Kanzaki Motoko, Wada Jun, Kikumoto Yoko, Akagi Shigeru, Nakao Kazushi, Sugiyama Hitoshi, Makino Hirofumi
Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
Int J Nephrol Renovasc Dis. 2012;5:91-6. doi: 10.2147/IJNRD.S32191. Epub 2012 Jun 5.
In nephrotic syndrome, the combination of furosemide and albumin infusion is a standard regimen to treat systemic edema. The efficacy of synthetic human atrial natriuretic peptide (hANP) for nephrotic syndrome to ameliorate the systemic edema and retain renal functions has not been fully demonstrated.
We conducted a prospective, randomized, controlled, open-label clinical trial. Patients were randomly assigned by a stratified biased coin design.
A total of 12 patients with nephrotic syndrome between the ages of 20 to 79 years were enrolled and randomly assigned to either the conventional (CON) group treated with furosemide and albumin, and hANP group, in which carperitide was administered in addition to the conventional therapies. The primary end points were: (1) the differences in serum creatinine levels, and (2) the reduction of total dosage of furosemide and albumin by the treatments of hANP. Secondary end points were body weight, systolic blood pressure, heart rate, serum protein, albumin, and urinary protein excretion.
A total of 13 patients were enrolled, and one patient was excluded due to severe pneumonia. In both hANP (n = 7) and CON (n = 5) groups, body weight was reduced after 2-week treatments. Serum creatinine levels at follow-up significantly increased compared with baseline. The increase in serum creatinine levels (Δ serum creatinine) was smaller in the hANP group compared with the CON group (P = 0.31). The serum uric acid, serum urea nitrogen, and urinary protein excretion were reduced in the hANP group, and increased in the CON group, though these differences were not statistically significant. The usage of hANP significantly reduced the total dosage of furosemide (P < 0.05) during the treatment periods. No adverse effects were observed.
The concomitant use of synthetic hANP with conventional therapies is beneficial for reducing the dosage of loop diuretics, and the elevation of serum creatinine and uric acid may be avoided.
在肾病综合征中，呋塞米与白蛋白输注联合使用是治疗全身性水肿的标准方案。合成人心房利钠肽（hANP）治疗肾病综合征改善全身性水肿并保留肾功能的疗效尚未得到充分证实。
我们进行了一项前瞻性、随机、对照、开放标签的临床试验。患者通过分层偏倚硬币设计进行随机分配。
共纳入12例年龄在20至79岁之间的肾病综合征患者，随机分为接受呋塞米和白蛋白治疗的传统（CON）组以及除传统治疗外还给予卡培立肽的hANP组。主要终点为：（1）血清肌酐水平的差异，以及（2）hANP治疗使呋塞米和白蛋白总剂量的减少。次要终点为体重、收缩压、心率、血清蛋白、白蛋白和尿蛋白排泄。
共纳入13例患者，1例因严重肺炎被排除。在hANP组（n = 7）和CON组（n = 5）中，经过2周治疗后体重均减轻。随访时血清肌酐水平与基线相比显著升高。hANP组血清肌酐水平的升高（血清肌酐变化量）低于CON组（P = 0.31）。hANP组血清尿酸、血清尿素氮和尿蛋白排泄减少，CON组则增加，尽管这些差异无统计学意义。hANP的使用在治疗期间显著降低了呋塞米的总剂量（P < 0.05）。未观察到不良反应。
合成hANP与传统疗法联合使用有利于减少袢利尿剂的剂量，并且可能避免血清肌酐和尿酸升高。
