| Research purposeTo compare the clinical efficacy and safety of Fuzi Xiexin decoction and lactulose oral liquid.To provide a basis for Fuzi Xiexin decoction in the treatment of FC.Research Method60 patients with FC were randomly divided into control group and treatment group with30 cases in each group.The treatment group was treated with Fuzi Xiexin decoction and the control group was treated with oral lactulose oral liquid.15 ml each time,twice a day,Take warm on an empty stomach.The treatment cycle of both groups was 4 weeks.After joining the group,the two groups of general items: sex and age were compared.The following aspects were compared between the two groups before treatment,after 2 weeks of treatment and after4 weeks of treatment,respectively.including: mean proportion of patients with CSBM ≥3 times per week,TCM symptom efficiency,total TCM symptom score,each TCM primary symptom score,each TCM secondary symptom score,PAC-QOL score,PAC-SYM score,safety indicators and adverse effects.Patients in both groups were followed up at 4 weeks after the end of the study to compare the recurrence rate between the two groups.After clinical observation,use Excel 2019 to sort out the data and create a database,and use SPSS23.0software for statistical analysis,and draw conclusions.Research Results1.Baseline comparison before treatment: There was no significant difference in age,sex,course of disease the proportion of patients with CSBM/W ≥ 3 times,the total score of TCM symptoms,the main symptoms of TCM,the scores of secondary symptoms,PAC-QOL score and PAC-SYM score before treatment between the two groups(P>0.05).2.Comparison of patient proportion with CSBM/W≥3times: The proportion of patients with CSBM/W ≥3 times after 2 weeks of treatment was 36.7% in the control group and 33.0%in the treatment group.After 4 weeks of treatment,the proportion of patients with CSBM/W≥3 times was 43.3% in the control group and 36.7% in the treatment group,CSBM/M was improved in both groups,and there was no significant difference between the two groups(P>0.05).3.Comparison of the first defecation time between the two groups: the first defecation time of the two groups conformed to the normal distribution,the control group(14.6 ±5.72)h,the treatment group(17.2 ±3.83)h,the variance was uniform,by independent sample t-test,the difference was significant(P < 0.05).4.Curative effect of TCM syndromes: After 2 weeks of treatment,the total effective rate of the treatment was 66.7%and control groups and was 40% respectively.After 4 weeks of treatment,the total effective rate of the treatment was 96.7% and control groups was 60%,respectively.The effect of the treatment group was better(P<0.05)5.Symptom score of traditional Chinese medicine(1)Comparison of total TCM symptom scores(1)After 2 weeks and 4 weeks of treatment,the total TCM symptom scores of both groups decreased significantly compared with the previous ones(P<0.01).There was a significant difference in the total score of TCM symptoms between the two groups(P < 0.05),and the effect of the treatment group was better.(2)After 4 weeks of treatment,the scores of symptoms were decreased in both groups(P <0.05),and the effect in the treatment group was better than that in the treatment group in terms of the three main symptoms of difficult stool,urgent abdominal pain,reduction of warm pain,noisy stomach heat and fullness of stomach,and four secondary symptoms,such as dry mouth,lukewarm limbs,cold fear and abdominal pain such as thorn(P < 0.05).6.PAC-QOL scoreAfter 2 and 4 weeks of treatment,the scores of all dimensions and the total score of the scale in the treatment group were significantly lower than those before treatment,(P < 0.05).The scores of other dimensions and total scores in the control group before and after treatment were significantly lower than those before treatment(P < 0.05),except that there was no significant change in the dimension of worry and anxiety in the control group before and after treatment(P < 0.05).Comparison between groups: the treatment group had better effect in the three dimensions of "psychosocial discomfort","physical discomfort","worry and anxiety" and the total score of the scale,(P < 0.05).7.PAC-SYM scoreAfter 2 and 4 weeks of treatment,the scores of each dimension and the total score of the scale in the two groups were significantly lower than those before treatment(P < 0.01).Comparison between groups: the improvement of abdominal symptoms in the treatment group was significantly better than that in the control group,(P < 0.05).Research Conclusion1.The effective rate of Fuzi Xiexin decoction in the treatment of cold and heat mixed FC was higher than that of lactulose oral liquid.2.The two drugs have achieved significant clinical effects in improving TCM symptoms,PAC-SYM scores and PAC-QOL scores in patients with FC,while Fuzi Xiexin decoction has a more significant effect;especially for the treatment of secondary diseases,Fuzi Xiexin decoction shows outstanding advantages.3.Compared with lactulose oral liquid,Fuzi Xiexin decoction can effectively reduce the recurrence of FC and has long-term therapeutic effect.4.It provides a new idea for the differential diagnosis and treatment of cold-heat mixed type of FC with traditional Chinese medicine. |
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