腰痛宁胶囊治疗腰椎骨性关节炎寒湿瘀阻证240例多中心随机对照临床研究
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摘要
目的评价腰痛宁胶囊治疗腰椎骨性关节炎寒湿瘀阻证的临床疗效和安全性。方法采用多中心随机对照临床研究方法,将360例患者随机分为腰痛宁低剂量组、高剂量组和痹痛宁组各120例,腰痛宁低剂量组给予腰痛宁胶囊每次4粒,每日1次口服;腰痛宁高剂量组给予腰痛宁胶囊每次6粒,每日1次口服;痹痛宁组给予痹痛宁胶囊每次2粒,每日2次口服,共4周。各组于治疗前及治疗2、4周时比较静息痛与活动痛VAS评分、Oswestry功能障碍指数(ODI),并评价ODI疗效,观察静息痛与活动痛止痛时间及不良反应情况。结果各组患者治疗2、4周时静息痛、活动痛VAS评分及ODI均较本组治疗前明显下降(P <0. 05)。腰痛宁高、低剂量组治疗2、4周时,静息痛、活动痛VAS评分及ODI均较同时间点的痹痛宁组降低(P <0. 05)。治疗2、4周时ODI疗效优秀率腰痛宁高剂量组>腰痛宁低剂量组>痹痛宁组,差异均有统计学意义(P <0. 05)。各组患者静息痛、活动痛的止痛时间组间比较差异均有统计学意义(P <0. 05),以腰痛宁高剂量组效果最好。腰痛宁低剂量组发生不良事件2例,腰痛宁高剂量组3例,痹痛宁组2例,各组比较差异均无统计学意义(P> 0. 05)。结论腰痛宁胶囊能减轻腰椎骨性关节炎寒湿瘀阻证疼痛程度,缩短疼痛时间,改善腰部功能,以高剂量效果更好,且不良反应少。
Objective To evaluate the clinical efficacy and safety of Yaotongning Capsule( 腰痛宁胶囊,YTN)on lumbar osteoarthritis with cold-dampness and blood-stasis syndrome. Methods With the method of multi-center randomized controlled trial,totally 360 patients of lumbar osteoarthritis with cold-dampness and blood-stasis syndrome were randomly divided into YTN low-dose group( 4 grains each time,once a day),YTN high-dose group( 6 grains each time,once a day),and Bitongning Capsule group( 2 grains each time,twice a day). All patients were treated for 4 weeks. The visual analogue scale( VAS) of rest and activity pain,Oswestry disability index( ODI) before treatment,2 weeks and 4 weeks after treatment were compared. ODI efficacy was evaluated. The analgesic time of rest pain and activity pain,and adverse reactions were observed. Results After 2 and 4 weeks treatment,VAS( rest and activity pain) and ODI score of all groups were decreased when compared with those before treatment( P <0. 05). The VAS( rest and activity pain) and ODI score of YTN low-dose group and YTN high-dose group were significantly decreased in comparison to those of Bitongning Capsule group( P < 0. 05). The ODI excellent rate of YTN high-dose group was greater than YTN low-dose group,greater than Bitongning Capsule group,and the difference was statistically significant( P < 0. 05). The differences of analgesic time of rest pain and activity pain among groups were statistically significant( P < 0. 05),and the YTN high-dose group had the best effects. Two cases of adverse reactions appeared in YTN low-dose group,3 cases in YTN high-dose group and 2 cases in Bitongning Capsule group. There was no statistically significant difference between groups( P > 0. 05). Conclusions YTN can alleviate the pain of lumbar osteoarthritis with cold-dampness and blood-stasis syndrome,improve analgesic effect and the waist function.The high dose group has the best effects and less adverse reaction.
Objective To evaluate the clinical efficacy and safety of Yaotongning Capsule( 腰痛宁胶囊,YTN)on lumbar osteoarthritis with cold-dampness and blood-stasis syndrome. Methods With the method of multi-center randomized controlled trial,totally 360 patients of lumbar osteoarthritis with cold-dampness and blood-stasis syndrome were randomly divided into YTN low-dose group( 4 grains each time,once a day),YTN high-dose group( 6 grains each time,once a day),and Bitongning Capsule group( 2 grains each time,twice a day). All patients were treated for 4 weeks. The visual analogue scale( VAS) of rest and activity pain,Oswestry disability index( ODI) before treatment,2 weeks and 4 weeks after treatment were compared. ODI efficacy was evaluated. The analgesic time of rest pain and activity pain,and adverse reactions were observed. Results After 2 and 4 weeks treatment,VAS( rest and activity pain) and ODI score of all groups were decreased when compared with those before treatment( P <0. 05). The VAS( rest and activity pain) and ODI score of YTN low-dose group and YTN high-dose group were significantly decreased in comparison to those of Bitongning Capsule group( P < 0. 05). The ODI excellent rate of YTN high-dose group was greater than YTN low-dose group,greater than Bitongning Capsule group,and the difference was statistically significant( P < 0. 05). The differences of analgesic time of rest pain and activity pain among groups were statistically significant( P < 0. 05),and the YTN high-dose group had the best effects. Two cases of adverse reactions appeared in YTN low-dose group,3 cases in YTN high-dose group and 2 cases in Bitongning Capsule group. There was no statistically significant difference between groups( P > 0. 05). Conclusions YTN can alleviate the pain of lumbar osteoarthritis with cold-dampness and blood-stasis syndrome,improve analgesic effect and the waist function.The high dose group has the best effects and less adverse reaction.
引文
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[3]王惠,袁强,苗柳,等.腰痛宁胶囊治疗腰椎骨性关节炎寒湿瘀阻型72例临床观察[J].中医杂志,2015,56(17):1491-1494.
[4]张竞,杨晓利,张静,等.腰痛宁胶囊治疗寒湿瘀阻型腰椎骨性关节炎量效关系分析[J].中医药临床杂志,2015,27(1):99-101.
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[8]胡思源,马融.中药临床试验设计实践[M].北京:科学出版社,2017:718-729.
[9]郑光新,赵晓鸥,刘广林,等. Oswestry功能障碍指数评定腰痛患者的可信性[J].中国脊柱脊髓杂志,2002,12(1):13-15.
[10]何惠生.腰椎椎间关节骨关节炎的早期诊治[J].河南外科学杂志,2006,7(12):27-28.
[11]黄阿勇,栗国强,曹连波,等.活血痹痛膏治疗血瘀寒湿阻络型腰椎骨性关节炎临床研究[J].中国中医药信息杂志,2015,22(6):28-31.
[12]张超,杨少锋.补肾活血汤综合治疗腰椎骨性关节炎60例疗效观察[J].湖南中医杂志,2014,30(10):69-70.
[13]倪力军,朱婷婷,王南南,等.腰痛宁胶囊组方不同有效部位细胞药理活性评价[J].世界科学技术-中医药现代化,2015,17(5):963-970.
[2]戎利民,冯丰.腰椎骨关节炎源性腰痛的诊断和治疗[J].新医学,2009,40(9):569-570.
[3]王惠,袁强,苗柳,等.腰痛宁胶囊治疗腰椎骨性关节炎寒湿瘀阻型72例临床观察[J].中医杂志,2015,56(17):1491-1494.
[4]张竞,杨晓利,张静,等.腰痛宁胶囊治疗寒湿瘀阻型腰椎骨性关节炎量效关系分析[J].中医药临床杂志,2015,27(1):99-101.
[5]孙树椿,孙之镐.中医筋伤学[M]. 2版.北京:人民卫生出版社,2010:181-202.
[6]郑筱萸.中药新药临床研究指导原则(试行)[M].北京:中国医药科技出版社,2002:29-30.
[7]国家技术监督局.中医临床诊疗术语·证候部分[S].北京:中国标准出版社,1997:8.
[8]胡思源,马融.中药临床试验设计实践[M].北京:科学出版社,2017:718-729.
[9]郑光新,赵晓鸥,刘广林,等. Oswestry功能障碍指数评定腰痛患者的可信性[J].中国脊柱脊髓杂志,2002,12(1):13-15.
[10]何惠生.腰椎椎间关节骨关节炎的早期诊治[J].河南外科学杂志,2006,7(12):27-28.
[11]黄阿勇,栗国强,曹连波,等.活血痹痛膏治疗血瘀寒湿阻络型腰椎骨性关节炎临床研究[J].中国中医药信息杂志,2015,22(6):28-31.
[12]张超,杨少锋.补肾活血汤综合治疗腰椎骨性关节炎60例疗效观察[J].湖南中医杂志,2014,30(10):69-70.
[13]倪力军,朱婷婷,王南南,等.腰痛宁胶囊组方不同有效部位细胞药理活性评价[J].世界科学技术-中医药现代化,2015,17(5):963-970.