Article(id=1292126512866685221, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126460546929080, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.03.002, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1747929600000, receivedDateStr=2025-05-23, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785996567217, onlineDateStr=2026-08-06, pubDate=1771257600000, pubDateStr=2026-02-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785996567217, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785996567217, creator=13701087609, updateTime=1785996567217, updator=13701087609, issue=Issue{id=1292126460546929080, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='3', pageStart='301', pageEnd='450', issueExtLink='null', onlineDate='null', pubDate='1771257600000', pubDateStr='2026-02-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785996554742, creator='13701087609', updateTime=1786014541627, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201903060963536, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126460546929080, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201903060963537, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126460546929080, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=306, endPage=311, ext={EN=ArticleExt(id=1292126513055428902, articleId=1292126512866685221, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial of cinacalcet combined with calcitriol in hemodialysis patients with diabetic nephropathy, 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 cinacalcet tablets combined with calcitriol pills in diabetic nephropathy (DN) patients undergoing hemodialysis.
Methods DN patients receiving hemodialysis in our hospital were divided into treatment group and control group based on different medication regimens. The control group was treated with calcitriol pills, administered orally twice a week. The dosage was 0.25-1.5 μg for patients with intact parathyroid hormone (iPTH) 300-600 ng·L-1, 0.5-2.0 μg for those with (iPTH) 600-1 000 ng·L-1, and 2.0-4.0 μg for those with iPTH > 1 000 ng·L-1. The treatment group received cinacalcet tablets in addition to the control group’s treatment. The initial dose of cinacalcet tablet was 25 mg per day, adjusted every 2-4 weeks, the dose remained unchanged for patients with serum calcium < 2.1 mmol·L-1; increased to 50 mg per day for those with serum calcium>2.0 mmol·L-1; and decreased to 75 mg per day for those with serum calcium<1.8 mmol·L-1. Both groups were treated for 6 months. Clinical efficacy, calcium-phosphorus metabolism, renal function, bone metabolism, iPTH levels and parathyroid gland volume were compared between the two groups, and safety was evaluated.
Results A total of 94 patients were included in this study, with 47 cases in each of treatment and control groups. After treatment, the total effective rates were 95.74% (45 cases/47 cases) in treatment group and 80.85% (38 cases /47 cases) in control group, showing statistically significant difference (P<0.05). After treatment, the blood calcium levels in treatment and control groups were (2.78±0.21) and (2.49±0.23) mmol·L-1, respectively; blood phosphorus levels were (1.11±0.13) and (1.39±0.17) mmol·L-1, respectively; calcium-phosphorus product levels were 3.09±0.24 and 3.46±0.29, respectively; fibroblast growth factor 23 (FGF23) levels were (60.55±7.21) and (71.62±7.84) ng·L-1, respectively; alkaline phosphatase levels were (91.06±28.43) and (110.35±32.19) U·L-1, respectively; osteoprotegerin levels were (6 892.43±395.46) and (7 142.58±411.27) ng·L-1, respectively; iPTH levels were (623.08±57.19) and (721.57±61.46) ng·L-1, respectively; and parathyroid gland volumes were (0.81±0.19) and (1.11±0.18) cm3, respectively. All of these indicators in treatment group showed statistically significant differences compared to control group (all P<0.05). The main adverse drug reactions in treatment group included pruritus (2 cases), myalgia (3 cases), nausea and vomiting (1 case) and diarrhea (1 case). In the control group, adverse drug reactions were pruritus (1 case), myalgia (2 cases), nausea and vomiting (2 cases) and diarrhea (1 case). The total incidence of adverse drug reactions were 12.77% (6 cases/47 cases) in treatment group and 14.89% (7 cases/47 cases) in control group, with no statistically significant difference (P>0.05).
Conclusion The combination of cinacalcet tablets and calcitriol pills effectively corrects disorders of calcium-phosphorus and bone metabolism, reduces iPTH levels, and decreases parathyroid gland volume in DN patients on hemodialysis, with a favorable safety profile.
, authors=Hui-min ZHU
a, Chang-xi SUN
a, Chun-yan Zhang
b, authorsList=Hui-min ZHU, Chang-xi SUN, Chun-yan Zhang, authorCompany=null, correspAuthors=Chang-xi SUN, 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=1292126513403556135, articleId=1292126512866685221, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=西那卡塞联合骨化三醇在糖尿病肾病血液透析患者中的临床研究, 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 观察西那卡塞片联合骨化三醇丸对糖尿病肾病（DN）血液透析患者的临床疗效和安全性。
方法 将我院接受血液透析的DN患者根据给药方案不同分为试验组和对照组。对照组用骨化三醇丸进行治疗，1周2次口服，其中全段甲状旁腺激素（iPTH）300～600 ng·L-1的患者给予0.25～1.5 μg；（iPTH）600～1 000 ng·L-1的患者给予0.5～2.0 μg；iPTH>1 000 ng·L-1的患者给予2.0～4.0 μg。试验组在对照组的基础上联合西那卡塞片进行治疗，初始剂量为每天25 mg，每2～4周调整剂量，其中血钙<2.1 mmol·L-1的患者维持剂量不变；血钙>2.0 mmol·L-1的患者应用剂量为每天50 mg；血钙<1.8 mmol·L-1的患者应用剂量每天75 mg。2组均治疗6个月。比较2组患者的临床疗效、钙磷代谢、肾功能、骨代谢、iPTH、甲状旁腺体积，并进行安全性评价。
结果 本研究共纳入94例患者，试验组和对照组各47例。治疗后，试验组和对照组总有效率分别为95.74 %（45例/47例）和80.85 %（38例/47例），在统计学上差异有统计学意义（P<0.05）。治疗后，试验组和对照组的血钙分别为（2.78±0.21）和（2.49±0.23）mmol·L-1，血磷分别为（1.11±0.13）和（1.39±0.17）mmol·L-1，钙磷乘积分别为3.09±0.24和3.46±0.29，成纤维细胞生长因子23（FGF23）分别为（60.55±7.21）和（71.62±7.84）ng·L-1，碱性磷酸酶分别为（91.06±28.43）和（110.35±32.19）U·L-1，骨保护素分别为（6 892.43±395.46）和（7 142.58±411.27）ng·L-1，iPTH分别为（623.08±57.19）和（721.57±61.46）ng·L-1，甲状旁腺体积分别为（0.81±0.19）和（1.11±0.18）cm3，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有瘙痒2例，肌肉酸痛3例，恶心呕吐1例，腹泻1例，对照组瘙痒1例，肌肉酸痛2例，恶心呕吐2例，腹泻1例，试验组和对照组的药物不良反应总发生率分别为12.77%（6例/47例）和14.89%（7例/47例），在统计学上差异无统计学意义（P>0.05）。
结论 西那卡塞片联合骨化三醇丸能够有效纠正DN血液透析患者钙磷代谢及骨代谢紊乱，降低iPTH，减小甲状旁腺体积，同时具有较高安全性。
, authors=朱慧敏
a, 孙长喜
a, 张春艳
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朱慧敏（1979-），女，副主任医师，主要从事肾内科和血液净化相关的临床工作和研究
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