CAJ | 학술논문

目的:如何选择对照组是临床随机对照试验设计的关键环节之一.通过对Cochrane图书馆发表的关于中草药治疗2型糖尿病系统评价中所包含的66个临床试验进行对照组设计的评价分析,探讨如何提高中草药临床试验中对照组设计的质量.方法:文献检索2005年7月前发表于Cochrane图书馆且纳入临床试验最多的系统评价--中草药治疗2型糖尿病系统评价中的66个临床试验,分析中草药临床随机对照试验在对照组设计方面存在的问题.结果:在66个临床试验中,所采用的对照组包括安慰剂组、阳性药物组及空白对照组等,但在临床试验设计中则并未说明对照组的选择理由;其中27个临床试验采用中、西药结合与西药疗效的比较;24个临床试验采用中药与西药疗效的比较;5个临床试验采用中药与安慰剂疗效的比较;3个临床试验比较了中、西药结合与西药合安慰剂治疗的疗效;3个临床试验比较了中、西药结合与其他中药治疗的疗效;中药治疗组与空白对照组比较、中药合安慰剂治疗与西药合安慰剂治疗的比较则各为1个临床试验;另有1个临床试验采用了中药分别与中、西药结合,西药以及安慰剂的比较;有1个试验则采用了中药分别与西药及中、西药结合的比较.结论:基于不同的临床试验目的选择对照组是进行对照组设计的根本依据.建议:(1)研究者与设计者必须正确理解对照组选择的重要意义;(2)对照组的选择必须以试验设计目的为基础;(3)选择阳性药物对照组必须有充足的证据证明该阳性药物的疗效,同时必须遵照推荐方法使用阳性药物;(4)必须确保安慰剂所含成分为惰性成分,对所研究疾病无任何治疗作用,且在色、泽、味、形等方面尽可能与试验药物一致;(5)空白对照组的选择必须充分考虑伦理道德因素,且不会因为非盲法评估而对结局评估产生任何偏倚;(6)在对慢性、稳定性疾病进行的研究中,交叉对照试验常较随机对照试验更为适宜. 目的:如何選擇對照組是臨床隨機對照試驗設計的關鍵環節之一.通過對Cochrane圖書館髮錶的關于中草藥治療2型糖尿病繫統評價中所包含的66箇臨床試驗進行對照組設計的評價分析,探討如何提高中草藥臨床試驗中對照組設計的質量.方法:文獻檢索2005年7月前髮錶于Cochrane圖書館且納入臨床試驗最多的繫統評價--中草藥治療2型糖尿病繫統評價中的66箇臨床試驗,分析中草藥臨床隨機對照試驗在對照組設計方麵存在的問題.結果:在66箇臨床試驗中,所採用的對照組包括安慰劑組、暘性藥物組及空白對照組等,但在臨床試驗設計中則併未說明對照組的選擇理由;其中27箇臨床試驗採用中、西藥結閤與西藥療效的比較;24箇臨床試驗採用中藥與西藥療效的比較;5箇臨床試驗採用中藥與安慰劑療效的比較;3箇臨床試驗比較瞭中、西藥結閤與西藥閤安慰劑治療的療效;3箇臨床試驗比較瞭中、西藥結閤與其他中藥治療的療效;中藥治療組與空白對照組比較、中藥閤安慰劑治療與西藥閤安慰劑治療的比較則各為1箇臨床試驗;另有1箇臨床試驗採用瞭中藥分彆與中、西藥結閤,西藥以及安慰劑的比較;有1箇試驗則採用瞭中藥分彆與西藥及中、西藥結閤的比較.結論:基于不同的臨床試驗目的選擇對照組是進行對照組設計的根本依據.建議:(1)研究者與設計者必鬚正確理解對照組選擇的重要意義;(2)對照組的選擇必鬚以試驗設計目的為基礎;(3)選擇暘性藥物對照組必鬚有充足的證據證明該暘性藥物的療效,同時必鬚遵照推薦方法使用暘性藥物;(4)必鬚確保安慰劑所含成分為惰性成分,對所研究疾病無任何治療作用,且在色、澤、味、形等方麵儘可能與試驗藥物一緻;(5)空白對照組的選擇必鬚充分攷慮倫理道德因素,且不會因為非盲法評估而對結跼評估產生任何偏倚;(6)在對慢性、穩定性疾病進行的研究中,交扠對照試驗常較隨機對照試驗更為適宜.
목적:여하선택대조조시림상수궤대조시험설계적관건배절지일.통과대Cochrane도서관발표적관우중초약치료2형당뇨병계통평개중소포함적66개림상시험진행대조조설계적평개분석,탐토여하제고중초약림상시험중대조조설계적질량.방법:문헌검색2005년7월전발표우Cochrane도서관차납입림상시험최다적계통평개--중초약치료2형당뇨병계통평개중적66개림상시험,분석중초약림상수궤대조시험재대조조설계방면존재적문제.결과:재66개림상시험중,소채용적대조조포괄안위제조、양성약물조급공백대조조등,단재림상시험설계중칙병미설명대조조적선택이유;기중27개림상시험채용중、서약결합여서약료효적비교;24개림상시험채용중약여서약료효적비교;5개림상시험채용중약여안위제료효적비교;3개림상시험비교료중、서약결합여서약합안위제치료적료효;3개림상시험비교료중、서약결합여기타중약치료적료효;중약치료조여공백대조조비교、중약합안위제치료여서약합안위제치료적비교칙각위1개림상시험;령유1개림상시험채용료중약분별여중、서약결합,서약이급안위제적비교;유1개시험칙채용료중약분별여서약급중、서약결합적비교.결론:기우불동적림상시험목적선택대조조시진행대조조설계적근본의거.건의:(1)연구자여설계자필수정학리해대조조선택적중요의의;(2)대조조적선택필수이시험설계목적위기출;(3)선택양성약물대조조필수유충족적증거증명해양성약물적료효,동시필수준조추천방법사용양성약물;(4)필수학보안위제소함성분위타성성분,대소연구질병무임하치료작용,차재색、택、미、형등방면진가능여시험약물일치;(5)공백대조조적선택필수충분고필윤리도덕인소,차불회인위비맹법평고이대결국평고산생임하편의;(6)재대만성、은정성질병진행적연구중,교차대조시험상교수궤대조시험경위괄의.
Objective: To discuss the types of control groups in randomized controlled trials (RCTs) of Chinese herbal medicine (CHM), and to provide suggestions for improving the design of control group in future clinical studies in this therapeutic area. Methods: A search of the Cochrane Library was conducted in July 2005 to identify RCTs of CHM, and 66 RCTs with CHM for type 2 diabetes mellitus were obtained as the basis for further analysis. Results: Of 66 RCTs with CHM for type 2 diabetes mellitus, 61 (92.4%) trials had both a treatment group and a control group. Twenty-seven (40.9%) RCTs compared CHM plus conventional drugvs conventional drug, 24 (36.4%) compared CHM vs conventional drug, 5 (7.6%) compared CHM vs placebo, 3 (4.5%) compared CHM plus conventional drug vs conventional drug plus placebo, 3 (4.5%) compared CHM plus conventional drug vs other CHM, 1 (1.5%) compared CHM vs no treatment, 1 (1.5%)compared CHM plus placebo vs conventional drug plus placebo, 1 (1.5%) compared CHM vs CHM plus conventional drug vs conventional drug vs placebo, and 1 (1.5%) compared CHM vs conventional drug vs CHM plus conventional drug. Conclusion: A variety of control groups were used in RCTs of CHM for type 2 diabetes mellitus, including placebo, active, and no treatment control groups. Justification for selecting particular types of control groups were not provided in the trials reviewed in this study. Different control groups may be appropriate according to the study objectives, and several factors should be considered prior to selecting control groups in future RCTs of CHM. Recommendations: (1) Investigators of CHM who design clinical trials should understand the rationale for selecting different types of control groups; (2) Control groups for RCTs should be selected according to study objectives; (3) Active control groups should select interventions for comparisons that have the strongest evidence of efficacy and prescribe them as recommended; (4) Placebo control groups should select a placebo that mimics the physical characteristics of test intervention as closely as possible and is completely inert; (5) No treatment control groups should only be used when withholding treatment is ethical and objectives outcomes will not be subject to bias due to absent blinding; (6) Crossover control groups may be appropriate in chronic and stable conditions.