济泰片治疗阿片类急性及稽延性戒断综合征有效性和安全性的随机双盲对照研究

发布时间：2018-05-24 20:15

本文选题：阿片轻度依赖 + 济泰片　；参考：《新乡医学院》2012年硕士论文

【摘要】：目的 1.客观评价单药济泰片与济泰片联合丁丙诺啡治疗海洛因依赖戒断综合征的有效性及安全性。 2.客观评价济泰片治疗海洛因依赖急性脱毒后稽延性戒断综合征的有效性及安全性。方法本研究分为急性脱毒期和巩固康复期两个阶段。采用随机、对照、双盲双模拟临床试验方法。 1.急性脱毒期,共纳入150例海洛因依赖者,随机进入济泰片组、济泰片+丁丙诺啡组和安慰剂组(济泰模拟片+丁丙诺啡模拟片)各50例,进行为期10天的治疗比较。每日进行戒断症状评分、戒断症状中医评分。治疗前、治疗第5天和第10天进行汉密尔顿焦虑量表评分。评定时间为每次服药后1-2小时。通过急性戒断症状总分减分率、戒断症状评分逐日变化、戒断症状中医总分逐日变化、焦虑量表评分变化等指标来评估有效性。每日检测不良事件和生命体征,并分别于治疗前后检查血常规、尿常规、肝功能、肾功能、尿吗啡定性、心电图等来评估安全性。 2.急性脱毒后第15天进入巩固康复期,稽延性戒断症状评分10分以上。共纳入病例100例,随机进入济泰片组和安慰剂组(济泰模拟片)各50例,进行为期24周的治疗比较。在治疗前、治疗第1、2、4、8、12、16、20、24周进行稽延性戒断症状评分和稽延性中医症候评分。在治疗前、治疗第4、8、12、24周进行汉密尔顿焦虑量表、汉密尔顿抑郁量表及心理渴求程度评分。采用稽延性戒断症状减分率、稽延性戒断症状总分、稽延性戒断症状中医评分、焦虑量表评分、抑郁量表评分、心理渴求程度来评估有效性。检测不良事件和生命体征,并分别于治疗前、治疗第4、12、18、24周检查血常规、尿常规、肝功能、肾功能、尿吗啡定性、心电图等来评估安全性。结果 1.急性脱毒期共完成142例,济泰片组48例、济泰片合并丁丙诺啡组48例和对照组46例。治疗前,三组受试者急性戒断症状总分分别为43.520±19.786、42.640±17.648、47.100±24.450,差异无显著性。在为期10天的治疗过程中,三组受试者急性戒断症状总分减分率逐日递增,急性戒断症状评分、戒断症状中医总分逐日递减,焦虑量表评分逐渐降低,但三组之间总体差异无显著性,两两比较差异也无显著性(P0.05)。济泰片对血压、呼吸、心率、心肝肾功能无影响,未检测到不良事件。 2.巩固康复期共完成81例,济泰片组40例、安慰剂组41例。治疗前,两组受试者稽延性戒断症状总分分别为13.50±4.967、13.10±2.528,差异无显著性。在为期24周的治疗过程中,两组受试者稽延性戒断症状总分减分率逐周递增,稽延性戒断症状评分、稽延性戒断症状中医评分、焦虑及抑郁量表评分、心理渴求程度评分均逐周递减,但两组之间总体差异无显著性(P0.05)。仅在第8周济泰片组心理渴求程度评分低于安慰剂组,差异具有统计学意义(P0.05)。济泰片对血压、呼吸、心率、心肝肾功能无影响,未检测到不良事件。结论 1.济泰片或济泰片与丁丙诺啡含片联合用于海洛因依赖者轻度戒断综合征的急性脱毒治疗缺乏有效性。轻度海洛因依赖戒断综合征逐日减轻主要为自然消退过程,与济泰片或济泰片与丁丙诺啡含片联合治疗关系不密切。未显示出有效性的主要原因与本研究受试者的急性戒断综合征较轻有关。但本研究不排除济泰片在海洛因依赖者中重度戒断综合征治疗中的有效性。济泰片在急性脱毒期治疗过程中显示出良好的安全性。 2.济泰片用于海洛因依赖者稽延性戒断综合征的巩固康复治疗缺乏有效性。海洛因依赖稽延性戒断综合征逐周减轻主要为自然消退过程,与济泰片治疗关系不密切。未显示出有效性的主要原因与本研究受试者的稽延性戒断综合征较轻有关。但本研究不排除济泰片在海洛因依赖者中重度稽延性戒断综合征治疗中的有效性。济泰片在巩固康复期治疗过程中显示出良好的安全性。
[Abstract]:objective
1. objective to evaluate the efficacy and safety of buprenorphine combined with single drug Ji Tai tablet and Ji Tai tablet in the treatment of heroin withdrawal syndrome.
2. objective to evaluate the efficacy and safety of Ji Tai tablet in the treatment of protracted withdrawal syndrome after acute detoxification of heroin.
Method
This study is divided into two stages: acute detoxification and consolidation rehabilitation. A randomized, controlled, double-blind, double simulation clinical trial was conducted.
1. in the period of acute detoxification, 150 heroin addicts were enrolled in a total of 50 cases of Jin Tai tablet group, buprenorphine group and placebo group (the analogue tablet + buprenorphine analogue tablet) for 10 days. The daily withdrawal symptom score and the withdrawal symptom TCM score were carried out. The treatment was carried out for fifth days and tenth days before the treatment. The Milton Anxiety Scale score. The assessment time was 1-2 hours after each medication. The score reduction rate of the acute withdrawal symptoms, the daily change of the withdrawal symptom score, the daily change of the total score of the withdrawal symptoms, the changes of the anxiety scale and other indexes were used to evaluate the effectiveness. Safety was assessed by blood routine, urine routine, liver function, renal function, urine morphine, electrocardiogram and so on.
2. after fifteenth days of acute detoxification, the consolidated rehabilitation period was entered, and the symptom score of detracted abstinence was more than 10. A total of 100 cases were included, and 50 cases were randomly entered in the Ji Tai Group and the placebo group (50 cases of the placebo group) for a period of 24 weeks. Before treatment, the symptom score and delay of the detracted abstinence were performed at week 1,2,4,8,12,16,20,24. Before treatment, the Hamilton anxiety scale, the Hamilton depression scale and the degree of psychological craving were performed before 4,8,12,24 treatment. The reduction rate of the detracted abstinence symptom, the total score of the detracted abstinence symptoms, the TCM score of the detracted abstinence symptom, the Anxiety Scale score, the Depression Scale score, and the degree of psychological craving were evaluated. Effectiveness. Detection of adverse events and physical signs, and before treatment, treatment of blood routine, urine routine, liver function, renal function, urine morphine qualitative, electrocardiogram and so on to evaluate safety before treatment for 4,12,18,24 week.
Result
1. the acute detoxification period was completed in 142 cases, 48 in the Ji Tai tablet group, 48 in the buprenorphine group and 46 in the control group. Before the treatment, the total score of the acute abstinence symptoms in the three groups was 43.520 + 19.786,42.640 + 17.648,47.100 + 24.450 respectively. In the course of treatment for 10 days, the total scores of acute abstinence symptoms in the three groups of subjects were divided. The reduction rate increased day by day, the acute abstinence symptom score, the total score of the withdrawal symptom decreased day by day, the Anxiety Scale score gradually decreased, but there was no significant difference between the three groups, and there was no significant difference (P0.05). There was no effect on blood pressure, respiration, heart rate, heart, liver and kidney function, and no adverse events were detected.
2. a total of 81 cases were completed in the period of rehabilitation, 40 cases in Ji Tai tablet group and 41 in placebo group. Before treatment, the total score of detracted abstinence symptoms in the two groups was 13.50 4.967,13.10 + 2.528, respectively, and there was no significant difference. In the course of the treatment for 24 weeks, the total score reduction rate of the delayed withdrawal symptom in the two groups was increased by week, and the symptom score of detracted abstinence was evaluated. The TCM score of detracted withdrawal symptom, anxiety and Depression Scale score and psychological craving score decreased week by week, but there was no significant difference between the two groups (P0.05). Only in the eighth Zhou Ji group, the score of psychological craving was lower than that of the placebo group, the difference was statistically significant (P0.05). There is no impact and no adverse events are detected.
conclusion
1. the combination of zigai tablets or buprenorphine buccal tablets combined with buprenorphine buccal tablets for the treatment of heroin addicts with mild withdrawal syndrome is not effective. Mild heroin dependence is mainly a natural regression process, which is not closely related to the combination of zigai tablet or zigai tablet and buprenorphine buccal tablet. The main causes of sex are less related to the acute abstinence syndrome of the subjects in this study. However, this study does not exclude the effectiveness of the tablets in the treatment of moderate and severe withdrawal syndrome in heroin addicts. The efficacy of the tablets in the treatment of acute detoxification is good.
2. the consolidation rehabilitation therapy for heroin addicts with detracted abstinence syndrome is lack of effectiveness. The reduction of heroin addicts is mainly the process of natural withdrawal, which is not closely related to the treatment of Ji Tai tablets. The main reasons for not showing the effectiveness of heroin addicts are less than the delayed withdrawal syndrome of the subjects in this study. But this study does not exclude the effectiveness of the tablets in the treatment of moderate and severe detracted abstinence syndrome in heroin addicts. It shows good safety during the treatment of rehabilitation during the rehabilitation period.
【学位授予单位】：新乡医学院
【学位级别】：硕士
【学位授予年份】：2012
【分类号】：R749.64

【参考文献】