Frustaci S, Foladore S, De Pascale A, Freschi A, Lo Re G, Sorio R, Errante D, Monfardini S
Division of Medical Oncology, Centro di Riferimento Oncologico, Aviano, Italy.
Ann Oncol. 1992 Apr;3 Suppl 2:S115-8. doi: 10.1093/annonc/3.suppl_2.s115.
Tolerability and efficacy of the new uroprotective agent ARGIMESNA was assessed within a randomized cross-over study comparing it to sodiummercaptoethanesulfonate (MESNA), in patients treated with IFO. MESNA i.v., 20% of IFO dose, was given to all patients before chemotherapy; 4 h later, at random, they received ARGIMESNA p.o., 20% of IFO dose every 2 h x 4, or MESNA p.o., 40% of IFO dose every 4 h x 2. Overall, 78 cycles of oral uroprotection were administered: 37 for ARGIMESNA capsules; 41 for MESNA vials p.o. ARGIMESNA was subjectively better tolerated, determining gastro-intestinal discomfort in only 12 out of 37 cycles versus 34/41 of MESNA p.o. (p less than 0.001). Both preparations were equivalent for subjective and objective efficacy since no cycles were complicated by urinary symptoms (dysuria, stranguria, or hematuria). Nevertheless, 2 patients (7.7%) refused further oral assumption of both uroprotectors, whereas MESNA i.v. was added in other 7 patients because of nausea and vomiting caused by chemotherapy. In conclusion, this new oral preparation of mercaptoethanesulfonate turned out to be well tolerated, safe and active in the prevention of haemorrhagic cystitis from IFO.
在一项随机交叉研究中，对新的尿路保护剂ARGIMESNA与巯基乙磺酸钠（MESNA）进行了耐受性和疗效评估，研究对象为接受异环磷酰胺（IFO）治疗的患者。所有患者在化疗前静脉注射MESNA，剂量为IFO剂量的20%；4小时后，随机给予患者口服ARGIMESNA，剂量为IFO剂量的20%，每2小时一次，共4次，或口服MESNA，剂量为IFO剂量的40%，每4小时一次，共2次。总体而言，共进行了78个周期的口服尿路保护：37个周期使用ARGIMESNA胶囊；41个周期使用口服MESNA小瓶。主观上，ARGIMESNA的耐受性更好，37个周期中只有12个周期出现胃肠道不适，而口服MESNA的这一比例为34/41（p<0.001）。两种制剂在主观和客观疗效方面相当，因为没有周期出现泌尿系统症状（尿痛、排尿困难或血尿）。然而，2例患者（7.7%）拒绝继续口服两种尿路保护剂，另外7例患者因化疗引起的恶心和呕吐而加用了静脉注射MESNA。总之，这种新的巯基乙磺酸钠口服制剂在预防IFO引起的出血性膀胱炎方面耐受性良好、安全且有效。
