针灸治疗甲状腺功能亢进症临床研究文献质量评价

Evaluation of Quality of Literature of Clinical Studies on Acupuncture and Moxibustion Treatment of Hyperthyroidism

目的:评价我国针灸治疗甲状腺功能亢进症(甲亢症)的临床试验质量。方法:通过机检和手检获得针灸治疗甲亢症的临床试验文献,并按国际 Cochrane 协作网 Cochrane 手册随机对照研究标准及临床流行病学评价方法对文献的随机化、对照、研究对象选择(纳入与排除标准的确定)、组间可比性、样本含量、样本来源的描述及控制、诊断标准、盲法的运用、疗效判定标准、统计方法、副反应、随访等方面进行分析评价。结果:63篇文献中针灸治疗甲亢症的临床随机对照试验论文仅占22.2%,但近年来呈逐年增加趋势。结论:尽管针灸已被广泛运用于甲亢症的防治中,但因其临床随机对照性试验(RCT)数量较少、质量水平仍然较低,尚无法为临床提供可信性高的证据,严重阻碍了针灸临床疗效的验证和发展。建议有条件的研究机构进行针灸治疗甲亢症的前瞻性、多中心、随机对照试验,探索出疗效确切,可行性强的针灸方法,为进一步开展针灸治疗甲亢症的系统评价提供基础条件。

Objective:To evaluate quality of clinical trials about acupuncture and moxibustion treatment of hyperthyrodism in China. Methods:Literature of clinical trials of acupuncture and moxibustion treatment of hyperthyroidism were attained by computer and manual retrieval,and randomization,control,selection of study objects,comparability between groups,amount of samples, description and control of source of samples,criteria for diagnosis,application of blind method,criteria for assessment of therapeutic effects,statistical method,adverse effects,follow-up,and others in the literature were analyzed and evaluated by the randomized controlled test criteria and the clinical assessing method in Cochrane handbook of international Cochrane cooperation net.Results:In 63 papers,clinical randomized controlled tests of acupuncture and moxibustion treatment of hyperthyroidism only accounted for 22.2%,but with increasing tend year by year in recent years.Conclusion:Though acupuncture and moxibustion have been widely applied in prevention and treatment of hyperthyroidism,it could not provide evidences of higher reliability for clinical treatment due to less clinical randomized controlled tests and lower quality,which severely hinder testing and verifying of clinical therapeutic effects of acupuncture and moxibustion.It is proposed that multiple central and randomized controlled test should be made,so as to search for feasible acupuncture and moxibustion methods with definite therapeutic effect for hyperthyroidism,and provide basis for further systematical evaluation of acupuncture and moxibustion treatment of hyperthyroidism.