The expanded clinical trial system is designed to provide clinical trial drugs for patients suffering from serious or life-threatening diseases for which there is no effective treatment， essentially seeking a balance between the accessibility of drugs to patients and the soundness of the development of the pharmaceutical industry， as well as between the risk of expanding the use of clinical trial drugs and the need to safeguard the rights and interests of patients’ lives and health. Article 23 of China's Drug Administration Law provides only a principled description of the applicable standards and operating procedures for this system， with no implementing regulations， making it difficult for the system to function effectively in practice. The United States， Japan， and Canada have made detailed provisions on the conditions of application， applicants， review subjects and contents， and safeguards of the system through laws， regulations， and guidelines. Based on China's legislative environment and regulatory reality， and considering that the system is still in the initial stage in China， it is recommended that appropriate reference be made to the beneficial experience of foreign countries and that regulations and normative documents be promulgated as soon as possible to clarify the types of expanded clinical trials， applicants， review subjects etc.， and to determine the responsibilities of all the parties involved， to promote the standardization of China’s expanded clinical trial system， to promote the availability of medicines to patients， and to effectively safeguard the rights and interests of patients’ lives and health， and the soundness and safety of the development of the pharmaceutical industry.

Objective To systematically assess the efficacy and safety of combining acupoint massage with lactulose for constipation treatment.Methods Randomized controlled trials on the effects of acupressure combined with lactulose on constipation were searched in PubMed,Web of Science,Cochrane Library,Embase,China National Knowledge Infrastructure,SinoMed,VIP and Wanfang Data Knowledge Service Platform.The search timeframe was from the establishment of the database to July 2024,and Meta-analysis was performed using RevMan5.3 and Stata15.1 software.Results A total of 8 randomized controlled trials including 675 study participants were included.Meta-analysis showed that the acupoint massage combined with lactulose group was superior to control group in terms of total effective rate,abdominal distension score,and constipation quality of life score.Furthermore,its recurrence rate was lower than that of control group.Both groups showed no statistically significant difference in adverse reactions(P＞0.05).Conclusion Acupressure combined with lactulose can effectively improve the efficiency and quality of life in the treatment of constipation,and can be safe.Due to the limitation of the quantity and quality of the included literature,more high-quality studies with long-term follow-up are still needed to supplement and validate the above conclusions in the future.

Objective To systematically assess the efficacy and safety of combining acupoint massage with lactulose for constipation treatment.Methods Randomized controlled trials on the effects of acupressure combined with lactulose on constipation were searched in PubMed,Web of Science,Cochrane Library,Embase,China National Knowledge Infrastructure,SinoMed,VIP and Wanfang Data Knowledge Service Platform.The search timeframe was from the establishment of the database to July 2024,and Meta-analysis was performed using RevMan5.3 and Stata15.1 software.Results A total of 8 randomized controlled trials including 675 study participants were included.Meta-analysis showed that the acupoint massage combined with lactulose group was superior to control group in terms of total effective rate,abdominal distension score,and constipation quality of life score.Furthermore,its recurrence rate was lower than that of control group.Both groups showed no statistically significant difference in adverse reactions(P＞0.05).Conclusion Acupressure combined with lactulose can effectively improve the efficiency and quality of life in the treatment of constipation,and can be safe.Due to the limitation of the quantity and quality of the included literature,more high-quality studies with long-term follow-up are still needed to supplement and validate the above conclusions in the future.

A 58-year-old male patient took Weikening tablets 1.24 g thrice daily orally for gastric ulcer by himself. The patient did not take other drugs during the same period. After 1 month of medication, the patient developed the symptoms such as abdominal distension, yellowish sclera, yellowish urine, and fatigue. Laboratory tests showed alanine aminotransferase (ALT) 1 272 U/L, aspartate aminotransferase (AST) 507 U/L, total bilirubin (TBil) 59 μmol/L, and direct bilirubin (DBil) 34 μmol/L. Acute liver injury caused by Weikening tablets was considered. Then the drug was stopped and treatments such as liver protective, choleretic, and enzyme reduction drugs were given. Ten days later, the above symptoms disappeared, and the liver function reexamination showed ALT 163 U/L, AST 43 U/L, TBil 23 μmol/L, and DBil 17 μmol/L. One month later, the patient′s liver function test showed ALT 31 U/L, AST 24 U/L, TBil 14 μmol/L, and DBil 6 μmol/L. It was considered that the liver injury of the patient may be related to greater celandine contained in Weikening tablets.

Lymphoma is a malignant tumor of the lymphatic system, including Hodgkin's lymphoma and non-Hodgkin's lymphoma. Lymphoma is the fourth most common primary malignant tumor during pregnancy and one of the major malignant diseases affecting maternal and infant outcomes. This review summarizes the clinical features, diagnosis, maternal and fetal outcomes, and clinical lymphoma treatment during pregnancy. It is suggested that clinicians should pay attention to the symptoms, including unexplained lymphadenectasis, systemic symptoms, extranodal lesions, and the　symptoms of pressure exerted on the involved local organs, especially those in the breast and reproductive system, and make a timely diagnosis in line with the biopsy or puncture results. Management should be based on the classification, stage, and clinical manifestations of lymphoma. Besides, the gestational age at diagnosis, maternal and child conditions, and the willingness to continue the pregnancy should also be considered. Most mothers and their children can have good outcomes after individualized treatment through multidisciplinary cooperation and close perinatal management.

A 58-year-old male patient took Weikening tablets 1.24 g thrice daily orally for gastric ulcer by himself. The patient did not take other drugs during the same period. After 1 month of medication, the patient developed the symptoms such as abdominal distension, yellowish sclera, yellowish urine, and fatigue. Laboratory tests showed alanine aminotransferase (ALT) 1 272 U/L, aspartate aminotransferase (AST) 507 U/L, total bilirubin (TBil) 59 μmol/L, and direct bilirubin (DBil) 34 μmol/L. Acute liver injury caused by Weikening tablets was considered. Then the drug was stopped and treatments such as liver protective, choleretic, and enzyme reduction drugs were given. Ten days later, the above symptoms disappeared, and the liver function reexamination showed ALT 163 U/L, AST 43 U/L, TBil 23 μmol/L, and DBil 17 μmol/L. One month later, the patient′s liver function test showed ALT 31 U/L, AST 24 U/L, TBil 14 μmol/L, and DBil 6 μmol/L. It was considered that the liver injury of the patient may be related to greater celandine contained in Weikening tablets.

A 25-year-old female patient took 4 Rupi Sanjie capsules orally (0.55 g/capsule) thrice daily and Xiangshao granules 1 bag (4 g/bag) orally thrice daily by herself for breast nodule. After 2 months, the patient developed yellow urine, skin itching, and yellowish skin and sclera. Laboratory tests showed alanine aminotransferase (ALT) 1 334 U/L, aspartate aminotransferase (AST) 717 U/L, alkaline phosphatase (ALP) 164 U/L, total bilirubin (TBil) 88 μmol/L, and γ-glutamyltransferase (γ-GT) 127 U/L. Liver injury caused by Rupi Sanjie capsules and Xiangshao granules were considered. The 2 drugs were stopped and the treatments of liver protection and cholagogic were given. Three weeks later, her symptoms above-mentioned disappeared and the laboratory tests showed ALT 106 U/L, AST 88 U/L, ALP 88 U/L, TBil 13 μmol/L, and γ-GT 32 U/L. At 1 month of follow-up, the patient′s liver function returned to normal. The patient′s liver injury might be related to the component of bupleurum in Rupi Sanjie capsules and Xiangshao granules and the component of prunella vulgaris in Rupi Sanjie capsules.

Objective:To explore the effect of visual mind mapping based on Mini-CEX evaluation combined with case-based learning (CBL) on improving the learning ability and teaching satisfaction of nursing students in department of general surgery.Methods:A total of 120 nurses rotating in the Department of General Surgery, Panzhihua Central Hospital (Clinical Medical College of Panzhihua University) from September 2019 to July 2020 were selected as research objects, and randomly divided into a control group and a study group, with 60 nurses in each group. The control group used traditional teaching, and the study group used visual mind mapping based on Mini-CEX evaluation combined with CBL. After the training, the clinical comprehensive ability of the nurses was evaluated by theoretical and practical assessment, and the self-learning ability and teaching satisfaction of the nurses were analyzed through self-made questionnaire survey. SPSS 22.0 was used for t test and chi-square test. Results:The theoretical and practical assessment scores of nursing students in the study group were significantly higher than those in the control group[(95.01±3.52) vs. (83.26±4.05); (96.14±3.22) vs. (81.17±4.30)] ( P=0.001). Before the rotation training, there was no statistical difference between the study group and the control group in the scores of self-motivation beliefs, task analysis, self-monitoring and adjustment, and self-evaluation ( P>0.05). After the rotation training, the scores of above 4 aspects were significantly higher in study group than the control group ( P<0.05). The nurse trainees in the study group were significantly superior to those in control group in the following 7 aspects: reasonable arrangement of the teaching plan, novelty of the teaching mode, improvement of clinical nursing skills, improvement of the nurse-patient communication ability, improvement of the emergency response ability, and overall teaching satisfaction ( P=0.001). Conclusion:Visual mind mapping based on Mini-CEX evaluation combined with CBL applied to clinical teaching training of nursing students in the department of general surgery can effectively improve the effectiveness of nursing teaching and teaching satisfaction, improve the learning ability of nurses, and improve the nursing level of nursing students in the department of general surgery.

A 25-year-old female patient took 4 Rupi Sanjie capsules orally (0.55 g/capsule) thrice daily and Xiangshao granules 1 bag (4 g/bag) orally thrice daily by herself for breast nodule. After 2 months, the patient developed yellow urine, skin itching, and yellowish skin and sclera. Laboratory tests showed alanine aminotransferase (ALT) 1 334 U/L, aspartate aminotransferase (AST) 717 U/L, alkaline phosphatase (ALP) 164 U/L, total bilirubin (TBil) 88 μmol/L, and γ-glutamyltransferase (γ-GT) 127 U/L. Liver injury caused by Rupi Sanjie capsules and Xiangshao granules were considered. The 2 drugs were stopped and the treatments of liver protection and cholagogic were given. Three weeks later, her symptoms above-mentioned disappeared and the laboratory tests showed ALT 106 U/L, AST 88 U/L, ALP 88 U/L, TBil 13 μmol/L, and γ-GT 32 U/L. At 1 month of follow-up, the patient′s liver function returned to normal. The patient′s liver injury might be related to the component of bupleurum in Rupi Sanjie capsules and Xiangshao granules and the component of prunella vulgaris in Rupi Sanjie capsules.

BACKGROUND: Autophagy plays a crucial role in chemotherapy resistance of triple-negative breast cancer (TNBC). Hence, autophagy-related gene 5 (ATG5), an essential molecule involved in autophagy regulation, is presumably associated with recurrence of TNBC. This study was aimed to investigate the potential influence of single-nucleotide polymorphisms in ATG5 on the disease-free survival (DFS) of early-stage TNBC patients treated with anthracycline- and/or taxane-based chemotherapy. METHODS: We genotyped ATG5 SNP rs473543 in a cohort of 316 TNBC patients treated with anthracycline- and/or taxane-based chemotherapy using the sequenom's MassARRAY system. Kaplan-Meier survival analysis and Cox proportional hazard regression analysis were used to analyze the association between ATG5 rs473543 genotypes and the clinical outcome of TNBC patients. RESULTS: Three genotypes, AA, GA, and GG, were detected in the rs473543 of ATG5 gene. The distribution of ATG5 rs473543 genotypes was significantly different between patients with and without recurrence (P = 0.024). Kaplan-Meier survival analysis showed that patients carrying A allele of ATG5 rs473543 had an increased risk of recurrence and shorter DFS compared with those carrying the variant genotype GG in rs473543 (P = 0.034). In addition, after adjusting for clinical factors, multivariate Cox regression analyses revealed that the AA/GA genotype of rs473543 was an independent predictor for DFS (hazard risk [HR], 1.73; 95% confidence interval [CI], 1.04-2.87; P = 0.034). In addition, DFS was shorter in node-negative patients with the presence of A allele (AA/GA) than in those with the absence of A allele (P = 0.027). CONCLUSION ATG5 rs473543 genotypes may serve as a potential marker for predicting recurrence of early-stage TNBC patients who received anthracycline-and/or taxane-based regimens as adjuvant chemotherapy.
Adult ; Aged ; Anthracyclines ; administration & dosage ; adverse effects ; Autophagy-Related Protein 5 ; genetics ; Bridged-Ring Compounds ; administration & dosage ; adverse effects ; Chemotherapy, Adjuvant ; Disease-Free Survival ; Female ; Genetic Association Studies ; Genetic Predisposition to Disease ; Humans ; Kaplan-Meier Estimate ; Middle Aged ; Neoplasm Recurrence, Local ; drug therapy ; genetics ; pathology ; Polymorphism, Single Nucleotide ; genetics ; Taxoids ; administration & dosage ; adverse effects ; Triple Negative Breast Neoplasms ; drug therapy ; genetics ; pathology