[Preventive efficacies of china-made tropisetron hydrochloride and Navoban on chemotherapy-induced nausea and vomiting: a randomized controlled clinical trial].
OBJECTIVE
Navoban (import tropisetron hydrochloride) can effectively prevent chemotherapy-induced nausea and vomiting; however, it is too expensive to be used extensively in clinic. This study was designed to compare the antiemetic efficacies and side effects of China-made tropisetron hydrochloride with Navoban.


METHODS
A multicenter and randomized controlled trial was carried out. A total of 132 cancer patients were randomized into 2 groups and received 5 mg of China-made tropisetron hydrochloride (group A, 66 patients) or Navoban (group B, 66 patients) intravenously before cisplatin- or adriamycin-based chemotherapy. The gastrointestinal reactions induced by chemotherapy and side effects of the antiemetics were recorded within 7 days after chemotherapy.


RESULTS
Acute nausea was prevented completely in 48.5% of the patients in group A and in 43.8% of group B; acute vomiting was prevented completely in 69.7% of the patients in group A and in 67.2% of group B. Delayed nausea was prevented completely in 25.8% of the patients in group A and in 28.1% of group B; delayed vomiting was prevented completely in 47.0% of the patients in group A and in 51.6% of group B. No significant differences in complete control of nausea and vomiting showed between group A and group B (P > 0.05). Both antiemetic regimens were well tolerated, and no difference in adverse events between the 2 groups was observed (P > 0.05).


CONCLUSIONS
China-made tropisetron hydrochloride is as effective as Navoban in the prevention of chemotherapy-induced nausea and vomiting, and only causes mild, infrequent side effects.
Xie
Mian
M
Skate Key Laboratory of Oncology in Southern China, Cancer Center, Sun Yat-sen University, Guangzhou, Guangdong, P. R. China.
Wu
Hai-Ying
HY
Guo
Ying
Y
Liu
Jun-Ling
JL
Guan
Zhong-Zhen
ZZ
Liu
Ya-Li
YL
Wang
Ping-Hui
PH
Chen
Qiang
Q
Huang
Ping
P
Yang
Jian-Wei
JW
D000328:Adult; D000932:Antiemetics / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy; D002945:Cisplatin / Q000009:adverse effects; D004317:Doxorubicin / Q000009:adverse effects; D005260:Female; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D008175:Lung Neoplasms / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D000077526:Tropisetron; D014840:Vomiting, Anticipatory / Q000517:prevention & control*
D000932:Antiemetics; D007211:Indoles; D000077526:Tropisetron; D004317:Doxorubicin; D002945:Cisplatin