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针刺治疗癌性疼痛的系统评价及临床预初试验

Systematic Evaluation of the Effect of Acupuncture Therapy on Cancer Pain and a Pilot Clinical Trial

【作者】 彭浩

【导师】 许玲; 劳力行; 彭海东; 陆健;

【作者基本信息】 第二军医大学 , 中西医结合临床, 2009, 硕士

【摘要】 第一部分针刺治疗癌痛疗效的系统评价目的:评价针刺治疗癌痛的疗效。方法:计算机检索Cochrane图书馆临床对照试验数据库(2008年第3期)、MEDLINE(1966~2008.6)、EMBASE(1974~2008.6)、PUBMED(1950~2008.6)、SCIENCEDIRECT(1995~2008.6)、CONTROLLED-TRIALS(1999~2008.6)、中文科技期刊全文数据库(VIP)(1989~2008.6)、中国学术期刊全文数据库(CNKI)(1994~2008.6)、中国生物医学文献数据库(CBM) (1978~2008.6),手工检索2007年1月至2008年6月发表的其它相关中文文献。由两名评价者独立对纳入文献进行质量评价并提取资料,如遇分歧,通过讨论解决。对纳入文献用RevMan5.0进行Meta分析,如果无法进行Meta分析,则进行定性分析。结果:8篇随机对照临床试验,共700例病人符合纳入标准,其中高质量研究1篇。由于绝大部分文献在试验设计、报道上存在明显缺陷,以及各试验间存在较大差异,不符合Meta分析条件,因而只进行了定性分析。结果显示,除一篇有关耳针疗法的高质量研究展示耳针组在镇痛效果上要显著优于安慰耳针组外,其它均为与非安慰对照组相比较且低质量的临床对照试验,但都提示针刺疗法有一定效果。结论:针刺治疗癌痛有效,但入选的绝大部分试验质量不高,降低了该结论的可靠性,还需更多设计严谨的高质量随机对照试验来证实。第二部分临床研究目的:观察针刺疗法对癌痛的镇痛效果及对癌痛患者生活质量、精神状态的影响。方法:将22例癌痛患者根据疼痛的轻、中、重不同程度分为3层,按照随机数字表把每一层病人随机分配到针刺组和安慰组。两组均可在研究期间维持基线期的镇痛药使用情况。研究期间用VAS疼痛量表评价疼痛缓解的临床疗效,并分别用QLQ-C30量表以及SCL-90量表评价癌痛患者的生活质量及精神状态。结果:针刺组及安慰组在第7天、第14天及第21天这3个时间点的VAS疼痛评分前后差值组间比较无显著性差异,且针刺组在以上3个时间点的前后差值组内比较亦无显著性差异。但安慰组在第14天及第21天的前后差值组内比较P<0.05,具有显著性差异。QLQ-C30量表评分结果显示,除在食欲丧失计分因子方面,针刺组与安慰组第7天的组间比较P<0.05,有显著差异外,其它因子评分方面的比较,无论是组间还是组内均无明显差异。SCL-90量表评分结果显示,除在强迫症状因子方面,针刺组在第7天的组内比较P<0.05,具有显著性差异外,其它因子评分方面的比较,无论是组间还是组内均无明显差异。结论:由于本初步研究的病例数较少,尚无法确定针刺对癌痛是否有效,亦无法证明其能否改善癌痛患者的生活质量和整体精神状态,但研究结果提示针刺可能会对癌痛患者的强迫症状有一定的改善作用,可是仍需更大规模的试验来证实。本试验对未来大规模的随机对照临床试验在设计上的思考:1、采取多中心合作的方式扩大研究病例数;2、增加对针刺治疗癌痛即时效果的观察;3、采用VAS与VRS-5相结合的疼痛评价方法。

【Abstract】 The First Part: Systematic Evaluation of the Effect ofAcupuncture Therapy on Cancer PainObjectives: To evaluate the effect of acupuncture therapy on cancer pain.Methods:Computer database searches of clinica l controlled trials: Cochrane Library(Issue 3, 2008), MEDLINE (1966-June 2008), EMBASE (1974-June 2008),PUBMED (1950-June 2008), SCIENCEDIRECT (1995-June 2008), CONTROLLEDTRIALS(1999-June 2008), Chinese S&T Period icals Database (VIP; 1989-June2008), China Academic Journal Full-text Database (CNKI; 1994-June 2008), andChinese BioMed ica l Literature Database (CBM; 1978-June 2008). Manual searches ofother releva nt literature published between January 2007 and June 2008. Two separateevaluators assessed the quality of the included literature and extracted the usefulinformation. Disa greements were resolved though discussion. Meta-analysis of theincluded literature was done with RevMan5.0, and qualitative analysis was employedwhen meta-a nalysis was not appropriate.Results:Eight published randomizedcontrolled clinica l trials (RCTs), one of high quality, with a total of 700 patients, metthe inclusion criteria. Due to flaws in design and reporting that precluded theapplica tion of meta-a nalysis, only qualitative analysis was done on the majority of thepapers. The high-quality paper showed that ear needle therapy is significa ntlysuperior to placebo in pain alleviation. The other seven (low-q uality clinica l controlledtrials with non-placebo control groups) all showed that acupuncture therapy had somepositive effect. Conclusion:Acupuncture is effective for pain relief. However, the poorquality of the majority of the papers reduces the reliability of the conclusion. Morehigh quality RCTs are needed to verify the effects.The Second Part: The Clinical StudyObjectives: To observe analgesic effect of acupuncture on carcinous pain and itseffect on the quality of patient’s life and patient’s mental status. Methods: 22 patients with carcinous pain were stratified into 3 levels, light, moderate and severe pain, andthen were assigned into acupuncture group and placebo group according to randomnumber table. Both groups can ma inta in the usage of analgesic drug of baseline levelduring the study period. Visua l analog scale (VAS) was employed during study periodto evaluate clinica l effect of acupuncture on pain alleviation, and QLQ-C30 scale andSCL-90 scale were used to evaluate improvement of quality of patient’s life andpatient’s mental status. ResultResults: No statistica lly significa nt difference was foundbetween acupuncture group and placebo group in VAS pain score measured at 7th,14th, 21st day of treatment, while within acupuncture group at the above 3 time points,no statistica lly significa nt differe nce was found in VAS score between pre- and posttreatment.Within placebo group, statistica lly significa nt difference was found in VASscore between pre- and post-treatment at 14th and 21st day (P<0.05). Result of QLQC30scale showed that no statistica lly significa nt difference was found in any otherscore factors both between the two groups and between pre- and post-treatment at 7thday of treatment within each of the two groups, with an exception of the score factorof "Loss of Appetite" between the two groups at 7th day of treatment (P<0.05). Resultof SCL-90 scale showed that no statistica lly significa nt difference was found in anyother score factors both between the two groups and between pre- and post-treatmentat 7th day of treatment within each of the two groups, with an exception of the scorefactor of "Compulsive Symptom" within acupuncture group at 7th day of treatment(P<0.05). Conclusion: Due to the limited number of study subjects, effect ofacupuncture on carcinous pain can not be determined, nor can it be proved thatacupuncture can improve patient life’s quality and overa ll mental status. However,study result indica ted that acupuncture can, to some extent, improve compulsivesymptom for patients. Still, a large scale study is needed to confirm it. Considerationson the design of future large-scale randomized controlled clinica l trial: 1. Multi-centercooperation method should be employed to increase number of study subjects; 2.Observe more on the immed iate effect of acupuncture in treating carcinous pain; 3. Acombination of VAS and VRS-5 should be used for evaluation of pain.

  • 【分类号】R246
  • 【下载频次】341
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