1.Development and verification of a reversed phase high-performance liquid chromatography method for purity determination of recombinant Mycobacterium tuberculosis Ag85b protein stock solution
Chinese Journal of Biologicals 2024;37(1):86-91
Objective To develop and verify a reversed phase high-performance liquid chromatography method for the determination of the purity of recombinant Mycobacterium tuberculosis(Mtb)Ag85b protein stock solution.Methods Fourfactor,three-level orthogonal test was designed,with the area,trailing factor,peak area and peak area RSD as the evaluation indexes to explore the optimal detection conditions. The methodology verification of specificity,linear range,precision and durability was conducted in accordance with the general principles of Chinese Pharmacopoeia(Volume Ⅳ,2020 edition)9101.Results The results of all the evaluation indexes were good when the elution ratio of organic phase was30% ~ 95%,the detection temperature was 35 ℃,the sample volume was 3 μg,and the elution time of 95% organic phase was 15 min. The method had the linear correlation coefficient(R2)of 0. 998 5,the linear range of 1. 8 ~ 4. 2 μg,the reproducibility RSD of 0. 01%,and the intermediate precision RSD of 0. 16%,with good durability under slight changes of column temperature and flow rate.Conclusion The reversed phase high-performance liquid chromatography method for the purity determination of recombinant Mtb Ag85b protein stock solution was developed,which has good specificity,precision and durability,and can be used for the quality control of recombinant Mtb Ag85b protein stock solution.
2.Genetically predicted waist circumference and risk of atrial fibrillation
Wenting WANG ; Jiang-Shan TAN ; Jingyang WANG ; Wei XU ; Liting BAI ; Yu JIN ; Peng GAO ; Peiyao ZHANG ; Yixuan LI ; Yanmin YANG ; Jinping LIU
Chinese Medical Journal 2024;137(1):82-86
Introduction::Observational studies have revealed an association between waist circumference (WC) and atrial fibrillation (AF). However, it is difficult to infer a causal relationship from observational studies because the observed associations could be confounded by unknown risk factors. Therefore, the causal role of WC in AF is unclear. This study was designed to investigate the causal association between WC and AF using a two-sample Mendelian randomization (MR) analysis.Methods::In our two-sample MR analysis, the genetic variation used as an instrumental variable for MR was acquired from a genome-wide association study (GWAS) of WC (42 single nucleotide polymorphisms with a genetic significance of P <5 × 10 –8). The data of WC (from the Genetic Investigation of ANthropometric Traits consortium, containing 232,101 participants) and the data of AF (from the European Bioinformatics Institute database, containing 55,114 AF cases and 482,295 controls) were used to assess the causal role of WC on AF. Three different approaches (inverse variance weighted [IVW], MR–Egger, and weighted median regression) were used to ensure that our results more reliable. Results::All three MR analyses provided evidence of a positive causal association between high WC and AF. High WC was suggested to increase the risk of AF based on the IVW method (odds ratio [OR] = 1.43, 95% confidence interval [CI], 1.30–1.58, P = 2.51 × 10 -13). The results of MR–Egger and weighted median regression exhibited similar trends (MR–Egger OR = 1.40 [95% CI, 1.08–1.81], P = 1.61 × 10 -2; weighted median OR = 1.39 [95% CI, 1.21–1.61], P = 1.62 × 10 -6). MR–Egger intercepts and funnel plots showed no directional pleiotropic effects between high WC and AF. Conclusions::Our findings suggest that greater WC is associated with an increased risk of AF. Taking measures to reduce WC may help prevent the occurrence of AF.
3.Construction of a model based on multipoint full-layer puncture biopsy for predicting pathological complete response after neoadjuvant therapy for locally advanced rectal cancer
Ying JIN ; Zhiwei ZHAI ; Liting SUN ; Pingdian XIA ; Hang HU ; Chongqiang JIANG ; Baocheng ZHAO ; Hao QU ; Qun QIAN ; Yong DAI ; Hongwei YAO ; Zhenjun WANG ; Jiagang HAN
Chinese Journal of Gastrointestinal Surgery 2024;27(4):403-411
Objective:To investigate the value of transanal multipoint full-layer puncture biopsy (TMFP) in predicting pathological complete response (pCR) after neoadjuvant radiotherapy and chemotherapy (nCRT) in patients with locally advanced rectal cancer (LARC) and to establish a predictive model for providing clinical guidance regarding the treatment of LARC.Methods:In this multicenter, prospective, cohort study, we collected data on 110 LARC patients from four hospitals between April 2020 and March 2023: Beijing Chaoyang Hospital of Capital Medical University (50 patients), Beijing Friendship Hospital of Capital Medical University (41 patients), Qilu Hospital of Shandong University (16 patients), and Zhongnan Hospital of Wuhan University (three patients). The patients had all received TMFP after completing standard nCRT. The variables studied included (1) clinicopathological characteristics; (2) clinical complete remission (cCR) and efficacy of TMFP in determining pCR after NCRT in LARC patients; and (3) hospital attended, sex, age, clinical T- and N-stages, distance between the lower margin of the tumor and the anal verge, baseline and post-radiotherapy serum carcinoembryonic antigen (CEA) and carbohydrate antigen (CA)19-9 concentrations, chemotherapy regimen, use of immunosuppressants with or without radiotherapy, radiation therapy dosage, interval between surgery and radiotherapy, surgical procedure, clinical T/N stage after radiotherapy, cCR, pathological results of TMFP, puncture method (endoscopic or percutaneous), and number and timing of punctures. Single-factor and multifactorial logistic regression analysis were used to determine the factors affecting pCR after NCRT in LARC patients. A prediction model was constructed based on the results of multivariat analysis and the performance of this model evaluated by analyzing subject work characteristics (ROC), calibration, and clinical decision-making (DCA) curves. pCR was defined as complete absence of tumor cells on microscopic examination of the surgical specimens of rectal cancer (including lymph node dissection) after NCRT, that is, ypT0+N0. cCR was defined according to the Chinese Neoadjuvant Rectal Cancer Waiting Watch Database Study Collaborative Group criteria after treatment, which specify an absence of ulceration and nodules on endoscopy; negative rectal palpation; no tumor signals on rectal MRI T2 and DWI sequences; normal serum CEA concentrations, and no evidence of recurrence on pelvic computed tomography/magnetic resonance imaging.Results:Of the 110 patients, 45 (40.9%) achieved pCR after nCRT, which was combined with immune checkpoint inhibitors in 34 (30.9%). cCR was diagnosed before puncture in 38 (34.5%) patients, 43 (39.1%) of the punctures being endoscopic. There were no complications of puncture such as enterocutaneous fistulae, vaginal injury, prostatic injury, or presacral bleeding . Only one (2.3%) patient had a small amount of blood in the stools, which was relieved by anal pressure. cCR had a sensitivity of 57.8% (26/45) for determining pCR, specificity of 81.5% (53/65), accuracy of 71.8% (79/110), positive predictive value 68.4% (26/38), and negative predictive value of 73.6% (53/72). In contrast, the sensitivity of TMFP pathology in determining pCR was 100% (45/45), specificity 66.2% (43/65), accuracy 80.0% (88/110), positive predictive value 67.2% (45/67), and negative predictive value 100.0% (43/43). In this study, the sensitivity of TMFP for pCR (100.0% vs. 57.8%, χ 2=24.09, P<0.001) was significantly higher than that for cCR. However, the accuracy of pCR did not differ significantly (80.0% vs. 71.8%, χ 2=2.01, P=0.156). Univariate and multivariate logistic regression analyses showed that a ≥4 cm distance between the lower edge of the tumor and the anal verge (OR=7.84, 95%CI: 1.48-41.45, P=0.015), non-cCR (OR=4.81, 95%CI: 1.39-16.69, P=0.013), and pathological diagnosis by TMFP (OR=114.29, the 95%CI: 11.07-1180.28, P<0.001) were risk factors for pCR after NCRT in LARC patients. Additionally, endoscopic puncture (OR=0.02, 95%CI: 0.05-0.77, P=0.020) was a protective factor for pCR after NCRT in LARC patients. The area under the ROC curve of the established prediction model was 0.934 (95%CI: 0.892-0.977), suggesting that the model has good discrimination. The calibration curve was relatively close to the ideal 45° reference line, indicating that the predicted values of the model were in good agreement with the actual values. A decision-making curve showed that the model had a good net clinical benefit. Conclusion:Our predictive model, which incorporates TMFP, has considerable accuracy in predicting pCR after nCRT in patients with locally advanced rectal cancer. This may provide a basis for more precisely selecting individualized therapy.
4.A case analysis of medication adjustments on a moyamoya disease patient with endometriosis by DAPT treatment during perioperative period and formulation of DIE postoperative recurrence prevention
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(5):495-500
AIM:To explore the key points of per-sonalized treatment and medication monitoring by clinical pharmacists in the perioperative period of moyamoya disease patients with endometriosis.METHODS:This study showed a moyamoya disease patient with endometriosis who accepting dual an-tiplatelet therapy and how to adjust medication during the perioperative period.Besides,monitor-ing the use proton pump inhibitors in the perioper-ative period and the formulating a plan of DIE post-operative recurrence prevention are also our objec-tives.RESULTS:Through individualized assessment of the patient,a personalized medication adjust-ments for dual antiplatelet therapy was deter-mined.Individualized perioperative proton pump inhibitor regimen and postoperative prevention plan for endometriosis recurrence were developed.CONCLUSION:The development of individualized medication regimens and medication monitoring is the breakthrough point for clinical pharmacists to carry out pharmaceutical services.
5.Construction of a model based on multipoint full-layer puncture biopsy for predicting pathological complete response after neoadjuvant therapy for locally advanced rectal cancer
Ying JIN ; Zhiwei ZHAI ; Liting SUN ; Pingdian XIA ; Hang HU ; Chongqiang JIANG ; Baocheng ZHAO ; Hao QU ; Qun QIAN ; Yong DAI ; Hongwei YAO ; Zhenjun WANG ; Jiagang HAN
Chinese Journal of Gastrointestinal Surgery 2024;27(4):403-411
Objective:To investigate the value of transanal multipoint full-layer puncture biopsy (TMFP) in predicting pathological complete response (pCR) after neoadjuvant radiotherapy and chemotherapy (nCRT) in patients with locally advanced rectal cancer (LARC) and to establish a predictive model for providing clinical guidance regarding the treatment of LARC.Methods:In this multicenter, prospective, cohort study, we collected data on 110 LARC patients from four hospitals between April 2020 and March 2023: Beijing Chaoyang Hospital of Capital Medical University (50 patients), Beijing Friendship Hospital of Capital Medical University (41 patients), Qilu Hospital of Shandong University (16 patients), and Zhongnan Hospital of Wuhan University (three patients). The patients had all received TMFP after completing standard nCRT. The variables studied included (1) clinicopathological characteristics; (2) clinical complete remission (cCR) and efficacy of TMFP in determining pCR after NCRT in LARC patients; and (3) hospital attended, sex, age, clinical T- and N-stages, distance between the lower margin of the tumor and the anal verge, baseline and post-radiotherapy serum carcinoembryonic antigen (CEA) and carbohydrate antigen (CA)19-9 concentrations, chemotherapy regimen, use of immunosuppressants with or without radiotherapy, radiation therapy dosage, interval between surgery and radiotherapy, surgical procedure, clinical T/N stage after radiotherapy, cCR, pathological results of TMFP, puncture method (endoscopic or percutaneous), and number and timing of punctures. Single-factor and multifactorial logistic regression analysis were used to determine the factors affecting pCR after NCRT in LARC patients. A prediction model was constructed based on the results of multivariat analysis and the performance of this model evaluated by analyzing subject work characteristics (ROC), calibration, and clinical decision-making (DCA) curves. pCR was defined as complete absence of tumor cells on microscopic examination of the surgical specimens of rectal cancer (including lymph node dissection) after NCRT, that is, ypT0+N0. cCR was defined according to the Chinese Neoadjuvant Rectal Cancer Waiting Watch Database Study Collaborative Group criteria after treatment, which specify an absence of ulceration and nodules on endoscopy; negative rectal palpation; no tumor signals on rectal MRI T2 and DWI sequences; normal serum CEA concentrations, and no evidence of recurrence on pelvic computed tomography/magnetic resonance imaging.Results:Of the 110 patients, 45 (40.9%) achieved pCR after nCRT, which was combined with immune checkpoint inhibitors in 34 (30.9%). cCR was diagnosed before puncture in 38 (34.5%) patients, 43 (39.1%) of the punctures being endoscopic. There were no complications of puncture such as enterocutaneous fistulae, vaginal injury, prostatic injury, or presacral bleeding . Only one (2.3%) patient had a small amount of blood in the stools, which was relieved by anal pressure. cCR had a sensitivity of 57.8% (26/45) for determining pCR, specificity of 81.5% (53/65), accuracy of 71.8% (79/110), positive predictive value 68.4% (26/38), and negative predictive value of 73.6% (53/72). In contrast, the sensitivity of TMFP pathology in determining pCR was 100% (45/45), specificity 66.2% (43/65), accuracy 80.0% (88/110), positive predictive value 67.2% (45/67), and negative predictive value 100.0% (43/43). In this study, the sensitivity of TMFP for pCR (100.0% vs. 57.8%, χ 2=24.09, P<0.001) was significantly higher than that for cCR. However, the accuracy of pCR did not differ significantly (80.0% vs. 71.8%, χ 2=2.01, P=0.156). Univariate and multivariate logistic regression analyses showed that a ≥4 cm distance between the lower edge of the tumor and the anal verge (OR=7.84, 95%CI: 1.48-41.45, P=0.015), non-cCR (OR=4.81, 95%CI: 1.39-16.69, P=0.013), and pathological diagnosis by TMFP (OR=114.29, the 95%CI: 11.07-1180.28, P<0.001) were risk factors for pCR after NCRT in LARC patients. Additionally, endoscopic puncture (OR=0.02, 95%CI: 0.05-0.77, P=0.020) was a protective factor for pCR after NCRT in LARC patients. The area under the ROC curve of the established prediction model was 0.934 (95%CI: 0.892-0.977), suggesting that the model has good discrimination. The calibration curve was relatively close to the ideal 45° reference line, indicating that the predicted values of the model were in good agreement with the actual values. A decision-making curve showed that the model had a good net clinical benefit. Conclusion:Our predictive model, which incorporates TMFP, has considerable accuracy in predicting pCR after nCRT in patients with locally advanced rectal cancer. This may provide a basis for more precisely selecting individualized therapy.
6.Feasibility analysis of independent extracorporeal cardiopulmonary resuscitation treatment for adult cardiac arrest in county-level hospitals
Chaoyi WANG ; Sheng QIU ; Qi JIN ; Liuqian BAO ; Liting PANG
Chinese Journal of Emergency Medicine 2024;33(6):814-818
Objective:To summarize the experience and outcomes of independent extracorporeal membrane oxygenation (ECMO) assistance for adult cardiac arrest patients conducted by a county-level hospital.Methods:Clinical data of 23 adult cardiac arrest patients treated with extracorporeal cardiopulmonary resuscitation (ECPR) at Tiantai County People's Hospital from January 2020 to October 2023 were retrospectively reviewed. Data, including initial cardiac rhythm, ECMO initiation time, cardiopulmonary resuscitation (CA)-Pump On time, ECMO initiation-Pump On time, ECMO cannulation-Pump On time, complications, neurological function prognosis, mortality rate, and survival rate, were collected and analyzed. Collect and analyze the mortality and survival rates of 33 adult cardiac arrest (CA) patients meeting the criteria for extracorporeal cardiopulmonary resuscitation (ECPR) but receiving only conventional cardiopulmonary resuscitation (CCPR) from January 2020 to October 2023, and compare these rates with those of patients who underwent CA-ECPR.Results:Among the 23 cardiac arrest patients, 16 patients achieved spontaneous heart rhythm recovery, 15 patients experienced death, and 8 patients showed improved conditions upon discharge, with 6 patients exhibiting good neurological function prognosis. Compared to CA-CCPR, patients who received CA-ECPR showed a significant decrease in mortality rate (65.21% vs. 90.91%, P=0.017) and a significant increase in survival rate (34.78% vs. 9.09%, P=0.017). After gradual optimization of the ECPR process, the 2022-2023 group showed a significantly increased survival rate compared to the 2020-2021 group(46% vs. 20%). ECMO initiation-Pump On time [41( IQR36.5-44.5)min vs.43( IQR32.75-58.5)min, P=0.709] and ECMO cannulation-Pump On time[30( IQR24.0-37.0)min vs. 33( IQR27.25-55.00)min, P=0.575] decreased, although the differences between the two groups were not statistically significant. In the comparison between survival and death groups, the proportion of initial shockable rhythm was significantly higher in the survival group (75% vs. 20%). CA-Pump On time [61( IQR49.25-69.25)min vs.69( IQR58.0-89.0)min, P=0.287]and ECMO initiation-Pump On time[39( IQR29.25-51.75)min vs.43( IQR34.0-52.0)min, P=0.539] were lower in the survival group, but the differences were not statistically significant. Conclusions:Independent implementation of ECPR for adult cardiac arrest at the county-level primary hospital improves the success rate of resuscitation and enhances patient prognosis. The promotion of ECPR rescue technology in county hospitals is feasible and significant, benefiting a larger population of cardiac arrest patients.
7.Risk Factors for Returning of Pediatric Liver Transplant Recipients to the Intensive Care Unit
Leiqing GAO ; Liting QI ; Jing JIN ; Yanfen GU ; Yefeng LU
Acta Academiae Medicinae Sinicae 2024;46(5):678-684
Objective To explore the risk factors for the returning of pediatric liver transplant recipi-ents to the intensive care unit(ICU)and provide reference for the clinical decision-making after surgery.Methods A retrospective analysis was conducted with the information of all the pediatric patients who underwent liver transplantation in Ren Ji Hospital,Shanghai Jiao Tong University School of Medicine and were returned to the ICU from 2019 to 2021.The patients returned to the ICU during hospitalization and the reasons for the return were recorded.Each patient of ICU return was matched with three pediatric patients who did not return to the ICU during hospitalization.The basic information,the vital signs and laboratory indicators on the day of transfer from ICU,immunosuppressants and drug concentrations were compared between the two groups.Multivariate Logistic regression analysis was performed to explore the risk factors for the returning of pediatric liver transplant recipients to the ICU.Results The returning rate of pediatric liver transplant recipients to the ICU was 4.36%,and it was 16.00%within 48 h.The main reasons for the return included respiratory complications,abdominal infections,and hepatic vascular occlusion.Multivariate Logistic regression analysis showed that post-operative red blood cell transfusion(OR=4.554,95%CI=1.743-11.901,P=0.002)and high serum level of uric acid(OR=1.005,95%CI=1.001-1.009,P=0.014)were the risk factors for returning to the ICU.High diastolic blood pressure(OR=0.922,95%CI=0.885-0.960,P<0.001)and high total protein level(OR=0.937,95%CI=0.891-0.986,P=0.012)were the protective factors for returning to the ICU.Conclusion Post-operative red blood cell transfusion and high serum level of uric acid are independent risk factors for the returning of pediatric liver transplant recipients to the ICU.
8.Current status of surgery for portal hypertension in China: a national multi-center survey analysis
Lei ZHENG ; Haiyang LI ; Jizhou WANG ; Xiao LIANG ; Jian DOU ; Jitao WANG ; Qiang FAN ; Xiong DING ; Wenlong ZHAI ; Yun JIN ; Bo LI ; Songqing HE ; Tao LI ; Jun LIU ; Kui WANG ; Zhiwei LI ; Yongyi ZENG ; Yingmei SHAO ; Yang BU ; Dong SHANG ; Yong MA ; Cheng LOU ; Xinmin YIN ; Jiefeng HE ; Haihong ZHU ; Jincai WU ; Zhidan XU ; Dunzhu BASANG ; Jianguo LU ; Liting ZHANG ; Jianguo ZHAO ; Ling LYU ; Guoyue LYU ; Nim CHOI ; To Tan CHEUNG ; Meng LUO ; Wanguang ZHANG ; Xiaolong QI ; Xiaoping CHEN
Chinese Journal of Organ Transplantation 2023;44(3):152-159
Objective:To explore the current status of surgery for portal hypertension to grasp current status and future development of surgery in China.Methods:This study is jointly sponsored by China Hepatobiliary & Pancreatic Specialist Alliance & Portal Hypertension Alliance in China (CHESS).Comprehensive surveying is conducted for basic domestic situations of surgery for portal hypertension, including case load, surgical approaches, management of postoperative complications, primary effects, existing confusion and obstacles, liver transplantation(LT), laparoscopic procedures and transjugular intrahepatic portosystemic shunt(TIPS), etc.Results:A total of 8 512 cases of portal hypertension surgery are performed at 378 hospitals nationwide in 2021.Splenectomy plus devascularization predominated(53.0%)and laparoscopy accounted for 76.1%.Primary goal is preventing rebleeding(67.0%) and 72.8% of hospitals used preventive anticoagulants after conventional surgery.And 80.7% of teams believe that the formation of postoperative portal vein thrombosis is a surgical dilemma and 65.3% of hospitals practiced both laparoscopy and TIPS.The major reasons for patients with portal hypertension not receiving LT are due to a lack of qualifications for LT(69.3%)and economic factors(69.0%).Conclusions:Surgery is an integral part of management of portal hypertension in China.However, it is imperative to further standardize the grasp of surgical indications, the handling of surgical operation and the management of postoperative complications.Moreover, prospective, multi-center randomized controlled clinical studies should be performed.
9.Digital and 3D printing technologies in design of superficial iliac circumflex artery flap for coverage of donor site of anterolateral thigh flap: Report of 8 cases
Hao LU ; Mingyu XUE ; Jin WANG ; Liting GAO ; Xiao ZHOU
Chinese Journal of Microsurgery 2023;46(2):168-173
Objective:To explore the efficacy of digital and 3D printing technologies on design of superficial iliac circumflex artery flap for coverage the donor site of anterolateral thigh flap(ALTF).Methods:Clinical data of 8 patients were studied retrospectively for treatment of soft tissue defects of hand in the Department of Hand Surgery, Wuxi NO.9 People's Hospital Affiliated to Soochow University, from April 2017 to October 2021. The patients were 6 males and 2 females, aged from 29 to 59 years(mean, 45.8 years). Cause of injury: 3 patients were crushed, 2 by hot pressing, and 3 by machine strangulation. Site of injury included: 5 cases were dorsal hand defects and 3 cases were palm defects. All the wounds were contaminated to varying degrees with soft tissue defects. The areas of soft tissue defect ranged from 11 cm×10 cm to 22 cm×14 cm. Four patients had combined injuries of open fracture of metacarpals and phalanges and 3 with tendon defects. All wounds were repaired by free ALTF transplantation. And the donor sites in the thigh were repaired by superficial iliac circumflex artery flaps. The secondary wounds caused by flap harvesting on abdominal wall were closed directly. The targeted perforator vessels were detected preoperatively by CTA combined with CDU. 3D printed models of the affected hand were obtained before operation for individualised repairs according to the shape and area of the wounds. After the operation, all patients entered scheduled follow-ups at the outpatient clinic and via internet by observing the flap shape and testing the recovery of sensory and movement of adjacent joint.Results:The shapes and sizes of the wounds and the flaps were found basically in accordance with those in the preoperative simulative designs. All flaps in 8 patients survived and the wounds healed completely. All patients entered follow-ups for 8 to 24(average, 17.5) months. The donor thighs presented good appearance and colour, pliability without bloating. The range of motion of the hips and knees was not affected. Only linear scars remained in the abdominal donor sites, with natural colour and appearance.Conclusion:Digital and 3D printing technologies in preoperative design of flaps can help to locate the perforator vessels intraoperatively and guide the individualised design of the flaps with improved operation efficiency and satisfactory appearance of the flaps.
10.Research progress in photobiomodulation therapy in the prevention and treatment of acute radiation dermatitis
Jian HE ; Jing YANG ; Yangyang ZHANG ; Liping YANG ; Jin GAO ; Liting QIAN
Chinese Journal of Radiation Oncology 2023;32(11):1015-1019
Acute radiation dermatitis (ARD) is one of the most common toxicities of radiotherapy. Currently, there is still no standardised protocol and guideline on the prevention and treatment of ARD. Photobiomodulation therapy (PBMT) has the functions of stimulating wound healing, reducing inflammatory reaction and mitigating pain, etc. Consequently, recent research progress at home and abroad in the application of PBMT for the prevention and treatment of acute radiation skin reactions was reviewed, aiming to provide reference for clinical application of PBMT in radiation protection.


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