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Objective:The study aims to analyze the problems faced in the clinical research and management of stem cells, explore the construction of the entire process of stem cells clinical research, and promote the healthy and orderly development of the clinical research of stem cells.Methods:By consulting the literature and retrieval of relevant policies and regulations, this study analyzed the problems faced by the supervision and management department, medical institutions and researchers, this study and discussed the countermeasures for strengthening the management of the entire process of clinical research of stem cells in medical institutions.Results:There were imperfect internal system and poor management process, insufficient quality control of cell products, low quality of project management, and insufficient clinical research consciousness of stem cell clinical research management in medical institutions.Conclusions:Combined with the current management measures, guidance principles and medical institutions, we should improve the internal system of medical institutions, promote the centralized management and informatization construction of projects, strengthen cell quality control in the hospital, cultivate talent echelons and improve academic and ethical review capabilities, actively explore the management model that is suitable for the entire process of stem cell clinical research for medical institutions in China.
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Objective:To analyze and study the difficulties and countermeasures in the implementation of the Qualified Person(QP) system for stem cell clinical research, and share the experience of QP management practice in our hospital in order to promote and improve the construction of the QP management system in medical institutions.Methods:Comprehensive investigations were conducted to summarize and analyze the shortage of talents, unclear qualifications, unclear responsibilities, and lack of assessment standards in the QP system of medical institutions.Results:In view of the difficulties in the implementation of the current QP system, it is suggested to consider a combination of improving the system of laws and regulations, strengthening the top-level design of stem cell research institutions, clarifying the qualification threshold, refining QP responsibilities, continuing training and assessment system, establishing QP support system, etc.Conclusions:Medical institutions are responsible for stem cell clinical research, and the improvement of the QP system can promote the development of the cell industry in China.
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Objective:To explore the application of information management platform for Investigator Initiated clinical trials (IIT).Methods:Elaborate the design and application of Clinical Information Management Platform (CIMP). Discuss the obstacles in platform development.Results:Compared with regions where clinical research is more developed, there is still a lack of standardized and efficient information management methods in China. Through the construction of the IIT information management platform, the scientific management of the IIT and the SWOT analysis of the use of the platform have been conducted. Further exploration and improvement are needed in terms of the collaboration of the information platform, data standardization, and information sharing security.Conclusions:The management efficiency can be improved by applying CIMP, which will also promote the smooth implementation of IITs.
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Objective With the fast development of Investigator-Initiated Trials (IIT),more and more resources from the national and local governments,universities and hospitals were invested.It is important to clarify the content and methodologies of quality evaluation of the IITs at the early approval stage to assure more complete and systematic quality assessment,improve resource allocation,enhance the research ability,as well as the protection of human subject.Methods This article summarized the content and related safeguarding measures of quality assessment during the early stage of project setup.Discussed relative practice and experiences of our center.Results The contents of quality evaluation include research topic,study protocol,research team and qualifications,quality assurance plan and risk management.The organizing work and attention of the research administrative department,qualified departments and experts,as well as information platform are the required safeguarding measures for effective assessment.Conclusions Quality evaluation of IITs at the early approval stage is critical segment of study quality assurance.More attention should be paid to make every effort counts.
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Recruitment advertising for clinical trials is a communication carrier of research information prior to participants' participation in the trial, and an important part of the form to recruit and inform subjects. Recruitment advertising should include the necessary information about the clinical trial, but cannot contain the inappropriate content such as those misleading and inducting information, and the content and the modality of advertising must be approved by ethics committee before being used. At present, there are laws and regulations, ethical review, re-searchers' understanding, non-standard operation and other issues in the advertising for recruitment. Therefore, it ' s need to continuously strengthen the ethical review and management of advertising to protect the rights and inter-ests of subjects from the angles of improving relevant laws and regulations, enhancing ethical review ability, raising researchers' awareness and strengthening fighting force on the illegal activities and so on.
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Objective To discuss the clinical application value of omeprazole and rabeprazole quadruple therapy on Helicobacter pylori associated peptic ulcer.Methods 360 patients with Helicobacter pylori associated peptic ulcer were selected.They were divided into two groups randomly.The rabeprazole group (180 cases) was treated with rabeprazole with quadruple therapy based,omeprazole group (180 cases) was treated with omeprazole quadruple therapy of short acting as the foundation,to observe and record the two groups of patients with clinical curative effect,the healing rate of ulcer,Helicobacter pylori eradication rate,histopathology and treatment of gastric mucosa during adverse reaction condition.Results The cure rate of rabeprazole group was significantly higher than that of omeprazole group (P ＜ 0.05).Compared the two groups before treatment,upper abdominal pain,abdominal discomfort,belching symptoms,no significant difference,the two groups after treatment in patients with upper abdominal pain,abdominal discomfort and belching percentage of patients decreased,and Rebela was the proportion of patients with lower group (P ＜ 0.05).After treatment,the rabeprazole group of ulcer healing rate 90.5％ (163/180),Helicobacter pylori eradication rate was 87.8％ (158/180),omeprazole group of ulcer healing rate was 70.5％ (127/180),Helicobacter pylori eradication rate was 72.2％ (130/180).The rabeprazole group of the healing rate of ulcer and Helicobacter pylori eradication rate were higher (P ＜ 0.05).Before treatment,there was no significant difference on gastric mucosal histopathological score between two groups.After treatment,two groups of gastric mucosa pathological score were decreased (P ＜ 0.05),no difference between the two groups.During the treatment,there was no significant difference on adverse reactions between two groups.Conclusion Rabeprazole with short acting quadruple therapy can significantly treat Helicobacter pylori causes,promote gastric mucosa repair,improve the clinical symptoms of peptic ulcer,the medication is safe,it is worthy of clinical use.
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OBJECTIVE:To investigate the anti-inflammatory and analgesic effects of mongolian medicine Cymbaria dahurica extract. METHODS:96 KM mice(or SD rats)were randomly divided into model group(water),positive control group(aspirin, 0.5 g/kg),C. dahurica ethanol extract (70% ethanol) low-dose,medium-dose and high-dose groups (0.325,0.650,1.300 g/kg, calculated by crude drug) and C. dahurica aqueous extract of the residue of alcohol extraction low-dose, medium-dose and high-dose groups(0.325,0.650,1.300 g/kg,calculated by crude drug). They were given relevant medicine intragastrically,once a day,for consecutive 7 d. The xylene-induced ear edema method was used to determine the degree of ear edema,and egg white-in-duced paw edema method was used to determine paw edema after inducing inflammation 1,2,4,6 h;anti-inflammatory activity of C. dahurica extract was investigated. 96 KM mice were grouped and given medicine with same method;the number of writhing within 20 min was determined by acetic acid writhing method. Another 64 KM mice were grouped with same method,with 8 mice in each group;except positive control group was given tramadol hydrochloride(0.5 g/kg)intragastrically,other groups were given relevant medicine with same method. Pain thresholds of mice were determined by hot-plate test before and after medication 30,45, 60,90 min,and analgesic effects of C. dahurica extract were investigated. RESULTS:Compared with model group,C. dahurica extract could obviously restrain the ear edema of mice and paw edema of rats 6 h after egg white-induced inflammation. Except paw edema of rats in C. dahurica aqueous extract of the residue of alcohol extraction high-dose group was decreased slightly,there was statistical significance among other groups (P<0.05 or P<0.01). C. dahurica extract decreased the number of writhing in mice within 20 min,and extended pain thresholds of mice 30,60,90 min after medication (P<0.05). CONCLUSIONS:Both C. dahurica ethanol extract and aqueous extract of the residue of alcohol extraction posses certain anti-inflammatory and analgesic effects.
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Objective To analyze the clinical data of recipients over 15 years after renal transplantation,and to find the factors that affect the long-term survival of recipients after renal transplantation.Method Before June 30,2000,326 renal transplant recipients in our hospital were collected retrospectively.The risk factors which affect the survival of kidney transplant recipients and kidney were analyzed from four dimensions.A Cox model was established to analyze these multi factors.Result Cox hazard model indicated that advanced age (P=0.010,RR =1.052),AMR (P＜0.001,RR =18.311),nonadherence (P =0.001,RR =2.854),smoking (P =0.025,RR =2.097)were the risk factors for recipients' survival.Using immunosuppressive regimen FK506 + MMF+ Pred (P =0.019,RR =0.433),or CsA + MMF + Pred (P =0.019,RR =0.413) was the protective factor for recipients' survival.Nonadherence (P＜0.001,RR =5.645),and diabetes (P＜0.001,RR =3.310) were the risk factors of grafts' survival.Using immunosuppressive regimen FK506 + MMF + Pred (P＜0.001,RR =0.236),or CsA + MMF + Pred (P =0.002,RR =0.317) was the protective factor of grafts' survival.Conclusion To enhance the long-term outcome of recipients and grafts,the individualization of immunosuppressive regiments and controlling of the chronic diseases progress by changing the unhealthy life style are cutting on edge.
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Objective Data on applications and grants of general program on health science of National Natural Science Fund from Shanghai First People's Hospital,Shanghai Jiao Tong University (SFPH) during 2011-2014 were analyzed with an attempt to explore the ways to promote the funding rate.Methods x2 test and t test were performed,and a binary Logistic regression model was established to determine variables influencing the results of applications.Results There were 367 applications in SFPH during 2011-2014,86 of which were granted.The funding rate was higher than that of Department of Health Science.The total and highest impact factor of SCI articles published by applicants of granted programs were both higher than those of non-granted programs.The significance of these two factors in predicting whether an application will be granted was confirmed by the results of Logistic regression analysis.Conclusions SCI article is an important aspect of academic achievements of applicants,which is a prerequisite for an application to be granted.However,a scientific and innovative project may be critical for the outcome of an application.
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Objective To explore the clinical eficacy of umbilical cord blood stem cell transplantation in treatment of decompensated cirrhosis.Methods Thirty patients with decompensated cirrhosis were given umbilical cord blood stem cell transplantation (treatment group) and 30 patients with decompensated cirrhosis were given traditional treatment (control group).Liver function and blood coagulation function was tested after 4,8 weeks treatment respectively,and adverse effects were recorded at the same time.Results After 8 weeks treatment,total bilirubin,albumin and prothrombin time in treatment group was improved compared with that before treatment[(71.3 ± 37.8) μ mol/L vs.(107.3 ± 53.2) μ mol/L,(30.1 ± 4.9) g/L vs.(27.5 ± 5.1) g/L,(15.0 ± 2.9) s vs.(16.7 ± 3.9) s],and there was significant difference (P ＜ 0.05).There was no significant difference in the index before and after treatment in control group (P＞ 0.05).No obvious adverse reactions were observed in the process of umbilical cord blood stem cell transplantation.Conclusion Umbilical cord blood stem cell transplantation is safe and effective in treatment of deeompensated cirrhosis.
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In China , some ophthalmic new drug clinical trials used placebo as control .Two principles should be con-sidered in ethical review when placebo was used in these ophthalmic new drug clinical trials .Firstly, using placebo couldn't lead to irreversible or permanent vision loss .Secondly , there should be proper risk management in protocol and risk dis-closure in consent process .There are several important factors , including effects of standard treatment , risks of using pla-cebo, risk management in protocol and risk information in informed consent form , which should be used to assess the ra-tionality of placebo in ethical review .
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ObjectiveTo evaluate the prevention and treatment of primary graft dysfunction (PGD) after lung transplantation (LTx).MethodsWe retrospectively analyzed clinical data of108 cases of lung transplantation from September 2002 to June 2011. All the recipients were given continuous monitoring of invasive arterial pressure,pulmonary artery pressure and (or) central venous pressure and artery blood gas analysis and chest X-ray examination postoperatively.The negative fluid balance of the recipients in the first 3 days was maintained.The inspired oxygen (FiO2) or ventilator parameters was adjusted according to the arterial oxygen tension (PaO2) and (or) oxygen saturation,to prevent the occurrence of PGD.Once PaO2/FiO2 sharp decline (less than 200),and chest X-ray showed higher density of the lower transplanted lung fields in the early postoperative period,PGD could be diagnosed when acute rejection,venous anastomotic obstruction,cardiogenic pulmonary edema and pulmonary infections were excluded.According to the standards set by the International Association of Heart and Lung Transplantation,PGD is divided as 0,1,2 and 3.Different levels of PGD were treated by ventilatory support,negative fluid balance,extending the treatment time of the ventilator,the use of pulmonary vasodilators,such as prostaglandin E1and the use of ECMO.Results PGD occurred in10 cases,and the incidence rate was 9.3％. 6 cases were given conventional ventilatory support for (285.8 + 238.6) h (Two cases obtained reversal of PGD,and four cases died) ; the rest four cases were given ECMO (Two cases were supported by ECMO in 24 h after the occurrence of PGD and had a long-term survival after a successful reversal of PGD,and the rest two cases died from acute renal failure and multiple organ failure induced by PGD on the 8th and11th day of the application of ECMO due to the late application of ECMO (after 24 h).ConclusionThe high incidence of PGD causes high mortality perioperatively after lung transplantation.Preventing PGD can improve the survival rate of the lung transplant patients.Once PGD happens,appropriate treatment should be given as soon as possible.
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Objective To analyze the diagnosis and treatment of airway stenosis in a consecutive series of bronchial anastomosis after lung transplantation in our center.Methods We performed a retrospective study on 100 cases of lung transplants in our center from September 2002 to December 2010.Seventy-two cases were subjected to single lung transplants (SLT), and twenty-eight to bilateral sequential single lung transplantation (BSSLT). There were totally 128 bronchial anastomoses.All recipients received long-term follow-up to monitor the lung function.Lung CT and fibrobronchoscopic examinations were done when necessary. Results Twenty-five cases with 37 bronchial anatomoses were died.A total of 12 airway stenosis occurred in 10 cases (12/128,9.4 ％).Four cases underwent telescopic anastomosis and 6 cases underwent end-to-end anastamosis.Mean diagnosis time was 60.1 35.6 days post-operation (ranging from 15-120 days,median 59 days).There were 8 cases of unilateral airway stenosis (3 on the left,and 5 on the right) and 2 cases of bilateral airway stenosis.The number of simple airway stenosis was 3,that of exophytie granulation tissue was 8,and that of bronchus intermedius stenosis was 1.Culture of bacteria by fibrobronchoscopy with protected specimen brush revealed:3 strains of Pseudomonas aeruginosa,2 strains of Klebsiella pneumoniae,2 strains of Aspergillus,1 strain of Escherichia Coli. 10 cases were treated with fiberoptic bronchoscopic balloon dilation:5 cases with high-frequency electrotome,4 cases with stent placement,and 1 case with argon plasma coagulation (APC).Seven cases were cured or improved and 3 cases died.Conclusion Airway stenosis after lung transplantation remains a major problem.The fiberoptic bronchoscopic procedure is the gold standard to diagnose. The preferred treatment is fiberoptic bronchoscopic balloon under expansion,and other approaches include high-frequency electrotome,APC and stem placement,etc.
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Objective To estimate the indications, operative technique, perioperative treatment, postoperative complications and the outcome of lung transplantation (LTx) for end-stage pulmonary diseases. Methods The clinical data of 100 patients with end-stage lung diseases receiving LTx in our hospital were retrospectively analyzed. The main indications for LTx were as follows:idiopatic pulmonary fibrosis (IPF, 47/100), chronic obstructive pulmonary disease (COPD, 33/100),silicosis (5/100 ), bronchiectasis ( 5/100 ), Eisenmenger syndrome (4/100 ), secondary lung tuberculosis (2/100), idiopathic pulmonary hypertension ( 2/100 ), lung lymphangioleiomyomatosis ( 1/100), primary alveolar cell carcicoma (1/100). There were 72 patients receiving single LTx and 28 patients receiving bilateral LTx. Sixty-one patients received lTx under circulation support, including 5 cases of cardiopulmonary bypass (CPB) support and 56 cases of extracorporeal membrane oxygenation (ECMO) support. All the patients were followed up when they discharged from our hospital. The issues including postoperative complications and prognosis were observed. Results The perioperative survival rate was 82. 0 % (82/100). There were 18 deaths in early stage (30 days) after LTx: 10 due to pulmonary infection, 6 due to primary graft dysfunction (PGD), 1 due to acute rejection (AR) and 1 due to pulmonary infarction. The common complications included lung infection (11 cases), PGD (10 cases), AR (3 cases), tracheostenosis (10 cases), stoma fistula (3 cases),hemorrhage (3 cases), pulmonary embolism (3 cases), pulmonary artery stenosis (one case) and thrombus in the deep veins of lower limb (one case). During long-term follow-up period, 15 patients developed obliterative bronchiolitis, and one patient suffered from lung cancer in his contralateral native lung. The 1-, 2-, 3- and 5-year survival rate after LTx was 73.3 %, 61.6 %, 53.5 % and 40. 7 % respectively. Conclusion LTx is an effective therapy for various end-stage pulmonary diseases. Perioperative mortality is especially high in patients undergoing LTx. Consummate perioperative management is the key to increase survival rate.
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Objective To evaluate the operative technique, perioperative management and outcomes of bilateral lung transplantation for idiopathic pulmonary artery hypertension. Methods There were 2 cases of idiopathic pulmonary hypertension subject to bilateral sequential lung transplantation with ECMO support (16, 17 years old, respectively). The pulmonary artery pressure was 10/70 and 148/72 mm Hg respectively. The heart function was NYHA Ⅳ, the operative procedure was right lung first, then left lung, and the cold ischemia time was 230 min/430 min and 185 min/300 min respectively. The ECMO support time was 550 min and 450 min respectively. The blood loss during the operation was 3000 and 1200 ml, respectively. Resuits The ECMO was withdrawn 16 and 13 h postoperation respectively. There was unstable hemadynamics and acute left heart failure on the 3rd and 4th day after the operation. The patients were treated with ventilate support and tracheotomy on 3rd and 6th day respectively. Additionally, the patients were given cardiotonic, dieresis and the ventilation was withdrawn on 33rd and 12th day after the operation respectively. They were discharged from the hospital on 93rd and 32nd day after the operation. The heart function both reached NYHA I, two cases were followed up for 25 and 10 months respectively.Both of them had an excellent quality life. Conclusion Bilateral lung transplantation is effective for end-stage idiopathic pulmonary artery hypertension even with slight right ventricular dysfunction with satisfactory short-term outcome. A limited operative time, an ECMO support for heart and lung during the peri-operative period and a perfect management for the left ventricular dysfunction after surgery are key roles for the success. Closed follow-up and surveillance are needed for long-term outcomes.
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Objective To observe the therapeutic effects of lung transplantation for diffuse pulmonary disease. Methods From September 2002 to April 2009, lung transplantation was performed on 72 cases in our hospital. Thirty-seven cases of these recipients were suffered from diffuse pulmonary disease, including idiopathic pulmonary fibrosis (30/37), pneumosilicosis (4/37), vascular leiomyoma (2/37) ,diffuse panbronchiolitis (1/37),30 males and 7 females with age ranging from 22 to 73 years old (mean 52.9 ± 13.2). All the patients received pulmonary function test and echocardiography (ECHO) to test the pulmonary artery systolic pressure before transplantation and artery blood gas to calculate the oxygenation index (PaO2/FiO2 ). Results The systolic pulmonary artery pressure (Ppa,syst) was monitored by Swan-Gans catheterization one week post-transplant, and decreased significantly from 54. 30 ± 17. 41 to 41.52 ± 9. 36 mm Hg (P＜0. 05). Simultaneously, oxygenation index was improved from 185. 89 ± 77. 25 to 392. 12 ± 98. 23 (P＜0. 05). The pulmonary function was also improved significanzly one month post-operation. The volume in the first second was improved from (1.33 ± 0. 64) to (1.81 ± 0. 57) L, and the diffusion capacity of carbonmonoxide was increased from (2. 87 ± 1.26) to (4. 22 ± 2. 05) L. Conclusion Lung transplantation is feasible and efficient to deal with diffuse pulmonary disease.
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Objective Analysis of the operational efficiency trends of and problems with the public tertiary hospitals. Methods A retrospective statistics analyzed the indicators of ten public tertiary general hospitals in Shanghai during 1997-2006. Results The outpatients number per capita for the hospital staff maintains an rising trend, averaging 12.2% per year prior to year 2000; The yearly-averaged total assets turnover of the hospitals decreases from 0.89 in 1997 to 0.69 in 2003, then maintaining unchanged; The yearly-averaged receivables turnover began to fall since 1999, falling from 21.4 in 1999 to 9.7 in 2006; hospital income growth fluctuated during the years, yet with a high level of total assets growth; given the fluctuations in asset-liability ratio, such ratio has been growing slowly, maintaining at 20 % since 2004. Conclusion Problems are found with the operational efficiency of these public tertiary general hospitals as follows: the rapid growth of productivity in such hospitals finds no concurrent improvements in assets related indicators. Against a low income ratio, high debt ratio will plague hospital development to some extent.
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Objective To discuss the feasibility of the lung transplantation as an effective treatment for end-stage pulmonary diseases domestically and to compare the major issues involving the practice of lung transplantation domestically and overseas.Methods After the foundation of group of lung transplantation in May 2002, lung transplantation models of porcine were set up. From September 2002 to April 2005, in the 18 cases undergoing lung transplantation, there were subjected to single-lung transplantion (SLT, 83.3%) and 3 bilateral sequential single lung transplants without CPB (DSSLT, 16.7%). Indications for SLT (n=15) included emphysema (n=9), pulmonary fibrosis (n=3), pneumosilicosis (n=1), lymphangioleiomyomatosis (n=1) and ventricular septal defect (VSD) induced Eisenmenger's syndrome (n=1); for DSSLT (n=3) bronchiectasis (n=1) and pulmonary emphysema (n=2). Among the 15 SLTs, there were 9 cases of left SLT and 6 right SLT. Among them, 2 cases shared one same donor's lung block, one case received contralateral lung transplantation―a left donor lung implanted in the recipient’s right thorax, and one case simultaneous right SLT and VSD repair. Results In hospital mortality (HM) was 3/18 ( 16.7%). Among SLTs, early death was due to severe rejection on the 30th postoperative day in one patient and acute rejection on the 15th postoperative day in other patients, and another patient died due to pulmonary vein embolism on the 36th day. There were 3 and 2 patients with the survival time longer than 1 and 2 years respectively. The median overall survival was 10 (2 to 32) months. Conclusions Our LT program shows similar results to those reported by the International Society for Heart and Lung Transplantation for developed countries. The key of successful operation depends on the establishment of group of lung transplantation and cooperation of multi-department. Ischemic-reperfusion injury, acute-rejection and infection are the major reasons of deaths shortly after the operations.
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Objective To compare the difference in cost formation between hemodialysis and peritoneal dialysis so as to provide basis for the formulation and perfection of medical security policies. Methods An analysis was made of the cost formation and profits of hemodialysis and peritoneal dialysis in 4 hospitals of Shanghai in 1999. Results Of the average cost of each performance of hemodialysis, the cost of materials accounted for 35% to 47% and the cost of equipment accounted for 38% to 44%, while the scope of increase in profits was affected both by the number of patients and the average profits per performance. Of the average cost of each performance of peritoneal dialysis, the cost of materials exceeded 97% while profits were related only to the number of patients. Conclusion There is a marked difference in profits between the two forms of dialysis, leading to an improper expansion in the use of hemodialysis and an inhibition in the rational use of the technique of peritoneal dialysis.
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Objective To investigate the protective immunity of the vaccine against schistosomiasis,a mutant of Mr 23 000 membrane protein DNA(Sj23DNA) without the homologous sequence of ME491.Methods The mutant of Sj23 DNA with no homologous sequence of ME491 on the cell membrane of human melanoma was obtained by overlap PCR.The mutant was transfected into human embryonic kidney cells of the line HEK293.Indirect fluorescent antibody test(IFAT) was used to detect the expressed protein.Expression of the mutant of Sj23DNA in muscular cells of mice was conducted through vaccinating the mouse with 100 ?g purified plasmids by injecting them into the quadriceps muscle of thigh.Four weeks after the immunization,the quadriceps muscles were taken and cryostat sections were prepared for detecting the expression by IFAT.Forty BALB/c mice were randomly divided into four groups and injected with the mutant of pcDNA3-Sj23 plasmid DNA,pcDNA3-Sj23 plasmid DNA,pcDNA3 blank plasmid(100 ?g per mouse) and sterile saline(30 ?l per mouse) respectively.Four weeks after the immunization,mice were challenged with cercariae(40?2 cercariae per mouse) by abdominal skin penetration.Mice were then killed 6 weeks later,perfusion and squash methods were carried out to collect the adult worms and the number of eggs per gram of liver tissue was calculated.Worm and egg reduction rates were used to evaluate the protective immunity.Results Specific fluorescence was demonstrated in muscular cells of mice vaccinated with the mutant of pcDNA3-Sj23.The worm reduction rate and egg reduction rate were 40.3% and 42.8% respectively in the mutant of pcDNA3-Sj23 group,which were higher than those in the pcDNA3-Sj23 plasmid group(33.1% and 28.9% respectively).The difference between these two groups was significant(P