| Objective:Through Randomized controlled study of 90 cases from the Community generalized anxiety disorder (GAD) patients,Provide safety and effectiveness of treatment for GAD clinical evidence, we are committed to promote the application of traditional Chinese medicine in the treatment of GAD in the community, improving community health agencies focus on GAD achieve timely detection and effective treatment purposes.Methods:Choose GAD patients from the three community centers of Third Affiliated Hospital of Beijing University of TCM and recruitment of the four community centers surrounding the hospital. Select 90 cases of GAD patients met the inclusion criteria were randomly divided into experimental and control groups,45 cases each. Test group to DZXS Chinese medicine granules treatment, control group received lorazepam,The treatment lasted two weeks. Post respectively before treatment, one week and two weeks of treatment Hamilton Anxiety Scale (HAMA), generalized anxiety syndromes assessment form (liver-fire type), Social Disability Scale (SDSS), the amount of side effects table (TESS) evaluation, three months after the end of the trial follow-up. Results using HAMA reduction rate, to assess the clinical syndromes index to evaluate the clinical efficacy; and before treatment and after 2 weeks of treatment were general physical examination, liver and kidney function, urine will be routine and electrocardiogram to evaluate drug safety.Result:1. Clinical Observation indicators:the experimental group and the control group HAMA score and traditional Chinese medicine syndrome has declined, compared with pre-treatment differences were statistically significant (P<0.01); But the two groups compare HAMA reduction rate was no significant difference in treatment (P>0.05)at one week and two weeks,both groups showed considerable improvement in HAMA score on effectwhile in TCM syndrome indices difference is statistically significant (P<0.05), indicating that the test group improve the TCM syndrome score than the control group.2. Comparison of clinical efficacy:Anxiety level of test group and the control group to improve the total 56.25% and 54.76% respectively after 1 week of treatment efficiency,81.25% and 80.95%, respectively, after two weeks, the total effective rate between the two groups comparison shows that in both 1 and 2 weeks no statistically significant difference (P> 0.05); indicating the degree of anxiety to improve the clinical efficacy of the two regimens considerable effect. Syndromes clinical efficacy aspects: one week after the test group and the control group, the total efficiency of 70.83% and 57.14%, respectively, after two weeks,91.67% and 76.19%, the statistical analysis, TCM clinical efficacy between the groups compare candidates 1 week difference was statistically significant (P<0.05), the test group higher than the control group, when two weeks this difference is more obvious (P<0.01), the performance of the test group of TCM syndrome index higher than the control group.3. Safety and side effects observed:During treatment, no serious adverse events. General inspection of the two groups of patients before and after treatment, liver and kidney function, urine will be routine and no significant changes in ECG. And the side effects, the control group of patients with mild headache one case, four cases of loss of appetite, mild drowsiness five cases, slight sweating five cases, withdrawal symptoms may disappear over; the test group 2 patients had mild diarrhea, without stopping and special treatment can be restored. TESS scores between the two groups was statistically significant(P<0.01), showed adverse test group than the control group.4. Quality of life assessment:Compare the SDSS score of two groups patients after 1/2 weeks with before treatment in the same group, the difference was not statistically significant (P>0.05), indicating that both short-term treatment regimens not improve the quality of life of patients.5. Follow-up Results:The test group of patients,17 patients with no recurrence, and the remaining patients discontinued less than three months, has not found relapse. There are 19 cases in the control group of patients in case the withdrawal occurs within a month recurrent disease, requiring re-medication,4 patients had no recurrence within three months, the remaining patients discontinued less than three months, has no recurrence.Conclusion:DZXS treatment of liver-fire type GAD safe and effective, can improve the clinical symptoms and syndromes of anxiety and have few side effects, short-term efficacy and good in the community use of Chinese medicine treatment and the promotion of practical value GAD significance. |