1.Analysis on the expression of drug standards and related issues in the newly revised Drug Administration Law
Heyun NIE ; Minxian SONG ; Guiping YAN ; Ming XIE ; Yongmei GUAN ; Dongmei YAN ; Weifeng ZHU
China Pharmacy 2022;33(15):1806-1809
OBJECTIVE To sort out and analyze the expression and provisions of drug standards in the text of the newly revised Drug Administration Law ,and to explore the connotation and legal positioning of drug registration standards so as to provide reference for the rational application and interpretation of relevant provisions of drug standards in Drug Administration Law . METHODS Through the review of the evolution of drug standard management in China ,the legal provisions of drug standard in the Drug Administration Law were analyzed. Comparative study and literature research methods were used to analyze the legal expression and connotation of drug standards. RESULTS & CONCLUSIONS There were different expressions about “national drug standards ”“drug standards ”and“quality standards ”in the current provisions of the newly revised Drug Administration Law ; the legal position of the provincial-level standard for the preparation of Chinese herbal pieces was not clear ,and there may be insufficient legal regulation in the enforcement of drug administration. It is necessary to make an administrative interpretation for the content of relevant drug standards and provisions ,and further clarify the legal attributes of drug standards in the processing of provincial Chinese herbal pieces in order to promote the standardized management of Chinese herbal pieces.
2.Effects of high expression of Wnt/β-catenin signaling pathway on growth plate development of tibial growth plate in young rats with chronic renal failure
Xiaojian WANG ; Guiping GUAN ; Xiao LU ; Yafeng LI ; Yanfang GAO ; Gang ZHENG ; Hong BI ; Yunxing SU ; Rongshan LI
Chinese Journal of Nephrology 2021;37(2):137-142
Objective:To explore the effect of Wnt/β-catenin signaling pathway on growth plate development of tibial growth plate in young chronic renal failure (CRF) rats.Methods:Four-week-old male SD rats were randomly divided into control group and CRF group ( n=20/per group). Control group was intragastric administration with distilled water, and CRF group was given adenine suspension (150 mg·kg -1·d -1). All the young rats were sacrificed after continuous gavages for 6 weeks. The full length of tibia was compared between the two groups. The width of tibia proximal growth plates was measured by micro-CT scanning, and the width of the growth plate was also measured in histological sections. Chondrocytes isolated from growth plate in two groups were cultured in vitro to P3 generation. Immunohistochemical staining was used to detect the expression of collagen Ⅱ, matrix metalloproteinase 13 (MMP-13) and β-catenin in chondrocytes. Western blotting was used to detect the protein expressions of collagen Ⅱ, MMP-13 and β-catenin. Results:Compared with the control group, the tibial length of rats in the CRF group was shorter [(27.32±5.81) mm vs (35.43±3.61) mm, t=5.226, P<0.001], the width of growth plate in micro-CT picture was more narrow [(0.72±0.22) mm vs (1.13±0.27) mm, t=5.096, P<0.001], and the relative width of the growth plate was also more narrow ( t=6.744, P<0.001) in histological sections. The results of immunohistochemistry and Western blotting showed the expressions of collagen Ⅱ in the CRF group decreased significantly ( t=8.212, P<0.001), MMP-13 ( t=13.091, P<0.001) and β-catenin ( t=7.534, P<0.001) increased significantly compared the control group in chondrocytes. Conclusion:The Wnt/β-catenin signaling pathway is highly expressed in the tibial growth plate of young rats with chronic renal failure, which leads to accelerated degeneration and differentiation of chondrocytes and a closure tendency of growth plate.
3.Coronavirus disease 2019 vaccination in patients with autoimmune diseases
Yue GUAN ; Fei MU ; Wei ZHANG ; Yi QIAO ; Congcong WANG ; Sunin CHEN ; Guiping GUO ; Jingwen WANG
Adverse Drug Reactions Journal 2021;23(7):342-347
Benifits outweigh the risks for patients with autoimmune disease (AID) in remission period to be vaccinated with coronavirus disease 2019 (COVID-19) vaccines. The mRNA vaccines, inactivated vaccines, and recombinant protein subunit vaccines are safe for AID patients, whereas the safety of recombinant adenovirus vector-based vaccines is still uncertain. Some drugs for the treatment of AID may reduce the immune response of the body to the COVID-19 vaccines and affect the immune efficacy of the vaccine, which may be related to the timing of vaccination. Based on several published relevant guidelines and recommendations for the COVID-19 vaccines in AID patients, this article elaborates on vaccination problems to be paid attention to in patients with AID treated with different drugs.
4.Coronavirus disease 2019 vaccination in patients with autoimmune diseases
Yue GUAN ; Fei MU ; Wei ZHANG ; Yi QIAO ; Congcong WANG ; Sunin CHEN ; Guiping GUO ; Jingwen WANG
Adverse Drug Reactions Journal 2021;23(7):342-347
Benifits outweigh the risks for patients with autoimmune disease (AID) in remission period to be vaccinated with coronavirus disease 2019 (COVID-19) vaccines. The mRNA vaccines, inactivated vaccines, and recombinant protein subunit vaccines are safe for AID patients, whereas the safety of recombinant adenovirus vector-based vaccines is still uncertain. Some drugs for the treatment of AID may reduce the immune response of the body to the COVID-19 vaccines and affect the immune efficacy of the vaccine, which may be related to the timing of vaccination. Based on several published relevant guidelines and recommendations for the COVID-19 vaccines in AID patients, this article elaborates on vaccination problems to be paid attention to in patients with AID treated with different drugs.
5.Study on Methodology Re-evaluation for Systematic Review/Meta-analysis of Antidepressants in the Treatment of Post-stroke Depression
Yue GUAN ; Guiping GUO ; Jingwen WANG ; Mingming WANG ; Fei MOU ; Yi QIAO ; Qiongge LI
China Pharmacy 2020;31(24):3036-3041
OBJECTIVE: To re-evaluate t he methodology quality of published systematic review/Meta-analysis of antidepressants in the treatment of post-stroke depression. METHODS :Retrieved from Cochrane Library ,PubMed,Embase, SinoMed,CNKI,Wanfang database ,VIP,CBM and other databases ,systematic review/Meta-analysis of antidepressants in the treatment of post-stroke depression were collected during the inception to Dec. 2019. After literature screening and data extraction , methodology quality of included literatures were evaluated by using the AMSTAR scale. RESULTS :A total of 33 systematic reviews/Meta-analysis were included ,involving 523 RCTs and 41 020 patients. Average score of AMSTAR methodological quality evaluation was 6.76. Citalopram ,duloxetine and paroxetine were effective for the therapy of post-stroke depression ,but the conclusions about the effectiveness among antide-pressants were not consistents. The ADR incidence of Paroxetine was low. It was not clear that sertraline and citalopram may improve the neurological function of patients. CONCLUSIONS :The methodological quality of systematic review/Meta-analysis of antidepressants in the treatment of post-stroke depression is medium ,and the conclusions about the effectiveness of antidepressants ,improvement of daily life ability and the recovery of neurological function are still controversial.
6.Mental disorders caused by an interaction of oxycodone and pregabalin
Nan ZHOU ; Guiping GUO ; Lichao MAO ; Yue GUAN
Adverse Drug Reactions Journal 2020;22(10):597-598
A 51-year-old male patient received an operation treatment for paranasal sinusitis induced by radiotherapy and chemotherapy of nasopharyngeal carcinoma. One oxycodone and acetaminophen tablet (each tablet contains oxycodone hydrochloride 5 mg and acetaminophen 325 mg) was given orally thrice daily before and after the operation. Pregabalin 75 mg twice daily was added because of the poor analgesic effectiveness. During the treatment, oral oxycodone hydrochloride 10 mg was given once daily by his family members for 2 days. Two days after the addition of pregabalin, the patient developed mental disorders, such as delirium, irritability, involuntary convulsions of limbs, cognitive impairment, and disorientation. All above-mentioned analgesics were discontinued and dexmedetomidine was given for pain relief and sedation. Three days later, the mental state of the patient was improved, there was no obvious delirium, the discrimination and orientation returned to normal, and dexmetomidine was discontinued. There was an obvious time correlation between the occurrence and disappearance of mental disorders and the combination of analgesic drugs. Referring to the previous literature, it was considered that the mental disorders of the patient were caused by the interaction between oxycodone and pregabalin.
7.Mental disorders caused by an interaction of oxycodone and pregabalin
Nan ZHOU ; Guiping GUO ; Lichao MAO ; Yue GUAN
Adverse Drug Reactions Journal 2020;22(10):597-598
A 51-year-old male patient received an operation treatment for paranasal sinusitis induced by radiotherapy and chemotherapy of nasopharyngeal carcinoma. One oxycodone and acetaminophen tablet (each tablet contains oxycodone hydrochloride 5 mg and acetaminophen 325 mg) was given orally thrice daily before and after the operation. Pregabalin 75 mg twice daily was added because of the poor analgesic effectiveness. During the treatment, oral oxycodone hydrochloride 10 mg was given once daily by his family members for 2 days. Two days after the addition of pregabalin, the patient developed mental disorders, such as delirium, irritability, involuntary convulsions of limbs, cognitive impairment, and disorientation. All above-mentioned analgesics were discontinued and dexmedetomidine was given for pain relief and sedation. Three days later, the mental state of the patient was improved, there was no obvious delirium, the discrimination and orientation returned to normal, and dexmetomidine was discontinued. There was an obvious time correlation between the occurrence and disappearance of mental disorders and the combination of analgesic drugs. Referring to the previous literature, it was considered that the mental disorders of the patient were caused by the interaction between oxycodone and pregabalin.

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