This article was inspired by the paper that Clinical Research of Traditional Chinese Medicine NeedsA Breakthrough, which was written by Shang Hongcai. This article took the 11th Five-year Plan of the National Science and Technology Support Project and the National Public Welfare Projects of Chinese Medicine, which were undertaken by the Heilongjiang Gynecology , which is one of the National Trial Bases of Chinese Medicine as an example to illustrate the Chinese medicine clinical trial management , achievement producing , and realization of achievement transformation . The emphasis should be made on the optimization of Chinese medicine clinical trial from the topic selection , operation mode and quality control . A comprehensive and detailed management system should be worked out to ensure the smooth conduction of clinical trials. The clinical research results should be clarified to achieve high quantity and quality outputs . The article was aimed to provide references for the development and breakthrough of Chinese medicine clinical trials .

With the spread of the new coronavirus pneumonia in China, medical researchers at home and abroad have carried out clinical studies in order to find the best way to combat the epidemic. The quality control measures are the key to ensure the scientificity of results. An overview of a multi-center randomized controlled double-blind clinical study was presented which was on the efficacy and safety of terazavirin in the treatment of COVID-19. It has pointed out that the difficulty of quality control in this study lies in obtaining the first-line data for the research assistant due to the isolation, and the delay of quality control only through the verification of EDC data. And these problems could be solved by using "core data targeting" quality control form. The features of this form include the concise content directly aiming at the main chart data in the research report for quality control, focusing on the implementation of the core elements of the programme and function of reminding and helping research assistants understand the capabilities of the project.

Objective: To study the correlation between electronic screen use and myopia among primary and secondary school students in six provinces and cities in China, in order to provide a scientific basis for comprehensive prevention and control of myopia. Methods: From November 2020 to June 2022, a total of 16 557 primary and secondary school students from six provinces and cities in China (Beijing City, Liaoning Province, Zhejiang Province, Henan Province, Shaanxi Province, Chongqing City) were selected by stratified cluster random sampling and probability smampling methods, and a questionnaire prepared by Beijing Center for Disease Control and Prevention was used to investigate their electronic screen use. According to Screening Criteria for Myopia in Children and Adolescents, 0.5% mass concentration of compound topicamide eye drops was used to paralyze the ciliary muscle and undergo slit lamp optometry. Chisquare test was used to compare the differences between groups, and binary Logistic regression was used to analyze the association between electronic screen use and myopia. Results: About 58.3% of primary and secondary school students used electronic screens for more than two hours a day on average, and 63.4% of primary and secondary school students used continuously electronic products for more than 15 minutes at a time for nonstudy purposes. After adjusting for confounding factors, parents unrestricted use of electronic screen time and electronic screen time ≥2 h/d were positively correlated with myopia (OR=1.27, 1.13, P<0.05). Gender stratified analysis showed that boys who used electronic screen time ≥2 h/d had a higher risk of myopia (OR=1.15, P<0.05). The results of grade stratification analysis showed that parents unrestricted electronic screen use time and electronic screen time ≥2 h/d were positively correlated with myopia in the lower grade of primary school students (OR=1.34, 1.18, P<0.05). Among the higher grade of primary school students, continuous use of electronic screens for nonstudy purposes for more than 15 minutes at one time was positively correlated with myopia (OR=1.18, P<0.05). There was a multiplicative interaction between total screen time and one continuous screen time (OR=1.04, P<0.05). Conclusions Primary and secondary students in six provinces and cities in China reports excessive electronic screen usage which is associated with myopia. Schools and parents should jointly limit the use of electronic screen among primary and secondary students to reduce the occurrence of myopia.

The design of research protocol and quality control are the key to ensure the quality of clinical trial. A randomized clinical trial regarding the effects of medication combined with acupuncture on live birth rate in polycystic ovary syndrome (PCOS), which was initially designed as a comparative effectiveness research, then added with an acupuncture control group and finally became a factorial analysis, is taken as an example to explain the protocol design and optimization process, demonstrating the high level of methodology design and international recognization. By a series of measurements, such as unified purchase of acupuncture equipment, multiple trainings and assessments for acupuncturists' knowledge and operation standardization, in-site supervision of local center experts, the standard operation of acupuncture could be ensured and the credibility and scientificity of research results could be improved.

OBJECTIVE To explore the mechanism of modified Xianfang huoming decoction in the treatment of sepsis- induced liver injury from the perspective of gut microbiota and metabolites. METHODS Sixty SD rats were divided into blank group （normal saline）， model group （normal saline）， positive control drug group （Dexamethasone tablet， 5.0 mg/kg）， modified Xianfang huoming decoction high-dose， middle-dose and low-dose groups （6.0， 3.0， 1.5 g/kg， calculated by crude drug） according to equilibrium-partitioning approach of body mass， with 10 rats in each group. They were given relevant drug/normal saline 10 mL/ kg， once a day， for consecutive 14 days. After the last medication， except for blank group， other groups were given intraperitoneal injection of lipopolysaccharide 10 mg/kg to induce sepsis model. Twelve hours after modeling， serum levels of inflammatory indexes in rats [interleukin-1β （IL-1β）， IL-6， tumor necrosis factor-α （TNF-α）] and liver function indicators [total cholesterol （TC）， triglyceride （TG）， aspartate transaminase （AST）， alanine transaminase （ALT）] were detected. The changes of gut microbiota and liver metabolites in rats were analyzed by 16S rRNA technology and liver metabolomics. RESULTS Modified Xianfang huoming decoction could significantly improve the indexes of serum inflammatory indexes and liver function in rats with sepsis-induced liver injury （P＜0.05 or P＜0.01）； there was a significant callback effect on the relative abundance of 11 genera of bacteria （such as Akkermansia， Lactobacillus and Bilophila） among the 5 dominant phyla（P＜0.05 or P＜0.01）. Twelve metabolites related to liver injury caused by sepsis were identified， such as glycine cholic acid， phosphatidylcholine， taurine （P＜0.05 or P＜0.01）， mainly involving glycerol phospholipid metabolism， purine metabolism and primary bile acid metabolism. CONC LUSIONS Modified Xianfang huoming decoction can improve liver injury induced by sepsis by regulating gut microbiota and liver metabolites.

OBJECTIVEThis article aims to introduce the benefits of qualitative research and to discuss how such research can be applied to the study of polycystic ovary syndrome (PCOS).

DATA SOURCESRelevant articles were published in English as of May 2013 from Pubmed. Terms "polycystic ovary syndrome/PCOS, qualitative research and methodology" were used for searching.

STUDY SELECTIONArticles studying PCOS with qualitative methods were reviewed. Articles associated with the use of qualitative research in clinical research were cited.

RESULTSSix qualitative studies related to PCOS were found in the literature search. These studies addressed different aspects in PCOS women including their womanhood, lived experience, information need, and experience of treatment with acupuncture. Five of these six studies used phenomenology as guiding theory.

CONCLUSIONQuantitative research has been the dominant approach in the field so far, qualitative research is relevant to the advancement of PCOS.

Acupuncture Therapy ; methods ; Female ; Humans ; Polycystic Ovary Syndrome ; therapy