【作者】 刘建德；

【导师】 庄礼兴；

【作者基本信息】 广州中医药大学 ， 针灸推拿学， 2009， 博士

【摘要】 目的本临床对照研究探讨针灸治疗小儿多动症的临床疗效;疗效与证型的关系、疗效与年龄的关系等。通过随机照的临床试验,客观评价靳三针为主治疗儿童多动证的的疗效及其安全性。方法研究对象为2007年6月-2008年12月在台湾省台北市政德中医诊所门诊临床诊断为儿童多动症(attention deficit hyperacticivity disorder,ADHD,又称为注意力缺陷多动性疾病)且符合纳入病例标准的病人。西医诊断标准:主要依据美国精神病学会《精神障碍诊断和统计手册第四版,(The Diagnostic and StatisticalManual of Menzal Disorders,简称DSM-Ⅳ)》中儿童多动综合症(ADHD)诊断标准实施,参照《中国精神障碍分类与诊断标准》第3版标准。中医辨证属肝肾阴虚,虚阳上亢者。试验设计采用随机对照试验方法。病例分组采用简单随机的方法。具体的随机化分配方法由课题组相关研究人员通过操作Casio(fx-3600p)计算器的随机键(INV,RAN)得出随机数字,并制成随机分配卡片,加信封密封,信封序号与卡片序号相同。108例合格病例进入试验时,按其进入的先后次序,拆开号码相同的信封,按信封内卡片规定的分组进行治疗。108例患者随机分为针灸组及西药组。其中针刺组63例,接受针刺治疗,针刺方法以靳三针疗法为标准;药物组45例,采用口服利他林治疗。针刺组取穴原则是:(1)针刺主穴取四神针(百会穴前后左右各旁开1.5寸),均向外平刺、定神针(印堂上5分,双侧阳白各上5分)均向下平刺。治疗方法及疗程:使用30号1寸不锈钢毫针,头部穴位平刺进针8-9分。以上穴位进针得气后留针30 min,隔15 min运针1次,平补平泻,每周治疗2次,3个月为1个疗程。(2)耳穴贴压主穴取神门皮质下脑干随证配穴:肝肾阴虚加肝、肾、交感点。肝郁气滞(内扰心神)加心、肝、脾点。心脾气血虚加心、脾、兴奋点。治疗方法及疗程:耳廓局部用75%酒精消毒后,将王不留行籽粘在。0.5×0.5cm大小胶布上分别贴在上述耳穴,左右耳交替。并嘱家长每次按压5~10分钟,每日不少于3次,以耳廓充血、发热为度。每周治疗2次,3个月为1个疗程。西药利他林(Ritalin)治疗方法及疗程:利他林服法为每次5-10mg,每日2次,于早、中饭前半小时各服1次,一般每日小于30mg,每周5日,双休日停服2次。3个月为1个疗程。观察项目:对儿童多动症患者的临床信息进行全面采集,具体包括一般资料,安全性检测,疗效性观察,对临床症状观察。包括中医辨证、症状、体征、各种他检查项目。观察方法:每周观察及记录中医证候、中医辨证、症状、评分指数、舌脉象各一次。必要时可随时进行检测。疗效判定标准,参照全国中医理论整理委员会多动症专业委员会制定的标准。ADHD疗效标准如下:临床痊愈:DSM-Ⅳ中ADHD18项症状基本消失。显效:ADHD18项症状中较治疗前减少5项及5项以上者。有效:较治疗前减少2项及2项以上者。无效:症状无改善者。资料收集及数据处理:试验结束后,严格按临床试验研究方案进行病例报告表的检查、验收,病例报告表应记录完整,不得有漏缺项。收集所有观察表,一起汇总,以别进行资料的分析总结。收集资料、核对后输入计算机,用EPIDATA3.0软件建立数据库,并进行统计学处理和分析,进行临床试验总结,就靳三针为主治疗儿童多动症的治疗作用和安全性作出客观的评价。统计分析方法:分类资料用χ~2检验,等级资料用两样本比较Wilcoxon秩和检验(校正)或Wilcoxon秩和检验,计量资料用两样本均数比较用t检验,自身前后比较用配对t检验或Wilcoxon配对秩和检验。统计分析运用SPSS11.5软件完成。结果本研究共有合格受试者108例,治疗组例,对照组45例;西医诊断均为儿童多动症,中医辨证为肝肾阴虚(虚阳上亢)。两组患者基线特征的可比性分析,性别、年龄构成、平均年龄、病程、中医证候总积分、多动指数总积分、中医主证、多动不宁、注意力不集中、学习效率低、中医次证、五心烦热、烦躁易怒、发泽不荣、唇红而干、喜食冷饮、盗汗、舌质、舌苔、脉象、DSM-Ⅳ中ADHD18项症状情况、多动程度等各指标比较,差异均无统计学意义。上述治疗前可比性检测表明,中医主证、中医次证、DSM-Ⅳ中ADHD18项症状比较,差异均无显著性意义。提示影响两组预后的主要因素具有均衡性。两组治疗3月后总疗效比较,差异有统计意义(P=0.012)。中医证候总积分(P=0.00)、中医主证多动不宁(P=0.026)、注意力不集中(P=0.001)、学习效率低的改善程度(P=0.035)、中医次证五心烦热(P=0.014)、烦躁易怒(P=0.042)、发泽不荣(P=0.011)、唇红而干(P=0.007)、喜食冷饮(P=0.017)、盗汗(P=0.036)等指标的改善程度比较.差异均有统计意义。提示针灸组中医疗效优于西药组。两组治疗3月后DSM-Ⅳ中ADHD18项症状改善程度比较,多动指数(P=0.00)、注意分散情况中的常不能按别人的指示完成作业.家务或工作(不是由于违抗行为或未能理解所致)的消失率(P=0.0496)等指标的比较,差异均有统计意义。针灸组疗效与年龄之间有统计意义(P=0.03),年龄小者针刺疗效较佳。两组阶段性总有效率对比分析,针灸组疗效优于西药组。两组副作用对比分析,针灸组副作小于西药组。综上所述,靳三针治疗儿童多动症取得了较好疗效,其总有效率优于内服西药。结论靳三针治疗儿童多动症的疗法是以中医基础理论为指导,根据中医辩证施以不同的穴位和相应的针法治疗儿童多动症。临床观察显示,靳三针治疗儿童多动症的疗效肯定,其总有效率优于内服西药,儿童多动症患者年龄小者疗效较好。从改善率、复常率、副作用、对主证、次证的治疗的改善情况,说明本针灸疗法治疗小儿多动症有良好的疗效,且痛苦小,易于患儿接受,适合临床推广。由于儿童多动症病程一般较长,甚至可伴随终生,复发率较高,更需要得到长期随访和追踪观察,这样可以更加明确靳三针治疗儿童多动症的疗法对该病的确切疗效,也可以帮助忠儿改善其社会功能,提高生存质量。这也提示我们下一步的研究方向。治疗过程中未发现其对心、肝、肾功能及血液系统有明显损害,临床应用安全。更多还原

【Abstract】 Aim:This clinical comparison research intends to discuss the clinical efficacy of attention deficit hyperacticivity disorder（ADHD） with acupuncture;the relationship between curative efficacy and syndromes,and between the curative efficacy and age,etc.With randomized clinical trial,this paper objectively evaluates the efficacy and safety of Jin’ s Three-needle Therapy in ADHD treatment.Methods:Research objects are patients who were diagnosed as ADHD from June 2007 to December 2008 in Zhengde Chinese Medicine Clinic in Taipei city,Taiwan Province and who met the inclusion criteria.Western Medicine:diagnosis is enacted according to ADHD diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders（DSM-Ⅳ） by American Psychiatry Society with reference to the 3^rd Version of the Classification and Diagnostic Criteria of Chinese Psychiatric Disorders.Chinese Medicine diagnoses it as liver and kidney-yin deficiency.The trial adopts randomized comparison method.Cases’ grouping is undertaken in the simple randomized way.The detailed randomization way is that the research panel members get the randomized figure by clicking the INV or RAN key on calculators of Casio（fx-3600p）,make the randomization cards and put them in envelopes.The serial number on the envelopes and cards are the same.In the trial,the 108 qualified patients open the envelopes with same number in order and go to the corresponding group to receive treatment,including Acupuncture Group and Western Medicine Group. 63 patients are in the Acupuncture Group and receive acupuncture treatment in accordance with Jin’ s Three-needle Therapy.45 patients are in the Western Medicine Group and take Ritalin orally.The acupoint-selection principles are:（1） the major acupoints are Sishenzhen（1.5 cun lateral and circa to the Baihui point） which is punctured externally and horizontally and Dingshenzhen （5 fen above ophryon,5 fen above Yangbai on both sides） which is punctured downward and horizontally.Treatment method and curative course:insert the needle horizontally on the acupoints on the head for 8-9 fen with stainless steel fine needles of 1 cun of No.30.Remain the needles for 30 minutes after the acupoints obtain qi and move the needles every 15 minutes.Take the mild reinforcing-reducing method and treat twice each week.Take 3 months as a curative course.（2） In ear acupoint paste and pressing,select the corresponding acupoints on the subcortex brain stem:liver,kidney and sympathesis point are selected for liver and kidney-yin deficiency;heart, liver and spleen points are selected for stagnation of liver-qi;heart,spleen and excitement point are selected for liver and spleen qi and blood deficiency. Treatment methods and curative course:Sterilize the auricles with 75%alcohol and paste the cowherb seeds on the strapping of 0.5*0.5cm and paste them on the ear acupoints.Left and right ears are treated alternatively.Ask the parents to press for 5-10 minutes each time and no less than 3 times each day until the auricles engorge and generate heat.Treat twice each week and 3 months as a curative course.Treatment methods and curative course of Ritalin:take 5-10 mg each time and twice a day before breakfast and lunch and generally the daily dosage is less than 30 mg.Take it 5 days a week and stop twice on weekends.3 months form a curative course.The observation items:collect the comprehensive clinical information of ADHD patients,including general information,safety observation,curative efficacy observation,clinical symptoms observation;Chinese Medicine differentiation,symptoms,body signs and other various examination items. Observation methods:observe every week and record Chinese Medicine syndromes, Chinese Medicine differentiation,symptoms,scoring index and tongue and pulse parameters.Examination may be undertaken anytime when necessary.The curative efficacy evaluation criteria refer to the criteria made by the ADHDPanel of National Chinese Medicine Theory Committee.The ADHD curative efficacy are made as follows:clinical cure:18 items of symptoms basically disappear of ADHD of DSM-Ⅳ:excellence:5 or more than 5 symptoms of the 18 items of ADHD disappear compared with that before treatment;utility:2 or more than 2 symptoms disappear compared with that before treatment;invalidity: no symptom improvement.Material collection and data processing:check and accept the case reports according to the clinical trial plan strictly.The case reports shou]d be complete and don’ t omit any items.Collect all the observation forms for material analysis and summary.Input the information into computer,set up database with the software of EPIDATA 3.0,process and analyze statistically, summarize the clinical trials and give objective evaluation of the curative effect and safety of Jin’ s Three-needle Therapy on ADHD.Statistical and analysis methods:examine the classified material withχ²;the ranked data is obtained by comparing the two samples with Wilcoxon rank sum test;the measurement data is obtained by comparing the mean of the two samples with t analysis;self circa comparison takes the t analysis or Wilcoxon rank sum test:the statistical analysis is completed with SPSS 11.5 software.Result:This trial takes 108 qualified examinees with 45 patients in the Controlled Group.The Western Medicine diagnosis is ADHD and the Chinese Medicine diagnosis is liver and kidney-yin deficiency.Take the comparability analysis of the baseline features of patients in two groups and find there’ s no statistical significance in gender,age,average age,disease course,Chinese Medicine total score,hyperactivity index total score,Chinese Medicine major syndromes like restlessness,distraction of attention,low learning efficiency,Chinese Medicine minor syndromes like burning sensation of 5 centers,frigidity,loss of nourishment in hair,vermilion and dryness of lips, fond of cold drinks,night sweat,tongue texture,coated tongue,pulse tracing, 18 ADHD symptoms of DSM-Ⅳand hyperactivity level,etc.The above comparability examination before treatment shows that there’ s no significant difference in Chinese Medicine major and minor syndromes and 18 ADHD symptoms of DSM-Ⅳ.It indicates that there’ s equilibrium in the major prognostic factors of the two groups.There’ s statistical significance of the total curative efficacy 3 months after treatment in the 2 groups（P=0.012）.There’ s no statistical significance in the improvement level of indexes like Chinese Medicine syndrome total score（P=0.00 ）,Chinese Medicine major symptoms like restlessness（P=0.026）,distraction of attention（P=0.001）,low learning efficiency（P=0.035）,Chinese Medicine minor syndromes like burning sensation of 5 centers（P=0.014）,frigidity（P=0.042）,loss of nourishment in hair （P=0.011）,vermilion and dryness of lips（P=0.007）,fond of cold drinks （P=0.017） and night sweat（P=0.036）,etc.It indicates that the curative efficacy of Acupuncture Group is better than that of the Western Medicine Group.Compare the 18 items of ADHD symptoms’ improvement 3 months after treatment of two groups and find there’ s statistical difference in hyperactivity indexes（P=0.00）,the disappearance rate of distraction of attention（P=0.0496） like not being able to finish homework,housework or work according to other’ s instructions not because of defiance or inability to understand,etc.There’ s statistical significance between curative efficacy and age in the Acupuncture Group（P=0.03）.The younger the age,the better the effect.Compare the total periodic efficacy of two groups and find the Acupuncture Group has better curativeefficacy than the Western Medicine group.Compare the side effects and find that the Acupuncture Group has fewer side effects than the Western Medicine group.In summary,ADHD treatment with Jin’ s Three-needle Therapy achieves good curative effect and the total efficacy is better than taking Western Medicine orally.Conclusion:Jin’ s Three-needle Therapy on ADHD treatment takes Chinese Medicine basic theories as guidance and selects different acupoints and corresponding needling methods according to Chinese Medicine differentiation.The clinical observation shows that it has confirmed good efficacy and little pain.It’ s easy to be accepted by children patients and suitable for clinical promotion. As ADHD has long disease course and may accompany patients life long and has high recurrence rate,therefore it needs long-term follow up and interviews, so as to clarify Jin’ s Three-needle Therapy’ s efficacy more definitely and help children patients improve their social functions and improve their survival quality.This also indicates us the next research direction.No obvious impairment to heart,liver,kidney and blood system is found in clinic and it’ s safe in clinical application.更多还原