1.Treatment of active ulcerative colitis with Yinmei Kuijie decoction combined with 5-aminosalicylic acid: A non-randomized multicenter prospective observational protocol based on real-world conditions
Xinyu Zhang ; Yuan Li ; Ping Li ; Yunze Liu ; Junmei Zhang ; Jingwei Wu ; Qi Wag ; Xia Ding
Journal of Traditional Chinese Medical Sciences 2024;11(4):423-427
Objective:
To determine the efficacy and safety of the Yinmei Kuijie decoction combined with 5-aminosalicylic acid (5-ASA) in treating mildly to moderately active ulcerative colitis (UC) under real-world conditions.
Methods:
This multicenter, prospective, non-randomized, observational study will be conducted in real-world settings. A total of 204 eligible patients will be consecutively enrolled in the study. Patients in the combination treatment group will receive Yinmei Kuijie decoction in combination with 5-ASA, whereas those in the control group will be treated with 5-ASA alone. The primary endpoint will be a clinical response at week 12, defined as a ≥3 point and ≥30% reduction from baseline in the Mayo total score with ≥1 reduction in rectal bleeding or rectal bleeding score = 0 or 1. Secondary efficacy endpoints at week 12 will include health-related quality of life, mucosal healing, and inflammation indicators.
Conclusion
The results of this study may provide evidence of the efficacy and safety of Yinmei Kuijie decoction combined with 5-ASA in treating patients with mildly to moderately active UC under real-world principles. The results will provide a basis for further confirmatory studies on the efficacy of Yinmei Kuijie decoction.
2.Current status and prospects for the application of robot-assisted spine surgery
Da HE ; Qi ZHANG ; Jingwei ZHAO
Chinese Journal of Surgery 2024;62(3):177-181
Traditional spine surgery frequently encounters difficulties with inadequate surgical visualization and high risk.Robot-assisted spine surgery is quickly evolving,particularly in screw placement,providing three-dimensional imaging and precise positioning to optimize the surgical process. Robot-assisted systems can increase surgical precision,reduce operating time and radiation exposure,and improve patient prognosis. They also have strong image recognition and analysis capabilities,reducing intraoperative instability and fatigue and allowing remote manipulation.While robot-assisted spine surgery has demonstrated noteworthy advantages in regards to screw placement accuracy and reduced radiation exposure,its effects on operative time remain subject to debate,with cost being a significant hindrance to widespread implementation.Long-term clinical validation and studies of outcomes are necessary for the extensive use of robotic-assisted spine surgery.Future priorities include the enhancement of surgical navigation and imaging,integration of artificial intelligence,improvement of telesurgical capabilities,expansion of robotic functionality,and the development of policy guidance and clinical guidelines to accompany the growth of technology.Robot-assisted spine surgery enhances accuracy and safety,and is anticipated to assume an increasingly crucial role in spine surgery as technology advances and becomes more widely available.
3.Current status and prospects for the application of robot-assisted spine surgery
Da HE ; Qi ZHANG ; Jingwei ZHAO
Chinese Journal of Surgery 2024;62(3):177-181
Traditional spine surgery frequently encounters difficulties with inadequate surgical visualization and high risk.Robot-assisted spine surgery is quickly evolving,particularly in screw placement,providing three-dimensional imaging and precise positioning to optimize the surgical process. Robot-assisted systems can increase surgical precision,reduce operating time and radiation exposure,and improve patient prognosis. They also have strong image recognition and analysis capabilities,reducing intraoperative instability and fatigue and allowing remote manipulation.While robot-assisted spine surgery has demonstrated noteworthy advantages in regards to screw placement accuracy and reduced radiation exposure,its effects on operative time remain subject to debate,with cost being a significant hindrance to widespread implementation.Long-term clinical validation and studies of outcomes are necessary for the extensive use of robotic-assisted spine surgery.Future priorities include the enhancement of surgical navigation and imaging,integration of artificial intelligence,improvement of telesurgical capabilities,expansion of robotic functionality,and the development of policy guidance and clinical guidelines to accompany the growth of technology.Robot-assisted spine surgery enhances accuracy and safety,and is anticipated to assume an increasingly crucial role in spine surgery as technology advances and becomes more widely available.
4.Effectiveness of 5G-based robot-assisted remote thoracolumbar internal fixation surgery
Da HE ; Qi ZHANG ; Jingwei ZHAO ; Mingxing FAN ; Bo LIU ; Xieyuan JIANG
Chinese Journal of Orthopaedics 2024;44(15):995-1001
Objective:To assess the effectiveness and viability of 5G-enabled robot-assisted thoracolumbar internal fixation surgery, scrutinizing its benefits and potential limitations in a clinical setting.Methods:This retrospective case series study analyzed 61 patients who underwent robot-assisted remote thoracolumbar internal fixation surgery between April and December 2021. The orthopaedic robotic telesurgery system, centered at Beijing Jishuitan Hospital and utilizing 5G technology for network transmission, was used to assist in screw placement. The surgeries, distributed across ten hospitals and executed over an average distance of 1 617 km (maximum exceeding 3 000 km), were appraised by examining the accuracy of screw placement, intraoperative communication efficacy, complication rates, among other metrics, and benchmarked against traditional local procedures.Results:Telesurgery was completed successfully in all patients, averaging 92±32 minutes per operation. Out of 354 screws placed, 89.8% were positioned perfectly and 97.5% were deemed clinically acceptable. The 61 patients, followed-up for an average of 18.9±1.9 months, exhibited significant postoperative improvement in pain. The preoperative visual analogue scale (VAS) pain score was 5.74±1.30 and improved to 2.30±0.90 at discharge, a statistically significant difference ( t=11.002, P<0.001). 6 patients with thoracolumbar degenerative spine disease showed significant relief of claudication and pain symptoms postoperatively. 55 patients with thoracolumbar spine fractures had a preoperative height ratio of 62.78%±12.60% at the anterior margin of the injured vertebrae, which recovered to 85.36%±8.35% postoperatively, a statistically significant difference ( t=16.977, P<0.001). All fractures were healed at final follow-up. No perioperative complications, such as vascular or nerve injuries or infections, occurred. Additionally, there were no complications related to the use of the robot. The 5G network ensured stable transmission of robotic control signals, images, and audio signals during the procedure, with no signal delays or communication failures observed. The perfect rate (90.2% vs. 93.8%, χ 2=0.169, P=0.681) and clinical acceptability rate (99.0% vs. 100.0%, P=1.000) of remote versus local robotic-assisted screw placement in participating hospital 1 (Shantou Xin Sheng Orthopaedic Hospital) were similar. The perfect rate (87.0% vs. 85.4%, χ 2=0.075, P=0.784) and clinical acceptability rate (100.0% vs. 96.6%, χ 2=0.580, P=0.446) of remote versus local robotic-assisted screw placement in participating hospital 2 (Guizhou Provincial People's Hospital) were similar. Conclusion:5G technology enhances the remote application of robotic thoracolumbar surgery without compromising patient safety or outcome quality. It underscores the potential for broader adoption of surgical robotics, aiding in the standardization of medical practices across China, boosting healthcare efficiency, and aligning with the Healthy China strategy.
5.Analysis of reproductive outcomes in the first IVF-ET cycle after laparoscopic treatment in patients with endometriosis
Qi ZHANG ; Feng ZHOU ; Lan LI ; Xiaoni GUO ; Jingwei YANG ; Shubiao HAN ; Xiaodong ZHANG
Chinese Journal of Obstetrics and Gynecology 2023;58(2):91-97
Objective:To explore the effect of endometriosis (EM) on reproductive outcomes of young patient with EM after laparoscopic treatment in the first in vitro fertilization-embryo transfer (IVF-ET) cycle.Methods:The clinical data and reproductive outcomes of 394 infertile patients with EM after laparoscopic treatment (EM group) and 3 242 infertile patients caused by gamete transport disorder (control group) in the first IVF-ET cycle were collected in Chongqing Health Center for Women and Children from January 2016 to June 2021. The information included baseline characteristics, oocyte retrieval, embryo development, clinical pregnancy, miscarriage, and live birth. Propensity score matching (PSM) method was used to perform 1∶2 matching between EM group and control group. The impact of EM on reproductive outcomes was analyzed in the retrospective observational study.Results:In the initial data, compared with control group, the number of two pronucleus (2PN) zygotes (9.7±4.8 vs 9.0±4.4), the number of transferable embryos (6.2±3.6 vs 5.5±3.4) and the rate of transferable embryos (64.0% vs 60.8%) on the third day were significantly lower in EM group, and the differences were statistically significant (all P<0.05). After PSM was performed, there were 394 and 787 cases in EM group and control group, respectively. Compared with control group, the number of 2PN zygotes (9.7±4.9 vs 9.0±4.4), the 2PN fertility rate (77.1% vs 75.3%), the number of transferable embryos on the third day (6.2±3.6 vs 5.5±3.4), the transferable embryos rate on the third day (63.8% vs 60.8%) were significantly lower in EM group, and the differences were statically significant (all P<0.05). The study did not find the effect of EM on embryo implantation rate, pregnancy rate, early miscarriage rate, live birth rate and preterm birth rate (all P>0.05). Conclusions:EM might interfere with the development of oocytes and embryos. Obtaining top-quality embryos may be an effective way to improve the prognosis of patients with EM after laparoscopic treatment.
6.Clinical application of preferential manual bronchoplasty in single-port video-assisted thoracoscopic upper lobectomy: A retrospective analysis in a single center
Kang QI ; Gang LIN ; Xining ZHANG ; Haibo LIU ; Weiming HUANG ; Jingwei LIU ; Jian LI
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2023;30(10):1422-1428
Objective To explore the safety and feasibility of preferential manual bronchoplasty in single-port video-assisted thoracoscopic surgery (VATS) upper lobectomy. Methods The clinical data of 457 patients with non-small cell lung cancer who underwent single-port VATS lobectomy in the Department of Thoracic Surgery of Peking University First Hospital from March 2020 to March 2022 were retrospectively analyzed. The patients were divided into a preferential manual bronchoplasty group and a traditional single-port VATS lobectomy group with a 1 : 1 propensity score matching for further research. Results A total of 204 patients were matched, and there were 102 patients in each group. There were 50 males and 52 females aged 62.2±10.1 years in the preferential bronchoplasty group, and 49 males and 53 females aged 61.2±10.7 years in the traditional single-port VATS group. The preferential bronchoplasty group had shorter surgical time (154.4±37.0 min vs. 221.2±68.9 min, P<0.01), less bleeding (66.5±116.9 mL vs. 288.6±754.5 mL, P=0.02), more lymph node dissection (19.8±7.5 vs. 15.2±4.7, P<0.01), and a lower conversion rate to multi-port or open surgery (2.3% vs. 13.8%, P=0.04) in left upper lobe resection. In the right upper lobe resection surgery, there was no statistical difference in postoperative results between two groups. There was no perioperative death or occurrence of bronchopleural fistula in both groups. Conclusion Compared with traditional single-port VATS upper lobectomy, preferential bronchoplasty has similar safety and feasibility. In addition, priority bronchoplasty in left upper lobectomy has the advantages of shorter surgical time, less bleeding, more lymph node dissection, and lower conversion rate to multi-port or open surgery.
7.Clinical Efficacy and Bone Turnover Markers of Buzhong Yiqitang in Treatment of Senile Osteoporotic Vertebral Compression Fracture After Operation Based on ''Spleen Governing Muscle''
Yadong WU ; Zhenguang GUO ; Wenjie DENG ; Xiaoyan QI ; Jingwei XU ; Yuzhou LU ; Bocheng LIANG
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(17):91-97
ObjectiveTo study the effect on quality of life and the bone turnover markers of Buzhong Yiqitang in the treatment of senile osteoporotic vertebral compression fracture (OVCF, syndrome of Qi deficiency in spleen and stomach) after operation based on ''spleen governing muscle''. MethodA total of 135 senile patients with OVCF treated by percutaneous kyphoplasty in Rizhao Hospital of Traditional Chinese Medicine from January 2020 to January 2021 were enrolled in this study. They were randomly assigned to two groups on the basis of block randomization at a ratio of 2∶1 (90 cases in the observation group and 45 cases in the control group). Both groups were administrated with calcitriol capsules (0.5 μg·d-1) and caltrate D (1 200 mg·d-1) for basic treatment of osteoporosis. The observation group was additionally treated with Buzhong Yiqitang. Bone mineral density (BMD), procollagen type Ⅰ N-terminal propeptide (PINP), osteocalcin (OST), β cross-linked C-telopeptide of type 1 collagen (β-CTx), appendicular skeletal muscle mass index (ASMI), and quadriceps muscle strength were compared between the two groups before and 6, 12 months after treatment. Additionally, traditional Chinese medicine (TCM) symptom score and visual analogue score (VAS) before and 3, 6 months after treatment, as well as quality of life questionnaire of the European Foundation for osteoporosis (QUALEFFO) score before and 3, 6, 12 months after treatment, were compared between the two groups. ResultA total of 85 patients in the observation group and 41 patients in the control group were followed up. The general curative effect of the observation group was better than that of the control group (χ2=10.503, P<0.05). Specifically, the observation group had higher PINP, BMD, ASMI, and quadriceps muscle strength but lower β-CTx, TCM symptom score, VAS, and QUALEFFO score than the control group (P<0.05, P<0.01). No adverse reactions related to Buzhong Yiqitang were observed. ConclusionBuzhong Yiqitang can regulate bone metabolism indexes, promote osteogenesis, increase bone density, enhance skeleton appendiculare and quadriceps muscle strength, relieve clinical symptoms, and improve quality of life in patients with senile OVCF (syndrome of Qi deficiency in spleen and stomach), being worthy of promotion in clinical application.
8.Establishment and application value of a radiomics prediction model for lymph node metas-tasis of gallbladder carcinoma based on dual-phase enhanced CT
Qi LI ; Zhechuan JIN ; Dong ZHANG ; Chen CHEN ; Jian ZHANG ; Jingwei ZHANG ; Zhiqiang CAI ; Shubin SI ; Min YANG ; Qiuping WANG ; Zhimin GENG ; Qingguang LIU
Chinese Journal of Digestive Surgery 2022;21(7):931-940
Objective:To investigate the establishment and application value of a radio-mics prediction model for lymph node metastasis of gallbladder carcinoma based on dual-phase enhanced computed tomography (CT).Methods:The retrospective cohort study was conducted. The clinicopathological data of 194 patients with gallbladder carcinoma who were admitted to the First Affiliated Hospital of Xi'an Jiaotong University from January 2012 to December 2020 were collected. There were 70 males and 124 females, aged (64±10)years. All patients underwent curative-intent resection of gallbladder carcinoma. A total of 194 patients were randomly divided into 156 cases in training set and 38 cases in test set according to the ratio of 8:2 based on random number method in R software. The training set was used to establish a diagnostic model, and the test set was used to validate the diagnostic model. After the patients undergoing CT examination, image analysis was performed, radiomics features were extracted, and a radiomics model was established. Based on clinicopathological data, a nomogram prediction model was established. Observation indicators: (1) lymph node dissection and histopathological examination results; (2) establishment and characteristic analysis of a radiomics prediction model; (3) analysis of influencing factors for lymph node metastasis of gallbladder carcinoma; (4) establishment of a nomogram prediction model for lymph node metastasis; (5) comparison of the predictive ability between the radiomics prediction model and nomogram prediction model for lymph node metastasis. Measurement data with normal distribution were represented as Mean± SD, and measurement data with skewed distribution were represented as M(range). Count data were expressed as absolute numbers, and comparison between groups was performed by the chi-square test. Univariate analysis was conducted by the chi-square test, and multivariate analysis was performed by the Logistic regression model forward method. The receiver operating characteristic curve was drawn, and the area under curve, decision curve, confusion matrix were used to evaluate the predictive ability of prediction models. Results:(1) Lymph node dissection and histopathological examination results. Of the 194 patients, 182 cases underwent lymph node dissection, with the number of lymph node dissected as 8(range, 1?34) per person and the number of positive lymph node as 0(range, 0?11) per person. Postoperative histopathological examination results of 194 patients: 122 patients were in stage N0, with the number of lymph node dissected as 7(range, 0?27) per person, 48 patients were in stage N1, with the number of lymph node dissected as 8(range, 2?34) per person and the number of positive lymph node as 1(range, 1?3) per person, 24 patients were in stage N2, with the number of lymph node dissected as 11(range, 2?20) per person and the number of positive lymph node as 5(range, 4?11) per person. (2) Establishment and characteristic analysis of a radiomics prediction model. There were 107 radiomics features extracted from 194 patients, including 18 first-order features, 14 shape features and 75 texture features. According to the intra-group correlation coefficient and absolute median difference of each radiomics feature, mutual information, Select K-Best, least absolute shrinkage and selection operator regression were conducted to further reduce dimensionality. By further combining 5 different machine learning algorithms including random forest, gradient boosting secession tree, support vector machine (SVM), K-Nearest Neighbors and Logistic regression, the result showed that the Select K-Best_SVM model had the best predictive performance after analysis, with the area under receiver operating characteristic curve as 0.76 in the test set. (3) Analysis of influencing factors for lymph node metastasis of gallbladder carcinoma. Results of univariate analysis showed that systemic inflammation response index, carcinoembryonic antigen (CEA), CA19-9, CA125, radiological T staging and radiological lymph node status were related factors for lymph node metastasis of patients with gallbladder cancer ( χ2=4.20, 11.39, 5.68, 11.79, 10.83, 18.58, P<0.05). Results of multivariate analysis showed that carcinoembryonic antigen, CA125, radiological T staging (stage T3 versus stage T1?2, stage T4 versus stage T1?2), radiological lymph node status were independent influencing factors for lymph node metastasis of patients with gallbladder carcinoma [ hazard ratio=2.79, 4.41, 5.62, 5.84, 3.99, 95% confidence interval ( CI) as 1.20?6.47, 1.81?10.74, 1.50?21.01, 1.02?33.31, 1.87?8.55, P<0.05]. (4) Establishment of a nomogram prediction model for lymph node metastasis. A nomogram prediction model was established based on the 4 independent influencing factors for lymph node metastasis of gallbladder carcinoma, including CEA, CA125, radiological T staging and radiological lymph node status. The concordance index of the nomogram model was 0.77 (95% CI as 0.75?0.79) in the training set and 0.73 (95% CI as 0.68?0.72) in the test set, respectively. (5) Comparison of the predictive ability between the radiomics predic-tion model and nomogram prediction model for lymph node metastasis. The receiver operating characteristic curve showed that the areas under the curve of Select K-Best_SVM radiomics model were 0.75 (95% CI as 0.74?0.76) in the training set and 0.76 (95% CI as 0.75?0.78) in the test set, respectively. The areas under the curve of nomogram prediction model were 0.77 (95% CI as 0.76?0.78) in the training set and 0.70 (95% CI as 0.68?0.72) in the test set, respectively. The decision curve analysis showed that Select K-Best_SVM radiomics model and nomogram prediction model had a similar ability to predict lymph node metastasis. The confusion matrix showed that Select K-Best_SVM radiomics model had the sensitivity as 64.29% and 75.00%, the specificity as 73.00% and 59.09% in the training set and test set, respectively. The nomogram had the sensitivity as 51.79% and 50.00%, the specificity as 80.00% and 72.27% in the training set and test set, respectively. Conclusion:A dual-phase enhanced CT imaging radiomics prediction model for lymph node metastasis of gallbladder carcinoma is successfully established, and its predictive ability is good and consistent with that of nomogram.
9.Experience and lessons on guiding and governing clinical applications of chromosome microarray analysis in the United States.
Xiaolei XIE ; Jingwei YU ; Zhongxia QI ; Liming BAO ; Yiping SHEN ; Tianjian CHEN ; Peining LI
Chinese Journal of Medical Genetics 2021;38(5):419-424
Chromosome microarray analysis (CMA) has become the first-tier testing for chromosomal abnormalities and copy number variations (CNV). This review described the clinical validation of CMA, the development and updating of technical standards and guidelines and their diagnostic impacts. The main focuses were on the development and updating of expert consensus, practice resources, and a series of technical standards and guidelines through systematic review of case series with CMA application in the literature. Expert consensus and practice resource supported the use of CMA as the first-tier testing for detecting chromosomal abnormalities and CNV in developmental and intellectual disabilities, multiple congenital anomalies and autism. The standards and guidelines have been applied to pre- and postnatal testing for constitutional CNV and tumor testing for acquired CNV. CMA has significantly improved the diagnostic yields but still needs to overcome its technical limitations and face challenges of new technologies. Guiding and governing CMA through expert consensus, practice resource, standards and guidelines in the United States has provided effective and safe diagnostic services to patients and their families, reliable diagnosis on related genetic diseases for clinical database and basic research, and references for clinical translation of new technologies.
Child
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Chromosome Aberrations
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Chromosomes
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DNA Copy Number Variations
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Developmental Disabilities/genetics*
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Humans
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Intellectual Disability/genetics*
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Microarray Analysis
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United States
10.A prognostic model of intrahepatic cholangiocarcinoma after curative intent resection based on Bayesian network
Chen CHEN ; Yuhan WU ; Jingwei ZHANG ; Yinghe QIU ; Hong WU ; Qi LI ; Tianqiang SONG ; Yu HE ; Xianhan MAO ; Wenlong ZHAI ; Zhangjun CHENG ; Jingdong LI ; Shubin SI ; Zhiqiang CAI ; Zhimin GENG ; Zhaohui TANG
Chinese Journal of Surgery 2021;59(4):265-271
Objective:To examine a survival prognostic model applicable for patients with intrahepatic cholangiocarcinoma (ICC) based on Bayesian network.Methods:The clinical and pathological data of ICC patients who underwent curative intent resection in ten Chinese hepatobiliary surgery centers from January 2010 to December 2018 were collected.A total of 516 patients were included in the study. There were 266 males and 250 females.The median age( M( Q R)) was 58(14) years.One hundred and sixteen cases (22.5%) with intrahepatic bile duct stones,and 143 cases (27.7%) with chronic viral hepatitis.The Kaplan-Meier method was used for survival analysis.The univariate and multivariate analysis were implemented respectively using the Log-rank test and Cox proportional hazard model.One-year survival prediction models based on tree augmented naive Bayesian (TAN) and na?ve Bayesian algorithm were established by Bayesialab software according to different variables,a nomogram model was also developed based on the independent predictors.The receiver operating characteristic curve and the area under curve (AUC) were used to evaluate the prediction effect of the models. Results:The overall median survival time was 25.0 months,and the 1-,3-and 5-year cumulative survival rates was 76.6%,37.9%,and 21.0%,respectively.Univariate analysis showed that gender,preoperative jaundice,pathological differentiation,vascular invasion,microvascular invasion,liver capsule invasion,T staging,N staging,margin,intrahepatic bile duct stones,carcinoembryonic antigen,and CA19-9 affected the prognosis(χ 2=5.858-54.974, all P<0.05).The Cox multivariate model showed that gender,pathological differentiation,liver capsule invasion, T stage,N stage,intrahepatic bile duct stones,and CA19-9 were the independent predictive factors(all P<0.05). The AUC of the TAN model based on all 19 clinicopathological factors was 74.5%,and the AUC of the TAN model based on the 12 prognostic factors derived from univariate analysis was 74.0%,the AUC of the na?ve Bayesian model based on 7 independent prognostic risk factors was 79.5%,the AUC and C-index of the nomogram survival prediction model based on 7 independent prognostic risk factors were 78.8% and 0.73,respectively. Conclusion:The Bayesian network model may provide a relatively accurate prognostic prediction for ICC patients after curative intent resection and performed superior to the nomogram model.


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