[Application of objective performance criteria in post-marketing evaluation schemes of traditional Chinese medicine].

Traditional Chinese medicines(TCMs) have certain limitations in the clinical research design in their post-marketing evaluation, so that randomized controlled programs cannot be strictly implemented in some studies, while the objective performance criteria is a reasonable external controlled research method that has been gradually recognized at home and abroad in recent years in addition to randomized controlled trial(RCT) method. It is more mature in medical devices, surgery and other research fields, but there is no relevant report in the field of post-marketing evaluation of Chinese patent medicines. In this paper, the application prospect of the objective performance criteria and the problems were discussed in the field of post-marketing evaluation of TCM. The characteristics of as TCM are more consistent with the scope of the objective performance criteria, the application of the objective performance criteria in post-marketing evaluation of Chinese patent medicines, especially in single arm research, can break through the limitations of existing conventional clinical research methods, and improve the level of evidence, with good feasibility and advantages. However, in the application process, we should pay attention to the key issues such as the selection of index, research population, follow-up period and the reference selection, to ensure the quality of research. This research group has carried out some exploration and practice in the field of post-marketing evaluation of TCM injections by using single arm combined with the objective performance criteria, hoping to establish the key technology in this field, and provide certain research and design reference for the secondary development of Chinese patent medicines.

[Groundwater Chemical Characteristics and Analysis of Their Controlling Factors in an Alluvial Fan of Jianjiang River].

The Jianjiang alluvial fan is one of the frontal alluvial fan clusters in the Longmen Mountains of the Chengdu Plain. In order to study the groundwater chemical characteristics and controlling factors, we collected 30 groups of groundwater samples on site in May 2018. Descriptive statistical analysis, Piper diagrams, ArcGIS spatial analysis, ion-scale coefficients, and other methods were used to analyze the chemical types and ion spatial distribution characteristics. The main factors controlling the chemical evolution processes of the groundwater and the main sources of ions are discussed. The northeast area of the alluvial fan contains mostly weakly acidic waters, accounting for 13.33%, the rest being weakly alkaline. Groundwater chemical types included HCO3·SO4-Ca, HCO3-Ca, HCO3·SO4-Ca·Mg, and HCO3·SO4-Ca·Na, and all groundwater was freshwater. The main ion spatial variation coefficient were between 0.22 and 0.91, and the variability was moderate. The chemical evolution processes of groundwater was mainly controlled by leaching, and human activities have certain influence. The effect of evaporation and concentration, and atmospheric rainfall, and alternating cation adsorption were not obvious.

[Hydrochemical Characteristics of Karst Groundwater in the Mountains of Northern Bazhong City, China].

To study the hydrogeochemical characteristics and formation mechanism of groundwater in a karst development transition zone in southern and northern China, 25 groundwater samples were collected from the Shuangfengya area in the northern part of Bazhong City. Descriptive statistics, coefficients of variation, Schoeller diagrams, Sukalev classification, Piper diagrams, and Gibbs and ion scale coefficients were used to analyze the karst water chemistry and distribution characteristics. The main processes controlling the chemical evolution of the groundwater are also discussed. The research shows that the degree of groundwater mineralization in the study area is generally low, with mostly neutral water and alkaline water. There are some differences in groundwater between the northern and southern regions; the anions and cations in the groundwater in the northern area were mainly HCO3-, Ca2+, and Mg2+, with HCO3-Ca·Mg being the main water chemistry type; the anions and cations in the groundwater in the northern area were mainly HCO3-, and Ca2+, and HCO3-Ca was the main water chemistry type. The chemical character of groundwater was controlled by rock weathering and alternate cation adsorption, and evaporation crystallization in the southern region was more significant than in the northern region. Furthermore, rainfall in the northern region had a more significant effect on groundwater geochemistry than in the south. The differences in climate and lithology between the northern and southern region are the dominant factors influencing the differences in hydrochemistry.

Adverse reactions and their management in the treatment of malignant tumors using cytokine-induced killer cells.

OBJECTIVE: To identify the causes and the corresponding management of adverse reactions during the treatment of malignant tumors using cytokine-induced killer cells. METHODS: From January 2012 to December 2012, 441 patients received a total of 1,393 autologous cytokine-induced killer cell transfusion cycles in our department. The adverse reactions after the procedures were observed (assessed using the National Cancer Institute Common Toxicity version 2.0), and targeted care and health education were delivered by nurses. RESULTS: All treatment sessions were successfully completed, and the following adverse reactions were found: grade 1/3 fever in 1.36% (19/1,393) patients; grade 2/3 fever in 0.86% (12/1,393) patients; grade 2/3 chills in 0.65% (9/1,393) patients; and grade 1/3 dizziness in 0.29% (4/1,393) patients. CONCLUSIONS: After timely intervention of the adverse reactions, all patients were treated successfully. The best timing of the CIK cell therapy for cancer patients is when the tumor burden, or the number of tumor cells, reaches the minimal level after the end of surgery, chemotherapy and radiation therapy.

[A study of the effect of interstitial (125)I seed implantation on ward nurses' hemogram and relevant protection investigations].

OBJECTIVE: To analyze the blood picture changes of the ward nurses who nurse the patients received (125)I seeds implantation. METHODS: 32 ward nurses who nurse the patients for (125)I seeds implantation were involved in the experimental group, the control group included 32 ward nurses from the medical oncology never exposed to (125)I seeds. The WBC count, hemoglobin concentration and platelet counts from the two groups were analyzed statistically, respectively. 30 patients received (125)I seeds implantation were selected randomly and γ-ray dose from the unshielded group and lead rubber cloth covering group was detected at a distance of 0, 15, 30, 50, 100 cm from patient body surface and at different angles. RESULTS: No significant statistical difference was found between the two groups of WBC count, hemoglobin concentration and platelet count (7.1 ± 1.7 vs 6.8 ± 2.0, 132 ± 11 vs 136 ± 11, 236 ± 57 vs 242 ± 61) . The measured radiation dose was close to the natural background dose (10.2-10.8 µSv/h) at a distance of 50 cm from the body surface [ (12.7 ± 4.3) µSv/h] and the same as after 0.125 mm lead equivalent (Pb) rubber cloth shield protection[ (11.2 ± 3.1) µSv/h]. CONCLUSION: Interstitial (125)I seed implantation is safe on the blood picture of the ward nurses after taking appropriate protective measures.