1.Effects of Total Intravenous Anesthesia and Inhalational Anesthesia on Postoperative Recovery in Patients Undergoing Transsphenoidal Pituitary Surgery:A Systematic Review.
Yun-Ying FENG ; Yu-Pei ZHANG ; Yue-Lun ZHANG ; Bing XING ; Wei LIAN ; Xiao-Peng GUO ; Lu-Lu MA ; Yu-Guang HUANG
Acta Academiae Medicinae Sinicae 2025;47(3):434-440
Objective To systematically evaluate the effects of total intravenous anesthesia and inhalational anesthesia on postoperative recovery in patients undergoing transsphenoidal pituitary tumor resection.Methods A comprehensive search was conducted in international biomedical databases including Ovid Medline,Embase,CINAHL(EBSCO),Cochrane Library,and Web of Science,from inception to July 4,2023.Additionally,ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing and completed trials.The randomized controlled trials(RCT)comparing total intravenous anesthesia and inhalational anesthesia in patients undergoing transsphenoidal surgery for pituitary tumors were included.The methodological quality of the included studies was evaluated by the Cochrane Collaboration tool.Relevant data were extracted and synthesized for analysis.Results A total of 327 records were identified,of which eight RCTs met the inclusion criteria.Four studies showed that the patients receiving desflurane or sevoflurane anesthesia experienced faster emergence from anesthesia than those receiving propofol.Two studies indicated that patients in the propofol group had lower levels of emergence agitation and a lower incidence of early postoperative nausea and vomiting.The results on postoperative cognitive function were inconsistent across studies.No differences were found between the groups in terms of postoperative complications or overall recovery quality during hospitalization.Conclusions Inhalational anesthesia appears to provide an advantage in promoting faster emergence following transsphenoidal pituitary surgery,whereas total intravenous anesthesia may contribute to smoother and more stable recovery.Further high-quality studies are needed to clarify the effects of different anesthetic techniques on both short- and long-term postoperative recovery.
Humans
;
Anesthesia, Intravenous
;
Pituitary Neoplasms/surgery*
;
Anesthesia, Inhalation
;
Randomized Controlled Trials as Topic
;
Anesthesia Recovery Period
;
Pituitary Gland/surgery*
;
Postoperative Period
2.Clinical Analysis of Bloodstream Infection after Hematopoietic Stem Cell Transplantation.
Ying-Ying WU ; Bei-Cai LIU ; Lian-Jin LIU ; Shi-Si YUAN ; Jie-Min WEI ; Li-Lin WANG ; Pei-Xi WANG ; Ji-Cong LIU ; Yong-Rong LAI ; Qiao-Chuan LI
Journal of Experimental Hematology 2022;30(1):292-297
OBJECTIVE:
To analyze the clinical characteristics of bloodstream infection (BSI) in patients treated by hematopoietic stem cell transplantation (HSCT).
METHODS:
The clinical characteristics, distribution of pathogenic bacteria causing BSI and drug sensitivity of 910 patients treated by HSCT in our department from January 2013 to June 2020 were retrospectively analyzed.
RESULTS:
Among 910 HSCT patients, 111 patients were diagnosed as BSI within 100 days after transplantation, and 98 patients showed BSI during the period of agranulocytosis. Multivariate analysis showed that the usage of anti-thymocyte globulin (ATG), long duration of agranulocytosis and low infusion volume of mononuclear cell (MNC) were the independent risk factors affecting BSI after HSCT. Among 121 pathogenic bacteria isolated, 76 Gram-negative (G-) bacteria (62.8%), 40 Gram-positive (G+) bacteria (33.0%), and 5 fungi (4.1%) were detected out. The top three pathogens were Escherichia coli, Staphylococcus epidermidis and Pseudomonas aeruginosa. The drug-resistance rates of Escherichia coli and Klebsiella pneumoniae to carbapenems was 14.3% and 7.7%, respectively, and Pseudomonas aeruginosa was 66.7%. The susceptibility of G+ bacteria to vancomycin, linezolid and teicoplanin was 97.5%, 100% and 100%, respectively. The crude mortality rate of the patients with BSI at 100 days after HSCT was significantly higher than that of patients without BSI (P<0.001).
CONCLUSION
The usage of ATG, long duration of agranulocytosis and low infusion volume of MNC are independent risk factors for BSI after HSCT. The pathogens after HSCT are mainly G- bacteria. Pseudomonas aeruginosa is highly resistant to carbapenems. Key words ;
Bacteremia/epidemiology*
;
Bacteria
;
Hematopoietic Stem Cell Transplantation
;
Humans
;
Retrospective Studies
;
Sepsis
3.Effect of hollow lag screw combined with calcaneal locking plate in the treatment of Letenneur type III Hoffa fracture
Xuan PEI ; Guodong WANG ; Wei ZHOU ; Junhong LIAN ; Ximing LIU
Chinese Journal of Trauma 2022;38(2):130-135
Objective:To compare the clinical effect of cannulated lag screw combined with calcaneal locking plate versus cannulated lag screw in the treatment of Letenneur type III Hoffa fracture.Methods:A retrospective cohort study was performed on clinical data of 41 patients with Letenneur type III Hoffa fracture admitted to General Hospital of Central Theater Command of PLA from January 2010 to June 2020. There were 22 males and 19 females, aged 28-78 years[(51.9±1.9)years]. A total of 18 patients were treated with cannulated lag screw combined with calcaneal locking plate (plate-screw group) and 23 patients were treated with cannulated lag screw (screw group). The bed rest time, hospital time and bone healing time were compared between the two groups. Range of motion (ROM) of the knee at 3 and 6 months postoperatively, knee society score (KSS) at 3 and 6 months postoperatively and incidence of long-term complications were compared between the two groups.Results:All patients were followed up for 10-24 months[(14.5±2.1)months]. The bed rest time was (37.6±2.4)days in plate-screw group, lower than (45.2±1.6)days in screw group ( P<0.05). The hospital time was (16.7±3.7)days in plate-screw group, and (15.8±3.7)days in screw group ( P>0.05). The bone healing time was (12.2±0.9)weeks in plate-screw group and (12.7±0.7) weeks in screw group ( P>0.05). ROM of the knee at 3 and 6 months after operation was (119.9±2.9)° and (125.4±4.5)° in plate-screw group, greater than (116.6±4.5)°and (122.1±3.9)° in screw group (both P<0.05). KSS at 3 and 6 months after operation was (83.4±3.1)points and (86.2±2.5)points in plate-screw group, greater than (79.5±2.1)points and (82.2±2.2)points in screw group (both P<0.05). ROM of the knee and KSS in two groups increased significantly over time (both P<0.01). The long-term complications in plate-screw group included delayed fracture healing in 1 patient, traumatic arthritis in 1 and stiff joint in 1, showing the complication rate of 17% (3/18). The long-terem complications in screw group included internal fixation failure in 1 patient, delayed fracture healing in 2, nonunion in 1, traumatic arthritis in 2 and stiff joint in 2, showing the complication rate of 35% (8/23). The two groups had no significant difference in the complication rate ( P>0.05) .Conclusion:For Letenneur type III Hoffa fracture, cannulated lag screw fixation combined with calcaneal locking plate is superior to seperate cannulated lag screw fixation in aspects of short bed-term bed rest, early functional exercise, improved ROM and good function recovery.
4.A multicenter epidemiological study of acute bacterial meningitis in children.
Cai Yun WANG ; Hong Mei XU ; Jiao TIAN ; Si Qi HONG ; Gang LIU ; Si Xuan WANG ; Feng GAO ; Jing LIU ; Fu Rong LIU ; Hui YU ; Xia WU ; Bi Quan CHEN ; Fang Fang SHEN ; Guo ZHENG ; Jie YU ; Min SHU ; Lu LIU ; Li Jun DU ; Pei LI ; Zhi Wei XU ; Meng Quan ZHU ; Li Su HUANG ; He Yu HUANG ; Hai Bo LI ; Yuan Yuan HUANG ; Dong WANG ; Fang WU ; Song Ting BAI ; Jing Jing TANG ; Qing Wen SHAN ; Lian Cheng LAN ; Chun Hui ZHU ; Yan XIONG ; Jian Mei TIAN ; Jia Hui WU ; Jian Hua HAO ; Hui Ya ZHAO ; Ai Wei LIN ; Shuang Shuang SONG ; Dao Jiong LIN ; Qiong Hua ZHOU ; Yu Ping GUO ; Jin Zhun WU ; Xiao Qing YANG ; Xin Hua ZHANG ; Ying GUO ; Qing CAO ; Li Juan LUO ; Zhong Bin TAO ; Wen Kai YANG ; Yong Kang ZHOU ; Yuan CHEN ; Li Jie FENG ; Guo Long ZHU ; Yan Hong ZHANG ; Ping XUE ; Xiao Qin LI ; Zheng Zhen TANG ; De Hui ZHANG ; Xue Wen SU ; Zheng Hai QU ; Ying ZHANG ; Shi Yong ZHAO ; Zheng Hong QI ; Lin PANG ; Cai Ying WANG ; Hui Ling DENG ; Xing Lou LIU ; Ying Hu CHEN ; Sainan SHU
Chinese Journal of Pediatrics 2022;60(10):1045-1053
Objective: To analyze the clinical epidemiological characteristics including composition of pathogens , clinical characteristics, and disease prognosis acute bacterial meningitis (ABM) in Chinese children. Methods: A retrospective analysis was performed on the clinical and laboratory data of 1 610 children <15 years of age with ABM in 33 tertiary hospitals in China from January 2019 to December 2020. Patients were divided into different groups according to age,<28 days group, 28 days to <3 months group, 3 months to <1 year group, 1-<5 years of age group, 5-<15 years of age group; etiology confirmed group and clinically diagnosed group according to etiology diagnosis. Non-numeric variables were analyzed with the Chi-square test or Fisher's exact test, while non-normal distrituction numeric variables were compared with nonparametric test. Results: Among 1 610 children with ABM, 955 were male and 650 were female (5 cases were not provided with gender information), and the age of onset was 1.5 (0.5, 5.5) months. There were 588 cases age from <28 days, 462 cases age from 28 days to <3 months, 302 cases age from 3 months to <1 year of age group, 156 cases in the 1-<5 years of age and 101 cases in the 5-<15 years of age. The detection rates were 38.8% (95/245) and 31.5% (70/222) of Escherichia coli and 27.8% (68/245) and 35.1% (78/222) of Streptococcus agalactiae in infants younger than 28 days of age and 28 days to 3 months of age; the detection rates of Streptococcus pneumonia, Escherichia coli, and Streptococcus agalactiae were 34.3% (61/178), 14.0% (25/178) and 13.5% (24/178) in the 3 months of age to <1 year of age group; the dominant pathogens were Streptococcus pneumoniae and the detection rate were 67.9% (74/109) and 44.4% (16/36) in the 1-<5 years of age and 5-<15 years of age . There were 9.7% (19/195) strains of Escherichia coli producing ultra-broad-spectrum β-lactamases. The positive rates of cerebrospinal fluid (CSF) culture and blood culture were 32.2% (515/1 598) and 25.0% (400/1 598), while 38.2% (126/330)and 25.3% (21/83) in CSF metagenomics next generation sequencing and Streptococcus pneumoniae antigen detection. There were 4.3% (32/790) cases of which CSF white blood cell counts were normal in etiology confirmed group. Among 1 610 children with ABM, main intracranial imaging complications were subdural effusion and (or) empyema in 349 cases (21.7%), hydrocephalus in 233 cases (14.5%), brain abscess in 178 cases (11.1%), and other cerebrovascular diseases, including encephalomalacia, cerebral infarction, and encephalatrophy, in 174 cases (10.8%). Among the 166 cases (10.3%) with unfavorable outcome, 32 cases (2.0%) died among whom 24 cases died before 1 year of age, and 37 cases (2.3%) had recurrence among whom 25 cases had recurrence within 3 weeks. The incidences of subdural effusion and (or) empyema, brain abscess and ependymitis in the etiology confirmed group were significantly higher than those in the clinically diagnosed group (26.2% (207/790) vs. 17.3% (142/820), 13.0% (103/790) vs. 9.1% (75/820), 4.6% (36/790) vs. 2.7% (22/820), χ2=18.71, 6.20, 4.07, all P<0.05), but there was no significant difference in the unfavorable outcomes, mortility, and recurrence between these 2 groups (all P>0.05). Conclusions: The onset age of ABM in children is usually within 1 year of age, especially <3 months. The common pathogens in infants <3 months of age are Escherichia coli and Streptococcus agalactiae, and the dominant pathogen in infant ≥3 months is Streptococcus pneumoniae. Subdural effusion and (or) empyema and hydrocephalus are common complications. ABM should not be excluded even if CSF white blood cell counts is within normal range. Standardized bacteriological examination should be paid more attention to increase the pathogenic detection rate. Non-culture CSF detection methods may facilitate the pathogenic diagnosis.
Adolescent
;
Brain Abscess
;
Child
;
Child, Preschool
;
Escherichia coli
;
Female
;
Humans
;
Hydrocephalus
;
Infant
;
Infant, Newborn
;
Male
;
Meningitis, Bacterial/epidemiology*
;
Retrospective Studies
;
Streptococcus agalactiae
;
Streptococcus pneumoniae
;
Subdural Effusion
;
beta-Lactamases
5.A follow-up study on the introduction of vegetables and fruits during infants aged 4-8 months in Beijing and Chenzhou City of Hunan Province.
Pin LI ; Ai ZHAO ; Wei WU ; Jian ZHANG ; Pei Yu WANG ; Hang Lian LAN ; Yu Mei ZHANG
Journal of Peking University(Health Sciences) 2022;54(3):526-531
OBJECTIVE:
To investigate the introduction of vegetables and fruits in 4-8 months old infants, and to describe the maternal and infants' characteristics associated with the introduction of vegetables and fruits.
METHODS:
Mother-infant dyads (n=228) were recruited from 12 to 16 weeks postpartum and formally entered the study at 4 months of age. Data collected via face to face interview at 4-8 months postpartum, including the timing and types of added vegetables and fruits, as well as a variety of maternal and infant characteristics (n=204). Rank sum test and multiple linear regression were used to analyze the maternal and infant characteristics related to the introduction of vegetables and fruits.
RESULTS:
The time of introducing vegetables was concentrated at the age of 7 months, and the time of adding fruits was mainly at 6 months. Fruits were added earlier than vegetables (P < 0.001), and the variety of the added fruits was higher than that of vegetables (P=0.045). 48% (n=98) of infants had no more than three types of fruits and vegetables at 8 months. Only 9.8% (n=20) had added more than 10 kinds of fruits and vegetables at 8 months. Green leafy vegetables were the most commonly added vegetable, and apple was the most popular fruit. Compared with women who were 35 years of age or younger, women beyond 35 years old introduced vegetables to their babies 0.6 months later. 4-month-old exclusively breastfed infants had vegetables 0.4 months later than mixed-fed infants. Women with a bachelor's degree or above added 2-3 more types of fruits and vegetables to their babies than those with junior high school education and below.
CONCLUSION
The adding time of fruits was earlier than that of vegetable. Apples and green leafy vegetables are commonly added. Women with lower educational backgrounds add fewer types of fruits and vegetables to their babies. Mothers who choose exclusive breastfeeding and those over 35 years of age at childbirth add vegetables to their babies later than others. They should be targeted for health promotion programs that aim to improve the intake of fruits and vegetables among infants.
Adult
;
Beijing
;
Breast Feeding
;
Female
;
Follow-Up Studies
;
Fruit
;
Humans
;
Infant
;
Infant, Newborn
;
Vegetables
6.An analysis on senior pupil's tobacco use and exposure in Shandong province in 2012 and 2019.
Xia WEI ; Yan LENG ; Tong SUN ; Jia Xiang HOU ; Lian Sen WANG ; Ting LIU ; Rui LI ; Pei Jing ZHOU ; Yong Juan LIU ; Dian Min KANG
Chinese Journal of Epidemiology 2022;43(5):681-685
Objective: To analyze the changes in tobacco use and exposure in primary school students in Shandong province in 2012 and 2019. Methods: A multi-stage stratified cluster random sampling method was used in the survey. In 2012 and 2019, 5 861 and 4 021 students from 3 different cities of Shandong province were selected as the study population. The questionnaire was filled anonymously by the subjects. χ2 test was conducted to compare the difference of groups. Results: In 2012 and 2019, the rate of attempting smoking among pupils under this study in Shandong province were 6.0%and 6.3%, respectively, while the current smoking rate were 1.2%and 2.3%, respectively. The sex ratio of male and female students attempting to smoke was 2.56∶1 in 2012 and 1.31∶1 in 2019. The sex ratio of current smoking rate was 2.43∶1 and 2.00∶1, respectively in 2012 and in 2019. The rate of tobacco exposure in the public places was 50.5%and 41.4%, respectively. The rate of tobacco exposure in family was 49.7% and 46.4%, respectively. Two rates of tobacco exposure decreased, but the reduction in family (3.3%) was far less than that in public places (9.1%). In 2019, the rate of tobacco exposure in family was higher than that in public places. Conclusions: The tobacco exposure rate declined in senior pupils in Shandong province. However, the situation is still grim for the current smoking rate, growth trend of girls tobacco use, and tobacco exposure in family.
Cities
;
Environment
;
Female
;
Humans
;
Male
;
Prevalence
;
Students
;
Surveys and Questionnaires
;
Tobacco Smoke Pollution
;
Tobacco Use/epidemiology*
7.Identification of traditional Chinese drugs containing active ingredients for treating myocardial infarction and analysis of their therapeutic mechanisms by network pharmacology and molecular docking.
Shi ZHAO ; Ke Di LIU ; Jia Lin DUAN ; Xing Ru TAO ; Wei Hong LI ; Yang BAI ; Pei Feng WEI ; Miao Miao XI ; Hong Lian YANG
Journal of Southern Medical University 2022;42(1):13-25
OBJECTIVE:
To identify traditional Chinese drugs that contain active ingredients for treatment of myocardial infarction (MI) and explore their therapeutic mechanisms using network pharmacology and molecular docking technology.
METHODS:
The TCMSP database was used for screening the traditional Chinese drugs containing active ingredients for treating MI, and the related targets of MI and the candidate drugs were obtained from Genecards, OMIM, PharmGkb and PharmMapper databases. The common target network of the drug targets and disease targets was established using Venny2.1.0 software. GO and KEGG signal pathway enrichment analysis of the common targets was performed, and the protein-protein interaction (PPI) network was constructed for the targets. The targets in the PPI network were analyzed to identify the key targets, for which GO and KEGG pathway enrichment analyses were performed. Molecular docking was performed for the candidate ingredients and the key targets, and a total score ≥6 was used as the criteria for screening the therapeutic ingredients and their docking binding with key targets was verified. A human umbilical vein endothelial cell (HUVEC) model of oxygen-glucose deprivation (OGD) was used to validate the candidate ingredients and the key therapeutic targets for MI by Western blotting.
RESULTS:
Our analysis identified Salvia miltiorrhiza and Dalbergiae odoriferae as the candidate drugs rich in active ingredients for treatment of MI. These ingredients involved 16 key therapeutic targets for MI, which participated in such biological processes as inflammatory response, angiogenesis, energy metabolism and oxidative stress and the pathways including HIF-1, VEGF, and TNF pathways. Sclareol and PTGS2 in Salvia miltiorrhiza and formononetin and KDR in Dalbergiae odoriferae all had high docking total scores. Western blotting showed that at medium and high doses, sclareol significantly inhibited PTGS2 expression and formononetin promoted KDR expressions in the cell models in a dose-dependent manner (P < 0.05).
CONCLUSION
Both Salvia miltiorrhiza and Dalbergiae odoriferae have good therapeutic effects on MI. Sclareol in Salvia miltiorrhiza and formononetin in Dalbergiae odoriferae regulate the expressions of KDR and PTGS2, respectively, to modulate the inflammatory response, angiogenesis, oxidative stress and energy metabolism and thus produce myocardial protective effects.
China
;
Drugs, Chinese Herbal/therapeutic use*
;
Humans
;
Medicine, Chinese Traditional
;
Molecular Docking Simulation
;
Myocardial Infarction/drug therapy*
;
Network Pharmacology
8.Functional improvement after inpatient rehabilitation in community hospitals following acute hospital care.
Htet Lin HTUN ; Lok Hang WONG ; Weixiang LIAN ; Jocelyn KOH ; Liang Tee LEE ; Jun Pei LIM ; Ian LEONG ; Wei Yen LIM
Annals of the Academy of Medicine, Singapore 2022;51(6):357-369
INTRODUCTION:
There are limited studies exploring functional improvement in relation to characteristics of patients who, following acute hospital care, receive inpatient rehabilitation in community hospitals. We evaluated the association of acute hospital admission-related factors with functional improvement on community hospital discharge.
METHODS:
We conducted a retrospective cohort study among patients who were transferred to community hospitals within 14-day post-discharge from acute hospital between 2016 and 2018. Modified Barthel Index (MBI) on a 100-point ordinal scale was used to assess functional status on admission to and discharge from the community hospital. We categorised MBI into 6 bands: 0-24, 25-49, 50-74, 75-90, 91-99 and 100. Multivariable logistic regression models were constructed to determine factors associated with categorical improvement in functional status, defined as an increase in at least one MBI band between admission and discharge.
RESULTS:
A total of 5,641 patients (median age 77 years, interquartile range 69-84; 44.2% men) were included for analysis. After adjusting for potential confounders, factors associated with functional improvement were younger age, a higher MBI on admission, and musculoskeletal diagnosis for the acute hospital admission episode. In contrast, a history of dementia or stroke; lower estimated glomerular filtration rate; abnormal serum albumin or anaemia measured during the acute hospital episode; and diagnoses of stroke, cardiac disease, malignancy, falls or pneumonia; and other chronic respiratory diseases were associated with lower odds of functional improvement.
CONCLUSION
Clinicians may want to take into account the presence of these high-risk factors in their patients when planning rehabilitation programmes, in order to maximise the likelihood of functional improvement.
Aftercare
;
Aged
;
Female
;
Hospitals, Community
;
Humans
;
Inpatients
;
Male
;
Patient Discharge
;
Retrospective Studies
;
Stroke/complications*
;
Stroke Rehabilitation
9.Consensus on clinical management of tumor-induced osteomalacia.
Yan JIANG ; Xiang LI ; Li HUO ; Yong LIU ; Wei LYU ; Lian ZHOU ; Wei YU ; Huan-Wen WU ; Xiao-Ping XING ; Mei LI ; Ou WANG ; Yue CHI ; Rui-Zhi JIAJUE ; Yu PEI ; Jian-Min LIU ; Jian-Ming BA ; Qiao ZHANG ; Zhi-Feng SHENG ; Zhen-Lin ZHANG ; Jia-Jun ZHAO ; Salvatore MINISOLA ; Wei-Bo XIA
Chinese Medical Journal 2021;134(11):1264-1266
10.Bendamustine treatment of Chinese patients with relapsed indolent non-Hodgkin lymphoma: a multicenter, open-label, single-arm, phase 3 study.
Yuan-Kai SHI ; Xiao-Nan HONG ; Jian-Liang YANG ; Wei XU ; Hui-Qiang HUANG ; Xiu-Bin XIAO ; Jun ZHU ; Dao-Bin ZHOU ; Xiao-Hong HAN ; Jian-Qiu WU ; Ming-Zhi ZHANG ; Jie JIN ; Xiao-Yan KE ; Wei LI ; De-Pei WU ; Shen-Miao YANG ; Xin DU ; Yong-Qian JIA ; Ai-Chun LIU ; Dai-Hong LIU ; Zhi-Xiang SHEN ; Lian-Sheng ZHANG ; Leonard JAMES ; Edward HELLRIEGEL
Chinese Medical Journal 2021;134(11):1299-1309
BACKGROUND:
Bendamustine was approved in China on May 26th, 2019 by the National Medical Product Administration for the treatment of indolent B-cell non-Hodgkin lymphoma (NHL). The current study was the registration trial and the first reported evaluation of the efficacy, safety, and pharmacokinetics of bendamustine in Chinese adult patients with indolent B-cell NHL following relapse after chemotherapy and rituximab treatment.
METHODS:
This was a prospective, multicenter, open-label, single-arm, phase 3 study (NCT01596621; C18083/3076) with a 2-year follow-up period. Eligible patients received bendamustine hydrochloride 120 mg/m2 infused intravenously on days 1 and 2 of each 21-day treatment cycle for at least six planned cycles (and up to eight cycles). The primary endpoint was the overall response rate (ORR); and secondary endpoints were duration of response (DoR), progression-free survival (PFS), safety, and pharmacokinetics. Patients were classified according to their best overall response after initiation of therapy. Proportions of patients in each response category (complete response [CR], partial response [PR], stable disease, or progressive disease) were summarized along with a two-sided binomial exact 95% confidence intervals (CIs) for the ORR.
RESULTS:
A total of 102 patients were enrolled from 20 centers between August 6th, 2012, and June 18th, 2015. At the time of the primary analysis, the ORR was 73% (95% CI: 63%-81%) per Independent Review Committee (IRC) including 19% CR and 54% PR. With the follow-up period, the median DoR was 16.2 months by IRC and 13.4 months by investigator assessment; the median PFS was 18.6 months and 15.3 months, respectively. The most common non-hematologic adverse events (AEs) were gastrointestinal toxicity, pyrexia, and rash. Grade 3/4 neutropenia was reported in 76% of patients. Serious AEs were reported in 29 patients and five patients died during the study. Pharmacokinetic analysis indicated that the characteristics of bendamustine and its metabolites M3 and M4 were generally consistent with those reported for other ethnicities.
CONCLUSION:
Bendamustine is an active and effective therapy in Chinese patients with relapsed, indolent B-cell NHL, with a comparable risk/benefit relationship to that reported in North American patients.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, No. NCT01596621; https://clinicaltrials.gov/ct2/show/NCT01596621.
Adult
;
Antineoplastic Combined Chemotherapy Protocols
;
Bendamustine Hydrochloride/therapeutic use*
;
China
;
Humans
;
Lymphoma, Non-Hodgkin/drug therapy*
;
Neoplasm Recurrence, Local/drug therapy*
;
Prospective Studies
;
Rituximab/therapeutic use*

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