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近30年针灸治疗子宫肌瘤的文献研究
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摘要
目的:
     针对近30年针灸(含中西医结合)治疗子宫肌瘤现代文献进行研究分析,(1)分析文献的特征,以总结规律,指导临床及科研。(2)系统评价目前常用的针灸疗法与中、西药治疗子宫肌瘤疗效和安全性的差异。(3)总结针灸治疗子宫肌瘤的常用针灸疗法,及其取穴规律,以期寻找临床有效的针灸治疗方案。
     方法:
     制定文献检索策略、检索指标、检索工具、检索时间等后,进行检索,获取题录及全文。严格根据文献的纳入标准、排除标准纳入文献,并对这些文献进行发表时间、研究地区、发表来源、文献研究类型、研究单位、干预手段、文献质量等方面的进行计量学分析。基于计量学分析,按照系统评价的的纳入与排除标准,分别筛选电子文献中关于针灸疗法和针灸与中药、西药相结合的综合疗法与中、西药治疗子宫肌瘤疗效比较的临床随机对照试验(RCT),并对这些文献进行资料提取和方法学质量评价,采用Cochrance协作网站提供的软件RevMan5.1进行Meta分析。根据计量学分析,纳入临床针灸治疗子宫肌瘤疗效的文献报道,对其中的取穴方法及规律进行EXCEL软件进行分析、总结。
     结果:
     1、计量学分析:最终纳入122篇针灸(含中西医结合)治疗子宫肌瘤的文献,数量总体呈逐年上升趋势;广州、上海等地区的发表文献数量处于领先地位;研究主要在医院中进行;刊登报道主要以中医类的省级期刊、核心期刊为主;文献研究性质以防治措施研究、病例报告为主,治疗机制研究仅2篇;主要采用的治疗方法为针刺疗法及耳穴压丸疗法;疗效评价指标以观察患者临床疗效为主,主要观察患者临床症状体征及B超检查;临床对照试验有14篇,但RCT类文献仅10篇,且多为低质量文献,仅一篇4分的高质量文献。
     2、系统评价:(1)纳入系统评价的针灸与药物治疗子宫肌瘤比较RCT共为10个,794例子宫肌瘤患者,其中高质量文献仅1篇。(2)试验组均采用针灸为主的中医疗法。对照组均服用药物,其中6个试验采用中药作为对照组干预措施,4个试验采用西药作为对照组干预措施。(3)10个试验均采用了临床总有效率作为主要的结局指标,此外有3个试验进行了临床症状改善率及子宫肌瘤体积变化差的评价,2个试验测量了治疗前后血清激素水平,1个试验采用了血红蛋白含量、经期时间作为指标,1个试验采用了心理状态、舌苔脉象变化为评价指标。(4)对进行合并的4个试验进行异质性检验(P=0.70,I2=0%),表明合并的4个试验具有临床及统计学的同质性,采用固定效应模型进行Meta分析。发现整体效应检验表明两组在临床总有效率方面存在显著性差异(Z=3.22,P=0.001),针灸+中药治疗在临床总有效率方面优于中药组[OR=2.88,95%CI(1.51,5.48)]。
     3、取穴规律分析:(1)取穴归经情况:在针灸治疗子宫肌瘤的临床研究中,使用的腧穴涉及全部的经脉,但穴位主要集中在任脉、足太阴脾经和足阳明胃经上,其所属腧穴使用总频次分别为129(29.59%)、88(20.18%)和78(17.89%)。其中任脉最常用的腧穴为气海,脾经最常用的为三阴交,胃经最常用足三里。(2)选穴情况:作为主穴三阴交(足太阴脾经,11.62%)最常用,其次为关元(任脉,11.27%)和子宫(经外奇穴,10.21%);作为配穴气海(任脉,26.32%)最常用,其次为三阴交(足太阴脾经,9.21%)和太冲(足厥阴肝经,8.55%)。(3)取穴部位:以腹部穴位使用最多,共22个腧穴,占总腧穴个数的33.85%;暂未见选用胸部、肩部、上臂的腧穴。(4)耳穴分布情况:治疗子宫肌瘤的临床研究选用的耳穴共有15个,主要选用率超过5次的耳穴依次为内分泌、皮质下、子宫、肾和脾;其中,内分泌的使用率最高,其出现的频次为11,使用频次的百分比为20.4%;而皮质下和子宫出现的频次相等,均为8,使用频次的百分比为14.8%。
     结论:
     (1)近30年针灸对子宫肌瘤的治疗效果逐渐引起了医学工作者广泛的关注,相关研究不断增多,现已形成主要的研究地区、发表阵地、治疗手段等特征,为针灸治疗子宫肌瘤的研究及临床应用提供了一定的依据。但临床诊断标准仍不统一、临床随机对照试验规范程度及文献报道质量仍有待提高。
     (2)本研究初步认为针灸配合中药治疗子宫肌瘤较单纯使用中药效果好。但由于文献质量偏低,临床研究的方法学存在很多不足及问题,影响了该结果的可信度。因此在今后的临床及科研中,研究者需要完善临床研究的方法学,提高文献报道的规范程度,为临床应用针灸治疗子宫肌瘤提供高质量的依据。
     (3)本研究通过取穴规律分析,发现针灸医家治疗子宫肌瘤时,多采用辨病为主,较少采用辨证治疗;主要选穴原则为局部取穴与循经取穴相结合,同时辅助耳穴疗法。并且针灸治疗子宫肌瘤的处方呈现集中分布趋势与多经多穴分散使用并存的局面。今后,在针灸治疗子宫肌瘤的临床治疗型研究中,应当更多关注子宫肌瘤的中医辨证分型、月经分期,并据此总结出相应选穴规律,以提高其疗效。
Objective
     Modern literatures on Leiomyoma with acupuncture and moxibustion (including combine traditional Chinese and western medicine) treatment published in resent30years were studied.(1) Assess the characteristicof the literatures, and summarize the rules, guide clinical and scientific research.(2) Evaluate the differences of efficacy and safety between acupuncture treatment and medicine therapy for Leiomyoma by Systematic review.(3) Summarize the commonly used acupuncture therapy for Leiomyoma and the rules of Acupoint selection, as to find the effective acupuncture treatment scheme in clinic.
     Methods
     Formulate the retrieval strategy, retrieval index, retrieval tools and retrieval time, retrieve and get the citations and the full text. The literatures strictly satisfied the inclusion and exclusion criteria were included, and were metrology analysized on aspects of the published time, research areas, journal sources, research types, research units, intervention method and quality of the literatures. Based on the metrology analysis, according to the inclusion and exclusion criteria of systematic review, the clinical randomized controlled trials which observed the curative effect respectively on acupuncture treatment and the combination of acupuncture and Chinese herbology/western medicine therapy comparing with Chinese herbology/western medicine therapy on Leiomyoma, were screened. Then extracted the material of the literatures and evaluated the methodological quality. The Meta analysis was conducted using the software of RevMan5.1offered by Cochrance collaboration site. According to the metrology analysis, included the clinical curative effect reports of acupuncture treatment on Leiomyoma, the methods and rules of Acupoint selection were analysized and summarized by the software of EXCEL.
     Results
     1. Results of Bibliometric analysis:122literatures on Leiomyoma with acupuncture and moxibustion (including combine traditional Chinese and western medicine) treatment were included finally, with the overall quantity increasing year by year. The published literature number of the regions Guangzhou and Shanghai is in the lead. Researches were mainly carried out in the hospital. Reports were mainly published on the core and provincial periodicals of TCM, with the research types mainly of Preventive Measures Research and Case Presentation, only2treatment mechanism researches were published. The main intervention methods were Acupuncture and Scientific Pressure on Ear Acupiont. Curative effect evaluation index was mainly to observe the clinical curative effect, including the clinical symptoms and signs and B ultrasonic examination. There were14controlled clinical trials, but only10randomized controled trials, and more of the literatures for low quality, only one high quality literature with4points.
     2. Results of Systematic review:(1) There were10RCTs of comparison of acupuncture and drug treatment on Leiomyoma, with794cases of patients with Leiomyoma, including only1high quality literature.(2) Chinese medicine therapy primarily with acupuncture was adopted in treatment group, and medicaments in controlled group, in which6trails used traditional Chinese medicine, and4trails used Western medicine.(3) The total clinical effective rate was adopted as the main end outcome in all10trails, in addition improvement rate of clinical symptoms and the reduction of Leiomyoma volume in3trails, serum hormone level before and after treatmentin2trails, HGB and menstruation duration in1trail, psychological state and the changment of tongue coating and pulse condition in1trail.(4) A total of4trails were received heterogeneity test (P=0.70,12=0%), the results showed that these studies had the clinical and statistical homogeneity, and the fixed effects model was used for Meta analysis. Overall effect inspection showed significant differences between two groups in total clinical effective rate (Z=3.22, P=0.001), Acupuncture combined with Chinese medicine therapy had better total effect than Chinese medicine [OR=2.88,95%CI (1.51,5.48)].
     3. Rules of Acupoint selection:(1) In the clinical studies of acupuncture treatment on Leiomyoma, the acupoints which had been used involved all the meridians, but focused on Ren meridian, Spleen meridian of foot Taiyin and Stomach meridian of foot Yangming with the total frequency of129(29.59%)、88(20.18%)和78(17.89%) respectively. The most commonly used acupoints are Qi Hai(CV6) in Ren meridian, San Yinjiao(SP6) in Spleen meridian and Zu Sanli(ST36) in Stomach meridian.(2) As the main point, San Yinjiao (Spleen meridian,11.62%) is most commonly used, with Guan Yuan (Ren meridian,11.27%) and Zi Gong (Extra point,10.21%) as follow. As the matching acupoint, Qi Hai (Ren meridian,26.32%) is most commonly used, with San Yinjiao (Spleen meridian,9.21%) and Tai Chong (Liver meridian,8.55%) as follow.(3)22abdominal acu-points are used with33.85%of the total. The acupoints of chest, shoulder and upper arm haven't been selected.(4)15ear acupionts were mainly used in clinic to treat Leiomyoma, in which selection frequency more than5are endocrine, subcortical, uterus, kidney and spleen. Endocrine has highest frequency of utilization, with11times (20.4%) and subcortical, uterus have the same frequency of utilization, with8times (14.8%).
     Conclusion
     (1) In the recent30years, the therapeutic effect acupuncture treating Leiomyoma caused extensive attention of the medics, related reseaches have increased. The feature of the studies has been formed on the main area, published periodicals and treatment method. These feature provids evidence for acupuncture treating Leiomyoma in clinic and research. But clinical diagnosis standard is still not unified, the specification degree of the RCTs and the quality of the literatures should be further improved.
     (2) We primarily consider that acupuncture combined with Chinese medicine has better effect than Chinese medicine alone on Leiomyoma. But because of the low quality of literatures and shortcoming of methodology, the credibility of the results is lower. So in the future clinical and scientific research, researchers need to improve the methodology of the study, the specification degree of literature, and to provide high quality evidence for acupuncture treating Leiomyoma in clinic and research.
     (3) Acupuncture therapy in the treatment of Leiomyoma relied on the result of differentiation of symptoms and signs but not the syndromes. The mainly discipline of acupoints selection focused on the acupoints from the remote and local area, while combining with subsidiary auricular points therapy. And acupuncture prescription for leiomyoma appears the situation of combination with the concentration distribution trend and disperser using points in more meridians. In the future, in the clinical treatment studies of acupuncture treatment for Leiomyoma, researchers should pay more attention to the TCM Bian Zheng of Leiomyoma, Menstrual staging, and then sum up the relevant roles of acupoint selection, in order to improve the curative effect.
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