Clinical Observation Of Changweishu Capsule In The Treatment Of Tumor-related Constipation (spleen And Stomach Damp-heat Syndrome)

ObjectiveBased on the functional indications of Changweishu capsules,combined with modern prescriptions and modern pharmacological studies of single traditional Chinese medicine in prescription,it is speculated that Changweishu capsules can regulate constipation caused by spleen and stomach damp-heat moving down the large intestine.Based on the hypothesis that Changweishu Capsule has a therapeutic effect on spleen and stomach damp-heat moving down the intestine to cause constipation,and clinical observations have found that spleen and stomach damp-heat syndrome accounts for a considerable proportion in patients with tumor-related constipation.Therefore,we selected Changweishu Capsules as therapeutic drugs for clinical observation of TCM characteristics,To systematically evaluate the clinical efficacy,safety and possible mechanism of Changweishu Capsule in the treatment of tumor related constipation(spleen and stomach damp-heat syndrome),to provide theoretical and clinical research basis for tumor related constipation,and to improve the solutions for this kind of constipation.MethodsA randomized,positive controlled,multicenter,prospective clinical trial was conducted by seven tertiary hospitals.Cases that met the selection criteria were randomly divided into a test group or a control group by the method of removing envelopes.In the test group,4 pills of Changweishu Capsules were taken three times a day,30 minutes after breakfast,lunch and dinner;the control group used Maren Runchang Soft Capsules,8 pills each time,twice a day,30 minutes after breakfast and dinner.The entire study process was 2 weeks,and the peripheral blood signs,TCM symptoms and signs,exploratory indicators,and safety indicators of 3 efficacy,safety and possible mechanism of Changweishu Capsules were compared and analyzed.ResultsThis study was derived from the horizontal project of Changweishu Capsule in the treatment of spleen and stomach damp-heat syndrome international registration clinical research program.It is planned to complete 30 cases in the test group and 30 cases in the control group.Taking into account factors such as detachment and withdrawal,according to the calculation of 20%,36 patients in the test group were planned to complete and 36 patients in the control group.According to the inclusion criteria of the clinical trial protocol,from July 2018 to October 2019,a total of 73 patients with tumors of spleen and stomach damp-heat type constipation were included.There were 39 cases in the test group,34 cases in the control group,fall off in 12 cases,6 cases in the test group,6 cases in the control group,and a dropout rate of 16.43%.Finally,61 cases were statistically analyzed,33 cases in the test group,28 cases in the control group.There were no statistical differences in baseline data such as age,gender,height,weight,blood pressure,pulse,respiration and heart rate between the two groups(P>0.05),It showed that the baseline data of the two groups were balanced and comparable.Observation indicators:?The total effective rate was 87.9%in the test group and 67.8%in the control group.The comparison of the efficacy between the two groups was not statistically significant by x2 test(P>0.05).It shows that the TCM syndromes of both groups has improved.?The total syndrome scores of the two groups of patients before and after treatment were compared within each group.After t test,it was statistically significant(P<0.001),indicating that after treatment,the syndrome scores of both groups decreased compared with before.The comparison of the total scores of syndromes between the two groups before treatment was not statistically significant by t test(P>0.05),indicating that the total scores of the syndromes between the two groups were comparable before treatment.The comparison of the total score difference between the two groups of patients before and after treatment was statistically significant by t test(P<0.05).It shows that the test group is better than the control group in improving the overall curative effect of TCM syndromes.?Comparing the curative effect of single symptom between the two groups of patients,there was no statistical significance by the x2 test(P>0.05),It shows that the single symptom effect of the two groups of cases is equivalent.The comparison of the single symptom score between the two groups before and after treatment was statistically significant by t test(P<0.001).After treatment,the single symptom score of the two groups of patients decreased significantly.The comparison of the single symptom scores between the two groups before treatment showed no statistical significance by t test(P>0.05),indicating that the single symptom scores of the two groups were comparable before treatment.Comparison of the difference between the two groups before and after the treatment of single symptom scores showed no statistical significance in constipation,poor appetite,abdominal distention,dry mouth and bitter taste,tongue and pulse(P>0.05).Hiccup and nausea is statistically significant(P<0.05),indicating that the test group is superior to the control group in improving hiccup and nausea symptoms.?Comparing the efficacy of chemotherapy-related constipation and morphine-related constipation in two groups,there was no statistical significance by x2 test(P>0.05),indicating that the therapeutic effect of the two groups after stratification of etiology was similar.The score value of the two groups of patients with chemotherapy-related constipation and morphine-related constipation after treatment was significantly lower than that before treatment,which was statistically significant by t test(P<0.05).The scores of two groups of patients with chemotherapy-related constipation and morphine-related constipation before treatment were not statistically significant(P>0.05),indicating that the scores of the two groups before treatment were balanced and comparable.The difference between the two groups of chemotherapy-related constipation and morphine-related constipation,before and after treatment was not statistically significant(P>0.05),indicating that the test group and the control group had the same effect in improving chemotherapy-related constipation and morphine-related constipation.Exploratory indicators:Because some clinical trial centers did not have specimen storage conditions and compliance issues with some patients,they could not obtain a complete collection of exploratory indicators.Finally,14 exploratory indicators were collected.Because there are fewer samples for exploratory indicators to be statistically analyzed,and There is no centralized trend in the sample test data,and the data is quite different,so no statistical analysis was performed.Safety indicators:In the test group,4 cases had lower blood count than normal,4 cases in the control group had lower blood count,and 1 case in the test group had slightly elevated ALT before treatment and normal ALT after treatment.The above laboratory test abnormalities were determined based on clinical medication records and anti-tumor treatment drugs(chemical drugs,targeted therapy drugs)were related,no clinically significant changes have been seen in other indicators,and no adverse events have occurred in the test group and the control group.Conclusion(1)Changweishu Capsule can improve the spleen and stomach damp-heat syndrome of patients with tumor constipation,the therapeutic effect is similar to that of Maren Runchang Soft Capsules;(2)Changweishu Capsule can significantly improve the single symptoms of hiccup and nausea in patients with tumor-related constipation;(3)Changweishu Capsule has a good medication safety.