CN1259974C - 非阿片类药物组合的戒毒药 - Google Patents
非阿片类药物组合的戒毒药 Download PDFInfo
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- CN1259974C CN1259974C CNB2004100442484A CN200410044248A CN1259974C CN 1259974 C CN1259974 C CN 1259974C CN B2004100442484 A CNB2004100442484 A CN B2004100442484A CN 200410044248 A CN200410044248 A CN 200410044248A CN 1259974 C CN1259974 C CN 1259974C
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Abstract
本发明涉及一种复方药品，尤其是由非阿片类药物组配而成的具有生理戒毒作用、治疗或缓解“戒断综合征”的复方药物。本发明所述的非阿片类药物组合的戒毒药主要由以下重量百分比的药物组成：非阿片类镇痛药10-80%，抗胆碱类药物0.0001-5%，抗精神病类药10-80%。本发明的药物组合物不含任何阿片类成份，无成瘾性，属非替代型的脱毒制剂。能满意地控制戒毒时的不良躯体症状，即“戒断综合征”。使生理脱毒变得无痛苦和轻松。
Description
技术领域
本发明涉及一种复方药品，尤其是由非阿片类药物组配而成的具有生理戒毒作用(即脱毒)的药物组合物。
背景技术
阿片类物质(如海洛因)成隐的脱毒治疗，目前除了应用含有阿片类物质进行替代递减治疗外，尚无有效的、为脱毒者接受的药物。但阿片类物质仍使脱毒者产生依赖，非阿片类物质又达不到较好的效果，使脱毒过程很痛苦，很多吸毒者因为恐惧戒断综合症的痛苦而摆脱不了毒品。这大大影响了戒毒工作的开展。因此，目前应用的非阿片类戒毒药控制戒断综合征的效果差，脱毒者不接受，成了一个棘手的问题。
本申请人在先申请的“非阿片类药物组合的复方戒毒药”(申请号：00112778.0)，提出了一种非阿片类药物组合的复方戒毒药。其特征在于含(重量百分比)非阿片类镇痛药3.5-35％，苯二氮卓类药物0.002-32％，抗胆碱类药物0.006-0.8％，阿片受体拮抗剂0.001-5％，α2受体激动剂0.002-0.1％，β受体阻滞剂0.005-9％，抗抑郁药0.008-1.2％，助消化药0.008-82.9％。该药物能满意地控制戒断症状，解决抗复吸药纳屈酮的应用困难，但该药物的弊病在于组方庞杂，在组方中涉及的药物太多，从而在治疗的同时也增大了药物的副作用，如：体位性低血压、过度深睡眠、药物成本高、加工工艺复杂等等。
发明内容
本发明的目的在于克服现有组方的技术缺点，提供一种组方简洁有效，既能满意地控制戒断症状，又能有效地减少药物负作用的非阿片类药物组合的戒毒药。
本发明所述的非阿片类药物组合的戒毒药主要由以下重量百分比的药物组成：非阿片类镇痛药10-80％，抗胆碱类药物0.0001-5％，抗精神病药6-80％。
在上述药物组合物中还可分别或者共同加入重量百分比为0.001-20％的苯二氮卓类药物和0.0001-5％的α2受体激动剂。
在上述的药物组合物中：
非阿片类镇痛药可是①水杨性酸类及其衍生物，如阿斯匹林、精氨匹林、双水扬酸脂、双氟尼酸、扑热息痛、贝诺酯等；②吡唑酮类，如氨基比林、安替比林、安乃近、硫氧唑酮等；③苯胺类，如双氯芬酸等；④吲哚类，如吲哚拉新、氨糖美辛等；⑤酮酸类，如联苯丁酮酸、美丁酮酸等；⑥芳基丙酸类，如甲氧萘丙酸、布洛芬，吡布洛芬、卡布洛芬、酮洛芬、氟比洛芬、舒洛芬、非诺洛芬等；⑦其它，如延胡索乙素、克痛宁、平痛新、痛可宁、四氮卓、四氢巴马汀、曲吗多、罗通定等中的一种或几种的组合。
抗胆碱类药物可是颠茄、三分三、山莨菪碱、东莨菪碱、阿托品、苯托品、普鲁本辛、胃复康、苯羟乙酸奎宁酯、苯海索、樟柳碱、哌吡卓酮、丙基联苯酰胆碱氮芥、开马君、K毒素等中的一种或几种的组合。
抗精神病药可是阿米替林、米那普林、麦普替林、丙咪嗪、去甲丙咪嗪、氯丙咪嗪、氯丙嗪、去甲替林、氯氧平、苯乙肼、环苯丙胺、哌苯甲醇、氟西汀、氟戊肟胺，诺米芬辛、麻黄碱、舒必利、多虑平、万拉法新、甲硫达嗪等中的一种或几种的组合。
α2受体激动剂可是氯苯氧唑啉、氯醋胺咪、可乐定、洛非西定等中的一种或几种的组合。
苯二氮卓类药物可是安定，舒乐安定、硝基安定、氟安定、氟硝安定、氟胺安定、去甲羟基安定、氯羟去甲安定，氯硝安定、氯氮卓、阿普唑仑、依替唑仑、咪唑安定、甲恶安定等中的一种或几种的组合。
用本申请的组方，同时可与任何适当的赋形剂相结合而制得任何一种剂型药物。
本发明的药物组合物不含任何阿片类成份，无成瘾性，属非替代型的脱毒制剂。能满意地控制脱毒时的不良症状。解决了应用非替代型的脱毒药物戒毒效果不佳，难以有效控制戒断症状的难题。本发明的药物组合物组方简洁有效，负作用小，成本低。临床观察，已成功治疗吸毒者戒断综合征千余人，收到了令人振奋的临床治疗效果，受到广大戒毒医务工作者和脱毒人员的欢迎与信任，在不含阿片类物质的非替代型脱毒药物中，实属罕见。
本药物组合物的临床试验观察报告：
一、材料与方法
1、观察对象
本次验证共观察20例海洛因依赖者，入选标准如下：
a)符合卫生部《阿片类成瘾常用戒毒疗法的指导原则》的临床诊断标准；
b)排除精神障碍，心、肝、肾疾病和其他严重的躯体疾病；
c)尿吗啡检测为阳性；
d)治疗期间无偷吸毒品。
全部20例均按要求完成。所有吸毒者全部为强制戒毒所收容的吸毒人员。其中17人来自“强戒部”，3人来自“自戒部”。
表1 病人一般资料(X±SD)
| 性别 | 男性19人(95％)女性1人(5％) |
| 吸毒方式 | 唆吸3例(15％)静注17例(85％) |
| 合并用药 | 安定10例(50％) |
| 平均年龄(岁)平均吸毒年限(年)平均戒断次数(次)末次吸毒距治疗的时间(小时)近一月来的日均吸毒量(克/天) | 34.3±6.86.2±8.02.8 4-2.523.4±15.80.93±0.89 |
2、研究方法
本次验证在公安强制戒毒机构进行，为封闭式管理。所有病例只使用本药物组合物为脱毒治疗药物，严密隔绝毒品。
2.1疗效评定标准和方法
本次研究按卫生部规定的有关标准和方法严格评定。依据《戒断症状逐日观察评分表》(OWS量表)，全天护理观察，并在每日下午3时至4时由专人负责对病人的戒断症状，进行逐日评分记录。观察到用药后第7天止。
2.2毒性不良反应评定标准和方法
a)依据《新药不良反应观察量表》全天护理观察，并在每日下午3时至4时由专人负责对用药者的不良反应进行逐日评分记录。观察到用药后第7天止。
b)体检观察：在治疗的开始前及结束均对病人每天进行一般生命体征观察，在病程记录中如实记录。
2.3脱毒标准
a)疗程第8天停止使用本药物组合物；
d)急性戒断症状基本消除；
e)疗程第8天纳洛酮催瘾(0.4毫克肌肉注射)及尿吗啡检测阴性。
3、药物及给药方法
3.1药物：本药物组合物；
3.2给药方法
由医务人员逐一监督当场服药。温水送服，给药量根据受试者海洛因滥用时间、近一周海洛因使用量及戒断症状控制程度而定，具体指导用量为：
表2 本药物组合物脱毒治疗用量表
| 天数 | 剂量/次 | 次数/日 | 服药方式 |
| 第1天第2天第3天第4天第5～7天 | 1～4粒2～5粒2～5粒1～4粒1～3粒 | 1～2次1～2次1～2次1～2次1次 | 口服口服口服口服口服 |
4.观察结果
4.1对控制戒断症状疗效观察
4.1.1对戒断症状的控制程度
首次给药时间距末次吸毒时间平均为23.4小时，给药前所有病例均呈现明显的戒断症状，评分均数为34.7。服用本药物组合物后，戒断症状明显缓解。第一次给药后30分钟内，受试者全部入睡。以后为适应强戒所的管理制度，只在晚上给足药量让其入睡。白天用药量控制在清醒状态下。治疗前后戒断症状的逐日评分均数和逐日变化情况见如下表：
表3 戒断症状评分逐日变化均数表(n＝20)
| 治疗天数 | (X±SD) | P值 |
| 治疗前第1天第2天第3天第4天第5天第6天第7天 | 34.7±6.33.1±2.62.3±1.02.0±0.81.6±0.81.1±0.70.6±0.50.2±0.4 | ＜0.01＜0.01＜0.01＜0.01＜0.01＜0.01＜0.01 |
注：方差分析、与治疗前比较
由表3可见：
a)本药物组合物给药后当天，戒断症状明显控制，用药后每天戒断症状评分与用药前比较，差异有非常显著性意义(P＜0.01)；
b)戒断症状逐日减轻，未见麻醉品类替代递减疗法停药后戒断症状的反跳现象。
4.1.2戒断症状的出现率
在脱毒治疗期间，本药物组合物能明显、有效地控制戒断症状，为严格评价该药对消除或减轻不同戒断症状的效果差异，我们对各种戒断症状的出现率进行了观察和统计：
表4 戒断症状出现率 (n＝20)
| 戒断症状 | 出现例数 | 出现百分率(％) |
| 腹泻阵发性抽搐呕吐手震颤恶心腹痛喷嚏流清涕寒热交替出汗四肢关节疼痛全身疼痛怕冷鸡皮征哈欠流泪入睡困难睡眠质量不佳早醒疲惫虚弱感心悸坐卧不宁 | 000002020412442141000182 | 0000010010020602020107050009010 |
从表4中可见：
除疲惫虚弱感控制较差，四肢关节疼痛、打哈欠症状控制不太理想外，其他症状均能完全或基本控制。
4.2毒性及不良反应
在脱毒治疗期间，不良反应出现情况统计如下：
表5 不良反应出现率 (n＝20)
| 不良反应 | 出现例数 | 出现百分率(％) |
| 头晕恶心呕吐思睡失眠多汗心慌周身无力排尿困难厌食烦躁 | 17001400117010 | 85007000585050 |
表6 不良反应逐日变化均数表 (n＝20)
| 治疗天数 | 评分(X±SD) |
| 第1天第2天第3天第4天第5天第6天第7天第8天 | 2.4±1.22.5±1.12.1±1.11.5±0.91.4±0.91.2±0.70.3±0.50.1±0.3 |
从表5、表6中可见：
不良反应主要表现为头晕、乏力、思睡。不良反应与服药量呈正相关，头三天给药剂量较大，副反应评分也较高。以后随着给药量的减少，副反应也逐渐减轻，停药后完全消失。
4.3药物用量
给药量是根据受试者海洛因滥用时间、近一周海洛因使用量及控制戒断症状为标准的，因人而异。在对20例脱毒者的验证中，3人为戒毒所“自戒部”人员，17人为“强戒部”人员。两部分人在用药量上存在明显差异：
a)自戒部用药量：7天平均每人用药量为53粒；前5天平均每人用药量为42粒。
b)强戒部用药量：7天平均每人用药量为16粒；前5天平均每人用药量为13粒。
这样的差异是因为戒毒所不同的管理要求形成的，“自戒部”追求的，是舒适地脱毒；而“强戒部”要求的，是经济型脱毒。再者，“自戒部”的脱毒者吸食海洛因的时间和量，都比“强戒部”的要长、要大得多。
5.结论
5.1本药物组合物控制戒断症状效果显著
从表3和表4中可以看到：只要服药量正确合理，所有用药者都无一例外地、有效地、明显地控制了戒断症状。
5.2本药物组合物控制戒断症状作用迅速
在实际观察中看到，用药0.5小时后，戒断症状即得到控制。这时，如果给药量充足，脱毒者即可进入睡眠状态。
5.3本药物组合物是强戒所脱毒治疗的较好药品
该药的非替代性和有效性特征，是强戒所脱毒治疗的难得好药品。在戒断的头5天里，晚上给予适当药量进入睡眠状态，白天给予小剂量，仍然可以较好地控制住戒断症状，参加集体出操。“强戒部”的脱毒者就是这样顺利完成脱毒计划的。
5.4本药物组合物的副作用主要为头晕、乏力、思睡
从表5和表6中可以看出：该药在使用中，头晕、乏力的出现率为85％，思睡的出现率为70％。这些症状随着给药量的减少而减轻，停药后完全消失。服药量偏大会增大乏力症状，易导致摔倒，此时应注意看护。在这次试验中，没有一例发生摔倒的情况。
5.5本药物组合物服药安全
该药的成分中不含任何毒性药品和麻醉药品成分，所有成份都系国家药典收载的中西药品种。
具体实施方式
以下结合实施例对本发明作进一步详述。
实施例1：
胶囊剂。每粒中含重量百分比：吲哚拉斯50％，三分三0.3％，米那普林49.7％。
将淀粉、滑石粉等辅料与所有原料混匀后装填而成。
实施例2：
胶囊剂。每粒中含重量百分比：曲吗多40％，罗通定20％，颠茄0.2％，丙咪嗪0.7％，氯丙嗪39％。可乐定0.1％，
将淀粉、滑石粉等辅料与所有原料混匀后装填而成。
实施例3：
胶囊剂。每粒中含重量百分比：延胡索乙素10％，美丁酮酸19％，东莨菪碱0.2％，去甲丙咪嗪20.7％，舒必利50％，安定0.1％。
将淀粉、滑石粉等辅料与所有原料混匀后装填而成。
实施例4：
胶囊剂。每粒中含重量百分比：曲吗多40％，罗通定10％，颠茄0.2％，丙咪嗪10.7％，氯丙嗪39％。可乐定0.1％，安定0.1％。
将淀粉、滑石粉等辅料与所有原料混匀后装填而成。
Claims (8)
1、一种非阿片类药物组合的戒毒药，其特征在于主要由以下重量百分比的药物组成：非阿片类镇痛药10-80％，抗胆碱类药物0.0001-5％，抗精神病药6-80％。
2、按照权利要求1所述的非阿片类药物组合的戒毒药，其特征在于含有重量百分比为0.001-20％的苯二氮卓类药物。
3、按照权利要求1所述的非阿片类药物组合的戒毒药，其特征在于含有重量百分比为0.0001-5％的α2受体激动剂。
4、按照权利要求1所述的非阿片类药物组合的戒毒药，其特征在于所述的非阿片类镇痛药是①水杨性酸类；②吡唑酮类；③苯胺类；④吲哚类；⑤酮酸类；⑥芳基丙酸类；⑦延胡索乙素、克痛宁、平痛新、痛可宁、四氮卓、四氢巴马汀、曲吗多、罗通定中的一种或几种的组合。
5、按照权利要求1所述的非阿片类药物组合的戒毒药，其特征在于所述的抗胆碱类药物是颠茄、三分三、山莨菪碱、东莨菪碱、阿托品、苯托品、普鲁本辛、胃复康、苯羟乙酸奎宁酯、苯海索、樟柳碱、哌吡卓酮、丙基联苯酰胆碱氮芥、开马君、K毒素中的一种或几种的组合。
6、按照权利要求1所述的非阿片类药物组合的戒毒药，其特征在于所述的抗精神病药是阿米替林、米那普林、麦普替林、丙咪嗪、去甲丙咪嗪、氯丙咪嗪、氯丙嗪、去甲替林、氯氧平、苯乙肼、环苯丙胺、哌苯甲醇、氟西汀、氟戊肟胺，诺米芬辛、麻黄碱、舒必利、多虑平、万拉法新、甲硫达嗪中的一种或几种的组合。
7、按照权利要求2所述的非阿片类药物组合的戒毒药，其特征在于所述的苯二氮卓类药物是安定、舒乐安定、硝基安定、氟安定、氟硝安定、氯硝安定、氟胺安定、去甲羟基安定、氯羟去甲安定，氯硝安定、氯氮卓、阿普唑仑、依替唑仑、咪唑安定、甲恶安定中的一种或几种的组合。
8、按照权利要求3所述的非阿片类药物组合的戒毒药，其特征在于所述的α2受体激动剂是氯苯氧唑啉、氯醋胺咪、可乐定、洛非西定中的一种或几种的组合。
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| PCT/CN2005/000595 WO2005110403A1 (fr) | 2004-05-14 | 2005-04-28 | Medicaments de sevrage de la dependance a l'heroine de type non opiace |
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| CN1230401A (zh) * | 1998-03-27 | 1999-10-06 | 卢正堂 | 非阿片类药物组合的复方戒毒喷雾剂 |
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