| Objective: The purpose of this study was to observe the clinical efficacy of Qizhu Changbing Decoction in the treatment of diarrheal irritable bowel syndrome(IBS-D)with spleen deficiency and dampness retention syndrome and its effect on serum levels of TNF-αand IL-6,and to explore the clinical efficacy and mechanism of Qizhu Changbing Decoction,so as to provide reference and research ideas for the treatment of IBS-D with traditional Chinese medicine.Methods: Sixty-one patients with IBS-D spleen deficiency and dampness retention syndrome,conforming to western medicine diagnosis and TCM syndrome differentiation criteria were included,and 32 patients were randomly divided into the treatment group and 29 patients in the control group.The treatment group was treated with Qizhu Changbing Decoction and the control group was treated with trimebutine maleate dispersive tablets.The patients in both groups were treated for 4 weeks.The two groups were compared before and after treatment with TCM symptoms score,clinical total effective rate and the evaluation of IBS-Quality of Life(IBS-QOL),Hamilton anxiety scale(HAMA),Hamilton depression scale(HAMD),serum TNF-αand IL-6 levels.The two groups recurrence rate were compared.Results:(1)Comparison of overall efficacy: In the treatment group,six patients were cured,18 cases had obviously effective efficacy,6 cases had effective efficacy,two cases had ineffective efficacy,and the total effective rate was 93.75%.In the control group,two patients were cured,7 cases had obviously effective efficacy,11 cases had effective efficacy,9 case had ineffective efficacy,and the total effective rate was 68.97%.The efficacy of the treatment group was better than that of the control group(P<0.05).(2)Comparison of TCM symptoms total score: The total score of TCM syndromes in the treatment group decreased from 26.07±7.90 to 5.76±3.72,and that in the control group decreased from 26.36±8.33 to 13.58±6.05.The improvement of TCM syndromes in the treatment group was better than that in the control group(P<0.01).(3)Comparison of single symptom efficacy: After treatment,all symptoms in the treatment group were significantly improved compared with those before treatment(P<0.05).Treatment group of abdominal distension and anorexia symptoms improved better than the control group(P<0.05),and the rest of the symptoms improvement were significantly better than that of control group(P<0.01).In the control group,there was no significant improvement in symptoms of mental fatigue,lazy speech and limb weakness compared with those before treatment(P>0.05),the other symptoms were improved(P<0.05).(4)Comparison of IBS-QOL scale score: In the treatment group,except that there was no significant improvement in the score of the sexual behavior dimension after treatment,the score of the other seven dimensions was increased compared with that before treatment(P<0.05),the increase range of score of food avoidance and the other six dimensions was higher than that of the control group(P<0.05,P<0.01).In the control group,there was no significant improvement in body image,social reaction,sexual,relationship dimension after treatment.(5)HAMA and HAMD scale scores: After treatment,both scores of two groups were lower than before treatment(P<0.05),and the decrease of the scores of the two scales in the treatment group was larger than that in the control group(P<0.01).(6)Comparison of serum TNF-αand IL-6 levels: After treatment,the serum levels of TNF-α and IL-6 in both groups were lower than those before treatment(P<0.05),and the serum levels of TNF-αand IL-6 in the treatment group were lower than those in the control group(P<0.01).(7)Comparison of recurrence rate: One month after the clinical end,twenty-eight patients in the treatment group were followed up,of which 25 had no recurrence and 3 had recurrence,with a recurrence rate of 10.71%.Sixteen patients in the control group were followed up,of which 9 had no recurrence and 7 had recurrence,with a recurrence rate of 43.75%.The recurrence rate in treatment group was significantly lower than that in control group(P<0.05).(8)Safety comparison: In the whole course of treatment,no obvious abnormalities were found in all examinations of two groups patients,and no serious adverse events occurred in the follow-up patients within 1 month after the end of the course of treatment.Conclusion: The Qizhu Changbing Decoction treatment of IBS-D with spleen deficiency and dampness retention syndrome curative effect is better than that of trimebutine maleate dispersive tablets,which can effectively improve patients with abdominal pain,diarrhea,abdominal distension,defecate pond,tenesmus,mental fatigue,and limb weakness symptoms,improve patients’ anxiety,depression,improve survival quality of patients life from many aspects.It’s therapeutic mechanism may be related to the reduction of patients’ serum TNF-α and IL-6 level.The Qizhu Changbing Decoction treatment has good long-term curative effect and high safety,which is worth popularizing further clinical application. |