[Comparative trial of granisetron versus granisetron plus methylprednisolone for the prevention of nausea and vomiting induced by cancer chemotherapy].
Preclinical and clinical studies have demonstrated the effectiveness of granisetron in preventing emesis induced by antineoplastic chemotherapy. This comparative study was undertaken to investigate the efficacy and safety of granisetron (40 micrograms/kg) and granisetron plus methylprednisolone (MPL; 10 mg/kg). Sixty-eight patients were given granisetron 170 times and thirty-nine patients were given a combination of granisetron and MPL 81 times. Sixty-one patients received the treatment in crossover fashion during the same chemotherapy regimens. The emetic and nausea episodes were counted during the 24 hours following each chemotherapy treatment. Complete response, no emesis or less than two episodes, were obtained in 75.3% (128/170 times) of patients receiving granisetron alone compared to 85.2% (69/81 times) of patients receiving the combination of granisetron plus MPL. There were no significant differences in complete responses between the two groups, male and female, and each age group. However, 11 of eighteen patients receiving granisetron alone who responded mildly, if at all, with respect to nausea and vomiting, showed a complete or major response when MPL was added to granisetron. There were two patients who developed temporal paresthesia of the both hands as an adverse effect, but there was spontaneous recovery after 3 hours. Our data suggested that granisetron plus MPL was slightly more effective than granisetron alone and a safe antiemetic drug.
Hirota
T
T
Dept. of Pediatrics, Aichi Medical University.
Shimizu
H
H
Fujimoto
T
T
Koike
A
A
Kojima
T
T
Noguchi
M
M
Yabushita
H
H
Kato
R
R
Daimaru
O
O
Noda
A
A
D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; 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 / Q000517:prevention & control*; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*
D000970:Antineoplastic Agents; D017829:Granisetron; D008775:Methylprednisolone