Effect of Modified Qilang Prescription on Drug-dependent Constipation of Qi-Yin Deficiency Type
10.13422/j.cnki.syfjx.20222494
- VernacularTitle:加味芪榔方治疗气阴两虚型药物依赖性便秘临床疗效
- Author:
Mengxing CAO
1
;
Mengen ZHOU
1
;
Yong LI
1
Author Information
1. Shanghai Municipal Hospital of Traditional Chinese Medicine（TCM） Affiliated to Shanghai University of TCM，Shanghai 200071，China
- Publication Type:Journal Article
- Keywords:
modified Qilang prescription;
drug-dependent constipation;
lactulose;
quality of life;
clinical study
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2022;28(24):145-152
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo observe the clinical effect of modified Qilang prescription on the treatment of drug-dependent constipation of Qi-Yin deficiency type. MethodIn a randomized double-blind clinical trial， 160 patients with drug-dependent constipation were randomly divided into two groups， namely， the treatment group （80 cases） and the control group （80 cases）. The treatment group was treated with modified Qilang prescription and lactulose oral liquid simulator， while the control group was treated with lactulose oral liquid and the simulator of modified Qilang prescription. The course of treatment of both groups was 8 weeks. The scores of main syndromes of constipation， traditional Chinese medicine （TCM） syndromes， patient assessment of constipation symptom （PAC-SYM） scale， and patient assessment of constipation quality of life （PAC-QOL） scale before and after treatment were recorded. The patients were followed up at the 2nd and 4th week after drug withdrawal. ResultAfter treatment， the full analysis set （FAS） analysis showed that the total effective rate was 91.14% （72/79） in the treatment group and 73.33% （55/75） in the control group. The treatment group had a higher total effective rate than the control group （Z=-6.62， P<0.01）. The per-protocol set （PPS） analysis showed that the total effective rate was 93.51% （72/77） in the treatment group and 76.39% （55/72） in the control group. The treatment group had a higher total effective rate than the control group （Z=-6.77， P<0.05）. After treatment， the FAS and PPS analysis showed that the main syndrome scores of constipation were lower in both groups than those before treatment （P<0.05）. Except the syndromes of falling， overexertion defecation， and distension， the scores of other syndromes in the treatment group were lower than those in the control group （P<0.05）. The scores of TCM primary syndromes in the two groups were lower than those before treatment （P<0.05）， and the scores of the treatment group were significantly lower than those of the control group （P<0.05）. The scores of TCM secondary syndromes in the treatment group were significantly lower than those before treatment （P<0.05）. The syndrome scores of abdominal distension， fatigue， and lack of sleep in the treatment group were significantly lower than those in the control group （P<0.05）. The scores of PAC-SYM scale were improved in both groups after treatment （P<0.05）， and the treatment group was superior to the control group in improving fecal syndromes and abdominal syndromes. The scores of PAC-QOL scale were improved in both groups after treatment， and the treatment group was superior to the control group in improving patients’ physiological function， social psychology， anxiety， and satisfaction. After drug withdrawal， the recurrence rate was lower in the treatment group at the 2nd（χ2 =5.65，P<0.05） and 4th week （χ2 =12.37，P<0.01）. Conclusionmodified Qilang prescription is effective in the treatment of drug-dependent constipation， and its clinical effect is better than that of lactulose oral liquid. The curative effect of modified Qilang prescription is stable and lasting without obvious adverse reactions.
