1.Using Liquid Chromatography-Tandem Mass Spectrometry in Detecting Plasma Lyso-GL3 Levels in Patients with Fabry Disease and the Association Analysis of Phenotype-Genotype of the Disease
Yan OUYANG ; Bing CHEN ; Xiaoxia PAN ; Hong REN ; Jingyuan XIE ; Chaohui WANG ; Xiao LI ; Weiming WANG ; Xialian YU ; Li YANG ; Nan CHEN
JOURNAL OF RARE DISEASES 2024;3(1):42-49
Using the liquid chromatography-tandem mass spectrometry (LC-MS/MS) to determine the plasma level of Lyso-GL3 in patients with Fabry disease and to analyze the clinical application of the method. Thirty-nine patients with a genetic diagnosis of Fabry disease were included, and plasma levels of Lyso-GL3 were measured by LC-MS/MS analysis, and detailed clinical information of the patients was obtained including: α-galactosidase A activity, genetic variants, quantification of urine protein, mean arterial pressure, and estimation of glomerular filtration rate, and the differences in the levels of Lyso-GL3 in different clinical phenotypes and genotypes were statistically analyzed, as well as the association with clinical indicators. Lyso-GL3 showed good linearity within 0.7856-400 ng/mL( The using of LC-MS/MS to quantify plasma Lyso-GL showed significant differences in Lyso-GL3 concentrations between classical and atypical phenotypes, suggesting that plasma Lyso-GL3 may help with clinical phenotypes. However, Lyso-GL3 levels is found to be overlapped between genotypes. No significant linear correlation was found between Lyso-GL3 and renal clinical indicators, suggesting the urgent need in finding a more accurate tool to assess renal involvement and prognosis in patients with Fabry disease.
2.Design and Application of the Information System for Free Examination and Settlement of Pediatric Drug Clinical Trials
Chaohui YE ; Yingyan YAN ; Zhuo' ; er ZHU ; Yi CHEN
Chinese Journal of Modern Applied Pharmacy 2024;41(3):393-397
OBJECTIVE
To optimize the free examination, traceability, cost settlement and privacy protection during the development of pediatric drug clinical trials by means of information technology, so as to improve the efficiency and quality of project operation.
METHODS
Based on the existing hospital information system, multi department joint designed and implemented an information system for the settlement of the diagnosis and treatment expenses for drug clinical trial, which realized the real-time settlement of medical costs for drug clinical trials without the need for advance reimbursement of subjects' guardians.
RESULTS
This system took into account both cost and function, and had good feasibility. It could effectively improve the operation efficiency of drug clinical institutions, ensure the traceability of diagnosis and treatment data, and optimize the experience and privacy protection of child subjects.
CONCLUSION
The development and design of this system can effectively improve the operating efficiency of pediatric drug clinical trials, and has a good reference for other new record institutions to solve such problems.
3.Study on the role of changing lifestyle and diet in in the treatment of laryngopharyngeal reflux disease
Ming LU ; Jiyi CAI ; Zesheng HONG ; Yuming HONG ; Chaohui ZHENG ; Zhenyuan LIANG ; Yahong LI ; Xiaofang CHEN
Chinese Archives of Otolaryngology-Head and Neck Surgery 2024;31(4):255-259
OBJECTIVE To explore the effect of changing lifestyle diet in the treatment of laryngeal reflux disease(LRPD).METHODS A total of 92 patients with LRPD who received outpatient treatment in the Second Affiliated Hospital of Fujian Medical University from January 2022 to June 2023 were selected as the study control,divided into control group(46 cases)and treatment group(46 cases).The control group was treated with conventional acid suppression and gastric motogenic therapy.The treatment group was treated on the basis of the control group with giving guidance on lifestyle and diet.The changes of reflux symptom index scale(RSI)and reflux sign score scale(RFS)and the clinical efficacy of the two groups were compared 8 weeks and 12 weeks after treatment.RESULTS RSI total score was improved 8 weeks after treatment compared with before treatment in both RSI control group and treatment group(P<0.05).The total RSI score of 12 weeks after treatment was improved compared with that of 8 weeks after treatment in both control and treatment groups(P<0.05).The total RFS score at 8 weeks after treatment was improved in both control group and treatment group compared with before treatment(P<0.05).Compared with 8 weeks after treatment,the total RFS score in both control group and treatment group was improved(P<0.05).After 8 weeks of treatment,the total effective rate of the control group(60.9%)was compared with that of the treatment group(71.7%),and there was no significant difference between the two groups(χ2=1.335,P=0.513).After 12 weeks of treatment,the total effective rate of the control group(73.9%)was compared with the total effective rate of the treatment group(91.3%),and the difference between the two groups was statistically significant(χ2=6.226,P=0.044).CONCLUSION The change of lifestyle and diet should become an important part of the treatment of LRPD.By adjusting the unhealthy lifestyle and diet,the symptoms of patients can be significantly reduced and better clinical efficacy can be obtained.
4.Recurrence outcomes of robotic-versus laparoscopic-assisted gastrectomy for gastric cancer: a multi-center propensity score-matched cohort study
Jun LU ; Taiyuan LI ; Li ZHANG ; Junjun SHE ; Junyu CHEN ; Qing ZHONG ; Zukai WANG ; Changming HUANG ; Chaohui ZHENG
Chinese Journal of Gastrointestinal Surgery 2024;27(8):799-807
Objective:To compare and evaluate recurrence patterns after robotic-assisted gastrectomy (RAG) versus laparoscopic-assisted gastrectomy (LAG).Methods:This was a retrospective cohort study of 2915 consecutive patients with gastric adenocarcinoma confirmed by postoperative histology as T1-4aN0-3M0, who had undergone minimally invasive radical gastrectomy at four large gastric cancer treatment centers (Fujian Medical University Union Hospital: 1426 patients; the First Affiliated Hospital, Nanchang University: 1108; Tianjin Medical University Cancer Institute and Hospital: 196; and First Affiliated Hospital of Xi'an Jiaotong University: 185 cases) between 1 January 2015 and 30 June 2019. 930 patients had undergone RAG (RAG group) and 1985 had undergone LAG (LAG group). We assessed the following characteristics: age, sex, body mass index, American Society of Anesthesiologists score, comorbidities, tumor size, extent of surgery, extent of lymph node dissection, pT, pN, year of surgery, and adjuvant chemotherapy, after propensity score matching (1:1). There were no significant differences in baseline clinical characteristics between the two groups formed by propensity score matching (837 in each group) (all P>0.05). The 3-year recurrence-free survival (RFS), recurrence pattern, and conditional RFS were compared. Results:We detected no significant differences in the overall recurrence rate at 3 years (128/837 [15.3%] vs. 141/837 [16.8%], P=0.387) or time to recurrence (15.7±8.1 months vs. 16.4±8.4 months, P=0.449) between the RAG and LAG groups. Peritoneal recurrence was the most common type of recurrence in both groups (55 [6.6%] vs. 69 [8.2%], P=0.524). The difference in 3-year RFS between the RAG and LAG groups was not statistically significant (83.2% vs. 82.5%, P=0.781). We found that age > 60 years, total gastrectomy, and worse pT stage and pN stage were independent risk factors for recurrence in the study patients (all P<0.05), whereas the surgical procedure (RAG or LAG) was not an independent risk factor for RFS ( P=0.242). The 3-year conditional RFS at various time points was comparable between the two groups (1 year postoperatively: 84.6% vs. 84.7%, P=0.793; 3 years postoperatively: 91.5% vs. 94.9%, P=0.647). Conclusions:In this multicenter study of patients with locally resectable gastric cancer, we demonstrated that RAG performed by surgeons at large gastric cancer centers is not inferior to LAG in 3-year recurrence rate or recurrence patterns.
5.Recurrence outcomes of robotic-versus laparoscopic-assisted gastrectomy for gastric cancer: a multi-center propensity score-matched cohort study
Jun LU ; Taiyuan LI ; Li ZHANG ; Junjun SHE ; Junyu CHEN ; Qing ZHONG ; Zukai WANG ; Changming HUANG ; Chaohui ZHENG
Chinese Journal of Gastrointestinal Surgery 2024;27(8):799-807
Objective:To compare and evaluate recurrence patterns after robotic-assisted gastrectomy (RAG) versus laparoscopic-assisted gastrectomy (LAG).Methods:This was a retrospective cohort study of 2915 consecutive patients with gastric adenocarcinoma confirmed by postoperative histology as T1-4aN0-3M0, who had undergone minimally invasive radical gastrectomy at four large gastric cancer treatment centers (Fujian Medical University Union Hospital: 1426 patients; the First Affiliated Hospital, Nanchang University: 1108; Tianjin Medical University Cancer Institute and Hospital: 196; and First Affiliated Hospital of Xi'an Jiaotong University: 185 cases) between 1 January 2015 and 30 June 2019. 930 patients had undergone RAG (RAG group) and 1985 had undergone LAG (LAG group). We assessed the following characteristics: age, sex, body mass index, American Society of Anesthesiologists score, comorbidities, tumor size, extent of surgery, extent of lymph node dissection, pT, pN, year of surgery, and adjuvant chemotherapy, after propensity score matching (1:1). There were no significant differences in baseline clinical characteristics between the two groups formed by propensity score matching (837 in each group) (all P>0.05). The 3-year recurrence-free survival (RFS), recurrence pattern, and conditional RFS were compared. Results:We detected no significant differences in the overall recurrence rate at 3 years (128/837 [15.3%] vs. 141/837 [16.8%], P=0.387) or time to recurrence (15.7±8.1 months vs. 16.4±8.4 months, P=0.449) between the RAG and LAG groups. Peritoneal recurrence was the most common type of recurrence in both groups (55 [6.6%] vs. 69 [8.2%], P=0.524). The difference in 3-year RFS between the RAG and LAG groups was not statistically significant (83.2% vs. 82.5%, P=0.781). We found that age > 60 years, total gastrectomy, and worse pT stage and pN stage were independent risk factors for recurrence in the study patients (all P<0.05), whereas the surgical procedure (RAG or LAG) was not an independent risk factor for RFS ( P=0.242). The 3-year conditional RFS at various time points was comparable between the two groups (1 year postoperatively: 84.6% vs. 84.7%, P=0.793; 3 years postoperatively: 91.5% vs. 94.9%, P=0.647). Conclusions:In this multicenter study of patients with locally resectable gastric cancer, we demonstrated that RAG performed by surgeons at large gastric cancer centers is not inferior to LAG in 3-year recurrence rate or recurrence patterns.
6.Prognostic significance of textbook outcome in advanced gastric patients who underwent neoadjuvant chemotherapy followed by surgical resection
Yihui TANG ; Zening HUANG ; Qiyue CHEN ; Ping LI ; Jianwei XIE ; Jiabin WANG ; Jianxian LIN ; Jun LU ; Longlong CAO ; Mi LIN ; Ruhong TU ; Chaohui ZHENG ; Changming HUANG
Chinese Journal of Surgery 2024;62(5):379-386
Objective:To investigate the risk factors and prognostic value of the textbook outcome (TO) in patients with advanced gastric cancer (AGC) who underwent neoadjuvant chemotherapy followed by surgical resection.Methods:This is a retrospective cohort study. A total of 253 patients with AGC who underwent neoadjuvant chemotherapy combined with gastrectomy and D2 lymphadenectomy in the Department of Gastric Surgery, Fujian Medical University Union Hospital from January 2010 to December 2019 were retrospectively included. There were 195 males and 58 females, aged (60.3±10.0) years (range: 27 to 75 years). The patients were then divided into the TO group ( n=168) and the non-TO group ( n=85). Multivariate Logistic regression was used to analyze the independent predictors of TO. Univariate and multivariate Cox analysis were used to analyze independent prognosis factors for overall survival (OS) and disease-free survival (DFS). Propensity score matching was performed to balance the TO and non-TO groups, and the Kaplan-Meier method was used to calculate survival rates and draw survival curves. Results:Among the 253 patients, 168 patients (66.4%) achieved TO. The Eastern Cooperative Oncology Group score ( OR=0.488, 95% CI: 0.278 to 0.856, P=0.012) and ypN stage ( OR=0.626, 95% CI:0.488 to 0.805, P<0.01) were independently predictive of TO. Multivariate analysis revealed that TO was an independent risk factor for both OS ( HR=0.662, 95% CI: 0.457 to 0.959, P=0.029) and DFS ( HR=0.687, 95% CI: 0.483 to 0.976, P=0.036). After matching, the 5-year OS rate (42.2% vs. 27.8%) and the 5-year DFS rate (37.5% vs. 27.8%) were significantly higher in the TO group than in the non-TO group (both P<0.05). Furthermore, patients in the non-TO group benefited significantly from postoperative chemotherapy (both P<0.05), but those in the TO group did not (both P>0.05). Conclusion:TO is an independent prognosis factor in patients undergoing neoadjuvant chemotherapy and surgery for AGC and is associated with postoperative chemotherapy benefits.
7.Prognostic significance of textbook outcome in advanced gastric patients who underwent neoadjuvant chemotherapy followed by surgical resection
Yihui TANG ; Zening HUANG ; Qiyue CHEN ; Ping LI ; Jianwei XIE ; Jiabin WANG ; Jianxian LIN ; Jun LU ; Longlong CAO ; Mi LIN ; Ruhong TU ; Chaohui ZHENG ; Changming HUANG
Chinese Journal of Surgery 2024;62(5):379-386
Objective:To investigate the risk factors and prognostic value of the textbook outcome (TO) in patients with advanced gastric cancer (AGC) who underwent neoadjuvant chemotherapy followed by surgical resection.Methods:This is a retrospective cohort study. A total of 253 patients with AGC who underwent neoadjuvant chemotherapy combined with gastrectomy and D2 lymphadenectomy in the Department of Gastric Surgery, Fujian Medical University Union Hospital from January 2010 to December 2019 were retrospectively included. There were 195 males and 58 females, aged (60.3±10.0) years (range: 27 to 75 years). The patients were then divided into the TO group ( n=168) and the non-TO group ( n=85). Multivariate Logistic regression was used to analyze the independent predictors of TO. Univariate and multivariate Cox analysis were used to analyze independent prognosis factors for overall survival (OS) and disease-free survival (DFS). Propensity score matching was performed to balance the TO and non-TO groups, and the Kaplan-Meier method was used to calculate survival rates and draw survival curves. Results:Among the 253 patients, 168 patients (66.4%) achieved TO. The Eastern Cooperative Oncology Group score ( OR=0.488, 95% CI: 0.278 to 0.856, P=0.012) and ypN stage ( OR=0.626, 95% CI:0.488 to 0.805, P<0.01) were independently predictive of TO. Multivariate analysis revealed that TO was an independent risk factor for both OS ( HR=0.662, 95% CI: 0.457 to 0.959, P=0.029) and DFS ( HR=0.687, 95% CI: 0.483 to 0.976, P=0.036). After matching, the 5-year OS rate (42.2% vs. 27.8%) and the 5-year DFS rate (37.5% vs. 27.8%) were significantly higher in the TO group than in the non-TO group (both P<0.05). Furthermore, patients in the non-TO group benefited significantly from postoperative chemotherapy (both P<0.05), but those in the TO group did not (both P>0.05). Conclusion:TO is an independent prognosis factor in patients undergoing neoadjuvant chemotherapy and surgery for AGC and is associated with postoperative chemotherapy benefits.
8.Application and practice of indocyanine green-guided laparoscopic radical gastrec-tomy for gastric cancer
Huang CHANGMING ; Liang HAN ; Zheng CHAOHUI ; Chen QIYUE ; Zhong QING ; Qiu TAOYUAN
Chinese Journal of Clinical Oncology 2024;51(13):663-669
Indocyanine green(ICG)near-infrared imaging technology has significant research value in laparoscopic radical gastrectomy and has garnered widespread attention and research both domestically and internationally.However,the application of ICG near-infrared ima-ging technology in laparoscopic radical gastrectomy is still in the exploratory stage in current clinical practice,with no unified standards es-tablished as yet.This review introduces the mechanism of ICG fluorescence imaging and discusses the indications and contraindications of ICG use in laparoscopic radical gastrectomy.The application methods and procedures of ICG molecular fluorescence imaging technology in laparoscopic radical gastrectomy and its clinical applications are elaborated upon.Finally,the practical applications of ICG-guided laparo-scopic radical gastrectomy is summarized and generalized to help facilitate its promotion and further standardization.
9.Discussion on implementation risks and countermeasures of investigator-initiated pediatric drug clinical trials based on drug management
Chaohui YE ; Yingyan YAN ; Zhuoer ZHU ; Yi CHEN
Chinese Journal of Medical Science Research Management 2024;37(5):424-428
Objective:This study aimed to discuss the risks associated with investigator-initiated pediatric drug clinical trials in terms of drug management and put forward relevant suggestions to improve the standardization and quality of pediatric clinical trials.Methods:The risk in the implementation of pediatric drug clinical trials initiated by domestic researchers were discussed and the countermeasures were put forward by reviewing literature, laws and regulations, and combining with the problems related to research drugs in project management.Results:In investigator-initiated pediatric drug clinical trials, the variety of research drug sources, such as sponsor donations, hospital pharmacy supplies, and community pharmacy provisions, posed distinct management risks that would require tailored attention. Moreover, the specific risk of pediatric medication should be fully considered during study execution. It was imperative for medical institutions to strengthen comprehensive management of research drugs to ensure the trial′s smooth operation.Conclusions:Investigator-initiated pediatric drug clinical trials serve as valuable supplements that expand new drugs′ trial scope for children. While actively conducting these trials, it is recommended that medical institutions should strengthen project approval reviews from the perspectives of drug supply, subject compensation and child dosage form, implement centralized management of research drugs, attach importance to ethical review of adverse drug events, strengthen personnel training and leverage information settlement, so as to improve work efficiency and research quality-ultimately providing support for pediatric pharmaceutical development efforts as well as promoting high-quality advancements within Chinese pediatrics medicine.
10.Risk factors for moderate and severe femoral neck shortening in displaced femoral neck fractures following treatment by a femoral neck system
Dongze LIN ; Peisheng CHEN ; Chaohui LIN ; Bin CHEN ; Ke ZHENG ; Shunze ZHENG ; Jiajie LIU ; Fengfei LIN
Chinese Journal of Orthopaedic Trauma 2023;25(11):952-958
Objective:To investigate the incidence of and risk factors for femoral neck shortening in young and middle-aged patients with displaced femoral neck fracture treated by a femoral neck system (FNS).Methods:A retrospective study was conducted to analyze the clinical data of 135 patients with displaced femoral neck fracture who had been treated by closed reduction and FNS internal fixation at Department of Orthopaedics, The Second Hospital of Fuzhou from December 2019 to December 2021. There were 85 males and 50 females, with an age of 51 (42, 57) years and a body mass index of 22.6 (20.9, 24.2) kg/m 2. According to the Garden classification, there were 29 cases of type Ⅲ and 106 cases of type Ⅳ. Femoral neck shortening was observed. The patients' gender, age, side of shortening, body mass index, fracture type, high-energy injury, time from injury to surgery, cortical comminution at the fracture end, reduction quality (Garden index), partial weight bearing time, complete weight bearing time, and functional evaluation (Harris score) were recorded for a univariate analysis. Multivariate logistic regression was used to analyze the influencing factors for moderate to severe shortening. Results:All the 135 patients were followed up for 17.2 (15.0, 20.2) months. Different degrees of femoral neck shortening happened in all patients, yielding an incidence of 100%(135/135). The femoral neck shortening was 4.2 (2.6, 7.7) mm in displaced femoral neck fractures fixated by FNS. The shortening continued to worsen within the first 3 months after operation, reaching a stable state in the first 6 months. Persistent shortening hardly occurred after 6 months. According to the shortening distance, the patients were divided into a mild shortening group (76 cases <5 mm) and a moderate to severe shortening group (59 cases ≥ 5 mm). The Harris score at the last follow-up in the mild shortening group (91.7 ± 2.3) was significantly higher than that in the moderate to severe shortening group (87.9 ± 3.8) ( P<0.001). The fracture healing rate was 98.7% (75/76) in the mild shortening group and 98.3% (58/59) in the moderate to severe shortening group, showing no significant difference ( P=1.000). Logistic regression analysis found that the risk factors for moderate to severe shortening were fracture type (type Ⅳ) ( OR = 10.227, 95% CI: 1.845 to 56.693, P = 0.008), cortical comminution at the fracture end (if present) ( OR=52.697, 95% CI: 9.870 to 281.352, P<0.001), and partial weight bearing time <4 weeks ( OR = 0.168, 95% CI: 0.032 to 0.893, P = 0.036). Conclusions:The incidence of femoral neck shortening may be high in young and middle-aged patients with displaced femoral neck fracture treated by FNS, leading to decreased hip function. The main risk factors for femoral neck shortening are fracture type (Garden type Ⅳ), cortical comminution at the fracture end and partial weight-bearing time less than 4 weeks.


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