Objective: To explore the dynamic changes of Distress Thermometer scores and the relationship between psychological distress and quality of life in Chinese early breast cancer patients during chemotherapy. Methods: This prospective study enrolled 110 Chinese postoperative early breast cancer patients between March 2019 and December 2019. The psychological distress and quality of life (QOL) of patients were assessed by using the psychological distress management screening tool and the patient quality of life scale. Logistic regression model was used to analyze the influencing factors of psychological distress degree. The correlation between distress thermometer (DT) score changes and quality of life was analyzed by Pearson correlation analysis. Results: In total, 96 valid cases were analyzed. Before chemotherapy, 47 cases (49.0%) had DT score ≥4 points. After 2 cycles of chemotherapy, 40 cases (41.7%) had DT score ≥4 points. Thirty-four patients (35.4%) had DT score ≥4 points after chemotherapy. The DT score after chemotherapy was lower than that before chemotherapy and after 2 cycles of chemotherapy. Univariate analysis showed that income level and pathological stage were still significant related to the detection of DT score ≥4 points after chemotherapy (P<0.05). The changes of DT scores before and after chemotherapy were negatively correlated with the changes of quality of life ( r=-0.298, P=0.003). Conclusions: The detection rate of psychological distress in patients with early breast cancer during chemotherapy showed a decreasing trend. Income level and tumor stage are significant factors affecting the psychological distress of patients. There is a significant correlation between the psychological distress and the quality of life during chemotherapy. We should pay attention to the evaluation and monitoring state of psychological distress of patients during chemotherapy.
Humans ; Female ; Quality of Life/psychology* ; Breast Neoplasms/psychology* ; Stress, Psychological/psychology* ; Prospective Studies ; Psychological Distress ; China ; Neoplasms ; Surveys and Questionnaires

Objective: To understand the current situation regarding pediatric off-label use of drugs recommendations in Chinese clinical practice guidelines and to make recommendations for standardized reporting format regarding off-label use of drugs for children. Methods: This cross-sectional study was carried out by systematically searching the databases for Chinese guideline consensus articles published in journals between 2018 and 2020 and extracting recommendations regarding off-label use of drugs from those articles. The essential characteristics of the included guidelines, the ranking of off-label drug types, the order of drug information, the type of off-label drug use, and the percentage of citation studies on which the recommendations were based were analyzed. Results: Among 108 studies that included Chinese off-label guidelines and consensus, 364 recommendations on pediatric off-label use of drugs were included. The Chinese Medical Association published the most, 48 out of the 108 studies (44.4%), and of those 14 studies (13.0%) were on infectious and parasitic diseases. Of the 364 recommendations on off-label use of drugs, the most commonly addressed drugs were 16 recommendations (4.4%) for cyclosporine A, 11 recommendations (3.0%) for methotrexate , and 11 recommendations (3.0%) for fentanyl. The most commonly addressed drug categories were as follows: 68 recommendations (18.6%) were immune system drugs, 66 recommendations (18.1%) were anti-infectives, and 56 recommendations (15.4%) were oncology drugs. The most commonly addressed drug information accounts were as follows: 364 recommendations (100.0%) were indications, 204 recommendations (56.0%) were dosages, and 198 recommendations (54.4%) were the route of administration. Based on the instructions approved by the Chinese Food and Drug Administration, the main forms of the off-label drug were as follows: 175 recommendations (48.1%) were unapproved indications, 127 recommendations (34.9%) were unapproved populations, and 72 recommendations (19.8%) were unapproved ages. Only 129 recommendations (35.4%) were cited, mainly including clinical guidelines (48 studies, 23.4%), reviews (22 studies, 10.7%), and pediatric randomized controlled trials (22 studies, 10.7%). Conclusions: Off-label use of drugs is commonly recommended in pediatric guidelines and consensus documents written by Chinese authors. However, the reporting of the recommendations varies widely, and the quality of the supporting evidence is poor.
Child ; China ; Consensus ; Cross-Sectional Studies ; Humans ; Off-Label Use ; Pharmaceutical Preparations

Objective:To observe the effect of Jianpi Xiaoai prescription on the activation of normal human embryonic lung fibroblasts （HFL1） into tumor-associated fibroblasts （CAFs） induced by human colon cancer cells （HCT116） derived exosomes. Method:SD rats were gavaged with 13.1 g·kg^-1 of Jianpi Xiaoai prescription to prepare drug-containing serum， and HCT116 cell exosomes-containing 10% exosomes-free serum and 20% Jianpi Xiaoai prescription drug serum were isolated by ultra-high speed centrifugation. The particle size distribution of exosomes were detected by Nanoparticle tracking analyzer （Zetaview）， and the exosomes' marker proteins apoptotic transfer gene 2 interaction protein X （Alix）， heat shock protein 70 （HSP70）， and tumor-susceptibility gene 101 （TSG101） were identified by Western blot， and the uptake of exosomes labeled with cell membrane staining kit （PKH67） by HFL1 was observed by fluorescence microscope. HFL1 cells were divided into six groups： the blank group， the transforming growth factor-β₁ （TGF-β₁） group， the TGF-β₁ combined with HCT116 exosomes of 2 mg·L^-1 group， the TGF-β₁ combined with HCT116 exosomes of 4 mg·L^-1 group， the TGF-β₁ combined with Jianpi Xiaoai prescription exosomes of 2 mg·L^-1 group， and the TGF-β₁ combined with Jianpi Xiaoai prescription exosomes of 4 mg·L^-1 group， and all groups were cultivated for 48 h. Western blot and Real-time fluorescence quantitative polymerase chain reaction （Real-time PCR） were used to determine the protein and mRNA expressions of α-smooth muscle actin （α-SMA）. Result:The particle size distribution detected by Zetaview was mainly between 50-100 nm， and the exosomes were verified based on the expressions of marker proteins Alix， HSP70 and TSG101. After co-incubation of HFL1 cells with exosomes， a large number of exosomes were absorbed by HFL1 cells under fluorescence microscope. Compared with the blank control group， the protein and mRNA expressions of α-SMA in the TGF-β₁ group and TGF-β₁ combined with HCT116 exosome groups were increased （P<0.01）. Compared with the TGF-β₁ combined with HCT116 exosome groups， the protein and mRNA expressions of α-SMA were decreased in the TGF-β₁ combined with Jianpi Xiaoai prescription exosome groups （P<0.01）. Conclusion:Human colon cancer cell exosomes combined with TGF-β₁ can induce the activation of HFL1 into CAFs， and Jianpi Xiaoai prescription can reduce the activation of HFL1 by affecting the expressions of α-SMA， thus antagonizing the lung metastasis of colon cancer.