Based on the collation and analysis of 178 informed consent forms of clinical research projects related to human accepted by the ethical review committee of one hospital in 2007 and 2008,major problems were summarized as follows:the expression was difficult to be understood and was unsuitable for popular apprehension;lack of basic elements or insufficiently informed;inductive or advertising expressions existed,etc.Accordingly,the discussion was made for some recommendations of improvement.

Objective To explore the relationship between the levels of Cu, Fe, Mn, Zn in serum and Parkinson disease (PD). Methods A total of 40 patients with PD (PD group) and 40 control subjects (control group)were enrolled in this study. Serum levels of Mn were measured by graphite atomic absorption, and Cu ,Fe, Zn were measured by inductively coupled plasma(ICP)mass spectrometry. Resudts There were significantly increase in the levels of Mn and Fe in PD group than those in control group [(0.269±0.326) μ mol/L vs (0.125±0.054) μmol/L, P< 0.05, (1.512±0.949) μmol/L vs (0.676±0.111) μmol/L, P< 0.01)]. There were no significant difference in the levels of Cu and Zn between two groups (P> 0.05). Condusion Micreelements may play important roles in pathogenesis and development of PD, especially Fe and Mn.

Objective:To investigate the effect of continuous renal replacement therapy (CRRT) based on kidney disease improving global outcomes organization (KDIGO) staging on mononuclear cell microtubule-associated protein 1 light chain 3-Ⅱ (LC3-Ⅱ), autophagy related protein 5 (ATG5) and autophagy genes Beclin-1 in the treatment of patients with acute kidney injury (AKI) and its relationship with prognosis.Methods:Eighty patients who were diagnosed with AKI and treated with CRRT in Shaoxing Central Hospital from January 2019 to December 2020 were selected as the research object. According to the KDIGO-AKI standard, they were divided into stageⅠ(24 cases), stageⅡ(26 cases) and stage Ⅲ (30 cases). The prognosis, general data, autophagy related molecular mRNA levels were compared among the three groups and multivariate Logistic regression was used to analyze the risk factors of the prognosis of patients.Results:The age, CRRT treated time, ICU stay time, mean arterial pressure, blood lactic acid and 24 hlactate clearance rate in three groups had no significant differences ( P>0.05). The levels of LC3-Ⅱ in the three group were 1.13 ± 0.11, 1.47 ± 0.23, 1.66 ± 0.19, and the levels of ATG5 in the three group were 1.24 ± 0.26, 1.48 ± 0.17, 1.62 ± 0.16, the levels of Beclin-1 in three group were 1.23 ± 0.15, 1.51 ± 0.12, 1.71 ± 0.13, there were statistical differences ( P<0.05). The 28 d survival rate and the hospital mortality rate in the three group had significant differences ( P<0.05), the patients in the stage Ⅲ group had lowest 28 d survival rate and highest hospital mortality rate. Multivariate Logistic regression analysis results showed that LC3-Ⅱ, Beclin-1 levels and AKI grading were the risk factors affecting the 28 d survival rate and the hospital mortality rate. Conclusions:Starting CRRT based on KDIGO stage in the treatment of AKI can improve the prognosis of patients, and autophagy factor LC3-Ⅱ, Beclin-1 and AKI stage are risk factors affecting the prognosis of patients.

With the promulgation of a series of laws and regulations in our country, the requirement for stand-ardized management of clinical research process are gradually clear, and higher requirements on the following-up review management of ethics committee also are put forward. Through concluding and summarizing 128 noncompli-ance/violation or protocol deviation reports accepted by a hospital in recent two years, this paper analyzed four main problems including that the researchers at management level failed to report or report timely; the researchers reported in irregular filling;the same type of violation/deviation program happened repeatedly and the rectification to the review opinions of ethics committee was ineffective, and also put forward the corresponding suggestions, in order to strengthen and perfect the standard management of noncompliance/violation or protocol deviation report.

Objective:To investigate the curative effect of Haikunshenxi capsule combined with losartan potassium tablets on chronic kidney disease (CKD) and its effect on renal function and inflammatory factors.Methods:One hundred patients with chronic kidney disease in Shaoxing Central Hospital from January 2018 to December 2019 were selected and randomly divided into observation group (50 cases) and control group (50 cases). The control group was treated with losartan potassium tablets based on conventional therapy, and the observation group was treated with Haikunshenxi capsulebase on control group. The treatment course of the two groups was 12 weeks. The curative effect, renal function, inflammatory factors, 24h urinary protein (24 h Upro) and glomerular filtration rate (GFR) were compared between the two groups before and after treatment.Results:The total effective rate in the observation group was higher than that in the control group: 90.0%(45/50) vs. 72.0%(36/50), χ2 = 5.26, P<0.05. After treatment, the levels of serum creatinine (Scr) and blood urea nitrogen (BUN) in the two groups were decreased and the levels of Scr and BUN in the observation group were lower than those in the control group: (63.27 ± 2.89) μmol/L vs. (67.89 ± 2.35) μmol/L, (5.23 ± 0.19) mmol/L vs. (5.56 ± 0.16) mmol/L, the differences were statistically significant ( P<0.05). After treatment, the levels of serum C-reactive protein (CRP) , interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) in the two groups were decreased and the levels of CRP, IL-6 and TNF-α in the observation group were lower than those in the control group: (2.97 ± 0.34) mg/L vs. (3.58 ± 0.42) mg/L, (3.64 ± 0.68) ng/L vs. (4.97 ± 0.96) ng/L, (14.32 ± 2.17) ng/L vs. (17.86 ± 2.06) ng/L, the differences were statistically significant ( P<0.05). After treatment, the level of 24 h Upro in two groups was decreased, while the level of GFR was increased, and the level of 24 h Upro in the observation group was lower than that in the control group: (0.87 ± 0.09) g vs. (1.15 ± 0.13) g , but the level of GFR in the observation group was higher than that in the control group: (101.73 ± 3.12) ml/(min·m 2) vs. (96.75 ± 2.35) ml/(min·m 2), the differences were statistically significant ( P<0.05). Conclusions:Haikunshenxi capsule combined with losartan potassium tablets has obvious curative effect on patients with chronic kidney disease, and can improve renal function and micro inflammation.