本文選題：阿片輕度依賴(lài) + 濟(jì)泰片��； 參考：《新鄉(xiāng)醫(yī)學(xué)院》2012年碩士論文

【摘要】：目的 1.客觀評(píng)價(jià)單藥濟(jì)泰片與濟(jì)泰片聯(lián)合丁丙諾啡治療海洛因依賴(lài)戒斷綜合征的有效性及安全性。 2.客觀評(píng)價(jià)濟(jì)泰片治療海洛因依賴(lài)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(fù)期兩個(gè)階段。采用隨機(jī)、對(duì)照、雙盲雙模擬臨床試驗(yàn)方法。 1.急性脫毒期,共納入150例海洛因依賴(lài)者,隨機(jī)進(jìn)入濟(jì)泰片組、濟(jì)泰片+丁丙諾啡組和安慰劑組(濟(jì)泰模擬片+丁丙諾啡模擬片)各50例,進(jìn)行為期10天的治療比較。每日進(jìn)行戒斷癥狀評(píng)分、戒斷癥狀中醫(yī)評(píng)分。治療前、治療第5天和第10天進(jìn)行漢密爾頓焦慮量表評(píng)分。評(píng)定時(shí)間為每次服藥后1-2小時(shí)。通過(guò)急性戒斷癥狀總分減分率、戒斷癥狀評(píng)分逐日變化、戒斷癥狀中醫(yī)總分逐日變化、焦慮量表評(píng)分變化等指標(biāo)來(lái)評(píng)估有效性。每日檢測(cè)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(lái)評(píng)估安全性。 2.急性脫毒后第15天進(jìn)入鞏固康復(fù)期,稽延性戒斷癥狀評(píng)分10分以上。共納入病例100例,隨機(jī)進(jìn)入濟(jì)泰片組和安慰劑組(濟(jì)泰模擬片)各50例,進(jìn)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(jìn)行稽延性戒斷癥狀評(píng)分和稽延性中醫(yī)癥候評(píng)分。在治療前、治療第4、8、12、24周進(jìn)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(píng)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(píng)分、焦慮量表評(píng)分、抑郁量表評(píng)分、心理渴求程度來(lái)評(píng)估有效性。檢測(cè)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(lái)評(píng)估安全性。 結(jié)果 1.急性脫毒期共完成142例,濟(jì)泰片組48例、濟(jì)泰片合并丁丙諾啡組48例和對(duì)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(wú)顯著性。在為期10天的治療過(guò)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(píng)分、戒斷癥狀中醫(yī)總分逐日遞減,焦慮量表評(píng)分逐漸降低,但三組之間總體差異無(wú)顯著性,兩兩比較差異也無(wú)顯著性(P0.05)。濟(jì)泰片對(duì)血壓、呼吸、心率、心肝腎功能無(wú)影響,未檢測(cè)到不良事件。 2.鞏固康復(fù)期共完成81例,濟(jì)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(wú)顯著性。在為期24周的治療過(guò)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(píng)分、稽延性戒斷癥狀中醫(yī)評(píng)分、焦慮及抑郁量表評(píng)分、心理渴求程度評(píng)分均逐周遞減,但兩組之間總體差異無(wú)顯著性(P0.05)。僅在第8周濟(jì)泰片組心理渴求程度評(píng)分低于安慰劑組,差異具有統(tǒng)計(jì)學(xué)意義(P0.05)。濟(jì)泰片對(duì)血壓、呼吸、心率、心肝腎功能無(wú)影響,未檢測(cè)到不良事件。 結(jié)論 1.濟(jì)泰片或濟(jì)泰片與丁丙諾啡含片聯(lián)合用于海洛因依賴(lài)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(lài)戒斷綜合征逐日減輕主要為自然消退過(guò)程,與濟(jì)泰片或濟(jì)泰片與丁丙諾啡含片聯(lián)合治療關(guān)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(guān)。但本研究不排除濟(jì)泰片在海洛因依賴(lài)者中重度戒斷綜合征治療中的有效性。濟(jì)泰片在急性脫毒期治療過(guò)程中顯示出良好的安全性。 2.濟(jì)泰片用于海洛因依賴(lài)者稽延性戒斷綜合征的鞏固康復(fù)治療缺乏有效性。海洛因依賴(lài)稽延性戒斷綜合征逐周減輕主要為自然消退過(guò)程,與濟(jì)泰片治療關(guān)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(guān)。但本研究不排除濟(jì)泰片在海洛因依賴(lài)者中重度稽延性戒斷綜合征治療中的有效性。濟(jì)泰片在鞏固康復(fù)期治療過(guò)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(xué)位授予單位】：新鄉(xiāng)醫(yī)學(xué)院
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2012
【分類(lèi)號(hào)】：R749.64

【參考文獻(xiàn)】

相關(guān)期刊論文 前10條

1 林江;楊繼峰;艾軍;林ng;;中醫(yī)對(duì)阿片類(lèi)物質(zhì)依賴(lài)的證治研究概述[J];廣西中醫(yī)藥;2007年01期

2 張開(kāi)鎬;;丁丙諾啡的藥理學(xué)研究進(jìn)展[J];國(guó)際藥學(xué)研究雜志;2010年03期

3 高劍峰,王曉輝,邱學(xué)才;川芎嗪可抑制嗎啡戒斷大鼠的高血壓及血清單胺類(lèi)遞質(zhì)的升高[J];河南中醫(yī)藥學(xué)刊;2002年04期

4 曲巧敏，李爭(zhēng)，屈冰，，張炬，金玉勇;癮消舒合劑戒斷阿片成癮的臨床觀察[J];河南中醫(yī);1996年02期

5 欒小敏;中藥濟(jì)泰片治療海洛因依賴(lài)40例[J];九江醫(yī)學(xué);1999年02期

6 宋樹(shù)立,楊征,金周淑;阿片類(lèi)物質(zhì)依賴(lài)稽延性戒斷癥狀機(jī)制和治療的中西醫(yī)比較研究[J];北京中醫(yī)藥大學(xué)學(xué)報(bào);2003年03期

7 李樹(shù)春,李博,程德綱,李峰;中醫(yī)藥治療阿片類(lèi)物質(zhì)依賴(lài)的研究進(jìn)展(綜述)[J];北京中醫(yī)藥大學(xué)學(xué)報(bào);2005年01期

8 辛玉虎,莫啟忠,陸英,胡軍;中醫(yī)藥戒毒的歷史與現(xiàn)狀[J];上海中醫(yī)藥雜志;1999年10期

9 劉振明,陳萍,衣秀義,冉玫;洋金花對(duì)嗎啡鎮(zhèn)痛作用耐受性的影響[J];時(shí)珍國(guó)藥研究;1996年04期

10 宋普球;陳光輝;劉竹煥;錢(qián)韻旭;;阿片成癮的治療及戒毒中藥的研究進(jìn)展[J];現(xiàn)代中西醫(yī)結(jié)合雜志;2005年23期

相關(guān)會(huì)議論文 前1條

1 張煥松;孫干程;;濟(jì)泰片對(duì)海洛因依賴(lài)者的脫毒治療——附90例臨床療效觀察[A];第四屆全國(guó)中西醫(yī)結(jié)合戒毒學(xué)術(shù)研討會(huì)教材、論文摘要集[C];2000年

相關(guān)碩士學(xué)位論文 前1條

1 高磊;中藥復(fù)元顆粒和鹽酸洛非西丁控制阿片類(lèi)戒斷癥狀隨機(jī)雙盲臨床療效研究[D];四川大學(xué);2006年

本文編號(hào)：1930403