Dynamic medication management can help to improve efficacy and save consumption in such trials when an investigational medication is expensive or in short supply or has a fairly short shelf-life in a long-lasting clinical trial, or, if protocol changes during study period. We presented the standard operating procedure of dynamic medication management and drug labeling through an instance of double-blind randomized controlled trial of Chinese Medicine for hepatopathy. Compared to conventional drug labeling, dynamic medication management and drug labeling is more flexibility to deal with problems during the study period, such as protocol update, medication waste, and outdated medication and so on. Appropriate method and reasonable procedure can ensure the precise implementation for drug labeling and medication management of double-blinded randomized controlled trials.
ObjectiveTo explore the dyeing conditions of reticular fiber staining of liver puncture tissue stained by BenchMark automatic special staining instrument, evaluate the staining effect, and share the using experience.MethodsA total of 30 cases of liver puncture specimens from April to May 2019 in West China Hospital of Sichuan University were selected. They were fixed with 4% neutral formaldehyde fix solution, treated with automatic dehydrator, embedded in paraffin, stained with adhesive slides, and baked in 65℃ oven for 30 min. Each specimen was sliced in duplicate, with a thickness of 5 μm. One was reticular fiber stained with BenchMark automatic special staining instrument under the dyeing condition according to the using experience of the laboratory, and the other was reticular fiber stained by manual Foot staining method according to the standard operating procedure of the laboratory. The staining effect under microscope was observed by a chief pathologist with extensive slide-reading experience.ResultsThe success rate of instrumental method was 100.0% (30/30), and that of the manual method was 76.7% (23/30). The difference in success rate between the two methods was statistically significant (χ2=5.143, P=0.023).ConclusionThe reticular fiber staining effect of BenchMark automatic special staining instrument is stable and reliable, and the success rate is higher than that of manual Foot staining.
Intravitreal drug injection is a treatment for common chronic fundus diseases such as age-related macular degeneration and diabetic retinopathy. The “14th Five-Year” National Eye Health Plan (2021-2025) recommends focusing on fundus diseases and improve the management mode of patients with chronic eye diseases. Therefore, it is imperative to explore how to further optimize the service process of intravitreal injection under the premise of guaranteeing patients' medical safety, to promote medical service efficiency and standardized management level and improve the medical experience of patients. Based on the quality control standard of vitreous cavity injection for retinopathy in China, Chinese fundus disease and related field experts developed the present expert consensus on the establishment of a one-stop intravitreal injection model and the management of its organization after a serious, comprehensive, and complete discussion, focusing on a standardized operation process, quality control, and safety management, providing more references for establishing a suitable intravitreal injection management model for ophthalmology and promoting the development of diagnostic and treatment models for fundus disease in China.