| Background and ObjectiveChronic kidney disease (CKD) is one of the world's most concerned public health issue. In addition to its etiology due to primary glomerular disease, also can be secondary to diabetes mellitus, hypertension, etc., the incidence rate and mortality are increasing. According to K/DOQI guidelines, based on their GFR values, CKD can be divided into 5 different stages, while in the later stages CKD leads to end-stage renal disease (ESRD). Peritoneal dialysis is the preferred treatment of choice in ESRD; there are simple, effectively preserves the residual renal function and other advantages. In CKD patients, intact parathyroid hormone level abnormality is a common complication. Intact Parathyroid hormone (iPTH) is a polypeptide molecule synthesized by and secreted from the chief epithelial cells of parathyroid glands. Intact parathyroid hormone (iPTH) is a regulator of mineral homeostasis, acting mainly on bone and kidney. Intact parathyroid hormone (iPTH) is considered as one of the biomarks of the development of chronic renal failure. Previous investigations have demonstrated that intact parathyroid hormone (iPTH) can also affect the function of various target organs-brains, heart, lungs, pancreas, adrenal glands, testes and cells-lymphocytes, red blood cells and smooth muscles. This clinical study intends to investigate the intact PTH (iPTH) level in Chronic Kidney Disease and observe it is an best indicator of kidney damage, the correlation between intact parathyroid hormone (iPTH) level and creatinine clearance rate (CrCl), hemoglobin (Hb), serum calcium (Ca) and hypertension, and finally to review the strategies for the better treatment modalities in chronic kidney disease (CKD) and Continuous Ambulatory Peritoneal Dialysis (CAPD) patients.Methods and MaterialsIn a Randomized Prospective Study, medical record data of the eligible patients were collected from the Medical Record Department of 3rd Xiang-Ya Hospital, who were managed as Chronic Kidney Disease (CKD) and Continuous Ambulatory Peritoneal Dialysis (CAPD) patients, at the Nephrology Department,3rd Xiang-Ya Hospital, Central South University between January 2006 and December 2009. For the clinical analysis, patients were selected in accordance with the guidelines of the Kidney Disease Outcome Quality Initiative (K/DOQI) Clinical Practice Guidelines for Chronic Kidney Disease:Evaluation, Classification, and Stratification 2003 set out by the National Kidney Foundation (NKF). After thorough review, in accordance to the (NKF), (K/DOQI) guidelines, finally recruited 157 eligible Chronic Kidney Disease (CKD), where etiology was:Chronic Glomerulonephritis (52.23%), followed by Hypertensive Nephrosclerosis (21.02%), Obstructive Nephropathy (8.28%), Diabetic Nephropathy (7.64%), other causes (7.64%) and Polycystic Kidney Disease (3.18%) respectively, and 68 eligible Continuous Ambulatory Peritoneal Dialysis (CAPD) subjects respectively. All the normal healthy patients (n=22) were recruited from the Department of Health Management,3rd Xiang-Ya Hospital of Central South University, after the patient gave their written consent to participate in the clinical research program. Every subject were thoroughly ruled out the presence of heart, liver, lungs, spleen and any other major organs damage and pathological changes, too.The definition of Chronic Kidney Disease (CKD) from the Kidney Disease Outcome Quality Initiative (K/DOQI) clinical practice guideline that was published in 2003 by the National Kidney Foundation (NKF) states "chronic kidney disease is defined as either kidney damage or GFR<60 ml/min/1.73m2 for≥3 months. Kidney damage is defined as pathological abnormalities, including abnormalities in blood, urine tests or imaging studies". Most commonly and standard Continuous Ambulatory Peritoneal Dialysis (CAPD) employs 4-6 exchanges per day.The staging of the Chronic Kidney Disease (CKD) patients were done according to National Kidney Foundation (NKF), Kidney Disease Outcome Quality Initiative (K/DOQI) guideline from CKD stage 1 to CKD stage 5, and is based on an estimated glomerular filtration rate (eGFR), calculated from the serum creatinine level, using the equation abbreviated MDRD equation:GFR (ml/min/1.73m2)= 186.3* (serum creatinine)-1.154* (age)-0.203*(0.742 if female)* (1.21 if African American). Chronic Kidney Disease (CKD) stage 1 is defined by an eGFR of≥90 ml/min/1.73 m2 or other evidence of structural damage to the kidney; Chronic Kidney Disease (CKD) stage 2 has a similar definition, but an eGFR of 60-89 ml/min/1.73 m2. And, Chronic Kidney Disease (CKD) stages 3,4, and 5 are defined solely by an estimated glomerular filtration rate (eGFR) of 30-59,15-29, and less than 15 ml/min/1.73 m2 respectively. Continuous Ambulatory Peritoneal Dialysis (CAPD) group was categorized into 3 groups depending upon the duration of dialysis, as before continuous ambulatory peritoneal dialysis, after 3 months on continuous ambulatory peritoneal dialysis and after 6 months on continuous ambulatory peritoneal dialysis respectively. Finally, had CKD 1 (n=11, Male=5, Female=6, mean age=41.54±15.44 years); CKD 2 (n=14, Male=11, Female=3, mean age=55.07±18.29 years); CKD 3 (n=32, Male=19, Female=13, mean age=55.40±14.76 years); CKD 4 (n=50, Male=32, Female=18, mean age=53.7614.17 years); CKD 5 (n=50, Male=20, Female=30, mean age=45.32±12.68 years); before continuous ambulatory peritoneal dialysis group (n=25, Male=16, Female=9, mean age=47.64±14.89 years); after 3 months on CAPD group (n=17, Male=8, Female=9, mean age=47.47.40±14.63 years), after 6 months on CAPD group (n=26, Male=12, Female=14, mean age=53.96±15.29 years) and Control group (n=22, Male=16, Female=6, mean age=43.95±6.10 years).Inclusion characteristics consisted of patients with the diagnosis of Chronic Kidney Disease in accordance with National Kidney Foundation (NKF), Kidney Disease Outcome Quality Initiative (K/DQOI) guidelines 2003; either sex of age 18 years and above; patients on continuous ambulatory peritoneal dialysis (CAPD) and chronic kidney disease (CKD) patients not yet on any form of dialysis; while exclusion characteristics consisted of primary hyperparathyroidism; previous parathyroidectomy; neoplasia; osteoporosis under treatment; congenital conditions; wasting; obese; acute kidney failure (ARF); kidney transplantation patients and severe liver disease.Early morning fasting venous blood was collected and analyzed with Instrument HITACHI 7600 automatic chemical analyzer (detection of BUN and Cr), and Roche E601 fully-automatic electrochemiluminescence assay (detection of iPTH; normal range 15-65 pg/ml),at the clinical laboratory and the Nuclear medicine laboratory of the 3rd Xiang-Ya hospital, Central South University respectively.After staging, significant differences among Chronic Kidney Disease (CKD) stages and Continuous Ambulatory Peritoneal Dialysis (CAPD) groups were obtained in gender, age, serum creatinine (Scr), creatinine clearance rate (CrCl), serum calcium (Ca), systolic blood pressure (SBP), diastolic blood pressure (DBP), hemoglobin (Hb), Blood Urea Nitrogen (BUN) and intact parathyroid hormone (iPTH) level, using ANOVA and later determined by Post Hoc test, respectively. All the data were compared between groups and later with Control group. To analyze the correlation between intact parathyroid hormone (iPTH) and other related variables we used Pearson correlation and by linear regression analysis the cause and effect was observed.Clinical data were presented as mean±SD or percentage. Data were analyzed using the statistical Package for the Social Sciences (SPSS) software package (16.0) for Windows (SPSS Inc., Chicago, IL, USA). Numeration data were analyzed by Chi-Square test (x2).Results were considered significant at P＜0.05.Result:1. Control group mean iPTH 33.84±9.27 pg/ml, CKD 1 mean iPTH 39.67±20.19 pg/ml, CKD 2 mean iPTH 36.08±17.12 pg/ml, CKD 3 mean iPTH 57.03±39.87 pg/ml, CKD 4 mean iPTH 104.58±72.85 pg/ml, CKD 5 mean iPTH 327.74±250.95 pg/ml; CKD 1 mean serum calcium 2.33±0.19 mmol/l, CKD 2 mean serum calcium 2.36±0.23 mmol/l, CKD 3 mean serum calcium 2.24±0.13 mmol/1, CKD 4 mean serum calcium 2.22±0.24 mmol/1, CKD 5 mean serum calcium 2.04±0.22 mmol/l; CKD 1 mean Hb 137.45±13.49 g/l, CKD 2 mean Hb 138.50±12.85 g/l, CKD 3 mean Hb 114.90±223.88 g/l, CKD 4 mean Hb 103.88±19.98 g/l, CKD 5 mean Hb 70.20±19.87 g/l; CKD 1 mean CrCl 116.54±27.73 ml/min, CKD 2 mean CrCl 67.85±18.97 ml/min, CKD 3 mean CrCl 39.59±9.57 ml/min, CKD 4 mean CrCl 21.44±4.65 ml/min, CKD 5 mean CrCl 7.92±2.84 ml/min; CKD 1 mean SBP 129.82±16.61 mmHg, CKD 2 mean SBP 131.29±14.36 mmHg, CKD 3 mean SBP 139.37±18.36 mmHg, CKD 4 mean SBP 138.76±16.81 mmHg, CKD 5 mean SBP 142.04±17.64 mmHg. The iPTH level was in increasing order, from control group, stage CKD 1 to CKD 5, was statistically significant (P<0.05). iPTH level was more prominently elevated at CKD 5 (P<0.05), which was statistically significant. iPTH level between the control group, stage CKD 1 and stage CKD 2 had no significant difference. Hemoglobin (Hb) level was significantly decreased as it progresses from control group and stage CKD 1 to CKD 5 (P<0.05), consistent with the advancing degree of renal failure, but no significant difference between stage CKD 1 and CKD 2. Serum calcium (Ca) level increases from stage CKD 1 to CKD 2 and decreases afterwards, with progression from stage CKD 1 to CKD 5, which reaches a statistically significant difference (P＜0.05) at stage CKD 4 and CKD 5, and CrCl was declining as it progresses from control group, stage CKD 1 to CKD 5, which was statistically significant (P<0.05), but no significant difference between stage CKD 1 and Control group (P<0.05).iPTH was negatively correlated with CrCl (r=-0.429, P＜0.01), Serum Calcium (Ca) (r=-0.282, P＜0.01) and Hemoglobin (Hb) (r=-0.546, P＜0.01), which was statistically significant (P<0.01). But, the SBP (r=0.100, P=0.183), age (r=-0.019, P=0.805) and sex (r= 0.060, P =0.427) was not correlated significantly (P>0.01). In linear regression analysis, found that 29% variability of Hemoglobin (Hb), F (1,177)= 75.05, P＜0.05; 18% variability of Creatinine Clearance Rate (CrCl), F (1,177)= 39.88, P<0.05, predicted significantly but, cannot predict the variability of Systolic blood pressure (SBP), F (1,177)= 1.79, P>0.05 by the iPTH level.2. Control group mean iPTH 33.84±9.27 pg/ml, pre-dialysis group mean iPTH 288.76±175.74 pg/ml, after 3 months of dialysis mean iPTH 259.13±186.47 pg/ml, after 6 months of dialysis mean iPTH 302.69±274.80 pg/ml, pre-dialysis group mean serum calcium 2.02±0.22 mmol/l, mean Hb 78.28±14.97 g/l, after 3 months of dialysis mean serum calcium 2.05±0.17 mmol/1, mean Hb 71.76±13.78 g/l, after 6 months of dialysis mean serum calcium 2.11±0.19 mmol/l, mean Hb 86.00±24.63 g/l. iPTH level was a statistically significant between Control group and other CAPD groups (P＜0.05). But, between before PD group, after 3 months and 6 months CAPD groups, there was no statistical significant (P>0.05). iPTH level in control group, pre-dialysis, after 3 and 6 months of CAPD groups was in increasing order, respectively. iPTH was negatively correlated with Hemoglobin (Hb) (r= -0.480, P= 0.000), which was statistically significant (P<0.01). But, other variables SBP (r= 0.180, P= 0.090), Serum calcium (Ca) (r= 0.013, P= 0.917), and age (r=-0.020, P= 0.851) was not significantly correlated (P>0.01). In linear regression analysis, found that 23% variability of Hemoglobin (Hb), F (1,88)= 26.32, P<0.05; can be predicted significantly by the iPTH level.Conclusion:1) Serum intact parathyroid hormone (iPTH) is one of the important indicators of kidney damage in patient with End-Stage Renal Disease (ESRD).2) Serum calcium (Ca), Creatinine Clearance Rate (CrCl) and Hemoglobin (Hb) are negatively correlated with intact parathyroid hormone (iPTH) in patients with Chronic Kidney Disease (CKD), which was statistically significant.3) Peritoneal Dialysis can partially eliminate intact parathyroid hormone (iPTH).
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