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

Yaotongning Capsule(腰痛宁胶囊) in Treating 240 Cases of Lumber Osteoarthritis with Cold-dampness and Blood-stasis Syndrome: A Multi-center Randomized Controlled Trial

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.