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电针“中髎”与非经穴改善中重度良性前列腺增生症状的效应对比
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摘要
研究目的
     1.明确“中髎”穴在改善前列腺增生相关症状方面是否比同节段非穴点疗效更好。
     2.通过对照组的设置,除外了其他因素的影响,明确疗效的差异是穴位区别于非穴点的相对特异性效应。
     研究方法
     1研究对象
     2010年6月1日~2011年10月30日由医院门诊海报和报纸公开招募的已由泌尿专科医生诊断明确的良性前列腺增生患者。
     2研究方法
     采用前瞻性、随机、单盲(盲患者)、对照的研究设计。
     2.1随机方法:按照计算机随机的方法将100例入选患者分为试验组50例和对照组50例。随机程序是由广安门医院药物临床试验机构办公室制作,随机程序隐藏在不透光的信封里,所有的随机信封由一名不参与针刺操作和数据分析的研究者保存。在基线评价和签署知情同意书后,研究者根据患者入组顺序拆开一个信封取得患者随机号,得到随机号的患者被带到临床医生处。随机信封有2套,以避免研究者随意调整分组情况。
     2.2单盲法:盲患者是因为穴位位于骶尾部,患者俯卧位针刺,不能判断针刺的部位。
     3病例选择
     3.1样本量计算
     按照样本量计算公式,脱落病例按20%计,经矫正后,试验组与对照组每组需要各50例。
     3.2有明确的诊断、纳入、排除标准,以及病例剔除、脱落和中止试验的标准。
     4干预方案
     试验组:针刺治则:调理膀胱气机。穴方:中髎(双侧)。针灸工具:电针采用上海华谊医用仪器有限公司生产的G6805-Ⅱ型治疗仪,穴位针刺使用苏州医疗用品厂有限公司生产的华佗牌0.30×100mm或0.30×125mm的毫针治疗。取穴方法:中髎穴:俯卧位,于第3骶后孔取穴。以髂后上棘与督脉垂直连线为边长,向下作一等边三角形,此等边三角形的顶点即为第3骶后孔针刺进针点。操作方法:患者取俯卧位,中髎穴用100mm或125mm毫针斜向下45。角刺入60-80mm(依据患者胖瘦定),针尖向下刺入第3骶后孔,局部酸胀感,然后加电针后可见会阴表浅肌收缩及双大腿内旋。双侧中髎穴加电针:选用电针频率20Hz,疏密波,缓慢调节电流量至患者能耐受的最大量,然后回调0.1-0.2mA至患者能接受为度。留针30min。前两周每周治疗5次,后两周每周治疗3次,共治疗4周。
     对照组:双侧中髎穴向外侧平开约4cm取穴。操作方法:针刺角度、方向、深度、得气及电针刺激参数、频次、疗程同试验组。
     针灸操作由一名针灸住院医师负责,大学本科毕业,针灸临床工作经验2年。
     5评价指标
     5.1疗效指标
     5.1.1主要疗效指标:国际前列腺症状评分(IPSS)。IPSS为美国泌尿协会(AUA)衡量委员会所制定的症状量化评估法,为世界性公认的BPH的评估方法。
     5.1.2次要疗效指标:生存质量评分(QOL)、残余尿(PVR)和最大尿流率(Qmax)。
     4个指标在基线、入组第6周结束时进行评价,随访在第18周结束时和第32周结束时进行,仅评价IPSS和QOL。
     5.2安全性观察指标:观察针刺治疗过程中发生的不良事件及转归。
     5.3依从性观察:计算患者的针刺依从情况,针刺次数>13次为依从性好。如依从性不好,应查找原因并记录在案。
     6统计方法
     对于观察开始后不能耐受针刺治疗、针刺次数不满13次的患者,均视为脱落病例。脱落原因须详细记录,课题完成后针对脱落病例进行以下处理。
     6.1数据集
     全分析集(Full Analysis Set,FAS)用于主要和次要疗效指标的分析,是本次研究疗效评价的主要数据集。
     符合方案集(Per-Protocol Set, PPS)是本次研究疗效评价的次要数据集。
     安全性数据集(Safety Set, SS)是本次研究安全性评价的主要数据集。
     6.2统计方法
     对计量资料,采用均数、标准差进行描述;与入组时的基础值进行比较,采用配对t检验,比较两组间疗效差异,采用独立样本t检验或秩和检验;对计数资料,采用构成比进行描述,两组治疗前后的变化采用x2检验。采用SPSS16.0统计软件。
     研究结果
     共筛选192例患者,剔除92例,共100例患者入选本研究,其中试验组50例,对照组50例。试验组完成治疗45例,效果不佳脱落1例,用药4例;对照组完成治疗42例,效果不佳脱落1例,用药7例;试验组完成18周随访41例,失访3例,用药1例;对照组完成18周随访36例,失访3例,用药3例;试验组完成32周随访35例,失访3例,用药3例,对照组完成32周随访32例,失访2例,用药2例。
     2治疗4周后疗效分析
     2.1主要疗效指标评价—IPSS
     治疗4周后,两组患者IPSS分值均有明显下降,前后差异具有统计学意义(P值分别为0.000和0.001,<0.05);并且两组患者的疗后IPSS评分及IPSS评分差值均有统计学差异(P<0.05),试验组评分较低。表明两种刺法均可改善患者国际前列腺症状评分,试验组疗效更好。
     考虑年龄、病程可能会对结果有影响,因此,将IPSS(?)(?)分值作为因变量,组别作为因素变量,年龄、病程分别作为协变量,进行协方差分析,结果表明:年龄和病程对IPSS减分值均无影响(P值分别为0.283和0.705,均>0.05)。
     2.2次要疗效指标评价QOL、PVR、Qmax
     2.2.1治疗4周后QOL的评价
     两组患者治疗4周后QOL,分值均有明显下降,前后差异均具有统计学意义(P值都=0.000<0.05);并且QOL分值及变化值组间差异显著,具有统计学意义(P=0.000<0.05),试验组变化较大。表明两种刺法均可改善患者生活质量评分,试验组疗效更好。
     2.2.2治疗4周后PVR的评价
     两组患者治疗4周后PVR分值无明显变化,前后差异无统计学意义(P值分别为0.706和0.202,均>0.05);并且疗后的QOL分值及QOL变化值组间无统计学差异(P值分别为0.660和0.608,均>0.05)。表明两种刺法均不能明显改善患者的膀胱残余尿。
     2.2.3治疗4周后Qmax的评价
     两组患者治疗4周后Qmax分值无明显变化,前后差异无统计学意义(P值分别为0.583和0.098,均>0.05);并且疗后Qmax分值及Qmax变化值组间无统计学差异(P值分别为0.066和0.485,均>0.05)。表明两种刺法均不能明显改善患者的最大尿流率。
     3随访结果
     3.118周随访
     3.1.118周时IPSS评价
     治疗后第1次随访时,两组患者IPSS分值均有明显下降,前后差异具有统计学意义(P值分别为0.000和0.030,均<0.05);并且两组患者的IPSS评分差值有统计学差异(P=0.005<0.05),试验组变化较大。表明两种刺法在18周时改善患者国际前列腺症状评分的针刺效应仍然存在,且试验组疗效更好。
     3.1.218周时QOL评价
     治疗后第1次随访时,两组患者QOL分值均有明显下降,前后差异具有统计学意义(P值分别为0.000和0.000,均<0.05);并且两组患者的QOL评分和QOL评分差值均有统计学差异(P=0.019和0.010,均<0.05),试验组变化较大。表明两种刺法在18周时改善患者生存质量评分的针刺效应仍然存在,且试验组疗效更好。
     3.232周随访
     3.2.132周时IPSS评价
     治疗后第2次随访时,试验组患者IPSS评分明显下降,和疗前比有统计学差异(P=0.001<0.05),对照组患者IPSS评分和疗前比无统计学差异(P-0.123>0.05)。32周时两组患者的IPSS分值及IPSS变化值无统计学差异。表明,在32周时,试验组的针刺效应仍能见到,对照组的治疗效应已消失,但两组患者的国际前列腺症状评分无明显差异。
     3.2.232周时QOL评价
     治疗后第2次随访时,两组患者QOL评分和疗前比无统计学差异(P值分别为0.583和0.098,均>0.05)。两组患者的QOL分值及QOL变化值无统计学差异(P值分别为0.071和0.085,均>0.05)。表明,在第32周时,两种针刺方法对患者生活质量的治疗效应均已消失。
     4两组患者IPSS和QOL变化趋势分析
     采用重复测量设计的方差分析对4个评价时点的IPSS评分和QOL评分变化趋势进行分析,结果表明:IPSS评分和QOL评分在4个评价时点差异有统计学意义(P=0.000<0.05),评价时点与组别之间存在交互效应(P=0.000<0.05)。试验组在针刺4周时的效应较对照组更明显,在18周时试验组的优势效应仍然存在,在32周时两组效应无明显差异。
     5IPSS单项症状分析
     疗前:两组患者的7个症状的病例分布均无统计学差异,即两组患者7个症状的病情轻重一致;
     6周时:试验组“排尿间隔<2小时”的改善程度较对照组多;
     18周时:试验组“尿不尽感”、“夜尿次数多”的改善程度较对照组多;
     32周时:试验组“夜尿次数多”的改善程度较对照组多;
     结论
     1.电针中髎穴可以有效改善良性前列腺增生的相关症状,如尿频、夜尿多、排尿不尽感等,这种效应和同神经节段非穴点比较,是相对特异的治疗效应。
     2.电针中髎穴对BPH相关症状的治疗效应可以维持到疗后12周。
     3.电针中髎穴在改善BPH的下尿路刺激症状方面显示出了更好的疗效。
     4.下一步继续完善中髎对BPH的穴位特异性研究工作,设立和同经不同穴、不同经不同穴的比较以及同一穴位针刺深浅的比较,同时尽可能的延长治疗疗程。
Objectives
     1. Make clear whether the improvement of benign prostatic hyperplasia related symptoms is better in the group of acupuncture at Zhongliao (BL33) than that at non-acupoint in the same segment.
     2. Through the setting of the control group, with the exception of other factors, we can make clear that the effect is the relative specificity effect of the acupoint differing from the non-acupoint in the same segment.
     Methods
     A prospective, randomized, double-blind (blind patients, blind evaluators), controlled study design is carried out. Patients with benign prostatic hyperplasia definitely diagnosed by urologists were recruited through posters and newspapers from June1,2010to October30,2011.100patients were randomly divided into two groups,50in treatment group and50in control group.
     1. Treatment group:Needle at bilateral BL33with a45°angle. A feeling of soreness and distension will be felt when needling into the3rd posterior sacral foramina (S3) and finally with radiation of sensation to the perineum. Needle60-80mm without lifting, thrusting or rotating. Put on the electric stimulator with a disperse-dense wave,20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level.
     2. Control group
     Take the site4cm lateral BL33as the non-point for the control group. Manipulation methods and electric stimulator parameters are the same with those of the treatment group. The pilot study shows that patients in the control group have the same feeling with those of the treatment group.
     There are16sessions for all patients (5sessions in the1st and2nd weeks,3sessions in the3rd and4th weeks) and each session last30minutes. Acupuncture for the two groups will be operated by the same acupuncturist with more than ten years of experience. This acupuncturist is blinded to the outcome assessment at baseline, the6th week, the18th week and the32nd week.
     Results
     A total of192patients were screened, and92cases were excluded, a total of100patients were enrolled in this study.
     1. Age and course of disease have no effect on the efficacy evaluation of IPSS which is the primary outcome measure.
     2. In the6th week, electro-acupuncture at BL33and non-acupoint can both improve the international prostate symptom score and the score of quality of life, with a better efficacy in the treatment group.
     3. In the6th week, electro-acupuncture at BL33and non-acupoint had no clear effect on the maximum flow rate or the bladder residual urine, and the effects on the two acupoints had no statistical difference.
     4. The evaluation carried out in the18th week found that the electro-acupuncture at BL33and non-acupoint could still improve both the international prostate symptom score and the score of quality of life, with a still better efficacy in the group of BL33.
     5. The evaluation carried out in the32th week after treatment found that besides the improving effect on IPSS in the treatment group, no therapeutic effects were made on IPSS in the control group or on QOL in both groups. The effects of both acupuncture methods had no significant difference.
     6. Differences of the IPSS socre and the QOL score at four evaluation time points had statistical significance, which means the IPSS socre and the QOL score significantly changed at every time point and interactive effect exists between the evaluation time point and the group. Therapeutic effect at the4th week after acupuncture in the treatment group was much more obvious than that in the control group. Better effects still existed at the18th week in the treatment group. Comparision of the effects of the two groups had no statistical significance at the32th week.
     Conclusion
     1. EA at BL33can effectively improve the symptoms associated with benign prostatic hyperplasia, such as frequent urination, frequent urination at night, urine retention and so on. Compared with the effect of EA at non-acupoint in the same nerve segment, the effect of EA at BL33is a relatively specific therapeutic effect.
     2. The therapeutic effect of EA at BL33on BPH-related symptoms can be maintained until12weeks after treatment.
     3. EA at BL33shows a better therapeutic effect on improving the stimulation symptoms of lower urinary route in BPH.
     4. Further study will be carried out to improve the specificity research of the acupoints in BPH, such as comparative studies of different acu-points in the same meridian, different points in different meridians and different acupuncturing depth at the same point. At the meantime, the course of treatment will be prolonged as much as possible.
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