[A clinical phase III trial of MR-20 in gynecologic nephrotoxicity of cisplatin--a comparative study in MR-20-treated and control patients on cyclical intermittent cisplatin treatment].
MR-20 was administered to 52 gynecological cancer patients who presented with nephrotoxicity from cisplatin (CDDP) treatment over 3 courses at 33 institutions throughout Japan during the period from July 1992 through March 1994, in order to study its suppressive effect on the nephrotoxicity as well as its safety; and the results are reported in this paper.


METHODS
The efficacy and usefulness of MR-20 were studied by a MR-20-untreated-controlled, non-double-blind manner. An efficacy rate of 72.0% was achieved in the MR-20 group, and 37.0% in the untreated group: MR-20 was significantly more effective for nephrotoxicity than the MR-20-untreated group. Ccr was prevented from significant variations in the MR-20 group, compared with the untreated group. It was considered that MR-20 is a safe drug, and that it is useful in suppressing the nephrotoxicity of CDDP treatment.
Ochiai
K
K
Dept. of Obstetrics and Gynecology, Jikei University School of Medicine.
Ikeda
M
M
Kobayashi
H
H
Nishimura
H
H
Shibasaki
T
T
Sakai
O
O
Oh-hashi
Y
Y
Terashima
Y
Y
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects*; D002945:Cisplatin / Q000009:adverse effects*; D004334:Drug Administration Schedule; D005260:Female; D006023:Glycoproteins / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007668:Kidney / Q000187:drug effects*; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D014361:Trypsin Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy; D014594:Uterine Neoplasms / Q000188:drug therapy*
D000970:Antineoplastic Agents; D006023:Glycoproteins; D014361:Trypsin Inhibitors; C028665:urinastatin; D002945:Cisplatin