1.Clinical Efficacy and Safety of Qingyusan Capsules in Treatment of Ulcerative Colitis with Syndrome of Large Intestine Dampness-heat
Xiaowen LIU ; Sizhen GU ; Danbo DOU ; Shigui XUE ; Yini TANG ; Gan CAI
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(14):114-121
ObjectiveTo evaluate the efficacy and safety of Qingyusan capsules in the long-term treatment of mild to moderate active ulcerative colitis (UC) with the syndrome of large intestine dampness-heat. MethodA randomized, controlled design was adopted, and 88 patients with mild to moderate UC and syndrome of large intestine dampness-heat were randomized into a Qingyusan (Qingyusan capsules, 0.8 g·d-1) group and a control (mesalazine, 0.4 g·d-1) group, with 44 patients in each group. Three and one patients dropped out in the control and Qingyusan groups, respectively, during the 32 weeks of treatment. The clinical remission rate, mucosal healing rate, and modified Mayo score, TCM symptom score, and short inflammatory bowel disease questionnaire (SIBDQ) score before and after treatment were compared between the two groups. The colonoscopic and pathological changes were observed, and the clinical safety was compared between the two groups. ResultAfter treatment, the clinical remission rate and mucosal healing rate in the Qingyusan group were 72.1% (31/43) and 74.4% (32/43), respectively, which were higher than those [26.8% (11/41) and 41.5% (17/41), respectively] in the control group (χ2=17.200, χ2=10.843, respectively, both P<0.01). The treatment in both groups decreased the modified Mayo score, partial Mayo score, and TCM symptom score (P<0.05), and the decreases in the Qingyusan group were higher than those in the control group (P<0.01). After treatment, the SIBDQ scores in both groups increased (P<0.05), and the increase was more pronounced in the Qingyusan group than in the control group (P<0.01). There was no difference in the incidence of adverse events between the two groups. ConclusionThe clinical efficacy of Qingyusan capsules is remarkable in the long-term treatment of UC with the syndrome of large intestine dampness-heat. Particularly, Qingyusan capsules demonstrates advantages in inducing and maintaining clinical remission, promoting mucosal healing, alleviating TCM symptoms, and enhancing the survival quality of patients, with high safety.
2.Efficacy and safety of chimeric antigen receptor T-cell therapy followed by allogeneic hematopoietic stem cell transplantation in 21 patients with Ph-like acute lymphoblastic leukemia
Haiping DAI ; Hongjie SHEN ; Zheng LI ; Wei CUI ; Qingya CUI ; Mengyun LI ; Sifan CHEN ; Mingqing ZHU ; Depei WU ; Xiaowen TANG
Chinese Journal of Hematology 2024;45(1):35-40
Objective:To evaluate the efficacy and safety of chimeric antigen receptor T-cell (CAR-T) therapy followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with Ph-like acute lymphoblastic leukemia (Ph-ALL) .Methods:Patients with Ph-ALL who underwent CAR-T therapy followed by allo-HSCT from March 2018 to August 2023 at the First Affiliated Hospital of Soochow University were included, and their clinical data were retrospectively analyzed.Results:Of the 21 patients, 14 were male and 7 were female. The median age at the time of CAR-T therapy was 22 (6-50) years. Seven patients had ABL1-like rearrangements, and 14 had JAK-STAT rearrangements. Prior to CAR-T therapy, 12 patients experienced hematologic relapse; 7 were multiparameter flow cytometry minimal residual disease (MFC-MRD) -positive and 2 were MFC-MRD-negative. CAR-T cells were derived from patients’ autologous lymphocytes. Nine patients were treated with CD19 CAR-T cells, and 12 were treated with CD19/CD22 CAR-T cells. After assessment on day 28 after CAR-T therapy, 95.2% of the patients achieved complete remission, with an MRD-negative remission rate of 75%. Nineteen patients developed grade 0–2 cytokine release syndrome (CRS) and 2 patients suffered grade 3 CRS, all cases of which resolved after treatment. All patients underwent allo-HSCT after CAR-T therapy. The median time from CAR-T therapy to allo-HSCT was 63 (38-114) days. Five patients experienced relapse after CAR-T therapy, including four with hematologic relapse and one with molecular relapse. The 3-year overall survival (OS) rates in the ABL1 and JAK-STAT groups were (83.3±15.2) % and (66.6±17.2) %, respectively ( P=0.68) . The 3-year relapse-free survival (RFS) rates were (50.0±20.4) % and (55.6±15.4) % in the ABL1 and JAK-STAT groups, respectively. There was no significant difference in 3-year OS or RFS between the two groups. Conclusions:CAR-T therapy followed by allo-HSCT leads to rapid remission in most patients with Ph-ALL and prolongs leukemia-free survival.
3.The efficacy and safety of protein A immunoadsorption combined with rituximab treatment for highly sensitized patients undergoing haplo-hematopoietic stem cell transplantation
Ling LI ; Wenjuan ZHU ; Qian ZHU ; Shiyuan ZHOU ; Chao MA ; Jun WANG ; Xiaohui HU ; Yue HAN ; Ying WANG ; Xiaowen TANG ; Xiao MA ; Suning CHEN ; Huiying QIU ; Luyao CHEN ; Jun HE ; Depei WU ; Xiaojin WU
Chinese Journal of Hematology 2024;45(5):468-474
Objective:To investigate the efficacy and safety of protein A immunoadsorption (PAIA) combined with rituximab (RTX) in highly sensitized patients who underwent haplo-hematopoietic stem cell transplantation (haplo-HSCT) .Methods:The clinical data of 56 highly sensitized patients treated with PAIA and RTX before haplo-HSCT at the First Affiliated Hospital of Soochow University and Soochow Hopes Hematonosis Hospital between March 2021 and June 2023 were retrospectively analyzed. The number of human leukocyte antigen (HLA) antibody types and the mean fluorescence intensity (MFI), humoral immunity, adverse reactions during adsorption, and survival within 100 days before and after adsorption were measured.Results:After receiving the PAIA treatment, the median MFI of patients containing only HLA Ⅰ antibodies decreased from 7 859 (3 209-12 444) to 3 719 (0-8 275) ( P<0.001), and the median MFI of HLA Ⅰ+Ⅱ antibodies decreased from 5 476 (1 977-12 382) to 3 714 (0-11 074) ( P=0.035). The median MFI of patients with positive anti-donor-specific antibodies decreased from 8 779 (2 697-18 659) to 4 524 (0–15 989) ( P<0.001). The number of HLA-A, B, C, DR, and DQ antibodies in all patients decreased after the PAIA treatment, and the differences were statistically significant (A, B, C, DR: P<0.001, DQ: P<0.01). The humoral immune monitoring before and after the PAIA treatment showed a significant decrease in the number of IgG and complement C3 ( P<0.001 and P=0.002, respectively). Forty-four patients underwent HLA antibody monitoring after transplantation, and the overall MFI and number of antibody types decreased. However, five patients developed new antibodies with low MFI, and nine patients continued to have high MFI. The overall survival, disease-free survival, non-recurrent mortality, and cumulative recurrence rates at 100 days post-transplantation were 83.8%, 80.2%, 16.1%, and 4.5%, respectively. Conclusions:The combination of PAIA and RTX has a certain therapeutic effect and good safety in the desensitization treatment of highly sensitive patients before haplo-HSCT.
4.Clinical and MRI nomogram model for predicting simultaneous liver metastasis of rectal cancer
Yudie PAN ; Shuxing WANG ; Xiaowen LIU ; Ting XU ; Changsi JIANG ; Xue TANG ; Yan LUO ; Jingshan GONG
Chinese Journal of Medical Imaging Technology 2024;40(9):1361-1365
Objective To explore the value of nomogram model based on clinical data and MRI findings for predicting simultaneous liver metastasis(SLM)of rectal cancer.Methods Clinical and MRI data of 356 patients with rectal cancer were randomly divided into training set(n=249,45 cases of SLM)and validation set(n=107,27 cases of SLM)at a ratio of 7∶3.Logistic regression analysis were used to screen the independent factors for predicting SLM of rectal cancer.The nomogram model was then constructed,and the efficacy of this model was evaluated.Results Tumor N-stage,serum carcinoembryonic antigen,carbohydrate antigen 19-9 and involvement of mesorectal fascia(MRF)or not were all independent factors for predicting SLM of rectal cancer.The area under the curve(AUC)of this nomogram model for predicting rectal cancer SLM in training set and validation set was 0.834(95%CI[0.776,0.893])and 0.769(95%CI[0.662,0.877]),respectively.The calibration curve showed good consistency between the predicted values and the measured values,and the decision curve analysis showed that the nomogram model had good clinical practicality.Conclusion The nomogram model based on clinical data and MRI findings could be used to predict SLM of rectal cancer.
5.Hip fracture is associated with a reduced risk of type 2 diabetes: A retrospective cohort study
Suhas KRISHNAMOORTHY ; Casey Tze-Lam TANG ; Warrington Wen-Qiang HSU ; Gloria Hoi-Yee LI ; Chor-Wing SING ; Xiaowen ZHANG ; Kathryn Choon-Beng TAN ; Bernard Man-Yung CHEUNG ; Ian Chi-Kei WONG ; Annie Wai-Chee KUNG ; Ching-Lung CHEUNG
Osteoporosis and Sarcopenia 2024;10(2):60-65
Objectives:
Type 2 diabetes mellitus (T2DM) shares a complex relationship with bone metabolism and few studies investigated the effect of impaired bone health on the risk of T2DM. This study was conducted to investigate the association between hip fractures and the risk of incident T2DM.
Methods:
This is a retrospective cohort study using data from the real-world hip fracture cohort. Hong Kong Chinese patients aged ≥ 65 years without T2DM who were admitted to public hospitals due to a fall between 2008 and 2015 were included in the study. Patients who sustained falls with and without hip fractures were matched by propensity score (PS) at a 1:1 ratio. Competing risk regression was used to evaluate the association between hip fracture and incident T2DM, with death being the competing event.
Results:
A total of 23,314 hip fracture cases were matched to 23,314 controls. The median follow-up time was 5.09 years. The incidence rate of T2DM was 11.947 and 14.505 per 1000 person-years for the hip fracture and control group respectively. After accounting for the competing risk of death, the hip fracture group had a significantly lower risk of developing T2DM (HR: 0.771, 95% CI: 0.719–0.827). Similar results were observed in all subgroups after stratification by age and sex.
Conclusions
Hip fracture was found to be associated with a reduced risk of T2DM. These findings provide insight into the topic of bone and glucose metabolism and prompt further research in evaluating the role of bone health in the management of T2DM.
6.Effect of blood sampling management on reducing blood transfusions in very preterm infants.
Jingjun PEI ; Jun TANG ; Yanling HU ; Xingli WAN ; Jing SHI ; Hua WANG ; Qiong CHEN ; Xiaowen LI ; Jian CHEN ; Chao CHEN ; Hongju CHEN ; Junjie YING ; Dezhi MU
Chinese Medical Journal 2023;136(19):2389-2391
7.Venous thromboembolism in children with acute lymphoblastic leukemia in China: a report from the Chinese Children's Cancer Group-ALL-2015.
Mengmeng YIN ; Hongsheng WANG ; Xianmin GUAN ; Ju GAO ; Minghua YANG ; Ningling WANG ; Tianfeng LIU ; Jingyan TANG ; Alex W K LEUNG ; Fen ZHOU ; Xuedong WU ; Jie HUANG ; Hong LI ; Shaoyan HU ; Xin TIAN ; Hua JIANG ; Jiaoyang CAI ; Xiaowen ZHAI ; Shuhong SHEN ; Qun HU
Frontiers of Medicine 2023;17(3):518-526
Venous thromboembolism (VTE) is a complication in children with acute lymphoblastic leukemia (ALL). The Chinese Children's Cancer Group-ALL-2015 protocol was carried out in China, and epidemiology, clinical characteristics, and risk factors associated with VTE were analyzed. We collected data on VTE in a multi-institutional clinical study of 7640 patients with ALL diagnosed in 20 hospitals from January 2015 to December 2019. First, VTE occurred in 159 (2.08%) patients, including 90 (56.6%) during induction therapy and 108 (67.92%) in the upper extremities. T-ALL had a 1.74-fold increased risk of VTE (95% CI 1.08-2.8, P = 0.022). Septicemia, as an adverse event of ALL treatment, can significantly promote the occurrence of VTE (P < 0.001). Catheter-related thrombosis (CRT) accounted for 75.47% (n = 120); and, symptomatic VTE, 58.49% (n = 93), which was more common in patients aged 12-18 years (P = 0.023), non-CRT patients (P < 0.001), or patients with cerebral thrombosis (P < 0.001). Of the patients with VTE treated with anticoagulation therapy (n = 147), 4.08% (n = 6) had bleeding. The VTE recurrence rate was 5.03% (n = 8). Patients with VTE treated by non-ultrasound-guided venous cannulation (P = 0.02), with residual thrombus (P = 0.006), or with short anticoagulation period (P = 0.026) had high recurrence rates. Thus, preventing repeated venous puncture and appropriately prolonged anticoagulation time can reduce the risk of VTE recurrence.
Humans
;
Child
;
Venous Thromboembolism/etiology*
;
East Asian People
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Precursor Cell Lymphoblastic Leukemia-Lymphoma/epidemiology*
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Risk Factors
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Thrombosis/chemically induced*
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China/epidemiology*
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Anticoagulants/adverse effects*
;
Recurrence
8.Willingness of pre-exposure prophylaxis use to prevent HIV infection and related factors in men who have sex with men in Yunnan Province
Zuyang ZHANG ; Jing MA ; Yanling MA ; Lijun SONG ; Minyang XIAO ; Youfang LI ; Xiaowen WANG ; Jue WANG ; Jin NIU ; Houlin TANG ; Hongbing LUO
Chinese Journal of Epidemiology 2023;44(1):145-150
Objective:To understand the willingness of pre-exposure prophylaxis (PrEP) use to prevent HIV infection and related factors in men who have sex with men (MSM) in Yunnan Province.Methods:Cross-sectional study method and snowball sampling method was used to carry out the survey in 14 cities (autonomous prefectures) in Yunnan from April to June 2021. According to national sentinel surveillance program, the sample size was 400 at national sentinel sites and 100 at provincial sentinel sites. The related factors of PrEP use willingness were analyzed by multiple logistic regressions with software SPSS 22.0.Results:A total of 2 450 questionnaires were completed, the rate of having heard of PrEP was 68.5% (1 677/2 449), the willingness rate of PrEP use was 56.7% (1 343/2 368), the willing rate of PrEP use at their own expense was 30.6% (724/2 368), and the willingness rate of free PrEP use was 56.2% (1 330/2 367). The of multivariate logistic analysis results showed that related factors of low willingness to use PrEP included aged 40-49 years and 50 years or above (a OR=2.49 and a OR=4.48), Han ethnic group (a OR=1.47), residence in other provinces (a OR=1.64), education level of senior high school (a OR=1.96) and college or above (a OR=3.49), sample source of bath house (a OR=3.53), online recruiting (a OR=2.53) and voluntary counseling and testing (a OR=1.42), local living time for 3-6 months and 7-12 months (a OR=0.18 and a OR=0.25) ,class 2 and 3 of survey areas (a OR=3.63 and a OR=1.71), having no anal sex with men in the past week (a OR=2.60), having no commercial homosexual behavior in the past six months (a OR=13.32) and self-perceived higer risk for HIV infection (a OR=0.50). Conclusions:There was more than half of MSM with willingness to use PrEP. The health education to promote PrEP use should be strengthen in MSM who had low willingness to use PrEP from underdeveloped areas, in Han ethnic group, with older age, from other provinces, with shorter local living time and self-perceived low risk for HIV infection.
9.Effect of different HER2 expression on the efficacy of immunotherapy for advanced urothelial carcinoma who failed the previous chemotherapy
Siming LI ; Xieqiao YAN ; Li ZHOU ; Huayan XU ; Xiaowen WU ; Juan LI ; Yiqiang LIU ; Bixia TANG ; Zhihong CHI ; Lu SI ; Chuanliang CUI ; Jun GUO ; Xinan SHENG
Chinese Journal of Urology 2022;43(1):28-34
Objective:To explore the effect of different HER2 expression levels and gene amplification on the efficacy of immunotherapy in metastatic urothelial carcinoma (UC).Methods:The clinical data of 77 patients with metastatic UC who received immunotherapy from June 2017 to April 2021 after failure to the previous chemotherapy were analyzed retrospectively, including 49 males and 28 females with the median age of 62 years. The primary tumors located in bladder in 28 cases (36.4%), renal pelvis in 25 cases (32.5%) and ureter in 24 cases (31.2%). The common metastatic sites included: lymph nodes (n = 45, 58.4%), lung (n = 40, 51.9%), bone (n = 20, 26.0%) and liver (n = 16, 20.8%). 27 patients with bladder UC received surgery on the primary tumors including radical cystectomy (n = 18), partial cystectomy (n = 4) and transurethral resection (n = 5). 43 patients with renal pelvis or ureteral UC received surgery on the primary tumors including radical nephroureterectomy (n = 38), local resection (n = 3) and palliative resection (n = 2). Postoperative intravesical chemotherapy was performed in 15 cases, adjuvant radiotherapy was performed in 6 cases. 3 patients who emerged postoperative bladder recurrence received local radiotherapy. 7 patients received radiotherapy and 1 case received microwave ablation to their metastatic sites. All patients had received first-line chemotherapy and 30 patients (40.0%) had received at least second-line treatment including 70 cases (90.9%) with platinum containing chemotherapy. All 77 patients received anti-PD-1 treatment. 38 patients received sequential regimen after failed to the anti-PD-1 therapy, including antibody-drug conjugate (n = 17), chemotherapy (n = 18) and chemotherapy combined with anti-angiogenesis drugs (n = 12). Immunohistochemical (IHC) staining was used to detect the expression level of HER2 protein in the tumor tissues (74 cases from primary tumors and 3 cases from metastatic tumors) obtained from the initial diagnosis. For patients with HER2 IHC (+ + ), the copy number (CN) of HER2 gene was detected by next-generation sequencing (NGS). HER2 copy number amplification [CN (+ )] was defined as CN ≥ 4, and HER2 copy number non-amplification [CN(-)] was defined as CN < 4. HER2 IHC (0) was defined as HER2 negative, IHC (+ ) or IHC (+ + ) / CN (-)was defined as HER2 low expression, while IHC (+ + ) / CN(+ ) and IHC (+ + + ) were defined as HER2 high expression. Chi-square test or Fisher exact test were used to evaluate the correlation between HER2 expression and objective response rate (ORR) after anti-PD-1 treatment. Kaplan-Meier method and log-rank test were used to compare the differences of median progression free survival (PFS) and overall survival (OS) under different HER2 expression status.Results:All the 77 patients received a median of 11 (range: 2 - 45) doses of anti-PD-1 treatment with a median duration of treatment of 6.4 (range: 1.5 - 47.8) months and the ORR was 33.8% (26/77). The median follow-up time was 30.9 months. The overall median PFS time was 5.8 (95% CI: 3.0 - 8.6) months and the median OS time was 23.6 (95% CI: 8.5 - 38.7) months. HER2 IHC tests were performed in 77 patients. HER2 IHC levels of (0), (+ ), (+ + ) and (+ + + ) were found in 33 (42.9%), 19 (24.7%), 20 (26.0%) and 5 (6.5%) patients, respectively. HER2 copy number was detected in 20 patients with IHC (+ + ), while 1 CN(+ ) and 19 CN(-) were found. The ORR of HER2 negative, low expression and high expression patients were 42.4% (14/33) vs. 31.6% (12/38) vs. 0 (0/6) ( P = 0.08), respectively. The median PFS of the three groups were 11.0 months, 3.7 months and 1.8 months, respectively, with significant differences in overall and pairwise comparison( P=0.001). The median OS of patients with HER2 negative and low expression after anti-PD-1 treatment were 23.6 months and 22.7 months, respectively, while the median OS of patients with HER2 high expression had not been reached, with no significant difference in the overall comparison ( P=0.623). Conclusions:For patients with metastatic UC received anti-PD-1 treatment, the PFS of patients with high HER2 expression was significantly worse than that of patients with low or negative HER2 expression. HER2 expression may have potential value in predicting the efficacy of immunotherapy for metastatic UC who failed the previous chemotherapy, which needs further research.
10.Effects of electroacupuncture on angiogenesis and cortical VEGF and BDNF expression inrats with focal cerebral ischemia
Mengxing LI ; Yu WANG ; Yunyun GAO ; Xiaowen YAO ; Wei LAN ; Wei TANG
Journal of Acupuncture and Tuina Science 2022;20(2):91-103
Objective: To observe the effect of electroacupuncture (EA) of "concurrent treatment of the brain and heart" on angiogenesis and cortical vascular endothelial growth factor (VEGF) and brain-derived neurotrophic factor (BDNF) in rats with focal cerebral ischemia, and to explore the mechanism of EA in cerebral ischemia treatment. Methods: A total of 108 Sprague-Dawley rats, 27 rats were randomly selected as the sham-operation group, and the rest rats received the right middle cerebral artery occlusion operation for model preparation firstly, and then were divided into a model group, a traditional acupoint group, and a concurrent treatment of the brain and heart group, with 27 rats in each group. In the sham-operation group, only the carotid artery was isolated. EA at Shuigou (CV26), Quchi (LI11), Hegu (LI4), and Zusanli (ST36) in the traditional acupoint group, and EA at Fengfu (GV16), Baihui (GV20), Xinshu (BL15), and Neiguan (PC6) in the concurrent treatment of the brain and heart group were performed 4 h after the operation, once a day, for 14 consecutive days. Rats in the sham-operation group and the model group were identically fixed without any treatment. Before and after treatment, the modified neurological severity score (mNSS), regional cerebral blood flow (rCBF), and CD34 positive expression by immunohistochemistry were measured. The positive protein expression levels of VEGF and BDNF were detected by immunofluorescence, and the mRNA expression levels of VEGF and BDNF were detected by quantitative reverse transcription-polymerase chain reaction (qRT-PCR). Results: Compared with the sham-operation group, the mNSS, rCBF, and ischemic side cortical micro-vessel density (MVD) decreased, and the protein and mRNA expression levels of VEGF and BDNF increased in the model group (P<0.01). Compared with the model group, the mNSS of the two EA groups decreased, and the mNSS of the concurrent treatment of the brain and heart group was lower than that of the traditional acupoint group on the 14th day (P<0.05). Compared with the model group, the rCBF in the two EA groups increased, and the rCBF reached the highest on the 14th day (P<0.05 or P<0.01), and the rCBF in the concurrent treatment of the brain and heart group was higher than that in the traditional acupoint group (P<0.05); the MVD of the two EA groups was higher than that of the model group, and the MVD of the concurrent treatment of the brain and heart group was higher than that of the traditional acupoint group on the 7th and 14th days (P<0.05 or P<0.01). Compared with the model group, the protein and mRNA expression levels of VEGF and BDNF in the two EA groups increased (P<0.01). The VEGF expression level was the highest on the 7th day in the concurrent treatment of the brain and heart group (P<0.05), and the BDNF expression level was higher on the 7th and 14th days than on the 3rd day (P<0.05). The mRNA expression levels of VEGF and BDNF in both EA groups reached the highest on the 7th day (P<0.05 or P<0.01). Conclusion: EA therapy can up-regulate the VEGF and BDNF expression levels and increase the rCBF in the cortex of rats with focal cerebral ischemia, which may be one mechanism of EA in the cerebral ischemia treatment. The therapeutic effect is accumulated with the effective time, and the concurrent treatment of the brain and heart group is superior to the traditional acupoint group in promoting angiogenesis.

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