| Objective:This study tries to explore and evaluate the clinical efficacy of Huoxiang Zhengqi Oral Liquid combined with Tropisetron and Dexamethasone in the prevention of nausea and vomiting caused by medium and high emetic risk chemotherapeutic drug(CINV),aiming to improve the overall response rate of CINV,relieve clinical symptoms of Traditional Chinese Medicine(TCM)of patients,and provide reliable clinical evidence for TCM prevention and treatment of CINV with Huoxiang Zhengqi Oral liquid through this treatment method.Methods: Eighty patients who met the inclusion and exclusion criteria were selected as the study subjects,and were divided into two groups by random digital table method,with 40 cases in each group.The control group was treated with the antiemetic regimen which contained Tolansetron and Dexamethasone;the observation group was supplemented with Huoxiang Zhengqi Oral Liquid on the basis of control group.Degree of nausea and vomiting,TCM syndrome score,rescue times,anxiety and depression scores,KPS score,body weight,safety indexes and adverse reactions were recorded,and the collected datas were statistically analyzed.Results: The number of exfoliated cases was three during the study period,and the final number of effective cases was 38 in the control group and 39 in the observation group.1.Clinical efficacy of nausea and vomiting: In the acute phase D0,there was no statistically significant difference in overall response rate(ORR)of nausea and vomiting between the two groups(P>0.05).In the delayed phase D1、D3、D5,the observation group was superior to the control group in terms of ORR of nausea(76.9% vs 57.8%,P<0.05;66.6% vs 42.1%,P<0.01;82.0% vs57.8%,P<0.01);ORR of vomiting in the observation group was also better compared with the control group(74.3% vs 52.6%,P<0.05;66.6% vs42.1%,P<0.05;79.4% vs 57.8%,P<0.05).2.The curative effect of TCM syndrome: In the acute phase D0,the difference 0f TCM symptom scores between the two groups was no statistically significant.As compared to the control group in the delay phase D1、D3、D5,the score of TCM main symptoms of nausea and vomiting,continuous abdominal pain,distension and fullness,postprandial abdominal distension in the observation group were lower(P<0.05).As compared to the control group in the delay phase D1、D3、D5,the scores of TCM secondary symptoms of epigastric noise,tastelessness without thirsty,bowel ringing and abnormal stool in the observation group were lower(P<0.05);however,the difference between the two groups in the scores of symptoms such as lack of appetite,lethargy,fatigue and complexion was no significant(P>0.05).3.Mental sentiment: The anxiety scores of the observation group was lower compared with the control group(46.54+7.957 vs 52.16+8.852,P<0.05);the depression scores,the observation group was also lower compared with the control group(52.62+6.885 vs 56.24+6.899,P< 0.05),and there are significant differences.4.Rescue times,KPS score and body weight: In terms of rescue treatment of explosive CINV,the average number of rescue in observation group was less compared with the control group(0.92+0.850 vs 0.51+0.644,P<0.05).The KPS score of observation group was better in comparison with the control group(84.10+6.373 vs 77.11+8.671,P<0.05).No difference found in body weight between the two groups by statistical significance(P>0.05).5.Safety evaluation:After treatment,the main blood routine and liver and kidney indexes had no significant differences from before.During the clinical trial,no adverse reactions related to Huoxiang Zhengqi Oral Liquid occurred.Conclusions: Huoxiang Zhengqi Oral Liquid combined with Tropisetron and dexamethasone can increase the overall response rate nausea and vomiting caused by medium and high emetic risk chemotherapeutic drug in the delayed phase,relieve partial TCM symptoms,ease the anxiety and depression of patients,reduce the rescue times of explosive CINV and improve the quality of life of patients.Moreover,the safety of Huoxiang Zhengqi Oral Liquid was good that no obvious adverse reactions observed was related to and can be used for further clinical promotion and research.. |
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