Ke Kevin, Pillai Krishna, Mekkawy Ahmed H, Akhter Javed, Badar Samina, Valle Sarah J, Morris David L
Department of Surgery, St. George Hospital, Kogarah, NSW, 2217, Australia.
Mucpharm Pty Ltd, Kogarah, NSW, 2217, Australia.
Discov Oncol. 2021 Aug 16;12(1):25. doi: 10.1007/s12672-021-00418-5.
Intraperitoneal administration of BromAc (bromelain + acetylcysteine) is currently undergoing a phase 1 clinical trial for pseudomyxoma peritonei at our institution. This study reports on analysis of routine blood parameters before and after treatment for a series of 25 patients in this trial. Blood parameters assessed included full blood count, electrolytes, urea, and creatinine, liver function tests, coagulation studies, as well as inflammatory markers (CRP). Certain parameters such as CRP, and white cell count, were significantly elevated after treatment whilst serum albumin level was reduced indicating an inflammatory reaction. However, liver enzymes, coagulation studies, and other parameters were not affected. Therefore, there are no additional safety signals evident upon analysis of routine blood parameter testing.
在我们机构，腹腔内注射BromAc（菠萝蛋白酶+乙酰半胱氨酸）目前正在进行一项针对腹膜假黏液瘤的1期临床试验。本研究报告了该试验中25例患者治疗前后常规血液参数的分析情况。评估的血液参数包括全血细胞计数、电解质、尿素、肌酐、肝功能测试、凝血研究以及炎症标志物（CRP）。某些参数，如CRP和白细胞计数，在治疗后显著升高，而血清白蛋白水平降低，表明存在炎症反应。然而，肝酶、凝血研究和其他参数未受影响。因此，分析常规血液参数检测时未发现明显的额外安全信号。
