The Relapse Prevention Effect And Safety Evaluation Of Ji Taipian With Methadone In Community Rehabilitation Process

ObjectiveTo compare the relapse prevention effect and withdraw difference of Ji Taipian with methadone in the community rehabilitation process, monitor the laboratory indicator and the adverse event to evaluate the effect and safety of Ji Taipian.MethodsCohort study was conducted,390qualified subjects were selected from7districts and65communities in Shanghai,, Ji Taipian Group (n=208) and methadone group (n=182). The incidence of relapse was measured at the8th week,26th week and52th week. At the same time, subjects received physiology intervention and social support. psychological intervention was conducted by shanghai social self-support organization. Social support included low income insurance, staff training, medical fees waiver. Follow-up was carried out at8th weeks,26th weeks, and52th weeks. Laboratory examination included physics examination, blood test, blood chemical test, urine test, human chorionic gonad hormone test and electrocardiogram test. Adverse effect included switched results from normal laboratory examination to abnormal and medical events during the whole process. The main indicator of this evaluation was relapse rate. The research would include the physical indictor examination and physical sample, the whole research plan was approved by shanghai mental hospital ethics committee.Results1.390subjects entered the cohort study,376subjects finished the baseline screening information collection,330subjects finished the8weeks interview,315subjects finished the26weeks interview and292subjects finished the52weeks interview.2.Among376subjects, the demographic test found no significance between two groups except job information (P<0.0001), details as follows:318male and58female, the percent was84.57and15.43for each, sex ratio was5.5:1; the mean age was41.59:The marriage situation:149unmarried,106married,11remarriage,99devoiced,6widowed.1missing, the percent was as follows:39.63%,28.19%,2.93%,26.33%,1.06%.1.59%,0.27%for each segment; the education background:14with primary school experience,240with middle school background,112high school or junior college,2with undergraduate or higher degree.1missing, the percent was as follows:3.72%,63.83%,29.79%,1.60%,0.53%.0.27%.3. Heroin was the main kind of drug which the population had used. The median time of drug using of Ji Taipian group was8.36and9.48in methadone group. Wilcoxon test found the significant difference; the rehabilitation times was3in both groups without significance.4.The baseline result of laboratory examination:physics examination:pulse and breath has significant difference in two groups(P=0.0190, P<0.0001), height and weight has no significant difference; blood test found red blood cell, globin and lymphocyte has significant difference among each group,(P values were P<0.0001, P<0.0001, P<0.0001); the dichotomous blood result has no significant difference between two groups. Blood chemistry test:the blood urea nitrogen had significant difference between two groups (P=0.0192), ALT, AST, Fasting plasma glucose had no significant difference; Urine drug test and human chorionic gonad hormone test had no statistical significance. ECG test found Ji Taipian group had29abnormal results and methadone group22abnormal ones, Chi-square test had no significant difference.5. The first follow up, physical examination had no significance except breath and pulse indicators (P=0.0002, P=0.0079). The drug test of urine and HCG test had no significance.6.The second follow up, physics examination only found breath had significant difference (P<0.0001); Blood wtest found red blood cell, globin and lymphocyte test has significance of each group,(P value were as follows:P<0.0004, P<0.0001, P<0.0001). the dichotomous result of blood had no significance between two groups. Blood chemistry test: Fasting plasma glucose indicator had significance between two groups, ALT, AST. Fasting plasma glucose, has no significance. Urine test had no significance in two groups, urine glucose, ketone and red blood cell test used Fisher exact probability method. Urine drug test and human chorionic gonad hormone test had no significant difference. ECG test shows that Ji Taipian group has27abnormal results and methadone group16abnormal results, Chi-square test had no significance between groups.7.The third follow up:physics examination show breath and pulse had significance (P=0.0165, P=0.0006), other indicators had no significance; blood test found red blood cell, globin and lymphocyte had significance among each group,(P value were as follows: P<0.0004, P<0.0001, P<0.0001), other indicators had no significance. The dichotomous result of blood result had no significance between two groups. Blood chemistry test had no significance, either the laboratory data or dichotomous classified results. Urine test shows that glucose, protein, ketone, alt, white blood cell, red blood cell had no significance. Fisher exact probability method was used to test the glucose, ketone, red blood cell. Urine drug test and human chorionic gonad hormone test had no statistical significance. ECG test shows that Ji Taipian group has20abnormal results, methadone group12abnormal, Chi-square test show no significance between two groups (P=0.3141).8.The drug compliance:in Ji Taipian group, the drugs compliance of this group was99.8%and100%in the methadone group, no significance between these groups.9.Relapse:among the subject who finished52weeks interview, there are22subjects relapse in Ji Taipian group and20in methadone group. Relapse rate were11.24%and11.11%, Chi-square test had no significance between these two groups (P=0.9694). The relapse subject of each interview was10,3,7and relapse rate were5.62%,1.69%and3.93%in Ji Taipian group; the relapse subject of methadone group was9,4,9and the relapse rate were4.55%,2.02%,4.55%. Exact Fisher probability shows the relapse rate of three follow up had no significance (Exact Fisher probability was0.9508).10.Withdraw:among the subject who finished52weeks interview:48subjects withdrawer in Ji Taipian group and36in methadone group. Withdraw rates were24.24%,20.22%, Chi-square test shows no significance of these two groups (P=0.3504).The drop-out subject of each interview was24,8,16and the drop rates were12.12%,4.04%,8.08%in Ji Taipian group. The drop-out subjects of each interview was22,7,7and the rates of drop-out were12.36%,3.93%,3.93%, Chi-square test show the withdraw rate of these three follow up had no significance (P=0.4172)11.Life test indicated that the relapse curve had no significance (log-rank test P=0.8205)12.Adverse effect:until the final52weeks interview,130adverse events were found in total,83in Ji Taipian group and47in methadone group, Chi-square test shows significance of this situation (P=0.0009), the adverse effect rate of Ji Taipian group was41.92%, which is higher than26.40%in methadone group. There is no serve adverse event in this research.100subjects had the Lab result switched from normal to abnormal,59in Ji Taipian group and41in methadone group. The number of Subjects who had uncomfortable experience because of drug using were30in total,24in Ji Taipian group, mainly symptoms included feeling thirty. sleepy, and loss of appetite, the number of uncomfortable symptoms in methadone group was6. The adverse effects in two groups had significance.Conclusion In the condition of psychology and social support, Ji Taipian had the similar function of relapse prevention with methadone in community rehabilitation process. There is no significance of laboratory monitor process results between Ji Taipian and methadone group. The adverse event monitor process in this research found that the adverse event rate of Ji Taipian group was a little higher than the methadone group, the component of Ji Taipian could be improved in new research.