RESUMEN
Strengthening the standard formulation and quality management of traditional Chinese medicine（TCM） dispensing granules is an important part of the strategic planning for the development of TCM in China. In order to examine the clinical application and overall quality control of the existing national standards for TCM dispensing granules， this study classified and summarized the varieties in the existing standards， analyzed their clinical applicability， and discussed the characteristics of the test methods for identification， content determination and specific chromatogram/fingerprint. It was found that the coverage of the existing standards was inadequate in terms of quantity， and it was even weaker in the aspects of therapeutic efficacy， herb family， processing method and preparation method of TCM dispensing granules. It was concluded that the characteristics of national standards in test methods were summarized as follows：guided by clinical application， based on the reference system， taking specific chromatogram as a breakthrough， so as to improve the overall quality control of TCM dispensing granules. It is suggested that the coverage of national standards should be subsequently expanded to meet the needs of market development. In order to enhance clinical applicability， the content of national quality standards should be increased， including increasing variety diversity to meet the needs of clinical application， raising the standard requirements to improve the clinical medication experience， and strengthening effectiveness research to highlight clinical efficacy. At the same time， the accessibility of regulatory inspection is enhanced， the rules for the management of varieties without national standards are promulgated to lay the foundation for the healthy and orderly development of TCM dispening granule industry.
RESUMEN
In the context of the national strategy of promoting the research and development of food and drug homologous substances, it is necessary to study the regulatory model of food and drug homologous substances as food. Medicinal and food homologous substances are regulated as "Chinese medicinal materials" or "Chinese decoction pieces" in the drug category, and as "food and drug homologous substances", "agricultural products" or "traditional Chinese medicine healthy food" in the food category. Drug supervision focuses on quality, while food supervision focuses on safety, and it is worth exploring whether there is a blind spot in the supervision of food and drug substances completely based on the food concept. In this paper, Lonicerae Japonicae Flos, as drug and food homologous substance, is selected as the research object, and its quality regulation status is investigated by reviewing the relevant laws and regulations and standards on food, analyzing the quality information and test results of the samples, and analyzing the necessity of quality regulation when serving as food, in order to provide a basis and reference for the way food substances are regulated.
RESUMEN
Objective:To evaluate the clinical features and follow-up effect of treatment for retinal capillary hemangioma (RCH) of myopic disc.Methods:Retrospective case series studies. A total of 14 patients (15 eyes) diagnosed with juxtapapillary RCH (JRCH) at Peking Union Medical College Hospital and followed up for more than 12 months from January 2007 to December 2019 were included. Among these patients, there were 7 males (7 eyes) and 7 females (8 eyes) with the average age of 29.8±12.7 years. There were 6 isolated JRCH cases, all of which were monocular patients, including 1 case with a single peripheral RCH; 8 cases with von Hippel-Lindau disease, including 5 cases of binocular RCH. Out of 15 eyes, 6 eyes were merged with peripheral RCH. Three eyes were simply observed, and 12 eyes were treated with photodynamic therapy (PDT) alone or PDT combined with other treatments. The average follow-up time was 55.2 months. Its clinical characteristics and long-term treatment effects were analyzed.Results:At the first visit, among the 15 eyes, 3 eyes had visual acuity <0.1, 5 eyes were 0.1-0.4, and 7 eyes were> 0.5. The endogenous and fixed exogenous JRCH were 12 (80%, 12/15) and 3 (20%, 3/15) eyes, respectively. The size of the tumor was 1/4 to 4 optic disc diameters (DD); the combined macular edema, epiretinal membrane, and macular hole were 11, 5, and 1 eyes, respectively. There were 3 eyes with tumor diameter less than 1 DD. The visual acuity at the first diagnosis was 0.6-1.0, and no treatment was given. The follow-up time was 12 months in 2 eyes and 120 months in 1 eye. At the last follow-up, his vision remained stable and the tumor did not enlarge. Six eyes with tumor diameter ranging from 1.0 to 2.5 DD, visual acuity was 0.06 to 0.6 at first diagnosis, accompanied by retinal exudation. 5 eyes were treated with PDT alone, and 1 eye was treated with PDT combined with anti-vascular endothelial growth factor drugs. The follow-up time was 12 to 84 months. At the last follow-up, the visual acuity improved or stabilized in 5 eyes and decreased in 1 eye. There were 6 eyes with peripheral RCH, including 4 eyes with retinal detachment, 2 eyes with epiretinal membrane, and 1 eye with vitreous hemorrhage. The visual acuity at the first visit was 0.02-0.6. All patients were treated with PDT combined with transpupillary thermotherapy, extrascleral drainage, and vitrectomy. The follow-up time was 12 to 132 months. At the last follow-up, all eyesight decreased.Conclusions:Visual decrease cause by JRCH often occurs at young adults. Bilateral JRCH are more common in patients with von Hippel-Lindau's disease. The tumor can cause retinal exudation, macular edema, epiretinal membrane and macular hole, resulting in gradual vision loss. PDT and/or combined anti-vascular endothelial growth factor drugs for medium sized JRCH with retinal exudation can maintain long-term vision stability. Patients with large JRCH or severe complications such as retinal detachment tend to have poor prognosis.