| 1.Objective To observe the effect of modification of Guilu Erxian pill combined with methylprednisolone on clinical symptoms,quality of daily life and indexes of CK to provide basis for evaluating the curative effect of integrated traditional Chinese and western medicine in the treatment of DMD.Eventually to explore the method of integrated traditi onal Chinese and western medicine to improve the clinical curative effect of DMD.2.Methods 2.1 Pull in criteria for final participantsIn the group of patients after clinical,muscle pathological and immunohistochemical diagnosis of 49 patients with DMD,from Dec 2017 to Dec 2019 in hospitalized patients with neurological research institute affiliated hospital of anhui medical university,by random allocation principle,choice of 19 patients with DMD as treatment group,at the same time,choose to match t he age of 30 cases of DMD patients as control group.2.2 Preparation before enrolling groupTo establish the diagnostic criteria for the enrolled cases enrolled in the g r o u p.The clinical manifestations,CK,E C G,EMG,muscle biopsy and muscle pathology we re firstly used to make a clear diagnosis of DMD,which met the diagnostic criteria of western medicine.To summarize the pathological manifestations of HE staining and the immunohistochemical characteristics of Dystrophin in DMD patients.2.3 Selection of treatment for participantsAfter a clear diagnosis by western medicine detection technology,Then make TCM diagnosis and TCM syndrome differentiation.According to the principle of randomization,the treatment group of Guilu erxian pill combined with methyl prednisolone treatment and the control group of methylprednisolone treatment were selected.Guilu erxian pill is based on guilu erxian paste,which is added and reduced dialectically according to the symptoms of each patient.The duration of treatment was 3 months.2.4 Monitoring and evaluation of efficacy indicatorsThe scores of main symptom scale and secondary symptom scale were recorded in both groups before and after medication,and the adverse reactions occurred in the course of treatment were record ed in time.After two months of continuous treatment,the clinical indicators,laboratory indicators and general indicators of safety before and after treatment were compared and analyzed.3.Results 3.1 Results of muscle pathology in DMD patients49 patients with DMD muscle pathological damage,5 cases of early pathological changes,mid 40 cases of pathological changes,4 cases of late pathological changes,and the severity of the patients with DMD,muscle pathological changes associated with biopsy age,y oung children with muscle pathological changes is lighter,older children pathological change of the heavy,this group of 49 patients with muscle specimens Dystrophin-rod area completely missing.3.2 Comparison of total response rate between two groupsThe total effective rate of 68.4%(13 cases)in the experimental group treated with modification of Guilu Erxian pill combined with methylprednisolone and 33.3%(10 cases)in the control group treated with methylprednisolone alone was statistically significant(P<0.05).3.3 Comparison of clinical symptoms between two groupsIn each clinical improvement,the primary and secondary symptoms of patients in the experimental group improved to different degrees before and after treatment,and the improvement rate was significantly better than that of the control group(P<0.05).After the treatment,the total score of clinical symptoms in both groups decreased to different degrees,and the scores of self-induced sweating,night sweats,walking,walking up and down stairs,muscle contraction,appetite,fatigue and lazy talk in the experimental group were significantly different from those before the treatment(P<0.05);In the control group,there were also significant differences in the scores of walking,sleep quality,fat igue and lazy talk after treatment compared with those before treatment(P<0.05).It is suggested that modification of Guilu Erxian pill combined with methylprednisolone is superior to only methylprednisolone in the improvement of main clinical symptoms and secondary symptoms,especially in the aspects of walking ability,spontaneous sweating,night sweats,appetite,fatigue and lazy speech.3.4 Results of blood biochemical and anxiety depression scaleTwo groups after treatment of CK,LDH,AST,ALT all hav e varying degrees of decline,the treatment group CK values have significant difference in comparison before and after the treatment,CK values between the two groups after treatment is also have significant difference,the experimental group before CK val ues not only is this treatment has obvious drop,and the control group after treatment CK values have declined,differences were statistically significant.The score of anxiety and depression scale also improved,and SAS score of the experimental group after treatment significantly decreased compared with that of the control group after treatment(P<0.05).4.Conclusions 4.1 The severity of muscle pathological changes in DMD patients is related to the age of biopsy.The pathological changes in younger child ren are mild,while those in older children are severe.The complete loss of immunohistochemical Dystrophin expression is the gold standard for diagnosis.4.2 Modification of Guilu Erxian pill combined with methylprednisolone is effective in the treatment of DMD,and the efficacy rate is higher than that of methylprednisolone alone.4.3 Modification of Guilu Erxian pill combined with methylprednisolone in the treatment of DMD is superior to methylprednisolone alone in the treatment of main clinical sympto ms and secondary symptoms of patients,which is mainly manifested in the improvement of patients' walking ability,spontaneous sweating,night sweats,appetite,fatigue and lazy speech.4.4 Modification of Guilu Erxian pill combined with methylprednisolon e in the treatment of DMD also has positive efficacy in blood biochemical examination indicators and scores of anxiety and depression scale,especially in the improvement mood of the DMD patients,which has important clinical significance for improving cli nical treatment compliance and the quality of family life. |
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