In drug clinical trials,the protection of subjects'privacy should take precedence over scientific exploration and societal benefits.This paper compared the differences in legal systems for the protection of subjects'privacy in China and abroad by employing methods such as literature review,case analysis,and comparison of domestic and foreign situations.It also elucidated the current ethical challenges faced by the protection of subjects'privacy,which primarily included imperfect laws and regulations,insufficient protection awareness among relevant personnel,risks of privacy breaches in critical links,and increased difficulty in data confidentiality under emerging technologies.From the perspective of responsible innovation,specific paths were proposed to protect subjects'privacy by using the four-dimensional structure of"prediction-reflection-negotiation-feedback,"maintaining a balance between ethical principles and technological innovation,ensuring the ethical and compliant nature of drug clinical trials,and thus better contributing to the cause of human health.

In drug clinical trials,the protection of subjects'privacy should take precedence over scientific exploration and societal benefits.This paper compared the differences in legal systems for the protection of subjects'privacy in China and abroad by employing methods such as literature review,case analysis,and comparison of domestic and foreign situations.It also elucidated the current ethical challenges faced by the protection of subjects'privacy,which primarily included imperfect laws and regulations,insufficient protection awareness among relevant personnel,risks of privacy breaches in critical links,and increased difficulty in data confidentiality under emerging technologies.From the perspective of responsible innovation,specific paths were proposed to protect subjects'privacy by using the four-dimensional structure of"prediction-reflection-negotiation-feedback,"maintaining a balance between ethical principles and technological innovation,ensuring the ethical and compliant nature of drug clinical trials,and thus better contributing to the cause of human health.

Objective:To investigate the level of functional fitness of elderly hypertensive patients in the community and to analyze its influencing factors.Methods:A cross-sectional survey was used from November 2021 to September 2022, questionnaire survey and Senior Functional Fitness Test (SFT) were conducted on 189 elderly hypertensive patients in the community by convenience sampling method, multiple linear regression was used to analyze the influencing factors of SFT in elderly hypertensive patients in the community.Results:Totally 189 cases of community-aged hypertensive patients completed the investigation, 88 cases were male and 101 were female. The total SFT score of community-aged hypertensive patients was (58.61 ± 16.07). Single factor analysis showed that there were significant differences in SFT scores among patients with different gender, age and education ( t=-2.57, F=6.24, 7.54, all P<0.05). Multifactorial analysis revealed that age ( t=-5.55), gender ( t=2.63), and literacy ( t=5.69) were influential factors in the total SFT scores of community-dwelling elderly hypertensive patients (all P<0.05). Conclusions:Age, gender, and literacy level are the main factors affecting the total SFT scores of elderly hypertensive patients in the community, and community caregivers should pay close attention to the above elderly hypertensive population.

Objective To investigate the effects of kuwanon G(KG)on proliferation,apoptosis,migration and invasion of gastric cancer cells and the molecular mechanisms.Methods The effects of KG on proliferation and growth of gastric cancer cells were assessed with CCK-8 assay and cell clone formation assay,by observing tumor formation on the back of nude mice and using immunohistochemical analysis of Ki-67.The effect of KG on cell apoptosis was analyzed using Annexin V-FITC/PI apoptosis detection kit,Western blotting and TUNEL staining.The effects of KG on cell migration and invasion were detected using Transwell migration and invasion assay and Western blotting for matrix metalloproteinase(MMP).The role of phosphatidylinositol 3-kinase(PI3K)/protein kinase B(AKT)/mammalian target of rapamycin(mTOR)pathway in KG-mediated regulation of gastric cancer cell proliferation,migration,and invasion was verified by Western blotting and rescue assay.Results KG significantly inhibited proliferation and reduced clone formation ability of gastric cancer cells in a concentration-dependent manner(P<0.05).KG treatment also increased apoptosis,enhanced the expressions of cleaved caspase-3 and Bax,down-regulated Bcl-2,lowered migration and invasion capacities and inhibited the expression of MMP2 and MMP9 in gastric cancer cells(P<0.05).Mechanistic validation showed that KG inhibited the activation of the PI3K/AKT/mTOR pathway,and IGF-1,an activator of the PI3K/AKT/mTOR pathway,reversed the effects of KG on proliferation,migration and invasion of gastric cancer cells(P<0.05).Conclusion KG inhibits proliferation,migration and invasion and promotes apoptosis of gastric cancer cells at least in part by inhibiting the activation of the PI3K/AKT/mTOR pathway.

Yinchenhao Tang has definite clinical efficacy. It has been inherited and documented since the ancestor of Shanghanlun in the Eastern Han dynasty and is a classical formulas for clearing away heat， promoting diuresis， and eliminating jaundice adopted by medical experts of successive generations. It has been included in the Catalogue of Ancient Classical Formulas （the Second Batch of Han Medicine） published by the National Administration of Traditional Chinese Medicine （TCM） in 2023. By means of bibliometrics， 801 pieces of ancient literature data related to Yinchenhao Tang were collected， and 36 pieces of effective data were selected， involving 36 ancient books of TCM. The origin， name， composition， efficacy， formula and meaning analysis， drug origin， dosage， preparation method and usage， indications， and modern clinical application of Yinchenhao Tang were analyzed. It was suggested that the modern dosage and application of Yinchenhao Tang should be as follows： The 82.8 g of Artemisiae Scopariae Herba， 12.6 g of Gardeniae Fructus， and 27.2 g of Rhei Radix et Rhizoma. The formulas was prepared by firstly adding 2 400 mL of water into Artemisiae Scopariae Herba and boiling it to about 1 200 mL， then adding Gardeniae Fructus and Rhei Radix et Rhizoma to boil it for 600 mL， and removing the residue. It could be orally taken for 200 mL each time in warm conditions， three times a day. Yinchenhao Tang has the effect of clearing away heat， promoting diuresis， and eliminating jaundice， and it mainly treats symptoms of hygropyretic jaundice. In the formulas， Yinchenhao Tang is the monarch drug， which is mainly to remove dampness and jaundice. Gardeniae Fructus is the ministerial drug， which is mainly responsible for clearing the triple energizer and facilitating urination. Rhei Radix et Rhizoma is an adjuvant， mainly responsible for clearing away heat and eliminating jaundice. The modern application of this formulas involves the hepatobiliary system， skin system， endocrine system， digestive system， etc.， and it has more advantages in treating jaundice， icteric hepatitis， and hepatitis B. In this study， the ancient literature related to Yinchenhao Tang was sorted out to determine its key information， so as to provide a scientific reference for clinical application of classic formulas and new drug development.

Objective To investigate the effects of kuwanon G(KG)on proliferation,apoptosis,migration and invasion of gastric cancer cells and the molecular mechanisms.Methods The effects of KG on proliferation and growth of gastric cancer cells were assessed with CCK-8 assay and cell clone formation assay,by observing tumor formation on the back of nude mice and using immunohistochemical analysis of Ki-67.The effect of KG on cell apoptosis was analyzed using Annexin V-FITC/PI apoptosis detection kit,Western blotting and TUNEL staining.The effects of KG on cell migration and invasion were detected using Transwell migration and invasion assay and Western blotting for matrix metalloproteinase(MMP).The role of phosphatidylinositol 3-kinase(PI3K)/protein kinase B(AKT)/mammalian target of rapamycin(mTOR)pathway in KG-mediated regulation of gastric cancer cell proliferation,migration,and invasion was verified by Western blotting and rescue assay.Results KG significantly inhibited proliferation and reduced clone formation ability of gastric cancer cells in a concentration-dependent manner(P<0.05).KG treatment also increased apoptosis,enhanced the expressions of cleaved caspase-3 and Bax,down-regulated Bcl-2,lowered migration and invasion capacities and inhibited the expression of MMP2 and MMP9 in gastric cancer cells(P<0.05).Mechanistic validation showed that KG inhibited the activation of the PI3K/AKT/mTOR pathway,and IGF-1,an activator of the PI3K/AKT/mTOR pathway,reversed the effects of KG on proliferation,migration and invasion of gastric cancer cells(P<0.05).Conclusion KG inhibits proliferation,migration and invasion and promotes apoptosis of gastric cancer cells at least in part by inhibiting the activation of the PI3K/AKT/mTOR pathway.

AIM:To investigate the molecular mechanism of inhibition of miR-421 expression promoting radiosensitivity in the cervical cancer cells.METHODS:Cervical cancer lines HeLa, SiHa, C33A and CaSki were transfected with miR-421 inhibitor or negative control nucleotide using Lipofectamine 2000 kit, and the levels of miR-421 expression in the cervical cancer lines and endometrial epithelium cell line ESC were detected by real-time PCR.These cells with transfection were exposed to various doses of X-ray (0, 2, 4, 6 and 8 Gy).After 48 h, the cell viability, LDH leakage rate and apoptotic rate were measured respectively by MTT assay, ELISA and flow cytometry with Annexin V-FITC/PI staining.The protein levels of cleaved caspase-9, caspase-9, cleaved PARP, PARP, Bcl-2 and Bax were monitored by Western blot.RESULTS:Low miR-421 levels was found in the ESC cells, while high miR-421 levels were observed in the HeLa, SiHa, C33A and CaSki cells.The level of miR-421 in the cells transfected with miR-421 inhibitor was significantly lower than that in negative control group (P<0.05).The viability and LDH leakage rate of the cervical cancer cells with low miR-421 expression were notablely lower than those in negative control group, and the apoptotic rate at 72 h was remarkablely increased (P<0.05) under the same conditions.The results of Western blot indicated that, after exposure to ionizing radiation, the protein levels of cleaved caspase-9, cleaved PARP and Bcl-2 were significantly increased, while the protein level of Bax was significantly decreased in the cervical cancer cells with low miR-421 expression compared with negative control group (P<0.05).CONCLUSION:miR-421 is lowly expressed in the normal endometrial epithelial cells, but highly expressed in the cervical cancer cells.Down-regulation of miR-421 expression significantly inhibits the growth and enhances the radiosensitivity of cervical cancer cells at least partly via activating caspase-9 apoptosis pathway, thus promoting Bcl-2 and inhibiting Bax expression.

Objective To study the relationship between umbilical cord leptin levels and fetal growth as well as neonatal birth weight. Methods One hundred and forty - two neonates selected from February 2009 to June 2013 in Shangqiu First People's Hospital according to the different gestational age and birth weight were divided into 3 groups. Group A included 44 cases(small for gestational age,birth weight below the average weight of the 10th percentile at the same gestational age),23 boy cases,21 girl cases;group B included 56 cases(appropriate for gestational age,birth weight at the average weight of the 10th to 90th percentile at the same gestational age),30 boy cases,26 girl cases;group C included 42 cases(large for gestational age,birth weight above the average weight of the 90th percentile at the same gestational age),22 boy cases,20 girl cases. Neonatal body mass index,birth weight,placenta weight and umbilical lep-tin levels of three groups were compared. Results Neonatal birth weight,neonatal body length,body mass index and the placenta weight leptin levels in group A were significantly lower than those of group B,having statistically significant difference(all P ﹤ 0. 001);Neonatal birth weight,neonatal body length,body mass index and the placenta weight leptin levels in group C were significantly higher than those in group B,with statistically significant difference( all P ﹤0. 001). Neonatal birth weight in the boy group was obviously higher than that of the girl group,and the difference was statistically significant(P ﹤ 0. 001). Neonatal leptin levels in the boy group were significantly lower than that of the girl group,and the difference was statistically significant(P ﹤ 0. 001). There were positive correlations between the umbili-cal cord leptin levels and the neonatal birth weight,neonatal length,neonatal weight index and the placenta weight(r =0. 382,0. 276,0. 358,0. 412,all P ﹤ 0. 01). Conclusions The umbilical cord leptin levels are closely associated with neonatal birth weight and intrauterine growth retardation,and it can be used as one of the important indicators for reflec-ting neonatal birth weight and fetal growth.

10.3969/j.issn.2095-4344.2013.24.007

Objective To investigate the anti-tumor effect of ultrasound-targeted microbubble destruction (UTMD) mediated herpes simplex virus thymedine kinase (HSV-TK) on mice ovarian cancer.Methods Forty female BALB/c-nu mice were randomly divided into four groups after the models of subcutaneous transplantation tumors were established:(A)HSV-TK + Microbubbles + Ultrasound (HSV-TK+ MBs + US);(B) HSV-TK+ Ultrasound (HSV-TK + US);(C) HSV-TK;(D) PBS.TheTK protein and mRNA expression were separately detected by western-blot and real time RT-PCR.TUNEL staining was used to detect the tumor cell apoptosis.The inhibition rates and survival time of the animals were compared among all groups.Results The HSV-TK gene transfection efficacy and tumor inhibitory effect of HSV-TK on mice transplantable tumor in group A (HSV-TK + MBs + US) were significantly improved compared with group B (HSV-TK + US),group C (HSV-TK) and group D (PBS) (P ＜0.05).However,group A has no significant difference (P ＞0.05) with other groups in improving the survival time of tumor-bearing mice.Conclusions Ultrasound-targeted microbubble destruction can effectively transfect HSV-TK gene into target tissues and play a significant inhibition effect on ovarian cancer in mice.However,this new method is not able to improve the survival time of mice for a short-term observation.