Analysis of ethical review issues of informed consent form for clinical trials of registered anti-tumor drugs in our hospital / 中国药房

OBJECTIVE To promote the standardization and integrity of the informed consent form for clinical trials of registered anti-tumor drugs， and to protect the legitimate rights and interests of the subjects. METHODS The ethical review resolutions of clinical trial projects of registered anti-tumor drugs that were initially reviewed by the Ethics Committee of our hospital from July 1st， 2020 to July 1st， 2022 were summarized to statistically analyze the problematic items according to the “Quality Analysis Form of Informed Consent” prepared by our hospital. RESULTS Of the 316 clinical trials of registered anti- tumor drugs that were initially reviewed， 257 （81.3%） had problems with the contents of informed consent form， mainly domestic multi-center trials and phase Ⅲ trials. The main problems included the vague notification of the test fee bearer （68.5%）， the incomplete notification of the test content （59.1%）， the insufficient notification of rights and interests and risks （58.4%）， the insufficient notification of personal information protection （56.0%）， and the nonstandard expression of the informed consent form （52.5%）. CONCLUSIONS There is still a gap between the informed consent form of the clinical trials of registered anti-tumor drugs in our hospital and the requirements of the new version of Good Clinical Practice for Drugs （GCP）. The parties involved in the test can take a number of measures to improve the standardization and integrity of the informed consent form， and the research team should design the informed consent form in strict accordance with the requirements of the new GCP and pay attention to the comprehensive notification about the test. The Ethics Committee can provide the sponsor and researcher with the template of informed consent form and the key points of writing， continue to strengthen the examination ability， improve the examination quality， and effectively protect the safety and interests of the subjects.

Chlamydia trachomatis infection in the genital tract is associated with inflammation and hypospermia in the infertile male of China / 亚洲男科学杂志(英文版)

Chlamydia trachomatis (CT) infection is the most prevalent sexually transmitted bacterial disease worldwide. However, unlike that in female infertility, the role of CT infection in male infertility remains controversial. The objective of this retrospective study was to explore the impacts of CT infection in the genital tract on sperm quality, sperm acrosin activity, antisperm antibody levels, and inflammation in a large cohort of infertile males in China. A total of 7154 semen samples were collected from infertile male subjects, 416 of whom were CT positive (CT+ group) and 6738 of whom were CT negative (CT- group), in our hospital between January 2016 and December 2018. Routine semen parameters (semen volume, pH, sperm concentration, viability, motility, morphology, etc.), granulocyte elastase levels, antisperm antibody levels, and sperm acrosin activity were compared between the CT+ and CT- groups. Our results showed that CT infection was significantly correlated with an abnormally low semen volume, as well as an increased white blood cell count and granulocyte elastase level (all P < 0.05) in the semen of infertile males; other routine semen parameters were not negatively impacted. The antisperm antibody level and sperm acrosin activity were not affected by CT infection. These findings suggested that CT infection might contribute to inflammation and hypospermia but does not impair sperm viability, motility morphology, and acrosin activity or generate antisperm antibodies in the infertile males of China.

Thoughts on extracurricular research activities of clinical medicine undergraduates / 中华医学教育探索杂志

Carrying out extracurricular research activities for undergraduates in medical colleges and universities can stimulate the creativity of undergraduates. This article analyzes the significance, existing problems, and solutions of extracurricular research activities for clinical medical undergraduates. At the same time, corresponding countermeasures are proposed, including standardized training of research operations for students, time coordination of extracurricular research activities for undergraduates, and reasonable arrangement of teaching tasks for tutors. Medical students need to handle the relationship among study, community, part-time jobs, extracurricular activities, and extracurricular research, and make a rational time arrangement for participation. Young teachers in medical colleges and universities should arrange their time reasonably to undertake the corresponding tasks of research and teaching.

Application of nursing clinical ladder program based on Benner theory in nurses′ stratified training / 中国实用护理杂志

Objective To explore the effect of advanced hierarchical training based on Benner theory on nurses' core competence and post competency. Methods A total of 499 nurses were selected to participat in the training from January 2016 to December 2017. They were divided into before-training group and after- training group, the training method was based on the advanced hierarchical training model of energy level under the guidance of Benner′ s theory.The nurse′ s core competence, post competency, and nursing satisfaction were compared. Results The ratings of nurses′ critical thinking and research, clinical nursing, ethics and legal practice, professional development and education consultation (34.21±4.56), (30.12±5.25), (27.12±5.24), (25.46±4.52), (26.24±4.21), (20.21±3.56), (23.12± 5.24) points in after-training group were significantly higher than in before-training group (28.36±4.12), (26.45±4.52), (26.72±4.52), (25.12±4.12), (24.50±3.25), (18.65±3.12), (20.24±4.65) points (t=7.308-21.264, P<0.05 or 0.01). The scores of nurses' professional knowledge, professional skills, professional ability, and overall quality (72.32 ± 9.21),(93.24 ± 12.35), (43.34 ± 4.12), (54.20 ± 4.23) points were significantly higher than before training (68.25±8.32), (86.42±10.21), (41.05±5.24), (52.12±5.25) points (t=6.892-9.507, P<0.05 or 0.01), and patient satisfaction 92.67％(12164/13126) was significantly higher than before training 88.68％ (11106/12524) (χ2=121.409, P<0.01). Conclusion The advanced level-stratified training model based on Benner theory is helpful to promote the development of nurses′ core competence and post competency, and improve patient satisfaction.

Screening and identification of aptamers against the recombinant transpeptidase domain of PBP 2a / 重庆医学

Objective To screen and identify the aptamers of the recombinant transpeptidase domain of PBP2a(penicillin binding protein 2a ,PBP2a) .Methods By using the recombinant transpeptidase domain of PBP2a as the screening target ,oligonucle-otides which were capable of specifically binding to the protein were screened by a random oligonucleotide library through the stem -atic evolution of ligand by exponential enrichment (SELEX )technique .The ssDNA was cloned and sequenced ,and the secondary structure of aptamer clones was predicted with mfold program .Results After 11 cycles of the selection ,the aptamers which were capable of binding to PBP2a with high affinity have been selected .40 clones from the 8 and 10 cycles were selected randomly and se-quenced .The aptamers obtained had no obvious homology according to their sequences by the sequence alignments ,and the 40 aptamers were classified to three groups according to their secondary structures .The aptamer 13 was found to be specific for the target protein with the highest affinity .Conclusion Aptamers for the recombinant transpeptidase domain of PBP2a with high affili-ty and specificity were successfully screened by SELEX ,which lays a foundation for exploring new ways of diagnosis and treatment of MRSA infection .

Pathogen profile of bloodstream infections in low birth weight preterm infants:a report of 95 cases / 中国感染与化疗杂志

Objective To study the etiology and antibiotic resistance of bloodstream infections in low birth weight preterm infants .Methods A total of 95 cases of bloodstream infections in low birth weight preterm infants were treated in our hospital from January 2011 to April 2014 .The clinical data of these patients were analyzed retrospectively .Results A total of 96 pathogens were isolated ,including 57 strains of gram‐negative bacilli ,38 strains of gram‐positive cocci ,and 1 strains of Trichosporon asahii .The most frequently isolated pathogens were Klebsiella pneumoniae (40 strains)and coagulase‐negative Staphylococcus(31 strains).All gram‐negative bacilli were sensitive to carbapenems such as imipenem and panipenem . Streptococcus isolates were sensitive to most antibiotics .Most Staphylococcus isolates were methicillin‐resistant ,which were highly resistant to common antibiotics but all sensitive to linezolid , vancomycin and teicoplanin . Conclusions The most important pathogens responsible for bloodstream infections in low birth weight preterm infants in our hospital are K lebsiella pneumoniae and coagulase‐negative Staphylococcus . Early identification of responsible pathogen and rational antimicrobial therapy are critical for good prognosis of bloodstream infections in low birth weight preterm infants .

Effects of different extracts from Hippocampus japonicus on kidney-yang deficiency mice induced by extradiol / 中草药

Objective To observe effects of four extracts (water, n-butanol, acetoacetate and petro-leum benzine extracts) from Hippocampus japonicus on kidney-yang deficiency mice induced by extradiol, and reveal the modern scientific connotation about sweet-flavor, warm-nature, meridian tropism in liver and kidney. Methods Kidney-yang deficiency mice was induced by intraperitoneal injection of estradiol benzoate. Effects of four extracts from H. japonicus were observed by measuring physical signs, rectal temperature, grip strength, swimming time, autonomic mobility, creatinine (Cr) and urea (UR) level in serum, haematological indexes, testis index and seminal vesicle index. Results All the four extracts from H. japonicus could markedly improve physical signs and increase seminal vesicle index, RBC, Hb and PLT in blood, and decrease UR level in serum of kidney-yang deficiency mice, water extract and petoleum benzine extract could increase rectal temperature, grip strength, swimming time, autonomic mobility, testis index, WBC, lymphocyte (LY), monocyte (MO), and neutrophilic granulocyte (NE), n-butanol extract could increase autonomic mobility and NE, acetoacetate extract could enhance grip strength and prolong swimming time. Conclusion All above effects of extracts from H. japonicus could be as the basic of improving kidney-yang deficiency, could be an important part of the modern scientific connotation about sweet-flavor, warm-nature, meridian tropism in liver and kidney. Effects of water extract and petroleum ether extract were closer and stronger, which offer enlightenment for searching the common effective substance groups of H. japoniacs.