摘要
目的:本研究旨在评价中芍红健腰颗粒治疗急性腰扭伤的临床疗效及安全性。方法:144例急性腰扭伤患者随机平均分为两组,每组各72人,治疗组患者给予芍红健腰颗粒治疗,对照组患者给予云南白药胶囊治疗。记录并统计分析患者初诊、治疗后第3天、第7天、第14天及3个月后的VAS评分、腰椎活动度、ODI评分,同时观察并记录患者的不良反应,评价综合治疗的安全性。结果:两组基线资料差异无统计学意义(P>0.05)。治疗后第3天,两组患者的腰椎活动度明显改善,VAS、ODI均明显降低且差异有统计学意义(P<0.05),治疗组的治疗效果要优于对照组(P<0.05);治疗后第7天后,两组患者的VAS、ODI指数下降,两者差异较前有统计学意义(P<0.05),治疗组优于对照组(P<0.05);治疗第14天,两组患者的VAS、ODI指数进一步下降,腰椎活动度继续上升,两组间VAS评分的差异有统计学意义(P<0.05),治疗组优于对照组(P<0.05)。治疗3月后,两组患者的VAS、ODI指数稍有下降,腰椎活动度稍有改善但差异无统计学意义(P>0.05)。治疗组有4例治疗期间接受针灸推拿、低频康复治疗,7例失访,1例服用非甾体类消炎止痛药;对照组有5例接受针灸推拿治疗、中药定向透药仪器治疗,7例失访,1例服用非甾体类消炎止痛药。结论:芍红健腰颗粒的临床疗效优于对照组云南白药,它能更快速、也更有效的减轻患者腰扭伤后的腰部疼痛程度,有效增加患者的腰椎活动度,患者的日常工作和社会生活等起到更快速、更有效的改善,其近期和远期疗效均值得肯定。
This study was aimed to evaluate the therapeutic effect and safety of Shaohongjianyao（SHJY） granules in the treatment of acute lumbar sprain. A total of 144 acute lumbar sprain cases were randomly divided into two groups, with 72 cases in each group. Patients in the treatment group were treated with SHJY granules. Yunnan Baiyao（YNBY） capsule was used in the control group. Then, Visual Analogue Scale（VAS） scores, lumbar activity and Oswestry disability index（ODI） scores were recorded and evaluated on the first day, three days, seven days, fourteen days and three months after treatment, respectively. Adverse reactions of patients were observed and recorded at the same time. The safety of comprehensive treatment was evaluated. The results showed that there were no significant differences between two groups in any of the baseline characteristics（P〈 0.05）. Three days after the treatment, the lumbar activities of patients in both groups were obviously improved; the VAS scores and ODI scores were obviously decreased with significant differences（P〈 0.05）. The therapeutic effects of the treatment group were better than the control group（P〈 0.05）. Seven days after the treatment, VAS scores and ODI scores decreased with significant differences（P〈 0.05）. The therapeutic effects of the treatment group were better than the control group（P〈 0.05）. Fourteen days after the treatment, VAS scores and ODI scores further decreased and the lumbar activities increased. VAS scores between two groups had significant differences（P〈 0.05）. The therapeutic effects of the treatment group were better than the control group（P〈 0.05）. Three month after the treatment, VAS scores and ODI scores mildly decreased and the lumbar activities mildly improved with no statistical differences（P〉 0.05）. There were four patients received acupuncture, massage and low-frequency therapy during the treatment, seven cases to be lost to follow-up, one case took non-steroidal anti-inflammatory painkiller in the treatment group. There were 5 patients received acupuncture and massage, orientation transdermal Chinese medicine delivery device treatment, seven cases to be lost to follow-up, one case took non-steroidal anti-inflammatory painkiller in the control group. It was concluded that the therapeutic effects of SHJY granules were better than YNBY capsule in the control group. It could relieve pain of acute lumbar sprain; improve the activities of lumber activity as well as the patient＇s daily life and social life quickly and effectively. Its short-term effects and long-term effects were both worth confirming.
出处
《世界科学技术-中医药现代化》
2016年第3期434-440,共7页
Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology
基金
上海市科学技术委员会中医药现代化专项(12401902104):芍红健腰颗粒治疗急性腰扭伤的临床再评价研究
负责人:莫文
国家自然科学基金委青年基金项目(81403419):益气化瘀补肾方介导NF-κB信号通路调控BMSCs治疗骨质疏松性骨折的研究
负责人:许金海
上海市中医药事业发展三年行动计划(2014年-2016年)(ZY3-LCPT-1-1003):上海市骨退行性病中医临床研究基地建设
负责人:莫文
上海市卫生系统优秀学科带头人培养计划(XBR2013104):腰椎间盘突出症的中医规范化方案研究
负责人:莫文
上海市自然科学基金项目(13ZR1442100):TNF-α/NF-κB信号通路调控BMSCs治疗骨延迟愈合的研究
负责人:马俊明
关键词
急性腰扭伤
中药
芍红健腰颗粒
随机对照临床试验
Acute lumbar sprain
traditional Chinese medicine
Shaohongjianyao granules
randomized clinical trial
