| Objective: To observe the clinical effect of modified Xiangshaliujunzi decoction and Sini powder on treating diarrhea of liver depression and spleen deficiency type after cholecystectomy for benign lesion of gallbladder,and to explore the possible mechanism.Methods:74 patients who underwent cholecystectomy for benign lesions of the gallbladder and met the diagnostic criteria of traditional Chinese and western medicine for diarrhea(liver depression and spleen deficiency type)after cholecystectomy were collected.They were randomly divided into observation group(Chinese medicine treatment group)and control group(western medicine treatment group),with 37 cases in each group.The general data of two groups were compared before the treatment,including age,sex,primary disease,surgical way,severity of disease and course of disease.The two groups were both given basic treatments such as diet and emotional guidance,lifestyle adjustment,etc.Then,the observation group was given the modified Xiangshaliujunzi decoction and Sini powder.The control group was given Live Combined Bifidobacterium and Lactobacillus Tablets(Golden Bifid)and Montmorillonite Powder(Smecta)orally on this basis.The two groups were treated continuously for 4 weeks and followed up for 6 months.The changes of the condition and the fecal fat globules count in the two groups before and after treatment were observed.Relevant scales were developed to score the Traditional Chinese Medicine syndromes(TCM syndromes)before and after treatment in both groups.Results :1.There were 32 final effective cases in each group.2.In terms of clinical efficacy,the effective rate was 96.88%in the observation group and 90.61% in the control group,but the difference was not statistically significant(P >0.05).In terms of theefficacy of TCM syndromes,the effective rate was 96.88% in the observation group and 78.13% in the control group,with statistically significant differences(P < 0.05).3.In terms of the scores of TCM syndromes,the comparison between groups showed that there were statistically significant differences between the two groups in fecal characters,fecal frequency,abdominal distension,flank distension or pain,abdominal pain,the association between abdominal pain and diarrhea,emotion,the association between emotion and diarrhea,belching,appetite,spirit,physical strength,tongue and pulse(P < 0.05).There were no statistically significant differences in defecation insufficiency,defecation urgency and sleep(P≥0.05).Compared with the symptoms before treatment,the difference of each TCM syndromes score in the observation group was statistically significant(P < 0.05),and so was the control group(P < 0.05),excepting the belching(P >0.05).4.In terms of severity level,after treatment,there were 31 cases were mild in the observation group while 19 cases in the control group,1 cases were moderate in the observation group while13 cases in the control group.The difference of severity level between the two groups was of statistically significance(P <0.05).5.In terms of Body Mass Index(BMI),both groups decreased after cholecystectomy compared to the preoperative level.After treatment,the BMI of each group increased and the increase in the observation group was slightly higher than that in the control group,but the difference was not statistically significant(P >0.05).The BMI in both groups was still lower after treatment than before surgery.6.In terms of the fecal fat globules count,the number of fecal fat globules in both observation group and control group was significantly lower than that before treatment,the difference is statistically significant.However,the difference of the observation group before and after treatment was higher than the control group and the difference was statistically significant(P< 0.05).7.In terms of recurrence rate,there were 3 patients relapsed in the observation group while 10 patients relapsed in the control group during follow-up.The difference was statistically significant(P < 0.05).8.In terms of safety,no adverse reaction occurred in either group.Conclusion:Both modified Xiangshaliujunzi decoction and Sini powder and western medicine(gold bifidum and smecta)could achieve good clinical effects on diarrhea(liver depression and spleen deficiency type)after cholecystectomy.But the former was more efficient in improving TCM syndromes of PCD patients with liver depression and spleen deficiency type.Both modified Xiangshaliujunzi decoction and Sini powder and western medicine(gold and smecta)could improve the BMI of PCD patients and both had good security.Both of them can effectively reduce fecal fat globules count,but the former is better than the latter.What′s more,the recurrence rate of the former was lower.There are many limitations and deficiencies in this study,which need to be verified by a multi-center,large-sample,deeper and more extensive study. |