1.Establishment of patent ductus arteriosus model in Bama miniature pigs using autogenous jugular vein
Jian LI ; Wenchao LI ; Fengwen ZHANG ; Donglin ZHUANG ; Peijian WEI ; Hang LI ; Min ZHANG ; Wenbin OUYANG ; Xiangbin PAN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(12):1832-1837
Objective To explore the method and feasibility of establishing patent ductus arteriosus (PDA) model in Bama miniature pig by using autologous jugular vein, and to provide a large animal model for the development of PDA occluder and the study of pulmonary hypertension associated with congenital heart disease. Methods Five male Bama miniature pigs weighing about 45 kg were selected to gain the PDA model of the autogenous jugular vein, which was fixed by glutaraldehyde and anastomosed between the ascending aorta and the main pulmonary artery. The patency of PDA was confirmed by echocardiography and angiocardiography immediately and one week after the operation. Two animals were selected to undergo transcatheter closure of PDA via femoral vein 1 week after the operation, and the rest were euthanized to obtain PDA and lung tissue for pathological examination. Results The PDA model was successfully established in all five animals with a success rate of 100.0%. Immediately and 1 week after the operation, echocardiography and angiography showed that PDA blood flow was unobstructed, and hematoxylin-eosin staining showed that PDA endothelialization was good. One week after the operation, two animals were successfully treated with transcatheter femoral vein occlusion. The pathological examination of lung tissue showed thickening of the intima and muscular layer of pulmonary arterioles, thickening of pulmonary interstitium and infiltration of neutrophils. Conclusion It is safe and feasible to establish a large animal model of PDA by using autogenous jugular vein anastomosis between the ascending aorta and the main pulmonary artery. The model can be used for the development of PDA interventional occlusive devices and the pathophysiological study of congenital heart disease-related pulmonary hypertension.
2.Application of flat-sided culture tubes during prenatal diagnosis.
Tiansheng LIU ; Hongqian HUANG ; Jiangyu SU ; Wangshang QIN ; Dongmei FEI ; Luping OUYANG ; Minpan HUANG ; Jinwu YU ; Yaqin LEI ; Shan OU ; Weijia SUN ; Qingming QIU ; Qian ZHENG
Chinese Journal of Medical Genetics 2023;40(10):1306-1311
OBJECTIVE:
To assess the value of using flat-sided culture tubes for preparing chromosomes through chorionic villi (CV) and amniotic fluid (AF) cell cultures during prenatal diagnosis.
METHODS:
From February to March 2020, 157 CV samples and 147 AF samples subjected to prenatal diagnosis at the Maternal and Child Health Care Hospital of Guangxi Zhuang Autonomous Region were selected as the study subjects. For each sample, one flat-sided tube and one flask culture were set up by following the standard protocols. The methods were evaluated by comparing the cell growth, experimental process, quality of chromosome preparation and costs.
RESULTS:
The success rates for the culturing of CV and AF samples by the flat-sided culture tube method were 97.45% (153/157) and 97.96% (144/147), respectively. By contrast, the success rates for the conventional flask method were 98.72% (155/157) for CV and 98.64% (145/147) for AF samples. No significant difference was found between the two methods (P > 0.05). The average harvest time required by the flat-sided culture tube method was 8.45 days for CV and 9.43 days for AF cultures, whilst the average harvest time for conventional flask method was 9.05 days and 9.54 days, respectively. The flat-sided culture tube method for CV had required significantly shorter average harvest time than the conventional method (P < 0.001). No statistical significant difference was found in the average harvest time for AF by the two methods (P > 0.05). The conventional culturing method had required three containers with two sample transfers. By contrast, the flat-sided culture tube method was carried out in one tube without any sample transfer. The average total amount of medium used was 3.91 mL for each flat-sided culture tube and 6.26 mL for each conventional flask.
CONCLUSION
The flat-sided culture tube method can provide a simple, cost-effective and error-reducing procedure for the CV and AF samples culture during prenatal diagnosis.
Child
;
Female
;
Pregnancy
;
Humans
;
China
;
Prenatal Diagnosis
;
Chorionic Villi Sampling
;
Amniotic Fluid
;
Cell Proliferation
3.Performance evaluation of serum progesterone measurement by ID-LC/MS/MS candidate reference methods and their clinical application value
Fen OUYANG ; Qiaoxuan ZHANG ; Jun YAN ; Liqiao HAN ; Jianbing WANG ; Peifeng KE ; Junhua ZHUANG ; Xianzhang HUANG
Chinese Journal of Laboratory Medicine 2022;45(5):456-462
Objective:To establish a candidate reference method for serum progesterone using isotope dilution liquid chromatography tandem mass spectrometry (ID-LC/MS/MS) in our laboratory, validate the analytic performance of five clinical routine detection systems to explore the comparability of serum progesterone detection by different detection systems.Methods:A candidate reference method for serum progesterone using ID-LC/MS/MS method was established. The sample was pretreated by liquid-liquid extraction method, and the reversed phase liquid phase separation in positive ion mass spectrometry mode was used to detect progesterone in human serum, and the detection time of a single sample was controlled within 5 minutes by gradient elution. In order to improve the accuracy of the method, the bracketing calibration method (BCM) was used to establish the standard curve. The sensitivity, accuracy, precision and specificity of BCM and classical calibration curve method were evaluated according to CLSI C62-A, EP15-A2, EP6-A2 and EP9-A3, and the analytical performance and comparability of five clinical routine progesterone detection systems were evaluated,compared with ID-LC/MS/MS method, the bias at medical decision level 2 and 25 ng/ml was evaluated to see if they were <1/2TEa (12.5%).Results:The limit of detection (LOD) of ID-LC/MS/MS was 0.005 ng/ml. The recoveries of BCM method and classical calibration curve method are 97.95%-101.58% and 96.88%-110.70%, respectively. The measurement results of BCM method for certified reference materials are within its declared uncertainty range. The intra-and inter-assay coefficient of variation ( CV) of BCM method was less than 3.0%, which was better than that of classical calibration curve method ( CV: 2.48%-9.33%). The precision and linear range of the five clinical routine detection systems can meet the detection requirements. The measurement bias of detection system 1, 3 and 5 at 25 ng/ml of medical decision level was less than 1/2TEa, and the measurement bias at 2 ng/ml of medical decision level was more than 1/2TEa. The measurement bias of detection system 2 and 4 at two medical decision levels was less than 1/2TEa. Conclusion:The candidate reference method for serum progesterone ID-LC/MS/MS established in our laboratory meets the requirements of the reference method. BCM has better detection performance than classical calibration curve method. The precision and linearity of the five progesterone clinical detection systems are satisfactory. The five clinical detection systems could meet the clinical requirements at the medical determination level of 25 ng/ml, however, only two of the five clinical detection systems meet the clinical requirements at the medical determination level of 2 ng/ml.
4.Comparison of performance of two prenatal diagnostic techniques for the detection of chromosomal mosaicisms in amniocytes.
Weijia SUN ; Jiasun SU ; Tiansheng LIU ; Hongqian HUANG ; Luping OUYANG ; Linlin WANG ; Jiao LI ; Jingsi LUO
Chinese Journal of Medical Genetics 2022;39(8):842-847
OBJECTIVE:
To assess the value of chromosomal karyotyping analysis and single nucleotide polymorphism-based microarray (SNP-array) for the detection of chromosomal mosaicisms in amniotic fluid samples.
METHODS:
Seventy four pregnant women with fetal mosaicisms detected by both methods were retrospectively analyzed.
RESULTS:
Among the 74 mosaicisms, 12 were pseudo and 62 were true mosaicisms, which included 1 Robertsonian translocation, 3 deletions, 4 supernumerary markers, 19 autosomal aneuploidy mosaicisms, 30 sex chromosome aneuploidy mosaicisms and 5 isometric chromosome mosaicisms.
CONCLUSION
Chromosome karyotyping analysis and SNP-array have their own advantages and limitations for the diagnosis of mosaicisms. When the two methods have yielded inconsistent results, fluorescence in situ hybridization may be used for further verification.
Aneuploidy
;
Chromosome Aberrations
;
Female
;
Humans
;
In Situ Hybridization, Fluorescence
;
Mosaicism
;
Pregnancy
;
Prenatal Diagnosis/methods*
;
Retrospective Studies
;
Sex Chromosome Aberrations
5.Application value of a new internal cold circulation bipolar radio frequency device in open hepatectomy
Yanzhao ZHOU ; Zhengzheng WANG ; Xun CHEN ; Ruili ZHU ; Jingzhong OUYANG ; Qingjun LI ; Hao ZHUANG ; Jinxue ZHOU
Chinese Journal of Digestive Surgery 2021;20(8):898-905
Objective:To investigate the application value of a new internal cold circula-tion bipolar radio frequency device in open hepatectomy.Methods:The retrospective cohort study was conducted. The clinical data of 85 patients with hepatocellular carcinoma who underwent open hepatectomy at the Affiliated Tumor Hospital of Zhengzhou University from February 2017 to January 2020 were collected. There were 48 males and 37 females, aged from 32 to 74 years, with a median age of 52 years. Of 85 patients, 45 cases undergoing hepatectomy assisted by the new internal cold circulation bipolar radio frequency device were allocated into new internal cold circulation bipolar radio frequency device group, and 40 cases undergoing hepatectomy assisted by Habib-4X bipolar radio frequency device were allocated into Habib-4X group, respectively. Observation indicators: (1) intraoperative situations; (2) postoperative situations; (3) follow-up. Follow-up was conducted by outpatient, inpatient reexamination and telephone interview to detect the postoperative complications and death of patient within postoperative 30 days up to May 2020. Measurement data with normal distribution were represented as Mean± SD, and independent sample t test was used for comparison between groups. Measurement data with skewed distribution were expressed as M(range), and nonparametric Mann-Whitney U test was used for comparison between groups. Count data were represented as absolute numbers, and comparison between groups was analyzed using the chi-square test or Fisher exact probability. Repeated measurement data were anlyzed by the repeated ANOVA. Results:(1) Intraoperative situations: the time of crosscutting process for liver parenchyma, average area transection speed, coagulation tissue width, cases with needle bleeding rate and electrode needle charring were (55±16)minutes, (4.8±1.2)cm 2/minute, (1.4±0.2)cm, 6, 10 for the new internal cold circulation bipolar radio frequency device group, versus (64±15)minutes, (3.6±1.0)cm 2/minute, (1.8±0.2)cm, 14, 25 for the Habib-4X group, respectively, showing significant differences in the above indicators between the two groups ( t=2.665, 4.973, 9.204, χ2=5.525, 14.184, P<0.05). (2) Postoperative situations: for the new internal cold circulation bipolar radio frequency device group, the total bilirubin (TBil) was (20±12)μmol/L, (25±12)μmol/L, (20±14)μmol/L at postoperative 1, 3, 7 days, the prothrombin time (PT) was (15.4±2.2)seconds, (14.2±2.1)seconds, (12.7±0.8)seconds, the alanine aminotransferase (ALT) was (288±248)IU/L, (132±61)IU/L, (67±32)IU/L, the aspartate aminotransferase (AST) was (279±114)IU/L, (50±22)IU/L, (30±13)IU/L. For the Habib-4X group, the TBil was 1(22±15)μmol/L, (23±10)μmol/L, (19±8)μmol/L at postoperative 1, 3, 7 days, PT was (15.8±2.8)seconds, (14.3±2.0)seconds, (13.6±1.3)seconds, the ALT was (369±269)IU/L, (133±99)IU/L, (54±30)IU/L, the AST was (345±125)IU/L, (60±36)IU/L, (32±11)IU/L. There were significant differences in the time effect of PT, ALT, AST between the two groups ( F=18.364, 23.020, 93.786, P<0.05). There was no significant difference in the time effect, between-group effect, interaction effect of TBil or between-group effect, interaction effect of PT, ALT, AST between the two groups ( F=2.421, 1.424, 0.522, 1.593, 0.312, 0.121, 0.267, 1.027, 0.600, P>0.05). (3) Follow-up: 85 patients were followed up for 4 to 39 months, with a median follow-up time of 16 months. There were 5 patients in the new internal cooling circulation bipolar radiofrequency device group and 8 patients in the Habib-4X group with complications, respectively, showing no significant difference in overall complications between the two groups ( χ2=1.292, P>0.05). The number of deaths in the new internal cooling circulation bipolar radio frequency device group and Habib-4X group was 0 and 1, respectively, showing no significant difference between the two groups ( P>0.05). Conclusion:The new internal cold-circulating bipolar radio frequency device for open hepatectomy is safe and effective, which cuts the liver parenchyma faster, has lower carbonization rate at the tip of electrode needle, and has more accurate coagulation range.
6. Analysis on efficacy and safety of total neoadjuvant therapy in patients with locally advanced rectal cancer with high risk factors
Ganlu OUYANG ; Wenjian MENG ; Pei SHU ; Xiangbing DENG ; Bing WU ; Dan JIANG ; Hua ZHUANG ; Yali SHEN ; Zongguang ZHOU ; Ziqiang WANG ; Xin WANG
Chinese Journal of Gastrointestinal Surgery 2019;22(4):349-356
Objective:
To evaluate the safety and preliminary efficacy of total neoadjuvant therapy (TNT) in patients with locally advanced rectal cancer (LARC) with high risk factors.
Methods:
Data of 101 patients who were diagnosed with stage II-III rectal cancer with high risk factors and received TNT between March 2015 and January 2018 at West China Hospital of Sichuan University were analyzed retrospectively. Inclusion criteria: (1) patients were diagnosed with stage II-III rectal cancer by high-resolution MRI combined with CT and endorectal ultrasound; (2) at least one high risk factor: cT4a, cT4b, cN2, EMVI+, CRM+ and lateral lymph node+; (3) distance from tumor to anal verge was within 15 cm; (4) Eastern Collaborative Oncology Group (ECOG) performance status score was 0-1; bone marrow function, liver function and kidney function were suitable for chemoradiotherapy; (5) patients were treated with TNT strategy; (6) the follow-up data and postoperative pathological data were complete. Patients with previous rectal cancer surgery (except prophylactic colostomy), pelvic radiotherapy, and systemic chemotherapy, those with distant metastases, those without neoadjuvant radiotherapy, those receiving less than 4 cycles of neoadjuvant chemotherapy were excluded. The regimen of TNT: 3 cycles of induction CAPOX (oxaliplatin plus capecitabine) were followed by pelvic radiotherapy and concurrent CAPOX, then 3 cycles of consolidation CAPOX were delivered after radiotherapy. Total mesorectal resection (TME) or watch-and-wait strategy was selected according to the therapeutic effect and patients' wishes. Short-term efficacy, including tumor regression grade (TRG), pathological complete response (pCR), clinical complete response (cCR), postoperative complications within 30 days of surgery, and adverse events (AE) to radiotherapy and chemotherapy (measured using CTCAE 4.0) was analyzed.
Results:
The 101 patients included 68 males (67.3%) and 33 females (32.7%) with a median age of 54 years. The proportion of patients with cT4a, cT4b, cN2 and enlarged lateral lymph node was 13.9%, 29.7%, 56.4% and 43.6%, respectively. The mean cycle of neoadjuvant chemotherapy was 6.0±1.3. Seventy-five patients (74.3%) received at least 6 cycles of neoadjuvant chemotherapy and 100 (99.0%) completed radiotherapy. The mean cycle of induction and consolidation chemotherapy was 2.0±0.9 and 2.8±1.0 respectively. Most common grade 3 AE was leucopenia (
7.Effect of Quercetin on Apoptosis of Platelets and Its Mechanism.
Qian XIAO ; Xiong-Yan CHEN ; Qing OUYANG ; Li-Xing JIANG ; Yi-Qian WU ; Yan-Fang JIANG
Journal of Experimental Hematology 2019;27(5):1612-1616
OBJECTIVE:
To investigate the effects of quercetin on the apoptosis of platelets and to analyze the intrinsic mechanism.
METHODS:
Firstly, the effects of quecetin on the apoptosis of platelets was detected by flow cytometry. Secondly, Western blot was used to detect the expression of apoptosis-related proteins in the platelets treated with quercetin for 2 and 4 day.
RESULTS:
By flow cytometry, it was found that the apoptosis of platelets in the quercetin-treated group (2, 4 and 8 μmol/L) was inhibited, the apoptosis rate of platelets in 2, 4 and 8 μmol/L quercetin group was 3.12%±0.32%, 2.89%±0.15% and 2.31%±0.28%, respectively, which were signigicantly lover than that in control group (P<0.01). With the increase of quecetin concentration, the proportion ratio of platelets significantly decreased in a concentration-dependent manner(r=-0.9985). Similar results were observed on the 4th day. Western blot showed that the treatment with quercetin (2, 4 and 8 μmol/L) promoted the expression of anti-apoptotic protein BCL-2, inhibited the expression of pro-apoptotic protein BAX, resulting in a significant increase in the ratio of BCL-2/BAX (P<0.01), thereby inhibiting the apoptosis of platelets. Similar results were observed on the 4th day.
CONCLUSION
Quercetin can inhibit platelet apoptosis by increasing the ratio of apoptosis-related protein BCL-2/BAX in a concentration-dependent manner.
Apoptosis
;
Apoptosis Regulatory Proteins
;
Blood Platelets
;
Quercetin
8.Analysis on efficacy and safety of total neoadjuvant therapy in patients with locally advanced rectal cancer with high risk factors
Ganlu OUYANG ; Wenjian MENG ; Pei SHU ; Xiangbing DENG ; Bing WU ; Dan JIANG ; Hua ZHUANG ; Yali SHEN ; Zongguang ZHOU ; Ziqiang WANG ; Xin WANG
Chinese Journal of Gastrointestinal Surgery 2019;22(4):349-356
Objective To evaluate the safety and preliminary efficacy of total neoadjuvant therapy (TNT) in patients with locally advanced rectal cancer (LARC) with high risk factors. Methods Data of 101 patients who were diagnosed with stage II?III rectal cancer with high risk factors and received TNT between March 2015 and January 2018 at West China Hospital of Sichuan University were analyzed retrospectively. Inclusion criteria: (1) patients were diagnosed with stage II?III rectal cancer by high?resolution MRI combined with CT and endorectal ultrasound; (2) at least one high risk factor: cT4a, cT4b, cN2, EMVI+, CRM+and lateral lymph node+; (3) distance from tumor to anal verge was within 15 cm;(4) Eastern Collaborative Oncology Group (ECOG) performance status score was 0?1; bone marrow function, liver function and kidney function were suitable for chemoradiotherapy; (5) patients were treated with TNT strategy; (6) the follow?up data and postoperative pathological data were complete. Patients with previous rectal cancer surgery (except prophylactic colostomy), pelvic radiotherapy, and systemic chemotherapy, those with distant metastases, those without neoadjuvant radiotherapy, those receiving less than 4 cycles of neoadjuvant chemotherapy were excluded. The regimen of TNT: 3 cycles of induction CAPOX (oxaliplatin plus capecitabine) were followed by pelvic radiotherapy and concurrent CAPOX, then 3 cycles of consolidation CAPOX were delivered after radiotherapy. Total mesorectal resection (TME) or watch?and?wait strategy was selected according to the therapeutic effect and patients' wishes. Short?term efficacy, including tumor regression grade (TRG), pathological complete response (pCR), clinical complete response (cCR), postoperative complications within 30 days of surgery, and adverse events (AE) to radiotherapy and chemotherapy (measured using CTCAE 4.0) was analyzed. Results The 101 patients included 68 males (67.3%) and 33 females (32.7%) with a median age of 54 years. The proportion of patients with cT4a, cT4b, cN2 and enlarged lateral lymph node was 13.9%, 29.7%, 56.4% and 43.6%, respectively. The mean cycle of neoadjuvant chemotherapy was 6.0 ± 1.3. Seventy?five patients (74.3%) received at least 6 cycles of neoadjuvant chemotherapy and 100 (99.0%) completed radiotherapy. The mean cycle of induction and consolidation chemotherapy was 2.0 ± 0.9 and 2.8 ± 1.0 respectively. Most common grade 3 AE was leucopenia (n=13, 12.9%) and thrombocytopenia (n=7, 6.9%). Grade 3 diarrhea and radiation dermatitis were observed in 5 cases (5.0%) respectively. Grade 3 anemia and rectal pain were observed in 4 cases (4.0%) respectively. And rectal mucositis was observed in 2 cases (2.0%). Most of the AE was observed during concurrent chemoradiotherapy. No grade 4 or higher AE was observed. After TNT, 32 patients (31.7%) achieved pCR or cCR, and 62 patients (60.4%) achieved partial response (PR). Only 2 patients (2.0%) developed distant metastasis after chemoradiotherapy, while the other patients did not show disease progression. Seven patients (6.9%) with cCR refused surgery and selected watch?and?wait, while 7 patients without cCR still refused surgery. The other 87 patients (86.1%) underwent TME successfully. The mean interval from the completion of chemoradiotherapy to surgery was (20.1±8.5) weeks. The R0 resection rate was 97.7% (85/87).The morbidity of surgical complication was 16.1% (14/87), including pelvic infection or abscess in 6 cases (6.9%), anastomotic leakage in 3 (3.4%), hemorrhage in 2 (2.3%), and gastrointestinal dysfunction in 3 (3.4%). Pathological findings revealed that 24 cases (27.6%) had TRG 0, 20 (23.0%) had TRG 1, 30 (34.5%) TRG 2, and 13 (14.9%) TRG 3. Conclusion TNT is safe and has good short?term efficacy for locally advanced rectal cancer patients with high risk factors.
9.Analysis on efficacy and safety of total neoadjuvant therapy in patients with locally advanced rectal cancer with high risk factors
Ganlu OUYANG ; Wenjian MENG ; Pei SHU ; Xiangbing DENG ; Bing WU ; Dan JIANG ; Hua ZHUANG ; Yali SHEN ; Zongguang ZHOU ; Ziqiang WANG ; Xin WANG
Chinese Journal of Gastrointestinal Surgery 2019;22(4):349-356
Objective To evaluate the safety and preliminary efficacy of total neoadjuvant therapy (TNT) in patients with locally advanced rectal cancer (LARC) with high risk factors. Methods Data of 101 patients who were diagnosed with stage II?III rectal cancer with high risk factors and received TNT between March 2015 and January 2018 at West China Hospital of Sichuan University were analyzed retrospectively. Inclusion criteria: (1) patients were diagnosed with stage II?III rectal cancer by high?resolution MRI combined with CT and endorectal ultrasound; (2) at least one high risk factor: cT4a, cT4b, cN2, EMVI+, CRM+and lateral lymph node+; (3) distance from tumor to anal verge was within 15 cm;(4) Eastern Collaborative Oncology Group (ECOG) performance status score was 0?1; bone marrow function, liver function and kidney function were suitable for chemoradiotherapy; (5) patients were treated with TNT strategy; (6) the follow?up data and postoperative pathological data were complete. Patients with previous rectal cancer surgery (except prophylactic colostomy), pelvic radiotherapy, and systemic chemotherapy, those with distant metastases, those without neoadjuvant radiotherapy, those receiving less than 4 cycles of neoadjuvant chemotherapy were excluded. The regimen of TNT: 3 cycles of induction CAPOX (oxaliplatin plus capecitabine) were followed by pelvic radiotherapy and concurrent CAPOX, then 3 cycles of consolidation CAPOX were delivered after radiotherapy. Total mesorectal resection (TME) or watch?and?wait strategy was selected according to the therapeutic effect and patients' wishes. Short?term efficacy, including tumor regression grade (TRG), pathological complete response (pCR), clinical complete response (cCR), postoperative complications within 30 days of surgery, and adverse events (AE) to radiotherapy and chemotherapy (measured using CTCAE 4.0) was analyzed. Results The 101 patients included 68 males (67.3%) and 33 females (32.7%) with a median age of 54 years. The proportion of patients with cT4a, cT4b, cN2 and enlarged lateral lymph node was 13.9%, 29.7%, 56.4% and 43.6%, respectively. The mean cycle of neoadjuvant chemotherapy was 6.0 ± 1.3. Seventy?five patients (74.3%) received at least 6 cycles of neoadjuvant chemotherapy and 100 (99.0%) completed radiotherapy. The mean cycle of induction and consolidation chemotherapy was 2.0 ± 0.9 and 2.8 ± 1.0 respectively. Most common grade 3 AE was leucopenia (n=13, 12.9%) and thrombocytopenia (n=7, 6.9%). Grade 3 diarrhea and radiation dermatitis were observed in 5 cases (5.0%) respectively. Grade 3 anemia and rectal pain were observed in 4 cases (4.0%) respectively. And rectal mucositis was observed in 2 cases (2.0%). Most of the AE was observed during concurrent chemoradiotherapy. No grade 4 or higher AE was observed. After TNT, 32 patients (31.7%) achieved pCR or cCR, and 62 patients (60.4%) achieved partial response (PR). Only 2 patients (2.0%) developed distant metastasis after chemoradiotherapy, while the other patients did not show disease progression. Seven patients (6.9%) with cCR refused surgery and selected watch?and?wait, while 7 patients without cCR still refused surgery. The other 87 patients (86.1%) underwent TME successfully. The mean interval from the completion of chemoradiotherapy to surgery was (20.1±8.5) weeks. The R0 resection rate was 97.7% (85/87).The morbidity of surgical complication was 16.1% (14/87), including pelvic infection or abscess in 6 cases (6.9%), anastomotic leakage in 3 (3.4%), hemorrhage in 2 (2.3%), and gastrointestinal dysfunction in 3 (3.4%). Pathological findings revealed that 24 cases (27.6%) had TRG 0, 20 (23.0%) had TRG 1, 30 (34.5%) TRG 2, and 13 (14.9%) TRG 3. Conclusion TNT is safe and has good short?term efficacy for locally advanced rectal cancer patients with high risk factors.
10.Three-year Follow-up on the Safety and Effectiveness of Rituximab Plus Chemotherapy as First-Line Treatment of Diffuse Large B-Cell Lymphoma and Follicular Lymphoma in Real-World Clinical Settings in China: A Prospective, Multicenter, Noninterventional Study.
Jian-Qiu WU ; Yong-Ping SONG ; Li-Ping SU ; Ming-Zhi ZHANG ; Wei LI ; Yu HU ; Xiao-Hong ZHANG ; Yu-Huan GAO ; Zuo-Xing NIU ; Ru FENG ; Wei WANG ; Jie-Wen PENG ; Xiao-Lin LI ; Xue-Nong OUYANG ; Chang-Ping WU ; Wei-Jing ZHANG ; Yun ZENG ; Zhen XIAO ; Ying-Min LIANG ; Yong-Zhi ZHUANG ; Ji-Shi WANG ; Zi-Min SUN ; Hai BAI ; Tong-Jian CUI ; Ji-Feng FENG
Chinese Medical Journal 2018;131(15):1767-1775
Background:
Prospective real-life data on the safety and effectiveness of rituximab in Chinese patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) are limited. This real-world study aimed to evaluate long-term safety and effectiveness outcomes of rituximab plus chemotherapy (R-chemo) as first-line treatment in Chinese patients with DLBCL or FL. Hepatitis B virus (HBV) reactivation management was also investigated.
Methods:
A prospective, multicenter, single-arm, noninterventional study of previously untreated CD20-positive DLBCL or FL patients receiving first-line R-chemo treatment at 24 centers in China was conducted between January 17, 2011 and October 31, 2016. Enrolled patients underwent safety and effectiveness assessments after the last rituximab dose and were followed up for 3 years. Effectiveness endpoints included progression-free survival (PFS) and overall survival (OS). Safety endpoints were adverse events (AEs), serious AEs, drug-related AEs, and AEs of special interest. We also reported data on the incidence of HBV reactivation.
Results:
In total, 283 previously untreated CD20-positive DLBCL and 31 FL patients from 24 centers were enrolled. Three-year PFS was 59% (95% confidence interval [CI]: 50-67%) for DLBCL patients and 46% (95% CI: 20-69%) for FL patients. For DLBCL patients, multivariate analyses showed that PFS was not associated with international prognostic index, tumor maximum diameter, HBV infection status, or number of rituximab treatment cycles, and OS was only associated with age >60 years (P < 0.05). R-chemo was well tolerated. The incidence of HBV reactivation in hepatitis B surface antigen (HBsAg)-positive and HBsAg-negative/hepatitis B core antibody-positive patients was 13% (3/24) and 4% (3/69), respectively.
Conclusions:
R-chemo is effective and safe in real-world clinical practice as first-line treatment for DLBCL and FL in China, and that HBV reactivation during R-chemo is manageable with preventive measures and treatment.
Trial Registration
ClinicalTrials.gov, NCT01340443; https://clinicaltrials.gov/ct2/show/NCT01340443.
Aged
;
Aged, 80 and over
;
Antineoplastic Combined Chemotherapy Protocols
;
therapeutic use
;
China
;
Cyclophosphamide
;
administration & dosage
;
Doxorubicin
;
administration & dosage
;
Female
;
Follow-Up Studies
;
Humans
;
Lymphoma, Follicular
;
drug therapy
;
Lymphoma, Large B-Cell, Diffuse
;
drug therapy
;
Male
;
Middle Aged
;
Prospective Studies
;
Rituximab
;
therapeutic use
;
Vincristine
;
administration & dosage

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