Repairing effect of sulodexide on diabetic retinopathy and the regulation of MAPK pathway in rats / 解剖学报

[ Abstract] Objective To study the effect of sulodexide on the repair of diabetic retinopathy and the regulation of MAPK pathway in rats. Methods Totally 72 rats were randomly divided into normal control group, diabetic retinopathy group, low, middle and high dose of sulodexide group and metformin hydrochloride group. Except normal control group, other rats were intraperitoneally injected with streptozotocin to establish the rat model of diabetic retinopathy. Rats in the low, middle and high dose sulodexide groups were given sulodexide by intragastric administration of 10 mg / kg,20 mg / kg and 40 mg / kg, respectively. Metformin hydrochloride group was given metformin hydrochloride of 200 mg / kg, once a day for 12 weeks. The levels of fasting blood glucose (FBG), glycosylated hemoglobin (HbA1c) and serum levels of advanced glycation end products (AGEs), interleukin-6 (IL-6), IL-1β, and levels of glucose transporter 1 (GLUT-1), glucose transporter 3(GLUT-3), superoxide dismutase (SOD) and malondialdehyde (MDA) in retina were detected. The levels of p38 MAPK and phosphorylated p38 MAPK (p-p38 MAPK) in retina were detected by immunohistochemistry and Western blotting. Retinal pathological changes and ganglion cell count were examined by HE staining. Results The levels of FBG and HbA1c, serum AGEs, IL-6, IL-1 β, GLUT-1, GLUT-3, MDA and p38 MAPK mRNA, p38 MAPK, p-p38 MAPK / p38 MAPK and immunohistochemical integral optical density of retina in sulodexide group were significantly lower than those in diabetic retinopathy group (P < 0. 05), while the SOD level and ganglion cell number in retinal tissue were significantly higher than those in diabetic retinopathy group (P < 0. 05) . Conclusion Sulodexide can regulate blood glucose level and retinal glucose metabolism in diabetic retinopathy rats, and repair retinal pathological damage, and its mechanism may be related to the regulation of MAPK pathway.

Bendamustine combined with pomalidomide and dexamethasone in relapsed multiple myeloma with extramedullary disease: a multicenter study / 中华血液学杂志

Objective: To evaluate the efficacy and safety of bendamustine combined with pomalidomide and dexamethasone (BPD regimen) in the treatment of relapsed multiple myeloma (MM) with extramedullary disease. Methods: This open, single-arm, multicenter prospective cohort study included 30 relapsed MM patients with extramedullary disease diagnosed in seven hospitals including Qingdao Municipal Hospital. The patients were treated with BPD regimen from February 2021 to November 2022. This study analyzed the efficacy and adverse reactions of the BPD regimen. Results: The median age of the 30 patients was 62 (47-72) years, of which 18 (60% ) had first-time recurrence. The overall response rate (ORR) of the 18 patients with first-time recurrence was 100%, of which three (16.7% ) achieved complete remission, 10 (55.5% ) achieved very good partial remission (VGPR), and five (27.8% ) achieved partial remission (PR). The ORR of 12 patients with recurrence after second-line or above treatment was 50%, including zero patients with ≥VGPR and six patients (50% ) with PR. Three cases (25% ) had stable disease, and three cases (25% ) had disease progression. The one-year progression free survival rate of all patients was 65.2% (95% CI 37.2% -83.1% ), and the 1-year overall survival rate was 90.0% (95% CI 76.2% -95.4% ). The common grade 3-4 hematology adverse reactions included two cases (6.7% ) of neutropenia and one case (3.3% ) of thrombocytopenia. The overall adverse reactions are controllable. Conclusions: The BPD regimen has good efficacy and tolerance in relapsed MM patients with extramedullary disease.

Expression of Cyclooxygenase-2 in Patients With Snow-White Sign of Advanced Colorectal Adenomas / 中国医学科学院学报

Objective To analyze the expression of cyclooxygenase-2 (COX-2) in the patients with snow-white sign of advanced colorectal adenoma (ACA) and explore its clinical significance.Method Western blotting was employed to determine the expression of COX-2 in the adenoma tissue and the normal tissue adjacent to the adenoma tissue (>5 cm away from the distal end of the adenoma tissue) of 40 ACA patients with snow-white sign and 40 ACA patients without snow-white sign.Results The appearance of snow-white sign in ACA patients was associated with patient age (P=0.001) and not associated with sex,smoking history,drinking history,ethnic groups,family history of colorectal cancer,abdominal pain,diarrhea,constipation,fecal occult blood,or tumor markers (all P>0.05).Snow-white sign mainly appeared in the ACA patients with multiple adenomas (P=0.004),large adenomas (P=0.006),adenomas in distal colon (P=0.015),protruding polyps (P=0.044),and late-stage pathology (P=0.010).The occurrence of snow-white sign showed no difference in the ACA patients with different results of Japan NBI Expert Team classification (P=0.502).The expression of COX-2 in the adenoma tissue was higher than that in the adjacent normal tissue in the patients with and without snow-white sign (P<0.001,P=0.004).The patients with snow-white sign had higher expression of COX-2 protein in the adenoma tissue than the patients without snow-white sign (P=0.001).The expression of COX-2 protein in the adjacent healthy tissue had no significant difference between the patients with and without snow-white sign (P=0.603).Conclusions Snow-white sign is more like to appear in the ACA patients with young age,multiple and large adenomas,adenomas in distal colon,protruding polyps,and late-stage pathology.Moreover,the expression of COX-2 in the ACA patients with snow-white sign is significantly higher than that in the ACA patients without snow-white sign.The adults with snow-white sign are prone to cancerization than those without snow-white sign.

Analysis on the Current Situation of Third-party Recruitment Companies in Clinical Trials and Research on Ethical Management Countermeasures / 中国医学伦理学

【Objective:】 Third-party research participants recruitment companies and their recruitment businesses are in the ascendant. To analyze the current situation of company construction, clinical trial application, and ethical review, and discuss and propose ethical management suggestions based on work experience. 【Methods:】 The recruitment of research participants related to the projects approved by the ethics committee in our hospital in the past two years was investigated by questionnaire to comprehend and analyze the data of the third-party recruitment company in construction, application, and ethical review. 【Results:】 This paper found the problems of the third-party recruitment company in the application of clinical trials, the company’s own construction, and the standardization of ethical review, and analyzed the phenomenon and causes of the problems based on work experience. 【Conclusion:】 Although the application of third-party recruitment companies is becoming more and more extensive, it is still in a mixed state of pros and cons. It is necessary for all parties to work together to further standardize and constrain them, so as to protect the rights and interests of research participants and effectively support clinical trial research.

Multicenter Prospective Study of Different Induction Regimens of Azacytidine in Treatment of Elderly Patients with Acute Myeloid Leukemia / 中国实验血液学杂志

OBJECTIVE@#To observe the efficacy and safety of different induction regimens of same total dosage of azacitidine (Aza), including standard dose (standard dose group) and low-dose long-term (adjusted dose group), in the treatment of elderly acute myeloid leukemia (AML).@*METHODS@#A total of 103 elderly patients with AML (non-acute promyelocytic leukemia) from January 2020 to June 2021 were enrolled. Aza was administered at the standard dose of 75 mg/(m2·d) for 7 days in the standard dose group (50 cases), while at 100 mg/d for 7-12 days in the adjusted dose group (53 cases). The administration days in adjusted dose group was calculated based on the total standard dose of the patient's single course of treatment. The efficacy and safety between standard dose group and adjusted dose group were compared. Subgroup analysis were performed in the two groups for Aza alone, Aza combined with BCL-2 inhibitor, and Aza combined with low-dose chemotherapy for efficacy and safety.@*RESULTS@#There were no significant differences in overall response rate (ORR), incidence of adverse reaction, and 1-year overall survival (OS) rate between standard dose group and adjusted dose group (P >0.05). The ORR of combination was higher than that of Aza alone (P < 0.05), while there was no significant difference in ORR between Aza combined with BCL-2 inhibitor and Aza combined with low-dose chemotherapy (P >0.05). The combination of BCL-2 inhibitor did not increase the incidence of adverse reactions compared wtih Aza alone. There was a higher risk of myelosuppression and pulmonary infection with a combination of low-dose chemotherapy than with a combination of BCL-2 inhibitor and Aza alone (P <0.05). No significant difference was observed in 1-year OS between Aza alone, Aza combined with BCL-2 inhibitor, and Aza combined with low-dose chemotherapy (P >0.05).@*CONCLUSIONS@#Both two induction regimens can be used in elderly AML patients who cannot tolerate intensive chemotherapy with similar overall effectiveness and safety. Aza combined with low-dose chemotherapy may result in increased ORR and an increased incidence of serious adverse reactions, and may not result in longer survival compared with Aza alone. Aza combined with BCL-2 inhibitor not only has similar effect in complete remission, objective response rate, and OS compared with Aza combined with low-dose chemotherapy, but also has higher safety.

Evaluation and impact analysis of ChatGPT′s competence in ethical review management / 中华医学科研管理杂志

Objective:This paper tried to have a dialogue with ChatGPT about ethics review, to understand the degree of intelligence of this application in the field of ethical management, and to analyze its possible impact on the future ethics review work.Methods:The research team sorted out 43 questions, then the research team member at abroad accomplish the dialogue with ChatGPT in both Chinese and English. Feedback answers were summarized and analyzed to explore their advantages and problems.Results:Most of the ChatGPT′s answers of this test were reasonable, with obvious advantages in response speed, and the rigor and friendliness were relatively good. However, there were also problems in consistency, comprehensiveness and expertise, the accuracy and computing power also still have a lot of space for improvement.Conclusions:It is too early for AI to replace professionals, but we should fully develop and utilize the advantages of AI to help professionals get rid of inefficient labor and play a better role.

Association of Breastfeeding Duration with Body Composition in Children Aged 3-5 Years / 生物医学与环境科学（英文）

OBJECTIVE@#This study aimed to assess the relationship between the body composition of children aged 3-5 years and breastfeeding status and duration.@*METHODS@#The study was conducted using data from the National Nutrition and Health Systematic Survey for children 0-17 years of age in China (CNHSC), a nationwide cross-sectional study. Breastfeeding information and potential confounders were collected using standardized questionnaires administered through face-to-face interviews. The body composition of preschool children was measured using bioelectrical impedance analysis. A multivariate linear regression model was used to assess the relationship between breastfeeding duration and body composition after adjusting for potential confounders.@*RESULTS@#In total, 2,008 participants were included in the study. Of these, 89.2% were ever breastfed and the median duration of breastfeeding was 12 months (IQR 7-15 months). Among children aged 3 years, the height-for-age Z-score (HAZ) for the ever breastfed group was lower than that for never breastfed group (0.12 vs. 0.42, P = 0.043). In addition, the weight-for-age Z-score (WAZ) of the ever breastfed group was lower than that of the never breastfed group (0.31 vs. 0.65, P = 0.026), and the WAZ was lower in children aged 4 years who breastfed between 12 and 23 months than in those who never breastfed. Compared to the formula-fed children, the fat-free mass of breastfed infants was higher for children aged 3 years (12.84 kg vs. 12.52 kg, P = 0.015) and lower for those aged 4 years (14.31 kg vs. 14.64 kg, P = 0.048), but no difference was detected for children aged 5 years (16.40 kg vs. 16.42 kg, P = 0.910) after adjusting for potential confounders. No significant difference was detected in the weight-for-height Z-score (WHZ), body mass index (BMI)-for-age Z-score (BAZ), fat-free mass index, and body fat indicators in the ever breastfed and never breastfed groups and among various breastfeeding duration groups for children aged 3-5 years.@*CONCLUSION@#No obvious associations were detected between breastfeeding duration, BMI, and fat mass indicators. Future prospective studies should explore the relationship between breastfeeding status and fat-free mass.

Distribution of gene mutation sites affecting artemisinin metabolism in the Kazak population in Xinjiang / 中国热带医学

@#Abstract: Objective　To detect the distribution of CYP2A6∗2, CYP2A6∗10, CYP2A6∗17, CYP2B6∗4, CYP2B6∗6, and CYP2B6∗18 loci affecting the metabolism of artemisinins in Kazak population in Xinjiang. To explore the pharmacogenetic background of the Kazak population in Xinjiang for artemisinin drugs and provide clinical decision support for the treatment and prevention of malaria based on artemisinin drugs. Methods　Six SNPs including CYP2A6∗2, CYP2A6∗10, CYP2A6∗17, CYP2B6∗4, CYP2B6∗6, and CYP2B6∗18 were selected for the sequencing experiment. 330 whole blood samples were collected from the Kazak population in Xinjiang. After extracting the whole blood DNA genome, multiplex PCR and high-throughput sequencing were used for genotyping. The allele frequencies were analyzed using the Hardy-Weinberg equilibrium. Results　In this study all SNPs follow the Hardy-Weinberg equilibrium (P>0.05), there was no significant difference in the distribution of SNPs between different genders (P>0.05). The number of successfully sequenced samples of CYP2A6∗2, CYP2A6∗10, CYP2A6∗17, CYP2B6∗4, CYP2B6∗6, and CYP2B6∗18 were 326, 319, 328, 318, 322 and 328 respectively. The frequencies of variant alleles of CYP2A6∗2, CYP2A6∗10, CYP2A6∗17, CYP2B6∗4, CYP2B6∗6, and CYP2B6∗18 in Kazak population are: 0.61%, 0%, 0%, 30.97%, 22.98%, 0%. Conclusions　Mutation alleles affecting the metabolism of artemisinins exist in the Kazak population in Xinjiang. When using artemisinins, the relationship between the drug effect and individual pharmacogenetic background should be further explored.

Protective Effects of Raspberry Crude Polysaccharides on UVB-Induced Photodamage in HaCaT Cells / 中国生物化学与分子生物学报

Polysaccharide is one of the functional components of the raspberry, which has various pharmacological effects such as anti-inflammatory, antioxidant, anti-fatigue, hypoglycemic and immunomodulatory. However, whether raspberry polysaccharides have protective effects on UV-induced photodamage to skin cells has not been reported. This study aims to investigate the protective effect of Raspberry Crude Polysaccharide on Ultraviolet B (UVB) -induced photodamage of human immortalized keratinocytes (H a C a T). The photodamage model of HaCaT cells was established by UVB irradiation. To evaluate the anti-UVB activity of R C P, the cell viability was determined by the CCK-8 method, and the Enzyme-linked immunosorbent assays (ELISA) and microplate method were used to measure the contents of matrix metalloproteinase, inflammatory and antioxidant factors in the photodamaged HaCaT cells. The antioxidant activity of RCP was detected by radical scavenging assays against D P P H radical (D P P H •) and ABTS radical (ABTS •

Practical exploration and research on improving the efficiency of ethical review / 中华医学科研管理杂志

Objective:To solve the dilemma between the traditional ethics review management model and the fast development of biomedical research involving human subject, and to effectively summarize the practical experience to improve the efficiency of ethics review.Methods:A series of measures, such as reorganizing the ethics committee, adjusting the operating procedures of the office and optimizing the process of joint review were reviewed and summarized. The successful experience of relevant measures is systematically shared in practice.Results:The practice proved that these measures effectively guaranteed the fast development of clinical trials and research in our hospital during the past two years.Conclusions:The author hopes to strengthen the discussion and exchange with professionals in the industry through the successful practical experience of our hospital, and contribute to the improvement of the level of ethical management in China.

CERKL attenuates blue light-induced oxidative stress in human retinal pigment epithelial cells by activating the SIRT1/E2F1 axis / 国际眼科杂志(Guoji Yanke Zazhi)

AIM:To investigate whether ceramide kinase-like protein(CERKL)alleviates oxidative stress injury of retinal pigment epithelial(RPE)cells induced by blue light via activating the silent information regulator 1(SIRT1)/E2F transcription factor 1(E2F1)axis. METHODS:Cultured human retinal pigment epithelial-19(ARPE-19)cells were irradiated with blue light to observe the morphological changes, and the expression of CERKL was detected by PCR and Western blot. ARPE-19 cells were transfected with siRNA-CERKL and pcDNA3.1-CERKL respectively. After exposure to blue light, cell viability was determined by MTT assay, apoptosis was detected by TUNEL assay, content of oxidative stress markers and the expression of SIRT1/E2F1 axis was analyzed. Then siRNA-SIRT1 was transfected into ARPE-19 cells, and the oxidative stress damage of ARPE-19 cells under blue light irradiation was detected again.RESULTS:ARPE-19 cells gradually contracted into spheres and appeared vacuoles after exposure to blue light. Blue light irradiation led to the increase of CERKL expression level(P<0.05), meanwhile, the rate of cell viability was decreased(P<0.05), the rate of the apoptosis was increased(P<0.05), contents of reactive oxygen species, malondialdehyde and 8-hydroxydeoxyguanosine were increased(P<0.05). Silence of CERKL aggravated this phenomenon, while up-regulation of CERKL could alleviate this change(P<0.05). Up-regulation of CERKL also activated the expression of SIRT1 and promoted the deacetylation of E2F1(P<0.05). Silencing SIRT1 could reverse the alleviating effect of up-regulating CERKL on oxidative stress injury of ARPE-19 cells induced by blue light(P<0.05). CONCLUSION: CERKL can reduce oxidative stress damage of ARPE-19 cells induced by blue light via activating SIRT1 expression and promoting the deacetylation of E2F1.

Transformation Models for Characterization of Cancer Driver Genes / 中国生物化学与分子生物学报

The development of cancer is a complex process. Although many genetic and epigenetic alterations are detected in cancer cells, only small proportion of these alterations may function as cancer drivers. Because it is difficult to directly characterize driver factors in human body, alternative research models have continuously been developed. In the early stage from 1915 to 1980s, genetic activation of proto-oncogenes and inactivation of tumor suppressor genes were often characterized using various carcinogenicity tests, including animal tumor induction models, malignant transformation of normal human cells/tissues/organs cultured in vitro or transplanted into immuno-defected mice. Since 1990 to now, gene transfection and knockout technologies were frequently used to characterize cancer driver genes. Currently, 2-dimensional (2D) or 3-dimensional (3D) cell culture and organoid are also employed to test carcinogenicity of environmental factors and driver genes. In this review, we summarized the main models of malignant transformation and their advantages and disadvantages.

Research progress on preclinical efficacy evaluation of COVID-19 complicated with cytokine storm / 中国药理学通报

Studies have shown that COVID-19 patients infected with SARS-CoV-2 have severe pulmonary inflammation and cytokine storm, so the treatment of cytokine storm is an important part of rescuing critically ill patients with COVID-19. As an important cause of death, the preclinical study of cytokine storm is essential, and related experiments in vivo and in vitro are also the only way to develop new drugs for COVID-19 in the future. This paper reviews the in vitro and in vivo experimental methods of cytokine storm research articles at home and abroad in recent years, including the establishment of animal models, cell evaluation methods, pharmacodynamic evaluation indicators, etc., in order to provide reference and guidance for the experimental design methods of cytokine storm.

Diagnosis value of MRI in acute rotator interval injury / 中国骨伤

OBJECTIVE@#To compare clinical application of 1.5 T MRI in acute rotator interval injury.@*METHODS@#Totally 160 patients with acute rotator cuff tear by clinical diagnosis were retrospectively analyzed by MRI examination and arthroscopy from March 2016 to February 2019, including 122 males and 38 females, aged from 22 to 71 years old with an average of (42.35±3.48) years old. Based on the results of arthroscopy as the gold standard, the shape and signal changes of rotator cuff, rotator interval, peripheral bursa, bone and soft tissue were observed by MRI on axial, oblique coronal and oblique sagittal imagese.@*RESULTS@#The direct MRI signs of acute rotator interval injury displayed thickening, diminution, distortion, interruption of the coracohumeral ligament and superior glenohumeral ligament complex with highsignal intensity on fat-suppression by proton weighted sequence. The indirect MRI signs displayed rotator cuff, peripheral bone and soft tissue injury. The consistency of the results between the two methods was quite satisfactory (Kappa=0.85), and the concordance rate of the two methods has statistically significant (@*CONCLUSION@#MRI could clearly display acute rotator interval, and could accurately diagnose acute rotator interval injury, which provide more accurate imaging basis for clinical diagnosis and treatment.

National Nutrition and Health Systematic Survey for Children 0-17 Years of Age in China / 生物医学与环境科学（英文）

The main purpose of the National Nutrition and Health Systematic Survey for children 0-17 years of age in China (CNHSC) was to collect basic data on the nutrition, development, and health status for children in different regions across China using evidence-based, reliable, and cost-effective approaches. Children and their parents or guardians from seven regions (south, southwest, north, northwest, eastern, central, and northeast China) in China were recruited. A multi-stage stratified randomized sampling method was used. Two provinces were randomly sampled from each of the seven regions, from which one urban district and one rural country were also randomly sampled, resulting in a total of 28 survey counties/districts. Dietary surveys, health examinations, laboratory testing, and questionnaires were used to collect dietary intake, nutritional status, child development, and health status information. Nutrition, health, and lifestyle assessment of children and their parents was determined using the Knowledge Attitude Practice (KAP) survey. Greater than 100,000 children (38,000 children < 6 years of age and 66,000 children 6-17 years of age) completed the survey. The survey provided comprehensive data on child nutrition and health status for future studies and will serve as the basis for an integrated nutrition and health improvement strategies proposal for children in China.

The Patterns of Complementary Feeding and Growth among 12 to 23 Month-Old Children in China / 生物医学与环境科学（英文）

Objective@#This study aimed to understand the characteristics of dietary patterns among children aged 12 to 23 months and discusses the relationship between dietary patterns and the growth of children.@*Method@#Cross-sectional data were selected from the National Nutrition and Health Systematic Survey for 0 to 18 year-old children in China ( @*Results@#Four dietary patterns were identified among the children @*Conclusion@#Although China is undergoing rapid urbanization and economic development, there is still a phenomenon of insufficient intake of protein-rich foods and dairy-based dietary patterns at the stage of complementary food introduced among children aged 12 to 23 months.

Regulatory Effect of Modified Banxia Xiexintang on Insulin Resistance of Patients with Nonalcoholic Fatty Liver / 中国实验方剂学杂志

Objective:To observe the clinical efficacy of modified Banxia Xiexintang on nonalcoholic fatty liver （NAFLD） and the regulatory effect on insulin resistance （IR）. Method:One hundred and forty patients were randomly divided into control group and observation group. A total of 63 patients in control group completed the therapy （4 patients fell off or were lost to follow-up， 3 were eliminated）， while 65 patients in observation group completed the therapy （5 patients fell off or were lost to follow-up， none was eliminated）. Both groups' patients got lifestyle intervention， liver protection and lipid regulation. Patients in control group got Huazhi Rougan granule， 1 pack/time， 3 times/day. Patients in observation group got modified Banxia Xiexintang， 1 dose/day. And the course of treatment for the two groups was 12 weeks， and a 12 week follow-up was recorded. Before and after treatment and during the follow-up， fat content of liver was recorded by instantaneous elastic recorder， fasting blood glucose （FBG） and fasting insulin （FINS） were detected， and insulin sensitivity index （ISI）， insulin resistance index （HOMA-IR） and islet <italic>β</italic> cell function index （HOMA-<italic>β</italic>） were detected. After treatment， B-mode ultrasonography and ratio of liver/spleen CT were detected. And levels of alanine transaminase （ALT）， aspartate transaminase （AST）， total cholesterol （TC）， triglyceride （TG）， high-density lipoprotein cholesterol （HDL-C）， low-density lipoprotein cholesterol （LDL-C）， adiponectin， leptin， serine protease inhibitor （Vaspin）， tumor necrosis factor （TNF）-<italic>α</italic> and interleukin-6 （IL-6） were detected. And the safety was evaluated. Result:CAP and HOMA-IR in observation group were lower than those in control group after treatment and during the follow-up （<italic>P</italic><0.01）， and ISI and HOMA-<italic>β</italic> were higher than those in control group （<italic>P</italic><0.01）. Amelioration of indexes of blood lipid was better than those in control group （<italic>P</italic><0.01）. Levels of ALT， AST， FBG and FINS were lower than those in control group （<italic>P</italic><0.01）. Scores of traditional Chinese medicine （TCM） syndromes were lower than those in control group （<italic>P</italic><0.01）， ratio of liver/spleen CT and adiponectin was higher than that in control group （<italic>P</italic><0.01）. Levels of TNF-<italic>α</italic>， IL-6， vaspin and leptin were lower than those in control group （<italic>P</italic><0.01）. B-ultrasound efficacy and fat content of liver were superior to those of control group （<italic>P</italic><0.05）. There were no serious adverse events and drug-related adverse reactions. Conclusion:Modified Banxia Xiexintang can regulate glucose and lipid metabolism， improve insulin sensitivity and HOMA-<italic>β</italic> cell function， improve IR， regulate adipocytokines and inflammatory factors， relieve clinical symptoms and liver fat content， and improve CT ratio of liver/spleen， with a better clinical efficacy and safety.

Clinical Comparation of Two Kinds of Chemotherapy Regimens in the Treatment of Patients with MDS-RAEB/AML-MRC / 中国实验血液学杂志

OBJECTIVE@#To investigate the influence of conventional CAG regimen and decitabine + decreased dose CAG (D+dCAG) regimen on the clinical efficacy and safety of patients with MDS-RAEB/AML-MRC.@*METHODS@#The clinical data of 67 patients with MDS-RAEB/AML-MRC hospitalized in our hospital from March 2012 to July 2017 were analyzed retrospectively. According to chemotherapecctic regimens, 76 patients were divided into 2 groups: 37 patients treated with conventional CAG regimen were enrolled in control group, 30 patients treated with decitabine + decreased dose CAG regimen were enrolled in D+dCAG group. The complete remission (CR) rate, overall remission rate (ORR), OS and PFS time and incidence of adverse reactions in 2 groups were compared.@*RESULTS@#The CR in D+dCAG group was significantly higher than that in control group (P＜0.05). ORR was not significanly different between 2 groups (P＞0.05). There was no significant difference in the cumulative OS rate between 2 groups (P＞0.05). There was no significant difference in the cumulative OS rate and PFS rate in nonimplantation between 2 groups (P＞0.05). The incidence of adverse reactions of hematological system, pulmonary infection, skin and soft tissue infection, agranulocytosic fever and mycotic infection was not significanly different between 2 groups (P＞0.05). The duration of granulocyte deficiency and platelet count less than 20×10/L were not significanly different between 2 groups (P＞0.05).@*CONCLUSION@#Compared with conventional CAG regimen, decitabine + decreased dose CAG regimen in the treatment of patients with MDS-RAEB/AML-MRC can efficiently improve the remission effects and showed the well overall safety, but can not increase the survival rate.

Analysis and management of non-compliance/protocol violation or deviation during clinical trials / 中华医学科研管理杂志

Objective:To collect and analyze the non-compliance/protocol violation or deviation reported to the hospital Ethics Committee from 2017 to 2019, to explore the pattern of such events, as well as the causes and related logic. Empirical data evidence, lessons learned and preliminary advice were proposed to improve the understandings, management and implementation of clinical trials regarding to the non-compliance/protocol violation or deviations.Methods:The chi-square test and non-parameter test were conducted using SPSS 22.0.A total number of 754 reports received were analyzed, compared and summarized to provide the preliminary advice.Results:From 2017 to 2019, 754 reports on non-compliance/protocol violation or deviation, which covered 219 projects from 29 clinical departments, were received. 88% of these projects were drug/medical device clinical trials, while other 12% were investigator initiated trials. The reportrd events could be divided into 7 categories. The distribution of project resources, trial types and clinical specialties are significantly different. Meanwhile, the reports submitted by investigators have a lot of space for improvement.Conclusions:There were significant differences in the type and number of reported events on non-compliance/protocol violation or deviation between different trial types, as well as clinical trial specialties. The application report of protocol violation is generally poor. Combined with the working practice, the common reasons for the protocol violation are " the low overall compliance of the subjects" and " the insufficient compliance of the researchers" . Preliminary suggestions for management reform, such as increasing the training for researchers, improving the reporting mode, and regularly issuing follow-up and review research reports are recommended.

Research Progress on the Relationship between Genetic Polymorphism and Violent Behavior of Patients with Schizophrenia / 法医学杂志

Schizophrenia is a common disease characterized by thinking obstructions and accompanied by cognitive, emotional and behavioral disorders. Under the control of psychiatric symptoms, patients with schizophrenia may self-injure or impulsively wound others, resulting in public risk and increase in the burden of family and society. In recent years, many studies have shown that the violent behavior of patients with schizophrenia is related to genetic factors. This article reviews the research progress on the relationship between genetic polymorphism and violent behavior of patients with schizophrenia, analyzes the possible mechanism of the correlation between the two, puts forward the limitations of current research and the directions of future research, and provides scientific basis for risk assessment and prevention of violent behavior of patients with schizophrenia.