A Clinical Study Of The Efficacy And Safety Of Xuanfudaizhe Decoction In Prventing Chemotherapy-Induced Nausea And Vomiting

Objective:This study was designed to observe the therapeutic effects and safety of Xuanfudaizhe decoction on lessening vomiting in chemotherapy of cancer, to explore the treatment of vomiting caused by chemotherapy in Chinese and Western Integrative Medicine. Methods:This is a randomized, positive and own controlled clinical trial. Histological confirmed malignant. patients who were willing and qualified to take part in this clinical test all received moderate or high emetic risk chemotherapy.42 patients of cancer were randomized into two groups. There were 21 patients in the treatment(Xuanfudaizhe) group and 21 patients in the control (metoclopramide) group. Two groups were comparable. Both of the two groups were treated with chemotherapy, These patients all used high emetic risk chemotherapy:receiving cisplatin and receiving adriamycin or pharmorubicin. In addition, patients in the treatment group took Xuanfudaizhe decoction, and received an injection of metoclopramide before the beginning of chemotherapy in the control group. Both of the two groups were from the day before chemotherapy until the end of this course of the treatment. Observed the disease variety during the whole chemotherapy course, through observation of treatment and control groups the incidence and the severity of vomiting to determine the therapeutic effects of Xuanfudaizhe decoction. Observed the vomiting and the score of vomiting in patients, before and after treatment in the first day, third days, fifth days and seventh days. To compare the quality of life (KPS, QOL) of patients before and after treatment. As well as the safety indexes, such as vital signs, blood routine, liver and renal function would be observed. Then, the occurrence of the extrapyramidal system response, including dizziness, drowsiness, fatigue. and constipation, diarrhea, rash, galactorrhea, gynecomastia and arrhythmia would be observed. Results:(1)The Clinical comparison of chemotherapy-induced nausea and vomiting:the total effective rate in treatment group was 90.5%, higher than 66.7%; The difference between the two groups was not significant(P>0.05). (2)In the chemotherapy, the score of Karnofsky patients with health score (KPS) and quality of life (QOL) in treatment group were all lower than controls (P<0.05). (3)After chemotherapy, the physical condition of patients consist of the physical changes in blood, liver, kidney function and changes in the electrocardiogram in the treatment group were better than controls(P<0.05). (4)To compared with the side effects in the Two groups during the chemotherapy:the constipation, diarrhea, rash, galactorrhea, dizziness and arrhythmia in treatment group were all lower than controls (P<0.05). Conclusions:Xuanfudaizhe decoction can effectively combat chemotherapy-induced nausea and vomiting. There were significant effects on chemotherapy-induced vomiting compared with control groups. Xuanfudaizhe decoction also improve the patient's general condition. Xuanfudaizhe decoction have no toxic and side effects. The clinical application of Xuanfudaizhe decoction is safe and effective.