| Objective:To observe the efficacy and safety of Chaishaozhizhu Decoction in treating irritable bowel syndrome(IBS-C)with "Yang Weijie" constipation.Method:A randomized controlled research method was adopted,70 patients with IBS-C were included according to the inclusion and exclusion criteria,and randomly divided into experimental group and control group,35 cases each.The two groups of patients were adjusted for daily life,improved dietary structure,adjusted emotions and other general treatments.On this basis,the experimental group was treated with the oral Chinese medicine "Chaishaozhizhu decoction",and the control group was treated with the oral western medicine "Lactulose Oral Solution".Both groups were treated for 4 weeks.Observe the TCM syndromes of the two groups after 4 weeks of treatment phenomenon points,abdominal pain response rate,spontaneous bowel response rate,IBS-SSS score,quality of life score,and changes in safety indicators,and statistical analysis was performed to evaluate the effectiveness of Chaishaozhizhu decoction in the treatment of "Yang Weijie" IBS-C effectiveness and safety.Result:1.A total of 70 patients were included in this study,of which 64 patients completed the clinical observation,3 cases of each group fell off,and the total dropout rate was 8.57%.2.Baseline data comparison: There was no significant difference between the two groups in terms of gender,age,course of disease,and distribution of TCM syndromes(P>0.05),which was comparable.3.In terms of the efficacy of TCM syndromes:(1)After 4 weeks of treatment,the total effective rate in the experimental group was 90.63%,and the total effective rate in the control group was 65.63%.(2)The total scores of TCM syndromes after treatment in both groups were lower than before treatment(P<0.05),and the experimental group was better than the control group(P<0.05).(3)In terms of the individual scores of TCM syndromes: After treatment,the scores of each syndrome in the experimental group were lower than before treatment(P<0.05),and the control group had no significant difference in the scores before and after treatment in terms of head sweating,mild chills,and cold hands and feet(P>0.05),the scores of the remaining symptoms were lower after treatment than before treatment(P<0.05).After treatment,there was no significant difference between the two groups in terms of stool characteristics,frequency of defecation,difficulty in defecation,fullness under heart,and unwillingness to eat(P>0.05).In terms of abdominal pain,sweating in the head,mild chills,cold hands and feet,the score of the experimental group after treatment was lower than that of the control group(P<0.05).4.In terms of abdominal pain response rate and spontaneous bowel response rate: After 4weeks of treatment,the abdominal pain response rate and spontaneous bowel response rate in the test group were 75.00% and 71.88%,respectively,which were higher than the control group's 50% and 46.88%,and the differences Statistical significance(P<0.05).5.In terms of the efficacy of IBS-SSS: After 4 weeks of treatment,7 cases were markedly effective in the experimental group,21 cases were effective,and 4 cases wereineffective.In the control group,2 cases were markedly effective,19 cases were effective,and11 cases were ineffective.The experimental group was better than the control group(P<0.05);the total effective rate of the test group was 87.50%,and the total effective rate of the control group was 65.63%,the difference was statistically significant(P<0.05);In terms of IBS-SSS scores,the scores of the two groups after treatment were lower than before treatment,and the test group was better than the control group,the differences were statistically significant(P<0.05).6.In terms of quality of life score: Both groups can improve the quality of life of patients(P<0.05),and the experimental group is better than the control group(P<0.05).7.In terms of safety and adverse reactions: Before and after treatment,the two groups of patients underwent blood routine,urine routine,stool routine + OB,electrolytes,liver and kidney function and electrocardiogram,abdominal color doppler ultrasound,etc,no clinically significant abnormal changes were found.No adverse reactions and adverse events were observed in both groups.Conclusion:Chaishaozhizhu Decoction in the treatment of irritable bowel syndrome with "Yang Weijie" constipation can effectively improve the TCM syndrome score of patients with "Yang Weijie" IBS-C.In terms of abdominal pain response rate,spontaneous bowel response rate,IBS-SSS score and IBS-QOL score,the clinical efficacy is definite,the improvement of extraintestinal symptoms is obvious,and the safety is good. |
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