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  本文選題：阿片輕度依賴 + 濟泰片��； 參考：《新鄉(xiāng)醫(yī)學院》2012年碩士論文

【摘要】：目的 1.客觀評價單藥濟泰片與濟泰片聯合丁丙諾啡治療海洛因依賴戒斷綜合征的有效性及安全性。 2.客觀評價濟泰片治療海洛因依賴急性脫毒后稽延性戒斷綜合征的有效性及安全性。 方法 本研究分為急性脫毒期和鞏固康復期兩個階段。采用隨機、對照、雙盲雙模擬臨床試驗方法。 1.急性脫毒期,共納入150例海洛因依賴者,隨機進入濟泰片組、濟泰片+丁丙諾啡組和安慰劑組(濟泰模擬片+丁丙諾啡模擬片)各50例,進行為期10天的治療比較。每日進行戒斷癥狀評分、戒斷癥狀中醫(yī)評分。治療前、治療第5天和第10天進行漢密爾頓焦慮量表評分。評定時間為每次服藥后1-2小時。通過急性戒斷癥狀總分減分率、戒斷癥狀評分逐日變化、戒斷癥狀中醫(yī)總分逐日變化、焦慮量表評分變化等指標來評估有效性。每日檢測不良事件和生命體征,并分別于治療前后檢查血常規(guī)、尿常規(guī)、肝功能、腎功能、尿嗎啡定性、心電圖等來評估安全性。 2.急性脫毒后第15天進入鞏固康復期,稽延性戒斷癥狀評分10分以上。共納入病例100例,隨機進入濟泰片組和安慰劑組(濟泰模擬片)各50例,進行為期24周的治療比較。在治療前、治療第1、2、4、8、12、16、20、24周進行稽延性戒斷癥狀評分和稽延性中醫(yī)癥候評分。在治療前、治療第4、8、12、24周進行漢密爾頓焦慮量表、漢密爾頓抑郁量表及心理渴求程度評分。采用稽延性戒斷癥狀減分率、稽延性戒斷癥狀總分、稽延性戒斷癥狀中醫(yī)評分、焦慮量表評分、抑郁量表評分、心理渴求程度來評估有效性。檢測不良事件和生命體征,并分別于治療前、治療第4、12、18、24周檢查血常規(guī)、尿常規(guī)、肝功能、腎功能、尿嗎啡定性、心電圖等來評估安全性。 結果 1.急性脫毒期共完成142例,濟泰片組48例、濟泰片合并丁丙諾啡組48例和對照組46例。治療前,三組受試者急性戒斷癥狀總分分別為43.520±19.786、42.640±17.648、47.100±24.450,差異無顯著性。在為期10天的治療過程中,三組受試者急性戒斷癥狀總分減分率逐日遞增,急性戒斷癥狀評分、戒斷癥狀中醫(yī)總分逐日遞減,焦慮量表評分逐漸降低,但三組之間總體差異無顯著性,兩兩比較差異也無顯著性(P0.05)。濟泰片對血壓、呼吸、心率、心肝腎功能無影響,未檢測到不良事件。 2.鞏固康復期共完成81例,濟泰片組40例、安慰劑組41例。治療前,兩組受試者稽延性戒斷癥狀總分分別為13.50±4.967、13.10±2.528,差異無顯著性。在為期24周的治療過程中,兩組受試者稽延性戒斷癥狀總分減分率逐周遞增,稽延性戒斷癥狀評分、稽延性戒斷癥狀中醫(yī)評分、焦慮及抑郁量表評分、心理渴求程度評分均逐周遞減,但兩組之間總體差異無顯著性(P0.05)。僅在第8周濟泰片組心理渴求程度評分低于安慰劑組,差異具有統計學意義(P0.05)。濟泰片對血壓、呼吸、心率、心肝腎功能無影響,未檢測到不良事件。 結論 1.濟泰片或濟泰片與丁丙諾啡含片聯合用于海洛因依賴者輕度戒斷綜合征的急性脫毒治療缺乏有效性。輕度海洛因依賴戒斷綜合征逐日減輕主要為自然消退過程,與濟泰片或濟泰片與丁丙諾啡含片聯合治療關系不密切。未顯示出有效性的主要原因與本研究受試者的急性戒斷綜合征較輕有關。但本研究不排除濟泰片在海洛因依賴者中重度戒斷綜合征治療中的有效性。濟泰片在急性脫毒期治療過程中顯示出良好的安全性。 2.濟泰片用于海洛因依賴者稽延性戒斷綜合征的鞏固康復治療缺乏有效性。海洛因依賴稽延性戒斷綜合征逐周減輕主要為自然消退過程,與濟泰片治療關系不密切。未顯示出有效性的主要原因與本研究受試者的稽延性戒斷綜合征較輕有關。但本研究不排除濟泰片在海洛因依賴者中重度稽延性戒斷綜合征治療中的有效性。濟泰片在鞏固康復期治療過程中顯示出良好的安全性。
[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.
【學位授予單位】：新鄉(xiāng)醫(yī)學院
【學位級別】：碩士
【學位授予年份】：2012
【分類號】：R749.64

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