| Objective:Observe the clinical efficacy of Liangxue Tongyu prescription on cerebral hemorrhage,as well as its influence on intestinal flora and brain-gut peptides(GAS and MTL).Methods:127 patients with cerebral hemorrhage who were selected comed from five hospitals of Traditional Chinese Medicine,Nanjing,Kunshan,Suining County and Liyang,from August 2016 to October 2020.Because some cases’NIHSS score are less than 6 points,4 cases were eliminated,and 1 case was dropped.Through a multi-center,randomized,parallel controlled clinical trial design plan,122 patients were finally enrolled.All of them met the inclusion criteria,and were divided into two groups.The control group was cured in accordance with"standards of cerebral hemorrhage treatment",and the treatment group based on the control group’s treatment extrally used Liangxue Tongyu prescription.The treatment course was 14 days.Observe the stroke diagnosis score,NIHSS score,gastrointestinal dysfunction score,Bristol stool trait score before and after treatment in the two groups.Illumina high-throughput sequencing analyzes the intestinal flora from 6 levels of phyla,class,order,family,genus,and species,to compare the changes before and after treatment between the two groups;the ELISA method detects the serum brain-gut peptides GAS and MTL contents of the two groups.Results:(1)The two groups of patients have no statistical difference in gender,age,baseline before treatment(brain function indicators,cerebral hemorrhage,cerebral edema classification),past medical history,personal history,possible triggers,TCM classification,TCM syndrome elements,possible TCM syndrome types.(2)Brain function indicators:Compared with prior treatment,both of the two groups reduced obviously after treatment in stroke diagnostic score and NIHSS score(P<0.01);there is also a significant difference on those rating sccale between the two groups,and the treatment group can reduce the score better compared to the control group(P<0.05,P<0.01).(3)Gastrointestinal dysfunction score:d3 of the control group was significantly higher than before treatment(P<0.05),d7 and d3,d14 and d7 were significantly decreased(P<0.05,P<0.01);the treatment group had an average score at each time decrease,among which d3 and before treatment,d7 and d3 were significantly decreased(P<0.01),d14 and d7 were not significantly decreased(P>0.05);there is a great difference between between groups on decreasing the gastrointestinal dysfunction score,and the treatment group was significantly decreased(P<0.01).(4)Bristol fecal trait score:Bristol fecal trait score increased gradually after treatment in the two groups,it also showed a distinct addment in the top three timed(P<0.05),while it made no difference on the d14 and d7 scores were slightly higher Increased(P>0.05);while it made no difference on the d3 and before treatment in the control group,and the scores of d7 and d3,d14 and d7 were significantly increased(P<0.05);after treatment,both of the two groups made no difference(P>0.05).(5)Intestinal flora:The study analyzed it in accordaance with 6 levels of the intestinal flora,such as phyla,class,order,family,genus,and species.The treatment group can better restore the normal composition of intestinal microflora after 14 days of treatment.(6)Serum GAS and MTL:On the whole,compared to before treatment,we can see a obvious decrease in the level of the serum GAS and MTL levels in the treatment group while the control group gradually increased;comparison between the two groups,there were no statistics on GAS and MTL before treatment Compared with the control group,after seven days’treatment of Liangxue Tongyu prescription,the GAS did not decrease significantly(P>0.05),whlie it showed a obvious decrease on MTL at the same time compared with the control group(P<0.01);after fourteendays’treatment of Liangxue Tongyu prescription,GAS was seen much more less than the control group(P<0.01),and it was same to the MTL(P<0.05).Conclusions:The Liangxue Tongyu prescription has a definite clinical effect in the treatment of cerebral hemorrhage.It can significantly improve brain and intestinal functions,reduce neurological deficits,promote defecation,and improve stool characteristics.In addition,Liangxue Tongyu prescription can better restore the normal composition of the intestinal microflora in patients with cerebral hemorrhage,and regulate the secretion of brain-gut peptide GAS and MTL.This prescription may play a therapeutic effect by regulating the intestinal flora and regulating the secretion of brain-gut peptides. |