弱氦氖激光血管内照射治疗缺血性脑卒中临床试验文献评价

目的:了解中国弱氦氖激光血管内照射(intravascularlowleverHe-Nelaserirradiationonblood,ILIB)治疗缺血性脑卒中(cerebralischemicstroke,CIS)随机对照试验和临床对照试验(RCTs/CCTs)的现状,为其系统评价提供线索。方法:通过机检和手检获得发表的RCTs/CCTs共64篇,对文献的随机化分配方法、盲法采用、样本含量、患者纳入标准和排除标准、疗效判定标准、不良反应报告、治疗依从性、随访、失访报告等进行分析。结果:具有明确随机方法仅1篇占2%(1/64),有明确半随机方法3篇占5%(3/64),仅有1篇采用盲法,只有1篇运用空白对照,纳入/排除标准明确占6%,诊断标准明确占94%,疗效判定标准明确占100%,提及不良反应占12%,失访报告占3%,无一篇涉及随访和意向性分析。结论:按Jadad(Jadad1996)和Schulz(Schulz1995)提出的评价文献的质量标准,所调查的文献均存在高度偏倚,仅只有两个研究Jadad评分为2分。中国ILIB治疗CIS的RCTs/CCTs的质量有待进一步提高。

Methodological evaluation of clinical research literatures for intravascular He-Ne laser irradiation of blood in treatment of cerebral ischemic stroke

A IM :To assess the quality of randomized c linical trials(RCTs )and controlled cl inical trials(CCTs )relevant to intravascular low level He-Ne laser irradiat ion of blood(ILIB)in cerebral ischemic stroke(CIS)and to provide scientific basis for systematic review of ILIB using i n CIS.METHODS :Sixty-four article s with RCTs /CCTs were obtained by automatic and manual searches.Randomized al l ocation,blindness,sample sizes,i n-clusion /exclusion criteria,clini cal outcome assessment,adverse reaction,follow-up,drop-out were investigated a nd then methodologically evalu ated.RESULTS:Among the 64articles,only one s tudy(2%)had the clear ran-domization method,three studies(4.7%)had t he clear quasi-randomization method,only one study(2%)used the blind metho d,and only one study(2%)used the blank control.6.3%studies had the acc urate inclusion /ex-clusion criteria,94%with the expli cit diagnosis crite ria and 100%with the clinical outcome assessment.Twelv e point five per cen t studies reporte d the adverse effect,3.1%reported the dr op-out,and non e of the 64studies rep orted the follow-up outcome and intention analysis.CO