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.

OBJECTIVE：To study the imp rovement effects of β-boswellic acid on hippocampal neurons cells injury of rats induced by oxygen-glucose deprivation. METHODS ：The hippocampal neurons cell of rats were divided into normal control group ， model group and β-boswellic acid low-concentration ，medium-concentration and high-concentration groups （1，10，100 μmol/L）. Except for normal control group ，other groups were cultured with relevant medium and given oxygen glucose deprivation to induce oxygen-glucose deprivation induced injury model. MTT assay was adopted to detect cell viability. Chemical colorimetry was used to detect LDH activity in cell culture supernatant. Hoechst-PI staining was used to detect the morphology change of cells. Flow cytometry was used to detect early apoptosis rate of cells. The expression of apoptosis-related protein （Bcl-2，Bax and cleaved caspase-3） were detected by Western blot. RESULTS ：Compared with model group ，the survival rate of cells and protein expression of Bcl- 2 were increased significantly in β-boswellic acid medium-concentration and high-concentration groups （P＜ 0.01），while LDH activity ，early apoptosis rate ，protein expression of cleaved caspase- 3 and Bax were all decreased significantly （P＜0.05 or P＜0.01）. The densely stained nuclei and fragmentation decreased significantly. CONCLUSIONS ：β-boswellic acid can relieve oxygen-glucose deprivation induced injury of hippocampal neurons cells ，the mechanism of which may be associated with down-regulating the protein expression of cleaved caspase- 3 and Bax and up-regulating the protein expression of Bcl- 2.

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:To explore the application value of radioisotope tracer technology in clinical research of biological drugs.Methods:The pharmacokinetic properties of mepuzumab in healthy volunteers were evaluated by measuring the radioactive concentrations of iodine in blood and urine samples of 3 healthy volunteers at different time points within 14 days after intravenous infusion of 131I-labeled international class I new drug mepuzumab (Trial 1). Positron emission computed tomography (PET/CT) was performed on 6 healthy volunteers after intravenous injection of 68Ga-labeled nucleic acid aptamer Sgc8, and the standard uptake values of 68Ga-Sgc8 in different organs were measured to evaluate its biodistribution in healthy humans (Trial 2). Nine patients with suspected neuroendocrine tumors underwent single photon emission and X-ray computed tomography (SPECT/CT) 4 hours after intravenous injection of 99mTc-labeled octreotide to determine the radioactive uptake level in the regions of interest; the affinity and targeting of 99mTc-labeled octreotide to somatostatin receptor subtype 2 (SSTR2) were evaluated in combination with the immunohistochemical staining results of SSTR2 in patients′ biopsy tissues (Trial 3). Results:The 3 healthy volunteers included in Trial 1 were male, aged 28, 45, and 25 years respectively; the injection doses of 131I-labeled mepuzumab were 21.0, 25.9, and 17.6 mg, and the injection doses of radioactivity were 364, 420, and 304 MBq, respectively. Among the 6 healthy volunteers included in Trial 2, 3 were male and 3 were female, with an age of (46±11) years, ranging from 35 to 63 years. The dose of radioactivity injected was (80±7) MBq, ranging from 69 to 87 MBq. Among the 9 patients included in Trial 3, 5 were male and 4 were female, with an age of (54±10) years, ranging from 39 to 69 years. The dose of radioactivity injected was (777±74) MBq, ranging from 740 to 925 MBq. After intravenous infusion of 131I-labeled mepuzumab, the blood radioactivity concentration reached the peak 1.5 hours later. 131I-labeled mepuzumab mainly bound to blood cells, and its whole-blood clearance half-life was 420 hours. The urine radioactivity concentration reached the peak 16-24 hours after administration and then gradually decreased after 24 hours of administration. After intravenous injection of 68Ga-labeled Sgc8, the organs with strong to weak radioactive signals were bladder, kidney, heart, uterus, liver, spleen, gallbladder, large intestine and lung. Within 3 hours after drug administration, the clearance rate was fastest in heart, followed by uterus, kidney, and liver; the clearance rate was slower in spleen and gallbladder and were slowest in large intestine and lung. All of the 9 patients had abnormal radioactivity accumulation 4 hours after intravenous injection of 99mTc-labeled octreotide and the immunohistochemical staining results of biopsy tissues showed strong positive expression of SSTR2, indicating that 99mTc-labeled octreotide had good affinity and targeting to SSTR2. The safety evaluation showed that in Trail 1, one subject developed iodine-related hyperthyroidism one month after intravenously infusion of 131I-labeled mepuzumab, which returned to normal after 8 months of continuous monitoring without intervention. No adverse reactions occurred in other subjects. Conclusions:Radioisotope tracer technology can noninvasively, dynamically, and visually evaluate the pharmacokinetics, biological distribution, and targeting of biological drugs in human body. It has good safety and great application value in the clinical evaluation of biological 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:To explore the application value of radioisotope tracer technology in clinical research of biological drugs.Methods:The pharmacokinetic properties of mepuzumab in healthy volunteers were evaluated by measuring the radioactive concentrations of iodine in blood and urine samples of 3 healthy volunteers at different time points within 14 days after intravenous infusion of 131I-labeled international class I new drug mepuzumab (Trial 1). Positron emission computed tomography (PET/CT) was performed on 6 healthy volunteers after intravenous injection of 68Ga-labeled nucleic acid aptamer Sgc8, and the standard uptake values of 68Ga-Sgc8 in different organs were measured to evaluate its biodistribution in healthy humans (Trial 2). Nine patients with suspected neuroendocrine tumors underwent single photon emission and X-ray computed tomography (SPECT/CT) 4 hours after intravenous injection of 99mTc-labeled octreotide to determine the radioactive uptake level in the regions of interest; the affinity and targeting of 99mTc-labeled octreotide to somatostatin receptor subtype 2 (SSTR2) were evaluated in combination with the immunohistochemical staining results of SSTR2 in patients′ biopsy tissues (Trial 3). Results:The 3 healthy volunteers included in Trial 1 were male, aged 28, 45, and 25 years respectively; the injection doses of 131I-labeled mepuzumab were 21.0, 25.9, and 17.6 mg, and the injection doses of radioactivity were 364, 420, and 304 MBq, respectively. Among the 6 healthy volunteers included in Trial 2, 3 were male and 3 were female, with an age of (46±11) years, ranging from 35 to 63 years. The dose of radioactivity injected was (80±7) MBq, ranging from 69 to 87 MBq. Among the 9 patients included in Trial 3, 5 were male and 4 were female, with an age of (54±10) years, ranging from 39 to 69 years. The dose of radioactivity injected was (777±74) MBq, ranging from 740 to 925 MBq. After intravenous infusion of 131I-labeled mepuzumab, the blood radioactivity concentration reached the peak 1.5 hours later. 131I-labeled mepuzumab mainly bound to blood cells, and its whole-blood clearance half-life was 420 hours. The urine radioactivity concentration reached the peak 16-24 hours after administration and then gradually decreased after 24 hours of administration. After intravenous injection of 68Ga-labeled Sgc8, the organs with strong to weak radioactive signals were bladder, kidney, heart, uterus, liver, spleen, gallbladder, large intestine and lung. Within 3 hours after drug administration, the clearance rate was fastest in heart, followed by uterus, kidney, and liver; the clearance rate was slower in spleen and gallbladder and were slowest in large intestine and lung. All of the 9 patients had abnormal radioactivity accumulation 4 hours after intravenous injection of 99mTc-labeled octreotide and the immunohistochemical staining results of biopsy tissues showed strong positive expression of SSTR2, indicating that 99mTc-labeled octreotide had good affinity and targeting to SSTR2. The safety evaluation showed that in Trail 1, one subject developed iodine-related hyperthyroidism one month after intravenously infusion of 131I-labeled mepuzumab, which returned to normal after 8 months of continuous monitoring without intervention. No adverse reactions occurred in other subjects. Conclusions:Radioisotope tracer technology can noninvasively, dynamically, and visually evaluate the pharmacokinetics, biological distribution, and targeting of biological drugs in human body. It has good safety and great application value in the clinical evaluation of biological drugs.