西部中医药
西部中醫藥
서부중의약
GANSU JOURNAL OF TRADITIONAL CHINESE MEDICINE
2013年
12期
1-4
,共4页
黄芪注射液%糖尿病肾病%随机对照试验%CONSORT声明%报告质量评价
黃芪註射液%糖尿病腎病%隨機對照試驗%CONSORT聲明%報告質量評價
황기주사액%당뇨병신병%수궤대조시험%CONSORT성명%보고질량평개
HuangQi injection%diabetic nephropathy%randomized controlled trial%CONSORT standard%quality evaluation of the report
目的：应用CONSORT标准评价Jadad评分≥3分的有关黄芪注射液治疗糖尿病肾病的RCT报告质量。方法：按照Cochrane协作网制定的检索策略检索出2013年1月以前的所有有关黄芪注射液治疗糖尿病肾病的随机和半随机对照临床试验。应用CONSORT声明和一些中医药评价指标对Jadad评分≥3分的RCT文献的报告质量进行综合评价。数据提取和文献方法学质量评价由2名评价人员独立完成，如有争议通过讨论或由主要研究者解决。结果：共检出480篇文献，只有16篇RCT符合纳入标准。在纳入的16篇RCT中，含诊断标准的有16篇，占100.0%；说明详细用药方案及疗程的有14篇，占87.5%；正确地说明随机分配方法的有11篇，占68.75%；说明统计学方法的有15篇，占93.75%；描述对象纳入期间的有12篇，占75.0%；描述各组基线资料的有14篇，占87.5%；提及退出/失访例数的有5篇，占31.25%；提及不良反应的有9篇，占56.25%；描述中医证型的只有1篇，占6.25%。没有1篇文献提及样本含量的估计、分配方案的隐藏和实施、受试对象流程图，意向性治疗分析和终点指标观察。结论：大部分RCT的方法学及结果部分报告不够详细，建议尽量按照CONSORT标准来报告RCT以提高RCT的报告质量和真实性。
目的：應用CONSORT標準評價Jadad評分≥3分的有關黃芪註射液治療糖尿病腎病的RCT報告質量。方法：按照Cochrane協作網製定的檢索策略檢索齣2013年1月以前的所有有關黃芪註射液治療糖尿病腎病的隨機和半隨機對照臨床試驗。應用CONSORT聲明和一些中醫藥評價指標對Jadad評分≥3分的RCT文獻的報告質量進行綜閤評價。數據提取和文獻方法學質量評價由2名評價人員獨立完成，如有爭議通過討論或由主要研究者解決。結果：共檢齣480篇文獻，隻有16篇RCT符閤納入標準。在納入的16篇RCT中，含診斷標準的有16篇，佔100.0%；說明詳細用藥方案及療程的有14篇，佔87.5%；正確地說明隨機分配方法的有11篇，佔68.75%；說明統計學方法的有15篇，佔93.75%；描述對象納入期間的有12篇，佔75.0%；描述各組基線資料的有14篇，佔87.5%；提及退齣/失訪例數的有5篇，佔31.25%；提及不良反應的有9篇，佔56.25%；描述中醫證型的隻有1篇，佔6.25%。沒有1篇文獻提及樣本含量的估計、分配方案的隱藏和實施、受試對象流程圖，意嚮性治療分析和終點指標觀察。結論：大部分RCT的方法學及結果部分報告不夠詳細，建議儘量按照CONSORT標準來報告RCT以提高RCT的報告質量和真實性。
목적：응용CONSORT표준평개Jadad평분≥3분적유관황기주사액치료당뇨병신병적RCT보고질량。방법：안조Cochrane협작망제정적검색책략검색출2013년1월이전적소유유관황기주사액치료당뇨병신병적수궤화반수궤대조림상시험。응용CONSORT성명화일사중의약평개지표대Jadad평분≥3분적RCT문헌적보고질량진행종합평개。수거제취화문헌방법학질량평개유2명평개인원독립완성，여유쟁의통과토론혹유주요연구자해결。결과：공검출480편문헌，지유16편RCT부합납입표준。재납입적16편RCT중，함진단표준적유16편，점100.0%；설명상세용약방안급료정적유14편，점87.5%；정학지설명수궤분배방법적유11편，점68.75%；설명통계학방법적유15편，점93.75%；묘술대상납입기간적유12편，점75.0%；묘술각조기선자료적유14편，점87.5%；제급퇴출/실방례수적유5편，점31.25%；제급불량반응적유9편，점56.25%；묘술중의증형적지유1편，점6.25%。몰유1편문헌제급양본함량적고계、분배방안적은장화실시、수시대상류정도，의향성치료분석화종점지표관찰。결론：대부분RCT적방법학급결과부분보고불구상세，건의진량안조CONSORT표준래보고RCT이제고RCT적보고질량화진실성。
Objective:To evaluate the quality of randomized controlled trial (RCT) report about HuangQi in-jection in treating diabetic nephropathy (DN) with Jadad scales≥three points by CONSORT standard. Method:All the papers of randomized and semi-randomized controlled clinical trials about HuangQi injection in treating DN were searched before January, 2013, quality of RCT report with Jadad scales≥three points was assessed comprehen-sively by CONSORT statement and some TCM indexes. Data extraction and quality evaluation of literature method-ology were performed by two judges independently. If there was the dispute, it should be solved through discussion or main investigators. Result:Altogether 480 articles were detected, and only 16 pieces met the standard. Among 16 included articles, there were 16 articles with diagnostic criteria, which accounted for 100.0%;14 ones with detailed medication plan and the course of the treatment, which reached 87.5%;11 ones with right demonstration of random-ized distribution method, and 68.75%;15 with the presentation of statistical method, and 93.75%;12 pieces with the description of the included objects and 75.0%; 14 ones describing baseline information in different groups and 87.5%;five pieces referring to the number of the cases quit or dropped, and 31.25%;nine articles talking about ad-verse reactions and 56.25%;only one piece discussing TCM patterns and 6.25%. There was no article mentioning the estimate of samples contents, the hide and implementation of distribution plan, flowchart of the objects, inten-tion-to-treat analysis and observation of endpoint indexes. Conclusion:Since methodology and results for most of the RCT are not reported in detail, we suggest that RCT should be reported according to CONSORT standard to improve the quality and the authenticity of RCT.
