1.Retrospective analysis of adverse drug reactions of bevacizumab biosimilar and original drug in our hospital
Nianyang DING ; Li LI ; Panqi FANG ; Silu XU ; Min ZHAO ; Dan YAN
China Pharmacy 2024;35(4):472-475
OBJECTIVE To analyze the occurrence of adverse drug reactions (ADR) between bevacizumab biosimilars and original drugs, and to provide data support for rational use of drugs in clinical. METHODS ADR reports of bevacizumab biosimilars and original drugs reported by Jiangsu Cancer Hospital from January to December 2022 were retrospectively analyzed. RESULTS A total of 6 818 patients were treated with bevacizumab, and 136 ADR patients were reported. The incidence of ADR caused by bevacizumab biosimilars was higher than original drugs (2.18% vs. 0.71%, P=0.004). In ADR reports, the main treatment plan was bevacizumab combined with other tumor drugs (129 patients); 118 patients were cured and improved; there were 108 general reports and 28 serious reports; the main system/organ involved in ADR was the cardiovascular system; there were no statistical significance in the incidence rates of hypertension/blood pressure increase, leukocyte/platelet decrease, diarrhea and fever caused by bevacizumab biosimilars and original drugs. CONCLUSIONS The incidence of ADR related to bevacizumab biosimilars is significantly higher than that of the original drugs, but there is no significant difference in the clinical manifestation of ADR. Clinicians can use bevacizumab biosimilars or original drugs based on the willingness of patients and their families.
2.Herbal Textual Research on Asteris Radix et Rhizoma in Famous Classical Formulas
Hengyang LI ; Wenjie LI ; Xiaoying DING ; Dan ZHANG ; Zijing XUE ; Qi AN ; Zhilai ZHAN ; Yuguang ZHENG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(7):20-30
By reviewing the ancient and modern literature, the name, origin, scientific name evolution, place of origin, quality, harvesting, processing, efficacy and toxicity of Asteris Radix et Rhizoma(ARR) were systematically sorted out, so as to provide reference for the development and utilization of the relevant famous classical formulas. According to textual research, ARR was first contained in Shennong Bencaojing, all generations are Ziwan for its proper name, and there are still aliases such as Ziyuan, Ziqian and Xiaobianer. Its mainstream origin in successive generations was Aster tataricus, and there are also Ligularia fischeri and others in local area of use. The medicinal parts of ARR are root and rhizome, but in modern times, the rhizome is mostly used for propagation and cultivation, so some of ARR medicinal materials only have the root without the rhizome. The earliest recorded ancient origin of ARR was now Fangxian(Hubei), Zhengding and Handan(Heibei), then the range of production areas gradually expanded, the mainstream production areas from the Song dynasty to the Ming and Qing dynasties included Hebei, Jiangsu, Anhui, Henan and other places, since modern times, two major producing areas have been formed in Anguo, Hebei province and Bozhou, Anhui province. From the quality evaluation, it is clear that from ancient times, flexible roots and purple color are the best. The ancient harvesting was mainly in lunar February or March, and then dried in the shade, and the modern harvesting is mostly in spring and autumn, and the roots are braided into pigtails and then dried in the sun or dried in the sun after 1-2 d. The ancient and modern processing method of ARR are basically the same, mainly honey processing, there are still methods of frying, steaming, vinegar sizzling, etc. Based on the results, it is recommended that the dried roots and rhizomes of A. tataricus should be used in clinical and the development of related famous classical formulas, and those whose original formulas specify the processing requirements can be processed according to the relevant requirements, while whose processing requirements are not specified should be used in the form of raw products.
3. Advances on cardiovascular effects of GLP-lRAs
Zhi-Qiang KE ; Chao LIU ; Zhi-Qiang KE ; Qian-Qian MA ; Zheng-Ding SU ; Dan LI ; Xin-Yuan ZHAO
Chinese Pharmacological Bulletin 2024;40(3):426-430
Glucagon-like peptide-1 ( GLP-1 ) is secreted by gut enteroendocrine cells. GLP-1 receptor agonists ( GLP-1 RAs) control glucose-related augmentation of insulin and suppress glu-cagon secretion. GLP-lRAs also inhibit gastric emptying, food intake and limit weight gain. In the past decade, significant progresses have been made in the investigation on the effects of GLP-1 RAs on cardiovascular system. The potential advantages of oral small-molecule GLP-1 RAs could improve the application of this class of drugs. This review highlights the multiple cardiovascular profiles of GLP-1 RAs in the treatment of cardiovascular diseases to provide new insights into cardiovascular benefits of GLP-1 RAs.
4.Expression Level and Clinical Significance of Serum miR-181c and miR-578 in Patients with Sepsis Complicated by Acute Kidney Injury
Fei SONG ; Dan LI ; Meng YU ; Min LI ; Ji DING ; Lanlan LI
Journal of Modern Laboratory Medicine 2024;39(1):49-54
Objective To investigate the expression level and clinical significance of microRNA(miR)-181c and microRNA(miR)-578 in the serum of patients with sepsis complicated by acute kidney injury(AKI).Methods Eighty patients with sepsis complicated by AKI(AKI group)and 80 patients with simple sepsis(non AKI group)who were hospitalized in Sinopharm Gezhouba Central Hospital from January 2022 to December 2022 were collected as research subjects.The serum levels of miR-181c and miR-578 in two groups were detected and compared.Logistic regression was applied to analyze the influencing factors of sepsis patients complicated by AKI.Receiver operating characteristic(ROC)curve was applied to analyze the predictive value of serum miR-181c and miR-578 levels for patients with sepsis complicated by AKI.Results The proportion of pulmonary infection,the level of arterial blood lactic acid,creatinine,urea nitrogen and APACHEⅡ score in AKI group were higher than those in non-AKI group,and the oxygenation index was lower,the differences were statistically significant(χ2=7.364,t=14.298,26.691,17.925,7.104,12.676,all P<0.05).The serum miR-181c level in the AKI group(1.47±0.36)was higher than that in the non AKI group(1.03±0.28),the serum miR-578 level(0.76±0.19)was lower than that in the non AKI group(1.05±0.31),and the differences were statistically significant(t=8.629,7.134,all P=0.000).Logistic regression analysis showed that miR-181c[OR(95%CI):2.984(1.628~5.468)],pulmonary infection[OR(95%CI):1.946(1.250~3.031)],arterial blood lactic acid[OR(95%CI):1.457(1.073~1.978)],and APACHE Ⅱ score[OR(95%CI):2.283(1.393~3.741)]were risk factors for AKI in sepsis patients(all P<0.05);miR-578[OR(95%CI):0.742(0.631~0.873)]and oxygenation index[OR(95%CI):0.342(0.130~0.904)]were protective factors(all P<0.05).The combined prediction of serum miR-181c and miR-578 for AKI in sepsis patients had an AUC of 0.915,a sensitivity and a specificity of 83.65%,88.75%,respectively,which was superior to their individual predictions(Z=3.118,3.460,P=0.002,0.001).Conclusion The serum miR-181c expression is obviously up-regulated and miR-578 expression is obviously down-regulated in patients with sepsis complicated by AKI.The combination of the two has good reference value for predicting sepsis complicated by AKI.
5.Herbal Textual Research on Farfarae Flos in Famous Classical Formulas
Tao WANG ; Xiaoying DING ; Hengyang LI ; Qi AN ; Zijing XUE ; Huikang ZHANG ; Yuguang ZHENG ; Zhilai ZHAN ; Dan ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(4):67-76
By consulting ancient and modern literature, the herbal textual research of Farfarae Flos has been conducted to verify the name, origin, producing area, quality evaluation, harvesting and processing methods, so as to provide reference for the development and utilization of the famous classical formulas containing Farfarae Flos. According to the research, the results showed that Farfarae Flos was first described as a medicinal material by the name of Kuandonghua in Shennong Bencaojing(《神农本草经》), and the name was used and justified by later generations. The main origin was the folwer buds of Tussilago farfara, in addition, the flower buds of Petasites japonicus were used as medicine in ancient times. The ancient harvesting time of Farfarae Flos was mostly in the twelfth month of the lunar calendar, and the modern harvesting time is in December or before the ground freeze when the flower buds have not been excavated. Hebei, Gansu, Shaanxi are the authentic producing areas with the good quality products. Since modern times, its quality is summarized as big, fat, purple-red color, no pedicel is better. Processing method from soaking with licorice water in the Northern and Southern dynasties to stir-frying with honey water followed by micro-fire in the Ming dynasty, and gradually evolved to the modern mainstream processing method of honey processing. Based on the research results, it is suggested that the dried flower buds of T. farfara, a Compositae plant, should be selected for the development of famous classical formulas containing Farfarae Flos, and the corresponding processed products should be selected according to the specific processing requirements of the formulas, and raw products are recommended for medicinal use without indicating processing requirements.
6.Clinical efficacy of transcatheter arterial chemoembolization combined with lenvatinib and camrelizumab in the treatment of advanced hepatocellular carcinoma
Xuexian ZHANG ; Yuhan DING ; Wei LI ; Qingwei LI ; Jun ZHANG ; Dan DUAN ; Yongle LI ; Jian LONG ; Jidong YANG ; Chenglong ZHANG ; Peng WU ; Huijuan SUN ; Geng WU
Journal of Interventional Radiology 2024;33(1):57-62
Objective To evaluate the safety and efficacy of transcatheter arterial chemoembolization(TACE)combined with lenvatinib and camrelizumab in the treatment of advanced hepatocellular carcinoma(HCC).Methods The clinical data of a total of 63 patients with advanced HCC,who received TACE combined with lenvatinib and camrelizumab(triple therapy)or TACE combined with lenvatinib(dual therapy)at the Jingmen Municipal People's Hospital of China between April 2020 and December 2021,were retrospectively analyzed.Triple therapy group had 30 patients,and dual therapy group had 33 patients.The post-treatment tumor response,disease progression-free survival(PFS),overall survival(OS),and the incidence of adverse drug reactions were recorded.Results The median follow-up period of the two groups was 14 months(range of 4-26 months).Compared with the dual therapy group,in the triple therapy group the objective response rate(ORR)was remarkably higher(83.3%vs.57.6%,P=0.026),the disease control rate(DCR)was obviously higher(93.3%vs.69.7%,P=0.039),the median PFS was significantly longer(8.0 months vs.5.0 months,P<0.01),and the median OS was strikingly longer(24.0 months vs.12.0 months,P=0.004).No statistically significant difference in the incidence of adverse drug reactions existed between the two groups(P>0.05).Conclusion For the treatment of advanced HCC,TACE combined with lenvatinib and camrelizumab is clinically safe and effective.(J Intervent Radiol,2024,32:57-62)
7.Research status on the mechanism of action of Astragaloside Ⅳ on cardiovascular diseases
Er-Dan XIN ; Yu-Gui ZHANG ; Tian-Tian BIAN ; Ding-Cai MA ; Zhe WANG ; Mao-Mao WANG ; Yue-Feng LI
The Chinese Journal of Clinical Pharmacology 2024;40(17):2580-2585
Asragaloside Ⅳ(AS-Ⅳ)is one of the active ingredients of Astragalus membranaceus,and AS-Ⅳ can play a protective role in cardiovascular diseases by inhibiting inflammatory response,inhibiting cardiomyocyte apoptosis,improving myocardial ischemia reperfusion injury,regulating lipid metabolism,promoting cardiac vascular regeneration,inhibiting myocardial fibrosis,and improving myocardial hypertrophy.In this paper,we reviewed the relevant literature on the prevention and treatment of cardiovascular diseases of AS-Ⅳ,and summarized and analyzed its role and mechanism,in order to provide a reference for the in depth research on cardiovascular diseases and the development and application of drugs.
8.National bloodstream infection bacterial resistance surveillance report (2022) : Gram-negative bacteria
Zhiying LIU ; Yunbo CHEN ; Jinru JI ; Chaoqun YING ; Qing YANG ; Haishen KONG ; Haifeng MAO ; Hui DING ; Pengpeng TIAN ; Jiangqin SONG ; Yongyun LIU ; Jiliang WANG ; Yan JIN ; Yuanyuan DAI ; Yizheng ZHOU ; Yan GENG ; Fenghong CHEN ; Lu WANG ; Yanyan LI ; Dan LIU ; Peng ZHANG ; Junmin CAO ; Xiaoyan LI ; Dijing SONG ; Xinhua QIANG ; Yanhong LI ; Qiuying ZHANG ; Guolin LIAO ; Ying HUANG ; Baohua ZHANG ; Liang GUO ; Aiyun LI ; Haiquan KANG ; Donghong HUANG ; Sijin MAN ; Zhuo LI ; Youdong YIN ; Kunpeng LIANG ; Haixin DONG ; Donghua LIU ; Hongyun XU ; Yinqiao DONG ; Rong XU ; Lin ZHENG ; Shuyan HU ; Jian LI ; Qiang LIU ; Liang LUAN ; Jilu SHEN ; Lixia ZHANG ; Bo QUAN ; Xiaoping YAN ; Xiaoyan QI ; Dengyan QIAO ; Weiping LIU ; Xiusan XIA ; Ling MENG ; Jinhua LIANG ; Ping SHEN ; Yonghong XIAO
Chinese Journal of Clinical Infectious Diseases 2024;17(1):42-57
Objective:To report the results of national surveillance on the distribution and antimicrobial resistance profile of clinical Gram-negative bacteria isolates from bloodstream infections in China in 2022.Methods:The clinical isolates of Gram-negative bacteria from blood cultures in member hospitals of national bloodstream infection Bacterial Resistant Investigation Collaborative System(BRICS)were collected during January 2022 to December 2022. Antibiotic susceptibility tests were conducted by agar dilution or broth dilution methods recommended by Clinical and Laboratory Standards Institute(CLSI). WHONET 5.6 and SPSS 25.0 software were used to analyze the data.Results:During the study period,9 035 strains of Gram-negative bacteria were collected from 51 hospitals,of which 7 895(87.4%)were Enterobacteriaceae and 1 140(12.6%)were non-fermenting bacteria. The top 5 bacterial species were Escherichia coli( n=4 510,49.9%), Klebsiella pneumoniae( n=2 340,25.9%), Pseudomonas aeruginosa( n=534,5.9%), Acinetobacter baumannii complex( n=405,4.5%)and Enterobacter cloacae( n=327,3.6%). The ESBLs-producing rates in Escherichia coli, Klebsiella pneumoniae and Proteus spp. were 47.1%(2 095/4 452),21.0%(427/2 033)and 41.1%(58/141),respectively. The prevalence of carbapenem-resistant Escherichia coli(CREC)and carbapenem-resistant Klebsiella pneumoniae(CRKP)were 1.3%(58/4 510)and 13.1%(307/2 340);62.1%(36/58)and 9.8%(30/307)of CREC and CRKP were resistant to ceftazidime/avibactam combination,respectively. The prevalence of carbapenem-resistant Acinetobacter baumannii(CRAB)complex was 59.5%(241/405),while less than 5% of Acinetobacter baumannii complex was resistant to tigecycline and polymyxin B. The prevalence of carbapenem-resistant Pseudomonas aeruginosa(CRPA)was 18.4%(98/534). There were differences in the composition ratio of Gram-negative bacteria in bloodstream infections and the prevalence of main Gram-negative bacteria resistance among different regions,with statistically significant differences in the prevalence of CRKP and CRPA( χ2=20.489 and 20.252, P<0.001). The prevalence of CREC,CRKP,CRPA,CRAB,ESBLs-producing Escherichia coli and Klebsiella pneumoniae were higher in provinicial hospitals than those in municipal hospitals( χ2=11.953,81.183,10.404,5.915,12.415 and 6.459, P<0.01 or <0.05),while the prevalence of CRPA was higher in economically developed regions(per capita GDP ≥ 92 059 Yuan)than that in economically less-developed regions(per capita GDP <92 059 Yuan)( χ2=6.240, P=0.012). Conclusions:The proportion of Gram-negative bacteria in bloodstream infections shows an increasing trend,and Escherichia coli is ranked in the top,while the trend of CRKP decreases continuously with time. Decreasing trends are noted in ESBLs-producing Escherichia coli and Klebsiella pneumoniae. Low prevalence of carbapenem resistance in Escherichia coli and high prevalence in CRAB complex have been observed. The composition ratio and antibacterial spectrum of bloodstream infections in different regions of China are slightly different,and the proportion of main drug resistant bacteria in provincial hospitals is higher than those in municipal hospitals.
9.Diagnostic value of nucleic acid matrix-assisted laser desorption ionization-time of flight mass spectrometry in sputum smear-negative patients with nontuberculous Mycobacterial pulmonary disease
Xusheng GAO ; Caihong DING ; Qing WANG ; Dan XIE ; Fengmin MEN ; Peipei JIANG ; Qiang LI ; Lingjuan ZHOU ; Yu XIONG
Chinese Journal of Clinical Infectious Diseases 2024;17(1):58-63
Objective:To investigate the diagnostic value of nucleic acid matrix-assisted laser desorption ionization-time of flight mass spectrometry(MALDI-TOF MS)in sputum smear-negative patients with nontuberculous Mycobacterial(NTM)pulmonary disease.Methods:Clinical data of 123 patients suspected of NTM pulmonary disease admitted in Public Health Clinical Center Affiliated to Shandong University between July 2022 and November 2023 were retrospectively analyzed. Bronchoalveolar lavage fluid(BALF)specimens were collected for MALDI-TOF MS assay and MGIT 960 culture. The diagnostic efficacy of MALDI-TOF MS for NTM pulmonary disease in patients with negative sputum smears for acid-fast bacilli was evaluated with receiver operating characteristic(ROC)curve. Statistical analysis was performed using SPSS 26.0 software and MedCalc statistical software.Results:Diagnosis of NTM pulmonary disease was finally confirmed in 66 out of the 123 suspected patients. It took 8 to 24 h for MALDI-TOF MS to identify NTM species and resistance. By MALDI-TOF MS,72 NTM strains were identified,with the Mycobacterium avium complex being the most prevalent(34 strains,47.22%),followed by the Mycobacterium abscessus complex(13 strains,18.06%);resistance to macrolides was detected in 6 cases,while no resistance to aminoglycosides was found. It took 9 to 45 days for BALF MGIT 960 culture to identify NTM,and took 7 to 15 days for NTM typing and drug sensitivity testing. By BALF MGIT 960 culture,28 NTM strains were identified;and 1 case was found to be resistant to macrolides. Using confirmed diagnosis as the gold standard,MALDI-TOF MS demonstrated higher sensitivity,negative predictive value,and agreement rate compared to MGIT 960 culture(84.85% vs. 42.42%,81.13% vs. 56.32%,80.49% vs. 62.60%, χ2=25.667,8.998,9.664, P<0.05 or <0.01). The area under ROC curve(AUC)for MALDI-TOF MS was significantly higher than that of MGIT 960 culture(0.801 vs. 0.642, Z=3.300, P=0.001). Conclusion:Compared to MGIT 960 culture,MALDI-TOF MS exhibits superior diagnostic efficiency in detecting NTM pulmonary disease in patients with acid-fast bacilli smear-negative sputum,with advantage of rapidly identifying NTM species and resistance.
10.Effect of sling exercise with Tuina therapy on kinesiophobia in old patients with lumbar disc herniation:a ran-domized controlled trial based on concept of brain-bone axis
Yuqin DAN ; Jianing SU ; Yi DING ; Xueyan WANG ; Danghan XU ; Jinghua WANG ; Yujing WU ; Mengyuan ZHANG ; Meng YIN ; Haifeng LU ; Gongchang YU ; Li LI
Chinese Journal of Rehabilitation Theory and Practice 2024;30(7):861-868
Objective To explore the effect of sling exercise with Tuina therapy on kinesiophobia in old patients with lumbar disc herniation,and analyze the mechanism based on brain-bone axis. Methods A total of 56 old patients with chronic lumbar disc herniation and kinesiophobia were selected from the Reha-bilitation Hospital of the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine from September,2022 to December,2023;and randomly divided into control group(n=28)and experimental group(n=28).The control group accepted conventional exercise therapy,while the experimental group accepted sling exercise with Tuina therapy,for four weeks.They were assessed with simplified Chinese version of Tampa Scale of Kinesiophobia(TSK),Japanese Orthopaedic Association score(JOA)and Visual Analogue Scale for pain(VAS)before and after treatment,while the bone mineral density(BMD)was tested,the levels of osteoprote-gerin(OPG),norepinephrine(NE)and corticosteroids(Cor)in serum were measured,and the median frequency(MF)of weak-link erector spinae was detected with surface electromyography. Results Two cases dropped off in the control group,and one in the experimental group.The scores of all the assessment improved in both groups after treatment(|t|>14.168,P<0.001),as well as the serum levels of OPG,NE and Cor(|t|>2.103,P<0.05),BMD(|t|>2.726,P<0.05),and MF of erector spinae(|t|>14.736,P<0.001);all of them were better in the experimental group than in the control group(|t|>2.154,P<0.05). Conclusion Sling exercise with Tuina therapy can improve the pain and kinesiophobia of lumbar disc herniation in the old adults,which may promote the recovery of physical and mental function through regulating the levels of hor-mones and neurotransmitters related to the brain-bone axis.

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