Clinical Study Of The Treatment Of Opioid-induced Constipation(Liver Qi Stagnation And Spleen Deficiency Of TCM) By Modified Shutiao Tongbian Decoction

Objective: Through the observation of the clinical efficacy and the monitoring of the safety index of the cancer patients who took Modified Shutiao Tongbian Decoction for the treatment of opioid-induced constipation of liver stagnation and spleen deficiency,in order to provide a new treatment reference for the cancer patients with constipation caused by taking opioids.Methods: In this study,60 patients who met the inclusion criteria were divided into treatment group and control group with 30 patients in each group according to random number table method.The treatment group was given Modified Shutiao Tongbian Decoction orally,and the control group was given Maren Soft Capsule orally.After 2courses of treatment(14 days in total),patients in both groups were observed to compare the changes of constipation symptom score,TCM syndrome score,Numerial Rating Scale,Karnofsky Performance Status Scale and safety indexes before and after treatment,and to evaluate the efficacy of improving constipation degree,TCM syndrome and quality of life after treatment.Results:1.Baseline data analysis: Before treatment,there were no statistical differences between the two groups in gender,age,disease type distribution,oral morphine dose,Numerial Rating Scale,Karnofsky Performance Status Scale,constipation symptom score and TCM syndrome score,which were balanced and consistent between the two groups and comparable.2.Comparison of constipation degree and efficacy: After treatment,the degree of constipation in both groups was relieved(P<0.05),and the relief degree of constipation in the treatment group was better than that in the control group(P<0.05),the difference was statistically significant.After treatment,the effective rates of the treatment group and the control group were 90% and 76.67%,respectively,and the treatment group was superior(P< 0.05).3.Comparison of TCM syndrome scores: after treatment,both groups decreased(P<0.05),and the treatment group was significantly higher than the control group,the difference was statistically significant(P<0.05);After 2 courses of treatment,the effective rate of the two groups was as follows: 80% in the treatment group and 60% in the control group,and the treatment group was dominant(P<0.05).4.Comparison of Karnofsky Performance Status Scale: The treatment regimens in both groups could improve the Karnofsky Performance Status Scale of the subjects(P<0.05),and the improvement degree of Karnofsky Performance Status Scale in the treatment group was better than that in the control group(P<0.05),the difference was statistically significant.5.Comparison of pain scores: There was no significant difference in pain scores between the two groups before and after treatment(P>0.05).6.Comparison of safety indexes: All safety indexes in the two groups were within the safe range before and after treatment,with no significant difference(P>0.05).No adverse reactions were observed in patients during treatment.Conclusion:1.Modified Shutiao Tongbian Decoction can effectively improve the constipation of liver stagnation and spleen deficiency caused by opioids,and its curative effect is better than that of the control group using Maren soft capsule.2.Modified Shutiao Tongbian Decoction can effectively relieve the clinical symptoms of liver stagnation and spleen deficiency and effectively improve the quality of life of patients.3.Modified Shutiao Tongbian Decoction will not affect the pain of cancer patients and will not interfere with the control effect of opioids on cancer pain.4.Modified Shutiao Tongbian Decoction is safe and effective for constipation caused by opioids of liver depression and spleen deficiency,and no obvious adverse reactions have been found.It is worthy of further research and application.