| Objective:Secondary hyperparathyroidism(SHPT)is a common complication in hemodialysis patients,80%of them with their serum PTH above 150 ng/L.SHPT patients are often complicated by calcium and phosphorus metabolism disorders,bone abnormalities,and vascular and tissue calcification.These seriously affect the quality of life of patients,increase the risk of cardiovascular disease and all-cause mortality.The traditional treatment methods for SHPT in hemodialysis patients include the use of calcium-containing or non-calcium-phosphorus binders,and the use of active vitamin D,but the treatment effect is often poor and the comprehensive compliance rate is low.Cinacalcet,a new calcimimetic,can activate parathyroid calcium-sensing receptors and often used in patients with SHPT who have not been successfully treated with active vitamin D.Its therapeutic effect and safety are still controversial.Part of the mechanism,especially the effect of improving renal anemia and the way of action have not been fully elucidated.To observe the efficacy of active vitamin D(calcitriol)combined with Cinacalcet in the treatment of SHPT in patients with maintenance hemodialysis and its effects on serum transforming growth factor(TGF-β1)and soluble transferrin receptor(sTfR)levels.To provide a reference for clinically effective treatment of patients with refractory hyperparathyroidism secondary to hemodialysis and to reduce the risk of cardiovascular events and death.Methods:This study is an open-label,prospective study.A total of 90 patients with moderate or severe SHPT who underwent MHD treatment in the hemodialysis center of our hospital from January 2017 to December 2018 were selected.The enrolled patients were randomized into control group(n=45)and experimental group(n=45).There were no differences in general baseline data such as gender,age,dialysis month,primary disease,and time of each hemodialysis.The patients in the control group were given calcitriol capsules on the basis of routine blood pressure reduction,lipid regulation,correction of anemia and regular hemodialysis.On the basis of the conventional medication and calcitriol in the control group,the experimental group added oral Cinacalcet for 3 months.Serum calcium,serum phosphorus and intact parathyroid hormone(iPTH)levels should be closely monitored during treatment,and medication should be adjusted according to them.Medication may be discontinued if necessary.Blood was collected from patients before dialysis during the longest dialysis interval at the time of enrollment,each month,and at the end of the trial.To detect the blood routine,iPTH,serum calcium,serum phosphorus,urea nitrogen and other biochemical indicators,and the urea clearance index(Kt/V)was calculated based on these data.On the day after enrollment and at the end of the trial,parathyroid ultrasonography was performed to detect the size of the parathyroid glands.The levels of transforming growth factor-β1(TGF-β1),soluble transferrin receptor(sTfR)and fibroblast growth factor-23(FGF-23)were detected by enzyme-linked immunosorbent assay(ELISA).The correlation between TGF-β1,sTfR and iPTH was calculated respectively.The compliance rate of blood calcium,blood phosphorus and iPTH levels and the compliance rate of three at the same time were calculated respectively.The occurrence of adverse reactions in the two groups was observed separately.We used SPSS 20.0 software for statistical analysis.The measurement data conformed to a normal distribution,described as(x ± s).We used independent samples t-tests to compare within-group and between-group data.Enumeration data were expressed as percentages,using x 2 test or Fisher’s exact test.We take two-sided P<0.05 as statistically significant.Results:1.Before treatment,there were no significant differences in serum calcium,phosphorus and iPTH levels between the two groups(P>0.05).2.After treatment,the levels of blood calcium in the control group and the experimental group were significantly increased compared with those before treatment,and the levels of phosphorus and iPTH were significantly decreased(P<0.05).The above indicators in the experimental group had more obvious changes than those in the control group(P<0.05).After treatment,the compliance rate of blood calcium in the experimental group was 100%(45/45),and the compliance rate of blood calcium in the control group was 95.56%(43/45).There was no significant difference between the two groups(P>0.05).The compliance rate of serum phosphorus in the experimental group was 51.11%(23/45),and that in the control group was 22.22%(10/45).There were significant differences between the two groups,and the experimental group was significantly higher than that in the control group(P<0.05)..The iPTH compliance rate in the experimental group was 71.11%(32/45),and the rate in the control group was 28.89%(13/45).There were significant differences between the two groups,the experimental group was significantly higher than that in the control group also(P<0.05).The total compliance rate of serum calcium,blood phosphorus and iPTH in the experimental group was 37.78%(17/45),while that in the control group was 6.67%(3/45).The experimental group was significantly higher than that in the control group,and there was a significant difference between the two groups(P<0.05).3.Before treatment,at the baseline level,there was no statistical difference in the size of parathyroid glands between the two groups(P>0.05).After treatment,the length,width and thickness of parathyroid glands in the two groups were significantly decreased compared with those before treatment(P<0.05).And the experimental group decreased more significantly than the control group(P<0.05).4.There were no significant differences in Scr,BUN,Kt/V between the two groups before and after treatment(P>0.05).5.Before treatment,there was no significant difference in serum FGF-23,TGF-β1,sTfR and Hb levels between the two groups(P>0.05).After treatment,the levels of serum FGF-23,TGF-β1 and sTfR in the two groups were significantly lower than those before treatment(P<0.05),and the experimental group was more significantly lower than the control group(P<0.05).After treatment,the hemoglobin levels in the two groups were significantly increased compared with those before treatment(P<0.05),and there was no significant difference between the experimental group and the control group(P>0.05).The correlation test showed that there was a weak correlation between TGF-β1 and iPTH,and weak correlation between sTfR and iPTH only in the experimental group(P<0.05).6.No obvious discomfort was observed in all patients.Conclusions:Calcitriol combined with Cinacalcet in the treatment of patients with hyperparathyroidism secondary to maintenance hemodialysis,can effectively reduce the levels of parathyroid hormone and serum phosphorus.It can significantly increase the total compliance rate of blood calcium,blood phosphorus and parathyroid hormone;and can more effectively reduce the volune of parathyroid glands in patients.Combination therapy can effectively reduce the levels of TGF-β1 and sTfR,relieve the symptoms of SHPT,and improve the anemia state,without increasing adverse reactions,with high safety. |
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