1.Jujuboside A ameliorates tubulointerstitial fibrosis in diabetic mice through down-regulating the YY1/TGF-β1 signaling pathway.
Yang-Yang LIU ; Lin LI ; Bei JI ; Shi-Long HAO ; Xiao-Feng KUANG ; Xin-Yun CAO ; Jia-Yu YUAN ; Zhen-Zhou JIANG ; Si-Tong QIAN ; Chu-Jing WEI ; Jing XU ; Xiao-Xing YIN ; Qian LU ; Ting-Ting YANG
Chinese Journal of Natural Medicines (English Ed.) 2022;20(9):656-668
		                        		
		                        			
		                        			Diabetic nephropathy (DN) is one of the most common complications of diabetes mellitus, which is characterized in renal tubulointerstitial fibrosis (TIF). The current study was designed to investigate the protective effect of Jujuboside A (Ju A) on TIF in type 2 diabetes (T2DM) mice, and explore its underlying anti-fibrosis mechanism. A mouse T2DM model was established using high fat diet (HFD) feeding combined with intraperitoneal injection of streptozotocin (STZ). Then, diabetic mice were treated with Ju A (10, 20 and 40 mg·kg-1·d-1, i.g.) for 12 weeks. Results showed that administration of Ju A not only down-regulated fasting blood glucose (FBG) levels, but also improved hyperlipidemia and renal function in diabetic mice. Moreover, the reduced ECM accumulation was observed in the renal cortex of Ju A treated diabetic mice, while the TIF progression was also attenuated by Ju A through blocking the epithelial-to-mesenchymal transition (EMT) of renal tubular epithelial cells (RTECs). Further mechanism studies showed that Ju A treatment effectively down-regulated the protein expression and subsequent nuclear translocation of Yin Yang 1 (YY1) in the renal cortex of diabetic mice, and reduced the levels of transforming growth factor-β1 (TGF-β1) in the serum and renal cortex of Ju A treated mice. According to invitro studies, the up-regulated YY1/TGF-β1 signaling pathway was restored by Ju A in high glucose (HG) cultured HK-2 cells. Taken together, these findings demonstrated that Ju A can ameliorate the TIF of DN through down-regulating the YY1/TGF-β1 signaling pathway.
		                        		
		                        		
		                        		
		                        			Animals
		                        			;
		                        		
		                        			Blood Glucose
		                        			;
		                        		
		                        			Diabetes Mellitus, Experimental/metabolism*
		                        			;
		                        		
		                        			Diabetes Mellitus, Type 2/drug therapy*
		                        			;
		                        		
		                        			Diabetic Nephropathies/metabolism*
		                        			;
		                        		
		                        			Fibrosis
		                        			;
		                        		
		                        			Mice
		                        			;
		                        		
		                        			Saponins
		                        			;
		                        		
		                        			Signal Transduction
		                        			;
		                        		
		                        			Streptozocin
		                        			;
		                        		
		                        			Transforming Growth Factor beta1/metabolism*
		                        			
		                        		
		                        	
2.Pancreas multidisciplinary team optimizes the diagnosis and treatment of pancreas-related diseases and improves the prognosis of pancreatic cancer patients
Jian′ang LI ; Yaolin XU ; Ni DING ; Yuan JI ; Lingxiao LIU ; Shengxiang RAO ; Yiqun ZHANG ; Xiuzhong YAO ; Yue FAN ; Cheng HUANG ; Yuhong ZHOU ; Lili WU ; Yi DONG ; Lei ZHANG ; Yefei RONG ; Tiantao KUANG ; Xuefeng XU ; Liang LIU ; Dansong WANG ; Dayong JIN ; Wenhui LOU ; Wenchuan WU
Chinese Journal of Surgery 2022;60(7):666-673
		                        		
		                        			
		                        			Objectives:To evaluate the role of pancreas multidisciplinary team(MDT) clinic in the diagnosis of pancreatic diseases,patient compliance with MDT advice,and the impact of MDT on the postoperative survival of patients with pancreatic cancer.Methods:The study included 927 patients(554 males,373 females,aged (58.1±13.3)years (range: 15 to 89 years)) that had visited the pancreas MDT clinic of Zhongshan Hospital from May 2015 to December 2021,and 677 patients(396 males, 281 females, aged (63.6±8.9)years(range: 32 to 95 years)) who underwent radical surgery and with pathologically confirmed pancreatic adenocarcinoma from January 2012 to December 2020,of whom 79 patients had attended the pancreas MDT. The clinical and pathological data were collected and analyzed retrospectively. Diseases were classified in accordance with 2010 WHO classification of tumors of the digestive system and usual clinical practices. The Kaplan-Meier method was used for drawing the survival curve and calculating the survival rate. The univariate analysis was done by Log-rank test and the multivariate analysis was done by COX proportional hazards model. Survival rates were compared using χ 2 test. Results:Among the 927 patients that had visited the MDT clinic,233 patients(25.1%) were referred due to undetermined diagnosis. A direct diagnosis was made in 109 cases (46.8%,109/233) by the MDT clinic, of which 98 were consistent with the final diagnosis,resulting in an accuracy of 89.9%(98/109). The direct diagnosis rate in the recent years(36.6%(41/112),from June 2019 to December 2021) decreased compared to that in the previous years(56.2%(68/121),from May 2015 to May 2019),yet the accuracy in the recent years(90.2%,37/41) was basically the same as before (89.7%,61/68). The rate of compliance of the entire cohort was 71.5%(663/927), with the compliance rate in the recent two and a half years(81.4%,338/415) remarkably higher than that in the previous four years(63.4%,325/512). Patients with pancreatic cancer that attended the MDT exhibited a trend toward longer median postoperative survival than patients that did not attend the MDT,but the difference was not statistically significant(35.2 months vs.30.2 months, P>0.05). The 1-year and 3-year survival rates of patients that attended the MDT were significanly higher than patients that did not attend the MDT(88.6% vs. 78.4%, P<0.05;32.9% vs. 21.9%, P<0.05,respectively),but the 5-year survival rate was not statistically different(7.6% vs. 4.8%, P>0.05). Conclusions:The pancreas MDT clinic is an accurate and convenient way to diagnose intractable pancreatic diseases,and in the recent years the patients′ compliance rate with MDT advice has increased. Pancreatic cancer patients that have attended the MDT have higher 1-year and 3-year postoperative survival rates,but the long-term survival benefits of MDT still needs to be proved by clinical studies on a larger scale.
		                        		
		                        		
		                        		
		                        	
3.Pancreas multidisciplinary team optimizes the diagnosis and treatment of pancreas-related diseases and improves the prognosis of pancreatic cancer patients
Jian′ang LI ; Yaolin XU ; Ni DING ; Yuan JI ; Lingxiao LIU ; Shengxiang RAO ; Yiqun ZHANG ; Xiuzhong YAO ; Yue FAN ; Cheng HUANG ; Yuhong ZHOU ; Lili WU ; Yi DONG ; Lei ZHANG ; Yefei RONG ; Tiantao KUANG ; Xuefeng XU ; Liang LIU ; Dansong WANG ; Dayong JIN ; Wenhui LOU ; Wenchuan WU
Chinese Journal of Surgery 2022;60(7):666-673
		                        		
		                        			
		                        			Objectives:To evaluate the role of pancreas multidisciplinary team(MDT) clinic in the diagnosis of pancreatic diseases,patient compliance with MDT advice,and the impact of MDT on the postoperative survival of patients with pancreatic cancer.Methods:The study included 927 patients(554 males,373 females,aged (58.1±13.3)years (range: 15 to 89 years)) that had visited the pancreas MDT clinic of Zhongshan Hospital from May 2015 to December 2021,and 677 patients(396 males, 281 females, aged (63.6±8.9)years(range: 32 to 95 years)) who underwent radical surgery and with pathologically confirmed pancreatic adenocarcinoma from January 2012 to December 2020,of whom 79 patients had attended the pancreas MDT. The clinical and pathological data were collected and analyzed retrospectively. Diseases were classified in accordance with 2010 WHO classification of tumors of the digestive system and usual clinical practices. The Kaplan-Meier method was used for drawing the survival curve and calculating the survival rate. The univariate analysis was done by Log-rank test and the multivariate analysis was done by COX proportional hazards model. Survival rates were compared using χ 2 test. Results:Among the 927 patients that had visited the MDT clinic,233 patients(25.1%) were referred due to undetermined diagnosis. A direct diagnosis was made in 109 cases (46.8%,109/233) by the MDT clinic, of which 98 were consistent with the final diagnosis,resulting in an accuracy of 89.9%(98/109). The direct diagnosis rate in the recent years(36.6%(41/112),from June 2019 to December 2021) decreased compared to that in the previous years(56.2%(68/121),from May 2015 to May 2019),yet the accuracy in the recent years(90.2%,37/41) was basically the same as before (89.7%,61/68). The rate of compliance of the entire cohort was 71.5%(663/927), with the compliance rate in the recent two and a half years(81.4%,338/415) remarkably higher than that in the previous four years(63.4%,325/512). Patients with pancreatic cancer that attended the MDT exhibited a trend toward longer median postoperative survival than patients that did not attend the MDT,but the difference was not statistically significant(35.2 months vs.30.2 months, P>0.05). The 1-year and 3-year survival rates of patients that attended the MDT were significanly higher than patients that did not attend the MDT(88.6% vs. 78.4%, P<0.05;32.9% vs. 21.9%, P<0.05,respectively),but the 5-year survival rate was not statistically different(7.6% vs. 4.8%, P>0.05). Conclusions:The pancreas MDT clinic is an accurate and convenient way to diagnose intractable pancreatic diseases,and in the recent years the patients′ compliance rate with MDT advice has increased. Pancreatic cancer patients that have attended the MDT have higher 1-year and 3-year postoperative survival rates,but the long-term survival benefits of MDT still needs to be proved by clinical studies on a larger scale.
		                        		
		                        		
		                        		
		                        	
4.Correlation analysis between vitamin A, D and E levels with the altitude, seasonal variation and other factors in children with 0-6 years old in Tibetan Plateau of Ganzi Prefecture
Ping HUANG ; Xinmei LIN ; Quansheng WANG ; Gang KE ; Zhengrong WEI ; Duping GUO ; Xueguo BA ; Yongxiao YUAN ; Qun WANG ; Hongyan DING ; Maoyun HE ; Ligui XIAN ; Liping ZHANG ; Yufei WANG ; Lianhui YU ; Kehong KUANG ; Qingping LUO ; Zhu CHEN ; Hongmei LI ; Jing LUO ; Yilan XU
Chinese Journal of Applied Clinical Pediatrics 2021;36(22):1736-1741
		                        		
		                        			
		                        			Objective:To detect serum levels of vitamin A (Vit A), vitamin D(Vit D)25-hydroxy vitamin D[25-(OH)D] and vitamin E(Vit E) in children aged 0-6 years in Tibetan Plateau of Garzi Prefecture, thus providing references for physical examinations and prevention of 4 key diseases (rickets, malnutrition anemia, pneumonia and diarrhea) in children in plateau areas by relevant government departments.Methods:A total of 2 122 children who participated in physical examination in 12 townships of Xiangcheng County and 14 townships of Daocheng County, Garzi Tibetan Autonomous Prefecture, Sichuan Province from April 2017 to April 2019 with 0-6 years old were recruited for surveying physical measurements and collection of venous blood.Serum Vit A and Vit E levels were detected by high performance liquid chromatography.Serum levels of 25-(OH)D were detected by high performance liquid chromatography tandem mass spectrometry.The relationship between Vit A, Vit E and 25-(OH)D levels with the gender, age, seasonal change and altitude was analyzed.Results:The serum Vit A level, subclinical Vit A deficiency rate and marginal vitamin A deficiency rate were(1.05±0.27) μmol/L, 8.15%(173/2 122 cases) and 45.99%(976/2 122 cases), respectively in 2 122 children with 0-6 years old.There were significant differences in the serum Vit A level, the subclinical Vit A deficiency rate and the marginal vitamin A deficiency rate in children with different ages, seasons and altitudes (all P<0.05). The serum level of 25-(OH)D and 25-(OH)D deficiency rate insufficient rate were (24.65±6.45) ng/L, 6.03%(128/2 122 cases) and 16.59%(352/2 122 cases), respectively.There were significant differences in the serum level of 25-(OH)D, 25-(OH)D deficiency rate and 25-(OH)D insufficient rate in children with different ages and seasons (all P<0.05). The mean serum Vit E level, Vit E deficiency rate and Vit E insufficient rate were (7.81±1.74) mg/L, 2.78%(59/2 122 cases) and 29.59%(628/2 122 cases), respectively.There were significant differences in serum Vit E level, Vit E deficiency rate and Vit E insufficient rate in children with different ages and seasons (all P<0.05). The mean serum levels of Vit A and Vit D remained the lowest before the age of 1 year, and their deficiencies at this age were the most significant.The mean serum level of Vit E remained the lowest in >1-2 years old, and its deficiency and insufficient at this age were the most significant.Vit A, D and E levels were significantly affected by seasonal changes, which were significantly higher in the summer than in the spring, autumn and winter.In addition, Vit A and 25-(OH)D were significantly affected by the altitude, which were the lowest above 4 km altitude. Conclusions:The overall serum levels of Vit A, 25-(OH) D and E in children with 0-6 years old in Tibetan Plateau areas of Ganzi Prefecture are lower than those in plain areas.Vit A, 25-(OH) D and Vit E levels significantly differed in the age, season and altitude, which are related to the lack of local resources, insufficient maternal nutrition during pregnancy and insufficient intake after birth, as well as temperature and light caused by changes in local seasons and altitude.Therefore, it is necessary to make reasonable supplements during pregnancy to prevent vitamin deficiency.
		                        		
		                        		
		                        		
		                        	
5.Complications and management of penile augmentation with hyaluronic acid injection.
Yuan QUAN ; Zi-Rui GAO ; Xiang DAI ; Ling KUANG ; Min ZHANG ; Qing LI ; Tao XU ; Xiao-Wei ZHANG
Asian Journal of Andrology 2021;23(4):392-395
		                        		
		                        			
		                        			Hyaluronic acid injection is becoming a popular way for penile augmentation. However, only few studies and follow-ups have investigated the various complications of hyaluronic acid injection and their corresponding management. In this study, a total of 230 patients who had penile augmentation with hyaluronic acid injection from January 2018 to December 2019 were examined on follow-up for penile girth, complications, and their corresponding management. At 1-month, 3-month, and 6-month postoperative follow-ups, the penile circumference had increased by 2.66 ± 1.24 cm, 2.28 ± 1.02 cm, and 1.80 ± 0.83 cm, respectively. During the entire 6-month follow-up, 4.3% had complications such as subcutaneous bleeding, subcutaneous nodules, and infection. There were no systemic or local allergic reactions among all the patients. All complications were treated accordingly, and no further deterioration or severe sequelae were observed. Although complications of hyaluronic acid injections are mild and rare, these may affect the patient's satisfaction postoperatively. Preoperative redundant prepuce may increase the incidence of penile edema or postoperative gel migration. Standardization of the surgery protocol and elucidation of the effects of other injection parameters are still lacking. Nevertheless, it still highlights the importance of preoperative preparation and surgical technique.
		                        		
		                        		
		                        		
		                        	
6.Single Center Analysis of Bloodstream Infection Clinical Characteristics and Prognosis in Patients with Hematological Malignancies in the Tropics.
Long-Can CHENG ; Ting YANG ; Hui-Hui KUANG ; Shuai YU ; Li-Xun GUAN ; Zhen-Yang GU ; Yuan-Yuan XU ; Wen-Shuai ZHENG ; Lu WANG ; Ya-Lei HU ; Xiao-Ning GAO ; Quan-Shun WANG
Journal of Experimental Hematology 2021;29(1):265-271
		                        		
		                        			OBJECTIVE:
		                        			To analyze the characteristics, prognosis and risk factors of bloodstream infection in patients with hematological malignancies in the tropics, so as to provide evidence for the prevention and treatment of bloodstream infection.
		                        		
		                        			METHODS:
		                        			The clinical features, blood culture results and prognosis of patients with bloodstream infection in patients with hematological malignancies admitted to Hainan Hospital of PLA General Hospital were retrospectively studied.
		                        		
		                        			RESULTS:
		                        			The most common primary infection site of the 81 patients with hematological malignancies was lung (46.91%), followed by PICC (11.11%). The detection rate of Gram-positive bacteria and Gram-negative bacteria in the blood culture was 60.98% and 30.02%, respectively. Coagulase-negative staphylococci was the most common Gram-positive bacteria resulting in bloodstream infection in our study. Of the Gram-negatives, Klebsiella pneumoniae (34.38%) was predominant, followed by Escherichia coli (18.75%) and Pseudomonas aeruginosa (18.75%). Gram-positive bacteria was highly sensitive (100%) to vancomycin, linezolid and tigecycline. Study showed that Gram-negative bacteria had low sensitive to quinolones, in particular, the resistance rate of Escherichia coli to quinolones was as high as 83.33%. In terms of overall survival (OS), the 30-days OS of patients with Gram-negative and Gram-positive septicemia was 77.42% and 92.00%, respectively. There was no statistically significant difference between the two groups. Multivariate analysis revealed that septic shock (P=0.001, RR=269.27) was an independent risk factor for 30-day mortality, and remission status (P=0.027, RR=0.114) was an independent predictor of a favourable outcome of bloodstream infection in patients with hematological malignancies.
		                        		
		                        			CONCLUSION
		                        			Gram-positive bacteria are the main pathogens causing bloodstream infections in patients with hematological malignancies in the tropics. Improving the care of PICC is an important measure to reduce the incidence of bloodstream infection in patients with hematological malignancies in the tropics. A correct treatment relieving disease and effective prevention and treatment of septic shock can reduce mortality of patients with bloodstream infection in patients with hematological malignancies in the tropics.
		                        		
		                        		
		                        		
		                        			Anti-Bacterial Agents/therapeutic use*
		                        			;
		                        		
		                        			Bacteremia/drug therapy*
		                        			;
		                        		
		                        			Drug Resistance, Bacterial
		                        			;
		                        		
		                        			Gram-Negative Bacteria
		                        			;
		                        		
		                        			Hematologic Neoplasms/drug therapy*
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Microbial Sensitivity Tests
		                        			;
		                        		
		                        			Prognosis
		                        			;
		                        		
		                        			Retrospective Studies
		                        			;
		                        		
		                        			Sepsis
		                        			
		                        		
		                        	
7. The value of preoperative CA19-9 combined with platelet-to-lymphocyte ratio in predicting invasive malignancy in intraductal papillary mucinous neoplasms
Jian′ang LI ; Xu HAN ; Yuan FANG ; Lei ZHANG ; Wenhui LOU ; Xuefeng XU ; Wenchuan WU ; Tiantao KUANG ; Dansong WANG ; Yefei RONG
Chinese Journal of Surgery 2019;57(3):170-175
		                        		
		                        			 Objective:
		                        			To explore preoperative predictive markers for invasive malignancy in intraductal papillary mucinous neoplasm(IPMN).
		                        		
		                        			Methods:
		                        			The retrospective case-controlled study was adopted.Seventy-nine patients who underwent surgery and with pathologically confirmed IPMN from January 2005 to December 2014 at Department of Pancreatic Surgery, Zhongshan Hospital Fudan University were enrolled.Forty-six patients were male and 33 were female,with an average age of (62.9±8.9)years (range:37-82 years).Tumor sites:56 tumors were located at the head of the pancreas,22 were located at the body and tail of the pancreas,and 1 was located across the whole pancreas.Surgical procedures: 51 patients underwent pancreaticoduodenectomy, 22 patients underwent distal pancreatectomy, 4 patients underwent segmental pancreatectomy and 2 patients underwent total pancreatectomy.IPMNs were classified into non-invasive lesions and invasive carcinomas according to the histopathological findings of the tumor.Thirty-two tumors were non-invasive lesions and 47 were invasive carcinomas.The preoperative findings were compared between patients with non-invasive IPMN and patients with invasive carcinoma by univariate analysis using 
		                        		
		                        	
8.Single Center Analysis of Pathogenic Characteristics of Lung Candida Infection and Other Pathogenic Bacteria Infection in the Patients with Hemotological Maliglancies in the Tropical Region of Hainan.
Mei-Lu WANG ; Hui-Hui KUANG ; Long-Can CHENG ; Yu-Bing XU ; Ting-Yuan ZHAO ; Ting YANG ; Song-He XIANG ; Cheng-Yuan SHU ; Ping YU ; Li-Ping DOU ; Jian BO
Journal of Experimental Hematology 2018;26(3):911-916
OBJECTIVETo analyze the infection characteristics of sputum and venous blood pathogen in the patients with hematological malignancies and respiratory symptom in the Hematology Department in tropical region and to investigate its drug-resistance so as to provide etiological evidence for clinical treatment.
METHODSThe pathogens and their drug-resistance of 2466 samples in the patients with hematological malignancies and respiratory symptom in the Department were analyzed retrospectively from January 2013 to November 2017. The samples were collected from sputum and venous blood.
RESULTSThe sputum sample culture in patients with hematologic diseases showed that 224 strains were isolated, out of them 98 strains (43.75%) were fungi mainly candida albicans (41 strains); and then 88 Gram-negative strains (39.28%), among them the main pathogenic bacteria were Escherichia coli(22 strains) and klebsiella Klebsiella pneumoniae(12 strains); and then 38 Gram-positive strains (16.96%), among them the main pathogeni-bacteria were Enteroccocus (14 strains) and Gram-positive bacilli (14 strains). The blood samples culture of patients with hematologic diseases showed that 61 strains were isolated, out of them the isolated rate of Gram-positive bactetia was higherst, which accounted for 55.74%(34/61), mainly including staphylococcus lominis (19 strains); and the isolated rate of Gram-negative bacteria was 44.26% (27/61), among them main pathogenic bacteria was Klebsiella pneumoniae (12 strains). The resistance test of pathogenic bacteria to drugs showed that the resistant rate of Gram-negative bacteria to tigecycline, imipenem and atl-962 duenner was lowest, while the Gram-positive pathogenic bacteria such as Enterococcus, Gram-positive bacilli and Staphylococcus aureus were sensitive to vancomycin, tigecycline and linezolid was high.
CONCLUSIONthe patients in hematology department are infected easily in the hospital in tropical region. The main pathogens are fungal strains in the respiratory tract of patients with hematological malignancy according to the sputum culture results. The clinician in tropical regions should choose suitable antibiotics for anti-infective therapy, which is different from the situation in North China or other northern areas.
Bacteria ; Bacterial Infections ; Candida ; Candidiasis ; China ; Drug Resistance, Bacterial ; Hematologic Neoplasms ; Humans ; Microbial Sensitivity Tests ; Retrospective Studies
9.Identification of sarcosaphagous Calliphorid flies by analyzing the sequence of 16S rDNA.
Jian SHI ; Ya-Dong GUO ; Xu-Yuan KUANG ; Ling-Mei LAN ; Ji-Feng CAI ; Hong-Jie WANG
Journal of Forensic Medicine 2012;28(4):281-286
		                        		
		                        			OBJECTIVE:
		                        			To explore the application of a 289bp fragment of the 16S rDNA gene to identify various species of sarcosaphagous Calliphorid flies.
		                        		
		                        			METHODS:
		                        			Twenty-six Calliphorid flies were collected from 14 Chinese provinces. All specimens were properly assigned into three genera and six species. The DNA of the pectoralis was extracted using CTAB method. Then PCR amplification was done for the 289 bp fragment of the 16S rDNA gene. The PCR products were then purified and sequenced, and the obtained sequences were uploaded to GenBank. The phylogenetic tree was built by the neighbor-joining method and intraspecific and interspecific divergences were calculated by sequence analysis.
		                        		
		                        			RESULTS:
		                        			The above 26 sarcosaphagous flies could be well clustered according to different genera and species. The evolutional intraspecific values were all zero, the evolutional interspecific variations varied from 0.3% to 6.5%.
		                        		
		                        			CONCLUSION
		                        			The 289 bp fragment of the 16S rDNA of sarcosaphagous flies can be effectively used to identify most of the flies at species level. This method appears to be fast and low dissipative, which might be used to estimate postmortem interval by sarcosaphagous flies.
		                        		
		                        		
		                        		
		                        			Animals
		                        			;
		                        		
		                        			DNA Primers
		                        			;
		                        		
		                        			DNA, Mitochondrial/genetics*
		                        			;
		                        		
		                        			DNA, Ribosomal/genetics*
		                        			;
		                        		
		                        			Diptera/genetics*
		                        			;
		                        		
		                        			Entomology
		                        			;
		                        		
		                        			Forensic Medicine/methods*
		                        			;
		                        		
		                        			Phylogeny
		                        			;
		                        		
		                        			Polymerase Chain Reaction/methods*
		                        			;
		                        		
		                        			RNA, Ribosomal, 16S/genetics*
		                        			;
		                        		
		                        			Rabbits
		                        			;
		                        		
		                        			Sequence Analysis, DNA
		                        			;
		                        		
		                        			Species Specificity
		                        			
		                        		
		                        	
10.Prospective, naturalistic study of open-label OROS methylphenidate treatment in Chinese school-aged children with attention-deficit/hyperactivity disorder.
Yi ZHENG ; Yu-Feng WANG ; Jiong QIN ; Li-Wen WANG ; Li-Ping ZOU ; Xing-Ming JIN ; Tong XU ; Yi WANG ; Yuan-Li QI ; Mei-En GONG ; Qing-Yun YIN ; Jian-Ning MAI ; Jin JING ; Xiang-Yang LUO ; Hong-Wei MA ; Hai-Bo LI ; Ling XIE ; Yan LI ; Gui-Fang KUANG ; Ming-Ji YI ; Feng WANG ; Xiao-Hua ZHU ; Yan-Bin YAO
Chinese Medical Journal 2011;124(20):3269-3274
BACKGROUNDAttention deficit hyperactivity disorder (ADHD) is one of the most common mental disorders during childhood, characterized by the core symptoms of hyperactivity, impulsivity and inattention and puts great burden on children themselves, their families and the society. Osmotic release oral system methylphenidate (OROS-MPH) is a once-daily controlled-release formulation developed to overcome some of the limitations associated with immediate-release methylphenidate (IR-MPH). It has been marketed in China since 2005 but still lacks data from large-sample clinical trials on efficacy and safety profiles. The aim of this study was to evaluate the effectiveness and safety of OROS-MPH in children aged 6 to 16 years with ADHD under naturalistic clinical setting.
METHODSThis 6-week, multi-center, prospective, open-label study enrolled 1447 ADHD children to once-daily OROS-MPH (18 mg, 36 mg or 54 mg) treatment. The effectiveness measures were parent-rated Inattention and Overactivity With Aggression (IOWA) Conners I/O and O/D subscales, physician-rated CGI-I and parent-rated global efficacy assessment scale. Blood pressure, pulse rate measurement, adverse events (AEs) and concomitant medications and treatment review were conducted by the investigator and were served as safety measures.
RESULTSA total of 1447 children with ADHD (mean age (9.52 ± 2.36) years) were enrolled in this trial. Totally 96.8% children received an OROS-MPH modal dose of 18 mg, 3.1% with 36 mg and 0.1% with 54 mg at the endpoint of study. The parent IOWA Conners I/O score at the end of week 2 showed statistically significant (P < 0.001) improvement with OROS-MPH (mean: 6.95 ± 2.71) versus the score at baseline (10.45 ± 2.72). The change in the parent IOWA Conners O/D subscale, CGI-I and parent-rated global efficacy assessment scale also supported the superior efficacy for OROS-MPH treatment. Fewer than half of 1447 patients (511(35.3%)) reported AEs, and the majority of the events reported were mild (68.2%). No serious adverse events were reported during the study.
CONCLUSIONThis open-label, naturalistic study provides further evidence of effectiveness and safety of OROS-MPH in school-aged children under routine practice.
Adolescent ; Attention Deficit Disorder with Hyperactivity ; drug therapy ; Child ; Delayed-Action Preparations ; Female ; Humans ; Male ; Methylphenidate ; administration & dosage ; adverse effects ; therapeutic use ; Prospective Studies ; Treatment Outcome
            
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