1.Lymph node metastasis in the prostatic anterior fat pad and prognosis after robot-assisted radical prostatectomy.
Zhou-Jie YE ; Yong SONG ; Jin-Peng SHAO ; Wen-Zheng CHEN ; Guo-Qiang YANG ; Qing-Shan DU ; Kan LIU ; Jie ZHU ; Bao-Jun WANG ; Jiang-Ping GAO ; Wei-Jun FU
National Journal of Andrology 2025;31(3):216-221
OBJECTIVE:
To investigate lymph node metastasis (LNM) in the prostatic anterior fat pad (PAFP) of PCa patients after robot-assisted radical prostatectomy (RARP), and analyze the clinicopathological features and prognosis of LNM in the PAFP.
METHODS:
We retrospectively analyzed the clinicopathological data on 1 003 cases of PCa treated by RARP in the Department of Urology of PLA General Hospital from January 2017 to December 2022. All the patients underwent routine removal of the PAFP during RARP and pathological examination, with the results of all the specimens examined and reported by pathologists. Based on the presence and locations of LNM, we grouped the patients for statistical analysis, compared the clinicopathological features between different groups using the Student's t, Mann-Whitney U and Chi-square tests, and conducted survival analyses using the Kaplan-Meier and Log-rank methods and survival curves generated by Rstudio.
RESULTS:
Lymph nodes were detected in 77 (7.7%) of the 1 003 PAFP samples, and LNM in 11 (14.3%) of the 77 cases, with a positive rate of 1.1% (11/1 003). Of the 11 positive cases, 9 were found in the upgraded pathological N stage, and the other 2 complicated by pelvic LNM. The patients with postoperative pathological stage≥T3 constituted a significantly higher proportion in the PAFP LNM than in the non-PAFP LNM group (81.8% [9/11] vs 36.2% [359/992], P = 0.005), and so did the cases with Gleason score ≥8 (87.5% [7/8] vs 35.5% [279/786], P = 0.009). No statistically significant differences were observed in the clinicopathological features and biochemical recurrence-free survival between the patients with PAFP LNM only and those with pelvic LNM only.
CONCLUSION
The PAFP is a potential route to LNM, and patients with LNM in the PAFP are characterized by poor pathological features. There is no statistically significant difference in biochemical recurrence-free survival between the patients with PAFP LNM only and those with pelvic LNM only. Routine removal of the PAFP and independent pathological examination of the specimen during RARP is of great clinical significance.
Humans
;
Male
;
Prostatectomy/methods*
;
Robotic Surgical Procedures
;
Lymphatic Metastasis
;
Retrospective Studies
;
Prognosis
;
Prostatic Neoplasms/pathology*
;
Adipose Tissue/pathology*
;
Prostate/pathology*
;
Lymph Nodes/pathology*
;
Middle Aged
;
Aged
2.Short-term efficacy of empagliflozin in children with glycogen storage disease type Ⅰb.
Jing Jing JIANG ; Xin ZHENG ; Ming Sheng MA ; Xing Ge CUI ; Shan JIAN ; Xiao Yan TANG ; Xu Dong BAO ; Si Min ZHANG ; Jing Ran MA ; Hong Mei SONG ; Zheng Qing QIU
Chinese Journal of Pediatrics 2023;61(6):515-519
Objective: To analyze the short-time efficacy of empagliflozin in the treatment of glycogen storage disease type Ⅰb (GSD Ⅰb). Methods: In this prospective open-label single-arm study, the data of 4 patients were collected from the pediatric department in Peking Union Medical College Hospital from December 2020 to December 2022. All of them were diagnosed by gene sequencing and had neutropenia. These patients received empagliflozin treatment. Their clinical symptoms such as height and weight increase, abdominal pain, diarrhea, oral ulcer, infection times, and drug applications were recorded at 2 weeks, 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, and 15 months after treatment to assess the therapeutic effect. The liquid chromatography-tandem mass spectrometry method was used to monitor the changes in 1, 5-anhydroglucitol (1, 5AG) concentration in plasma. At the same time, adverse reactions such as hypoglycemia and urinary tract infection were closely followed up and monitored. Results: The 4 patients with GSD Ⅰb were 15, 14, 4 and 14 years old, respectively at the beginning of empagliflozin treatment, and were followed up for 15, 15, 12 and 6 months, respectively. Maintenance dose range of empagliflozin was 0.24-0.39 mg/(kg·d). The frequency of diarrhea and abdominal pain decreased in cases 2, 3, and 4 at 1, 2 and 3 months of treatment, respectively. Their height and weight increased at different degrees.The absolute count of neutrophils increased from 0.84×109, 0.50×109, 0.48×109, 0.48×109/L to 1.48×109, 3.04×109, 1.10×109, 0.73×109/L, respectively. Granulocyte colony-stimulating factor was gradually reduced in 1 patients and stopped in 3 patient. Plasma 1, 5 AG levels in 2 children were significantly decreased after administration of empagliflozin (from 46.3 mg/L to 9.6 mg/L in case 2, and from 56.1 mg/L to 15.0 mg/L in case 3). All 4 patients had no adverse reactions such as hypoglycemia, abnormal liver or kidney function, or urinary system infection. Conclusion: In short-term observation, empagliflozin can improve the symptoms of GSD Ⅰb oral ulcers, abdominal pain, diarrhea, and recurrent infection, also can alleviate neutropenia and decrease 1, 5AG concentration in plasma, with favorable safety.
Humans
;
Child
;
Child, Preschool
;
Adolescent
;
Prospective Studies
;
Glycogen Storage Disease Type I/drug therapy*
;
Neutropenia
;
Abdominal Pain
;
Diarrhea/drug therapy*
;
Hypoglycemia
3.Incidence and prognosis of olfactory and gustatory dysfunctions related to infection of SARS-CoV-2 Omicron strain: a national multi-center survey of 35 566 population.
Meng Fan LIU ; Rui Xia MA ; Xian Bao CAO ; Hua ZHANG ; Shui Hong ZHOU ; Wei Hong JIANG ; Yan JIANG ; Jing Wu SUN ; Qin Tai YANG ; Xue Zhong LI ; Ya Nan SUN ; Li SHI ; Min WANG ; Xi Cheng SONG ; Fu Quan CHEN ; Xiao Shu ZHANG ; Hong Quan WEI ; Shao Qing YU ; Dong Dong ZHU ; Luo BA ; Zhi Wei CAO ; Xu Ping XIAO ; Xin WEI ; Zhi Hong LIN ; Feng Hong CHEN ; Chun Guang SHAN ; Guang Ke WANG ; Jing YE ; Shen Hong QU ; Chang Qing ZHAO ; Zhen Lin WANG ; Hua Bin LI ; Feng LIU ; Xiao Bo CUI ; Sheng Nan YE ; Zheng LIU ; Yu XU ; Xiao CAI ; Wei HANG ; Ru Xin ZHANG ; Yu Lin ZHAO ; Guo Dong YU ; Guang Gang SHI ; Mei Ping LU ; Yang SHEN ; Yu Tong ZHAO ; Jia Hong PEI ; Shao Bing XIE ; Long Gang YU ; Ye Hai LIU ; Shao wei GU ; Yu Cheng YANG ; Lei CHENG ; Jian Feng LIU
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2023;58(6):579-588
Objective: This cross-sectional investigation aimed to determine the incidence, clinical characteristics, prognosis, and related risk factors of olfactory and gustatory dysfunctions related to infection with the SARS-CoV-2 Omicron strain in mainland China. Methods: Data of patients with SARS-CoV-2 from December 28, 2022, to February 21, 2023, were collected through online and offline questionnaires from 45 tertiary hospitals and one center for disease control and prevention in mainland China. The questionnaire included demographic information, previous health history, smoking and alcohol drinking, SARS-CoV-2 vaccination, olfactory and gustatory function before and after infection, other symptoms after infection, as well as the duration and improvement of olfactory and gustatory dysfunction. The self-reported olfactory and gustatory functions of patients were evaluated using the Olfactory VAS scale and Gustatory VAS scale. Results: A total of 35 566 valid questionnaires were obtained, revealing a high incidence of olfactory and taste dysfunctions related to infection with the SARS-CoV-2 Omicron strain (67.75%). Females(χ2=367.013, P<0.001) and young people(χ2=120.210, P<0.001) were more likely to develop these dysfunctions. Gender(OR=1.564, 95%CI: 1.487-1.645), SARS-CoV-2 vaccination status (OR=1.334, 95%CI: 1.164-1.530), oral health status (OR=0.881, 95%CI: 0.839-0.926), smoking history (OR=1.152, 95%CI=1.080-1.229), and drinking history (OR=0.854, 95%CI: 0.785-0.928) were correlated with the occurrence of olfactory and taste dysfunctions related to SARS-CoV-2(above P<0.001). 44.62% (4 391/9 840) of the patients who had not recovered their sense of smell and taste also suffered from nasal congestion, runny nose, and 32.62% (3 210/9 840) suffered from dry mouth and sore throat. The improvement of olfactory and taste functions was correlated with the persistence of accompanying symptoms(χ2=10.873, P=0.001). The average score of olfactory and taste VAS scale was 8.41 and 8.51 respectively before SARS-CoV-2 infection, but decreased to3.69 and 4.29 respectively after SARS-CoV-2 infection, and recovered to 5.83and 6.55 respectively at the time of the survey. The median duration of olfactory and gustatory dysfunctions was 15 days and 12 days, respectively, with 0.5% (121/24 096) of patients experiencing these dysfunctions for more than 28 days. The overall self-reported improvement rate of smell and taste dysfunctions was 59.16% (14 256/24 096). Gender(OR=0.893, 95%CI: 0.839-0.951), SARS-CoV-2 vaccination status (OR=1.334, 95%CI: 1.164-1.530), history of head and facial trauma(OR=1.180, 95%CI: 1.036-1.344, P=0.013), nose (OR=1.104, 95%CI: 1.042-1.171, P=0.001) and oral (OR=1.162, 95%CI: 1.096-1.233) health status, smoking history(OR=0.765, 95%CI: 0.709-0.825), and the persistence of accompanying symptoms (OR=0.359, 95%CI: 0.332-0.388) were correlated with the recovery of olfactory and taste dysfunctions related to SARS-CoV-2 (above P<0.001 except for the indicated values). Conclusion: The incidence of olfactory and taste dysfunctions related to infection with the SARS-CoV-2 Omicron strain is high in mainland China, with females and young people more likely to develop these dysfunctions. Active and effective intervention measures may be required for cases that persist for a long time. The recovery of olfactory and taste functions is influenced by several factors, including gender, SARS-CoV-2 vaccination status, history of head and facial trauma, nasal and oral health status, smoking history, and persistence of accompanying symptoms.
Female
;
Humans
;
Adolescent
;
SARS-CoV-2
;
Smell
;
COVID-19/complications*
;
Cross-Sectional Studies
;
COVID-19 Vaccines
;
Incidence
;
Olfaction Disorders/etiology*
;
Taste Disorders/etiology*
;
Prognosis
4.A multicenter analysis of bacteria distribution and antimicrobial resistance of bloodstream infection in Yunnan, 2017-2021
Hong-juan ZHANG ; Yun-min XU ; Xiao-xue DONG ; Rui ZHENG ; Bao-jun REN ; Bin SHAN
China Tropical Medicine 2022;22(12):1135-
Abstract: Objective To analyze the distribution and drug resistance evolution characteristics of pathogenic bacteria of bloodstream infection in nine tertiary hospitals in Yunnan Province from 2017 to 2021, so as to provide reliable basis for rational selection of antibiotics in clinic. Methods Using the drug sensitive paper method or instrument method, the bacteria identification and drug sensitivity test were carried out in nine tertiary hospitals in different regions according to the unified technical scheme. The results were judged according to the Clinical and Laboratory Standards Institute (CLSI) breakpoint standard in 2021, and use WHONET5.6 for data statistical analysis. Results A total of 12 003 strains of pathogenic bacteria were isolated from bloodstream infection samples in the past five years, including 7 442 strains of Gram-negative bacteria (62.0%) and 4562 strains of Gram-positive bacteria (38.0%), with an increasing trend in the number of isolated strains; of these, 163 strains (1.4%) were isolated from outpatients and 11 840 strains (98.6%) were isolated from inpatients. The top three gram-negative bacteria were Escherichia coli, Klebsiella pneumoniae and Acinetobacter baumannii, of which 309 strains (4.2%) were carbapenem-resistant Klebsiella pneumoniae (CR-KPN), 29 strains (0.4%) carbapenem-resistant Escherichia coli and 19 strains (0.3%) carbapenem-resistant Enterobacter cloacae, and the number of CR-KPN was on the rise year by year. The top three Gram-positive bacteria were coagulase-negative staphylococci, Staphylococcus aureus and Enterococcus faecium, of which methicillin-resistant Staphylococcus aureus (MRSA) was detected for 213 strains, accounting for 27.7%, and decreased from 40.0% in 2017 to 23.4% in 2021, showing a downward trend year by year. No vancomycin-resistant staphylococci and enterococci were found. Conclusions The detection and composition of bloodstream infection pathogenic bacteria in multicenter have not changed much in the past five years, but each hospital has its own characteristics. The number of carbapenem resistant Enterobacteriaceae increased year by year, which should be paid more attention.
5.Analysis of short-term efficacy of overlapping delta-shaped anastomosis in totally laparoscopic left hemicolectomy for digestive tract reconstruction.
Man Du La BAO ; Lei GE ; Hao SU ; Shou LUO ; Zheng XU ; Xue Wei WANG ; Qian LIU ; Zhi Xiang ZHOU ; Xi Shan WANG ; Hai Tao ZHOU
Chinese Journal of Gastrointestinal Surgery 2021;24(5):433-439
Objective: At present, though the laparoscopic delta-shaped anastomosis and overlapping delta-shaped anastomosis have been gradually applied to complete laparoscopic radical resection of left hemicolon cancer, the comparative evaluation of their efficacy has not been mentioned in the published literatures. This study aims to explore the safety, feasibility and short-term efficacy of overlapping delta-shaped anastomosis (ODA) in totally laparoscopic left hemicolectomy. Methods: A retrospective cohort study was performed. The clinical and pathological data of patients who underwent totally laparoscopic left hemicolectomy at Department of Colorectal Surgery, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College from May 2017 to October 2020 were retrospectively analyzed. The case inclusion criteria were as follows: (1) age of 18-75 years; (2) body mass index (BMI) of 18.5-30 kg/m(2); (3) descending colonic and proximal sigmoid colonic adenocarcinoma was confirmed by preoperative colonoscopy and pathology. The exclusion criteria: (1) multiple primary colorectal cancers; (2) uncontrolled or poorly controlled diabetes mellitus, immune system diseases, or hematological diseases; (3) severe intestinal obstruction; (4) left transverse colonic or splenic flexure colonic adenocarcinoma; (5) distant metastasis of liver, lung and other viscera determined by enhanced computed tomography in the chest, abdomen and pelvis. According to the above criteria, a total of 115 patients with left hemicolon cancer were enrolled. All the patients underwent totally laparoscopic left hemicolectomy. Patients who underwent laparoscopic traditional delta-shaped anastomosis were selected as the control group. Patients who underwent laparoscopic ODA were selected as the ODA group. Effects of these two laparoscopic reconstruction methods on postoperative recovery and perioperative complications were analyzed and compared. Results: A total of 60 patients were enrolled in the ODA group, including 32 males and 28 females, with mean age of (57.3±10.4) years and body mass index (BMI) of (25.0±3.1) kg/m(2). While mean 55 patients were enrolled in the control group, including 31 males and 24 females, with mean age of (56.7±9.9) years and BMI of (24.4±2.9) kg/m(2). There was no statistically significant differences between the two groups in gender, age, BMI, American Society of Anesthesiologist (ASA) classification, TNM staging, preoperative abdominal surgery history, neoadjuvant chemotherapy and nutritional status (levels of hemoglobin, lymphocyte count, prealbumin, and albumin) (all P>0.05). All the patients in both groups received R0 resection without conversion to open laparotomy or conversion to extra-abdominal anastomosis. The digestive tract reconstruction time of the ODA group was significantly shorter than that of the control group [(15.1±1.7) minutes vs. (15.9±2.4) minutes, t=-2.053, P=0.042]. There were no statistically significant differences in the total operation time, intraoperative blood loss, length of skin incision, tumor size, proximal and distal margins, harvested lymph nodes, postoperative first ambulatory time, and postoperative hospital stay (all P>0.05). However, the time to the first flatus and the first defecation in the ODA group was significantly shorter as compared to control group [(1.5±0.5) days vs. (1.7±0.5) days, t=-2.028, P=0.045; (3.1±0.6) days vs. (3.4±0.7) days, t=-2.095, P=0.039], indicating faster intestinal function recovery in patients with ODA. The morbidity of postoperative complication was 6.7% (4/60) in the ODA group and 7.3% (4/55) in the control group and no significant difference was found (χ(2)=0.016, P=0.898). Two cases of incision infection, 1 case of lung infection, and 1 case of intra-abdominal infection occurred in the ODA group, while 3 cases of lung infection and 1 case of intra-abdominal infection occurred in the control group. All these complications were resolved after conservative treatment, and no secondary operation was performed due to complications. Conclusion: Compared with the traditional delta-shaped anastomosis, ODA is associated with a faster recovery of postoperative intestinal function without increasing the morbidity of postoperative complications, and has the satisfactory short-term efficacy.
Adolescent
;
Adult
;
Aged
;
Anastomosis, Surgical
;
Colectomy
;
Female
;
Humans
;
Laparoscopy
;
Male
;
Middle Aged
;
Retrospective Studies
;
Treatment Outcome
;
Young Adult
6.Progress of cohort studies in countries from Asia and Europe
Wenya HUANG ; Jingli YANG ; Peiyao HUANG ; Nian LIU ; Kaifang BAO ; Jie DING ; Xiaoliang CHEN ; Ning CHENG ; Shan ZHENG ; Yana BAI
Chinese Journal of Epidemiology 2020;41(6):962-967
Objective:To share related knowledge and experiences with countries along the line, literature regarding current cohort studies was summarized. Distribution, establishment and development of cohort studies among large prospective general population were analyzed in 17 countries of Western Asia and the 16 countries of Central and Eastern Europe.Methods:Literature review was conducted to collect basic information on cohort studies, with descriptive study used to analyze the characteristics of these cohort studies.Results:There were 562 cohort studies with sample size as more than 1 000 stated in Western Asia and Central and Eastern Europe, including 468 (83.27 %) carried out in the nation itself and 94 (16.73 %) with international multicentered collaboration. According to the nature of cohort studies, 347 (61.74 %) were etiologically based. As for the contents involved, 310 (55.16 %) of them targeted on chronic/non-communicable diseases, 125 (22.24 %) concentrated on maternal and child health. Among those on chronic/non-communicable diseases, 51 (16.45 %) were on cancers and 83 (26.77 %) on cardiovascular disease studies. There appeared 10 large prospective cohort studies targeting on general population, mainly ongoing in Iran and European countries, with a duration of 8-29 years, including 4 of them with sample size as more than 50 000. In terms of the contents, epidemiological investigation, physical examination and biological samples collection took the major parts. Few papers were published in 9 out of the 10 cohort studies at the early stage of those projects but the number of papers increased annually and stabilized to certain extent. Conclusions:The regional distribution of cohort studies carried out in countries from the Western Asia and Central and Eastern European areas appeared unbalanced. Contents of these designs would mainly involve etiological studies, with focus on non-communicable diseases as cancer, cardiovascular disease, diabetes, respiratory diseases, mental and psychological diseases, and maternal and infant health etc.. However, only few large prospective cohort studies would base on general population.
7.Analysis of PIH1D3 variant in a Chinese pedigree affected with primary ciliary dyskinesia.
Shan WANG ; Bing LI ; Yafei CHEN ; Zheng ZHOU ; Ruiling BAO
Chinese Journal of Medical Genetics 2020;37(9):1021-1024
OBJECTIVE:
To detect variant of PIH1D3 gene in a Chinese pedigree affected with primary ciliary dyskinesia (PCD) and explore its genotype-relationship correlation.
METHODS:
PCD patients from the pedigree were analyzed. Ultrastructures of the cilia and flagella of the nasal mucosa were analyzed. DNA samples of the patients were sequenced.
RESULTS:
The proband and all other affected members of his pedigree had a history of various degree of respiratory tract infection. Two patients had visceral heterotopia, and one was infertile. Electronic microscopy revealed abnormal structures of cilia and flagella. The inner and outer dynein arms were missing, and the arrangement of cilia was disordered. DNA sequencing showed that all patients have carried a c.355C>T variant of the PIH1D3 gene. The corresponding nucleotide was located in a key PIH1 domain, and the site is highly conserved among human, macaque, domestic dog, mouse, xenopus and zebrafish.
CONCLUSION
Deletion of the PIH1D3 gene can lead to failure of assembly of inner and outer dynein arms in nasal cilia and sperm flagella, and failure of normal swimming of cilia and sperm. The diagnosis rate of PCD can be validated by genetic testing.
8.A multicenter survey of antibiotic use in very and extremely low birth weight infants in Hunan Province.
Ming-Jie WANG ; Shao-Jie YUE ; Jin LIN ; Xi-Rong GAO ; Xiao-Ming PENG ; Meng-Yu CHEN ; Hua-Bao PENG ; Bei CAO ; Yun-Qing ZENG ; Shu-Lian WANG ; Bo WEN ; Xi-Lin HUANG ; Xiao-Ping LI ; Ai-Zhen ZHANG ; Ting CAO ; Yi-Hua CHEN ; Tie-Qiang CHEN ; Chun-Hua YE ; Tao BO ; De-Lin JIANG ; Xiu-Qun HUANG ; Na-Fang REN ; Long-Zhang TAO ; Fang YAO ; Chang-Jun TIAN ; Hong-Ming LI ; Ai-Min ZHANG ; Fu-Rong HUANG ; Wei-Guo ZHANG ; Xiang-Hong CHEN ; Yu-Chan LIU ; Zheng-Lin LIU ; Yan-Shan XU ; Jing-Song MING ; Li CHEN ; Ning-Yi ZHU ; Jun-Min HE ; Sai-Jun YI ; Tuan-Mei WANG ; Zhao-Hui LI ; Gui-Tian WANG
Chinese Journal of Contemporary Pediatrics 2020;22(6):561-566
OBJECTIVE:
To investigate the current status of antibiotic use for very and extremely low birth weight (VLBW/ELBW) infants in neonatal intensive care units (NICUs) of Hunan Province.
METHODS:
The use of antibiotics was investigated in multiple level 3 NICUs of Hunan Province for VLBW and ELBW infants born between January, 2017 and December, 2017.
RESULTS:
The clinical data of 1 442 VLBW/ELBW infants were collected from 24 NICUs in 2017. The median antibiotic use duration was 17 days (range: 0-86 days), accounting for 53.0% of the total length of hospital stay. The highest duration of antibiotic use was up to 91.4% of the total length of hospital stay, with the lowest at 14.6%. In 16 out of 24 NICUs, the antibiotic use duration was accounted for more than 50.0% of the hospitalization days. There were 113 cases with positive bacterial culture grown in blood or cerebrospinal fluid, making the positive rate of overall bacterial culture as 7.84%. The positive rate of bacterial culture in different NICUs was significantly different from 0% to 14.9%. The common isolated bacterial pathogens Klebsiella pneumoniae was 29 cases (25.7%); Escherichia coli 12 cases (10.6%); Staphylococcus aureus 3 cases (2.7%). The most commonly used antibiotics were third-generation of cephalosporins, accounting for 41.00% of the total antibiotics, followed by penicillins, accounting for 32.10%, and followed by carbapenems, accounting for 13.15%. The proportion of antibiotic use time was negatively correlated with birth weight Z-score and the change in weight Z-score between birth and hospital discharge (r=-0.095, -0.151 respectively, P<0.01), positively correlated with death/withdrawal of care (r=0.196, P<0.01).
CONCLUSIONS
Antibiotics used for VLBW/ELBW infants in NICUs of Hunan Province are obviously prolonged in many NICUs. The proportion of routine use of third-generation of cephalosporins and carbapenems antibiotics is high among the NICUs.
Anti-Bacterial Agents
;
Birth Weight
;
Humans
;
Infant
;
Infant, Extremely Low Birth Weight
;
Infant, Newborn
;
Intensive Care Units, Neonatal
;
Surveys and Questionnaires
9.A double-blind, randomized, placebo- and positive-controlled phase III trial of 1% benvitimod cream in mild-to-moderate plaque psoriasis.
Lin CAI ; Gen-Hui CHEN ; Qian-Jin LU ; Min ZHENG ; Yu-Zhen LI ; Jin CHEN ; Jie ZHENG ; Fu-Ren ZHANG ; Jian-Bin YU ; Sen YANG ; Fu-Qiu LI ; Sheng-Xiang XIAO ; Qiu-Ning SUN ; Jin-Hua XU ; Xing-Hua GAO ; Hong FANG ; Tian-Wen GAO ; Fei HAO ; Quan-Zhong LIU ; Ya-Ting TU ; Ruo-Yu LI ; Bao-Xi WANG ; Dan-Qi DENG ; Qing-Shan ZHENG ; Hong-Xia LIU ; Jian-Zhong ZHANG
Chinese Medical Journal 2020;133(24):2905-2909
BACKGROUND:
Benvitimod cream, a novel synthetic small molecule, was effective in treating mild-to-moderate plaque psoriasis. We conducted a phase III clinical trial to assess the efficacy and safety of benvitimod cream in patients with mild-to-moderate plaque psoriasis.
METHODS:
We randomly assigned 686 patients (2:1:1) to receive 1% benvitimod cream, 0.005% calcipotriol ointment or placebo twice a day for 12 weeks. The primary efficacy end points were the percentage of patients with a 75% or greater reduction from baseline in the psoriasis area and severity index (PASI 75) score and with a score of 0 or 1 in static physician's global assessment (sPGA) at week 12.
RESULTS:
The results showed that 50.4% of patients in the benvitimod group achieved PASI 75, which was significantly higher than that in the calcipotriol (38.5%, P < 0.05) and placebo (13.9%, P < 0.05) groups. The proportion of patients achieving an sPGA score 0 or 1 was 66.3% in the benvitimod group and 63.9% in the calcipotriol group, which were both significantly higher than that in the placebo group (34%, P < 0.05). In the long-term follow-up study, 50.8% of patients experienced recurrence. After retreatment with 1% benvitimod, 73.3% of patients achieved an sPGA score of 0 or 1 again at week 52. Adverse events included application site irritation, follicular papules, and contact dermatitis. No systemic adverse reactions were reported.
CONCLUSION:
During this 12-week study, benvitimod cream was demonstrated with high effectiveness and safety in patients with mild-to-moderate plaque psoriasis.
TRIAL REGISTRATION
Chinese Clinical Trial Registry (ChiCTR), ChiCTR-TRC-13003259; http://www.chictr.org.cn/showprojen.aspx?proj=6300.
Double-Blind Method
;
Follow-Up Studies
;
Humans
;
Ointments
;
Psoriasis/drug therapy*
;
Resorcinols
;
Severity of Illness Index
;
Stilbenes
;
Treatment Outcome
10.2018 DMPK research progress in China
Lu-shan YU ; Hui-chang BI ; Bao-jian WU ; Guang-bo GE ; Jiang ZHENG ; Hai-ling QIAO ; Su ZENG
Acta Pharmaceutica Sinica 2019;54(6):963-970
This paper summarizes research progresses of Chinese scholars in the field of drug metabolism and pharmacokinetics (DMPK) in 2018. Chinese scholars focused on drug metabolizing enzymes and transporters, and carried out studies on the mechanisms of drug metabolism and transport of active molecules. Topics of research included regulatory mechanisms of drug metabolizing enzymes or transporters, and their implications in drug development and disease etiology or progression. Here, we summarized studies on drug toxicity based on drug metabolism or transport, rational drug use in the clinic, drug metabolism mediated by intestinal flora, metabolism of traditional Chinese medicines, and new technologies or models in DMPK. In recent years, the research focus of drug metabolism in China has transformed from serving for new drug discovery and rational use, to innovation driven and mechanism oriented research. The domestic research topics and technology utilization are gradually aligning with the international conventions.


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