| Objective: Efficacy and safety of Ningxin Fumai Decoction in the treatment of elderly patients with functional con Observing the clinicalstipation with deficiency of Qi and Yin.It provides evidence-based basis for Ningxin Fumai Decoction in the treatment of functional constipation in the elderly with deficiency of Qi and Yin,so as to promote its clinical use.Methods:Sixty cases of functional constipation in elderly patients who met the diagnostic criteria of Qi and Yin deficiency syndrome were randomly divided into treatment group and control group with 30 cases each by random number table method.In the treatment group,Ningxin Fumai Decoction was given 30 ml,BID,and orally taken before breakfast and lunch;The control group was given compound polyethylene glycol electrolyte powder(IV)(Shutaishen Pharmaceutical Co.,Ltd.,H20040034,A+B agent),1 package per time,qd,125 ml of water after breakfast.The treatment period of both groups was 4 weeks,and the patients were followed up 4 weeks after the end of medication.The TCM syndrome score,constipation symptom score,quality of life score,recurrence rate and safety of 2 groups were observed before and after treatment and 4 weeks after drug withdrawal.Results:(1)Comparison of general conditions between the two groups:There was no significant difference in gender,age and course of disease between the two groups(P > 0.05),and the two groups were comparable.(2)Comprehensive efficacy comparison between the two groups of patients:After 4 weeks of treatment,2 cases were cured,22 cases were significantly effective,5 cases were effective and 1 cases were ineffective in the treatment group.The number of effective cases was 29,and the effective rate was 96.7%;After 4 weeks of treatment,0 cases were cured,17 cases were significantly effective,6 cases were effective,and 7 cases were ineffective in the control group.The number of effective cases was 23,and the effective rate was 76.7%;By chi-square test,the effective rate of the treatment group was higher than that of the control group(P < 0.05);Follow-up 4 weeks after drug withdrawal showed that 6 cases recurred in the treatment group,and the recurrence rate was 21.43%.In the control group,12 cases recurred,with a recurrence rate of 50%;The recurrence rate of the treatment group was lower than that of the control group by chi-square test(P<0.05),The treatment group was superior to the control group in terms of long-term efficacy.Both groups were tested for safety before and after treatment,and the results showed no obvious abnormalities.(3)Comprehensive efficacy comparison between the two groups of patients:After 4 weeks of treatment,intra-group comparison showed that the total scores of constipation symptoms,fecal traits,defecation frequency,defecation time,defecation effort and abdominal distension in both groups were lower than those before treatment(P>0.05);After 4 weeks of treatment,comparison between groups showed that total scores of constipation symptoms,defecation frequency and defecation effort in the treatment group were lower than those in the control group(P<0.05),but there was no statistical significance in fecal traits,defecation time and abdominal distension scores between the two groups(P>0.05);Follow-up was conducted 4 weeks after drug withdrawal,and the comparison between groups showed that the total score of constipation symptoms,defecation frequency and defecation effort in the treatment group were still lower than those in the control group(P <0.05).(4)Comparison of TCM syndrome scores between the two groups before and after treatment:After 4 weeks of treatment,intra-group comparison showed that the scores of fatigue,shortness of breath and lazy speech,dizziness and tinnitus,hot flashes and night sweats in 2 groups were all decreased compared with those before treatment(P>0.05);After 4 weeks of treatment,the scores of fatigue and hot flashes and night sweats in the treatment group were lower than those in the control group(P<0.05);The scores of fatigue and hot flashes and night sweats in the treatment group were still lower than those in the control group(P<0.05).(5)Comparison of quality of life scores between two groups before and after treatment:After treatment,intra-group comparison showed that scores of both groups were lower than those before treatment(P>0.05);After 4 weeks of treatment,comparison was made between the two groups,and there was no significant difference in the scores between the two groups(P > 0.05);Four weeks after drug withdrawal,a return visit was made for comparison between groups,and there was statistically significant difference in the scores of patients in the treatment group(P<0.05).Conclusion:(1)Ningxin Fumai Decoction is better than the control group in improving constipation symptoms,fatigue,hot flashes and night sweats in the treatment of elderly patients with functional constipation of Qi and Yin deficiency.(2)Ningxin fumai decoction has good efficacy,low recurrence rate and good safety,which is worthy of further clinical promotion. |
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