[Comparison of clinical effects between granisetron alone and combination of granisetron and methylprednisolone against the nausea and vomiting induced by CDDP chemotherapy--comparative study by the cross-over trial. University of Tsukuba Antiemetics Study Group].
A cross-over clinical trial was carried out to compare the antiemetic effect and safety between granisetron alone (40 micrograms/kg) and the combination of granisetron and methylprednisolone (MP: 10 mg/kg) in urological cancer patients treated with cisplatin. Forty-eight courses were given with granisetron alone and 47 courses with both granisetron and MP. The antiemetic effect of nausea and vomiting was evaluated in the acute emetic phase. during the 24 hours following the CDDP administration, and in the delayed emetic phase, 2 to 7 days after the administration. Combination therapy of granisetron and MP demonstrated a greater antiemetic effect during the 72 hours following the CDDP administration than by granisetron alone. But there was no significant difference in antiemetic effect between combination therapy and granisetron alone after the 3rd day. Combination therapy also demonstrated more efficacy in complete antiemetic effect, with no emesis and less than moderate nausea, than by granisetron alone. Both treatments showed no side effects and were safe.
Dept. of Urology, University of Tsukuba.
K
K
Uchida
H
H
Akaza
T
T
Shimazui
K
K
Kikuchi
F
F
Manabe
A
A
Iwasaki
S
S
Ishikawa
R
R
Noguchi
M
M
Otani
K
K
Hattori
F
F
Kondo
Y
Y
Nishijima
K
K
Sato
K
K
Koiso
S
S
Hinotsu
D000368:Aged; D000932:Antiemetics / Q000008:administration & dosage*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects*; D018592:Cross-Over Studies; D004359:Drug Therapy, Combination; D005260:Female; D017829:Granisetron / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage*; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000188:drug therapy*; D014565:Urogenital Neoplasms / Q000188:drug therapy; D014839:Vomiting / Q000139:chemically induced / Q000188:drug therapy*
D000932:Antiemetics; D002945:Cisplatin; D017829:Granisetron; D008775:Methylprednisolone