1.Observation of the therapeutic effect of rituximab combined with traditional Chinese medicine syndrome differentiation on treating steroid-dependent nephrotic syndrome in children and the regularity of traditional Chinese medicine use
Xia ZHANG ; Xuejun LI ; Tingting XU ; Guang LI ; Yifan LI ; Chundong SONG ; Wensheng ZHAI ; Xianqing REN ; Ying DING
Journal of Beijing University of Traditional Chinese Medicine 2025;48(1):80-90
Objective:
To investigate the efficacy, safety, and traditional Chinese medicine (TCM) medication patterns of rituximab (RTX) combined with TCM on treating children with steroid-dependent nephrotic syndrome (SDNS).
Methods:
One hundred and forty-three children with SDNS who visited the Pediatric Nephrology Department of the First Affiliated Hospital of Henan University of Chinese Medicine from January 2018 to December 2022 were enrolled. A cohort study design was adopted, with " RTX treatment" as the exposure factor. Children who met this exposure factor were assigned to the RTX cohort (RTX, glucocorticoid, immunosuppressive agent, combined with traditional Chinese medicine syndrome differentiation treatment), whereas those who did not were assigned to the basic treatment cohort (glucocorticoid, immunosuppressive agent, combined with traditional Chinese medicine syndrome differentiation treatment ), and followed up for 6 months. The frequency of urinary protein recurrences, urinary protein remission duration, proportion and duration of steroid reduction and cessation, cumulative usage of steroids, proportion of recurrence, recurrence amount of steroid used, efficacy of TCM syndrome, and laboratory and safety indicators after treatment, and height and CD19+ B cell count before and after treatment were compared between the two cohorts. The medication patterns of TCM in the two cohorts were analyzed using frequency statistics, association rule analysis, and systematic clustering analysis.
Results:
Compared with the basic treatment cohort, the RTX cohort showed a decrease in the frequency of urinary protein recurrence, extended sustained remission of urinary protein, an increase in the proportion of steroid reduction and cessation, a shorter duration of steroid reduction and cessation, a decrease in cumulative steroid dosage, a lower recurrence rate, a decrease in CD19+ B cell count, and a decrease in 24-h urinary total protein quantification and the level of cholesterol (P<0.05). No significant difference in the recurrence amount of steroid used, height, TCM syndrome efficacy, albumin, aspartate transaminase, blood urea nitrogen, platelet count, and safety indicators between the two cohorts. Children with SDNS were mostly characterized by qi and yin deficiency syndrome, followed by spleen and kidney yang deficiency syndrome. A total of 175 TCMs were included, including 28 high-frequency drugs such as Huangqi, Fuling, Gancao, Baizhu, Dangshen, and Jiuyurou. The primary use of medication is to nourish the qi and spleen, nourish the kidney, and warm yang. The analysis of association rules yielded eight binary associations and ten three-phase associations, with Huangqi, Baizhu, Fuling, and Dangshen, being the most closely related. Cluster analysis identified four TCM combinations, primarily focusing on tonifying kidney and replenishing essence, benefiting qi and nourishing yin, and removing blood stasis.
Conclusion
RTX combined with TCM syndrome differentiation treatment can reduce the recurrence frequency of SDNS, prolong the remission period, reduce the glucocorticoid dosage, and have no marked effect on height growth. No apparent adverse reactions were observed. TCM should focus on nourishing qi and yin while removing blood stasis.
2.Analysis of Clinical Diagnosis and Traditional Chinese Medicine Medication Rule of Children with Nephrotic Syndrome in Single Center
Tingting XU ; Xia ZHANG ; Ying DING ; Long WANG ; Shanshan XU ; Yijin WANG ; Yue WANG ; Feiyu YAO ; Chundong SONG ; Wensheng ZHAI ; Xianqing REN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(12):176-184
ObjectiveTo analyze the clinical treatment plan and traditional Chinese medicine (TCM) medication rule of children with primary nephrotic syndrome (PNS) in the First Affiliated Hospital of Henan University of Chinese Medicine. MethodsThe gender and age of children firstly diagnosed with nephrotic syndrome in the pediatric nephrology department of the First Affiliated Hospital of Henan University of Chinese Medicine from November 2019 to December 2022 were collected, and the use of immunosuppressive agents and related frequencies were counted. According to the inclusion and exclusion criteria, an independent TCM prescription database for children with nephrotic syndrome was established. Excel was used to analyze the relevant information of the literature. The frequency counting, association rule analysis, and cluster analysis were carried out on TCM in the prescription, and the high-frequent drugs were analyzed. Results(1) General information: A total of 711 children were included, consisting of 522 males (73.42%) and 189 females (26.58%). The ratio of male to female was about 2.76∶1. The disease mainly occurred in infants and preschool age, and the average age of onset was (4.74 ± 3.48) years old. (2) Clinical treatment plan and use of immunosuppressive agents: Of the 711 children with PNS, 237 were treated with hormone alone (32.33%), and 474 (66.67%) received immunosuppressive agents combined with hormones. In the initial treatment, hormone combined with Tacrolimus (TAC) was the preferred treatment (32.91%). For children with refractory PNS who exhibited poor clinical efficacy, Rituximab (RTX) was mostly used for treatment, with a ratio of up to 23.63%. (3) TCM syndrome and medication rule: In PNS syndrome differentiation, Qi and Yin deficiency was identified as the main syndrome. This involved a total of 477 cases, accounting for 67.09%. Yang deficiency of spleen and kidney was observed in 118 cases, accounting for 16.60%. A total of 711 children were included, of which 706 children were treated with TCM. This involved a total of 706 prescriptions, 226 TCM, and 9 793 frequencies. There were 30 herbs used more than 95 times. The top five TCM were Radix et Rhizoma Glycyrrhizae (81.16%), Radix Astragali (71.81%), Poria (68.84%), Rhizoma Atractylodis Macrocephalae (63.60%), and Fructus Corni (57.37%). The drug association rules and network diagram showed that the combination of ''Radix Astragali-Rhizoma Atractylodis Macrocephalae-Poria'' was the closest, and five types of combinations were obtained by cluster analysis. ConclusionIn the diagnosis and treatment of PNS in children, TAC combined with hormones shows good clinical efficacy and high safety. For children with refractory PNS, RTX combined with hormones can be used. TCM medication for PNS should follow the basic principles of strengthening the body and vital Qi and make good use of drugs such as Radix Astragali, Poria, Rhizoma Atractylodis Macrocephalae, and cornus to regulate the Yin and Yang balance and achieve better clinical efficacy.
3.Analysis of Clinical Diagnosis and Traditional Chinese Medicine Medication Rule of Children with Nephrotic Syndrome in Single Center
Tingting XU ; Xia ZHANG ; Ying DING ; Long WANG ; Shanshan XU ; Yijin WANG ; Yue WANG ; Feiyu YAO ; Chundong SONG ; Wensheng ZHAI ; Xianqing REN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(12):176-184
ObjectiveTo analyze the clinical treatment plan and traditional Chinese medicine (TCM) medication rule of children with primary nephrotic syndrome (PNS) in the First Affiliated Hospital of Henan University of Chinese Medicine. MethodsThe gender and age of children firstly diagnosed with nephrotic syndrome in the pediatric nephrology department of the First Affiliated Hospital of Henan University of Chinese Medicine from November 2019 to December 2022 were collected, and the use of immunosuppressive agents and related frequencies were counted. According to the inclusion and exclusion criteria, an independent TCM prescription database for children with nephrotic syndrome was established. Excel was used to analyze the relevant information of the literature. The frequency counting, association rule analysis, and cluster analysis were carried out on TCM in the prescription, and the high-frequent drugs were analyzed. Results(1) General information: A total of 711 children were included, consisting of 522 males (73.42%) and 189 females (26.58%). The ratio of male to female was about 2.76∶1. The disease mainly occurred in infants and preschool age, and the average age of onset was (4.74 ± 3.48) years old. (2) Clinical treatment plan and use of immunosuppressive agents: Of the 711 children with PNS, 237 were treated with hormone alone (32.33%), and 474 (66.67%) received immunosuppressive agents combined with hormones. In the initial treatment, hormone combined with Tacrolimus (TAC) was the preferred treatment (32.91%). For children with refractory PNS who exhibited poor clinical efficacy, Rituximab (RTX) was mostly used for treatment, with a ratio of up to 23.63%. (3) TCM syndrome and medication rule: In PNS syndrome differentiation, Qi and Yin deficiency was identified as the main syndrome. This involved a total of 477 cases, accounting for 67.09%. Yang deficiency of spleen and kidney was observed in 118 cases, accounting for 16.60%. A total of 711 children were included, of which 706 children were treated with TCM. This involved a total of 706 prescriptions, 226 TCM, and 9 793 frequencies. There were 30 herbs used more than 95 times. The top five TCM were Radix et Rhizoma Glycyrrhizae (81.16%), Radix Astragali (71.81%), Poria (68.84%), Rhizoma Atractylodis Macrocephalae (63.60%), and Fructus Corni (57.37%). The drug association rules and network diagram showed that the combination of ''Radix Astragali-Rhizoma Atractylodis Macrocephalae-Poria'' was the closest, and five types of combinations were obtained by cluster analysis. ConclusionIn the diagnosis and treatment of PNS in children, TAC combined with hormones shows good clinical efficacy and high safety. For children with refractory PNS, RTX combined with hormones can be used. TCM medication for PNS should follow the basic principles of strengthening the body and vital Qi and make good use of drugs such as Radix Astragali, Poria, Rhizoma Atractylodis Macrocephalae, and cornus to regulate the Yin and Yang balance and achieve better clinical efficacy.
4.Application of quality monitoring indicators of blood testing in blood banks of Shandong province
Xuemei LI ; Weiwei ZHAI ; Zhongsi YANG ; Shuhong ZHAO ; Yuqing WU ; Qun LIU ; Zhe SONG ; Zhiquan RONG ; Shuli SUN ; Xiaojuan FAN ; Wei ZHANG ; Jinyu HAN ; Lin ZHU ; Xianwu AN ; Hui ZHANG ; Junxia REN ; Xuejing LI ; Chenxi YANG ; Bo ZHOU ; Haiyan HUANG ; Guangcai LIU ; Ping CHEN ; Hui YE ; Mingming QIAO ; Hua SHEN ; Dunzhu GONGJUE ; Yunlong ZHUANG
Chinese Journal of Blood Transfusion 2024;37(3):258-266
【Objective】 To objectively evaluate the quality control level of blood testing process in blood banks through quantitative monitoring and trend analysis, and to promote the homogenization level and standardized management of blood testing laboratories in blood banks. 【Methods】 A quality monitoring indicator system covering the whole process of blood collection and supply, including blood donation service, blood component preparation, blood testing, blood supply and quality control was established. The questionnaire Quality Monitoring Indicators for Blood Collection and Supply Process with clear definition of indicators and calculation formulas was distributed to 17 blood banks in Shandong province. Quality monitoring indicators of each blood bank from January to December 2022 were collected, and 31 indicators in terms of blood testing were analyzed using SPSS25.0 software. 【Results】 The proportion of unqualified serological tests in 17 blood bank laboratories was 55.84% for ALT, 13.63% for HBsAg, 5.08% for anti HCV, 5.62% for anti HIV, 18.18% for anti TP, and 1.65% for other factors (mainly sample quality). The detection unqualified rate and median were (1.23±0.57)% and 1.11%, respectively. The ALT unqualified rate and median were (0.74±0.53)% and 0.60%, respectively. The detection unqualified rate was positively correlated with ALT unqualified rate (r=0.974, P<0.05). The unqualified rate of HBsAg, anti HCV, anti HIV and anti TP was (0.15±0.09)%, (0.05±0.04)%, (0.06±0.03)% and (0.20±0.05)% respectively. The average unqualified rate, average hemolysis rate, average insufficient volume rate and the abnormal hematocrit rate of samples in 17 blood bank laboratories was 0.21‰, 0.08‰, 0.01‰ and 0.02‰ respectively. There were differences in the retest concordance rates of four HBsAg, anti HCV and anti HIV reagents, and three anti TP reagents among 17 blood bank laboratories (P<0.05). The usage rate of ELISA reagents was (114.56±3.30)%, the outage rate of ELISA was (10.23±7.05) ‰, and the out of range rate of ELISA was (0.90±1.17) ‰. There was no correlation between the out of range rate, outrage rate and usage rate (all P>0.05), while the outrage rate was positively correlated with the usage rate (r=0.592, P<0.05). A total of 443 HBV DNA positive samples were detected in all blood banks, with an unqualified rate of 3.78/10 000; 15 HCV RNA positive samples were detected, with an unqualified rate of 0.13/10 000; 5 HIV RNA positive samples were detected, with an unqualified rate of 0.04/10 000. The unqualified rate of NAT was (0.72±0.04)‰, the single NAT reaction rate [(0.39±0.02)‰] was positively correlated with the single HBV DNA reaction rate [ (0.36±0.02) ‰] (r=0.886, P<0.05). There was a difference in the discriminated reactive rate by individual NAT among three blood bank laboratories (C, F, H) (P<0.05). The median resolution rate of 17 blood station laboratories by minipool test was 36.36%, the median rate of invalid batch of NAT was 0.67%, and the median rate of invalid result of NAT was 0.07‰. The consistency rate of ELISA dual reagent detection results was (99.63±0.24)%, and the median length of equipment failure was 14 days. The error rate of blood type testing in blood collection department was 0.14‰. 【Conclusion】 The quality monitoring indicator system for blood testing process in Shandong can monitor potential risks before, during and after the experiment, and has good applicability, feasibility, and effectiveness, and can facilitate the continuous improvement of laboratory quality control level. The application of blood testing quality monitoring indicators will promote the homogenization and standardization of blood quality management in Shandong, and lay the foundation for future comprehensive evaluations of blood banks.
5.Analysis on clinical efficacy of ureteroscope-assisted laparoscopic ureteroplasty at lying and running position of healthy side in the treatment of postoperative ureteral stenosis
Hua CHEN ; Tairong LIU ; Qiuhua ZHU ; Leming SONG ; Qiliang ZHAI ; Jiaqi GE ; Jiansheng XIAO
Chinese Journal of Urology 2024;45(1):29-33
Objective:To explore the safety and efficacy of ureteroscopy-assisted laparoscopic ureteroplasty in the healthy side-lying running position for the treatment of ureteral stenosis after pelvic surgery.Methods:The data of 92 patients with ureteral stenosis after surgery admitted to Ganzhou People’s Hospital from June 2017 to February 2023 were retrospectively analysed. There were 31 male patients and 61 female patients, with an average age of (46.4±23.3) years. Of the 92 patients, 53 patients had previously undergone stone fragmentation or stone retrieval surgery for urinary system stones, 35 patients had undergone gynecologic laparoscopic surgery for gynecologic diseases, 2 patients had previous intestinal surgery, and 2 patients had undergone laparoscopic ureteral reconstruction surgery. The mean preoperative serum creatinine was (120.33±16.52) μmol/L, the mean blood urea nitrogen was (14.28 ± 2.47) mmol/L, and the mean renal pelvis dilation was (3.23±2.47) cm. All patients were placed in healthy side-lying running position with general anesthesia. The patient's lower limbs were in the oblique supine position, and the angle of the lower limbs was 60-80°. By using a transabdominal approach, the narrow section of the ureter was mobilized and excised under the guidance of ureteroscopy. The posterior wall of the ureter was sutured and a zebra guidewire was placed into the renal pelvis. An F7 double-J stent was then retrogradely advanced over the guidewire. Then the anterior wall of the ureter was anastomosed to complete the surgery. The operation time, average length of hospital stay, perioperative complications, preoperative and postoperative pyelectasis and renal function changes were recorded, and the clinical efficacy were evaluated by comparative analysis.Results:Of the 92 patients, 90 patients were successfully treated with ureterovesical anastomosis. Two patients underwent ureterovesical reimplantation because of the low position and heavy adhesion of the stenosis segment. There were no cases of conversion to open surgery or intraoperative death. The mean surgery duration was (121.52±22.35) min, the mean drainage tube indwelling time was (3.16±1.23) d, and the mean hospital stay was (6.46±2.37) d. A patient with moderate hydronephrosis exhibited postoperative urinary leakage. Two patients developed symptoms of hematuria after ambulation. Following treatment with bed rest, adequate drainage, and appropriate hemostatic medication, all patients recovered smoothly and were discharged. The double J tube was removed 3 months after operation, and the CT reexamination after extubation showed that the degree of pyelectasis was (2.52±1.54) cm, the average serum creatinine was (89.64±15.21) μmol/L, and urea nitrogen was (9.42±1.36) mmol/L, which was all significantly different from that before operation ( P<0.05). The patients were followed up for 6 to 12 months, and there was no ureteral restenosis. Conclusions:Ureteroscopic-assisted laparoscopic ureteroplasty in the healthy side-lying running position is a safe and effective surgical method for the treatment of short segment (narrow segment <3 cm) ureteral cicatrix stenosis after surgery. And this surgical method has the advantages of accurate positioning of the narrow segment, safe and convenient ureteral free, exact ureteral anastomosis, and easy placement of double J tube.
6.Effect of sevoflurane on Ca 2+ transporter expression in cardiomyocytes during right ventricular remodeling in rats with pulmonary arterial hypertension
Wenqian ZHAI ; Yanfei BIAN ; Yuezi SONG ; Yunfei LI ; Hong XU ; Zhigang GUO ; Jiange HAN
Chinese Journal of Anesthesiology 2024;44(3):313-317
Objective:To evaluate the effect of sevoflurane on Ca 2+ transporter expression in cardiomyocytes during right ventricular remodeling in rats with pulmonary arterial hypertension. Methods:Twenty-four clean-grade healthy male Sprague-Dawley rats, aged 8-10 weeks, weighing 200-250 g, were divided into 4 groups ( n=6 each) by the random number table method: control group (CM group), sevoflurane group (CS group), monocrotaline group (M group) and sevoflurane + monocrotaline group (S group). Monocrotaline 60 mg/kg was intraperitoneally injected in group M and group S, and monocrotaline lysate was intraperitoneally injected in group CM. The rats in S and CS groups inhaled 2.5% sevoflurane for 1 h, twice a week, at an interval of 3 days starting from the first day after injection of monocrotaline. Pulmonary artery acceleration time and pulmonary artery ejection time were measured by transthoracic echocardiography at 6 weeks after monocrotaline injection. The chest was exposed under 3% sevoflurane anesthesia, the heart was perfused, and the pulmonary artery branch and right ventricular myocardial tissues were retained. The wall thickness of pulmonary arterioles and cross-section area of right ventricular cardiomyocytes were observed by HE staining. The expression of Ca 2+ transporter in right ventricular cardiomyocytes was detected by Western blot. Results:Compared with CM group, the ratio of pulmonary artery acceleration time to pulmonary artery ejection time was significantly decreased, the cross-section area of right ventricular cardiomyocytes was increased, the wall thickness of pulmonary arteriole was increased, the expression of type 1 sodium-calcium exchange and inositol triphosphate receptor was up-regulated, and the expression of voltage-dependent L-type calcium channel α1C subunit, type 2 ryanodine receptor, sarcoplasmic reticulum calcium pump 2α and proteinphilin-2 was down-regulated in M group ( P<0.01). Compared with group M, the ratio of pulmonary artery acceleration time to pulmonary artery ejection time was significantly increased, the cross-section area of right ventricular cardiomyocytes was decreased, the wall thickness of pulmonary arteriole was decreased, the expression of type 1 sodium-calcium exchange and inositol triphosphate receptor was down-regulated, and the expression of voltage-dependent L-type calcium channel α1C subunit, type 2 ryanodine receptor, sarcoplasmic reticulum calcium pump 2α and proteinphilin-2 was up-regulated in group S ( P<0.01). Conclusions:The mechanism by which sevoflurane improves right ventricular remodeling is related to regulating the expression of Ca 2+ transporter in cardiomyocytes of rats with pulmonary arterial hypertension.
7.Visualization analysis of stem cell therapy for myocardial infarction based on Web of Science in recent ten years
Yukang SUN ; Lijuan SONG ; Chunli WEN ; Zhibin DING ; Hao TIAN ; Dong MA ; Cungen MA ; Xiaoyan ZHAI
Chinese Journal of Tissue Engineering Research 2024;28(7):1143-1148
BACKGROUND:Although traditional therapies,including drugs and surgery,cannot repair the damaged myocardial tissue,the mortality rate of myocardial infarction remains high.Stem cells provide the possibility to solve this problem due to their self-renewal and multi-directional differentiation potential. OBJECTIVE:To analyze the research progress of stem cell therapy for myocardial infarction in recent ten years by bibliometric analysis. METHODS:The related articles on stem cells and myocardial infarction published in SCI-E and SSCI from January 1,2012 to December 1,2022 in the Web of Science database were searched.EXCEL,CiteSpace and VOSviewer software were used to make statistical and visualization analyses of the data such as the number of publications,authors,institutions,journals,countries and keywords. RESULTS AND CONCLUSION:A total of 3 210 core articles were published,and the total number increased year by year.hausenloy,derek j.is the author with the largest number of publications,China is the country with the largest number of publications,and the Fourth Military Medical University is the institution with the largest number of publications.The research hotspots in this field are changing from cell experiments and animal experiments to clinical trials.In the past ten years,research in this field has been highly popular and still has great development prospects.It is necessary to promote international and inter-agency exchange and learning,and further explore the role of stem cells in the treatment of myocardial infarction.
8.A multicenter study on effect of delayed chemotherapy on prognosis of Burkitt lymphoma in children
Li SONG ; Ling JIN ; Yonghong ZHANG ; Xiaomei YANG ; Yanlong DUAN ; Mincui ZHENG ; Xiaowen ZHAI ; Ying LIU ; Wei LIU ; Ansheng LIU ; Xiaojun YUAN ; Yunpeng DAI ; Leping ZHANG ; Jian WANG ; Lirong SUN ; Rong LIU ; Baoxi ZHANG ; Lian JIANG ; Huixia WEI ; Kailan CHEN ; Runming JIN ; Xige WANG ; Haixia ZHOU ; Hongmei WANG ; Shushuan ZHUANG ; Chunju ZHOU ; Zifen GAO ; Xiao MU ; Kaihui ZHANG ; Fu LI
Chinese Journal of Pediatrics 2024;62(10):941-948
Objective:To analyze the factors affecting delayed chemotherapy in children with Burkitt lymphoma (BL) and their influence on prognosis.Methods:Retrospective cohort study. Clinical data of 591 children aged ≤18 years with BL from May 2017 to December 2022 in China Net Childhood Lymphoma (CNCL) was collected. The patients were treated according to the protocol CNCL-BL-2017. According to the clinical characteristics, therapeutic regimen was divided into group A, group B and group C .Based on whether the total chemotherapy time was delayed, patients were divided into two groups: the delayed chemotherapy group and the non-delayed chemotherapy group. Based on the total delayed time of chemotherapy, patients in group C were divided into non-delayed chemotherapy group, 1-7 days delayed group and more than 7 days delayed group. Relationships between delayed chemotherapy and gender, age, tumor lysis syndrome before chemotherapy, bone marrow involvement, disease group (B/C group), serum lactate dehydrogenase (LDH) > 4 times than normal, grade Ⅲ-Ⅳ myelosuppression after chemotherapy, minimal residual disease in the interim assessment, and severe infection (including severe pneumonia, sepsis, meningitis, chickenpox, etc.) were analyzed. Logistic analysis was used to identify the relevant factors. Kaplan-Meier method was used to analyze the patients' survival information. Log-Rank was used for comparison between groups.Results:Among 591 patients, 504 were males and 87 were females, the follow-up time was 34.8 (18.6,50.1) months. The 3-year overall survival (OS) rate was (92.5±1.1)%,and the 3-year event-free survival (EFS) rate was (90.5±1.2)%. Seventy-three (12.4%) patients were in delayed chemotherapy group and 518 (87.6%) patients were in non-delayed chemotherapy group. The reasons for chemotherapy delay included 72 cases (98.6%) of severe infection, 65 cases (89.0%) of bone marrow suppression, 35 cases (47.9%) of organ dysfunction, 22 cases (30.1%) of tumor lysis syndrome,etc. There were 7 cases of chemotherapy delay in group B, which were seen in COPADM (vincristine+cyclophosphamide+prednisone+daunorubicin+methotrexate+intrathecal injection,4 cases) and CYM (methotrexate+cytarabine+intrathecal injection,3 cases) stages. There were 66 cases of chemotherapy delay in group C, which were common in COPADM (28 cases) and CYVE 1 (low dose cytarabine+high dose cytarabine+etoposide+methotrexate, 12 cases) stages. Multinomial Logistic regression analysis showed that the age over 10 years old ( OR=0.54,95% CI 0.30-0.93), tumor lysis syndrome before chemotherapy ( OR=0.48,95% CI 0.27-0.84) and grade Ⅲ-Ⅳ myelosuppression after chemotherapy ( OR=0.55,95% CI 0.33-0.91)were independent risk factors for chemotherapy delay.The 3-year OS rate and the 3-year EFS rate of children with Burkitt lymphoma in the delayed chemotherapy group were lower than those in the non-delayed chemotherapy group ((79.4±4.9)% vs. (94.2±1.1)%, (80.2±4.8)% vs. (92.0±1.2)%,both P<0.05). The 3-year OS rate of the group C with chemotherapy delay >7 days (42 cases) was lower than that of the group with chemotherapy delay of 1-7 days (22 cases) and the non-delay group (399 cases) ((76.7±6.9)% vs. (81.8±8.2)% vs. (92.7±1.3)%, P=0.002).The 3-year OS rate of the chemotherapy delay group (9 cases) in the COP (vincristine+cyclophosphamide+prednisone) phase was lower than that of the non-chemotherapy delay group (454 cases) ((66.7±15.7)% vs. (91.3±1.4)%, P=0.005). Similarly, the 3-year OS rate of the chemotherapy delay group (11 cases) in the COPADM1 phase was lower than that of the non-chemotherapy delay group (452 cases) ((63.6±14.5)% vs. (91.5±1.3)%, P=0.001). Conclusions:The delayed chemotherapy was related to the age over 10 years old, tumor lysis syndrome before chemotherapy and grade Ⅲ-Ⅳ myelosuppression after chemotherapy in pediatric BL. There is a significant relationship between delayed chemotherapy and prognosis of BL in children.
9.Evidence-based guideline for the management of clinical application of biosimilars in China (2024 edition)
Zaiwei SONG ; Yang HU ; Lingling YU ; Jun ZHU ; Lingli ZHANG ; Yu ZHANG ; Liyan MIAO ; Suodi ZHAI ; Rongsheng ZHAO
China Pharmacy 2024;35(16):1933-1945
OBJECTIVE To provide standardized guidance for the clinical application and management of biosimilars, and promote their widespread and rational use in clinical treatment. METHODS The design, planning, and drafting process as well as the full report of Evidence-based Guideline for the Management of Clinical Application of Biosimilars in China (2024 Edition) followed the WHO Handbook for Guideline Development (2nd edition), which fully considered the best current evidence from evidence-based medicine, multidisciplinary expert experience, and patient preferences and values. Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was adopted to evaluate the quality of evidence and determine the strength of recommendations. RESULTS & CONCLUSIONS Evidence-based Guideline for the Management of Clinical Application of Biosimilars in China (2024 Edition) presented 10 recommendations including 7 strong recommendations and 3 weak recommendations. The recommendations covered the entire process of clinical application and management of biosimilars. Medical institutions and relevant health regulatory departments can refer to this guideline for the scientific management of the extrapolation of unapproved indications of biosimilars. Healthcare providers can refer to this guideline for pre-treatment assessments, patient education, pre-treatment regimen before administration, and dosage regimen adjustments. Multidisciplinary medical teams can refer to this guideline to provide pharmacovigilance and patient management throughout the treatment process.
10.Impact of early nasogastric tube removal on functional recovery after total gastrectomy
Ran HU ; Zhi ZHENG ; Yuhao ZHAI ; Lihong ZHAO ; Dan XUE ; Chenchen SONG ; Jun ZHANG ; Meng SUN
International Journal of Surgery 2024;51(8):542-547
Objective:To investigate the impact of early removal of nasogastric tubes on functional recovery after total gastrectomy for gastric cancer patients, to provide scientific evidence for enhanced recovery after surgery strategies in gastric cancer.Methods:A retrospective cohort study was conducted on 102 gastric cancer patients who underwent total gastrectomy at Beijing Friendship Hospital affiliated with the Capital Medical University from March 2018 to July 2022. Patients were divided into two groups based on whether the gastric tube was removed within 24 hours post-operation: the early removal group (within 24 hours, 55 patients) and the non-early removal group (beyond 24 hours, 47 patients). The recovery outcomes, including time to first flatus, time to fluid intake, length of hospital stay, and the incidence of postoperative complications, were compared between the two groups. Non-normally distributed data were expressed as M( Q1, Q3) and compared using the Wilcoxon rank-sum test. Categorical data were expressed as frequencies or percentages and compared using the chi-square test or Fisher′s exact test. To minimize the impact of potential confounders, multivariable linear regression and logistic regression analyses adjusted for propensity scores were further employed to compare quantitative and qualitative data between the groups. Statistical analyses were performed using R software. Results:The exhaust time, water intake time, and hospital stay in the early removal group were 3.0(2.0, 3.5) days, 4.0(3.0, 5.0) days, and 7.0(7.0, 8.0) days, respectively, while those in the non-early removal group were 4.0(3.0, 5.0) days, 6.0(5.0, 7.0) days, and 8.0(7.5, 11.0) days, respectively. Statistically significant differences were observed between the two groups ( P<0.05). However, there was no significant difference in the incidence of postoperative complications between the two groups (5.45% vs 17.02%, P=0.060). Propensity score-adjusted regression analysis suggested that early tube removal might reduce the risk of postoperative complications ( P=0.042). Conclusion:Early removal of nasogastric tubes can significantly accelerate functional recovery after total gastrectomy for gastric cancer patients and may reduce the risk of postoperative complications, providing important clinical guidance for enhanced recovery after surgery management in gastric cancer.


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