Significance of combined cyclosporine-prednisolone therapy and cyclosporine blood concentration monitoring for idiopathic membranous nephropathy with steroid-resistant nephrotic syndrome: a randomized controlled multicenter trial.
Significance of combined cyclosporine-prednisolone therapy and cyclosporine blood concentration monitoring for idiopathic membranous nephropathy with steroid-resistant nephrotic syndrome: a randomized controlled multicenter trial.
复制标题
DOI：
10.1007/s10157-013-0925-2
复制
发表时间：
2014-10
影响因子：
2.3
通讯作者：
Tomino, Yasuhiko
中科院分区：
文献类型：
--
作者：
Saito, Takao;Iwano, Masayuki;Matsumoto, Koichi;Mitarai, Tetsuya;Yokoyama, Hitoshi;Yorioka, Noriaki;Nishi, Shinichi;Yoshimura, Ashio;Sato, Hiroshi;Ogahara, Satoru;Shuto, Hideki;Kataoka, Yasufumi;Ueda, Shiro;Koyama, Akio;Maruyama, Shoichi;Nangaku, Masaomi;Imai, Enyu;Matsuo, Seiichi;Tomino, Yasuhiko
关键词：
环孢素微乳预浓缩物（CyA MEPC）和类固醇的联合治疗已广泛用于治疗与类固醇抵抗性肾病综合征（SRNS）相关的特发性膜性肾病（IMN）。最近的研究表明，每天一次和餐前服用 CyA MEPC 比传统的每天两次服用更有利于在给药后 2 小时达到目标血液 CyA 浓度 (C2)。我们设计了一项随机试验来比较这些给药方法。患有 SRNS 的 IMN 患者（年龄 16-75 岁）被前瞻性地随机分为 2 组。在第 1 组 (n = 23) 中，每天早餐前口服一次 2–3 mg/kg 体重 (BW) CyA MEPC。在第 2 组 (n = 25) 中，每天饭前两次给予 1.5 mg/kg BW CyA MEPC。 CyA + 泼尼松龙持续 48 周。第 1 组显示出显着更高的累积完全缓解 (CR) 率 (p = 0.0282)，但在添加不完全缓解 1（ICR1；尿蛋白 0.3–1.0 g/天）时则不然 (p = 0.314)。由于 C2 为 600 ng/mL 被确定为最佳截止点，因此第 1 组和第 2 组进一步分为 A 亚组 (C2 ≥ 600 ng/mL) 和 B 亚组 (C2 < 600 ng/mL)。 1A 组和 2A 组显示出显着更高的累积缓解率 (CR + ICR1) (p = 0.0069) 和单独 CR (p = 0.0028) 率。另一方面，1A组中有3名CyA水平高（C2>900ng/mL）的患者因并发症退出研究。 CyA + 泼尼松龙治疗对于 C2 ≥ 600 ng/mL 的 IMN 伴相关 SRNS 有效。为了实现缓解，每天一次餐前服用 2-3 毫克/千克体重的 CyA 可能是最合适的选择。但应通过治疗药物监测来调整CyA的剂量，以避免并发症。
Combined treatment with cyclosporine microemulsion preconcentrate (CyA MEPC) and steroids has been widely used for idiopathic membranous nephropathy (IMN) associated with steroid-resistant nephrotic syndrome (SRNS). Recent studies have shown that once-a-day and preprandial administration of CyA MEPC is more advantageous than the conventional twice-a-day administration in achieving the target blood CyA concentration at 2 h post dose (C2). We designed a randomized trial to compare these administrations. IMN patients with SRNS (age 16–75 years) were divided prospectively and randomly into 2 groups. In group 1 (n = 23), 2–3 mg/kg body weight (BW) CyA MEPC was given orally once a day before breakfast. In group 2 (n = 25), 1.5 mg/kg BW CyA MEPC was given twice a day before meals. CyA + prednisolone was continued for 48 weeks. Group 1 showed a significantly higher cumulative complete remission (CR) rate (p = 0.0282), but not when incomplete remission 1 (ICR1; urine protein 0.3–1.0 g/day) was added (p = 0.314). Because a C2 of 600 ng/mL was determined as the best cut-off point, groups 1 and 2 were further divided into subgroups A (C2 ≥600 ng/mL) and B (C2 <600 ng/mL). Groups 1A and 2A revealed significantly higher cumulative remission (CR + ICR1) (p = 0.0069) and CR-alone (p = 0.0028) rates. On the other hand, 3 patients with high CyA levels (C2 >900 ng/mL) in Group 1A were withdrawn from the study because of complications. CyA + prednisolone treatment is effective for IMN with associated SRNS at a C2 of ≥600 ng/mL. To achieve remission, preprandial once-a-day administration of CyA at 2–3 mg/kg BW may be the most appropriate option. However, we should adjust the dosage of CyA by therapeutic drug monitoring to avoid complications.
登录
查看更多内容
影响因子：
6.1
作者：
Einecke, G;Mai, I;Budde, K
通讯作者：
Budde, K
DOI：
10.1111/j.1365-2125.1990.tb03677.x
发表时间：
1990-05-01
影响因子：
3.4
作者：
LINDHOLM, A;HENRICSSON, S;DAHLQVIST, R
通讯作者：
DAHLQVIST, R
影响因子：
3.3
作者：
Sugioka, Nobuyuki;Kokuhu, Takatoshi;Takada, Kanji
通讯作者：
Takada, Kanji
影响因子：
6.1
作者：
Alexopoulos, Efstathios;Papagianni, Aikaterini;Memmos, Dimitrios
通讯作者：
Memmos, Dimitrios
影响因子：
6.2
作者：
Levy, G;Thervet, E;Uchida, K
通讯作者：
Uchida, K