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.     

腹腔镜胆囊切除术治疗急性结石性胆囊炎的疗效

目的探讨分析对急性结石性胆囊炎患者采用腹腔镜胆囊切除术进行治疗的临床效果,以及对患者的胃肠功能和C反应蛋白所造成的影响。方法本次研究对象乃是我院肝胆外科于2017年4月-2019年4月期间收治的急性结石性胆囊炎患者62例,按照患者就诊的先后顺序对其进行平均分组,比较两组患者的术后肠鸣音恢复时间、肛门排气时间、排便时间、C反应蛋白水平以及并发症发生率。结果腹腔镜手术组患者的术后肠鸣音恢复时间(13.6±3.5)小时、肛门排气时间(16.5±2.7)小时以及排便时间(25.7±3.3)小时,均明显少于开腹式手术组患者(P<0.05);腹腔镜手术组患者的术后并发症发生率(6.45%)明显低于开腹式手术组患者(25.80%)(P<0.05);腹腔镜手术组患者的C反应蛋白水平为(10.4±2.5)mg/L,少于开腹式手术组患者(P<0.05)。结论根据本次研究的结果可以确认,对急性结石性胆囊炎患者采用腹腔镜胆囊切除术进行治疗能够取得更好的效果,可以促使患者的胃肠功能在术后更快的恢复,提高患者的C反应蛋白,从而有效避免患者出现并发症。     

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。     

3M无痛保护膜联合造口袋治疗大便失禁相关性皮炎的临床观察

目的探讨用3M无痛保护膜联合造口袋治疗大便失禁相关性皮炎(Incontinent dermatitis,IAD)的疗效。方法选择我院2014年12月至2015年6月收治的50例IAD患者为研究对象,按照随机数表法将其分为对照组与实验组,每组25例。对照组患者予以传统皮肤护理方法;实验组的患者除传统皮肤护理外加用3M无痛保护膜联合造口袋治疗。并比较两组患者治疗后的皮炎改善情况、皮炎愈合时间及皮炎复发率。结果实验组患者治疗效果明显优于对照组,实验组皮炎愈合短于对照组,实验组皮炎复发率明显低于对照组,差异均有统计学意义(P<0.05)。结论 3M无痛保护膜联合造口袋治疗IAD,临床效果显著,且愈合快,复发低。