| Background The oncology medical treatment that includes chemotherapy,targeted therapy,immunotherapy and so on will inevitably cause adverse reactions to diarrhoea while suppressing and killing tumor cells.Malignant tumor medical treatment-related diarrhoea can affect the patient’s quality of life and treatment process,and even threaten the patient’s life in severe cases,so the prevention and treatment of malignant tumor medical treatment-related diarrhoea plays a vital importance in the whole process of treating tumor.Whether it is traditional Chinese medicine or ethnic medicine,that has a long history and rich experience in the treatment of diarrhoea,and there are certain effects.Objective To evaluate the clinical efficacy and medication safety of Changweishu Jiaonang in improving the malignant tumor medical treatment-related diarrhoea of spleen-stomach damp-heat syndrome;To explore the application of method and drugs clearing heat and eliminating dampeness in the treatment of malignant tumor medical treatment-related diarrhoea.Methods A randomized controlled,multi-center clinical trial method was completed in collaboration with seven top three hospitals.Cases that met the selection criteria were divided into a test group and a control group using the random envelope method.The test group was treated with Changweishu Jiaonang(4 capsules per time,3 times a day).The control group was treated with Xianglian tablets(5 tablets per time,3 times a day).Both groups were administered continuously for 2 weeks.The TCM syndrome scores,TCM syndrome efficacy,single symptom efficacy,exploratory index including VIP、CCK and PG were compared before and after treatment,and safety indicators(Blood-routine、Urine-routine、Stool-routine、Hepatorenal Function、ECG)were observed.Adverse reactions were recorded.SPSS 20.0 was used for statistics to compare and analyze the clinical efficacy and drug safety of Changweishu Capsule.Results A total of 63 patients were included,including 42 subjects and 21 controls.The analysis results showed that:① On the 7th day of medication,the total effective rate in the test group was 35.71%,and the total effective rate in the control group was 28.57%.On the 14th day of medication,the total curative effect of Changweishu Jiaonang on malignant tumor medical treatment-related diarrhoea was 88.1%,and the total curative effect of Xianglian tablets syndrome was 71.43%.Whether it is the 7th or 14th day of medication,comparison of curative effect between the two groups was not statistically significant by χ2 test(P>0.05).It shows that the symptoms curative effect of the two groups are equivalent.② Both drugs can reduce the total score of TCM syndromes of malignant tumor treatment-related diarrhoea.The t-test was statistically significant in comparing before and after treatment(P<0.001).On the 7th day of medication,there was no difference between the two groups(P>0.05).On the 14th day of medication,the comparison of syndrome scores between groups after treatment is statistically significant(P<0.05),indicating that the two medicines down-regulate malignant tumor medical treatment-related diarrhoea syndrome scores are different,and Changweishu Jiaonang is more advantage.③Comparing the effectiveness of individual symptoms between the two groups,on the 7th day,the difference between the two groups was not significant(P>0.05).On the 14th day,in tenns of abdominal fullness,the total effective rate was 66.7%in the test group.Among the 18 cases in the control group,the total effective rate was 27.8%.There was statistical significance between the two groups(P<0.05),indicating that the test group and the control group had different effects in improving abdominal fullness,and the test group had better efficacy than the control group.There were no statistically significant differences between the two groups in terms of abdominal pain and diarrhoea,food intake,hiccup and nausea,dry mouth and bitter taste(P>0.05),indicating that the effects of these symptoms are equivalent.④ Both drugs can reduce the abdominal pain and diarrhoea,food intake,hiccup and nausea,dry mouth and bitter taste scores.The t-test was statistically significant(P<0.05).In terms of abdominal fullness,the test group is statistically significant in comparing before and after treatment(P<0.001),the control group is not statistically significant in comparing before and after treatment(P>0.05).Comparing the single symptom between groups,abdominal fullness is statistically significant(P<0.05);abdominal pain and diarrhoea,food intake,hiccup and nausea,dry mouth and bitter taste are not statistically significant(P>0.05),Which indicating that the two drugs down-regulate abdominal fullness is different,and Changweishu Jiaonang has more advantages,and the two drugs have similar improvement in abdominal pain and diarrhoea,food intake,hiccup and nausea,dry mouth and bitter taste.⑤ According to the etiology of diarrhoea,the cases were stratified into four groups:chemotherapy-induced diarrhoea,targeted therapy-induced diarrhoea,immunotherapy-induced diarrhoea,and targeted therapy combined with chemotherapy-induced diarrhoea.The efficacy of the experimental group in each subgroup was comparable to that of the control group(P>0.05).It is effective in improving chemotherapy-induced diarrhea,targeted therapy-induced diarrhoea,immunotherapy-induced diarrhea,and targeted therapy combined with chemotherapy induced diarrhoea.⑥According to gender stratification analysis,there is no correlation between gender and efficacy of the two drugs(P>0.05).Age stratified analysis shows that in the middle-aged group(41-65 years old)Changweishu Jiaonang is more effective.⑦ No adverse reactions were found during the observation process.Conclusion(1)Changweishu Jiaonang has a certain effect in improving the traditional Chinese medicine syndrome of patients with malignant tumor medical treatment-related diarrhea,and the efficacy is comparable to Xianglian tablets.(2)Changweishu Jiaonang can significantly improve the single symptoms of abdominal fullness in patients with malignant tumor medical treatment-related diarrhea.(3)Changweishu Jiaonang has good clinical drug safety. |
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