中国中西医结合杂志2025，Vol.45Issue(2)：176-182,7.DOI:10.7661/j.cjim.20240914.217
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
摘要
Abstract
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 postoperatively(P＜0.01).Additionally,the Gushukang group had significantly higher serum calcium levels at 6 months postoperatively compared to the control group(P＜0.01).Both groups showed a reduction in total syndrome scores at 6 months postoperatively compared to their preoperative scores(P＜0.01).The Gushukang group also demonstrated a more pronounced reduction in total syndrome scores at 6 months postoperatively compared to the control group(P＜0.001),with marked alleviation in symptoms such as shortness of breath and reluctant to speak,soreness and weakness of the waist and knees,sphoria with feverish sensation in chest,palms and soles,and heaviness of the body(P＜0.01,P＜0.05).Conclusion Compared to TPTX+AT alone,Gushukang Capsule with TPTX+AT significantly improves the clinical symptoms of renal bone disease,such as bone pain and osteoporosis,corrects calcium and phosphorus metabolism,and enhances the quality of life of patients.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Key words
secondary hyperparathyroidism/renal bone disease/chronic kidney disease/abnormal mineral and bone metabolism/total parathyroidectomy/autotransplantation/Gushukang Capsules/Chhinese herbal compound/randomized controlled trial引用本文复制引用
徐婧,周鹏,刘永祥,贺青卿..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[J].中国中西医结合杂志,2025,45(2):176-182,7.基金项目
山东省医药卫生科技发展计划项目(No.202204011069) （No.202204011069）
