1.Mining and evaluation of relugolix-related cardiovascular safety signals
Yongchun LIN ; Long MENG ; Jiajun ZHENG ; Huiming JIANG
China Pharmacy 2024;35(18):2278-2282
OBJECTIVE To mine the cardiovascular safety signal of relugolix, and provide a reference for the listing of this drug in China and future clinical safety drug evaluation. METHODS The adverse event (AE) report data of relugolix, as the primary or secondary suspected drug, was collected from the FDA Adverse Event Reporting System (FAERS) from the first quarter of 2021 to the third quarter of 2023. The reporting odds ratio (ROR) method was used for data mining. The AEs in the FAERS database were identified and coded using preferred terms (PT) stated in version 24.0 of the Medical Dictionary for Drug Regulatory Activities (MedDRA). The AEs of the target drug were identified by the narrow standardized MedDRA query (SMQ) terms and high-level term (HLT). Sensitivity analysis was conducted using AEs suspected to be primarily or secondarily related to relugolix or related to drug interaction and concomitant drug, and broad SMQ terms. RESULTS A total of 4 354 relugolix-related AE reports were extracted. In the primary analysis, nine SMQ terms were analyzed, involving 2 positive signals such as dyslipidemia and hyperglycemia/new onset diabetes mellitus. Eleven HLTs were analyzed, and three positive signals were detected for three terms including cholesterol analyses, triglyceride analyses and hyperglycemia conditions (non-alternative analysis). Sensitivity analysis results indicated the reliability of the study findings. CONCLUSIONS Relugolix may induce risk signals related to high blood lipids and high blood glucose, but no moderate risk signals such as hypertension, heart disease, and stroke are found. During relugolix treatment in clinical practice, attention must be paid to hyperlipidemia and hyperglycemia-related AE.
2.Application of melatonin in peripheral nerve injury repair
Lining LIN ; Mouyuan SUN ; Huiming WANG
STOMATOLOGY 2024;44(8):617-623
The increasing incidence of peripheral nerve injuries brought on by trauma or tumors is substantially interfering with people's lives due to the causal sensory and motor dysfunctions.Peripheral nerves have some self-repair ability after injury,but they are limited by the degree of injury and the body's condition.The postoperative recovery of nerve function in patients is not satisfactory,which is closely related to the local inflammatory microenvironment after injury.Melatonin,a compound naturally synthesized in the pineal gland,protects peripheral nervous system cells from oxidative inflammation after injury and regulates their behavior and fate.Therefore,it has good application prospect in nerve tissue engineering.In this paper,we review the synthesis,metabolic processes un-derlying melatonin,mechanism of action as well as the current status of its application in peripheral nerve regeneration as well as poten-tial application for oral diseases.In this way,it further provides a new idea for the clinical treatment of peripheral nerve injury.
3.Expert consensus on the whole process management of bladder perfusion for bladder cancer
Jia LI ; Xuefang HUANG ; Xiling LIN ; Jiahui WU ; Huiming LU ; Yaqing LIANG ; Huiying QIN
Chinese Journal of Modern Nursing 2024;30(32):4341-4347
Bladder perfusion is one of the main methods for the treatment of bladder cancer. In order to further improve the standardization of bladder cancer bladder perfusion operation for nursing staff, this paper, guided by evidence-based methods, formed the expert consensus on the whole process management of bladder perfusion for bladder cancer through Delphi expert consultation and expert demonstration meeting, and provided guidance for the standardization of clinical nursing practice and management institutionalization of bladder cancer bladder perfusion from seven aspects, namely, perfusion environment, operators, drug allocation, operation process, adverse reactions, health education and continuous nursing.
4.Interpretation of the 2022 American College of Rheumatology/American Association of Hip and Knee Surgeons guideline for the perioperative management of antirheumatic medication in patients with rheumatic diseases undergoing elective total hip or total knee arthroplasty
Songlin LI ; Wenwei QIAN ; Qian WANG ; Xisheng WENG ; Jin LIN ; Jin JIN ; Xinping TIAN ; Huiming PENG ; Bin FENG ; Xiaofeng ZENG
Chinese Journal of Orthopaedics 2023;43(13):928-932
The American College of Rheumatology (ACR) and the American Association of Hip and Knee Surgeons (AAHKS) convened a writing group to develop a consensus report on the management of anti-rheumatic medication in patients with rheumatic diseases undergoing elective total hip or total knee arthroplasty in June 2022. In particular, the consensus provides significant updates on target synthetic disease modifying anti-rheumatic drugs and perioperative medication management in patients with systemic lupus erythematosus, as well as the addition of newly approved antirheumatic medications for administration. This article will interpret the consensus and provide a reference for the perioperative management of antirheumatic medications for hip and knee arthroplasty in patients with rheumatic diseases in China.
5.Efficacy of endoscopic ligation resection and endoscopic submucosal excavation for small gastrointestinal stromal tumors originating from muscularis propria
Chunhong WEN ; Jiang LIU ; Qinglin TANG ; Ming MA ; Huiming LIN ; Lixin DENG ; Zhicong ZENG ; Shuai ZHANG ; Xuejuan HUANG ; Mingqing ZHANG
Chinese Journal of Digestive Endoscopy 2022;39(11):921-924
Clinical data of 43 patients who underwent endoscopic resection for gastrointestinal stromal tumors (GIST) of length ≤1.2 cm at the Digestive Endoscopy Center of the 909th Hospital from January 2016 to December 2018 were retrospectively analyzed. The patients were divided into the endoscopic ligation resection (ELR) group ( n=27) and the endoscopic submucosal excavation (ESE) group ( n=16). The general, perioperative and follow-up data of the two groups were compared. The results showed that there was no significant difference in the general data between the two groups. The operation time was 20.0 (18.0,25.0) min in the ELR group and 27.5 (23.0,37.5) min in the ESE group, showing significant difference ( U=92.5, P=0.001). The en bloc resection rates were 100.0% (27/27) in the ELR group and 81.3% (13/16) in the ESE group, showing significant difference ( P=0.045). The postoperative hospital stays were 3 (2,4) days in the ELR group and 5 (4,6) days in the ESE group, showing significant difference ( U=125.5, P=0.020). There was no significant difference in the intraoperative bleeding rate, intraoperative hemorrhage volume, intraoperative perforation rate, number of hemostatic clips or postoperative complications including hemorrhage, fever and peritonitis between the two groups ( P>0.05). During the follow-up, there was no recurrence or metastasis of GIST in both groups. ELR and ESE can be safe and effective for small GIST ≤1.2 cm in diameter. Compared with the ESE group, the operation time and postoperative hospital stay are shorter with higher en bloc resection rate in the ELR group.
6.Association Between Lipid Profiles and Left Ventricular Hypertrophy: New Evidence from a Retrospective Study
Huang XUEWEI ; Deng KEQIONG ; Qin JUANJUAN ; Lei FANG ; Zhang XINGYUAN ; Wang WENXIN ; Lin LIJIN ; Zheng YUMING ; Yao DONGAI ; Lu HUIMING ; Liu FENG ; Chen LIDONG ; Zhang GUILAN ; Liu YUEPING ; Yang QIONGYU ; Cai JINGJING ; She ZHIGANG ; Li HONGLIANG
Chinese Medical Sciences Journal 2022;37(2):103-117
Objective To explore the association between lipid profiles and left ventricular hypertrophy in a Chinese general population. Methods We conducted a retrospective observational study to investigate the relationship between lipid markers [including triglycerides, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein (HDL) cholesterol, non-HDL-cholesterol, apolipoprotein A-I, apolipoprotein B, lipoprotein[a], and composite lipid profiles] and left ventricular hypertrophy. A total of 309,400 participants of two populations (one from Beijing and another from nationwide) who underwent physical examinations at different health management centers between 2009 and 2018 in China were included in the cross-sectional study. 7,475 participants who had multiple physical examinations and initially did not have left ventricular hypertrophy constituted a longitudinal cohort to analyze the association between lipid markers and the new-onset of left ventricular hypertrophy. Left ventricular hypertrophy was measured by echocardiography and defined as an end-diastolic thickness of the interventricular septum or left ventricle posterior wall > 11 mm. The Logistic regression model was used in the cross-sectional study. Cox model and Cox model with restricted cubic splines were used in the longitudinal cohort. Results In the cross-sectional study, for participants in the highest tertile of each lipid marker compared to the respective lowest, triglycerides [odds ratio (OR): 1.250, 95%CI: 1.060 to 1.474], HDL-cholesterol (OR: 0.780, 95%CI: 0.662 to 0.918), and lipoprotein(a) (OR: 1.311, 95%CI: 1.115 to 1.541) had an association with left ventricular hypertrophy. In the longitudinal cohort, for participants in the highest tertile of each lipid marker at the baseline compared to the respective lowest, triglycerides [hazard ratio (HR): 3.277, 95%CI: 1.720 to 6.244], HDL-cholesterol (HR: 0.516, 95%CI: 0.283 to 0.940), non-HDL-cholesterol (HR: 2.309, 95%CI: 1.296 to 4.112), apolipoprotein B (HR: 2.244, 95%CI: 1.251 to 4.032) showed an association with new-onset left ventricular hypertrophy. In the Cox model with forward stepwise selection, triglycerides were the only lipid markers entered into the final model. Conclusion Lipids levels, especially triglycerides, are associated with left ventricular hypertrophy. Controlling triglycerides level potentiate to be a strategy in harnessing cardiac remodeling but deserve to be further investigated.
7.COVID-ONE-hi:The One-stop Database for COVID-19-specific Humoral Immunity and Clinical Parameters
Xu ZHAOWEI ; Li YANG ; Lei QING ; Huang LIKUN ; Lai DAN-YUN ; Guo SHU-JUAN ; Jiang HE-WEI ; Hou HONGYAN ; Zheng YUN-XIAO ; Wang XUE-NING ; Wu JIAOXIANG ; Ma MING-LIANG ; Zhang BO ; Chen HONG ; Yu CAIZHENG ; Xue JUN-BIAO ; Zhang HAI-NAN ; Qi HUAN ; Yu SIQI ; Lin MINGXI ; Zhang YANDI ; Lin XIAOSONG ; Yao ZONGJIE ; Sheng HUIMING ; Sun ZIYONG ; Wang FENG ; Fan XIONGLIN ; Tao SHENG-CE
Genomics, Proteomics & Bioinformatics 2021;19(5):669-678
Coronavirus disease 2019(COVID-19),which is caused by SARS-CoV-2,varies with regard to symptoms and mortality rates among populations.Humoral immunity plays critical roles in SARS-CoV-2 infection and recovery from COVID-19.However,differences in immune responses and clinical features among COVID-19 patients remain largely unknown.Here,we report a database for COVID-19-specific IgG/IgM immune responses and clinical parameters(named COVID-ONE-hi).COVID-ONE-hi is based on the data that contain the IgG/IgM responses to 24 full-length/truncated proteins corresponding to 20 of 28 known SARS-CoV-2 proteins and 199 spike protein peptides against 2360 serum samples collected from 783 COVID-19 patients.In addition,96 clinical parameters for the 2360 serum samples and basic information for the 783 patients are integrated into the database.Furthermore,COVID-ONE-hi provides a dashboard for defining samples and a one-click analysis pipeline for a single group or paired groups.A set of samples of interest is easily defined by adjusting the scale bars of a variety of parameters.After the"START"button is clicked,one can readily obtain a comprehensive analysis report for further interpretation.COVID-ONE-hi is freely available at www.COVID-ONE.cn.
9.Survey of application value on an intelligent consultation system for common eye diseases
Jingjing CHEN ; Yifan XIANG ; Xiaohang WU ; Zhenzhen LIU ; Pisong YAN ; Weiling HU ; Zhihao LAO ; Zena MA ; Xiaodong XIE ; Caoxian ZHANG ; Hairong ZHANG ; Yu ZHANG ; Huiming XIAO ; Haotian LIN
Chinese Journal of Experimental Ophthalmology 2020;38(8):692-697
Objective:To survey the application of an intelligent consultation system for common eye diseases and evaluate its applicational effectiveness on an internet hospital platform.Methods:A cross-sectional study was performed in Zhongshan Ophthalmic Centre of Sun Yat-sen University.Natural language processing technology was applied to develop the intelligent consultation system for common eye diseases.Its efficiency and quality were evaluated.The survey data were collected from February 1 to 29, 2020 to analyze the demographic information, consultation time, consultation category, consultation content, service satisfaction.This study protocal was approved by an Ethic Committee of Zhongshan Ophthalmic Centre of Sun Yat-sen University(2020KYPJ095).Results:The intelligent consultation system for common eye diseases was developed and successfully deployed in Internet Hospital of Zhongshan Ophthalmic Center.The repeatability and accuracy of the intelligent consultation system were 100.0% and 99.8%, respectively.During February 1 to 29, 2020, the intelligent consultation system served 6 462 patients, including 3 082 males(47.7%) and 3 380 females(52.3%). The average age of patients was 32.3 years old.Total of 1 135(17.6%) patients used the intelligent guidance consultation, and 5 375(82.4%) patients used the intelligent outpatient consultation.The intelligence consultation system was applied by 223 patients per day with a maximum of 74 patients per hour.The survey showed that 25.6% and 36.4% of the patients felt very satisfied and relatively satisfied with the efficiency of the intelligent consultation service, respectively; 24.3% and 37.8% of the patients were very satisfied and relatively satisfied with the quality of the intelligent consultation service, respectively.Conclusions:Intelligent consultation system for common eye diseases can meet the needs of patients because of its high repeatability and accuracy.Patients are satisfied with the service efficiency and quality of the intelligent consultation system, which avoids the risk of cross infection and releases the burden of medical staff.
10.Rectum-preserving surgery after consolidation neoadjuvant therapy or totally neoadjuvant therapy for low rectal cancer: a preliminary report
Ying HUANG ; Shenghui HUANG ; Pan CHI ; Xiaojie WANG ; Huiming LIN ; Xingrong LU ; Daoxiong YE ; Yu LIN ; Yu DENG
Chinese Journal of Gastrointestinal Surgery 2020;23(3):281-288
Objective:To investigate the feasibility and safety of sphincter-preserving surgery after neoadjuvant chemoradiotherapy (nCRT) with consolidation chemotherapy in the interval period or total neoadjuvant therapy (TNT) for low rectal cancer.Methods:A descriptive case series study was carried out. Clinical data of patients with locally advanced low rectal cancer (LALRC) who achieved complete clinical response (cCR) or nearly cCR (near-cCR) after nCRT at the Department of Colorectal Surgery of Fujian Medical University Union Hospital from May 2015 to February 2019 were retrospectively analyzed. Case inclusion criteria: (1) Low rectal adenocarcinoma within 6 cm from the anal verge. (2) After nCRT, tumor presented markedly regression as mucosal nodule or abnormalities, superficial ulcer, scar or a mucosal erythema (< 2 cm); no regional lymph node metastasis or distant metastasis was found in rectal ultrasonography, pelvic MRI and PET-CT; MRI showed obvious fibrosis in the original tumor site; and post-treatment CEA was normal. (3) The patient and the family members adhered to receive the transanal full-thickness local excision with informed consent. (4) When the residual lesions were difficult to detect after nCRT, patients received the watch and wait (W&W) strategy. Exclusion criteria: (1) Before nCRT, pathological results showed poorly differentiated or signet-ring cell carcinoma; lateral lymph node metastasis was suspected. (2) When the residual lesion size was more than 3 cm after nCRT, it was difficult to perform local excision. The consolidation nCRT group received 3-4 cycles of CAPOX regimen (oxaliplatin and capecitabine) or six cycles of mFOLFOX6 (oxaliplatin, leucovorin, and 5-fluorouracil) combined with the long-course radiotherapy (intensity-modulated radiation therapy with a total dose of 50.4Gy). Patients with concurrent chemotherapy more than or equal to five cycles of CAPOX or eight cycles of mFOLFOX6 were defined as total neoadjuvant therapy (TNT) group. Local resection was recommended for patients who were near-cCR according to modified MSKCC criteria 8-33 weeks after the end of radiotherapy. Patients with a near-cCR, who were judged as ycN0 according to PET-CT and MRI and were ypT0 after local excision, could enter the W&W strategy. Patients with pathologic stage more advanced than ypT1, and those with positive resection margin, or lymphovascular invasion were recommended for salvage radical surgery after local excision. The ypT1 patients with a negative resection margin and without lymphovascular invasion might receive the W&W management carefully if they refused radicalsurgery to sacrifice the sphincter for low rectal cancer.Results:Of 32 patients, 14 were males and 18 were females with the average age of 59 years old. Twenty-three patients underwent consolidation nCRT, and 9 received TNT. The first evaluation after treatments showed 19 cases with cCR and 13 with near-cCR. Twenty-nine patients received local excision while 3 patients with undetectable lesions received W&W policy. Four cases (12.5%) underwent salvage radical surgery with abdominoperineal resection. After local excision, 3 cases underwent salvage radical surgery immediately, and the final pathologic result was ypT3N0, ypT2N0, and ypT2N0 respectively, of whom 2 cases were in the group of consolidation CRT and 1 was in the TNT group. Of these 3 cases, 1 case with an initial cT3 stage showed a pathologic stage of ypT1 and a negative circumferential resection margin after consolidation nCRT and local excision, however, the final pathologic stage was ypT3 with fragmented tumor deposits in the mesorectum after the salvage radical surgery. Meanwhile 1 patient in the TNT group receiving W&W suffered from intraluminal regrowth after 7.4 months follow-up and underwent salvage abdominoperineal resection. One patient in the consolidation nCRT group died of stroke 42.5 months after local resection. Another patient in the TNT group had cerebral metastasis 10 months after the W&W policy, but no local recurrence was found in the pelvic cavity, then received resection of the metastatic tumors. The average follow-up for all the patients was 23 (5-51) months. The cumulative local regrowth rate was 5.0%. The overall survival rate was 85.7%, and the sphincter-preservation rate was increased from 25.0% (28/32) in the original plan to 87.5% (28/32) actually. The 3-year disease-free survival rate was 89.7%. The 3-year organ-preserving survival rate was 85.7%, and the 3-year stoma-free survival rate was 82.5%. At present, 31 patients still survived.Conclusions:After nCRT with consolidation chemotherapy or TNT for low rectal cancer, patients with cCR, ycN0 according to PET-CT and MRI, and ypT0 after local excision, can consider the W&W strategy. Strict patient selection with a near-cCR for local resection and sphincter-preserving strategy can reduce the local regrowth of cancer, and the short-term outcomes are satisfactory.

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