Article(id=1291706997955646404, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291706987964822180, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.21.004, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1755532800000, receivedDateStr=2025-08-19, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896547067, onlineDateStr=2026-08-05, pubDate=1763308800000, pubDateStr=2025-11-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896547067, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896547067, creator=13701087609, updateTime=1785896547067, updator=13701087609, issue=Issue{id=1291706987964822180, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='21', pageStart='3001', pageEnd='3150', issueExtLink='null', onlineDate='null', pubDate='1763308800000', pubDateStr='2025-11-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896544684, creator='13701087609', updateTime=1785896721343, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291707729324826977, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291706987964822180, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291707729324826978, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291706987964822180, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=3019, endPage=3024, ext={EN=ArticleExt(id=1291706998194721733, articleId=1291706997955646404, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial on the treatment of uremic pruritus patients with nafurafine in China, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
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.
, authors=Yu LIU
1, Lin-mei JI
1, Wan-sheng ZHU
1, Chang-lian LI
1, Qiao-ling JIN
2, authorsList=Yu LIU, Lin-mei JI, Wan-sheng ZHU, Chang-lian LI, Qiao-ling JIN, authorCompany=null, correspAuthors=Qiao-ling JIN, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1291706998446379974, articleId=1291706997955646404, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=纳呋拉啡治疗中国尿毒症皮肤瘙痒患者的临床研究, columnId=1246531407485489349, journalTitle=中国临床药理学杂志, columnName=临床与基础桥接研究, runingTitle=null, highlight=null, articleAbstract=
目的 观察纳呋拉啡片在中国尿毒症皮肤瘙痒患者中的临床疗效与安全性。
方法 将内江市第二人民医院和四川大学华西第四医院血液透析中心确诊的尿毒症瘙痒患者按照给药方式分为试验组和对照组。对照组给予常规治疗，试验组在对照组基础上给予纳呋拉啡片治疗（2.5 μg，每晚口服，每日1次，疗程3个月）。对比2组的临床疗效、5-D瘙痒症量表评分、钙磷代谢指标、血尿素氮（BUN）、甲状旁腺激素水平（PTH）、β2微球蛋白（β2-MG）、P物质（SP）、白细胞介素-6（IL-6）、白细胞介素-31（IL-31）和生活质量评价，并进行安全性评价。
结果 本研究共纳入120例患者，其中对照组60例，试验组60例。治疗3个月后，试验组和对照组的总有效率分别为95.00%（57例/60例）和81.67%（49例/60例），试验组显著高于对照组（P<0.05）。治疗3个月后，试验组和对照组的5-D瘙痒症量表评分分别为（5.81±3.29）和（8.12±3.22）分；皮肤病生活质量指数（DLQI）量表评分分别为（24.56±2.87）和（21.23±2.45）分；血钙水平分别为（2.43±0.43）和（2.65±0.37）mmol；血磷水平分别为（1.34±0.26）和（1.50±0.31）mmol；BUN水平分别为（17.76±3.87）和（19.86±4.25）μmol·L-1；PTH水平分别为（322.45±76.54）和（356.12±87.65）pg·mL-1；β2-MG水平分别为（14.56±4.87）和（18.12±5.45）mg·L-1；SP水平分别为（82.45±18.76）和（93.06±20.45）pg·mL-1；IL-6水平分别为（7.56±2.47）和（10.12±2.45）pg·mL-1；IL-31水平分别为（52.45±10.87）和（58.11±12.45）pg·mL-1，试验组的上述指标与对照组比较，在统计学上差异均有统计学意义（均P<0.05）。试验组的主要药物不良反应分别为恶心3例、失眠3例、头晕1例、便秘2例，对照组为恶心2例、失眠1例、头晕2例、便秘2例。试验组和对照组的总药物不良反应发生率分别为15.00%和11.66%，在统计学上差异无统计学意义（P>0.05）。
结论 纳呋拉啡片可显著改善中国尿毒症患者皮肤瘙痒症状及钙磷代谢紊乱、肾功能及炎症反应，提升生活质量，且安全性良好。
, authors=刘钰
1, 吉琳梅
1, 朱万胜
1, 李昌联
1, 金巧玲
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刘钰（1984-）女，硕士，副主任医师，主要从事肾病相关临床工作和研究
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