小剂量钙三醇对慢性肾衰竭继发性甲旁亢早期的疗效研究

The Effects of Low Doses of Oral Calcitriol on Early Secondary Hyperparathyroidism Associated with Chronic Renal Failure

目的 :研究小剂量口服罗盖全治疗慢性肾衰竭 (CRF)继发性甲旁亢 (SHPT)早期患者的疗效和副作用。方法 :将观察期间 (3～ 12个月 )血清全段甲状旁腺激素 (iPTH)浓度动态升高且高达正常值 3～ 5倍的 180名CRF患者随机分为A、B两组 ,A组予罗盖全 0 .12 5 μg/d ,B组予罗盖全 0 .2 5 μg/d口服 ,以血清iPTH浓度降至正常值2 .5倍即 16 0ng/L为观察终点 ;另将血清iPTH浓度高达正常值 5倍以上的 15 3例患者随机分为C、D两组 ,C组予罗盖全 0 .5 μg/d上午口服 ,D组以相同剂量于晚上 10h口服 ,以血清iPTH浓度降至正常值 3倍即 195ng/L为观察终点。以到达终点的例数和时间为指标判断疗效 ,分别比较A、B两组及C、D两组疗效和高钙血症等副作用。结果 :各组均取得良好疗效。B组有效率 90 .91% ,明显高于A组的 5 7.30 % (P <0 .0 1) ,B组到达终点时间 (8.6 6± 3.2 )个月 ,明显早于A组 (15 .2 4± 3.7)个月 (P <0 .0 1)。C、D两组疗效相近 ,有效率分别为 86 .89%和 84 .2 9% (P >0 .0 5 ) ,到达终点的时间分别为 (9.5 1± 3.1)个月和 (9.97± 2 .9)个月 (P >0 .0 5 )。各组均无发生血清iPTH浓度过低 (<130ng/L)。A、B两组极少发生高钙血症 ,发生率分别为 1.11%和 2 .2 2 % ;D组高钙血症发生率为 9.72 % 。

Objective:To study the curative effect and side-effect of low doses of oral calcitriol on early secondary hyperparathyroidism(SHPT) associated with chronic renal failure(CRF).Methods:Following three to twelve months of observation, one hundred and eighty patients with CRF, whose initial serum concentrations of intact parathyroid hormone(iPTH) were three to five times the normal value of 65 ng/L(range 195～325 ng/L) with a tendency to rise, were divided into group A and B using a randomized crossover design. An oral administration of 0.125 micrograms calcitriol (Rocaltrol) per day in parallel with ordinary treatment were given to ninety patients of group A, while 0.25 micrograms calcitriol per day to the other ninety cases of group B, lasting up to 24 months in duration. The target point for group A and B was designated at two-and-a-half times the normal value (160 ng/L). One hundred and fifty-three patients with initial serum concentrations of iPTH higher than five times the normal value(>325 ng/L) were randomly divided into group C and D. An oral administration of 0.5 micrograms calcitriol per day in the morning were given to seventy-seven patients of group C, while the same doses orally administrated at night (10 pm) were given to seventy-six cases of group D, lasting up to 24 months in duration. The target point for group C and D was designated at three times the normal value (195 ng/L). The curative effect was judged by the time and percentage of the patients to target point. The curative effect and side-effects such as hypercalcemia were compared between group A and B, C and D.Results:A good curative effect was seen in all groups. The effective rate of 90.91% in group B was significantly higher than 57.30% in group A (P<0.01). The time to target point in group B (8.66±3.2 months) was significantly sooner than in group A (15.24±3.7 months)(P<0.01). There existed neither significant difference of effective rate (86.89% v 84.29%,P>0.05) nor the time to target point (9.51±3.1 months v 9.97±2.9 months, P>0.05) between group C and D. No unexpected extremely low level of serum iPTH (<130 ng/L) took place. There was a very few incidence of hypercalcemia in group A and B(1.11% and 2.22% respectively). The incident rate of hypercalcemia in group D was only 9.72%, which was significantly lower than in group C (32.88%). The renal and hepatic functions were stable throughout the study.Conclusion:It suggests that the administration of low doses of oral calcitriol from 0.125 to 0.5 micrograms for early SHPT is effective, safety and inexpensive. When given a dose of 0.5 micrograms calcitriol per day at night, fewer hypercalcemias occurred than in the morning.