趋势,关于此病的中医药治疗研究亦不断深入,桑杲教授据多年临床经验,提出“和稳论”学术思想,以此为治疗原则,用和稳阴阳、和畅气血、和畅情志三大法进行身心综合调理,并提炼总结,自拟经验方——和氤汤,疗效颇佳,兹以介绍。  相似文献   
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目的:比较我国《国家基本药物目录》(NEML)、《世界卫生组织(WHO)儿童基本药物目录》(WHO-EMLc)和其他19个国家基本药物目录中抗变态反应药物的差异,为进一步完善我国基本药物目录提供参考。方法:检索WHO官网,收集各国基本药物目录。通过Excel分析工具,比较抗变态反应药物种类、数量、剂型、规格等的差异,探讨基本药物对儿童的适宜性,总结收录的抗变态反应药物在我国的上市情况。结果:NEML与WHO-EMLc中相同的抗变态反应药物为氯雷他定。与NEML比较,WHO-EMLc和其他19国目录中抗变态反应药物增加了适合儿童使用的口服溶液剂,且部分国家注明了氯苯那敏和西替利嗪药物的年龄限制。各目录中收录的抗变态反应药物在我国上市剂型主要为普通片剂,适合儿童使用的颗粒剂、糖浆剂等特殊剂型虽有上市,但生产厂家较少。结论:以NEML与WHO-EMLc为基础,借鉴瑞典、马来西亚、马尔代夫等国家的经验,建议适当增加适宜儿童使用的第二代抗组胺药物剂型和规格,保障儿童临床用药的安全有效,完善国家基本药物目录  相似文献   
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摘要:目的 评价国内注射用克林霉素磷酸酯的质量,并对质量标准进行完善。方法 采用法定检验方法与探索性研究相 结合,对2021年国家药品抽验得到的142批次样品进行比较分析。结果 按法定标准检验142批次样品的合格率为100%。但现行 法定标准存在“一药多标”现象,且有关物质方法设置不合理,限度不同,含量测定方法待改进等问题。探索性研究新建了有 关物质和含量测定法,并采用LC/MS等方法确证了各杂质的结构,并对杂质的来源进行归属。结论 目前国内注射用克林霉素 磷酸酯总体质量良好,但存在杂质随着贮存时间的延长,含量明显增加的问题;此外法定检验标准未对含量最大的杂质B和F进 行控制,法定标准有待统一和提高。  相似文献   
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摘要:目的 探讨儿童肺炎克雷伯菌血流感染(Klebsiella pneumoniae bloodstream infection, KPBSI)临床特征及肺炎克雷伯 菌(Klebsiella pneumoniae, KP)对常用抗菌药物的敏感性,为儿童KPBSI合理治疗提供参考。方法 回顾性分析2014年1月至2019 年12月在重庆医科大学附属儿童医院住院的KPBSI患儿临床资料。结果 共纳入110例患儿,64例(58.2%)为院内感染,72例 (65.5%)有基础疾病,以血液系统肿瘤最多见。110例患儿PRISM Ⅲ评分为16.0(7.0~20.8),其中74例(67.3%)发生脓毒症,15例 (13.6%)发生脓毒性休克,18例(16.4%)发生呼吸衰竭,15例(13.6%)需有创机械通气,院内死亡共13例(11.8%)。KP菌株对阿米卡 星、碳青霉烯类抗菌药物敏感率>90%,对头孢噻肟、头孢曲松和头孢他啶的敏感率分别为58.3%、60.9%和70.9%,对头孢哌 酮/舒巴坦和哌拉西林/他唑巴坦的敏感率分别为59.5%和82.7%。检出ESBLs+菌株39株(39/86,45.3%),耐碳青霉烯类肺炎克雷 伯菌(CRKP)菌株10株(10/110,9.1%),ESBLs+KP菌株和CRKP在各年龄组间分布无统计学差异。结论 儿童KPBSI多见于有基 础疾病的患儿,脓毒症、脓毒性休克和呼吸衰竭发生率高;KP菌株对头孢他啶和哌拉西林/他唑巴坦敏感性较高,可经验性治 疗轻症KPBSI患儿。  相似文献   
8.
Tao Gao  Lei Liu  Yan Wu  Quan Du 《中国药学》2022,31(1):31-46
WangShiBaoChiWan (WSBCW) is a traditional Chinese medicine with a recorded administration history of more than 180 years. In the present study, the preclinical safety of WSBCW was evaluated the preclinical safety of WSBCW using a toxicity test, which consisted of an administration period of 28 d and a recovery period of 15 d. During the test, male and female SD rats were administered the medicine once a day by oral gavage, at a dose of 60 mg/kg/day, 600 mg/kg/day, or 1500 mg/kg/day. As a reference medicine, mosapride citrate was administered at a dose of 37.5 mg/kg/day, which was clinically equivalent to the high-dosage treatment of WSBCW. With all the dosage groups, statistically, no adverse effect was observed in terms of clinical observation, food intake, body weights, organ coefficient, blood biochemistry, and histopathology examination. No intestinal melanosis was observed in the rats. When the data were examined animal by animal, test substance-related adverse effects were found with the high-dosage rats in hematology assay. The deranged, however, reversible changes suggested a compromised intestinal barrier, which was also observed with in mosapride citrate-treated rats. In addition to the histopathology assay, molecular toxicology was explored using high-throughput gene sequencing. No evident toxicity was revealed. In summary, administration of WSBCW was well tolerated within a treatment of 28 d.  相似文献   
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Long noncoding RNA maternally expressed gene 3 (lncRNA MEG3) was down-regulated in pulmonary fibrosis of rats induced by Nickel oxide nanoparticles (NiO NPs), while the downstream regulatory mechanisms of MEG3 remain unclear. This study aimed to investigate the relationship among MEG3, Hedgehog (Hh) signaling pathway and autophagy in pulmonary fibrosis caused by NiO NPs. The pulmonary fibrosis model in rats was constructed by intratracheal instillation of 0.015, 0.06, and 0.24 mg/kg NiO NPs twice a week for 9 weeks. Collagen deposition model was established by treating A549 cells with 25, 50, and 100 μg/mL NiO NPs for 24 h. Our results indicated that NiO NPs activated Hh pathway, down-regulated the expression of MEG3, and reduced autophagy activity in vivo and in vitro. Meanwhile, the autophagy process was promoted by Hh pathway inhibitor (CDG-0449), while the collagen formation in A549 cells was reduced by autophagy activator (Rapamycin). Furthermore, the overexpressed MEG3 inhibited the activation of Hh pathway, resulting in autophagy activity enhancement along with collagen formation reduction. In summary, lncRNA MEG3 can restrain pulmonary fibrosis induced by NiO NPs via regulating hedgehog signaling pathway-mediated autophagy, which may serve as a potential therapeutic strategy for pulmonary fibrosis.  相似文献   
10.
Pan  Yuxia  Xu  Li  Yang  Xinchun  Chen  Mulei  Gao  Yuanfeng 《Heart failure reviews》2022,27(3):837-847
Heart Failure Reviews - Atrial fibrillation (AF) and heart failure (HF) are common chronic diseases noted in humans. AF and HF share several risk factors, such as age, hypertension, obesity,...  相似文献   
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