摘要
目的:探讨强骨宝在马来西亚膝骨关节炎患者中的临床应用;评估强骨宝治疗马来西亚患者膝骨关节炎的疗效;评价强骨宝对马来西亚膝骨关节炎患者心肝肾功能的影响。方法:将60例入选的膝骨关节炎患者按照要求,通过口服途径给药,受试者每天服强骨宝两次,每日1剂,每天服药两次,早、晚饭后30min各1次,400m L温水冲服,需连续8周。每个受试者一共需要参加5次随访(包括:筛查即随机访问)。每次随访均记录生命体征:心脏收缩压、心脏舒张压、心率;实验室检查:血液、尿液(生化全套、血常规、尿常规和类风湿因子等);安全监测指标:心电图(ECG)检查。12导联心电图测量在第1次的筛查和第6周末。随访8周后疗效评估,生命体征和实验室检查观测。结果:治疗8周后,研究组自身对照分析,结果表明:患者关节疼痛、生活质量在服药后2周内未发生明显变化,4周内关节肿胀未见明显消退,4-8周内关节疼痛、肿胀、僵硬、功能、生活质量均得到逐步改善(P<0.05);研究组治疗后生命体征仍然保持在正常范围内,无肝、肾功能异常;没有患者表现出异常的心率、心脏收缩压、心脏舒张压和心电图。结论:强骨宝治疗膝骨关节炎疗效确切;且无明显不良反应,安全。强骨宝方对骨关节炎有一定治疗效果,但为了更好地推广应用,证明其有效性,仍需扩大规模多中心进一步研究。
Objective: To study the clinical usage of of Chinese herbal medicine Qiang Gu Bao in the treatment of knee osteoarthritis in Malaysia, and to analyse the efficacy of Qiang Gu Bao in the treatment of Malaysian patients with knee osteoarthritis. To evaluate the possible effect of Qiang Gu Bao in liver, kidney and heart functions. Methods: Sixty participants were recruited into the study. Eligibleparticipants were to receive oral Chinese herbal medicine Qiang Gu Bao in 2 divided doses daily, half an hour after meals, over 8 weeks, with every 2 weeks follow-up. Each subject attended a total of five clinic visits including the screening visit. At each visit, vital signs(heart rate, blood pressure), laboratory tests(full blood picture, liver and renal function tests, urine test and rheumatoid factor) were conducted. Safety monitoring by 12-lead electrocardiogram(ECG) was carried out at visit 1(screening visit) and 4(the end of 6th week). Final assessment of the therapeutic effect, vital signs and laboratory tests were carried out at the end of visit 5(the end of 8th week). Results: After 8 weeks, within group analysis indicated that there was no significant improvement in pain and quality of life in earlystage(<2 weeks), and there was not much reduction in the joint swelling(<4 weeks), whereas all of these symptoms including stiffness of knee joint and physical activities respectively improved during 4-8 weeks(P<0.05). In the study group, the vital signs and the results of blood and urine tests remained within normal range through out the trial, and no participant demonstrated abnormal heart rate and ECG. Conclusion: The Chinese herbal medicine formula Qiang Gu Bao has significant therapeutic effect in Malaysian OA population. Larger scale studies over longer period of time are required.
出处
《中华中医药杂志》
CAS
CSCD
北大核心
2017年第7期3304-3308,共5页
China Journal of Traditional Chinese Medicine and Pharmacy
基金
福建省自然科学基金项目(No.2016J01380)~~
关键词
强骨宝
膝骨关节炎
临床疗效
安全性
Qiang Gu Bao
Knee osteoarthritis
Clinical efficacy
Safety
