Clinical comparative of tropisetron hydrochloride with or without traditional Chinese medicine compound in prevention of chemotherapy-induced nausea and emesis.

Objective To evaluate the efficacy and side effects of tropisetron hydrochloride plus three Traditional Chinese Medicine Compounds for the prophylaxis of chemotherapy-induced nausea and emesis.Methods A randomized trial was carried out.Eighty-four patients were randomly devided into group A and group B.According to the general appearances,Group B was further divided into B1(Stomach-Cold Group),B2(Stomach-Heat Group) and B3(Neutral Group).All patients received tropisetron hydrochloride before CTX-based or DDP-based chemotherapy.Participants in group B1,B2 and B3 were additionally treated with Ding-xiang-shi-di Decoction,Ju-pi-zhu-ru Decoction and Xiao-ban-xia Plus Fu-ling Decoction respectively.Gastrointestinal reactions induced by chemotherapy and side effects of the anti-emetics were recorded within 7d after chemotherapy.Results Acute nausea was prevented completely for 42.9% of the patients in group A and for 66.7% in group B(P0.05).Complete control rate of acute emesis was achieved for 61.9% of patients in group A and 85.7% in group B(P0.05).With regard to delayed nausea,complete control rate and effective control rate in Group A was 19.0% and 38.1%,while 42.9%(P0.05) and 63.5%(P0.05) in group B.Group B also had a better complete and effective control rate than Group A in delayed emesis with 56.7% vs.33.3%(P0.05) and 84.1% vs.54.1%(P0.01).Both anti-emetic regiments were well tolerated and no difference in adverse events between the two groups was observed(P0.05).Conclusion Tropisetron hydrochloride plus different Traditional Chinese Medicine Compound is more effective than Tropisetron hydrochloride alone in the prevention of chemotherapy-induced nausea and emesis.The therapeutic schedule is safe,effective and feasible.