Relationships among the Dosage of Erythropoiesis-Stimulating Agents, Erythropoietin Resistance Index, and Mortality in Maintenance Hemodialysis Patients.

BACKGROUND: Erythropoiesis-stimulating agents (ESAs) constitute an important treatment option for anemia in hemodialysis (HD) patients. We investigated the relationships among the dosage of ESA, erythropoietin resistance index (ERI) scores, and mortality in Chinese MHD patients. METHODS: This multicenter observational retrospective study included MHD patients from 16 blood purification centers (n = 824) who underwent HD in 2011-2015 and were followed up until December 31, 2016. We collected demographic variables, HD parameters, laboratory values, and ESA dosages. Patients were grouped into quartiles according to ESA dosage to study the effect of ESA dosage on all-cause mortality. The ERI was calculated as follows: ESA (IU/week)/weight (kg)/hemoglobin levels (g/dL). We also compared outcomes among the patients stratified into quartiles according to ERI scores. We used the Cox proportional hazards model to measure the relationships between the ESA dosage, ERI scores, and all-cause mortality. Using propensity score matching, we compared mortality between groups according to ERI scores, classified as either > or ≤12.80. RESULTS: In total, 824 patients were enrolled in the study; 200 (24.3%) all-cause deaths occurred within the observation period. Kaplan-Meier analyses showed that patients administered high dosages of ESAs had significantly worse survival than those administered low dosages of ESAs. A multivariate Cox regression identified that high dosages of ESAs could significantly predict mortality (ESA dosage >10,000.0 IU/week, HR = 1.59, 95% confidence intervals (CIs) (1.04, 2.42), and p = 0.031). Our analysis also indicated a significant increase in the risk of mortality in patients with high ERI scores. Propensity score matching-analyses confirmed that ERI > 12.80 could significantly predict mortality (HR = 1.56, 95% CI [1.11, 2.18], and p = 0.010). CONCLUSIONS: Our data suggested that ESA dosages >10,000.0 IU/week in the first 3 months constitute an independent predictor of all-cause mortality among Chinese MHD patients. A higher degree of resistance to ESA was related to a higher risk of all-cause mortality.

Predicting one-year mortality in peritoneal dialysis patients: an analysis of the China Peritoneal Dialysis Registry.

This study aims to investigate basic clinical features of peritoneal dialysis (PD) patients, their prognostic risk factors, and to establish a prognostic model for predicting their one-year mortality. A national multi-center cohort study was performed. A total of 5,405 new PD cases from China Peritoneal Dialysis Registry in 2012 were enrolled in model group. All these patients had complete baseline data and were followed for one year. Demographic and clinical features of these patients were collected. Cox proportional hazards regression model was used to analyze prognostic risk factors and establish prognostic model. A validation group was established using 1,764 new PD cases between January 1, 2013 and July 1, 2013, and to verify accuracy of prognostic model. Results indicated that model group included 4,453 live PD cases and 371 dead cases. Multivariate survival analysis showed that diabetes mellitus (DM), residual glomerular filtration rate (rGFR), , SBP, Kt/V, high PET type and Alb were independently associated with one-year mortality. Model was statistically significant in both within-group verification and outside-group verification. In conclusion, DM, rGFR, SBP, Kt/V, high PET type and Alb were independent risk factors for short-term mortality in PD patients. Prognostic model established in this study accurately predicted risk of short-term death in PD patients.

Comparison of two fluid solutions for resuscitation in a rabbit model of crush syndrome.

BACKGROUND: Crush syndrome is a common injury, the main characteristics of which include acute kidney injury. However, there is still lack of reliable animal model of crush syndrome, and it also remains controversial as to which type of fluid should be chosen as a more appropriate treatment option for prevention and treatment of acute kidney injury. METHODS: The rabbits were crushed at the lower limbs for 6 h with 36 times the body weight, which means the pressure of each leg was also 36 times the body weight. Fluid resuscitation was performed from 1 h prior to the end of the crush treatment until 24 h after the reperfusion. Tissue, blood and urine samples were collected at predetermined time points before and after reperfusion. Twelve rabbits in each group were taken for survival observation for 72 h. RESULTS: The model group showed elevated serum creatine kinase, aspartate aminotransferase, alanine aminotransferase, and K(+) level, reduced serum Ca(2+) level and Na(+) level, and increased serum creatinine and blood urea nitrogen levels, neutrophil gelatinase-associated lipocalin, and kidney injury molecule-1 (p < 0.05). The 0.9 % normal saline (SAL) group and SAL plus 6 % hydroxyethyl starch 130/0.4 SAL/HES group showed reduced serum creatinine and blood urea nitrogen levels (p < 0.05). The SAL/HES group also showed reduced serum IL-6 and IL-10 levels (p < 0.05). The 72 h survival rate of the SAL/HES group was higher than that of the model group (p < 0.05). CONCLUSION: The rabbit model of crush syndrome showed clinical features consistent with those of crush syndrome. There was no significant difference in the ability of preventing AKI after a crush injury between the two fluid solutions, while SAL/HES can improve the survival rate.

Effectiveness and Safety of Targeted Agents Combined With Chemoradiotherapy for the Treatment of Esophageal Cancer: A Network Meta-Analysis.

BACKGROUND: Concurrent chemoradiotherapy (CRT) is the preferred treatment strategy for inoperable esophageal cancer (EC). However, the effect of CRT needs to be improved. METHODS: This study comprehensively analyzed targeted agents combined with CRT for the treatment of EC by a network meta-analysis. The search was performed in public databases from incipient to 5 August 2021. Randomized controlled trials comparing the effect of targeted agents combined with CRT and CRT alone on EC patients were included. RESULTS: Ten studies were included. For progression-free survival (PFS), nivolumab (67.4%) and erlotinib (64.6%) had advantages based on Cox analysis. Regarding the frequency of PFS, cetuximab (OR: 1.39; 95% CI: 1.01, 1.91; p=0.042) and nivolumab (OR: 1.81; 95% CI: 1.34, 2.44; p<0.01) were significantly superior to the control. For overall survival (OS), nivolumab (71.6%) in Cox analysis and nimotuzumab (69.7%) in frequency analysis were found to have relative advantages. Nimotuzumab combined with CRT was significantly better than the control with regard to endoscopic and the pathologic complete response (epCR; OR: 2.81; 95% CI: 1.28, 6.14; p=0.011) and objective response rate (ORR; 4.71; 95% CI: 1.45, 15.29; p=0.008). The targeted drugs were not associated with significant SEA risk. CONCLUSION: In conclusion, compared to CRT alone, cetuximab and nivolumab combined with CRT were found to significantly improve the PFS rate only based on the frequency results. However, there was no benefit in terms of OS. For epCR and ORR, nimotuzumab was better than the blank control. Considering the limitations in this study, more well-designed RCTs are needed in the future to validate the results.

Diagnostic efficacy of serum anti-phospholipase A2 receptor antibodies for idiopathic membranous nephropathy in patients with diabetic kidney disease.

AIM: Serum anti-phospholipase A2 receptor (anti-PLA2R) antibodies are highly accurate in diagnosing idiopathic membranous nephropathy (IMN) in populations with kidney disease. However, the diagnostic value of anti-PLA2R antibodies for IMN in diabetic kidney disease (DKD) is unclear. The objective of this study is to determine the diagnostic efficacy and the optimal cut-off value of this marker in populations with DKD. METHODS: This study included 227 patients with type 2 diabetes who were admitted to the Department of Nephrology of the Chinese People's Liberation Army General Hospital from May 2016 to January 2018 and underwent pathological diagnosis by renal biopsy. Anti-PLA2R antibodies were detected by enzyme-linked immunosorbent assay in this population. According to the pathological results, the participants were divided into an IMN group and non-membranous nephropathy (non-MN) group. The clinical characteristics were analyzed, the diagnostic ability of anti-PLA2R antibodies was evaluated, and the receiver operating characteristic (ROC) curve was constructed to obtain the optimal cut-off value. RESULTS: There were 45 patients in the IMN group, accounting for 19.8% of the study sample. The patients in this group were older at the time of renal biopsy than the non-MN group and presented a shorter duration of diabetes, better glycemic control, lower blood pressure and uric acid, and better renal function; in addition, their clinical symptoms indicated nephrotic syndrome. The optimal cut-off value for anti-PLA2R antibodies for the diagnosis of IMN in DKD was 2.71 Ru/ml, sensitivity was 0.800, specificity was 0.951, positive predictive value was 0.800, negative predictive value was 0.951, accuracy was 0.921, and the Yoden index was 0.750. The area under the ROC curve was 0.87 (95% CI, 0.788-0.952) (p < 0.001). CONCLUSIONS: Patients in the IMN group were older, had better renal function and general condition, and the clinical symptoms indicated nephrotic syndrome. Anti-PLA2R antibodies had a good diagnostic performance for IMN in the population with DKD, and the optimal cut-off value was 2.71.

Validation of the 2007 kidney disease outcomes quality initiative clinical practice guideline for the diagnosis of diabetic nephropathy and nondiabetic renal disease in Chinese patients.

AIMS: Diabetes mellitus (DM) has overtaken infection and immunological factors as the most common cause of end-stage renal disease. The 2007 Kidney Disease Outcomes Quality Initiative (KDOQI) guideline is a widely accepted guideline for the clinical diagnosis of diabetic nephropathy (DN) and non-diabetic renal disease (NDRD). Our study sought to verify its diagnostic ability in the Chinese population. METHODS: We included 773 patients with DM who underwent a renal biopsy at the Chinese PLA General Hospital from 2007 to 2016. All patients were divided into three groups according to their pathological findings: isolated DN, isolated NDRD, and DN combined with NDRD. RESULTS: Good sensitivity and poor specificity were found for the prediction of NDRD in the Chinese population. Rapidly decreasing estimated glomerular filtration rate, systemic disease, refractory hypertension, and the existence of "grey area" patients may have contributed to the poor diagnostic ability. CONCLUSIONS: The diagnostic ability of the 2007 KDOQI guideline for DN and NDRD was unsatisfactory. The high sensitivity and low specificity of the guideline made it more suitable as screening criteria rather than as diagnostic criteria.

Safety, Effectiveness, and Manipulability of Peritoneal Dialysis Machines Made in China: A Randomized, Crossover, Multicenter Clinical Study.

BACKGROUND: Automated peritoneal dialysis (APD) can cater to individual needs, provide treatment while asleep, take into account the adequacy of dialysis, and improve the quality of life. Currently, independent research and development of APD machines made in China are more conducive to patients. A randomized, multicenter, crossover study was conducted by comparing an APD machine made in China with an imported machine. The safety, effectiveness, and manipulability of the two machines were compared. METHODS: Two hundred and sixty patients who underwent peritoneal dialysis (PD) on a regular basis in 18 centers between August 2015 and February 2016 were included. The inclusion criteria include age ≥18 years and PD ≥30 days. The exclusion criteria were as follows: hemodialysis; exit site or tunnel infection; and peritonitis ≤30 days. The patients were randomly divided into Group A, who were first treated with a FM machine made in China, then changed to an imported machine; and Group B, who were treated using the reverse sequence. APD treatment was performed with 10 L/10 h and 5 cycles of exchange. After 72 h, the daily peritoneal Kt/V, the accuracy of the injection rate, accuracy of the injection temperature, safety, and manipulability of the machine were assessed. Noninferiority test was conducted between the two groups. RESULTS: The daily peritoneal Kt/V in the APD machine made in China and the imported APD machine were 0.17 (0.14, 0.25) and 0.16 (0.13, 0.23), respectively. There was no significant difference between the groups (Z = 0.15, P = 0.703). The lower limit of the daily Kt/V difference between the two groups was 0.0069, which was greater than the noninferiority value of -0.07 in this study. The accuracy of the injection rate and injection temperature was 89.7% and 91.5%, respectively, in the domestic APD machine, which were both slightly better than the accuracy rates of 84.0% and 86.8% in the imported APD machine (89.7% vs. 84.0%, P = 0.2466; 91.5% vs. 86.8%, P = 0.0954). Therefore, the APD machine made in China was not inferior to the imported APD machine. The fuselage of the imported APD machine was space-saving, while the APD machine made in China was superior with respect to body mobility, man-machine dialog operation, alarm control, and patient information recognition. CONCLUSIONS: The FM machine made in China was not inferior to the imported APD machine. In addition, the FM machine made in China had better operability. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02525497; https://clinicaltrials.gov/ct2/results?cond=&term=NCT02525497&cntry=& state=&city=&dist=.

Evaluation of Neuroprotective Effect of Thymoquinone Nanoformulation in the Rodent Cerebral Ischemia-Reperfusion Model.

The purpose of the present study was to evaluate the neuroprotective efficacy of optimized thymoquinone loaded PLGA-chitosan nanoparticles delivered via nose to brain route in the rodent cerebral ischemia-reperfusion model. The neuroprotective efficacy of the optimized thymoquinone loaded PLGA-chitosan nanoparticles was evaluated in middle cerebral artery occluded rats by various pharmacodynamic and biochemical studies. The pharmacokinetics of thymoquinone loaded PLGA-chitosan nanoparticles in the brain and blood plasma together with qualitative localization of florescent labelled PLGA-chitosan nanoparticles in brain tissues were also determined. Intranasal delivery of optimized thymoquinone loaded PLGA-chitosan nanoparticles (183.5 ± 8.2 nm, 33.63 ± 2.25 mV) to brain significantly reduced the ischemia infarct volume and enhanced the locomotor activity and grip strength in the middle cerebral artery occluded rats. Biochemical studies showed that intranasal delivery of thymoquinone loaded PLGA-chitosan nanoparticles significantly reduced the lipid peroxidation but elevated the glutathione, catalase, and superoxide dismutase in the brain of middle cerebral artery occluded rats. The pharmacokinetic and localization studies showed that thymoquinone loaded PLGA-chitosan nanoparticles facilitated the delivery of thymoquinone to brain by intranasal nose to brain transport pathways and enhanced their pharmacokinetic profile in brain tissues. Thus, intranasal delivery of thymoquinone loaded PLGA-chitosan nanoparticles to brain could be potentially used for the neuroprotection and treatment of cerebral ischemia.

Long term effects on mineral and bone metabolism by low versus standard calcium dialysate in peritoneal dialysis: a meta-analysis.

BACKGROUND: Low calcium dialysate with 1.25 mmol/l calcium concentration has been proposed to replace standard calcium dialysate in peritoneal dialysis patients taking calcium-containing phosphate binder to prevent hypercalcaemia. We conducted a meta-analysis to evaluate long term effects on mineral and bone metabolism by low versus standard calcium dialysate in peritoneal dialysis. METHOD: Clinical studies comparing low versus standard calcium dialysate in peritoneal dialysis patients were identified by searching PubMed (from 1990 to October 2013) and EMBASE (from 1990 to October 2013). Major outcomes extracted for meta-analysis were: serum total and ionized calcium, phosphate, parathyroid hormone and bone metabolism. Statistical analyses were performed using the Review Manager, version 5.1.0 (Cochrane Collaboration, Oxford, UK). RESULTS: Four studies were identified for meta-analysis. A total of 240 peritoneal dialysis patients received standard calcium dialysate and 106 patients were given low calcium dialysate. 1-2 year after peritoneal dialysis, both serum total and ionized calcium were lower in low calcium dialysate patients as compared with standard dialysate patients (Total calcium: MD, 0.09; 95% CI, 0.05 0.13; P < 0.0001; Ionized calcium: MD, 0.04; 95% CI, 0.02 0.06; P < 0.0001). No statistical difference was observed in phosphate level between two groups (MD, -0.05; 95% CI, -0.13 0.02; P = 0.19). Intact parathyroid hormone level was significantly increased in low calcium dialysate patients. No clinically significant long term change of bone metabolism was observed between low and standard calcium dialysate treated patients. CONCLUSION: Long term (1-2 year) use of low calcium dialysate with 1.25 mmol/l calcium concentration in peritoneal dialysis patients results in decrease of serum total and ionized calcium level and does not change serum phosphate level. No clinical significance in the change of bone metabolism was observed between low and standard calcium dialysate patients despite the increase of serum parathyroid hormone in low calcium dialysate group.

Efficacy and safety of Flos Abelmoschus manihot (Malvaceae) on type 2 diabetic nephropathy: A systematic review.

OBJECTIVE: To evaluate the efficacy and safety of Flos Abelmoschus manihot (Malvaceae) on type 2 diabetic nephropathy (DN). METHODS: The Cochrane Library, PubMed/MEDLINE, Excerpta Medical Database, Chinese electronic literature databases, and the references of relevant articles were searched in March 2012 for randomized controlled trials (RCTs) that reported the effects of Flos A. manihot on type 2 DN patients with overt but subnephrotic-range proteinuria (500-3,500 mg/24 h). The quality of trials was evaluated using the Cochrane-recommended method. The results were summarized as risk ratios (RRs) for dichotomous outcomes or mean differences (MDs) for continuous outcomes. RESULTS: Seven trials (531 patients) were included. Flos A. manihot significantly decreased proteinuria [MD -317.32 mg/24 h, 95% confidence interval (CI) [-470.48, -164.17],P<0.01]. After excluding a trial that only included patients with well-preserved renal function, Flos A. manihot was associated with a significant decrease in serum creatinine (MD -11.99 µmol/L, 95% CI [-16.95, -7.04],P<0.01). Serious adverse events were not observed. The most common adverse event was mild to moderate gastrointestinal discomfort; however, patients receiving this herb did not have an increased risk for tolerated gastrointestinal discomfort (RR 1.48, 95% CI [0.39, 5.68],P=0.57). CONCLUSIONS: Flos A. manihot may be considered as an important adjunctive therapy with the first-line and indispensable therapeutic strategies for type 2 DN. High-quality RCTs are urgently needed to confirm the effect of Flos A. manihot on definite endpoints such as end-stage renal disease.

[Effects of DNA methylation on expression of TIG1 gene in acute leukemia].

This study was purposed to investigate the expression and methylation status of TIG1 in acute leukemia (AL). The TIG1 expression of 53 cases of AL and 20 cases of normal control (NC) were measured by using real-time quantitative PCR (RT-QT-PCR) and methylation-specific PCR(MS-PCR). The leukemia KG-1a, U937 and K562 cells were treated with 5-Aza-CdR. The results indicated that TIG1 gene expressed at a high level in cases of NC, but expressed at a low level in patients with AL. TIG1 gene was unmethylated in NC, but frequently methylated in AL. Aberrant methylation rate of TIG1 in AL was 75% (40/53). The expression of TIG1 in unmethylated patients was higher than that in methylated patients. Hypermethylation of TIG1 promoter CpG islands was detected in all the cell lines. 5-Aza-CdR treatment led to the hypomethylation of TIG1 promoter CpG islands. After the treatment with 5-Aza-CdR of different concentration, the expression of TIG1 was restored, and the effect of 5-Aza-CdR displayed dose-dependency. It is concluded that the reduced expression of TIG1 may play an important role in the pathogenesis of AL, and methylation may be responsible for the decreased transcription of TIG1 gene.

[Clinical analysis of 14 patients with thrombotic thrombocytopenic purpura].

In order to enhance the understanding of thrombotic thrombocytopenic purpura (TTP), the clinical features, laboratory characteristics, treatment and outcome of 14 patients with TTP were retrospectively analyzed and investigated. The results showed that 7 out of 14 patients with TTP had predisposing factors, such as pregnancy in 4 cases, infection in 3 cases, systemic lupus erythematosus (SLE) in 1 case and hematopoietic stem cell transplantation (HSCT) in 1 case. Fourteen patients all had neuropsychological symptoms, hemolytic anemia with negative-Coombs test, and decreased platelet counts. Eight patients had irregular fever with different degree. There were 8 patients with kidney damage including proteinuria in 8 cases and renal function abnormalities in 4 cases. The von Willebrand factor-cleaving protease (VWF-CP, ADAMTS13) activity of 13 cases out of 14 patients significantly decreased (less than 10%). At same time, plasma ADAMTS13 inhibitors were detected in 12 cases out of these 13 patients with decreased ADAMTS13 activity. After treatment with plasma exchange, glucocorticoid and rituximab so on, 12 cases achieved complete remission, in which 8 cases relapsed in two years. Two patients died at last, in which one case was secondary to HSCT. It is concluded that TTP is a kind of thrombotic microangiopathy due to platelet microthrombosis involved in multiple systems and multiple organs dysfunction with dangerous clinical process. The mortality of TTP patients is very high. Early diagnosis and early treatment with plasma exchange as the main means can greatly improve the prognosis of patients with TTP.

Clinical factors associated with the diagnosis and progression of diabetic nephropathy.

As an important complication of diabetic mellitus, diabetic nephropathy (DN) has been the main cause of end-stage renal disease. It is of great importance to diagnose DN early, and to identify the risk factors of disease progression in order to carry out in-time and effective therapies. Previous literatures have reported the role of several clinical factors in the diagnosis and progression of DN, including age, longer diabetes duration, diabetic retinopathy, higher level of hypertension and HbA1c, and so on. However, the significance of these clinical factors is still controversial and limited. This review aimed to evaluate the values and limitations of these factors in diagnosing and predicting the renal outcome of DN.

Validation of a differential diagnostic model of diabetic nephropathy and non-diabetic renal diseases and the establishment of a new diagnostic model.

BACKGROUND: The aims of the present study were to validate the differential diagnostic model of diabetic nephropathy (DN) and non-diabetic renal diseases (NDRD) established in 2003 and to establish a new diagnostic model suitable for the current clinical characteristics of DN. METHODS: We examined 200 patients with Type 2 diabetes who underwent kidney biopsy from 2004 to 2012. The 2003 differential diagnostic model based on the data collected from 1993 to 2003 was evaluated by the diagnostic test and changes in the clinical differentiation parameters of DN and NDRD were analyzed. Logistic regression, receiver operating characteristics (ROC) curve, net reclassification improvement (NRI), and integrated discrimination improvement (IDI) analysis were applied. RESULTS: The 2003 diagnostic model showed an accuracy of 77.5%. A significantly elevated incidence of hematuria, longer history of diabetes, and reduced level of glycated hemoglobin (HbA1c) were observed in the DN group from 2004 to 2012 compared with DN group from 1993 to 2003. Histories of diabetes mellitus (Dm), systolic blood pressure (Bp), HbA1c (Gh), hematuria (Hu), diabetic retinopathy (Dr), and hemoglobin (Hb) are independently related to DN. Thus, a new diagnostic model was constructed as follows: PDN = exp (0.846 + 0.022 Dm + 0.033Bp + 2.050 Gh-2.664 Hu-0.078 Hb + 2.942Dr)/[1 + exp (0.846 + 0.022 Dm + 0.033 Bp + 2.050 Gh-2.664 Hu-0.078 Hb + 2.942 Dr)].Validation tests determined that the accuracy of the new model were 90.9%. CONCLUSIONS: Changes in people with DN, clinical characteristics have reduced the diagnostic efficacy of the 2003 diagnostic model. The newly established model can provide a better, more current differentiation between DN and NDRD.

Identifying parameters to distinguish non-diabetic renal diseases from diabetic nephropathy in patients with type 2 diabetes mellitus: a meta-analysis.

BACKGROUND: Renal injuries in patients with diabetes include diabetic nephropathy (DN) and non-diabetic renal diseases (NDRD). The value of a clinical diagnosis of DN and NDRD remains inconclusive. We conducted a meta-analysis of the literature to identify predictive factors of NDRD and to compare the clinical characteristics of DN and NDRD for differential diagnosis. METHODS: We searched PubMed (1990 to January 2012), Embase (1990 to February 2009), and CNKI (1990 to January 2012) to identify studies that enrolled patients with DN and NDRD. Then, the quality of the studies was assessed, and data were extracted. The results were summarized as odds ratios (ORs) for dichotomous outcomes and weighted mean differences (WMDs) for continuous outcomes. RESULTS: Twenty-six relevant studies with 2,322 patients were included. The meta-analysis showed that the absence of diabetic retinopathy (DR) predicts NDRD (OR, 0.15; 95% confidence interval [CI], 0.09-0.26, p<0.00001). A shorter duration of diabetes mellitus (DM) also predicted NDRD (weighted mean difference, -34.67; 95% CI, -45.23--24.11, p<0.00001). The levels of glycosylated hemoglobin (HbA1C%), blood pressure (BP), and total cholesterol were lower in patients with NDRD, whereas triglycerides and body mass index were higher. Other clinical parameters, including age, 24-h urinary protein excretion, serum creatinine, creatinine clearance, blood urea nitrogen, and glomerular filtration rate were not different between patients with NDRD and DN. CONCLUSIONS: We identified that the absence of DR, shorter duration of DM, lower HbA1C, and lower BP may help to distinguish NDRD from DN in patients with diabetes. This could assist clinicians in making a safe and sound diagnosis and lead to more effective treatments.

Efficacy and safety of Changfu peritoneal dialysis solution: a multi-center prospective randomized controlled trial.

BACKGROUND: A multi-center large scale study is needed to confirm the efficacy and safety of domestic peritoneal dialysis (PD) solutions. Some researchers believe that 6 L/d is enough for adequate dialysis, but there is no multi-center prospective study on Chinese population to confirm this. In this study, we evaluated the efficacy and safety of domestic PD solution (Changfu) and its difference between 6 L and 8 L dosage. METHODS: Adult PD patients who had taken PD therapy for at least one month were selected and divided into four groups according to two dialysis solution brands and two dialysis dosages, i.e., 6 L dose with Changfu dialysis solution, 6 L dose with Baxter dialysis solution, 8 L dose with Changfu dialysis solution, and 8 L dose with Baxter dialysis solution. After 48 weeks, the changes of primary and secondary efficacy indices were compared between different types and different dosages. We also analyzed the changes of safety indices. RESULTS: Changes of Kt/V from baseline to 48 weeks between Changfu and Baxter showed no statistical differences; so did those of creatinine clearance rate (Ccr). Normalized protein catabolic rate (nPCR) from baseline to 48 weeks between Changfu and Baxter showed no statistical differences; so did those of net ultrafiltration volume (nUF) and estimated glomerular filtration rate (eGFR). Changes of nPCR from baseline to 48 weeks between 6 L and 8 L showed no statistical differences; so did those of nUF and eGFR. The decline of Kt/V from baseline to 48 weeks in 6 L group was more than that in 8 L group. Change of Ccr was similar. During the 48-week period, the mean Kt/V was above 1.7/w, and mean Ccr was above 50 L×1.73 m(-2)×w(-1). More adverse events were found in Changfu group before Changfu Corporation commenced technology optimization, and the statistical differences disappeared after that. CONCLUSIONS: The domestic PD solution (Changfu) was proven to be as effective as Baxter dialysis solution. During 48-week period, a dosage of 6 L/d was enough for these patients to reach adequate PD. Clinical study promotes technological optimization, further helps to improve the safety indices of the medical products.

[Multiple viral transmission chains of enterovirus 71 co-circulated in Jilin Province during 2009-2010].

OBJECTIVE: To analyze the genetic characterization of enterovirus type71 (EV71) associated with hand foot and mouth disease (HFMD) epidemics in Jilin province, during 2009-2010. METHODS: Randomly selected 31 representative EV71 strains from the cases of 8 prefectures to amplify and sequences of VP1 genes of EV71 strains, and analyzed with Bioedit and Mega4.0 program. RESULTS: All representative 31 EV71 strains belong to C4a subgenotype, the homology of nucleotide in VP1 region among the 31 EV71 strains were 94. 5%-100. 0%, and were clustered into 5 transmission chains respectively. 25 strains out of 31 strains were associated with a predominant transmission chain, and circulating in 8 prefectures, while other 6 strains clustered into 4 lineages. CONCLUSION: Multiple transmission chains of EV71 C4a subgenotype were co-circulating in Jilin province during 2009-2010, and a predominant transmission chain was circulating in 8 prefectures, associated with HFMD outbreaks of Jilin province.

[Transmission and prevalence patterns of C4a evolutionary lineage of human enterovirus 71 circulating in mainland China, 2008-2010].

OBJECTIVE: To understand the evolutionary relationship between the C4a evolutionary lineage of human enterovirus 71 (HEV71) strains circulating in mainland of China during 2008-2010 and 2008 Fuyang strains and study the prevalence and transmission patterns of 2008 Fuyang strains. METHODS: Download all the complete VP1 ( > or = 891 bp) or approximate complete VP1 (> or = 876 bp) gene nucleotide sequences from GenBank of HEV71 strains circulating in Mainland of China during 2008-2010. And analyze the phylogenetic relationship between Fuyang strains and other provinces' strains using the MEGA software, version 5.0. RESULTS: All of the HEV71 isolates circulating in Mainland of China during 2008-2010 were clustered into evolutionary lineage C4a except for eight strains grouped in the genotype A and one isolate belongs to evolutionary lineage C4b; the homology analysis showed there were 96.5%-100% identity between C4a viruses circulating in mainland China during 2008-2010 and 2008 Fuyang strains, and they were evolved from C4b viruses of 1998. The transmission chains of Fuyang strains were mainly transmitted in Guangdong, Jiangsu, Shanghai, Hunan, Shandong provinces. CONCLUSION: The predominant viruses circulating in Mainland of China during 2008-2010 were evolutionary lineage C4a of human Enterovirus 71; Fuyang transmission chains mainly distributed in southern of China and the Central China around Anhui provinces.

[Establishment of one-step reverse transcription-polymerase chain reaction method for mumps virus hydrophobin gene detection].

OBJECTIVE: To establish a kind of simple method for identifying mumps virus gene: one-step reverse transcription-polymerase chain reaction, RT-PCR). METHODS: To design primer in both sides of SH gene, and then to do the sensitivity and specificity test for the RT-PCR method. RESULTS: At least 10(0.7) TCID50 mumps virus can be detected by this method. 5 strains of mumps virus can be detected and 4 strains of non-mumps virus including measles and rubella virus can't be detected by this method. CONCLUSIONS: The one-step RT-PCR method is a rapid and simple method for identifying mumps virus gene.

[The establishment of method for identifying China vaccine strains and wild strains of measles virus].

OBJECTIVE: To establish a simple and quick method for identifying China vaccine strains and wild strains of Measles Virus. METHODS: To search the enzyme site in Hemagglutinin gene of measles virus for different domestic vaccine strains and wild strains of measles virus, and design the RT-PCR primer within the range covering the enzyme site, and then to confirm the specificity and sensibility of the RT-PCR method, and then identify the RT-PCR product by RFLP. RESULTS: The one-step RT-PCR method is sensitive, the measles virus of 4.64 TCID50 can be detected at least. No positive bands can be found in the non-measles virus strains, it means that the RT-PCR method has good specificity, the PCR products of Chian measles vaccine strains of Shang-191 and Chang-47 were all cut into two fragments (287 bp and 151 bp) by Afi II, but two measles wild virus strains can't be cut by Afl II. CONCLUSION: The RT-PCR-RFLP method which we established is a rapid and simple method for identifying China vaccine strain and wild strain.