中国临床药理学杂志2025，Vol.41Issue(21)：3019-3024,6.DOI:10.13699/j.cnki.1001-6821.2025.21.004
纳呋拉啡治疗中国尿毒症皮肤瘙痒患者的临床研究
Clinical trial on the treatment of uremic pruritus patients with nafurafine in China
摘要
Abstract
Objective To observe the clinical efficacy and safety of nafurafine tablets in patients with pruritus due to uremia in China.Methods Patients diagnosed with pruritus due to uremia in the Hemodialysis Center of the Second People's Hospital of Neijiang City and West China Fourth Hospital of Sichuan University were divided into treatment group and control group by treatment region.Control group was given conventional treatment,while treatment group was treated with nafurafine tablets(2.5 µg,orally every night,once a day,for a course of 3 months)on the basis of control group.The clinical efficacy,5-D pruritus scale score,calcium and phosphorus metabolism indicators,blood urea nitrogen(BUN),parathyroid hormone level(PTH),β 2-microglobulin(β2-MG),substance P(SP),interleukin-6(IL-6),interleukin-31(IL-31)and quality of life evaluation of the two groups were compared.And conducted a safety evaluation.Results A total of 120 patients were included,including 60 cases in control group and 60 cases in treatment group.After 3 months of treatment,the total effective rates of treatment group and control group were 95.00％(57 cases/60 cases)and 81.67％(49 cases/60 cases),respectively.The treatment group was significantly higher than control group(P＜0.05).After 3 months of treatment,the 5-D pruritus scale scores of treatment and control group were(5.81±3.29)and(8.12±3.22)points,respectively;the scores of the dermatology life quality index(DLQI)scale were(24.56±2.87)and(21.23±2.45)points,respectively;the blood calcium levels were(2.43±0.43)and(2.65±0.37)mmol,respectively;the blood phosphorus levels were(1.34±0.26)and(1.50±0.31)mmol,respectively;the BUN levels were(17.76±3.87)and(19.86±4.25)μmol·L-1,respectively;the PTH levels were(322.45±76.54)and(356.12±87.65)pg·mL-1,respectively;the levels of β2-MG were(14.56±4.87)and(18.12±5.45)mg·L-1,respectively;the SP levels were(82.45±18.76)and(93.06±20.45)pg·mL-1,respectively;the levels of IL-6 were(7.56±2.47)and(10.12±2.45)pg·mL-1,respectively;the levels of IL-31 were(52.45±10.87)and(58.11±12.45)pg·mL-1,respectively.Compared with control group,the above indicators in treatment group showed statistically significant differences(all P＜0.05).The main adverse drug reactions in treatment group were nausea in 3 cases,insomnia in 3 cases,dizziness in 1 case and constipation in 2 cases,while those in control group were nausea in 2 cases,insomnia in 1 case,dizziness in 2 cases and constipation in 2 cases.The total incidence of adverse drug reactions in treatment and control group were 15.00％and 11.66％,respectively,and there was no statistically significant difference(P＞0.05).Conclusion Nafurafine tablets can significantly improve the symptoms of skin pruritus,calcium and phosphorus metabolism disorders,renal function and inflammatory response in Chinese patients with uremia,enhance the quality of life,and has good safety.关键词
纳呋拉啡片/尿毒症/皮肤瘙痒/真实世界研究/有效性/安全性Key words
nafurafine tablet/uremia/itchy skin/real-world research/validity/safety分类
医药卫生引用本文复制引用
刘钰,吉琳梅,朱万胜,李昌联,金巧玲..纳呋拉啡治疗中国尿毒症皮肤瘙痒患者的临床研究[J].中国临床药理学杂志,2025,41(21):3019-3024,6.基金项目
四川省2024年度省级科研基金及青年科研基金资助项目(KY2024SJ0006) （KY2024SJ0006）
