[Tropisetron hydrochloride in preventing and treating chemotherapy-induced nausea and vomiting: a phase II, randomized, multicenter, double-blinded, comparative clinical trial].
OBJECTIVE
Tropisetron hydrochloride (Navoban), as a highly selective 5-hydroxytryptamine 3 (5-HT3) receptor antagonist, has been widely used in preventing and treating chemotherapy-induced nausea and vomiting for many years. This study was to evaluate the efficacy and safety of homemade tropisetron hydrochloride in preventing and treating cisplatin-based chemotherapy-induced nausea and vomiting.


METHODS
A randomized, double-blinded, multicenter, comparative trial was conducted in cancer patients receiving cisplatin-based chemotherapy. All patients were assigned to group A-B or B-A randomly, and took homemade tropisetron hydrochloride and Navoban (positive control agent) to treat chemotherapy-induced nausea and vomiting.


RESULTS
A total of 118 patients were enrolled: 60 in group A-B and 58 in group B-A. There was no difference in the efficacy of relieving acute vomiting between homemade tropisetron hydrochloride and Navoban (P>0.05). The inhibition rates of nausea and vomiting were 28.59% and 52.61% respectively in group A-B, while 29.21% and 51.94% in group B-A (P>0.05). In addition, quality of life (QOL) showed no significant difference between the 2 groups at Days 3, 6, 10, and 21 (P>0.05). Besides, the occurrence rate of adverse events, such as constipation, abdominal distention, vertigo, headache and fatigue, was 27.97% in group A-B and 22.03% in group B-A (P>0.05).


CONCLUSIONS
Homemade tropisetron hydrochloride injection has both reliable efficacy and safety in preventing and treating cisplatin-induced acute or chronic nausea and vomiting; it is comparable with Navoban on many aspects, such as long action time, less adverse effects and improved QOL.
Zhang
Wen-Dong
WD
Department of Cancer Center, Qilu Hospital, Shandong University, Jinan, Shandong, 250012, PR China. wendongz@163.com
Wang
Xiu-Wen
XW
Chen
Zhen-Dong
ZD
Qin
Feng-Zhan
FZ
Shu
Yong-Qian
YQ
Pan
Liang-Xi
LX
Zhang
Mao-Hong
MH
D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000188:drug therapy*; D009369:Neoplasms / Q000188:drug therapy*; D011788:Quality of Life; D012702:Serotonin Antagonists / Q000627:therapeutic use; D000077526:Tropisetron; D014839:Vomiting / Q000139:chemically induced / Q000188:drug therapy*
D000932:Antiemetics; D007211:Indoles; D012702:Serotonin Antagonists; D000077526:Tropisetron; D002945:Cisplatin