中医正骨2025，Vol.37Issue(9)：36-39,43,5.
肾髓同治方治疗膝骨关节炎肝肾亏虚证的临床研究
A clinical study of Shensui Tongzhi Fang(肾髓同治方)for treatment of knee osteoarthritis with liver-kidney deficiency syndrome
摘要
Abstract
Objective:To observe the clinical efficacy and safety of Shensui Tongzhi Fang(肾髓同治方,SSTZF)in treatment of knee osteoarthritis(KOA)with syndrome of liver-kidney deficiency.Methods:The patients with KOA and liver-kidney deficiency syndrome re-cruited from December 2023 to June 2024 were selected as the subjects,based on their clinical conditions and preferences,they were treated with oral application of SSTZF(SSTZF group)and imrecoxib capsule(imrecoxib group),respectively.The SSTZF was taken one dose a day in the morning(200 mL)and evening(200 mL),respectively,while,the imrecoxib capsules were taken twice a day,0.1 g at a time.Before the treatment and after 2-week treatment,the affected knee was evaluated using the Western Ontario and McMaster Universities osteoarthritis index(WOMAC)score,including the total score,pain score,stiffness score,and physical function score,and the sleep quality of the patients was assessed using the Pittsburgh sleep quality index(PSQI)score.The adverse reactions were monitored in the 2 groups.Results:One hundred and fifteen patients were enrolled in the study,68 cases in SSTZF group and 47 cases in imrecoxib group.Before the treatment,the WOMAC and PSQI scores showed no significant differences between the 2 groups.After 2-week treatment,the WOMAC total score,pain score,physical function score,and PSQI score were lower in SSTZF group compared to imrecoxib group(50.603±6.591 vs 54.936±8.015 points,t=-3.171,P=0.002;9.838±2.290 vs 11.128±2.401 points,t=-2.910,P=0.004;37.397±5.551 vs 40.340±6.545 points,t=-2.597,P=0.011;6.912±1.891 vs 9.106±2.238 points,t=-5.673,P=0.000),with no significant difference ob-served in the WOMAC stiffness score between the 2 groups.During the treatment period,no adverse reactions were observed in SSTZF group,whereas,in imrecoxib group,2 patients experienced nausea,vomiting,and decreased appetite,which resolved spontaneously after stopping the medication.There was no statistical difference in the incidence of adverse reactions between the 2 groups(P=0.165).Conclusion:SSTZF is superior to imrecoxib in alleviating knee pain,improving knee joint function,and enhancing sleep quality in patients with KOA and liver-kidney deficiency syndrome,while,both are comparable to each other in the safety.关键词
骨关节炎,膝/肝肾亏虚/消炎药,非甾类/肾髓同治方/非随机对照试验专题Key words
osteoarthritis,knee/deficiency of liver and kidney/anti-inflammatory agents,non-steroidal/Shensui Tongzhi Fang/non-rando-mized controlled trials as topic引用本文复制引用
孙烨凯,金红婷,何帮剑,胡松峰,王萧枫,袁文华..肾髓同治方治疗膝骨关节炎肝肾亏虚证的临床研究[J].中医正骨,2025,37(9):36-39,43,5.基金项目
国家自然科学基金项目(82274280) （82274280）
浙江省科技计划项目(2025C02177) （2025C02177）
浙江省基础公益研究计划项目(LR23H270001,LTGY23H270008) （LR23H270001,LTGY23H270008）
国家中医药管理局科技司-浙江省中医药管理局共建科技计划项目(GZY-ZJ-KJ-23093) （GZY-ZJ-KJ-23093）
