CAJ | 학술논문

目的:通过对中草药临床随机对照试验的设计及方法学进行质量评价,探讨如何提高中草药临床试验的质量.方法:文献检索2005年7月前发表于Cochrane图书馆的中草药系统评价共11篇,包含167个中草药临床随机对照试验.质量评价方法采用修订版CONSORT声明9项指标以及中草药剂型及质量控制标准指标.结果:所有167个临床试验都含有试验目的、方法、第1结局指标、统计学方法及中药剂型;其中163(97.6%)个临床试验说明了研究对象的纳入标准,只有26(15.6%)个临床试验说明了研究对象的排除标准;只有14(8.4%)个临床试验详细说明了随机序列的产生方法;4(2.4%)个临床试验提及了随机分配隐藏;绝大部分的临床试验(86.8%)属于开放性的,只有13.2%的临床试验采用了盲法设计;只有1个临床试验在试验前进行了样本含量的计算;在中草药剂型方面,45.5%的临床试验使用的是汤剂或中药茶包,只有1个临床试验提及了制剂的质量控制.在167个临床试验中,所有质量评价指标的涉及率只有36.0%.结论:现阶段中草药临床随机对照试验的质量还很低.建议:(1)试验设计者及实施者必须接受正规的临床试验基础知识的培训;(2)推荐采用临床试验设计流程图,逐一解决临床试验过程中的关键问题;(3)在方案正式实施前进行预试验,并根据预试验的结果对临床试验设计方案进行调整;(4)对临床试验设计的最终方案进行注册登记,并预先发表(最好是网上发表)临床试验设计方案;(5)广泛开展国际合作,特别是与对中医药研究感兴趣的国际知名学术研究机构进行合作,以提高中草药临床研究的质量.
목적:통과대중초약림상수궤대조시험적설계급방법학진행질량평개,탐토여하제고중초약림상시험적질량.방법:문헌검색2005년7월전발표우Cochrane도서관적중초약계통평개공11편,포함167개중초약림상수궤대조시험.질량평개방법채용수정판CONSORT성명9항지표이급중초약제형급질량공제표준지표.결과:소유167개림상시험도함유시험목적、방법、제1결국지표、통계학방법급중약제형;기중163(97.6%)개림상시험설명료연구대상적납입표준,지유26(15.6%)개림상시험설명료연구대상적배제표준;지유14(8.4%)개림상시험상세설명료수궤서렬적산생방법;4(2.4%)개림상시험제급료수궤분배은장;절대부분적림상시험(86.8%)속우개방성적,지유13.2%적림상시험채용료맹법설계;지유1개림상시험재시험전진행료양본함량적계산;재중초약제형방면,45.5%적림상시험사용적시탕제혹중약다포,지유1개림상시험제급료제제적질량공제.재167개림상시험중,소유질량평개지표적섭급솔지유36.0%.결론:현계단중초약림상수궤대조시험적질량환흔저.건의:(1)시험설계자급실시자필수접수정규적림상시험기출지식적배훈;(2)추천채용림상시험설계류정도,축일해결림상시험과정중적관건문제;(3)재방안정식실시전진행예시험,병근거예시험적결과대림상시험설계방안진행조정;(4)대림상시험설계적최종방안진행주책등기,병예선발표(최호시망상발표)림상시험설계방안;(5)엄범개전국제합작,특별시여대중의약연구감흥취적국제지명학술연구궤구진행합작,이제고중초약림상연구적질량.
Objective: To discuss the quality of randomized controlled trials (RCTs) in Chinese herbal medicine (CHM) with respect to design and methodology, and provide suggestions for further improvement in future clinical trials. Methods: A search of the Cochrane Library was conducted to identify RCTs of CHM on line in July 2005. Quality of the RCTs was assessed using a 11-item checklist modified from the revised CONSORT statement, with 2 items specific to CHM (i. e. herb preparation form and quality control of herbs). Results:The search yielded 167 RCTs that were selected for assessment. All trials included statements about the interventions, objectives, primary outcome design, statistical methods, and herb preparation form. Although 163 (97.6%) trials reported inclusion criteria, exclusion criteria were only reported in 26 (15.6%) trials.Fewer than 10% of trials clearly stated the random allocation sequence generation methods, and only 2.4%mentioned allocation concealment. The vast majority (86.8%) of trials were open-label, while only 13.2%used blinding. Almost half (45.5%) administered the CHM intervention as a tea or decoction. Only one trial (0.6%) reported a sample size calculation, and a single trial (0.6%) discussed quality control of the CHM intervention. Conclusion: The overall methodologic quality of RCTs in CHM was poor. It is essential to improve the design of future RCTs in this clinical area. Recommendations: (1) Investigator conducting RCTs should have formal training about clinical trial design; (2) A flow chart is recommended to ensure that all essential steps of clinical trial design are included. (3) Conducting pilot studies prior to RCTs may help improve their design; (4) Registration of clinical trials and publishing their protocols prior to enrolment may reduce publication bias and solicit peer reviews of the proposed design; (5) Collaboration between CHM investigators and traditional medicine academic research centers interested in integrative medicine may lead to quality improvement of RCTs of CHM.