Medicine
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Clinical and basic research supports that blood glucose fluctuation is an important predictor of diabetic vascular disease and an etiology of lower extremity atherosclerosis, which is an important pathological basis for lower extremity vascular diseases. Previous Chinese National Natural Science Foundation trials (No. 81503566) have reported that the traditional Chinese medicine Shenqi compound can reduce blood glucose fluctuation and low-grade inflammation, and protect blood vessels; however, there are no high-quality clinical evidences available to support the same. This multicenter randomized controlled trial aims to obtain more clinical evidence to confirm the efficacy and safety of Shenqi compound in type 2 diabetes with lower extremity atherosclerosis. ⋯ Explore the clinical effect of traditional Chinese medicine "Shenqi Compound" to reduce blood glucose fluctuation and use HOMA-IR, the area under the glucose curve, and the area under the C-peptide curve to evaluate the effect of protecting islet β cell function.
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Traumatic flap dislocation might occur anytime after laser in situ keratomileusis (LASIK), but it is rarely concomitantly complicated with epithelial ingrowth, infectious keratitis, and diffuse lamellar keratitis altogether. Here we report a case of traumatic LASIK flap inversion with epithelial ingrowth, Propionibacterium acnes infection, and diffuse lamellar keratitis. ⋯ This is the first report of Propionibacterium acnes keratitis after traumatic flap inversion. Although epithelial ingrowth, infectious keratitis, and diffuse lamellar keratitis all developed after the flap inversion, early recognition and proper intervention lead to a good result without sequels.
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Randomized Controlled Trial
Development and validation of a driving simulator for evaluating the residual effects of drugs on driving performance - sensitivity analysis using zopiclone as a positive control: Study Protocol Clinical Trial (SPIRIT Compliant).
Drugs acting on the central nervous system (CNS), especially hypnotics, can impair driving. The US Food and Drug Administration started requiring pharmaceutical companies to evaluate the residual influence of CNS agents on driving performance to review their recommended doses. Although it is important for physicians to discuss automobile driving while on medication with patients to promote traffic safety, the package inserts of most CNS agents in Japan uniformly prohibit patients from driving. Although more evidence-based information regarding the effects of drugs on driving performance is needed, the current evaluation methods for driving performance abroad cannot be applied directly to Japanese drivers because of differences in traffic environments, laws, and constitutions. Therefore, we plan to establish a new driving simulator (DS) that would enable the next-day residual effects of drugs on driving performance to be examined. ⋯ In this double-blind, randomized, placebo-controlled, crossover trial, we plan to recruit 26 healthy Japanese males aged 21 to 64 years through advertisements. During the test periods, which will take place twice every other week, the participants will undergo a DS evaluation in the hospital for 2 days/1 night after the first and last doses of the study drug following 8 days of administration. The participants in the study drug group will take zopiclone 7.5 mg at bedtime on the first and eighth days in the hospital, and placebo on the other days. The DS evaluation consists of road tracking, car following, and harsh braking tests. The primary outcome is the standard deviation of lateral position (SDLP), which is a gold standard evaluation item, in the 60-min road-tracking test. The exploratory outcomes are other evaluation items in the DS tests, in the Karolinska Sleepiness Scale sleep questionnaire, and the Profile of Mood States Second Edition rating scale. The estimated difference in the SDLP between the zopiclone and placebo groups will then be calculated.
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Everolimus-eluting bioresorbable vascular scaffolds (BVS), which have the characteristics of scaffold absorption and vascular function recovery, are the latest innovation in the treatment of coronary artery disease. This new concept has become a hot topic in the field of interventional cardiology. Data regarding mid-term clinical outcomes of BVS in acute coronary syndromes are currently scarce. The aim of this systematic review and meta-analysis is to compare mid-term outcome data for BVS and second-generation drug-eluting stents (DES) in the treatment of acute coronary syndromes. ⋯ At mid-term follow-up, BVS had a higher risk of TLR and ST/ScT than the second-generation DES in patients with acute coronary syndromes. ST/ScT was the key factor indicating the decreased safety and effectiveness of BVS relative to DES.
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Meta Analysis Comparative Study
Comparison of the efficacy and safety of shockwave lithotripsy, retrograde intrarenal surgery, percutaneous nephrolithotomy, and minimally invasive percutaneous nephrolithotomy for lower-pole renal stones: A systematic review and network meta-analysis.
Shock wave lithotripsy (SWL), retrograde intrarenal surgery (RIRS), percutaneous nephrolithotomy (PCNL), and minimally invasive PCNL are currently therapeutic options for lower-pole renal stones (LPS). However, the optimal treatment for LPS remains unclear. A comprehensive evaluation of the efficacy and safety of each intervention is needed to inform clinical decision-making. This study aimed at assessing the efficacy and safety of different interventions for LPS. ⋯ PCNL was associated with the best stone free rate for LPS regardless of age, sex, and stone size. Each treatment achieved a similar complication rate compared with the others. Future large-scale RCTs are warranted to identify the most beneficial management for renal stones at a more complicated location.