OBJECTIVE To provide reference for the rational use of antiemetic drugs in tumor chemotherapy patients. METHODS The data of tumor patients who were given antiemetic drugs were collected from 9 departments of our hospital with hospital information system from Oct. 1st to Nov. 30th in 2022， such as oncology department， radiotherapy department， gynecology department， and gastroenterology department. The application of chemotherapy drugs and the use of antiemetic drugs were analyzed statistically， and the irrational use of antiemetic drugs was analyzed. RESULTS A total of 520 patients were included， involving 248 （47.69%） using chemotherapy drugs with a moderate emetogenic risk level and 135 （25.96%） with a high emetogenic risk level. A total of 461 cases （73.06%） of 5-hydroxytryptamine 3-receptor antagonists were used， including palonosetron in 333 cases， ondansetron in 106 cases， tropisetron in 15 cases and granisetron in 7 cases， and only 148 cases of patients were prioritized for the use of nationally procured medicines and national essential medicines （32.10%）. Neurokinin-1 receptor antagonists were used in 170 cases （26.94%）， including fosaprepitant in 112 cases and aprepitant in 58 cases. The use of antiemetic drugs was unreasonable in 162 patients （31.15%）； among the types of irrational drugs， the antiemetic regimen was unreasonable in the largest number of cases （22.40%）， followed by the irrational pharmacoeconomics （19.13%）. CONCLUSIONS The emetogenic risk levels of chemotherapy drugs used for tumor patients in our hospital are primarily moderate to high， and there is irrational use of antiemetic regimen and pharmacoeconomics. Clinicians， nurses， pharmacists and hospital departments should collaborate as multiple teams to strengthen full supervision of the standardization of antiemetic drugs， reasonably select antiemetic drugs based on emetogenicity rating， and improve the compliance of doctors with the guidelines to ensure the safety， effectiveness， and cost-effective of patient medication.

Acetaminophen is currently the most widely used antipyretic analgesics in clinical practice. The conventional dose of acetaminophen is safe and reliable, and long-term use in large quantities can cause damage to important organs. In recent years, some new safety issues of acetaminophen have been found, such as its possibility to increase blood pressure in patients with hypertension, its association with increased risk of cardiovascular disease and all-cause mortality with sodium-containing acetaminophen, the discovery of multiple biomarkers for predicting and diagnosing acetaminophen-related liver injury and its prognosis, and its possibility to increase the risk of kidney injury. The safety prevention strategies for important organ injuries related to acetaminophen include strict restrictions on medication dosage and duration, and attention to medication safety for special populations. For patients who have experienced significant organ damages, their causal relationship should be evaluated, acetaminophen should be stopped, and specific treatment, and symptomatic and supportive treatments should be provided.

Acetaminophen is currently the most widely used antipyretic analgesics in clinical practice. The conventional dose of acetaminophen is safe and reliable, and long-term use in large quantities can cause damage to important organs. In recent years, some new safety issues of acetaminophen have been found, such as its possibility to increase blood pressure in patients with hypertension, its association with increased risk of cardiovascular disease and all-cause mortality with sodium-containing acetaminophen, the discovery of multiple biomarkers for predicting and diagnosing acetaminophen-related liver injury and its prognosis, and its possibility to increase the risk of kidney injury. The safety prevention strategies for important organ injuries related to acetaminophen include strict restrictions on medication dosage and duration, and attention to medication safety for special populations. For patients who have experienced significant organ damages, their causal relationship should be evaluated, acetaminophen should be stopped, and specific treatment, and symptomatic and supportive treatments should be provided.

Monoclonal antibody (mAb) drugs belong to protein drugs, which are characterized by high relative molecular weight, strong polarity, and limited transmembrane. Their pharmacokinetics have certain particularity and complexity, and problems such as large individual differences in therapeutic effects, diverse biological effects, and loss of therapeutic response exist in clinical application. The blood concentration of mAb drugs is affected by many factors including the number of receptors at the target site, the level of anti-drug antibody, and the interaction between drugs. Early monitoring is helpful to timely adjust the dose of mAb drugs, improve the efficacy, and avoid or reduce the occurrence of adverse reactions. Clinical monitoring should be actively carried out to improve the level of rational use of mAb drugs and the ability of early warning of adverse reactions, so as to reduce the drug-induced injury in patients.

Monoclonal antibody (mAb) drugs belong to protein drugs, which are characterized by high relative molecular weight, strong polarity, and limited transmembrane. Their pharmacokinetics have certain particularity and complexity, and problems such as large individual differences in therapeutic effects, diverse biological effects, and loss of therapeutic response exist in clinical application. The blood concentration of mAb drugs is affected by many factors including the number of receptors at the target site, the level of anti-drug antibody, and the interaction between drugs. Early monitoring is helpful to timely adjust the dose of mAb drugs, improve the efficacy, and avoid or reduce the occurrence of adverse reactions. Clinical monitoring should be actively carried out to improve the level of rational use of mAb drugs and the ability of early warning of adverse reactions, so as to reduce the drug-induced injury in patients.

With the key mechanism of disease occurrence being revealed and rapid development of modern biopharmaceutical technology, more and more biological innovative drugs have been approved for marketing. With more clinical application of innovative biological drugs in recent years, more adverse reactions were reported. Therefore, it is of great significance and urgent in clinic to construct the supervision standard and system for the safe use of biological innovative drugs. At present, the main problems hindering the clinical safety supervision of biological innovative drugs are as follows. Firstly, the mechanism of adverse drug reactions is unclear and there is a lack of specific detection indicators to predict them. Secondly, the study on the relationship of "exposure-clinical efficacy-toxic and side effects" of drugs in vivo is still insufficient, so it is difficult to support the establishment of the rule of "quantity and toxicity" for safe drug use. Thirdly, there is a lack of clinical research evidence in line with the physiological and pathological characteristics of Chinese people, and the ideal randomized controlled trials results of clinical research on new drugs are not enough to support its safe drug use in the real world. Therefore, it is necessary to strengthen the supervision awareness of the clinical safe use, accelerate the process of clinical monitoring research on biological innovative drugs, reveal more scientific evidence of clinical safe use, so as to help the construction of the supervision standards and system for the safe use of biological innovative drugs.

With the key mechanism of disease occurrence being revealed and rapid development of modern biopharmaceutical technology, more and more biological innovative drugs have been approved for marketing. With more clinical application of innovative biological drugs in recent years, more adverse reactions were reported. Therefore, it is of great significance and urgent in clinic to construct the supervision standard and system for the safe use of biological innovative drugs. At present, the main problems hindering the clinical safety supervision of biological innovative drugs are as follows. Firstly, the mechanism of adverse drug reactions is unclear and there is a lack of specific detection indicators to predict them. Secondly, the study on the relationship of "exposure-clinical efficacy-toxic and side effects" of drugs in vivo is still insufficient, so it is difficult to support the establishment of the rule of "quantity and toxicity" for safe drug use. Thirdly, there is a lack of clinical research evidence in line with the physiological and pathological characteristics of Chinese people, and the ideal randomized controlled trials results of clinical research on new drugs are not enough to support its safe drug use in the real world. Therefore, it is necessary to strengthen the supervision awareness of the clinical safe use, accelerate the process of clinical monitoring research on biological innovative drugs, reveal more scientific evidence of clinical safe use, so as to help the construction of the supervision standards and system for the safe use of biological innovative drugs.

Objective:By observing the process of informed consent in clinical trials of one top three hospital, to disclose the non - standard phenomenon existingin the process of informed consent in clinical trials, and put for-ward that there should be special protection mechanism for vulnerable groups to participate in clinical trials. Meth-ods:Combined with the actual situation of one top three hospital, we comprehensively analyzed the problems exist-ing in the process of informed consent of clinical trials in our center, put forward strict solutions, and also formula-ted strict standards for the informed consent process of vulnerable groups. Results:Through the strict requirements of the informed consent process of vulnerable groups, the test process of vulnerable groups participating in the clini-cal trial was standardized; meanwhile the vulnerable groups were given special protection. Conclusion:Informed consent is an important guarantee that protects vulnerable groups to participate in clinical trials.

Carrying out clinical trial contract audit can audit the authenticity,legality and effectiveness of the contract and timely avoid the potential risks,clarify the responsibilities,rights and obligations of all parties participating in the clinical trials and clear the responsibility of each party in protecting the subjects,guarantee that the contracts include contents of subject protection and put them into practice.From the perspectives of establishing relevant documents,defining the main implementer,making the process,and confirming the core elements,this paper introduced how Xijing Hospital standardized clinical trial contract audit and expounded its significance in promoting the protection of subjects.

To construct, express and purify Exendin-4 analogue and detect its biological activity in vivo. Insert gene sequence into fusion partner ofpED plasmid which is helped to purification, entitled the new recombinant plasmid 5 Exendin-4 analogue polypeptide gene and fusion partner gene was linked by acid hydrolysisgene, transformed to E. coli BL21 and the fusion protein was induced by lactose. After acid hydrolysis, the Exendin-4 analogue polypeptide separated from fusion chaperon. Anion charge chromatography were used to further purification. 6 to 8 week-old ICR mice were injected (s.c) with Exendin-4 analogue, blood glucose and plasma insulin level was detected in different period after oral glucose tolerance test. The results show that high expression of inclusion body was induced by lactose, which accounted for 40% of germ proteins, the Exendin-4 analogue was obtained with the purity of 91.8% after being purified by anion charge chromatography. Bioactivity assay showed that the level of blood glucose of mouse which treated with exendin-4 analogue was obviously decreased to normal (P < 0.01), and the level of plasma insulin was increased obviously (P < 0.01).
Animals ; Cloning, Molecular ; Escherichia coli ; genetics ; metabolism ; Gene Transfer Techniques ; Hypoglycemic Agents ; metabolism ; pharmacology ; Insulin ; blood ; Male ; Mice ; Mice, Inbred ICR ; Peptides ; genetics ; pharmacology ; Recombinant Fusion Proteins ; biosynthesis ; genetics ; pharmacology ; Venoms ; biosynthesis ; genetics ; pharmacology