1.Literature analysis of tislelizumab-induced Stevens-Johnson syndrome and toxic epidermal necrolysis
Rui HAN ; Mingxi SHEN ; Hua YANG ; Zhaoshuai JI
China Pharmacy 2025;36(16):2046-2050
OBJECTIVE To analyze the clinical characteristics of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) induced by tislelizumab, providing evidence for clinical medication safety. METHODS Case reports of tislelizumab-related SJS/TEN were retrieved from CNKI, VIP, Wanfang Data, PubMed, ScienceDirect, and Embase. Descriptive analysis was performed. RESULTS Seventeen cases from 17 publications were included (SJS 4 cases, TEN 13 cases). Among them, there were 10 males and 7 females. Twelve patients were aged between 70 and 79 years. The predominant tumor type was lung cancer (10 cases). Thirteen patients received combination therapy with chemotherapeutic drugs. The median onset time of SJS/ TEN was 26 (4, 104) days. Nine patients developed SJS/TEN after the first administration of the drug. Sixteen patients exhibited prodromal rash symptoms, primarily characterized by severe skin damage such as skin detachment, accompanied by mucosal injury. Sixteen patients improved after symptomatic treatment, while one patient died. CONCLUSIONS Tislelizumab-associated SJS/TEN risk is higher in elderly patients, males, those with lung cancer and those receiving combination chemotherapy. Mucosal lesions and atypical rashes may indicate the early onset of SJS/TEN. During clinical use, pharmaceutical care can be carried out through measures such as identifying high-risk populations, closely monitoring skin symptoms from the first administration to the fifth treatment cycle, and enhancing patient education. When relevant symptoms occur, the medication should be promptly discontinued and symptomatic treatment should be administered to ensure the patient’s medication safety.
2.OCT and IVUS evaluating stent apposition and endothelialization after FD implantation in aneurysm animal models
Ji MA ; Shuhai LONG ; Jie YANG ; Zhen LI ; Haiqiang SANG ; Yi TANG ; Yuncai RAN ; Yong ZHANG ; Baohong WEN ; Shanshan XIE ; Ke CHEN ; Enjie LIU ; Xinwei HAN ; Tengfei LI
Chinese Journal of Neuromedicine 2024;23(3):256-262
Objective:To investigate the application value of optical coherence tomography (OCT) and intravascular ultrasound (IVUS) in evaluating flow diverter (FD) apposition and endothelialization in aneurysm animal models, and analyze the effect of incomplete stent apposition (ISA) on aneurysm lumen healing and stent endothelialization.Methods:Lateral common carotid artery aneurysm models in swines were established by surgical method and then FD was implanted. Immediately after surgery, OCT and IVUS were used to evaluate the locations and degrees of ISA, and difference between these 2 methods in evaluating FD apposition was compared. DSA was performed at 12 weeks after surgery to evaluate the aneurysm occlusion (Kamran grading) and stent patency. OCT and IVUS were used again to observe the stent endothelial situation; by comparing with histopathologic results, effect of ISA on aneurysm healing and stent endothelialization was analyzed.Results:Lateral common carotid artery aneurysm models in 6 swines were established, and 6 Tubridge FDs were successfully implanted. Compared with IVUS (3 stents, 4 locus), OCT could detect more ISA (6 stents, 14 locus); and the vascular diameter change area (7 locus), aneurysm neck area (4 locus) and the head and tail of FD (3 locus) were the main sites of FD malapposition; average distance between stent wire and vessel wall was (560.14±101.48) μm. At 12 weeks after surgery, DSA showed that 1 patient had a little residual contrast agent at the aneurysm neck (Kamran grading 3), and the remaining 5 had complete aneurysm occlusion (Kamran grading 4). One FD had moderate lumen stenosis, and the other 5 FDs had lumen patency. OCT indicated mostly disappeared acute ISA; ISA proportion decreased to 21.4 % (3/14), including 2 in the aneurysm neck and 1 in the partial stent. Histopathological results showed bare stent woven silk, without obvious endothelial coverage; in one FD with luminal stenosis, intimal hyperplasia was mainly composed of vascular smooth muscle cells.Conclusion:In carotid artery aneurysm model with FD implantation, OCT can detect more ISA than IVUS; most acute ISA have good outcome at 12 th week of follow-up, while severe ISA can cause delayed FD endothelialization and delayed aneurysm occlusion.
3.Clinical trial of brexpiprazole in the treatment of adults with acute schizophrenia
Shu-Zhe ZHOU ; Liang LI ; Dong YANG ; Jin-Guo ZHAI ; Tao JIANG ; Yu-Zhong SHI ; Bin WU ; Xiang-Ping WU ; Ke-Qing LI ; Tie-Bang LIU ; Jie LI ; Shi-You TANG ; Li-Li WANG ; Xue-Yi WANG ; Yun-Long TAN ; Qi LIU ; Uki MOTOMICHI ; Ming-Ji XIAN ; Hong-Yan ZHANG
The Chinese Journal of Clinical Pharmacology 2024;40(5):654-658
Objective To evaluate the efficacy and safety of brexpiprazole in treating acute schizophrenia.Methods Patients with schizophrenia were randomly divided into treatment group and control group.The treatment group was given brexpiprozole 2-4 mg·d-1 orally and the control group was given aripiprazole 10-20 mg·d-1orally,both were treated for 6 weeks.Clinical efficacy of the two groups,the response rate at endpoint,the changes from baseline to endpoint of Positive and Negative Syndrome Scale(PANSS),Clinical Global Impression-Improvement(CGI-S),Personal and Social Performance scale(PSP),PANSS Positive syndrome subscale,PANSS negative syndrome subscale were compared.The incidence of treatment-related adverse events in two groups were compared.Results There were 184 patients in treatment group and 186 patients in control group.After treatment,the response rates of treatment group and control group were 79.50%(140 cases/184 cases)and 82.40%(150 cases/186 cases),the scores of CGI-I of treatment group and control group were(2.00±1.20)and(1.90±1.01),with no significant difference(all P>0.05).From baseline to Week 6,the mean change of PANSS total score wese(-30.70±16.96)points in treatment group and(-32.20±17.00)points in control group,with no significant difference(P>0.05).The changes of CGI-S scores in treatment group and control group were(-2.00±1.27)and(-1.90±1.22)points,PSP scores were(18.80±14.77)and(19.20±14.55)points,PANSS positive syndrome scores were(-10.30±5.93)and(-10.80±5.81)points,PANSS negative syndrome scores were(-6.80±5.98)and(-7.30±5.15)points,with no significant difference(P>0.05).There was no significant difference in the incidence of treatment-related adverse events between the two group(69.00%vs.64.50%,P>0.05).Conclusion The non-inferiority of Brexpiprazole to aripiprazole was established,with comparable efficacy and acceptability.
4.Clinical value analysis of simple resection of pancreatic solid pseudopapillary tumor
Yujie GUO ; Ying TANG ; Jichun GU ; Feng YANG ; Huaye LIU ; Chen JIN ; Deliang FU ; Ji LI
Journal of Surgery Concepts & Practice 2024;29(1):27-33
Objective To explore the clinical application value of simple resection in the treatment of pancreatic solid pseudopapillary tumor(SPT).Methods Retrospective analysis of clinical and follow-up data of pancreatic SPT patients who underwent simple pancreatectomy and conventional pancreatectomy from January 2015 to December 2022 in the pancreatic cystic tumor database of Huashan Hospital,Fudan University.A total of 87 patients with pancreatic SPT,including 14 cases underwent simple resection and 73 cases underwent conventional resection,were included.The average age was(36.2±11.7)years old,and females accounting for 87.4%.Results The accuracy of preoperative imaging diagnosis reached 88.5%.Simple resection had a significant advantage over conventional resection in terms of surgical time[(138.3± 56.4)min vs.(241.2±89.2)min,P<0.05].Simple resection was not inferior to conventional resection in terms of common postoperative complications.Out of 87 cases,only 3 patients in conventional resection group experienced postoperative recurrence and metastasis,and all recurrent patients were still alive.There was no statistically significant difference in postoperative pancreatic endocrine and exocrine dysfunction,and quality of life between simple resection group and conventional resection group.Conclusions Simple resection of pancreatic SPT is reasonable and feasible,but the risks in actual clinical work cannot be ignored.Therefore,selective simple resection of SPT has certain clinical application value.
5.A clinical study on the treatment of relapsed/refractory acute myeloid leukemia with venetoclax regimen
Lei FANG ; Fei XIAOMING ; Yang YUANLIN ; Ji YANPING ; Yu XIANQIU ; Tang YU
Chinese Journal of Clinical Oncology 2024;51(7):348-353
Objective:To explored the feasibility and efficacy of a rapid ramp-up,2-week maximum regimen of venetoclax(VEN)plus low-dose cytarabine(LDAC)for treating relapsed/refractory acute myeloid leukemia(R/R AML).Methods:We retrospectively analyzed patients with venetoclax-na?ve R/R AML treated with VEN+LDAC between October 2018 and November 2023.On the first day,patients received 200 mg of VEN,and the dose was quickly increased to 400 mg for the rest of the treatment;cytarabine was administered subcutaneously at a low dose of 20 mg/m2/day.The treatment duration was 10 or 14 days,depending on the condition of bone marrow hyperplasia determined on the 8th day of treatment.No patients received venetoclax monotherapy.All patients responding to salvage therapy received VEN+LDAC until disease progression or transplantation.Results:Among the patients,the median follow-up duration was 27.5 months.No clinical mani-festations of tumor lysis syndrome(TLS)occurred during the treatment.The overall response rate(ORR)was 68.75%,including four com-plete responses(CR),one complete remission with incomplete hematologic recovery(CRi),and six partial responses(PR).The median num-ber of best treatment result cycles was one cycle.The median overall survival(OS)in the whole cohort was 5.8(0.5-47.2)months;the medi-an progression-free survival(PFS)was 22.2(7.3-42.9)months.The major adverse events were grade 3-4 hematologic adverse events and in-fections.Conclusions:The 8th-day myelosuppression-adjusted VEN+LDAC regimen is a feasible salvage option with a reasonable safety pro-file in patients with venetoclax-na?ve R/R AML.Most patients tolerated the 14-day treatment;the response was generally rapid in the re-sponding patients.
6.A nomogram to predict the risk of postoperative recurrence of hepatocellular carcinoma based on preoperative clinical indicators and ultrasound features
Yadan XU ; Feihang WANG ; Kailing CHEN ; Yang TANG ; Qi ZHANG ; Wenping WANG ; Wentao KONG ; Zhengbiao JI ; Xiaolong ZHANG
Chinese Journal of Hepatobiliary Surgery 2024;30(8):566-571
Objective:To establish a nomogram prediction model for recurrence within 2 years after radical resection of hepatocellular carcinoma (HCC) based on clinical and ultrasonographic characteristics.Methods:Clinical data from 405 HCC patients (including 327 males and 78 females), aged 60 (53, 66) years old, who underwent radical hepatectomy in the Zhongshan Hospital, Fudan University, from January to December 2021, were retrospectively collected. The patients were divided into two groups: the training group ( n=283) and the validation group ( n=122). Based on recurrence within 2 years after surgery, the 283 patients in the training group were further categorized into the recurrence group ( n=73) and the non-recurrence group ( n=210). Among the 122 patients in the validation group, 33 had recurrence within 2 years, while 89 did not. Data on age, microvascular invasion, alpha-fetoprotein (AFP), AFP lentil lectin-reactive fraction (AFP-L3), protein induced by vitamin K absence or antagonist-II (PIVKA-II), tumor number, and enhancement homogeneity were collected. Logistic regression analysis was performed on the training group to identify risk factors associated with postoperative recurrence, and a nomogram model for predicting HCC recurrence was constructed based on these factors. Calibration curves were used to compare the consistency between predicted and actual outcomes in both the training and validation groups. Results:Multivariate logistic regression analysis revealed that younger age ( OR=0.976, 95% CI: 0.953-1.000, P=0.004), higher AFP-L3 ( OR=1.066, 95% CI: 1.014-1.120, P=0.012), higher PIVKA-II ( OR=1.000, 95% CI: 1.000-1.001, P=0.042), multiple tumors ( OR=0.399, 95% CI: 0.225-0.706, P=0.038), and heterogeneous enhancement ( OR=0.472, 95% CI: 0.243-0.916, P=0.045) were significant risk factors for recurrence after partial hepatectomy in HCC patients. The nomogram constructed based on these variables had a C-index of 0.87 (95% CI: 0.81-0.93) in the training group and 0.83 (95% CI: 0.77-0.89) in the validation group. The calibration curves for predicting recurrence within 2 years after partial hepatectomy in HCC patients showed a high degree of fit in both the training and validation groups, indicating a good agreement between predicted and actual outcomes. Conclusion:The nomogram model constructed based on preoperative clinical and ultrasonographic characteristics can effectively predict the risk of recurrence within 2 years after radical resection of HCC.
7.Study on medication law of traditional Chinese medicine compound for prevention and treatment of viral pneumonia based on national patents
Dongdong XU ; Lei TANG ; Yang AN ; Zhaoshuai JI ; Qiantai MAO
China Modern Doctor 2024;62(33):79-83,102
Objective To analyze the medication rules of compound patents for the prevention and treatment of viral pneumonia through data mining technology,and to provide new ideas for clinical diagnosis and treatment and new drug research and development.Methods Summarizing the patents of traditional Chinese medicine compounds for the prevention and treatment of viral pneumonia in Patent Announcement module of China National Intellectual Property Administration website,search time is from database establishment to December 31,2023,and the statistics on the frequency of use,medicinal properties,efficacy classification,association analysis,and cluster analysis were carried out with the help of data mining software such as Excel 2019,IBM SPSS Statistics 26.0,and IBM SPSS Modeler 18.0.Results Through screening,a total of 218 compound patents met the inclusion criteria,involving 424 kinds of Chinese materia medica,and the top 5 herbs with the highest frequency of use were Glycyrrhizae Radix et Rhizoma,Lonicerae Japonicae Flos,Forsythiae Fructus,Scutellariae Radix,and Platycodon Radix.The medicinal properties are bitter and cold,and mostly belong to the lung meridian.There were 4 medicinal groups of pair medicine,13 medicinal groups of triple medicine,and 1 medicinal group with four related medicine exhibiting strong correlation.A total of 6 high-frequency combinations of traditional Chinese medicine were obtained by cluster analysis.Conclusion The basic pathogenesis of viral pneumonia is that internal deficiency and evil enter,heat toxin is trapped in the ling,the phlegm and blood stasis is occurred inside,and affecting the lung's function of purging and eliminating.In clinical practice,the deficiency tonic drugs Astragali radix and Glycyrrhizae Radix et Rhizoma,are used to strengthen resistance,the heat-clearing drugs Lonicerae Japonicae Flos,Forsythiae Fructus,the phlegm antitussive and antiasthmatic drugs,Platycodon Radix,Armeniacae Semen Amarum,etc,are used to treat the symptoms,simultaneous treatment of the symptoms and root cause,prevention and treatment are organically combined.
8.Effects of moxibustion at Yongquan (KI 1) on cognition function and lower limb motor function in patients with post-stroke cognitive impairment of kidney essence deficiency.
Yan-Sheng YE ; Qing-Tang YANG ; Ding-Yu ZHU ; Kai-Xiang DENG ; Hui-Juan LIN ; Xin ZHANG ; Ting JI ; Meng-Zhen ZHUO ; Yu-Mao ZHANG
Chinese Acupuncture & Moxibustion 2023;43(9):1018-1022
OBJECTIVE:
To observe the effects of moxibustion at Yongquan(KI 1) on the cognitive function and lower limb motor function in patients with post-stroke cognitive impairment of kidney essence deficiency.
METHODS:
Eighty-four patients with post-stroke cognitive impairment of kidney essence deficiency were randomly divided into an observation group(42 cases,1 case dropped off)and a control group(42 cases,1 case dropped off).The control group was treated with medication,electroacupuncture,rehabilitation training and repetitive transcranial magnetic stimulation(rTMS);on the basis of the treatment as the control group,moxibustion at bilateral Yongquan(KI 1)was adopted in the observation group.Both groups were treated once a day,5 days a week with 2-day interval,4 weeks were required. The Montreal cognitive assessment (MoCA) score, mini-mental state examination (MMSE) score, Fugl-Meyer assessment-lower extremity (FMA-LE) score, Berg balance scale (BBS) score, functional independence measure (FIM) score, modified fall efficacy scale (MFES) score and scale for the differentiation of syndromes of vascular dementia (SDSVD) score before and after treatment were observed in the two groups.
RESULTS:
After treatment,the MoCA, MMSE, FMA-LE, BBS, FIM and MFES scores were higher than those before treatment in both groups (P<0.05), and the scores in the observation group were higher than those in the control group (P<0.05). After treatment,the SDSVD scores were lower than those before treatment in both groups (P< 0.05), and the SDSVD score in the observation group was lower than that in the control group (P< 0.05).
CONCLUSION
Moxibustion at Yongquan(KI 1) can improve the cognitive function and motor and balance function of lower limbs in patients with post-stroke cognitive impairment of kidney essence deficiency,reduce the risk of fall and improve the quality of life.
Humans
;
Cognition
;
Cognitive Dysfunction/therapy*
;
Dementia, Vascular
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Kidney
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Lower Extremity
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Moxibustion
;
Quality of Life
;
Stroke/complications*
9.Research progress on structure, structure-activity relationship, and biological activity of Aconiti Lateralis Radix Praeparata polysaccharides.
Jun TANG ; Xin YANG ; Xin YANG ; Qi HU ; Ji-Hai GAO ; Ming YANG ; Ya-Nan HE ; Ding-Kun ZHANG
China Journal of Chinese Materia Medica 2023;48(20):5410-5418
Aconiti Lateralis Radix Praeparata polysaccharides(AP) are a class of bioactive macromolecules extracted from the herbs of Aconiti Lateralis Radix Praeparata and its various processed products. Since the AP was first separated in 1986, its pharmacological effects include immune regulation, anti-tumor, anti-depression, organ protection, hypoglycemia, and anti-inflammatory had been found. In recent years, with the development of polysaccharide extraction, separation, and structure identification technologies, more than 20 kinds of AP have been separated from Aconiti Lateralis Radix Praeparata and its processed products, and they have ob-vious differences in relative molecular weight, monosaccharide composition, glycosidic bond, structural characteristics, and biological activities. In particular, AP may be dissolved, degraded, or allosteric under the complex processing environment of fermentation, soaking, cooking, etc., leading to the diversified structure of AP, which provides a possibility for further understanding of the structure-activity relationship of AP. Therefore, this study systematically reviewed the research progress on the structure and structure-activity relationship of AP, summarized the biological activity and potential action mechanism of AP, and discussed the technical challenges in the development and application of AP, so as to promote the quality control and further development and utilization of AP.
Drugs, Chinese Herbal/chemistry*
;
Aconitum/chemistry*
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Polysaccharides/pharmacology*
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Structure-Activity Relationship
;
Technology
10.Efficacy and safety of sacubitril/valsartan after six months in patients with heart failure with reduced ejection fraction and asymptomatic hypotension.
An-Hu WU ; Zong-Wei LIN ; Zhuo-Hao YANG ; Hui ZHANG ; Jia-Yi HU ; Yi WANG ; Rui TANG ; Xin-Yu ZHANG ; Xiao-Ping JI ; Hui-Xia LU
Journal of Geriatric Cardiology 2023;20(12):855-866
BACKGROUND:
It is not clear whether sacubitril/valsartan is beneficial for patients with heart failure (HF) with reduced ejection fraction (HFrEF) and low systolic blood pressure (SBP). This study aimed to investigate the efficacy and tolerability of sacubitril/valsartan in HFrEF patients with SBP < 100 mmHg.
METHODS & RESULTS:
An observational study was conducted on 117 patients, 40.2% of whom had SBP < 100 mmHg without symptomatic hypotension, and 59.8% of whom had SBP ≥ 100 mmHg in an optimized HF follow-up management system. At the 6-month follow-up, 52.4% of patients with SBP < 100 mmHg and 70.0% of those with SBP ≥ 100 mmHg successfully reached the target dosages of sacubitril/valsartan. A reduction in the concentration of N-terminal pro-B-type natriuretic peptide was similar between patients with SBP < 100 mmHg and SBP ≥ 100 mmHg (1627.5 pg/mL and 1340.1 pg/mL, respectively; P = 0.75). The effect of sacubitril/valsartan on left ventricular ejection fraction was observed in both SBP categories, with a 10.8% increase in patients with SBP < 100 mmHg (P < 0.001) and a 14.0% increase in patients with SBP ≥ 100 mmHg (P < 0.001). The effects of sacubitril/valsartan on SBP were statistically significant and inverse across both SBP categories (P = 0.001), with an increase of 7.5 mmHg in patients with SBP < 100 mmHg and a decrease of 11.5 mmHg in patients with SBP ≥ 100 mmHg. No statistically significant differences were observed between the two groups in terms of the occurrence of symptomatic hypotension, deteriorating renal function, hyperkalemia, angioedema, or stroke.
CONCLUSIONS
Within an optimized HF follow-up management system, sacubitril/valsartan exhibited excellent tolerability and prompted left ventricular reverse remodeling in patients with HFrEF who presented asymptomatic hypotension.

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