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To derive the Chinese medicine (CM) syndrome classification and subgroup syndrome characteristics of ischemic stroke patients.By extracting the CM clinical electronic medical records (EMRs) of 7,170 hospitalized patients with ischemic stroke from 2016 to 2018 at Weifang Hospital of Traditional Chinese Medicine, Shandong Province, China, a patient similarity network (PSN) was constructed based on the symptomatic phenotype of the patients. Thereafter the efficient community detection method BGLL was used to identify subgroups of patients. Finally, subgroups with a large number of cases were selected to analyze the specific manifestations of clinical symptoms and CM syndromes in each subgroup.Seven main subgroups of patients with specific symptom characteristics were identified, including M3, M2, M1, M5, M0, M29 and M4. M3 and M0 subgroups had prominent posterior circulatory symptoms, while M3 was associated with autonomic disorders, and M4 manifested as anxiety; M2 and M4 had motor and motor coordination disorders; M1 had sensory disorders; M5 had more obvious lung infections; M29 had a disorder of consciousness. The specificity of CM syndromes of each subgroup was as follows. M3, M2, M1, M0, M29 and M4 all had the same syndrome as wind phlegm pattern; M3 and M0 both showed hyperactivity of Gan (Liver) yang pattern; M2 and M29 had similar syndromes, which corresponded to intertwined phlegm and blood stasis pattern and phlegm-stasis obstructing meridians pattern, respectively. The manifestations of CM syndromes often appeared in a combination of 2 or more syndrome elements. The most common combination of these 7 subgroups was wind-phlegm. The 7 subgroups of CM syndrome elements were specifically manifested as pathogenic wind, pathogenic phlegm, and deficiency pathogens.There were 7 main symptom similarity-based subgroups in ischemic stroke patients, and their specific characteristics were obvious. The main syndromes were wind phlegm pattern and hyperactivity of Gan yang pattern.

To explore the effect of Jianpi Tongluo Jiedu Recipe (JTJR) on protein expression levels of COX-2, NF-kappaBp65, Bcl-2, and Bax, mRNA expression levels of COX-2 and Bcl-2, and the apoptotic index (Al) in gastric mucosa of patients with precancerous lesions of gastric cancer (PL-GC).Totally 65 PLGC patients were recruited and treated by JTJR (modified by syndrome typing), one dose per day for six successive months. Protein expression levels of COX-2, NF-KBp65, Bcl-2, and Bax were detected in 65 patients using immunohistochemical (IHC) assay before and after treatment. mRNA expression levels of COX-2 and Bcl-2 were detected in 54 patients using reverse transcription-polymerase chain reaction (RT-PCR). Meanwhile, changes of Al was detected in 65 patients using TdT-mediated dUTP-biotin nick end labeling (TUNEL) fluorescence method.After treatment with JTJR, positive protein expression levels of COX-2, NF-KBp65, and Bcl-2 were obviously decreased in the gastric mucosa of PLGC patients (P0.01), but Bax positive protein expression was found to be higher (P0.05). At the same time mRNA expression levels of COX-2 and Bcl-2 were significantly lower after treatment than before treatment (P0.05, P0.01); Al also increased after treatment (P0.05).JTJR could promote apoptosis possibly via NF-kappaBp65/COX-2, COX-2/Bcl-2, and NF-kappaBp65/Bcl-2 signaling pathways, thereby affecting PLGC patients.

Data authenticity is the basic requirement of clinical studies. In actual clinical conditions how to establish formatted case report forms (CRF) in line with the requirement for data authenticity is the key to ensure clinical data quality. On the basis of the characteristics of clinical data in actual clinical conditions, we determined elements for establishing formatted case report forms by comparing differences in data characteristics of CRFs in traditional clinical studies and in actual clinical conditions, and then generated formatted case report forms in line with the requirement for data authenticity in actual clinical conditions. The data of formatted CRFs generated in this study could not only meet the requirement for data authenticity of clinical studies in actual clinical conditions, but also comply with data management practices for clinical studies, thus it is deemed as a progress in technical methods.

The paradigm of a real world study has become the frontiers of clinical researches, especially in the field of Chinese medicine, all over the world in recent years. In this paper, ethical issues which probably exist in real-world studies are raised and reviewed. Moreover, some preliminary solutions to these issues such as protecting subjects during the process of real-world studies and performing ethical review are raised based on recent years' practices to enhance the scientificity and ethical level of real-world studies.