1.Effect of High Suspension and Low Incision Surgery Based on Traditional Ligation of Chinese Medicine in Treatment of Mixed Haemorrhoids: A Multi-centre, Randomized, Single-Blind, Non-inferiority Clinical Trial.
Xiao-Qiang JIA ; Wei-Wei CAO ; Long-Fang QUAN ; Wei-Bing ZHAO ; Fang CHENG ; Shan JIA ; Liu-Quan FENG ; Xu-Feng WEI ; Zhen-Nian XIE ; Dong WANG ; Chun-Yan XU ; Chun-Hui CUI ; Xing-Juan CAI ; Lan-Ye HE ; Zhan-Jun WANG ; Ying TIAN ; Shu-Min SHI ; Si-Miao SUN ; Liang SU ; Meng-Fan ZHAI
Chinese journal of integrative medicine 2021;27(9):649-655
		                        		
		                        			OBJECTIVE:
		                        			To observe the clinical effect of high suspension and low incision (HSLI) surgery on mixed haemorrhoids, compared with Milligan-Morgan haemorrhoidectomy.
		                        		
		                        			METHODS:
		                        			A multi-centre, randomized, single-blind, non-inferiority clinical trial was performed. Participants with mixed haemorrhoids from Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing Rectum Hospital, Air Force Medical Center of People's Liberation Army of China, and Puyang Hospital of Traditional Chinese Medicine were enrolled from September 2016 to March 2018. By using a blocked randomization scheme, participants were assigned to two groups. The experimental group was treated with HSLI, while the control group was treated with Milligan-Morgan haemorrhoidectomy. The primary outcome was the clinical effect evaluated at 12 weeks after operation. The secondary outcomes included the number of haemorrhoids treated during the operation, pain scores, use of analgesics, postoperative oedema, wound healing, incidence of anal stenosis, anorectal manometry after operation, as well as surgical duration, length of stay and total hospitalization expenses. A safety evaluation was also conducted.
		                        		
		                        			RESULTS:
		                        			In total, 246 eligible participants were enrolled, with 123 cases in each group. There was no significant difference in the clinical effect between the two groups (100.00% vs. 99.19%, P>0.05). Compared with the control group, the number of external haemorrhoids treated during the operation and the pain scores after operation were significantly reduced in the experimental group (P<0.05 or P<0.01); the patient number with wound healing at 2 weeks after operation and the functional length of anal canal at 12 weeks after operation were significantly increased in the experimental group (P<0.05). There was no significant difference in the incidence of anal stenosis, the numbers of patients using analgesics and patients with postoperative oedema between the two groups after operation (P>0.05). The surgical duration and length of stay in the experimental group were significantly longer than those in the control group, and the total hospitalization expense was significantly higher than that in the control group (all P<0.05). No adverse events were reported in either group during the whole trial or follow-up period.
		                        		
		                        			CONCLUSION
		                        			HSLI had the advantages of preserving the skin of anal canal completely, alleviating postsurgical pain and promoting rapid recovery after operation. (Registration No. ChiCTR1900022883).
		                        		
		                        		
		                        		
		                        	
2.Efficacy and safety of Shenyankangfu Tablet, a Chinese patent medicine, for primary glomerulonephritis: A multicenter randomized controlled trial.
Jie WU ; Shu-Wei DUAN ; Hong-Tao YANG ; Yue-Yi DENG ; Wei LI ; Ya-Ni HE ; Zhao-Hui NI ; Yong-Li ZHAN ; Shan LIN ; Zhi-Yong GUO ; Jun ZHU ; Jing-Ai FANG ; Xu-Sheng LIU ; Li-Hua WANG ; Rong WANG ; Nian-Song WANG ; Xiao-Hong CHENG ; Li-Qun HE ; Ping LUO ; Shi-Ren SUN ; Ji-Feng SUN ; Ai-Ping YIN ; Geng-Ru JIANG ; Hong-Yu CHEN ; Wen-Hu LIU ; Hong-Li LIN ; Meng LIANG ; Lu MA ; Ming CHEN ; Li-Qun SONG ; Jian CHEN ; Qing ZHU ; Chang-Ying XING ; Yun LI ; Ji-Ning GAO ; Rong-Shan LI ; Ying LI ; Hao ZHANG ; Ying LU ; Qiao-Ling ZHOU ; Jun-Zhou FU ; Qiang HE ; Guang-Yan CAI ; Xiang-Mei CHEN
Journal of Integrative Medicine 2021;19(2):111-119
		                        		
		                        			BACKGROUND:
		                        			Shenyankangfu Tablet (SYKFT) is a Chinese patent medicine that has been used widely to decrease proteinuria and the progression of chronic kidney disease.
		                        		
		                        			OBJECTIVE:
		                        			This trial compared the efficacy and safety of SYKFT, for the control of proteinuria in primary glomerulonephritis patients, against the standard drug, losartan potassium.
		                        		
		                        			DESIGN, SETTING, PARTICIPANTS AND INTERVENTION:
		                        			This was a multicenter, double-blind, randomized, controlled clinical trial. Primary glomerulonephritis patients, aged 18-70 years, with blood pressure ≤ 140/90 mmHg, estimated glomerular filtration rate (eGFR) ≥ 45 mL/min per 1.73 m
		                        		
		                        			MAIN OUTCOME MEASURES:
		                        			The primary outcome was change in the 24-hour proteinuria level, after 48 weeks of treatment.
		                        		
		                        			RESULTS:
		                        			A total of 735 participants were enrolled. The percent decline of urine protein quantification in the SYKFT group after 48 weeks was 8.78% ± 2.56% (P = 0.006) more than that in the losartan 50 mg group, which was 0.51% ± 2.54% (P = 1.000) less than that in the losartan 100 mg group. Compared with the losartan potassium 50 mg group, the SYKFT plus losartan potassium 50 mg group had a 13.39% ± 2.49% (P < 0.001) greater reduction in urine protein level. Compared with the losartan potassium 100 mg group, the SYKFT plus losartan potassium 100 mg group had a 9.77% ± 2.52% (P = 0.001) greater reduction in urine protein. With a superiority threshold of 15%, neither was statistically significant. eGFR, serum creatinine and serum albumin from the baseline did not change statistically significant. The average change in TCM syndrome score between the patients who took SYKFT (-3.00 [-6.00, -2.00]) and who did not take SYKFT (-2.00 [-5.00, 0]) was statistically significant (P = 0.003). No obvious adverse reactions were observed in any group.
		                        		
		                        			CONCLUSION:
		                        			SYKFT decreased the proteinuria and improved the TCM syndrome scores of primary glomerulonephritis patients, with no change in the rate of decrease in the eGFR. SYKFT plus losartan potassium therapy decreased proteinuria more than losartan potassium therapy alone.
		                        		
		                        			TRIAL REGISTRATION NUMBER
		                        			NCT02063100 on ClinicalTrials.gov.
		                        		
		                        		
		                        		
		                        	
3.Large- scale prospective clinical study on prophylactic intervention of COVID-19 in community population using Huoxiang Zhengqi Oral Liquid and Jinhao Jiere Granules.
Bo-Hua YAN ; Zhi-Wei JIANG ; Jie-Ping ZENG ; Jian-Yuan TANG ; Hong DING ; Jie-Lai XIA ; Shao-Rong QIN ; Si-Cen JIN ; Yun LU ; Na ZHANG ; Zhi-Hong WANG ; Hai-Yan LI ; Xiao-Ya SANG ; Li-Na WU ; Shi-Yun TANG ; Yan LI ; Meng-Yao TAO ; Qiao-Ling WANG ; Jun-Dong WANG ; Hong-Yan XIE ; Qi-Yuan CHEN ; Sheng-Wen YANG ; Nian-Shuang HU ; Jian-Qiong YANG ; Xiao-Xia BAO ; Qiong ZHANG ; Xiao-Li YANG ; Chang-Yong JIANG ; Hong-Yan LUO ; Zheng-Hua CAI ; Shu-Guang YU
China Journal of Chinese Materia Medica 2020;45(13):2993-3000
		                        		
		                        			
		                        			To scientifically evaluate the intervention effect of Chinese medicine preventive administration(combined use of Huo-xiang Zhengqi Oral Liquid and Jinhao Jiere Granules) on community population in the case of coronavirus disease 2019(COVID-19), a large cohort, prospective, randomized, and parallel-controlled clinical study was conducted. Total 22 065 subjects were included and randomly divided into 2 groups. The non-intervention group was given health guidance only, while the traditional Chinese medicine(TCM) intervention group was given two coordinated TCM in addition to health guidance. The medical instructions were as follows. Huoxiang Zhengqi Oral Liquid: oral before meals, 10 mL/time, 2 times/day, a course of 5 days. Jinhao Jiere Granules: dissolve in boiling water and take after meals, 8 g/time, 2 times/day, a course of 5 days, followed up for 14 days, respectively. The study found that with the intake of medication, the incidence rate of TCM intervention group was basically maintained at a low and continuous stable level(0.01%-0.02%), while the non-intervention group showed an overall trend of continuous growth(0.02%-0.18%) from 3 to 14 days. No suspected or confirmed COVID-19 case occurred in either group. There were 2 cases of colds in the TCM intervention group and 26 cases in the non-intervention group. The incidence of colds in the TCM intervention group was significantly lower(P<0.05) than that in the non-intervention group. In the population of 16-60 years old, the incidence rate of non-intervention and intervention groups were 0.01% and 0.25%, respectively. The difference of colds incidence between the two groups was statistically significant(P<0.05). In the population older than 60 years old, they were 0.04% and 0.21%, respectively. The incidence of colds in the non-intervention group was higher than that in the intervention group, but not reaching statistical difference. The protection rate of TCM for the whole population was 91.8%, especially for the population of age 16-60(95.0%). It was suggested that TCM intervention(combined use of Huoxiang Zhengqi Oral Liquid and Jinhao Jiere Granules) could effectively protect community residents against respiratory diseases, such as colds, which was worthy of promotion in the community. In addition, in terms of safety, the incidence of adverse events and adverse reactions in the TCM intervention group was relatively low, which was basically consistent with the drug instructions.
		                        		
		                        		
		                        		
		                        			Adolescent
		                        			;
		                        		
		                        			Adult
		                        			;
		                        		
		                        			Betacoronavirus
		                        			;
		                        		
		                        			Coronavirus Infections
		                        			;
		                        		
		                        			drug therapy
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		                        			Drugs, Chinese Herbal
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Medicine, Chinese Traditional
		                        			;
		                        		
		                        			Middle Aged
		                        			;
		                        		
		                        			Pandemics
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		                        			Pneumonia, Viral
		                        			;
		                        		
		                        			drug therapy
		                        			;
		                        		
		                        			Prospective Studies
		                        			;
		                        		
		                        			Young Adult
		                        			
		                        		
		                        	
4.Transurethral seminal vesiculoscopy for recurrent hemospermia: experience from 419 cases.
Rui CHEN ; Lei WANG ; Xia SHENG ; Shu-Guang PIAO ; Xin-Wen NIAN ; Xin CHENG ; Tie ZHOU ; Hui-Zhen LI ; Ya-Wei LIU ; Guang-Hua CHEN ; Chun-Lei ZHANG ; De-Pei KONG ; Guang-An XIAO ; Xin LU ; Zhen-Yu JIA ; Zhi-Yong LIU ; Ying-Hao SUN
Asian Journal of Andrology 2018;20(5):438-441
		                        		
		                        			
		                        			We summarized our experience in transurethral seminal vesiculoscopy (TSV) for recurrent hemospermia by introducing surgical techniques, intraoperative findings, and treatment outcomes. TSV was performed in 419 patients with an initial diagnosis of persistent hemospermia at Shanghai Changhai Hospital (Shanghai, China) from May 2007 to November 2015. TSV was successfully performed in 381 cases (90.9%). Hemospermia was alleviated or disappeared in 324 (85.0%) patients by 3 months after surgery. Common intraoperative manifestations were bleeding, obstruction or stenosis, mucosal lesions, and calculus. Endoscopic presentation of the ejaculatory duct orifice and the verumontanum was categorized into four types, including 8 (1.9%), 32 (7.6%), 341 (81.4%), and 38 (9.1%) cases in Types A, B, C, and D, respectively. TSV is an effective and safe procedure in the management of seminal tract disorders. This study may help other surgeons to become familiar with and improve this procedure. However, further multicentric clinical trials are warranted to validate these findings.
		                        		
		                        		
		                        		
		                        			Adult
		                        			;
		                        		
		                        			Ejaculatory Ducts/surgery*
		                        			;
		                        		
		                        			Endoscopy/methods*
		                        			;
		                        		
		                        			Hemospermia/surgery*
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Magnetic Resonance Imaging
		                        			;
		                        		
		                        			Male
		                        			;
		                        		
		                        			Middle Aged
		                        			;
		                        		
		                        			Seminal Vesicles/surgery*
		                        			;
		                        		
		                        			Tomography, X-Ray Computed
		                        			;
		                        		
		                        			Treatment Outcome
		                        			;
		                        		
		                        			Urethra/surgery*
		                        			
		                        		
		                        	
5.Construction of right ventricular pulmonary artery coupling model in patients with pulmonary hypertension
Chang-Dong ZHANG ; Jun TIAN ; Xiao-Ke SHANG ; Rong LU ; Mei LIU ; Yi-Hua LIU ; Bin WANG ; Shu CHEN ; Jie WU ; Yong-Feng SUN ; Geng LI ; Nian-Guo DONG
Chinese Journal of Interventional Cardiology 2018;26(5):261-267
		                        		
		                        			
		                        			Objective To study the mechanism of right ventricular pulmonary artery coupling by fitting the pressure volume loop of pulmonary arterial hypertension patients and calculating the related parameters.Methods During January of 2015 to December of 2015,34 patients with pulmonary hypertension and 5 patients with patent oval foramen(PFO)were admitted in Wuhan Asian Heart Hospital,. Inclusion criteria for the pulmonary hypertension group were in accordance with the newest European guidelines for pulmonary hypertension . All of the patients were conducted invasive pressure catheter intervention and MRI. All the pressure data were digitized by GetData software and the CMR tools3D was used to derive right ventricular volume data, fitting the pressure volume loop and calculate the Pmax, Ees, Ea and other related parameters. 5 patients with PFO and 34 patients with pulmonary hypertension were divided into three groupswhich included:the control group (i.e. the patients with PFO), patients with pulmonary artery mean pressure less than 50 mmHg as group A and pulmonary artery mean pressure greater than or equal to 50 mmHg as group B. The pressure volume loop of the three groups were compared and the related parameters were calculated.Results The right ventricular Pmax were(53.05±12.87) mmHg, (134.73±26.38) mmHg, (207.88±65.67) mmHg, in the control group, group A and B respectively. There were significant differences when compared among the 3 groups. There was no statistical difference in Ees between the control group and group A(P>0.05). The Ees of group B was significantly higher than the control group[(1.53±0.97)vs.(0.60±0.28),P<0.05]. The Ea of group B was higher than the control[(1.34±0.74) vs.(0.39±0.15),P<0.05]. The overall ratio of Ees/Ea was lower in group B as compared to the control group [(1.12±0.47)vs.(1.62±0.51),P<0.05].Conclusions In the early stage of pulmonary hypertension, right ventricular contractility preserves and can overcome the slightly elevated afterload .The right ventricle and pulmonary artery coupled with good work. With the increasing mean pulmonary artery,the afterload of right ventricular increases and right ventricular contractility needs further increase to fight against the elevated afterload. The elevation of contractility cannot overcome the change of afterload, resulting in the off paired of mechanical efflciency, causing the right ventricle- pulmonary artery coupling decreases.
		                        		
		                        		
		                        		
		                        	
6.Determination of effective components and analysis of antioxidant enzyme activities of Ampelopsis grossedentata under different breeding modes
Yao-Bing CHEN ; Nian JIANG ; Zi-Wei SUN ; Shu-Rui TENG ; Xiao-Jiang ZHENG
Chinese Traditional Patent Medicine 2018;40(2):399-403
		                        		
		                        			
		                        			AIM To determine effective components of Ampelopsis grossedentata (Hand.-Mazz.) W.T.Wang under different breeding modes and to analyze the antioxidant enzyme activities.METHODS Single factor and orthogonal tests were adopted in screening the optimal extraction process of antioxidant enzymes and analyzing antioxidant enzyme activities of A.grossedentata under common cutting,two-phase cutting and tissue culture.Solvent extraction method was adopted in extracting the effective components of three breeding modes in stem leaves of A.grossedentata,whose contents were determined.RESULTS In three breeding modes,the content of polysaccharides in tissue culture seedling was the highest,while the contents of flavonoids and polyphenols in the two stage cutting seedlings were the highest.The optimal extraction process of antioxidant enzymes was determined to be 6.0 for pH,20 ℃ for processing temperature and 20 min for processing time.Antioxidant enzyme activities were in sequence of two stage cutting seedlings > common cutting seedling > tissue culture seedling.CONCLUSION Considering the contents of effective components and antioxidant enzyme activities,two stage cutting method is the best among 3 breeding modes.
		                        		
		                        		
		                        		
		                        	
7.Identification of gene mutation associated with familial dilated cardiomyopathy by whole-exome sequencing
Nian-Wei ZHOU ; Sheng-Mei QIN ; Yang LIU ; Wei-Peng ZHAO ; Jie CUI ; Cui-Zhen PAN ; Rui-Zhen CHEN ; Xiao-Lin WANG ; Xian-Hong SHU
Fudan University Journal of Medical Sciences 2018;45(2):164-168
		                        		
		                        			
		                        			Objective To identify the disease-causing gene in a Chinese pedigree with familial dilated cardiomyopathy (DCM) by whole-exome sequencing.Methods After collecting the clinical data and extracting the whole blood genomic DNA of the 5 family members form a Chinese DCM pedigree,whole-exome sequencing was performed to search the causative genes.Familial co-segregation analysis among the pedigree was subsequently confirmed by traditional Sanger sequencing.Results We performed whole exome sequencing (WES) on representative affected individuals and unaffected familial members from this pedigree.After comparison with variants identified in affected individuals and unaffected individuals,along with previously reported genetic mutations associated with DCM,we found that a heterozygous variant c.961 C>T (p.Arg321Ter) in exon 6 of the LMNA gene in affected individuals matched the criteria to be the potential disease-causing gene,which was confirmed by Sanger sequencing.This stop-gain mutation leads to only a small part of LMNA-coding protein expressed,therefore we concluded that LMNA c.961 C>T should be the causative mutation for this familial DCM case.Conclusions The nonsense mutation c.961 C> T in gene LMNA identified by whole-exome sequencing might be the pathogenic mutation in this DCM pedigree.
		                        		
		                        		
		                        		
		                        	
8.Analysis of Factors Associated with Death in Maintenance Hemodialysis Patients: A Multicenter Study in China.
Kang-Kang SONG ; De-Long ZHAO ; Yuan-Da WANG ; Yong WANG ; Xue-Feng SUN ; Li-Ning MIAO ; Zhao-Hui NI ; Hong-Li LIN ; Fu-You LIU ; Ying LI ; Ya-Ni HE ; Nian-Song WANG ; Cai-Li WANG ; Ai-Hua ZHANG ; Meng-Hua CHEN ; Xiao-Ping YANG ; Yue-Yi DENG ; Feng-Min SHAO ; Shu-Xia FU ; Jing-Ai FANG ; Guang-Yan CAI ; Xiang-Mei CHEN
Chinese Medical Journal 2017;130(8):885-891
BACKGROUNDPatients on hemodialysis have a high-mortality risk. This study analyzed factors associated with death in patients on maintenance hemodialysis (MHD). While some studies used baseline data of MHD patients, this study used the most recent data obtained from patients just prior to either a primary endpoint or the end of the study period to find the characteristics of patients preceding death.
METHODSParticipants were selected from 16 blood purification centers in China from January 2012 to December 2014. Patients' data were collected retrospectively. Based on survival status, the participants were divided into two groups: survival group and the death group. Logistic regression analysis was performed to determine factors associated with all-cause mortality.
RESULTSIn total, 4104 patients (57.58% male, median age 59 years) were included. Compared with the survival group, the death group had more men and more patients with diabetic nephropathy (DN) and hypertensive nephropathy. The patients preceding death also had lower levels of diastolic blood pressure, hemoglobin, serum albumin, serum calcium, serum phosphate, Kt/V, and higher age. Multivariate analysis revealed that male sex (odd ratio [OR]: 1.437, 95% confidence interval [CI]: 1.094-1.886), age (OR: 1.046, 95% CI: 1.036-1.057), and presence of DN (OR: 1.837, 95% CI: 1.322-2.552) were the risk factors associated with mortality. High serum calcium (OR: 0.585, 95% CI: 0.346-0.989), hemoglobin (OR: 0.974, 95% CI: 0.967-0.981), albumin (OR: 0.939, 95% CI: 0.915-0.963) levels, and dialysis with noncuffed catheter (OR: 0.165, 95% CI: 0.070-0.386) were protective factors based on a multivariate analysis.
CONCLUSIONSHemodialysis patients preceding death had lower hemoglobin, albumin, and serum calcium levels. Multivariate analysis showed that male sex, age, DN, low hemoglobin, low albumin, and low serum calcium were associated with death in hemodialysis patients.
Adult ; Aged ; China ; Female ; Humans ; Male ; Middle Aged ; Multivariate Analysis ; Renal Dialysis ; adverse effects ; mortality ; Retrospective Studies ; Risk Factors
9.Assessment of pressure-volume loop in patients with pulmonary hypertension and the correlation with New York Heart Function Classification
dong Chang ZHANG ; na Shu XIAO ; ke Xiao SHANG ; Rong LU ; jun Li WANG ; Jun TIAN ; guo Nian DONG ; Mei LIU ; hua Yi LIU
Chinese Journal of Interventional Cardiology 2017;25(9):512-519
		                        		
		                        			
		                        			Objective  To analyze the correlation between the pressure volume parameters and cardiac function in terms of New York Heart Association(NYHA) classification in patients with pulmonary arterial hypertension. Methods  Among 36 patients with pulmonary hypertension admitted in our center between April 2015 to June 2016, right heart catheterization recording right atrial pressure curve,right ventricular pressure curve,pulmonary arterial pressure and oxygen saturation curve in different parts was performal.All patients recived underwent cardiac MRI examination to obtain a single cardiac cycle and the use of Mass software to measure right ventricular volume continuously and right ventricular pressure-volume loop parameters were then obtained. Patients were divided into different groups according to the NYHA functional classification, and the correlation between the parameters of each group and the cardiac function classes a were analyzed. Results  Compare to patients with NYHA class Ⅰheart function,patients with NYHA heart function class Ⅱ and class Ⅲ had significantly higher right ventricular end diastolic pressure(P < 0.05)and higher right ventricular systolic pressure (P < 0.01). Spearman correlation analysis showed that cardiac function of NYHA classⅠ,Ⅱ and Ⅲhad position correlation with RVESV,RVEDP and RVESP wheras negative correlation with RVEDV. ROC curve analysis showed that,when the patients were divided into 2 groups as NYHAⅠvs. NYHA class Ⅱ + Ⅲ,NYHA classification for predicting the outcome of the NYHA class Ⅱ + Ⅲ level, pulmonary artery elasticity and right ventricular end systolic pressure had larger area under curves respectively. Conclusions  Pressure-volume parameters of right ventricles are more objective indicators for cardiac function assessment for pulmonary hypertension patients and evaluation of disease progression especialy in patients with mild symptoms.
		                        		
		                        		
		                        		
		                        	
10.Efficacy of Bosentan in patients after Fontan procedures: a double-blind, randomized controlled trial.
Xiao-Ke SHANG ; Rong LU ; Xi ZHANG ; Chang-Dong ZHANG ; Shu-Na XIAO ; Mei LIU ; Bin WANG ; Nian-Guo DONG
Journal of Huazhong University of Science and Technology (Medical Sciences) 2016;36(4):534-540
		                        		
		                        			
		                        			Fontan surgery is a widely used palliative procedure that significantly improves the survival period of patients with complex congenital heart disease (CHD). However, it does not decrease postoperative complication rate. Previous studies suggested that elevated mean pulmonary artery pressure (mPAP) and vascular resistance lead to decreased exercise tolerance and myocardial dysfunction. Therapy with endothelial receptor antagonists (Bosentan) has been demonstrated to improve the patients' prognosis. A double-blind, randomized controlled trial was performed to explore the efficacy of Bosentan in treating patients who underwent the Fontan procedure. Eligible participants were randomly divided into Bosentan group and control group. Liver function was tested at a local hospital and the results were reported to the phone inspector every month. If the results suggested abnormal liver function, treatment would be adjusted or terminated. All the participants finished the follow-up study, with no patients lost to follow-up. Unblinding after 2-year follow-up, no mortality was observed in either group. However, secondary end-points were found to be significantly different in the comparable groups. The cardiac function and 6-min walking distance in the Bosentan group were significantly superior to those in the control group (P=0.018 and P=0.027). Bosentan could improve New York Heart Association (NYHA) functional status and improve the results of the 6-min walking test (6MWT) in Fontan patients post-surgery, and no other benefits were observed. Furthermore, a primary meta-analysis study systematically reviewed all the similar clinical trails worldwide and concluded an overall NYHA class improvement in Fontan patients who received Bosentan treatments.
		                        		
		                        		
		                        		
		                        			Adolescent
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		                        			Child
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		                        			Double-Blind Method
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		                        			Female
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		                        			Follow-Up Studies
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		                        			Fontan Procedure
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		                        			Heart Defects, Congenital
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		                        			drug therapy
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		                        			pathology
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		                        			surgery
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		                        			Humans
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		                        			Liver
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		                        			drug effects
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		                        			pathology
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		                        			Male
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		                        			Palliative Care
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		                        			Prognosis
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		                        			Sulfonamides
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		                        			administration & dosage
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		                        			Treatment Outcome
		                        			
		                        		
		                        	
            
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