| 摘要: | 自民國94年起行政院衛生署為了降低海洛因成癮者靜脈注射的行為，而推廣減害療法，95年施行美沙冬替代療法，美沙冬替代療法用於治療海洛因成癮者已超過40年歷史，且有足夠研究證實其效益，如降低海洛因成癮，減少高風險的針具使用，降低犯罪活動等1，但美沙冬本身亦屬鴉片類藥物，有副作用如昏睡，便秘，失眠，噁心，嘔吐，流汗，甚至有呼吸抑制等中毒情形1，具有成癮性，且停藥時會有美沙冬戒斷症狀，因而影響海洛因成癮者長期規則服用美沙冬之意願，而增加再度使用海洛因或其他毒品的機會，自1996年世界衛生組織(WHO)已將戒毒列為針灸治療之適應症2，因此本試驗的目的即是要探討以相對副作用較少的針灸治療合併標準美沙冬替代療法，是否可以加強戒癮治療。 本試驗計劃將納入90位參加美沙冬替代療法之海洛因成癮者，研究對象為年齡20歲以上，診斷符合精神疾病診斷準則手冊第四版(DSM IV)之鴉片類依賴3，並規則接受美沙冬替代療法之門診患者，排除標準如:1.正在使用任何精神藥物，2.過去30天內曾使用針灸治療，3.已知過去對針灸有不良反應者，4.身體狀況危急者(例如:嚴重心血管疾病，嚴重呼吸疾病，嚴重肝功能異常，嚴重腎病)，5.有自殺危險者，6.外耳發炎，7.已懷孕或有計畫懷孕之女性患者，8.有凝血疾患者，9.有愛滋疾患者，10.有癲癇，腦血管疾患或腦傷者。 本試驗的實施方法是使用隨機分派之對照、單盲試驗，將90位受試者隨機分配成三組:第一組為控制組，單獨採美沙冬替代療法組，共30人；第二組為對照組，採美沙冬替代療法加上假針灸治療(sham acupuncture)，共30人；第三組實驗組，採美沙冬替代療法加上針灸治療(verum acupuncture)，共30人。 三組皆接受為期四週的評估，主要評估指標為每日美沙冬之平均使用劑量，渴藥程度變化及生活品質變化，次要評估指標為睡眠品質變化及心律變異分析。 預期效益包括:第一、可降低美沙冬使用劑量，降低社會成本，第二、由於劑量較低，患者可減少過量美沙冬所引起之副作用，因而減少使用其他藥物的機會，第三、運用針灸本身戒癮的效果，可以加強減少使用海洛因或其他毒品(如安非他命)的機會，第四、可改善患者的生活品質及睡眠狀態。
The Department of Health initiated a project entitled “Harm Reduction Therapy and Methadone Replacement Therapy” to reduce intravenous heroin addiction in 2005. Methadone replacement therapy has been used the treatment of heroin addicts for more than 40 years, and many studies have confirmed its effectiveness, such as reduction in heroin addiction, high-risk needle use and criminal activity. But as an opiate agonist drug, methadone has side effects such as drowsiness, constipation, insomnia, nausea, vomiting, sweating and respiratory depression. These side effects sometimes cause the patients who take the methadone replacement therapy re-use of heroin or other addictive drugs. Since 1996, the World Health Organization (WHO) has announced acupuncture indications, including drug abuse. The purpose of this study is to investigate the efficacy of acupuncture therapy combined with standard methadone maintenance therapy on the heroin addicts. The study will recruit 90 heroin addicts who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for opiate dependence, over 20 years of age, and receiving the methadone replacement treatment. Exclusion criteria included 1. taking any psychotropic drugs, 2. Over the past 30 days had received acupuncture treatment, 3. had adverse reactions to acupuncture in the past, 4. critical health conditions (for example: severe cardiovascular disease, severe respiratory diseases, severe liver dysfunction, severe kidney disease), 5. high suicide risk, 6. ear inflammation, 7. under pregnant or planning a pregnancy of the female patients, 8.had coagulopathy disease, 9. had HIV disease, 10. had epilepsy, cerebral vascular disease or brain injured history. The proposed study will be a randomized, single blind, placebo-controlled study design. Patients will be randomly assigned to (1) methadone only group (n=30), (2) methadone with sham acupuncture group (n=30) and (3) methadone with real acupuncture group (n = 30). Treatments will be offered 2 times weekly for 4 weeks. Weekly measures of methadone dosage and visual analog scale (VAS) will be performed as the primary endpoint to assess the craving severity for 4 weeks. The Short Form Health Survey (SF-36) and the Pittsburgh Sleep Quality Index (PSQI) will be performed as the secondary endpoint to provide an assessment of quality of life and sleep quality. The study hypothesis is that the acupuncture has clinical efficacy upon craving severity, life quality, reducing methadone dosage and sleep quality when provided as an adjunct to a standard methadone replacement treatment. |
