1.Epidemiological characteristics of early-onset colorectal cancer: a prospective cohort study from a single center
Tian JIN ; Yingshuang ZHU ; Chengcheng LIU ; Xing XU ; Wei LU ; Qian XIAO ; Kefeng DING ; Shu ZHENG
Chinese Journal of Gastrointestinal Surgery 2024;27(5):457-463
Objective:To explore the differences in distribution of colorectal cancer-related risk factors between patients with early-onset colorectal cancer (EOCRC) and those with late-onset colorectal cancer (LOCRC) in a Chinese cohort, and to provide reference and guidance for the prevention, diagnosis, and treatment of EOCRC.Methods:Using data from the National Colorectal Cancer Cohort study cohort, 5377 patients with newly diagnosed colorectal cancer (CRC) attending the Department of Colorectal Surgery and Oncology of the Second Affiliated Hospital, Zhejiang University School of Medicine from June 2018 to February 2023 were included in the study cohort. Questionnaires capturing epidemiological features, including lifestyle and dietary habits, were administered. The patients were divided into two groups, the cut-off age being 50 years. Those aged ≥50 years were defined as having LOCRC and those aged <50 years as having EOCRC. Wilcoxon (continuous variates) or χ 2 tests (categorical variates) were performed to compare differences in epidemiological features. Results:A total of 3799 people who had completed the questionnaire were included in this study, 491 of whom had EOCRC and 3308 LOCRC. The response rate to the questionnaire was 70.7%. The median ages of patients in the EOCRC and LOCRC groups were 43 and 66 years, respectively. There was a higher proportion of female patients (48.5% [253/491] vs. 35.8% [1184/3308], χ 2=28.8, P<0.001) in the EOCRC than the LOCRC group. Patients with EOCRC and lower body mass index (medium 22.1 kg/m 2 vs. 22.9 kg/m 2, W=744 793, P=0.005) and lower proportion of abdominal obesity (87.2% [428/491] vs. 93.8% [3103/3308], χ 2=38.3, P<0.001). Patients with EORC significantly less commonly reported a history of hypertension (5.9% [29/491] vs. 41.6% [1375/3308], χ 2=231.8, P<0.001), diabetes (1.4% [7/491] vs. 14.4% [476/3308], χ 2=63.6, P<0.001) and cardiovascular and cerebrovascular diseases (0.8% [4/491] vs. 7.3% [241/3308], χ 2=28.6, P<0.001). However, the proportion of patients with a family history of CRC was significantly higher ( P<0.05) in the EOCRC group (10.2% [50/491] vs. 6.9% [227/3 308], χ 2=6.5, P=0.010]. In terms of lifestyle, patients with EOCRC had shorter sleep duration (median: 8.0 hours vs. 8.5 hours, W=578 989, P<0.001), and were less likely to participate in physical exercise (29.5% [145/491] vs. 38.7% [1281/3308] χ 2=15.0, P<0.001) or engage in physical work (65.2% [320/491] vs. 74.1% [2450/3308], χ 2=16.7, P<0.001). Meanwhile, in the EOCRC group a lower percentage of patients were smokers (29.3% [144/491] vs. 42.7% [1411/3308], χ 2=46.9, P<0.001) and they smoked less (median 17.6 pack/year vs. 30.0 pack/year,W=55 850, P<0.001). Fewer patients in the EOCRC group habitually drank alcohol (21.0% [103/491] vs. 38.0% [1257/3308], χ 2=57.5, P<0.001) or tea (17.5% [86/491] vs. 28.7% [948/3308], χ 2=26.2, P<0.001) than in the LOCRC group. Compared with the LOCRC group, patients with EOCRC had a higher frequency of intake of fresh meat, fresh fruit, eggs, and dairy products and a lower frequency of intake of preserved meat and pickled vegetables; these differences are statistically significant (all P<0.05). There was no statistically significant difference in consumption of fresh vegetables or a high-sugar diet between the two groups (both P>0.05). Conclusions:This study highlights disparities in adverse lifestyle and dietary habits between patients in China with EOCRC versus LOCRC.
2.Application value of contrast-enhanced ultrasound lymphography in preoperative planning for lymphaticovenous anastomosis in secondary upper extremity lymphedema
Jinglan TANG ; Litao SUN ; Kefeng LU ; Yongfeng LI ; Lisong ZHU ; Han LIU ; Pei DU ; Chunjie HOU
Chinese Journal of Plastic Surgery 2024;40(7):755-764
Objective:To investigate the value of contrast-enhanced ultrasound (CEUS) as a preoperative planning strategy for lymphaticovenous anastomosis (LVA) in improving the quality of LVA and the outcome of short-term limb volume reduction in patients with secondary upper limb lymphedema.Methods:Patients with breast cancer-related upper extremity lymphedema who underwent LVA at the Department of General Surgery Cancer Center Division of Breast Surgery of Zhejiang Provincial People’s Hospital from August 2021 to August 2023 were enrolled retrospectively. According to whether preoperative ultrasound lymphography was performed, the patients were divided into CEUS assisted group and control group. In the CEUS assisted group, preoperative CEUS lymphography combined with high-frequency ultrasound color Doppler imaging was utilized for precise localization of lymphatic vessels and recipient veins, as well as surgical target planning for LVA. In the control group, preoperative indocyanine green lymphography was employed to guide surgical exploration. Mann-Whitney U test was used to compare the number of LVA surgical exploration incisions per limb and the number of successful anastomoses per limb between the two groups. The success rate of anastomosis (total number of successful anastomoses/total number of surgical exploration incisions) was compared by the chi-square test. The duration of single anastomosis, mean arm circumference, and the difference between preoperative and postoperative mean arm circumference were compared by independent sample t-test. Paired-sample t-test was used to compare the improvement of the mean arm circumference of the operated limb of the two groups after 3 months of follow-up. P < 0.05 was considered statistically significant. Results:A total of 47 female patients were enrolled, including 27 patients in the CEUS assisted group, with an average age of (57.1±9.0) years and a median edema course of 2 years. There were 20 cases in the control group, with an average age of (58.1±9.6) years and a median duration of edema of 2 years. The CEUS group, compared with the control group, exhibited a higher number of surgical exploration incisions per limb [6.0 (4.0, 7.0) cases vs. 5.0 (3.0, 6.0) cases], a greater number of successful anastomoses per limb [5.0 (3.0, 6v0) cases vs. 3.0 (2.0, 3.0) cases], and a significantly increased overall success rate of anastomosis [82.8% (125/151) vs. 61.4% (54/88)]. Additionally, there was a significant increase in the preoperative and postoperative mean arm circumference difference [(6.2±3.3) cm vs. (3.9±1.9) cm]. The duration of single anastomosis was significantly shortened [(57.4±16.0) min vs. (92.8±18.5) min], with statistically significant differences observed in all comparisons (all P < 0.05). The preoperative and postoperative mean arm circumference were compared between the CEUS group [(31.4±4.6) cm vs. (25.3±4.7) cm] and the control group [(31.3±4.3) cm vs. (27.5±3.8) cm], respectively, with statistically significant differences observed in both groups (both P < 0.01). Conclusion:CEUS lymphography, as a preoperative planning strategy for LVA, can significantly increase the number and success rate of LVA anastomosis in patients with secondary upper limb lymphedema, shorten the duration of single anastomosis, and improve the short-term effect of limb volume reduction after LVA.
3.Meta-analysis of the effects of SLCO1B1 gene polymorphisms on the efficacy and safety of rosuvastatin
Chunyun LU ; Song WANG ; Kefeng LIU ; Ying XUE ; Juanjuan CHEN ; Yuanxia ZHAO ; Shuzhang DU
China Pharmacy 2024;35(19):2397-2403
OBJECTIVE To study the correlation between SLCO1B1 (521T>C and 388A>G) gene polymorphisms and the efficacy and safety of rosuvastatin. METHODS Retrieved from PubMed, Embase, Cochrane Library, PharmGKB, CNKI database and Wanfang database, the studies about the effects of 521T>C and 388A>G gene polymorphisms on the efficacy and safety of rosuvastatin were collected during the inception to Dec. 2023. The included data were analyzed by using RevMan 5.3 software. RESULTS A total of 16 studies were included. The results of meta-analysis showed that 521T>C gene polymorphism was significantly correlated with the efficacy of rosuvastatin. In the dominant gene model, compared with TT genotype, CC+TC genotype significantly improved the efficacy of rosuvastatin in raising high-density lipoprotein cholesterol (HDL-C) [MD=2.38, 95%CI(0.61,4.16), P=0.009 0]. In the homozygous gene model, compared with TT genotype, CC genotype significantly improved the efficacy of rosuvastatin in reducing total cholesterol [MD=-7.50,95%CI(-13.05, -1.95), P=0.008 0]. In heterozygous gene model, compared with TT genotype, TC genotype significantly improved rosuvastatin in reducing low-density lipoprotein cholesterol (LDL-C) [MD=-5.14, 95%CI(-9.74, -0.53), P=0.03] and increasing HDL-C [MD=5.67, 95%CI 232102311200) (2.61, 8.73), P=0.000 3]. 388A>G gene polymorphism was also significantly correlated with the efficacy of rosuvastatin. In dominant or homozygous gene models, compared with AA E-mail:dushuzhang911@163.com genotype, GG+AG genotype [MD=-6.88, 95%CI (-7.46,-6.30),P<0.000 1] or GG genotype [MD=-9.23, 95%CI(-9.41, 9.04), P<0.000 1] significantly improved the efficacy of rosuvastatin in lowering LDL-C. In the heterozygous gene model, compared with AA genotype, AG genotype significantly improved the efficacy of rosuvastatin in lowering LDL-C [MD=-3.00, 95%CI(-3.19, -2.82), P<0.000 1], total cholesterol [MD=-5.80, 95%CI(-6.00, -5.59), P<0.000 1] and triglyceride [MD=-11.79, 95%CI(-19.57, -4.02), P=0.003 0]. In the recessive gene model, compared with AA+AG genotype, GG genotype significantly improved the therapeutic efficacy of rosuvastatin in reducing LDL-C[MD=-4.31, 95%CI(-8.47, -0.14), P=0.040 0] and elevating HDL-C [MD=4.49, 95%CI (2.20, 6.77), P=0.000 1]. Under 4 gene models, there was a significant correlation between 521T>C gene polymorphism and rosuvastatin-related ADR probability (P<0.05), but no significant correlation was found in 388A>G gene polymorphism (P>0.05). CONCLUSIONS The polymorphism of 521T>C gene is significantly related to the efficacy and safety of rosuvastatin in lowering lipid, and the C allele may be one of the factors leading to the increase of rosuvastatin in lipid-lowering efficacy and ADR. 388A> G gene polymorphism is significantly associated with the lipid-lowering efficacy of rosuvastatin, but not with its safety.
4.Application value of contrast-enhanced ultrasound lymphography in preoperative planning for lymphaticovenous anastomosis in secondary upper extremity lymphedema
Jinglan TANG ; Litao SUN ; Kefeng LU ; Yongfeng LI ; Lisong ZHU ; Han LIU ; Pei DU ; Chunjie HOU
Chinese Journal of Plastic Surgery 2024;40(7):755-764
Objective:To investigate the value of contrast-enhanced ultrasound (CEUS) as a preoperative planning strategy for lymphaticovenous anastomosis (LVA) in improving the quality of LVA and the outcome of short-term limb volume reduction in patients with secondary upper limb lymphedema.Methods:Patients with breast cancer-related upper extremity lymphedema who underwent LVA at the Department of General Surgery Cancer Center Division of Breast Surgery of Zhejiang Provincial People’s Hospital from August 2021 to August 2023 were enrolled retrospectively. According to whether preoperative ultrasound lymphography was performed, the patients were divided into CEUS assisted group and control group. In the CEUS assisted group, preoperative CEUS lymphography combined with high-frequency ultrasound color Doppler imaging was utilized for precise localization of lymphatic vessels and recipient veins, as well as surgical target planning for LVA. In the control group, preoperative indocyanine green lymphography was employed to guide surgical exploration. Mann-Whitney U test was used to compare the number of LVA surgical exploration incisions per limb and the number of successful anastomoses per limb between the two groups. The success rate of anastomosis (total number of successful anastomoses/total number of surgical exploration incisions) was compared by the chi-square test. The duration of single anastomosis, mean arm circumference, and the difference between preoperative and postoperative mean arm circumference were compared by independent sample t-test. Paired-sample t-test was used to compare the improvement of the mean arm circumference of the operated limb of the two groups after 3 months of follow-up. P < 0.05 was considered statistically significant. Results:A total of 47 female patients were enrolled, including 27 patients in the CEUS assisted group, with an average age of (57.1±9.0) years and a median edema course of 2 years. There were 20 cases in the control group, with an average age of (58.1±9.6) years and a median duration of edema of 2 years. The CEUS group, compared with the control group, exhibited a higher number of surgical exploration incisions per limb [6.0 (4.0, 7.0) cases vs. 5.0 (3.0, 6.0) cases], a greater number of successful anastomoses per limb [5.0 (3.0, 6v0) cases vs. 3.0 (2.0, 3.0) cases], and a significantly increased overall success rate of anastomosis [82.8% (125/151) vs. 61.4% (54/88)]. Additionally, there was a significant increase in the preoperative and postoperative mean arm circumference difference [(6.2±3.3) cm vs. (3.9±1.9) cm]. The duration of single anastomosis was significantly shortened [(57.4±16.0) min vs. (92.8±18.5) min], with statistically significant differences observed in all comparisons (all P < 0.05). The preoperative and postoperative mean arm circumference were compared between the CEUS group [(31.4±4.6) cm vs. (25.3±4.7) cm] and the control group [(31.3±4.3) cm vs. (27.5±3.8) cm], respectively, with statistically significant differences observed in both groups (both P < 0.01). Conclusion:CEUS lymphography, as a preoperative planning strategy for LVA, can significantly increase the number and success rate of LVA anastomosis in patients with secondary upper limb lymphedema, shorten the duration of single anastomosis, and improve the short-term effect of limb volume reduction after LVA.
5.Epidemiological characteristics of early-onset colorectal cancer: a prospective cohort study from a single center
Tian JIN ; Yingshuang ZHU ; Chengcheng LIU ; Xing XU ; Wei LU ; Qian XIAO ; Kefeng DING ; Shu ZHENG
Chinese Journal of Gastrointestinal Surgery 2024;27(5):457-463
Objective:To explore the differences in distribution of colorectal cancer-related risk factors between patients with early-onset colorectal cancer (EOCRC) and those with late-onset colorectal cancer (LOCRC) in a Chinese cohort, and to provide reference and guidance for the prevention, diagnosis, and treatment of EOCRC.Methods:Using data from the National Colorectal Cancer Cohort study cohort, 5377 patients with newly diagnosed colorectal cancer (CRC) attending the Department of Colorectal Surgery and Oncology of the Second Affiliated Hospital, Zhejiang University School of Medicine from June 2018 to February 2023 were included in the study cohort. Questionnaires capturing epidemiological features, including lifestyle and dietary habits, were administered. The patients were divided into two groups, the cut-off age being 50 years. Those aged ≥50 years were defined as having LOCRC and those aged <50 years as having EOCRC. Wilcoxon (continuous variates) or χ 2 tests (categorical variates) were performed to compare differences in epidemiological features. Results:A total of 3799 people who had completed the questionnaire were included in this study, 491 of whom had EOCRC and 3308 LOCRC. The response rate to the questionnaire was 70.7%. The median ages of patients in the EOCRC and LOCRC groups were 43 and 66 years, respectively. There was a higher proportion of female patients (48.5% [253/491] vs. 35.8% [1184/3308], χ 2=28.8, P<0.001) in the EOCRC than the LOCRC group. Patients with EOCRC and lower body mass index (medium 22.1 kg/m 2 vs. 22.9 kg/m 2, W=744 793, P=0.005) and lower proportion of abdominal obesity (87.2% [428/491] vs. 93.8% [3103/3308], χ 2=38.3, P<0.001). Patients with EORC significantly less commonly reported a history of hypertension (5.9% [29/491] vs. 41.6% [1375/3308], χ 2=231.8, P<0.001), diabetes (1.4% [7/491] vs. 14.4% [476/3308], χ 2=63.6, P<0.001) and cardiovascular and cerebrovascular diseases (0.8% [4/491] vs. 7.3% [241/3308], χ 2=28.6, P<0.001). However, the proportion of patients with a family history of CRC was significantly higher ( P<0.05) in the EOCRC group (10.2% [50/491] vs. 6.9% [227/3 308], χ 2=6.5, P=0.010]. In terms of lifestyle, patients with EOCRC had shorter sleep duration (median: 8.0 hours vs. 8.5 hours, W=578 989, P<0.001), and were less likely to participate in physical exercise (29.5% [145/491] vs. 38.7% [1281/3308] χ 2=15.0, P<0.001) or engage in physical work (65.2% [320/491] vs. 74.1% [2450/3308], χ 2=16.7, P<0.001). Meanwhile, in the EOCRC group a lower percentage of patients were smokers (29.3% [144/491] vs. 42.7% [1411/3308], χ 2=46.9, P<0.001) and they smoked less (median 17.6 pack/year vs. 30.0 pack/year,W=55 850, P<0.001). Fewer patients in the EOCRC group habitually drank alcohol (21.0% [103/491] vs. 38.0% [1257/3308], χ 2=57.5, P<0.001) or tea (17.5% [86/491] vs. 28.7% [948/3308], χ 2=26.2, P<0.001) than in the LOCRC group. Compared with the LOCRC group, patients with EOCRC had a higher frequency of intake of fresh meat, fresh fruit, eggs, and dairy products and a lower frequency of intake of preserved meat and pickled vegetables; these differences are statistically significant (all P<0.05). There was no statistically significant difference in consumption of fresh vegetables or a high-sugar diet between the two groups (both P>0.05). Conclusions:This study highlights disparities in adverse lifestyle and dietary habits between patients in China with EOCRC versus LOCRC.
6.Association of serum L-carnitine and intestinal flora metabolites trimethylamine with gestational diabetes mellitus in mid-pregnancy women in Shanghai
Shiyin WU ; Jie JIA ; Jie ZHU ; Kefeng YANG ; Hui WU ; Lingpeng LU ; Yuhong LIU ; Meiqin CAI
Chinese Journal of Diabetes 2024;32(6):401-407
Objective To investigate the relationship between serum L-carnitine and its related metabolites[trimethylamine(TMA)and trimethylamine N-oxide(TMAO)]levels and gestational diabetes mellitus(GDM)in the second trimester of pregnant women in Shanghai.Methods A case-control study was conducted in 280 pregnant women between 18 and 23 weeks of gestation from January 2018 to January 2021.Among them,134 cases of GDM were the case group(GDM),and 146 cases with normal blood glucose(BG)were the control group(Con).Serum L-carnitine,TMA and TMAO levels were quantified by ultra high performance liquid chromatography-mass spectrometry.Logistic regression analysis,stratified analysis and linear regression were used to explore the relationship between L-carnitine,TMA and TMAO levels and GDM and glucolipid metabolism.Results Serum L-carnitinelevelwas significantly lower in GDM group than that in Con group(P<0.01).After adjusting for confounders,logistic regression showed a 70%reduction in the risk of GDM in the group with highest tertile of L-carnitine compared with the group with lowest tertile(OR 0.30,95%CI 0.15~0.63).The risk of GDM decreased by 14%for each 1 μmol/L increase in serum L-carnitine(OR 0.86,95%CI 0.80~0.93).Serum L-carnitine was negatively correlated with 1 hPG(r=-0.21,P<0.01)and 2 hPG(r=-0.15,P<0.05),respectively,TMA was negatively correlated with 2 hPG(r=-0.21,P<0.01).Conclusions Higher serum L-carnitine level may be negatively associated with GDM.Serum L-carnitine and TMA levels were negatively correlated with blood glucose levels.
7.Prediction of invasiveness in follicular variant of papillary thyroid carcinoma using nomograms based on ultrasonic features
YuXin ZHENG ; Yajiao ZHANG ; Liyu CHEN ; Kefeng LU ; Jiangyan LOU ; Junping LIU ; Dong XU
Chinese Journal of Ultrasonography 2024;33(9):800-806
Objective:To explore the relationship between ultrasound characteristics and invasiveness in the follicular variant of papillary thyroid carcinoma (FVPTC), and to integrate multiple ultrasound parameters for visual assessment of predictive outcomes by using Nomogram.Methods:A total of 312 FVPTC patients who were pathologically confirmed through surgery in Zhejiang Cancer Hospital and Zhejiang Provincial People′s Hospital from January 2013 to December 2023 were retrospectively collected.Based on defined criteria, FVPTC patients were categorized into high-invasion and low-invasion groups. The dataset was divided into a training set and a validation set in a ratio of 7 to 3. Clinical information and ultrasound feature parameters were collected. Univariate and multivariate Logistic regression analyses were performed on the training set. A predictive model for FVPTC invasiveness was constructed based on ultrasound features. The model′s discriminative ability and calibration were evaluated in the validation set, and a nomogram was generated.Results:The training set included a total of 218 patients with FVPTC, among which 131 were classified as high invasive.The validation set consisted of 94 patients, with 53 cases of high invasive FVPTC patients. Multivariate logistic regression analysis on the training set revealed that tumor multifocality ( OR=6.505, P=0.016), hypoechoic ( OR=3.235, P=0.103), shape ( OR=0.521, P=0.049), and microcalcifications ( OR=2.479, P=0.004) were independent influencing factors for predicting invasiveness in FVPTC. In the training set, the area under the curve (AUC) of the ultrasound predictive model was 0.704 (95% CI=0.634-0.771), and in the validation set, the AUC was 0.650 (95% CI=0.531-0.770), indicated good discriminative ability.The calibration curve showed good alignment with the ideal curve, demonstrating favorable calibration performance. Conclusions:Ultrasound features provide valuable information for assessing the invasiveness of FVPTC, and the model constructed by combining ultrasound features demonstrates good predictive efficacy for the invasiveness of FVPTC.
8.Systematic evaluation of the efficacy and safety of intravenous human immunoglobulin combined with cyclophosphamide in the treatment of systemic lupus erythematosus
Junke ZHANG ; Jie HAO ; Yi ZHANG ; Rui ZHANG ; Xiaojing LU ; Kefeng LIU
China Pharmacy 2023;34(19):2396-2401
OBJECTIVE To systematically evaluate the safety and effectiveness of intravenous human immunoglobulin (IVIG) combined with cyclophosphamide in the treatment of systemic lupus erythematosus (SLE), and to provide an evidence-based basis for clinical medication. METHODS Retrieved from PubMed, Embase, Cochrane Library, CBM, CNKI and Wanfang database, randomized controlled trials (RCTs) about IVIG combined with cyclophosphamide versus cyclophosphamide alone based on glucocorticoids were collected. The quality of the included literature was evaluated with Cochrane 5.1.0 risk of bias assessment tool after literature screening and data extraction, and meta-analysis was performed by using RevMan 5.4 software. RESULTS A total of 13 RCTs were included, involving 842 patients. Meta-analysis showed that compared with cyclophosphamide alone, IVIG combined with cyclophosphamide improved the overall response rate of systemic lupus erythematosus [RR=1.23, 95%CI(1.15, 1.32), P<0.000 01], lowered the systemic lupus erythematosus disease activity index [MD=-2.05, 95%CI(-2.51, -1.60), P<0.000 01], relieved 24 h proteinuria [MD=-1.29, 95%CI(-1.57, -1.01), P<0.000 01], reduced the inflammatory factor MCP-4 [MD=-28.04, 95%CI(-32.72, -23.37, P<0.000 01)], IL-4 [MD=-1.66, 95%CI(-1.96, -1.36), P<0.000 01], and boosted immune complement C3 [SMD=0.74,95%CI(0.34,1.14), P=0.000 3] and complement C4 [SMD=0.99,95%CI (0.31,1.67), P=0.004]; it had similar incidence of adverse drug reactions to cyclophosphamide therapy alone [RR=0.81, 95%CI (0.57, 1.17), P=0.26]. CONCLUSIONS Compared with cyclophosphamide alone, IVIG combined with cyclophosphamide has a positive role in improving the overall response rate of treating SLE, improving clinical symptoms, reducing inflammatory factors, improving immune function, but the results should be interpreted with caution.
9.Meta-analysis of clinical efficacy and safety of blinatumomab for acute lymphoblastic leukemia
Yongjie YANG ; Qiwen ZHANG ; Jingli LU ; Kelei GUAN ; Kefeng LIU ; Nan YANG ; Shuzhang DU ; Jian KANG ; Xiaojian ZHANG
China Pharmacy 2022;33(12):1492-1499
OBJECTIVE To systema tically evaluate the efficacy and safety of blinatumomab for acute lymphoblastic leukemia (ALL)in order to provide evidence-based reference for clinical use. METHODS Retrieved from PubMed ,Embase,Web of Science,the Cochrane Library ,CNKI,Wanfang database and CBM during the inception to February 3,2022,randomized controlled trials (RCTs)and cohort studies of blinatumomab (experimental group ) versus conventional chemotherapy (control group )in the treatment of ALL were collected. After literature screening and data extraction ,the quality of RCTs was evaluated by the risk bias evaluation tool recommended by Cochrane handbook 5.1.0,and the quality of cohort studies was evaluated by the Newcastle-Ottawa scale (NOS). Meta-analysis was performed by RevMan 5.4 software. GRADE grading system was used to evaluate the evidence quality of outcomes. The publication bias was analyzed by inverted funnel plot. RESULTS A total of 8 studies were included ,involving 3 RCTs and 5 cohort studies ,with a total of 2 841 patients. Results of Meta-analysis showed that the overall survival rate more than one year [RR =1.30,95%CI(1.14,1.48),P<0.000 1],relapse-free survival rate [RR =1.78,95%CI(1.50,2.12),P<0.000 01],complete remission rate [RR =1.42,95%CI(1.11,1.82),P=0.006],the incidence of tremor [RR =16.98,95%CI(2.17,133.12),P=0.007],and the incidence of cytokine release syndrome [RR =14.11, 95%CI(3.43,58.01),P=0.000 2] in trial group were all significantly higher than control group ,but there was no statistical significance in the incidence of headache between two groups [RR =1.31,95%CI(0.66,2.59),P=0.44]. The incidence of adverse events with grade more than or equal to 3,infection,stomatitis,thrombocytopenia,febrile neutropenia ,anorexia, constipation,diarrhea,abdominal pain ,hypokalemia in trial group were significantly lower than control group (P<0.05). The incidence of cough ,rash and hypogamma globulinemia and fever in the trial group were significantly higher than control group (P<0.05). There was no statistical significance in the total incidence of adverse events ,sepsis,anemia,leucopenia,neutropenia, lymphopenia,nausea,vomiting,hyperglycemia,hypotension,hypertension,elevated transaminase or epistaxis between two groups(P>0.05). Results of subgroup analysis by study type showed that the overall survival rate ,relapse-free survival rate and complete response rate (except for cohort studies )of patients in trial group were significantly higher than control group in both RCTs and cohort studies (P<0.05). The results of GRADE evaluation showed that the overall quality of index evidence included in this study was low. There was little possibility of publication bias in this study based on the publication bias analysis. CONCLUSIONS Blinatumomab is effective in the treatment of ALL ,with low incidence of infection and adverse events of digestive system ,but high incidence of tremor ,cough,rash,fever,hypoproglobulinemia and cytokine release syndrome. The evidence quality of the indicators included in this study is generally low .
10.Meta-analysis of efficacy and safety of oral JAK inhibitor for alopecia areata
Yongjie YANG ; Qiwen ZHANG ; Jingli LU ; Gaoxing QIAO ; Kefeng LIU ; Qi ZHOU ; Nan YANG ; Jian KANG ; Xiaojian ZHANG
China Pharmacy 2022;33(19):2398-2403
OBJECTIVE To systematically evaluate the efficacy and safety of oral Janus kinase (JAK) inhibitor in the treatment of alopecia areata (AA)in order to provide evidence -based reference for clinical use . METHODS PubMed,Embase, Web of Science ,the Cochrane Library ,CNKI,Wanfang and CBM were searched from the inception to March 29,2022. Randomized controlled trials (RCTs)of oral JAK inhibitors (trial group )versus placebo (control group )in the treatment of AA were collected . Two researchers independently screened the literature ,extracted the data ,and evaluated the quality of the included studies. RevMan 5.4 software was used for meta -analysis and analysis of publication bias . RESULTS A total of 2 170 patients were enrolled in 5 RCTs,including 1 619 in the trial group and 551 in the control group . Meta-analysis results showed that :compared with control group ,the ratio of the patients with the Severity Alopecia Tool (SALT)score ≤20 at 24th week [RR=6.10,95%CI (3.86,9.63),P<0.000 01] and 36th week [RR=6.59,95%CI(4.16,10.43),P<0.000 01] were both higher ;Hospital Anxiety and Depression Scale -Anxiety (HADS-A) score [RR=0.35, 95%CI (0.07,0.64),P=0.02] and Hospital Anxiety and 1009) Depression Scale -Depression (HADS-D) score [RR=0.50, 95%CI(0.22,0.77),P=0.000 4] were more decreased at 24th week . HADS-A score [RR=0.55,95%CI(0.21,0.89), 话:0371-66913047。 P=0.001] and HADS -D score [RR=0.50, 95%CI (0.16,0.84),P=0.004] were also significantly decreased at 36th week . The incidence of acne [RR=4.07,95%CI(1.83,9.08),P=0.000 6] and low density lipoprotein (LDL)elevation [RR=1.66,95%CI(1.21,2.28),P=0.002] in trial group were incr eased significantly (P<0.05). There were no significant differences in the incidence of urinary tract infection,upper respiratory tract infection , headache,nasopharyngitis and creatine phosphokinase elevation between 2 groups (P>0.05). There was little possibility of publication bias in this study based on the publication bias analysis . CONCLUSIONS Oral JAK inhibitor can significantly improve AA patients ’hair regrowth ,anxiety and depression . Acne and LDL elevation are the main adverse events .

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