ABSTRACT
Objective:To review and summarize the current research status of traditional Chinese medicine（TCM） for the treatment of chronic atrophic gastritis（CAG），provide references and hints for relevant studies，and contribute to the further understanding of TCM and the application of TCM in the treatment of CAG with scientific evidence. Method:The PubMed and Web of Science databases were searched for relevant literature on the treatment of CAG with TCM from their establishment to August 31，2020. Eligible randomized controlled trials （RCTs） and animal studies were included according to the inclusion and exclusion criteria，and then the information of the included studies was extracted，summarized，and organized for further analysis. Result:A total of 4 RCTs and 21 animal studies （including 13 papers on compound studies，3 papers on single herb studies，and 5 papers on monomer studies） about TCM treatment for CAG were included in this study. RCTs showed that TCM could work well in improving the pathological state of gastric mucosa and clinical symptoms in patients. However，there were problems of low study quality，and non-uniform diagnostic criteria for gastric mucosal pathology and clinical efficiency evaluation. Animal experiments mainly focused on the study of drug mechanism exploration，and their results showed that TCM treatment of CAG was characterized by multi-target action. However，the animal experiments also had some problems such as inconsistence of CAG animal model establishment，positive drug selection，drug intervention methods as well as intervention cycles among different experiments. Conclusion:The efficacy of TCM in the treatment of CAG has gradually gained global recognition，but there is still a need for further standardization and unification of research methods. In the future，high-quality clinical trials and standardized animal experiments are still needed to conduct in-depth studies on the time for intervention，intervention methods，active ingredients and mechanisms of TCM，so as to make contributions to the full understanding and application of TCM in the treatment of CAG.
ABSTRACT
Qingxin Lianzi Yin （QXLZY）， as an ancient classical formula for clearing the heart and nourishing the Yin， was composed of nine herbs （Scutellariae Radix， Ophiopogonis Radix， Lycii Cortex， Plantaginis Semen， Glycyrrhizae Radix et Rhizoma Praeparata Cum Melle， Nelumbinis Semen， Poria， Astragali Radix and Ginseng Radix et Rhizoma）， coming from Prescriptions of the Bureau of Taiping People's Welfare Pharmacy. It could clear away the heart-fire， promote the interaction of the heart and kidney， replenish Qi and Yin， and stop strangury-turbidity. It was used to treat gonorrhea of urination， seminal emission， restlessness， wasting-thirst and so on. At present， the usage and dosage of QXLZY and its addition and subtraction are different in clinical practice. Most of the studies just focus on its clinical efficacy， and there is few review literature reflecting its historical evolution. Based on this， this paper systematically clarified the historical evolution， composition， preparation， interpretation， function， and modern clinical application of QXLZY. This work has been explained the historical evolution of QXLZY， and found that it was wildly used in modern clinical， especially suitable for the treatment of chronic urinary system diseases. At the same time， QXLZY also had significant therapeutic effects on neurasthenia， stomatitis， diabetic nephropathy and other aspects. Through the comprehensive analysis of ancient and modern literature， this work explores the true connotation of QXLZY from the perspective of traditional Chinese medicine theory， which can point out the direction of the clinical application and positioning of this famous classical formula after it comes into the market， and also can provide reference basis for its subsequent in-depth research and development.
ABSTRACT
According to the existing Provisions for Drug Registration (SFDA Order No. 28), applications for new drugs of traditional Chinese medicine are divided into two parts: the applications for drug clinical trial and for drug production (including new drug certificate). It will last for about 10 years from the application for drug clinical trial to get approving, and it also remains many problems and the low probability to succeed. From the sight of pharmaceutical review, there are mainly two aspects of regulatory compliance and technical issues, mainly for changes without approval of the competent authorities of the country. For example, sample preparation and approval of clinical trial process are significant changes. Technical problems are reporting incomplete data or information submitted does not comply with the technical requirements for review, such as: production process validation does not provide information, the preparation of samples for clinical trials and field inspection, production information, or the information provided does not meet the technical requirements. This paper summarizes the frequently asked questions and to make recommendations to advise applicants concerned, timely detection of problems, avoid risk, improving the quality and efficiency of the application for registration.