A Phase I Dose Escalation Study of the Safety,Tolerability, and Pharmacokinetics of Ipilimumab in Chinese Patients with Select Advanced Solid Tumors

Lessons Learned

• The overall safety profiles of ipilimumab 3 mg/kg and 10 mg/kg administered every 3 weeks, were consistent between Chinese patients with solid tumors in the current study and patients from previous U.S. ipilimumab monotherapy studies. No new safety signals were identified.
• The mean systemic exposures to ipilimumab (assessed by first dose area under the curve during the dosing interval and maximum serum concentration) were numerically lower in the Chinese patient population than in U.S. patients for both 3 mg/kg and 10 mg/kg doses; however, the range of serum concentrations in the Chinese and U.S. populations overlapped (3 mg/kg and 10 mg/kg), suggesting that ipilimumab pharmacokinetics was ethnically insensitive in this study.

BackgroundThis phase I, open‐label study assessed ipilimumab safety, tolerability, pharmacokinetics (PK), immunogenicity, and antitumor activity in Chinese patients with unresectable, metastatic, recurrent malignant melanoma (MM) or nasopharyngeal carcinoma (NPC).MethodsOf 39 patients enrolled, 25 received ipilimumab (11 patients received 3 mg/kg, and 14 patients received 10 mg/kg). Reasons for not receiving treatment were withdrawal of consent (3 patients), no longer meeting the criteria (10 patients), and one recorded as “other.” During the induction phase, patients received ipilimumab (3 mg/kg, i.v.), on day 1 of a 3‐week cycle, to a maximum of four doses or progressive disease (PD). During the maintenance phase at week 24, patients received ipilimumab (3 mg/kg, i.v.) on day 1 of a 12‐week cycle, to a maximum of 3 years or PD. Considering the co‐primary safety and PK endpoints, the successive dosing required nine patients with two or fewer dose‐limiting toxicities during the 42‐day observation period to proceed with a new cohort of nine patients at 10 mg/kg.ResultsIpilimumab safety and PK profiles were similar in Chinese and predominantly White populations. Ipilimumab was well tolerated. Most adverse events (AEs) were grades 1–2 and experienced by 11 patients treated with 3 mg/kg and 14 patients treated with 10 mg/kg. There were no new safety concerns. Incidence of anti‐ipilimumab antibodies was low (1 of 10 in the 3 mg/kg patients and 2 of 13 in the 10 mg/kg patients) and without safety implications. In the 3 mg/kg group, 8 of 11 patients had PD. In the 10 mg/kg group (all NPC, 0 MM patients), 11 of 14 patients had PD. Three patients had stable disease (one at 3 mg/kg and two at 10 mg/kg).ConclusionIpilimumab was well tolerated in Chinese patients, showing similar safety and PK to previous studies in predominantly White populations.     

从《温疫论》浅谈调脾胃防治新型冠状病毒肺炎

新型冠状病毒肺炎(COVID-19)患者除呼吸道症状以外,常伴有纳差腹胀、大便不调等消化道症状,舌苔往往厚腻,有湿邪侵犯中焦的特点。中医认为脾胃与肺关系密切,手太阴肺经起于中焦,下络大肠,还循胃口,与脾共司水液代谢。同时从国家及各地区发布的COVID-19中医诊疗方案中也可看出,针对脾胃的治疗贯穿始终,与《温疫论》中的观点不谋而合,因此在治肺的基础上应当重视脾胃的治疗。结合《温疫论》中相关论述及现有的报道和临床资料,参照《新型冠状病毒感染的肺炎诊疗方案(试行第五版)》疾病分期,探讨从脾胃角度防治COVID-19。     

经9次核酸检测终确诊的新型冠状病毒肺炎患者1例分析

目前新型冠状病毒肺炎(COVID-19)疫情在全球蔓延,形势严峻,并对全球公共卫生事业构成巨大挑战,快速准确的诊断COVID-19对疫情的防控有重要意义。本文报道1例COVID-19患者的调查和确诊过程,以对COVID-19确诊和疫情防控提供有价值的参考。患者为赴渝务工于2020年1月23日返乡人员,在渝期间,其同工地的一同事确诊为COVID-19,之后该工地接连有另外8位同事被确诊。患者返乡后2月2日被当地疫情防控单位采取医学隔离。患者于隔离后不久出现咳嗽,阵发性,干咳为主,偶可咳出黄色痰液等COVID-19相关临床症状,遂被当地新型冠状病毒肺炎定点医疗单位收治,后经市级新型冠状病毒肺炎诊治专家组远程视频会诊转入四川大学华西医院资阳医院。患者先后经历9次核酸检测,在前8次核酸检测均为阴性的情况下,于第9次核酸检测结果为阳性,2月21日最终确诊为新型冠状病毒肺炎。     

康复护理教学中应用Seminar教学法的分析

目的 探讨康复护理教学中应用Seminar教学法的效果.方法 选择医院2018年6月—2019年6月在肿瘤科实习的80名护理学生作为本次研究入组对象,根据随机数字表随机分为研究组和对照组,每组40名学生.对照组采用传统护理教学方法 ,研究组采用Seminar教学法,分析对比两组护理学生的教学效果.结果 研究组护理学生理论考试、技能考试、综合成绩高于对照组护理学生成绩(P<0.05).研究组护理学生自主学习情况由于对照组护理学生(P<0.05).结论 康复护理教学中应用Seminar教学法的效果好,有利于激发学生学习兴趣,巩固学生护理基本知识技能,提高护理思维能力,从而提高护理教学质量.     

皮肤鳞状细胞癌的中医药治疗进展

皮肤鳞状细胞癌是具有发病率高、发展快、可转移、易误诊等特点的一种恶性肿瘤，对人类的健康造成威胁。随着中医的发展和现代医学实验研究技术的进步，中医药在皮肤鳞状细胞癌的现代研究方面也取得一定成果。目前临床上治疗鳞状细胞癌多采取手术及药物化疗等，因不良反应的存在，患者接受度低。中药具有多靶点、安全性高、不良反应少等优势，在治疗皮肤鳞状细胞癌中中医具有一定优势，本文将围绕中药单体、中药复方，以及针灸在治疗皮肤鳞状细胞癌的研究进展展开论述和思考。