| Objective:The doctoral dissertation aims to establish a theory of assistant medications,which is explored with theoretical analyses from six aspects as followed: connotation,history,clinical application,relationship analysis,significance and the development direction.Based on theory of assistant medications,the clinical research is carried out to study the curative effects of assistant medications in treating patients suffering with cerebral small vessel disease through clinical observation built around a belief in traditional Chinese medicine.The direction of further research on theory of assistant medications has been pointed out in order to develop TCM basic theory,and obtain legal support in Chineses clinical medicine.Methods:A total of 120 cases which met the inclusion criteria were collected and randomly divided into control group,syndrome differentiation group and assistance medications group,with 40 cases in each group.Three groups of patients were given basic medical treatment of conventional Western Medicine.In addition,patients in syndrome differentiation group were given decoction which helped prevent phlegm from forming and accelerate circulation of blood.And patients in assistance medications group were treated with the aid of Radix Polygoni Multiflori and Polygonumcuspidatum based on the use of soup mentioned above.Liver and kidney function,blood,urine,blood sugar and other safety indicators of the patients from three different groups were assessed according to neurological deficit Scale(NIHSS)score,modified Rankin Scale score,Activities of Daily Living Scale(Barthel Index)scores,instrumental activities of daily living ability scale(IADL)score,Mini-mental state evaluation scale(MMSE)score,and Montreal cognitive assessment(Mo CA)score before treatment,14 days after treatment and 2 months after treatment.TCM syndrome scale of the patients from three different groups was also marked and the scalp retinal blood vessels,blood pressure were assessed before treatment and 2 months after treatment.Statistical analysis is launched to explain how four coagulation,D-dimer,high-sensitivity C-reactive protein hs-CRP),superoxide dismutase assay(SOD),serum homocysteine(hsy),lipoproteins and other possible mechanisms of cerebral small vessel disease index changed in the process of treatment.Overall,the dissertation attempts to evaluate the diagnosis and treatment evaluation of clinical efficacy of the Radix Polygoni Multiflori and Polygonumcuspidatum on the basis of traditional Chinese medicine and the application and clinical value of the theory of assistant medications are also explored.Results:Among three different groups,a total of 108 cases of clinical observation have been completed with 36 cases in each group.Clinical studies have shown that comparing the results of curative effect index of NIHSS score,modified Rankin scale score,Barthel index scale score among three groups before and after treatment,we can safely reach a conclusion that Syndrome differentiation group is comparable to treatment with the use of assistant medications in improving neurological deficit caused by cerebral vascular disease,with similar onset time(P>0.05).As it proves,its clinical efficacy and onset time are better than the control group(P<0.05).Compared the scores of the three groups according to IADL scale before and after treatment,we've found that the internal medicine had a slight effect on the instrumental activities of patients of daily living(P>0.05),and the treatment effect of the syndrome differentiation group was better than that of the control group(P <0.01).As to the onset time and the improvement of the activities of instrumental daily living,the assistant medications group was better than that of syndrome differentiation group(P<0.01).In the light of MMSE scale and Mo CA scale,results of three different groups before and after treatment were used to make a comparison.It has been found that,the improvement of cognitive ability and onset time of the assistant medications group were significantly better than the control group and the syndrome differentiation group(P<0.01)regarding cognitive dysfunction caused by cerebral small vessel disease.However,the syndrome differentiation group had better cognitive function than the control group(P<0.05).According to the Chinese medicine syndrome,there was no significant difference(P>0.05)between the syndrome differentiation group and the assistant medications group in improving TCM syndromes but they were better than that of control group(P<0.01).It has also been found that their symptom improvement efficiency was similar(P>0.05).There was no significant difference between the syndrome differentiation group and the assistant medications group in improving symptoms of TCM syndromes,which suggested that the traditional Chinese medicine treatment have not been changed after adding the assistant medications.Analysis of observation results of Blood pressure Indexes showed that before and after treatment there were no significant difference(P>0.05)among three groups as they all used effective chemical drugs to control the blood pressure.After observation of fundus retinal small blood vessels,simple western medical basic treatment of cerebral small vessel disease had no significant effects on patients to improve fundus retinal central artery diameter,vein diameter,and arteriovenous ratio(P>0.05).Both in syndrome group and assistant medications group,the diameter of the central retinal artery and arteriovenous ratio were increased(P<0.01)than before.Both the syndrome differentiation group and the assistant medications group could significantly reduce the degree of retinal arteriosclerosis.However,the assistant medications group had better impacts on retinal arteriosclerosis than the degree of improvement given by differentiation group(P<0.05).On the basis of results of the mechanism index,the analysis of the results of coagulation index showed that the effect of blood coagulation and anticoagulant system intervention was much alike between syndrome differentiation group and assistant medications group but they were better than the control group(P<0.01)in the patients with cerebral vascular disease).By using hs-CRP,SOD before treatment and after treatment,it was found that the indicators among control group,syndrome differentiation group and assistant medications group were improved(P<0.01),where the treatment effect of the assistant medications group was better than that of the syndrome differentiation effect(P<0.05),while the treatment effect of syndrome differentiation group is better than that of the control group(P<0.05).They had equivalent effects among three groups in the improvement of serum homocysteine levels(P>0.05).The results of low-density lipoprotein,triglyceride,total cholesterol test from three groups before and after treatment suggested that the regulation of lipoprotein among three groups were effective,among which assistant medications group significantly lowered low-density lipoprotein,triglycerides and total cholesterol,elevating high-density lipoprotein levels,whose effect was better than that of the syndrome group(P<0.05).The treatment effect of the syndrome group was better than that of control group(P<0.05).Safety Index Results showed that the results about the analysis of liver function of ALT and AST indicators before and 14 days after the treatment and two months after treatment suggested that the overall liver function indexes of the control group showed little change(P>0.05).Both the syndrome differentiation group and the assistant medications group could reduce the levels of ALT and AST and were better than that of the control group(P<0.01).From the exfoliation case analysis,the control group after taking Rosuvastatin displayed abnormal liver function,with 3 cases dropping out.There were no cases of abnormal liver function within the syndrome differentiation group and assistant medications group.Three cases from the assistant medications group left due to diarrhea stool since the patients couldn't tolerate.There were no significant changes(P>0.05)regarding their renal function,blood,urine,blood glucose and other safety indicators before and after treatment.Conclusion:Compared to western medicine for the current treatment with specific effects of blood pressure,blood glucose control,basic medical treatment and treatment with the use of traditional Chinese medicine and assistant medications are pretty wellmatched.What's more,traditional treatment based on Syndrome differentiation by activating Blood Circulation and removing phlegm is comparable to treatment with the use of assistant medications in improving neurological deficit,regulating human coagulation and anticoagulant function while the adding of Radix Polygoni Multiflori and Polygonumcuspidatum did not significantly enhance the efficacy of traditional Chinese medicine treatment in treatment.Whereas,the application of Radix Polygoni Multiflori and Polygonumcuspidatum wins out syndrome differentiation and treatment of traditional Chinese Medicine in the treatment to improve cerebral vascular disease mild cognitive impairment,fundus retina Small blood vessel sclerosis,vascular inflammatory index,oxidative stress index,lipoprotein metabolism index,liver function index,etc.As to the improvement of TCM syndromes and symptoms,the application of assistant medications has not changed the general direction of the traditional Chinese medicine treatment.However,from the case analysis of exfoliation which was caused by diarrhea in the assistant medications group,the theory of assistant medications is an innovation of traditional Chinese medicine thinking.In conclusion,the application of the theory of assistant medications has improved the clinical efficacy of modern TCM,and developed the theory of TCM syndrome differentiation and treatment,which is one of the "binding points" in the fusion of TCM and western medicine. |
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