1.Review of the Expanded Clinical Trial System in the United States, Japan and Canada and its Enlightenment for China
Meiying MA ; Xiaopei ZHAO ; Lulin LI
Chinese Medical Ethics 2025;38(1):78-88
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.
2.Acupoint massage combined with lactulose in the treatment of constipation:A Meta-analysis
Yunchuan LI ; Yang OU ; Meiying SONG ; Ping FANG ; Hongjie LI ; Weisha MA ; Feng'e QIAN ; Xiaoqian LI
China Modern Doctor 2025;63(24):6-11,43
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.
3.Acupoint massage combined with lactulose in the treatment of constipation:A Meta-analysis
Yunchuan LI ; Yang OU ; Meiying SONG ; Ping FANG ; Hongjie LI ; Weisha MA ; Feng'e QIAN ; Xiaoqian LI
China Modern Doctor 2025;63(24):6-11,43
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.
4.Diagnosis and management of lymphoma during pregnancy
Chinese Journal of Perinatal Medicine 2023;26(9):709-713
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.
5.Acute liver injury induced by Weikening tablets (胃刻宁片)
Yanli MA ; Pingping YUAN ; Wanhui ZHANG ; Meiying NING ; Jing ZHAO
Adverse Drug Reactions Journal 2023;25(12):757-758
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.
6.Acute liver injury induced by Weikening tablets (胃刻宁片)
Yanli MA ; Pingping YUAN ; Wanhui ZHANG ; Meiying NING ; Jing ZHAO
Adverse Drug Reactions Journal 2023;25(12):757-758
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.
7.Application of visual mind mapping based on Mini-CEX evaluation in the practical teaching of nursing students in department of general surgery
Meiying SHEN ; Yinhua MA ; Ping WANG ; Zeyu ZHANG ; Huihui LIANG
Chinese Journal of Medical Education Research 2022;21(3):363-367
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.
8.Severe liver injury due to Rupi Sanjie capsules (乳癖散结胶囊) and Xiangshao granules (香芍颗粒)
Yanli MA ; Yang ZHOU ; Donglei ZHANG ; Lijuan ZHANG ; Meiying NING ; Jing ZHAO
Adverse Drug Reactions Journal 2022;24(1):35-37
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.
9.Severe liver injury due to Rupi Sanjie capsules (乳癖散结胶囊) and Xiangshao granules (香芍颗粒)
Yanli MA ; Yang ZHOU ; Donglei ZHANG ; Lijuan ZHANG ; Meiying NING ; Jing ZHAO
Adverse Drug Reactions Journal 2022;24(1):35-37
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.
10. Effect of network system desktop exercise on sudden poisoning incidents
Bingling QUE ; Meiying OU ; Jiaxin JIANG ; Jiahua HUANG ; Jin WU ; Peibin MA ; Nan LANG ; Yongshun HUANG ; Jiabin CHEN
China Occupational Medicine 2018;45(01):46-50
OBJECTIVE: To explore the feasibility of using network system to carry out desktop health emergency response exercise for sudden poisoning incidents,and to understand the emergency response capability on sudden poisoning incident in Guangdong Province. METHODS: A chemical poisoning incident caused by drinking polluted water was simulated. Eight questions were designed in 4 sections including the emergency report,response,disposal and strain capacity to the emergency. A total of 10 teams from prefecture-level city in Guangdong Province answered through the desktop network exercise system designed by National Institute of Occupational Health and Poison Control. Meanwhile,the experts judged score using this system. RESULTS: Ten teams were familiar and adapted to the network system in a relatively short period of time. The scores of emergency report,response,disposal and strain capacity on emergency were(14. 9 ± 2. 3),(6. 0 ±2. 2),(20. 7 ± 4. 1) and(13. 2 ± 3. 5),respectively. The score rates of above 4 sections were(74. 5 ± 11. 5) %,(50. 4 ±18. 7) %,(43. 5 ± 8. 5) % and(66. 2 ± 17. 5) %,respectively. The score rate of emergency report was higher than that of response and disposal( P < 0. 05). The score rate of strain was higher than that of disposal( P < 0. 05). The total score of desktop exercises of the 10 teams was(55. 0 ± 8. 0),which was low on the whole. CONCLUSION: The network system can be used for desktop exercise for sudden poisoning incidents. There is a weak link in the health emergency response capacity of sudden poisoning incidents in Guangdong Province and the capability of emergency response and disposal should be strengthened.

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