[Clinical evaluation of granisetron for nausea and vomiting induced by anticancer drugs--multi-centered placebo-controlled double-blind comparative study].
A placebo-controlled double-blind comparative trial was conducted to objectively assess the antiemetic effect on nausea and vomiting induced by anticancer drugs including cisplatin (CDDP) and safety of granisetron tablet (2 mg). In the present trial, single oral administration of the trial drug was performed one hour before the start of CDDP administration. 1) In clinical efficacy, the drug was assessed as "remarkably effective" or "effective" in 76.9% (30/39) in G group and 15.2% (7/46) in P group. The drug was assessed as "extremely useful" or "useful" in 84.6% (33/39) and 13.3% (6/45) in respective groups. These results indicated that G group was statistically significantly better than P group in these parameters. 2) In safety rating, the drug was assessed as "safe" in 100% (49/49) in G group and 95.9% (47/49) in P group, indicating equivalent levels between these groups. 3) The antiemetic effect of granisetron tablet was not dependent on patient's background factors including sex, P.S., the dose of CDDP and the number of anticancer drugs concomitantly used with CDDP. 4) The clinical effect of single oral administration of granisetron tablet (2 mg) persisted for approximately 24 hours. 5) In terms of the safety of the trial drug, there was no adverse event or abnormal laboratory fluctuation which might pose a clinical problem. From the above results, it was concluded that single oral administration of granisetron at a dose of 2 mg could suppress nausea and vomiting induced by the administration of anticancer drugs.
4th Dept. of Internal Medicine, Teikyo University.
M
M
Suminaga
H
H
Furue
K
K
Ohta
T
T
Taguchi
H
H
Niitani
N
N
Ogawa
D000284:Administration, Oral; D000932:Antiemetics / Q000008:administration & dosage*; D002945:Cisplatin / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D017829:Granisetron; D006801:Humans; D007191:Indazoles / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000188:drug therapy*; D013607:Tablets; D014839:Vomiting / Q000139:chemically induced / Q000188:drug therapy*
D000932:Antiemetics; D002945:Cisplatin; D017829:Granisetron; D007191:Indazoles; D013607:Tablets