1.Key points of ethical review for non-inferiority clinical trials
Chinese Medical Ethics 2026;39(6):754-761
The iteration speed of drug innovation and novel therapeutic methods has fallen far short of expectations. Scientists have gradually shifted their focus to drugs or treatments that exhibit efficacy comparable to standard therapies but with fewer side effects, greater convenience, or lower costs. The application scenarios of non-inferiority trials (NITs) are gradually increasing. Among these, the rationality of the potential benefits in secondary indicators served as a prerequisite for implementing NITs. Ethics committees should conduct a thorough review of major parameters such as thresholds, positive controls, and sample size, make an overall judgment on trial quality, fully interpret the statistical analysis of study results and non-inferiority conclusions, and rigorously review informed consent forms. Only in this way can the smooth conduct of clinical trials be ensured, enabling more drugs and treatments with clinical benefits to enter clinical practice, advancing the development of medical research, and ultimately safeguarding the rights and interests, along with the safety of research participants.
2.Research on the chemical compositions and their biological activities of Piper nigrum L.
Xing GAO ; Fengping ZHAO ; Wentao WANG ; Wei TIAN ; Canhui ZHENG ; Xin CHEN
Journal of Pharmaceutical Practice and Service 2025;43(7):313-319
Piper nigrum L. is an evergreen climbing vine, which belongs to the genus Piperia in the Piperaceae family. Piper nigrum L., which known as the “king of spices”, is used as both food and medicine. The main active substances in Piper nigrum L. are alkaloids mainly composed of amides, and essential oil, as well as phenolic compounds. In this paper, the chemical compositions, especially amide alkaloids, and their biological activities of Piper nigrum L. were summarized. These studies showed that Piper nigrum L., as a medicinal and food plant, had a wide range of biological activities and was deserved further research and in-depth utilization.
3.Research progress on the treatment role and chemical synthesis methods of isoselenoazolones
Wentao WANG ; Xing GAO ; Fengping ZHAO ; Canhui ZHENG ; Xin CHEN
Journal of Pharmaceutical Practice and Service 2025;43(8):367-372
Glutathione peroxidase (GSH-Px) is a key selenoenzyme that protects the body from oxidative damage. A series of small molecular organic selenium compounds have been designed and synthesized as functional mimics of GPx, among which isoselenazolones are the most widely studied. Taking ebselen as a representative, the catalytic mechanism of isoselenazolones in mimicing GSH-Px activity in vivo, the therapeutic effects of isoselenazolones in stroke, sensorineurium deafness and tinnitus, treatmentresistant depression (TRD) and coronavirus disease 2019 (COVID-19), and research on their chemical synthesis methods were summarized and discussed in this paper.
4.Progress on the relationship of aldehyde dehydrogenase 2 with human diseases and its small-molecule activators
Xiangpei SUN ; Xing GAO ; Fengping ZHAO ; Wentao WANG ; Tianyi ZHANG ; Wei TIAN ; Canhui ZHENG ; Xin CHEN
Journal of Pharmaceutical Practice and Service 2024;42(1):6-11
Aldehyde dehydrogenase 2 (ALDH2) is one of important factors against from the damage under oxidative stress in human body. A high proportion of East Asians carry ALDH2 inactive mutation gene. There are many diseases closely related to ALDH2, such as cardiovascular diseases, neurodegenerative diseases and liver diseases. Recent studies also have found that ALDH2 is associated with ferroptosis. Therefore, ALDH2 has becoming a potential target for the treatment of the above related diseases. Several types of small molecule activators with potential value of clinical application have been reported. The research progress on the structure and function of ALDH2 , the relationship with human diseases and its activators were summarized in this paper.
5.Correlation between essential hypertension with serum adiponectin and lipoprotein associated phospholipase A 2
Lingjun GAO ; Xiangmei XIE ; Fengping HE ; Zhi HUANG ; Xin XU ; Zhihong HUANG
International Journal of Laboratory Medicine 2015;(8):1026-1027,1031
Objective To investigate the relations between adiponectin(APN) and lipoprotein associated phospholipase A2 (LP‐PLA2) with the development and progress of essential hypertension .Methods 60 patients with essential hypertension were collect‐ed and divided into 3 groups of the hypertension grade 1 ,2 ,3 groups according to the levels of blood pressure ,20 cases in each group .Contemporaneous 20 healthy controls were selected .The peripheral venous blood samples were collected from the cubital vein and the serum levels of APN and LP‐PLA2 were measured by ELISE .The related biochemical indicators were simultaneously detected .Results The serum APN levels in the hypertension grade 1 ,2 ,3 groups were significantly lower than that in the control group ,moreover which in the hypertension grade 3 group was significantly lower than that in the hypertension grade 1 group(P<0 .05);on the contrary ,serum levels of LP‐PLA2 in the hypertension grade 1 ,2 ,3 groups were significantly higher than that in the healthy control group ,moreover which in the hypertension grade 3 group was obviously higher than that in the hypertension grade 1 group(P<0 .05);serum APN was significantly negatively correlated with LP‐PLA2(r= -0 .772 ,P<0 .05) .Conclusion Serum levels of APN and LP‐PLA2 are closely related with the development and progress of essential hypertension .
6.The relationship between hypertensive disorder complicating pregnancy and serum free estriol and its impact on pregnancy outcomes
Lihua FU ; Yujie GAN ; Yanming GUAN ; Xihuan HUANG ; Jinwen GAO ; Fengping JIAN
Chinese Journal of Primary Medicine and Pharmacy 2013;20(1):11-13
Objective To research the relationship between hypertensive disorder complicating pregnancy and serum free estriol 3 (FE3) and explore its impact on pregnancy outcome.Methods Clinical data of 117 hypertensive disorder complicating pregnancy and 165 normal pregnant women were retrospectivly analyzed.Chemiluminescence immunoassay determination of maternal serum FE3 also had been conducted.Then analyzing the correlation between hypertensive disorder complicating pregnancy and FE3 and its impact on pregnancy outcomes.Results LDL cholesterol and the level of creatinine of observation group were significantly lower than the control group(t =3.129,9.372,all P < 0.05),while blood pressure,triglycerides,HDL,and 24-hour urinary protein content were significantly higher than control groug(t =7.361,2.398,2.833,all P < 0.05).The FE3 level of the observation group were significantly lower than the control group (t =2.913,P < 0.05).There was a significant positive correlation between the FE3 level of normal pregnant women and their gestational age (r =0.937,P < 0.05).The probabilities of premature birth,premature rupture of membranes,postpartum hemorrhage,and neonatal asphyxia of observation group were significantly higher than amtrol group (x2 =3.912,3.879,4.267,6.935,all P < 0.05).Conclusion There is a significant correlation between hypertensive disorder complicating pregnancy and FE3,which has an important significance on monitoring the health status of pregnant women and the fetal-placental function.
7.Effectiveness of integrated teaching designed according to nurse's core competency
Fengping LIU ; Yeqing ZHOU ; Cuixiang GAO ; Dan ZHENG ; Xiaoyan HUANG
Chinese Journal of Practical Nursing 2010;26(1):67-69
Objective To explore the effects of the integrated teaching," teaching,studying and doing",which designed according to the nurse's core competency. Methods The integrated teaching of "teaching,studying and doing" was applied to the experimental class. The basal portions of the integrated teaching were as follows:searching for the Internet information,Sharing information between groups,per-forming cleaning care for the elders living in welfare agency according to nursing process,writing Nursing History or reflections. Results Comparison of mean scores between the experimental class and the con-trol one predicted significant differcences on theoretical and practical test,and the former was better than the Last. Conclusions The integrated teaching designed according to the nurse's core competency was more effective than the traditional teaching method,since the students from the experimental class valued the knowledge and skills immanently,and were involved in applying,reviewing them in time.
8.Nursing cooperation during application of piezosurgery in jaw bone tumor operation
Fenglian LIU ; Yuqiao CHEN ; Zhiwei LU ; Fengping ZHOU ; Fang YANG ; Yongbo GAO
Chinese Journal of Practical Nursing 2010;26(22):18-20
Objective To make a summary of the clinical application and cooperation of piezosurgery in jaw bone tumour operation. Methods 64 patients with jaw bone tumour were selected since 2007 and were divided into the piezosurgery group and the routine group, they used piezosurgery and routine osteotome respectively. Feelings during operation, operation time, hemorrhage, postoperative reaction and complication were observed and compared. Results Discomfort and hemorrhage during operation was lighter, but operation was longer in the piezosurgery group compared with the routine group. Complications such as postoperative infection, hemorrhage and nerve damage did not occurred. Conclusions Application of piezosurgery in jaw bone tumor operation can increase comfort degree and reduce hemorrhage, it requires proficiency in operation procedures and master key aspects of nursing, so that can cooperate well.
9.The research of the effect of oral external suction on environmental pollution control in dental clinic
Jiquan WEN ; Xifeng WU ; Shuping CHEN ; Fengping ZHOU ; Ruozhu XU ; Quanghua XIAO ; Yongbo GAO
Chinese Journal of Primary Medicine and Pharmacy 2009;16(3):457-458
Objective To examine the effect of oral external suction on environmental pollution of microorganism in dental clinic.Methods Aerobe was counted na observation index of air contamination and air sample of the area leveal 1m and 2.5 m,hight 1m,which using oral cavity collectors of aspirator or not was collected by the method of sedimentation.Results The datum of the group with oral cavity collectors of aspirator was much lower than the group without it.Conclusion Environmental pollution from tooth treatment in dental clinic can be reduced by using oral extemal suction.
10.The microscopic extended transsphenoidal approach for the treatment of clival chordomas
Chao GAO ; Fengping HUANG ; Dongxiao ZHUANG
Chinese Journal of Microsurgery 2009;32(2):95-97,illust 1
Objective To evaluate the application of microscopic extended transsphenoidal approach in surgery for clival chordomas. Methods Nine patients with clival chordomas were managed by microscopic extended transsphenoidal approach from August 2007 to March 2008 with the assistance of neuro-navigation. Among those, 3-D stereoscopic virtual reality images of 4 cases were reconstructed successfully,which could identify the relationship between the tumors and surrounding structures and conduced to the operations. Results Total removal was achieved in 3 cases,which was confirmed by the imaging-scopy after the operations, subtotal removal in 6 cases. Because of the invasion of the subdural space by the tumor,CSF leakage occurred in 2 cases after the tumors were removed, which was cured by the reconstruction of the cranial base with the fat tissue and albumin gel. Conclusion The microscopic extended trans spbenoidal approach is a viable, minimally invasive alternative for surgical treatment of clival tumors. By this approach, the clivus including the anterior skull base and cavernous sinus can be exposed conveniently.

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