1.Clinical Safety Monitoring of 3 035 Cases of Juvenile Feilike Mixture After Marketing in Hospital
Jian ZHU ; Zhong WANG ; Jing LIU ; Jun LIU ; Wei YANG ; Yanan YU ; Hongli WU ; Sha ZHOU ; Zhiyu PAN ; Guang WU ; Mengmeng WU ; Zhiwei JING
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(10):194-200
ObjectiveTo explore the clinical safety of Feilike Mixture (FLK) in the real world. MethodsThe safety of all children who received FLK from 29 institutions in 12 provinces between January 21,2021 and December 25,2021 was evaluated through prospective centralized surveillance and a nested case control study. ResultsA total of 3 035 juveniles were included. There were 29 research centers involved,which are distributed across 12 provinces,including one traditional Chinese medicine (TCM) hospital and 28 general hospitals. The average age among the juveniles was (4.77±3.56) years old,and the average weight was (21.81±12.97) kg. Among them,119 cases (3.92%) of juveniles had a history of allergies. Acute bronchitis was the main diagnosis for juveniles,with 1 656 cases (54.46%). FLK was first used in 2 016 cases (66.43%),and 142 juvenile patients had special dosages,accounting for 4.68%. Among them,92 adverse drug reactions (ADRs) occurred,including 73 cases of gastrointestinal system disorders,10 cases of metabolic and nutritional disorders,eight cases of skin and subcutaneous tissue diseases,two cases of vascular and lymphatic disorders,and one case of systemic diseases and various reactions at the administration site. The manifestations of ADRs were mainly diarrhea,stool discoloration,and vomiting,and no serious ADRs occurred. The results of multi-factor analysis indicated that special dosages (the use of FLK)[odds ratio (OR) of 2.642, 95% confidence interval (CI) of 1.105-6.323],combined administration: spleen aminopeptide (OR of 4.978, 95%CI of 1.200-20.655),and reason for combined administration: anti-infection (OR of 1.814, 95%CI of 1.071-3.075) were the risk factors for ADRs caused by FLK. Conclusion92 ADRs occurred among 3 035 juveniles using FLK. The incidence of ADRs caused by FLK was 3.03%,and the severity was mainly mild or moderate. Generally,the prognosis was favorable after symptomatic treatment such as drug withdrawal or dosage reduction,suggesting that FLK has good clinical safety.
2.Surgical treatment of Stanford type A aortic dissection after coronary artery stenting
Shichao GUO ; Zhiyu QIAO ; Chengnan LI ; Lizhong SUN ; Junming ZHU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(01):111-115
Objective To retrospectively analyze the surgical treatment of Stanford type A aortic dissection after coronary artery stenting, and to explore the surgical techniques and surgical indications. Methods Clinical data of 1 246 consecutive patients who underwent operations on Stanford type A aortic dissection from April 2016 to July 2019 in Beijing Anzhen Hospital were retrospectively analyzed. Patients with Stanford type A aortic dissection after coronary artery stenting were enrolled. Results Finally 19 patients were collected, including 16 males and 3 females with an average age of 54±7 years ranging from 35 to 66 years. There were 11 patients in acute phase, 15 patients with AC (DeBakey Ⅰ) type and 4 patients with AS (DeBakey Ⅱ) type. In AC type, there were 10 patients receiving Sun's surgery and 5 patients partial arch replacement. Meanwhile, coronary artery bypass grafting was performed in 7 patients and mitral valve replacement in 1 patient. Stents were removed from the right coronary artery in 4 patients. In this group, 1 patient died of multiple organ failure in hospital after operation combined with malperfusion of viscera. Eighteen patients recovered after treatment and were discharged from hospital. The patients were followed up for 30 (18-56) months. One patient underwent aortic pseudoaneurysm resection, one thoracic endovascular aortic repair, one emergency percutaneous coronary intervention due to left main artery stent occlusion, and one underwent femoral artery bypass due to iliac artery occlusion. Conclusion Iatrogenic aortic dissection has a high probability of coronary artery bypass grafting at the same time in patients with Stanford type A aortic dissection after coronary artery stenting. Complicated type A aortic dissection after percutaneous coronary intervention should be treated with surgery aggressively.
3.Analysis of influencing factors for early tumor recurrence and efficacy of adjuvant chemotherapy in gallbladder carcinoma patients after curative-intent resection: a nationwide, multicenter clinical study
Dong ZHANG ; Qi LI ; Wei GUO ; Fan HUANG ; Yi ZHU ; Kecan LIN ; Dalong YIN ; Wei CHEN ; Rui DING ; Ping YUE ; Yunfeng LI ; Zhiyu CHEN ; Zhimin GENG
Chinese Journal of Digestive Surgery 2024;23(1):125-133
Objective:To investigate the influencing factors for early tumor recurrence and the efficacy of adjuvant chemotherapy in gallbladder carcinoma (GBC) patients after curative-intent resection.Methods:The retrospective case-control study was conducted. The clinicopathological data of 506 patients with GBC in 11 medical centers, including The First Affiliated Hospital of Xi'an Jiaotong University et al, from January 2016 to December 2020 were collected. There were 168 males and 338 females, aged (62±11)years. All patients underwent curative-intent resection of GBC, and they were divided into patients with and without early recurrence based on time to postoperative recurrence. Observation indicators: (1) treatment; (2) follow-up and survival of patients; (3) analysis of influencing factors for early tumor recurrence after curative-intent resection of GBC; (4) efficacy of postoperative adjuvant chemotherapy. Measurement data with normal distribution were represented as Mean± SD, and measurement data with skewed distribution were represented as M(range). Count data were described as absolute numbers, and comparison between groups was conducted using the chi-square test. Comparison of ordinal data was conducted using the Mann-Whitney U test. Univariate analysis was conducted using the corresponding statistical methods based on data type. Multivariate analysis was conducted using the Logistic regression model with forward method. The Kaplan-Meier method was used to draw survival curve and calculate survival rate, and Log-Rank test was used for survival analysis. Results:(1) Treatment. Of 506 patients, there were 112 cases with postoperative adjuvant chemotherapy, and 394 cases without postopera-tive adjuvant chemotherapy. They underwent 5(range, 3-9)cycles of postoperative adjuvant chemo-therapy. (2) Follow-up and survival of patients. All 506 patients underwent postoperative follow-up, with the follow-up time of 55(range, 34-93)months. During the follow-up, there were 248 patients with tumor recurrence, including 158 cases of early recurrence and 90 cases of late recurrence, and there were 258 patients without tumor recurrence. Of 506 patients, 275 cases survived, and 231 cases died of multiple organ failure caused by tumor recurrence and metastasis. The postoperative recurr-ence-free survival time, overall survival time were 52(range,1-93)months, 62(range, 2-93)months. The 1-, 3-, 5-year disease-free survival rates and 1-, 3-, 5-year overall survival rates of the 506 pati-ents were 68.8%, 53.8%, 47.9% and 78.3%, 58.7%, 51.6%, respectively. Results of survival analysis showed that the median overall survival time of 158 patients with postoperative early recurrence and 348 patients without postoperative early recurrence (including 90 cases of late recurrence and 258 cases of no tumor recurrence) were 9(range, 2-73)months and unreached, showing a significant difference between them ( χ2=456.15, P<0.05). (3) Analysis of influencing factors for early tumor recurrence after curative-intent resection of GBC. Results of multivariate analysis showed that carcinoembryonic antigen (CEA) >5.0 μg/L, poorly differentiated tumor, liver invasion, and tumor N staging as stage N1-N2 were independent risk factors influencing early tumor recurrence after cura-tive-intent resection of GBC ( odds ratio=2.74, 6.20, 1.81, 2.93, 4.82, 95% confidence interval as 1.62-4.64, 1.82-21.12, 1.15-3.08, 1.68-5.09, 1.91-12.18, P<0.05), while postoperative adjuvant chemo-therapy was an independent protect factor ( odds ratio=0.39, 95% confidence interval as 0.21-0.71, P<0.05). (4) Efficacy of postoperative adjuvant chemotherapy. The median overall survival time of 394 patients without postoperative adjuvant chemotherapy and 112 patients with postoperative adjuvant chemotherapy were 57(range, 2-93)months and unreached, showing a significant differ-ence between them ( χ2=9.38, P<0.05). Of the 158 patients with postoperative early recurrence after curative-intent resection of GBC, 135 cases didn't receive adjuvant chemotherapy and 23 cases received adjuvant chemotherapy, with the overall survival time of 8(range, 2-73)months and 17(range, 8-61)months, respectively, showing a significant difference between them ( χ2=7.68, P<0.05). Conclusions:CEA >5.0 μg/L, poorly differentiated tumor, liver invasion, and tumor N staging as stage N1-N2 are independent risk factors influencing early tumor recurrence after curative-intent resection of GBC, while postoperative adjuvant chemotherapy is an independent protect factor. Postoperative adjuvant chemotherapy can prolong the overall survival time of patients with post-operative tumor early recurrence.
4.Efficacy of stented elephant trunk procedure for right-sided aortic arch with Kommerell's diverticulum
Yongliang ZHONG ; Bing TANG ; Suwei CHEN ; Yipeng GE ; Hai' ; ou HU ; Zhiyu QIAO ; Chengnan LI ; Yongmin LIU ; Junming ZHU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(07):1020-1026
Objective To summarize our experience and the early and midterm outcomes of stented elephant trunk procedure for right-sided aortic arch (RAA) with Kommerell's diverticulum (KD). Methods From April 2013 to July 2020, patients with RAA and KD who underwent stented elephant trunk procedure at our center were collected. Surgery was performed under moderate hypothermic circulatory arrest combined with selective antegrade cerebral perfusion via median sternotomy. Results A total of 8 patients were included, including 7 males and 1 female with a mean age of 51.88±9.61 years. All patients had an aneurysmal KD and aberrant left subclavian artery. Preoperative comorbidities included acute Stanford type B aortic dissection in 1 patient, aortic arch pseudoaneurysm in 1 patient, acute type B intramural hematoma in 2 patients, and coronary artery disease in 1 patient. Concomitant procedures included reconstruction of the left subclavian artery in all patients and coronary artery bypass grafting in 1 patient. The mean time of operation, cardiopulmonary bypass, aortic cross-clamping, and selective cerebral perfusion was 6.25±1.16 h, 157.75±40.07 min, 77.75±33.10 min, and 28.50±5.55 min, respectively. No intraoperative death occurred. There was 1 in-hospital death. Follow-up was completed in all patients with a mean period of 3.58±2.08 years. No late death occurred. A persistent anastomotic leak of the proximal arch was detected in 1 patient, but reintervention was not performed because neither aortic dilatation nor symptoms of tracheal and esophageal compression were observed during the follow-up. The remaining 6 patients showed positive aortic remodeling with complete thrombosis of the aneurysmal KD, and neither aortic event nor tracheal and esophageal compression occurred. Conclusion Stented elephant trunk procedure is a safe and feasible technique for selected patients with RAA and KD, which can achieve favorable early and midterm outcomes.
5.Influence of curative-intent resection with textbook outcomes on long-term prognosis of gall-bladder carcinoma: a national multicenter study
Zhipeng LIU ; Zimu LI ; Yule LUO ; Xiaolin ZHAO ; Jie BAI ; Yan JIANG ; Yunfeng LI ; Chao YU ; Fan HUANG ; Zhaoping WU ; Jinxue ZHOU ; Dalong YIN ; Rui DING ; Wei GUO ; Yi ZHU ; Wei CHEN ; Kecan LIN ; Ping YUE ; Yao CHENG ; Haisu DAI ; Dong ZHANG ; Zhiyu CHEN
Chinese Journal of Digestive Surgery 2024;23(7):926-933
Objective:To investigate the influence of curative-intent resection with textbook outcomes of liver surgery (TOLS) on long-term prognosis of gallbladder carcinoma (GBC).Methods:The retrospective cohort study was conducted. The clinicopathological data of 824 patients with GBC in the national multicenter database of Biliary Surgery Group of Elite Group of Chinese Journal of Digestive Surgery, who were admitted to 15 medical centers from January 2014 to January 2021, were collected. There were 285 males and 539 females, aged (62±11)years. According to the evalua-tion criteria of TOLS, patients were divided into those who achieved TOLS and those who did not achieve TOLS. Measurement data with normal distribution were represented as Mean± SD, and com-parison between groups was conducted using the independent sample t test. Measurement data with skewed distribution were represented as M( Q1, Q3), and comparison between groups was conducted using the Mann-Whitney U test. Count data were described as absolute numbers, and comparison between groups was conducted using the chi-square test. Comparison of ordinal data were conduc-ted using the Mann-Whitney U test. The Kaplan-Meier method was used to calculate survival rate and draw survival curve, and the Log-rank test was used for survival analysis. The COX stepwise regression model with backward Wald method was used for univariate and multivariate analyses. Results:(1) Achievement of TOLS. Of the 824 patients undergoing curative-intent resection for GBC, there were 510 cases achieving TOLS and 314 cases not achieving TOLS. (2) Follow-up. Of the 824 patients undergoing curative-intent resection for GBC, after excluding 112 deaths within 90 days after discharge, 712 cases were included for the survival analysis. The median follow-up time, median overall survival time and 5-year overall survival rate of the 510 patients achieving TOLS were 22.1(11.4,30.1)months, 47.6(30.6,64.6)months and 47.5%. The median follow-up time, median overall survival time and 5-year overall survival rate of the 202 patients not achieving TOLS were 14.0(6.8,25.5)months, 24.3(20.0,28.6)months and 21.0%. There was a significant difference in overall survival between patients achieving TOLS and patients not achieving TOLS ( χ2=58.491, P<0.05). (3) Analysis of factors influencing prognosis of patients. Results of multivariate analysis showed that TOLS, carcinoembryonic antigen (CEA), CA19-9, poorly differentiation of tumor, T2 stage of eighth edition of American Joint Committee on Cancer (AJCC) staging, T3 and T4 stage of eighth edition of AJCC staging, N1 stage of the eighth edition of AJCC staging, N2 stage of the eighth edition of AJCC staging, adjuvant therapy were independent factors influencing overall survival time of patients undergoing curative-intent resection for GBC ( hazard ratio=0.452, 1.479, 1.373, 1.612, 1.455, 1.481, 1.835, 1.978, 0.538, 95% c onfidence interval as 0.352-0.581, 1.141-1.964, 1.052-1.791, 1.259-2.063, 1.102-1.920, 1.022-2.147, 1.380-2.441, 1.342-2.915, 0.382-0.758, P<0.05). Conclusion:Patients under-going curative-intent resection for GBC with TOLS can achieve better long-term prognosis.
6.Research on the application of PBL case library in integrated teaching of circulation system
Fang QIN ; Huang ZHOU ; Jun'an CHEN ; Lili ZOU ; Xiexin TAO ; Qingsong XIONG ; Zulong XIE ; Xinting ZHU ; Yunlin CHEN ; Zhiyu LING
Chinese Journal of Medical Education Research 2024;23(11):1519-1522
To evaluate the advantages of using PBL case library in teaching circulatory system diseases to clinical medicine undergraduate students, a PBL case library was established and applied in teaching practice in the reform of circulatory system teaching. The PBL case library achieved the characteristics of combining theories with cases, morphology with functions, and basic knowledge with clinical knowledge. The PBL case library also realized the informatization, query, and update of cases. Preliminary application showed that the median practical score of students in the case library group was 94.00 points, which was significantly higher than the 92.00 points in the control group ( P=0.005). The average lesson preparation time for teachers in the case library group was (5.00±1.00) hours, which was significantly shorter than the (6.89±0.42) hours in the control group ( P<0.001). The difficulty score for lesson preparation among teachers in the case library group was significantly lower than that of the control group [(1.89±1.05) vs. (3.22±0.44), P<0.001]. However, there were no significant difference in theoretical scores and student satisfaction with teachers and courses. These results suggest that the construction of case library can improve practical teaching effectiveness and enhance the efficiency of lesson preparation for teachers.
7.Feasibility study of visual positioning systems in the mechanical accuracy detection of radiotherapy equipment
Fen ZHENG ; Xianzhong XIE ; Zhiyu YANG ; Yakai ZHU ; Bing WU ; Nuoxi LI ; Bingwei HE ; Yifa ZHAO ; Xiaobo LI
Chinese Journal of Radiation Oncology 2024;33(12):1152-1157
Objective:To evaluate the feasibility of using a visual positioning system for both motion phantom and clinical quality control.Methods:A phantom experiment was conducted using the Dynamic Thorax Phantom from CIRS. Different ranges of motion were simulated to assess the discrepancies between camera-recorded positions and actual movements. Visual markers were also attached to the treatment bed and the collimator head, and their movements were simulated as part of the experiment. The experiment was repeated for three times. Discrepancies between system measurements and manual measurements were recorded and analyzed to assess the accuracy and reliability of the system.Results:In the motion phantom test, the deviation between the actual motion distance of the phantom and the system's recorded measurement was (0.18±0.07) mm. For linear motion analysis along the X, Y, and Z axes on the treatment table, the measurement errors were (0.14±0.08) mm, (0.15±0.09) mm, and (0.16±0.08) mm, respectively. Additionally, the measurement error in the rotational direction of the treatment couch was 0.18°±0.09°. For the rotational direction of the collimator head, the measurement error was 0.11°±0.02°. Conclusion:The system demonstrates good accuracy and stability, and has potential clinical application value.
8.Surgical treatment strategy for acute type A aortic dissection involving severe stenosis or occlusion of the carotid arteries
Jianji WANG ; Runqiao LI ; Jiazhen MEI ; Yongliang ZHONG ; Yu XIA ; Chengnan LI ; Zhiyu QIAO ; Haiou HU ; Yipeng GE ; Junming ZHU
Chinese Journal of Thoracic and Cardiovascular Surgery 2024;40(11):660-663
Objective:To explore surgical strategies for acute type A aortic dissection involving severe stenosis or occlusion of the carotid arteries.Methods:From January 2019 to March 2023, a total of 29 patients with acute type A aortic dissection involving severe stenosis or occlusion of the carotid arteries were included in the study. All patients underwent emergency surgery, with simultaneous intraoperative neck incision and replacement of the unilateral or bilateral carotid arteries. Among them, there were 19 males with a mean age of(49.57±2.14)years old. Preoperative brain CT indicated abnormalities in 15 cases, transient neurological dysfunction occurred in 5 cases, and syncope in 1 case.Results:Procedures included ascending aorta replacement in 10 cases, Bentall procedure in 18 cases, and Wheat procedure in 1 case. Arch operations involved partial arch replacement in 3 cases and Sun’s procedure in 26 cases. Simple left carotid artery replacement was performed in 6 cases, simple right carotid artery replacement in 19 cases, and bilateral carotid artery replacement in 4 cases. Cerebral protection measures during circulatory arrest included unilateral cerebral perfusion in 24 cases and bilateral cerebral perfusion in 5 cases. The mean operation time was(7. 6±0. 3) h, with a mean cardiopulmonary bypass time of(196. 3±8. 7) min, aortic cross-clamp time of(113.2±6.4) min, ischemic time 12(5-16.5) min, and lowest temperature of(26.3±0.4)°C. One patient experienced in-hospital mortality. Postoperatively, new neurological dysfunction occurred in 2 cases, including 1 case with coma and permanent neurological deficit.Conclusion:In patients with acute type A aortic dissection involving severe stenosis or occlusion of the carotid arteries, simultaneous carotid artery replacement via neck incision during aortic surgery is a safe and reliable surgical approach.
9.Incidence and mortality of lung cancer in countries with different human development index
Xiaoqiong ZHU ; Dongming JIANG ; Jiaying SHEN ; Zheyun NIU ; Ming HU ; Huixian ZENG ; Zhiyu YANG ; Zihan ZHANG ; Cunxi ZHAO ; Guangwen CAO
Shanghai Journal of Preventive Medicine 2023;35(4):305-313
ObjectiveTo compare the annual and age trends of the age-standard incidence rate (ASIR) and the age-standard mortality rate (ASMR) of lung cancer in countries with different human development index (HDI) from 1990 to 2019. MethodsThe data were collected from the global burden of disease study and GLOBOCAN 2020. The average annual percentage change (AAPC) and age trends of ASIR and ASMR in lung cancer were analyzed by the Joinpoint regression model, and the comparison between the four groups was analyzed by Kruskale-Wallis analysis. ResultsIn 2020, the incidence and mortality of lung cancer gradually increased with age and HDI grade. From 1990 to 2019, the global ASIR and ASMR of lung cancer decreased, and the ASIR of lung cancer among male decreased, while the ASIR of lung cancer among female increased. The results showed that ASIR of lung cancer in female residents in countries with very high HDI increased significantly from 1996 to 2011, resulting in an overall upward trend in female ASIR, while the other groups showed a downward trend. It was found that ASIR and ASMR of lung cancer in China and India were on the rise, while ASIR and ASMR of lung cancer in Russia and the United States were on the decline. ConclusionAlthough very high/high HDI countries face a higher burden of lung cancer occurrence and death, the accumulation of lung cancer burden is completed in the transitioning period. Therefore, lung cancer prevention measures in countries in transition are critical for global lung cancer control.
10.Relationship among spontaneous turning direction, balance and fall risk in stroke patients during walking
Xiaomin ZHU ; Huilin LIU ; Yuanmin LIU ; Zhiyu YAN ; Xuejing DU ; Ya'nan WANG ; Tong ZHANG
Chinese Journal of Rehabilitation Theory and Practice 2023;29(5):510-515
ObjectiveTo investigate the relationship among spontaneous turning direction, balance ability and fall risk in patients with stroke during walking. MethodsFrom December, 2021 to November, 2022, 94 patients with stroke were recruited from Beijing Bo'ai Hospital. They were assessed with simple Timed 'Up and Go' Test (TUGT, TUGT1), TUGT with a cup in hand (TUGT2), and TUGT with calculation task (TUGT3). The spontaneous turning directions at the turn point were recorded, and the patients were divided into no-same group (n = 34) and same group, and the same group was further divided into affected group (n = 33) and unaffected group (n = 27), according to the spontaneous turning direction. After a spontaneous turning of each TUGT, the patients were asked to finish another TUGT turning to the opposite direction. And then, they were assessed with single leg standing test, Functional Reach Test (FRT), 360° turning test and the Morse Fall Scale (MFS). ResultsThere were the most patients with left hemiplegia in the affected group (χ2 = 7.995, P < 0.05). The time of TUGT1, TUGT2 and TUGT3 was the most in the affected group and the least in the unaffected group (F > 4.009, P < 0.05), and it was more in the affected group than in the unaffected group as post-hoc test (P < 0.05). The one leg standing time (H = 9.403, P = 0.009) and FRT distance (F = 4.300, P = 0.016) were the least in the affected group and the most in the unaffected group, and it was less in the affected group than in the unaffected group as post-hoc test (P < 0.05). The turning time (F = 4.134, P = 0.019) and turning steps (F = 5.611, P = 0.003) were the most in the affected group and the least in the unaffected group, and it was more in the affected group than in the unaffected group as post-hoc test (P < 0.05). The score of MFS was the most in the affected group and the least in the unaffected group (H = 8.192, P = 0.017), and it was more in the affected group than in the unaffected group as post-hoc test (P < 0.05). ConclusionThe stroke patients spontaneously turning to the affected side during walking usually are poorer in balance function, and in a risk of fall.

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