强骨宝治疗马来西亚膝骨关节炎患者的临床研究

发布时间：2018-02-22 23:56

本文关键词： 强骨宝膝骨关节炎临床疗效安全性　出处：《中华中医药杂志》2017年07期 　论文类型：期刊论文

【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(P0.05);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。
[Abstract]:Objective: to investigate the clinical application of Qianggu Bao in the treatment of knee osteoarthritis in Malaysia, and to evaluate the curative effect of Qianggu Bao on knee osteoarthritis in Malaysian patients. To evaluate the effect of Qianggu Bao on heart, liver and kidney function in patients with knee osteoarthritis in Malaysia. Methods: 60 selected patients with knee osteoarthritis were given oral administration of QG twice a day, once a day. Taking medicine twice a day, early, 30 minutes after supper, taking 400 mL warm water for 8 consecutive weeks. Each subject was followed up for 5 times (including screening and random visit. Vital signs: systolic blood pressure) were recorded at each follow-up. Heart diastolic blood pressure, heart rate; laboratory tests: blood, urine (biochemistry complete, blood routine, Urine routine and rheumatoid factors, safety monitoring indicators: ECG) examination. 12-lead electrocardiogram measurement during the first screening and at the 6th weekend. Evaluation of curative effect, vital signs and laboratory examination after 8 weeks follow-up. Results: after 8 weeks of treatment, The results of self-control analysis of the study group showed that there was no significant change in the quality of life in the patients with joint pain within 2 weeks after taking the drug. The swelling of the joints did not abate significantly within 4 weeks and 8 weeks after treatment, and the pain, swelling, stiffness and function of the joints were not abated significantly within 4 to 8 weeks. The quality of life was improved gradually (P 0.05); the vital signs of the study group remained within the normal range after treatment, without liver and kidney function abnormalities; no patients showed abnormal heart rate and systolic blood pressure. Conclusion: Qianggu Bao is effective in treating knee osteoarthritis with no obvious adverse reaction and safety. Qianggu Bao has some therapeutic effect on osteoarthritis, but in order to promote its application, it is effective. There is still a need to expand the scale of multi-center further research.
【作者单位】：福建中医药大学;
【基金】：福建省自然科学基金项目(No.2016J01380)~~
【分类号】：R274.9

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