Objective To systematically review the effectiveness of endoscopic dacryocystorhinostomy (En-DCR) with versus without Mitomycin C (MMC) for nasolacrimal obstruction. Methods Databases such as PubMed, EMbase, CENTRAL (Issue 12, 2012), VIP, WanFang Data, CBM and CNKI were electronically searched to collect the randomized controlled trials (RCTs) which investigated the comparison between En-DCR with and without MMC for nasolacrimal obstruction. The searched data was updated to December 31st, 2012. According to the inclusion and exclusion criteria, literature was screened, data were extracted, and the methodological quality of the included studies was also assessed. Then, meta-analysis was performed using RevMan 5.2.0 software and the quality of evidences was graded using GRADEpro 3.6 software. Results A total of 9 RCTs were included in the meta-analysis. The results of meta-analysis showed that, the recovery rate in the MMC group was significantly elevated (RR=1.13, 95%CI 1.04 to 1.22, P=0.003), the area of ostium in the MMC group was bigger at 1, 6 and 12 months than in the control group, postoperatively (MD=6.68 mm2, 95% 5.43 to 7.94, Plt;0.000 01; MD=11.61 mm2, 95%CI 4.67 to 18.55, P=0.001; MD=15.65 mm2, 95%CI 2.95 to 28.34, P=0.02), respectively, but the area of ostium in the MMC group at the third month was bigger than that in the control group (MD=8.20 mm2, 95%CI –6.67 to 23.08, P=0.28). The operative time was significantly prolonged in the MMC group (MD=10.1 min, 95%CI 8.00 to 12.20, Plt;0.000 01). Conclusion En-DCR combined with MMC could improve the recovery rate and prevent the over shrinkage of ostium area effectively due to nasolacrimal obstruction.
Randomization was the basis for the design and conduct of clinical trials. However, the traditional randomized controlled trials (RCTs) were often randomized in a fixed manner with unbalanced potential covariates, which spured researchers to develop a more flexible and practical randomization method. Thus, the adaptive randomization emerged as the time needed. In this paper, the application of adaptive randomization in clinical trials was introduced, and its key points of implementation, advantages and disadvantages were summarized. The development space of the adaptive randomization in clinical applications was also discussed, and it provided evidence for the development of the drug clinical trials in China.
The modern clinical research evaluation system has been increasingly emphasizing the evaluation of individual patients' clinical characteristics, diagnosis and treatment plans, and complex intervention measures. Traditional randomized controlled trial evaluated fixed interventions and non-adaptive treatment plans, which cannot meet the needs of evaluating adaptive interventions. This made researchers more inclined to explore an individualized and adaptive clinical trial design, then sequential multiple assignment randomized trial (SMART) emerged as the time needed. This article introduces the principles, key elements, and implementation points of SMART design, further explores the limitations of the mismatch between traditional Chinese medicine clinical trial design and syndrome differentiation treatment, and proposes that SMART design can meet the needs of traditional Chinese medicine clinical trials to inspire researchers in designing their plans.