1.Clinical characteristics and prognosis of male dermatomyositis patients with positive anti-melanoma differentiation associated gene 5 antibody
Yitian SHI ; Fenghong YUAN ; Ting LIU ; Wenfeng TAN ; Ju LI ; Min WU ; Zhanyun DA ; Hua WEI ; Lei ZHOU ; Songlou YIN ; Jian WU ; Yan LU ; Dinglei SU ; Zhichun LIU ; Lin LIU ; Longxin MA ; Xiaoyan XU ; Yinshan ZANG ; Huijie LIU ; Tianli REN
Chinese Journal of Rheumatology 2024;28(1):44-49
Objective:To investigate the clinical features and prognosis of male with anti-melanoma differentiation-associated gene 5 (MDA5) autoantibody.Methods:The clinical data of 246 patients with DM and anti-MDA5 autoantibodies hospitalized by Jiangsu Myositis Cooperation Group from 2017 to 2020 were collected and retrospectively analyzed. Chi-square test was performed to compared between counting data groups; Quantitative data were expressed by M ( Q1, Q3), and rank sum test was used for comparison between groups; Single factor survival analysis was performed by Kaplan-Meier method and Log rank test; Cox regression analysis were used for multivariate survival analysis. Results:①The male group had a higher proportion of rash at the sun exposure area [67.1%(47/70) vs 52.8%(93/176), χ2=4.18, P=0.041] and V-sign [50.0%(35/70) vs 30.7%(54/176), χ2=8.09, P=0.004] than the female group. The male group had higher levels of creatine kinase [112(18, 981)U/L vs 57 (13.6, 1 433)U/L, Z=-3.50, P<0.001] and ferritin [1 500 (166, 32 716)ng/ml vs 569 (18, 14 839)ng/ml, Z=-5.85, P<0.001] than the female group. The proportion of ILD [40.0%(28/70) vs 59.7%(105/176), χ2=7.82, P=0.020] patients and the red blood cell sedimentation rate[31.0(4.0, 101.5)mm/1 h vs 43.4(5.0, 126.5)mm/1 h, Z=-2.22, P=0.026] in the male group was lower than that of the female group, but the proportion of rapidly progressive interstitial lung disease (PR-ILD) [47.1%(33/70) vs 31.3%(55/176), χ2=5.51, P=0.019] was higher than that of the female group. ②In male patients with positive anti-MDA5 antibodies,the death group had a shorter course of disease[1.0(1.0, 3.0) month vs 2.5(0.5,84) month, Z=-3.07, P=0.002], the incidence of arthritis [16.7%(4/24) vs 42.2%(19/45), χ2=4.60, P=0.032] were low than those in survival group,while aspartate aminotransferase (AST)[64(22.1, 565)U/L vs 51(14,601)U/L, Z=-2.42, P=0.016], lactate dehydrogenase (LDH) [485(24,1 464)U/L vs 352(170, 1 213)U/L, Z=-3.38, P=0.001], C-reactive protein (CRP) [11.6(2.9, 61.7) mg/L vs 4.95(0.6, 86.4) mg/L, Z=-1.96, P=0.050], and ferritin levels [2 000(681, 7 676) vs 1 125 (166, 32 716)ng/ml, Z=-3.18, P=0.001] were higher than those in the survival group, and RP-ILD [95.8%(23/24) vs 22.2%(10/45), χ2=33.99, P<0.001] occurred at a significantly higher rate. ③Cox regression analysis indicated that the course of disease LDH level, and RP-ILD were related factors for the prognosis of male anti-MDA5 antibodies [ HR (95% CI)=0.203(0.077, 0.534), P=0.001; HR (95% CI)=1.002(1.001, 1.004), P=0.003; HR (95% CI)=95.674 (10.872, 841.904), P<0.001]. Conclusion:The clinical manifestations of male anti-MDA5 antibody-positive patients are different from those of female. The incidence of ILD is low, but the proportion of PR-ILD is high. The course of disease, serum LDH level, and RP-ILD are prognostic factors of male anti-MDA5 antibody-positive patients.
2.Review on the registration of herbal drugs in north America and Europe
Yong TAN ; Bo WEN ; Jiayin WEI ; Xiaoyu FENG ; Yuwen XIA ; Lin LIN ; Longhui YANG
International Journal of Traditional Chinese Medicine 2024;46(2):162-167
International registration of herbal drugs is a necessary prerequisite for the internationalization of Chinese materia medica. North America and European Union occupy an important position in the world herbal drugs market, and their drug administration and quality supervision requirements are relatively complete and progressiveness. By summarizing the definition of herbal drugs in North America and European Union, combing and interpreting the relevant laws, regulations and policy documents, this article constructed the registration path of herbal drugs, and discussed the current status of market registration of herbal drugs in North America and European Union based on the examples of successful marketing of herbal drugs under current application and approval in overseas markets. This article believed that in the future, an internationally matched TCM quality standard evidence system should be built, clinical trials of TCM products in line with international standards should be carried out, standards that are the same or higher than international mainstream GMP should be developed, the registration path of TCM compounds should be explored, and professionals to establish an international registration application team should be recruited to provide theoretical and practical support for China's overseas registration of Chinese TCM products, promote TCM products to enter the world mainstream market, and achieve high-quality development of TCM internationalization.
3.Augmented reality navigation assisted design of chimeric twin-paddled anterolateral thigh perforator flap in reconstruction of soft tissue defects in extremities: a report of 8 cases
Xiang LUO ; Keqin YANG ; Ping'ou WEI ; Yongjun MO ; Xuquan LIANG ; Lin XU ; Ningxi ZHI ; Xiao TAN
Chinese Journal of Microsurgery 2024;47(1):28-33
Objective:To investigate the feasibility and clinical effects of the application of augmented reality (AR) navigation on assisted design of the chimeric twin-paddled anterolateral thigh perforator flap (ALTPF) in reconstruction of soft tissue defects in extremities.Methods:From June 2017 to June 2023, 8 patients with soft tissue defects in extremities received reconstruction of chimeric twin-paddled ALTPF designed with the assistance of AR navigation in Department of Hand & Foot Microsurgery Orthopaedics, Guigang City People’s Hospital. All of them were traffic accidents or machine injuries, with 3 cases of calf, 2 cases of ankle, 1 case of foot, and 2 cases of hand defects. All the wounds were wide or irregular (defect sized 14 cm×14 cm-25 cm×13 cm). The images of bilateral thighs were acquired by CT angiography preoperatively. The dominant side and dominant perforators were selected. Three dimensional reconstruction was performed by Mimics software. AR technology was applied to guide the design and harvest of the chimeric twin-paddled ALTPF. Flap area was 15 cm × 16 cm to 26 cm × 14 cm. The donor site was sutured directly. Follow-up with outpatient visits or WeChat images and videos at 1, 3, 6 and 12 months postoperatively to record the appearance, colour, texture, recurrence of infection, and knee extension function of the flap donor site.Results:According to the preoperative design, the perforator flaps were harvested and transferred in all the 8 patients. All flaps survived and the recipient and donor sites healed in one stage. All patients entered postoperative follow-up for 3 to 12 (mean, 8.6)months. The colour and texture of the flaps were excellent, and the appearance of donor and recipient sites was satisfactory. Two patients with hand injuries were evaluated using the brief Michigan Hand Outcomes Questionnaire (MHQ), with scores of 43.74 and 81.25, respectively. Six patients with lower limb injuries were evaluated using the Maryland foot score, with scores of 2 excellent, 3 good and 1 fair.Conclusion:The application of AR navigation can effectively assist the design of a chimeric twin-paddled ALTPF. It also provides an effective basis for clinical personalised flap design.
4.Research Strategy on the Standard Route of Overseas Registration of Traditional Chinese Medicine Formulations
Lin LIN ; Yong TAN ; Bo WEN ; Jiayin WEI ; Xiaoyu FENG ; Xiangpeng WANG ; Yuwen XIA ; Longhui YANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2024;26(3):557-563
Objective To explore the ideas,methods and pathways for the registration of Chinese medicine prescriptions in overseas countries,to form a strategy for overseas registration of Chinese medicine,and to provide technical support and reference for China's Chinese medicine prescriptions to go abroad.Methods Five representative countries were selected to form corresponding expert teams and exchange platforms for international cooperation.The laws,regulations,rules,standards,specifications and technical guidance documents related to Chinese medicine prescription preparations of the target countries were used as pathway research materials,and the documents were translated directly,naturalized,proofread and diagrammed,and a problem-oriented mechanism for consultation with domestic and international experts was established to form a pathway for overseas registration of Chinese medicine prescription preparations.Results The path for standardization of overseas registration of Chinese medicines was clarified,and the detailed registration paths and corresponding work strategies of Chinese medicines in five countries were formulated with flow charts,tables and explanatory texts.Conclusion By developing standardized registration pathways for traditional Chinese medicine in target countries,reference can be provided for the internationalization of Chinese herbal formula preparations.
5.Expert consensus on clinical application of 177Lu-prostate specific membrane antigen radio-ligand therapy in prostate cancer
Guobing LIU ; Weihai ZHUO ; Yushen GU ; Zhi YANG ; Yue CHEN ; Wei FAN ; Jianming GUO ; Jian TAN ; Xiaohua ZHU ; Li HUO ; Xiaoli LAN ; Biao LI ; Weibing MIAO ; Shaoli SONG ; Hao XU ; Rong TIAN ; Quanyong LUO ; Feng WANG ; Xuemei WANG ; Aimin YANG ; Dong DAI ; Zhiyong DENG ; Jinhua ZHAO ; Xiaoliang CHEN ; Yan FAN ; Zairong GAO ; Xingmin HAN ; Ningyi JIANG ; Anren KUANG ; Yansong LIN ; Fugeng LIU ; Cen LOU ; Xinhui SU ; Lijun TANG ; Hui WANG ; Xinlu WANG ; Fuzhou YANG ; Hui YANG ; Xinming ZHAO ; Bo YANG ; Xiaodong HUANG ; Jiliang CHEN ; Sijin LI ; Jing WANG ; Yaming LI ; Hongcheng SHI
Chinese Journal of Clinical Medicine 2024;31(5):844-850,封3
177Lu-prostate specific membrane antigen(PSMA)radio-ligand therapy has been approved abroad for advanced prostate cancer and has been in several clinical trials in China.Based on domestic clinical practice and experimental data and referred to international experience and viewpoints,the expert group forms a consensus on the clinical application of 177Lu-PSMA radio-ligand therapy in prostate cancer to guide clinical practice.
6.CT coronary perivascular fat attenuation combined with machine learning algorithms for diagnosis of myocardial ischemia in coronary heart disease
Yige LU ; Wei HE ; Hongyan LIN ; Furong HE ; Hanbo ZHANG ; Yao TAN ; Hongming ZHU
Chinese Journal of Arteriosclerosis 2024;32(6):514-520
Aim To explore the feasibility of using machine learning algorithms combined with coronary computed tomography(CT)derived perivascular fat attenuation index(FAI)and plaque information to evaluate myocardial ischemia in stable coronary heart disease patients.Methods A retrospective analysis was conducted on the clinical and imaging data of patients who underwent preoperative coronary CT angiography(CCTA),invasive coronary angiography(ICA),and flow reserve fraction(FFR)measurements at Zhongshan Hospital Affiliated to Fudan University from April 2019 to October 2021.206 patients with stable coronary heart disease were selected.The semi-automatic plaque analysis software was used for quantification of plaque and lumen parameters and perivascular FAI measurement,with man-ual delineation of a 40 mm segment of the coronary artery starting 10 mm from the ostium for perivascular FAI measure-ment.Differences in plaque characteristics,perivascular FAI,and coronary perivascular FAI between stable coronary heart disease patients with FFR≤0.8 and FFR>0.8 were compared.The diagnostic performance of combining perivascu-lar FAI,coronary perivascular FAI,and plaque features using machine learning algorithms for myocardial ischemia in stable coronary heart disease patients was evaluated through ROC curves.Results 206 stable coronary heart disease patients were divided into FFR≤0.8 group(50 cases)and FFR>0.8 group(156 cases).The mean periplaque FAI of patients with FFR≤0.8 was-69.28±5.65 HU,significantly higher than that of patients with FFR>0.8 at-80.10±7.75 HU(P<0.001).Further analysis was conducted using machine learning models,including XGBoost,random forest,and Logistic regression models,all of which had an accuracy rate of over 0.8 in diagnosing myocardial ischemia.Among them,the XGBoost model performed the best with an accuracy of 0.903,an F1 value of 0.774,and an AUC of 0.931,in-dicating its high effectiveness in diagnosing myocardial ischemia.Conclusion The combination of FAI and machine learning algorithm XGBoost model is a new method for diagnosing myocardial ischemia,which has better diagnostic value in evaluating myocardial ischemia in stable coronary heart disease patients.
7.Construction of an immune-related LncRNA prognostic risk model for gastric cancer based on bioinformatics
Huaji JIANG ; Wei DING ; Yulin TAN ; Lin ZHUANG ; Cheng XI ; Yixin XU ; Yibo WANG ; Xuezhong XU
Chinese Journal of Immunology 2024;40(6):1203-1209
Objective:Based on bioinformatics,new immune-related LncRNAs related to the prognosis of gastric cancer were screened,and a prognostic risk model of immune-related LncRNA was further constructed,in order to be used as a new indicator for early diagnosis and prognostic status of gastric cancer.Methods:The gastric cancer transcriptome data and corresponding clinical prog-nosis data were downloaded from multiple data platforms,and the immune-related LncRNAs of gastric cancer were screened by bioin-formatics methods.Cox regression analysis was used to screen LncRNAs related to immune prognosis in gastric cancer,and LncRNAs related to immune prognosis with independent prognostic significance were identified to construct a prognostic risk model,and the risk score of each patient was calculated.Patients were divided into low-risk and high-risk groups according to the cutpoint.Kaplan-Meier analysis was performed for survival analysis and survival curves were drawn,nomograms were drawn and internal validation was per-formed,and univariate and multivariate Cox regression analysis was performed to analyze the relationship between risk scores and clin-icopathological characteristics and survival prognosis of gastric cancer patients.Results:Three immune prognosis-related LncRNAs(UCA1,MIR4435-1HG,RP11-617F23.1)were identified by Cox regression analysis,and a predictive scoring model was constructed to divide the patients into high-risk group and low-risk group according to the prognosis score.There was a statistically significant dif-ference in the prognosis of patients between the two groups(P<0.05).The multivariate Cox regression analysis risk score was an inde-pendent risk factor for the prognosis of gastric cancer,and the internal verification of the nomogram showed good reliability.Conclu-sion:Three immune-related LncRNAs in gastric cancer are significantly correlated with the prognosis of gastric cancer patients,and the predictive scoring model constructed based on them can effectively predict the prognosis and can be used as their independent prog-nostic biomarkers.
8.Current situation and countermeasures for the management of surplus drugs in medical institutions of China
Guangjie WU ; Wei FU ; Lin QIU ; Dongyan LI ; Fanxue XIN ; Jianling ZHENG ; Xiaozhe DAI ; Qian CHEN ; Yan LIU ; Li TAN ; Dong LIU ; Juan LI
Chinese Journal of Hospital Administration 2024;40(6):444-447
The management of surplus drugs is an important part of drug administration. At present, China′s medical institutions are in the initial exploration stage in managing surplus drugs.This study analyzed the causes, safety hazards, management policies, and management problems of surplus drugs in medical institutions, and proposed targeted countermeasures and suggestions, including establishing unified and standardized management methods, consensus or guidelines, optimizing internal management of medical institutions, improving the management awareness of medical staff, and clarifying the benefits of surplus drugs, so as to provide references for medical institutions to manage surplus drugs reasonably.
9.Management of surplus drugs in a large tertiary hospital
Dongyan LI ; Wei FU ; Lin QIU ; Guangjie WU ; Fanxue XIN ; Jianling ZHENG ; Xiaozhe DAI ; Qian CHEN ; Yan LIU ; Li TAN ; Dong LIU ; Juan LI
Chinese Journal of Hospital Administration 2024;40(6):448-453
To standardize the management of surplus drugs, improve the efficiency of medical resource utilization, promote the rational use of medical insurance funds, and reduce the financial burden on patients, a large tertiary hospital implemented a practice for managing surplus drugs starting in May 2023. This practice encompassed multiple aspects, including the establishment of organizational structure, clarification of responsibilities, formulation of billing for fractional doses and a reasonable surplus drugs list, establishment of standardized management processes, and allocation of special funds for surplus drugs. These efforts had initially achieved effective management of surplus drugs. As of November 2023, the management of surplus drugs had benefited 136 908 patients, with an average savings of 873.61 yuan per patient and a cumulative savings of approximately 34.7 million yuan in medical insurance funds. This practice had effectively reduced the wastage of medical resources, and could provide references for promoting standardized management of surplus drugs in medical institutions of China. In the future, the hospital should further expand the coverage of surplus drugs, ensure patients′ rights to informed consent, and establish a comprehensive performance incentive mechanism to promote the sustainable development of surplus drug management.
10.Postoperative outcomes after prehabilitation for colorectal cancer patients undergoing surgery: a systematic review and meta-analysis of randomized and nonrandomized studies
Ian Jun Yan WEE ; Isaac SEOW-EN ; Aik Yong CHOK ; Eileen SIM ; Chee Hoe KOO ; Wenjie LIN ; Chang MEIHUAN ; Emile Kwong-Wei TAN
Annals of Coloproctology 2024;40(3):191-199
Purpose:
Prehabilitation (PH) is purported to improve patients’ preoperative functional status. This systematic review and meta-analysis sought to compare short-term postoperative outcomes between patients who underwent a protocolized PH program and the existing standard of care among colorectal cancer patients awaiting surgery.
Methods:
A search in MEDLINE/PubMed, the Cochrane Library, Embase, Scopus, and CINAHL was conducted to identify relevant articles. Repetitive and exhaustive combinations of MeSH search terms (“prehabilitation,” “colorectal cancer,” “colon cancer,” and “rectal cancer”) were used to identify randomized and nonrandomized studies comparing PH versus standard of care for colorectal cancer patients awaiting surgery. The primary outcomes included postoperative morbidity, length of hospital stay, and readmission rates.
Results:
Seven studies including 1,042 colorectal cancer patients (PH, 382) were included. No significant differences were found in intraoperative outcomes. The postoperative complication rates were comparable between groups (Clavien-Dindo grades I and II: risk ratio, 0.82; 95% confidence interval, 0.62–1.07; P=0.15; Clavien-Dindo grades ≥III: risk ratio, 1.02; 95% confidence interval, 0.72–1.44; P=0.92). There were also no significant differences in length of hospital stay (P=0.21) or the risk of 30-day readmission (P=0.68).
Conclusion
Although PH does not appear to improve short-term postoperative outcomes following colorectal cancer surgery, the quality of evidence is impaired by the limited trials and heterogeneity. Thus, further large-scale trials are warranted to draw definitive conclusions and establish the long-term effects of PH.

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