Article(id=1291704945632367102, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704892859638107, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.19.006, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1749398400000, receivedDateStr=2025-06-09, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896057755, onlineDateStr=2026-08-05, pubDate=1760630400000, pubDateStr=2025-10-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896057755, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896057755, creator=13701087609, updateTime=1785896057755, updator=13701087609, issue=Issue{id=1291704892859638107, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='19', pageStart='2701', pageEnd='2850', issueExtLink='null', onlineDate='null', pubDate='1760630400000', pubDateStr='2025-10-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896045171, creator='13701087609', updateTime=1785896787712, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291708007352656266, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704892859638107, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291708007352656267, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704892859638107, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2730, endPage=2734, ext={EN=ArticleExt(id=1291704945879831039, articleId=1291704945632367102, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical study on the treatment of stage 5 chronic kidney disease complicated with CKD-MBD using sevelamer, Shen Shuai Ning, and calcitriol, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective To investigate the clinical efficacy of sevelamer combined with Shenshuaining and calcitriol in the treatment of stage 5 chronic kidney disease (CKD) patients complicated with chronic kidney disease-mineral and bone disorder (CKD-MBD).
Methods Patients with stage 5 CKD and CKD-MBD were randomly assigned by a random number table method to the control group (n=54) and the treatment group (n=54). The control group received sevelamer (800 mg per dose, three times daily, taken with meals). On this basis, the treatment group additionally received Shenshuaining oral solution (10 mL per dose, three times daily) and calcitriol (0.25 μg, once daily, orally). The treatment lasted for 12 weeks. The two groups were compared in terms of clinical efficacy, renal function indicators [24-hour urinary total protein (24hUTP), serum creatinine (SCr), and blood urea nitrogen (BUN)], inflammatory cytokines [interleukin-6 (IL-6), high-sensitivity C-reactive protein (hs-CRP), and tumor necrosis factor-α (TNF-α)], biochemical indices [intact parathyroid hormone (iPTH)], bone metabolism indices [alkaline phosphatase (ALP) and 25-hydroxyvitamin D (25(OH)D)], and adverse reactions.
Results A total of 120 patients were screened, and 108 were enrolled (54 in each group). After treatment, the total effective rate was 96.30% (52 cases/54 cases) in the treatment group, higher than 81.48% (44 cases/54 cases) in the control group (P<0.05). After treatment, 24 h UTP, SCr, and BUN levels in the treatment and control groups were (0.83±0.25) vs. (1.32±0.41) g·L-1; (130.28±29.74) vs. (174.91±34.18) μmol·L-1; and (9.42±1.94) vs. (12.15±2.61) mmol·L-1; respectively. IL-6, hs-CRP, and TNF-α levels were (14.32±3.07) vs. (17.61±3.58) ng·L-1; (3.38±1.14) vs. (6.75±1.63) mg·L-1; and (16.93±3.15) vs. (21.34±3.81) ng·L-1, respectively. Serum phosphorus and PTH levels were significantly lower in the treatment group [(1.75±0.37) vs. (2.11±0.42) mmol·L-1; (101.78±8.68) vs. (125.46±10.73) pg·mL-1]; while ALP was reduced [(64.31±7.28) vs. (76.45±9.31) IU·L-1] (all P<0.05). The incidence of adverse drug reactions was 11.11% (6 cases/54 cases) in the treatment group and 7.41% (4 cases/54 cases) in the control group, with no significant difference (P>0.05).
Conclusion Sevelamer combined with Shen Shuai Ning and Calcitriol significantly improves renal function, bone metabolism, and inflammation in stage 5 CKD patients complicated with CKD-MBD compared to Sevelamer alone, with similar safety and better clinical efficacy.
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目的 探讨司维拉姆联合肾衰宁、骨化三醇治疗慢性肾脏病5期合并矿物质和骨异常（CKD-MBD）的临床研究。
方法 本研究将慢性肾脏病5期合并CKD-MBD患者，采用随机数表法分为对照组（n=54）和试验组（n=54），对照组予以司维拉姆治疗，口服800 mg·次-1，tid，餐中服用；试验组在此基础上加用肾衰宁口服溶液10 mL·次-1，tid，及骨化三醇0.25μg·d-1，口服。连续治疗12周。比较两组临床疗效、肾功能指标[24h尿蛋白定量（24hUTP）、血肌酐（SCr）、血尿素氮（BUN）]、炎症因子水平[白细胞介素-6（IL-6）、超敏C-反应蛋白（hs-CRP）、肿瘤坏死因子-α（TNF-α）]、血液生化指标[全段甲状旁腺激素（iPTH）]、骨代谢指标[碱性磷酸酶（ALP）、25-羟基维生素D[25（OH）D]]、不良反应发生情况。
结果 本研究共筛选120例，纳入108例，试验组和对照组各54例。治疗后，试验组总有效率为96.30%（52例/54例），高于对照组的81.48%（44例/54例）（P<0.05）。试验组和对照组的24hUTP分别为（0.83±0.25）和（1.32±0.41）g·L-1；SCr分别为（130.28±29.74）和（174.91±34.18）μmol·L-1；BUN分别为（9.42±1.94）和（12.15±2.61）mmol·L-1；IL-6分别为（14.32±3.07）和（17.61±3.58）ng·L-1；hs-CRP分别为（3.38±1.14）和（6.75±1.63）mg·L-1；TNF-α分别为（16.93±3.15）和（21.34±3.81）ng·L-1；磷分别为（1.75±0.37）和（2.11±0.42）mmol·L-1；PTH分别为（101.78±8.68）和（125.46±10.73）pg·mL-1；ALP分别为（64.31±7.28）和（76.45±9.31）IU·L-1；试验组上述指标与对照组比，在统计学上差异有统计学意义（P<0.05）。两组的总药物不良反应发生率分别为11.11%（6例/54例）和7.41%（4例/54例），在统计学上差异无统计学意义（P>0.05）。
结论 司维拉姆联合肾衰宁、骨化三醇治疗慢性肾脏病5期合并CKD-MBD较单独使用司维拉姆治疗能显著改善肾功能、骨代谢及炎症水平，且安全性相当，具有较好的临床疗效。
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刘青（1990-），女，主治医生，主要从事慢性肾衰竭方面的研究
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