摘要
目的了解中医药治疗干燥综合征随机对照试验(RCT)的现状,并评价其能否为临床应用提供高质量证据。方法计算机检索CNKI、VIP、CBM及PubMed,检索时间均从建库至2010年6月。按照所拟标准纳入中医药治疗干燥综合征的随机对照试验文献,采用Jadad评分量表、CONSORT声明修订版及自拟指标进行质量评价。结果共纳入19篇RCT,其中Jadad评分4分1篇、2分4篇、1分13篇、0分1篇。无一篇报告分配隐藏实施。按CONSORT标准,19篇纳入文献仅诊断标准、干预措施的实施和结果的报告率达100%,11篇采用2002年干燥综合征国际诊断(分类)标准,17篇采用阳性对照(其中1篇为标准治疗基础上阳性对照),2篇为标空白对照,无安慰剂对照。所有试验均以综合疗效评价为结局指标,仅6篇(31.6%)对临床疗效及中医证候疗效作了病证双重评价。6篇(31.6%)提到随机序列产生方式,但没有一篇报道随机是如何执行的。仅1篇(5.3%)实施双盲,余均为非盲法试验,所有试验仅1例采用模拟剂。结论目前中医药治疗干燥综合征临床研究的方法学和报告质量尚低,不能肯定其疗效。
Objective To investigate the current situation of randomized controlled trials（RCTs） on the treatment of Sjogren＇s syndrome with Traditional Chinese Medicine（TCM）,and to assess whether there is adequate evidence for clinical practice.Methods Such databases as CNKI,VIP,CBM and PubMed were searched from their establishment date to June 2010 to collect the RCTs on the treatment of Sjogren＇s syndrome with TCM according to the predefined inclusion criteria.And the quality was assessed by using the Jadad scale,the revised CONSORT statement and other self-defined indexes.Results Among 19 included RCTs,1 literature scored four points,4 scored two points,13 scored one point,and 1 scored zero point according to Jadad scale;no RCT performed the allocation concealment.According to the CONSORT criteria,19 RCTs accounting for 100% reported the diagnostic criteria,implement of interventions and result,11 RCTs applied the 2002 international diagnosis and classification criteria of Sjogren＇s syndrome,17 RCTs carried out positive control including one based on the standard treatment,and two RCTs applied only blank control without placebo control.All RCTs took the comprehensive efficacy assessment as the outcome index,but only 6 RCTs（31.6%） assessed both clinical efficacy and TCM syndrome efficacy.Among 6 RCTs（31.6%） describing the random sequence,no RCT reported the detailed methods.Except 1 RCT（5.3%） carried out the double blinding,all the others were non-blind trials.And only 1 RCT adopted analog.Conclusion Currently,the methodology and reporting quality of studies on the treatment of Sjogren＇s syndrome with TCM are not good enough to provide reliable evidence for clinical practice.
出处
《中国循证医学杂志》
CSCD
2011年第8期978-982,共5页
Chinese Journal of Evidence-based Medicine
基金
科技部"十一五"国家科技支撑计划(2007BAI20B055)
关键词
干燥综合征
中医药
随机对照试验
Jadad评分
CONSORT声明
Sjogren＇s syndrome
Traditional Chinese medicine
Randomized controlled trial
Systematic review
CONSORT statement
