骨疏康胶囊联合甲状旁腺切除治疗慢性肾脏病矿物质和骨代谢异常随机对照研究  

Efficacy of Gushukang Capsule Combined with Parathyroidectomy in the Treatment of Chronic Kidney Disease Mineral and Bone Disorder:A Randomized Controlled Trial

作　　者：徐婧 周鹏 刘永祥 贺青卿 XU Jing;ZHOU Peng;LIU Yong-xiang;HE Qing-qing(Department of Thyroid and Breast Surgery,the 960th Hospital of People's Liberation Army Joint Logistic Support Force,Jinan 250031)

机构地区：[1]中国人民解放军联勤保障部队第九六〇医院甲状腺乳腺外科,济南250031

出　　处：《中国中西医结合杂志》2025年第2期176-182,共7页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：山东省医药卫生科技发展计划项目(No.202204011069)。

摘　　要：目的 通过随机对照试验观察慢性肾脏病-矿物质和骨代谢异常(CKD-MBD)患者接受甲状旁腺手术及口服骨疏康胶囊治疗后临床症状、各项辅助检查指标的变化,观察骨疏康胶囊对肝肾亏虚兼瘀毒证型CKD-MBD的临床治疗效果。方法 选择2020年12月-2022年12月期间就诊于中国人民解放军联勤保障部队第九六〇医院甲状腺乳腺外科的114例CKD-MBD患者作为研究对象,根据随机数字表分为骨疏康组和对照组,每组57例。对照组行甲状旁腺全切+部分腺体自体移植术(TPTX+AT),骨疏康组在手术治疗的基础上口服骨疏康胶囊。观察两组患者术前、术后3、6个月临床症状、骨痛视觉模拟评分(VAS);术后1天、术后3、6个月检测甲状旁腺激素(PTH)水平;比较两组术前及术后6个月证候积分的变化。结果 骨疏康组脱落4例,最终完成53例,对照组因术后失访脱落5例,最终完成52例。两组患者术后3、6个月骨痛等症状较术前有显著改善,VAS降低(P<0.01),且骨舒康组在术后6个月骨痛症状的缓解优于对照组(P<0.01)。与本组术后第1天比较,术后3、6个月两组患者血钙、PTH含量增加(P<0.01)。与对照组比较,骨疏康组术后6个月血钙含量更高(P<0.01)。与本组术前比较,术后6个月两组证候总积分下降(P<0.01);与对照组比较,骨疏康组术后6个月总积分下降(P<0.01),尤其少气懒言、腰膝酸软、五心烦热、身体困重改善较为明显(P<0.01,P<0.05)。结论 相比单纯TPTX+AT,骨疏康胶囊联合TPTX+AT能够显著改善肾性骨病的骨痛、骨质疏松等临床症状,纠正血钙代谢,改善患者的生活质量。Objective To observe the clinical efficacy of Gushukang Capsule in the treatment of chronic kidney disease mineral and bone disorder(CKD-MBD) with Gan and Shen deficiency and blood stasis toxin syndrome by observing the changes of clinical symptoms and various auxiliary examination indicators of patients with CKD-MBD after parathyroidectomy by a randomized controlled trial,as well as following the administration of Gushukang Capsules. Methods A total of 114 patients with CKD-MBD who were hospitalized in the thyroid and breast surgery department of the the 960th Hospital of the PLA Joint Logistics Support Force between December 2020 and December 2022 were selected as the study subjects. The patients were randomly assigned to two groups using a random number table:the Gushukang group(57 cases) and the control group(57 cases). The control group underwent total parathyroidectomy with partial gland autotransplantation(TPTX+AT),while the Gushukang group received oral Gushukang Capsules in addition to the surgical treatment.The clinical symptoms,Visual Analog Scale(VAS) scores were observed in both groups preoperatively,and at 3 and 6 months postoperatively. The serum calcium,serum phosphorus,and parathyroid hormone(PTH) levels were detected at 1 day,3 and 6 months postoperatively. The changes in syndrome scores were compared between the two groups preoperatively and at 6 months postoperatively. Results In the Gushukang group, 4 patients dropped out,resulting in 53 patients completed the study. In the control group, 5 patients were lost to follow-up postoperatively,52 patients completed the study. Both groups showed significant alleviation in bone pain and other symptoms at 3 and 6 months postoperatively compared to preoperative levels,with a reduction in VAS scores(P<0.01). Notably,the Gushukang group experienced greater relief of bone pain at 6 months postoperatively compared to the control group(P<0.01). Compared to postoperative day 1 within each group,serum calcium and PTH levels increased at 3 and 6 months postope

关 键 词：继发性甲状旁腺功能亢进 肾性骨病 慢性肾脏病 矿物质和骨代谢异常 甲状旁腺全切 部分腺体自体移植术 骨疏康胶囊 中药复方 随机对照试验 

分 类 号：R69[医药卫生—泌尿科学]