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By analyzing the main problems existing in the current management of medical devices for clinical trials, this study proposes a feasible management model and specific requirements for acceptance, distribution, storage and recovery combining with the characteristics of medical consumable equipment and diagnostic reagent, which provides a favorable guarantee for the authenticity and reliability of clinical trials.
Subject(s)
Clinical Trials as Topic , Equipment and Supplies/standards , Indicators and Reagents/standards , Reproducibility of Results , Research Design/standardsABSTRACT
Objective To explore the insulin resistance(IR),serum cortisol.level and circadian secretion rhythm in the patients with pituitary adenoma(PA).Methods Sixty-seven patients with PA in this hospital from October 2016 to April 2017 were selected as the observation group,including 23 cases of pituitary Cushing syndrome,15 cases of growth hormone adenoma,16 cases of prolactinoma and 13 cases of non-functioning adenoma.Contemporaneous 49 individuals undergoing healthy physical examination were selected as the control group.The biochemical indexes of fasting plasma glucose(FPG),fasting insulin(FINS) and serum cortisol were measured and the homeostasis model assessment for insulin resistance(HOMA-IR) was determined.The correlation between insulin resistance and serum cortisol was analyzed.Results The incidence rate of cortisol circadian rhythm disorder in the observation group was 58.21％,the level of fasting serum cortisol in abnormal secretion rhythm of PA group was higher than that in normal secretion rhythm of PA group and control group(P＜0.05);the levels of FINS and HOMA-IR in the pituitary Cushing syndrome and growth hormone adenoma group were higher than those in the control group,the correlation analysis showed that HOMA-IR in PA patients was positively correlated with fasting serum cortisol level and FINS level(P＜0.05).Conclusion The IR occurrence exists in pituitary Cushing syndrome and growth hormone adenoma,which may be closely correlated with serum cortisol increase.
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Objective To study the expression of tumor necrosis factor -α (TNF-a) and correlation with TNF-a in breast cancer. Methods We used SABC method to detect the expression of TNF-a in 112 cases of primary breast cancer, and analysis the relationship between TNF-α with histologic grades and ER. Results The positive expression rate of TNF-α in breast cancer was higher than those of normal tissues and lobular hyperplasia of the breast (X2 =8.573, P =0.014). There was no significant correlation between histologic grades and TNF-α (X2 =1.304, P =0.521). TNF-a had a positive correlation with ER in breast cancer (X2=11.949, P =0.001). Conclusion The positive expression rate of TNF-α in breast cancer was higher than those of normal tissues and lobular hyperplasia of the breast.TNF-α had a positive correlation with ER in breast cancer, but the exact mechanism is unclear.
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Objective To determine the expression of Human Epidermal Growth Factor Receptor 2 (HER-2) in breast cancer and its correlation with Tumor Necrosis Factor-α (TNF-α). Methods We used SABC method to detect the expression of HER-2 and TNF-α in 112 cases of primary breast cancer, and analyzed the association of HER-2 expression with clinicopathological features and TNF-α expression. Results The positive expression rate of HER-2 in breast cancer was 35.71% (40/112), of which, the expression rate was 35.05% (34/97) in 97 invasive tubic breast cancer, and 33.33% (2/6) in invasive lobular breast cancer,25.00% (1/4) in mucinous carcinoma, and 50. 00% (2/4) in intraductal carcinoma. There was no significant correlation between HER-2 and any clinicopathological features of primary breast cancer ( P ＞ 0. 05 ). The expression of HER-2 in breast cancer had no signiciant association with TNM stage, age, age of menarche,menopause, gravidity, parity and family history of cancer ( Ps ＞ 0. 05 ), The positive rate of TNF-α was 23.61% (17/72) when HER-2 was negative, whereas the positive rate of TNF-α was 52. 50% (21/40) when HER-2 was positive. The expression of HER-2 was signiciantly positively correlated with the expression of TNF-α (r = 0. 881, P ＜ 0. 05 ). Conclusion HER-2 expression had a positive correlation with TNF-α in breast cancer,but the specific mechanism is still unclear.