养血软坚胶囊治疗膝骨关节炎疗效及安全性评价的随机对照试验

目的比较养血软坚胶囊以及市售中成药抗骨质增生胶囊、西药氨基葡萄糖(商品名维骨力)在治疗膝关节骨关节炎(OA)时的疗效、安全性。方法本试验设计为二家医院进行的随机对照研究。医院1为随机、双盲、阳性中成药抗骨质增生胶囊对照,患者分为2组,每组30例,治疗组服用养血软坚胶囊5粒,每日3次,每粒含药物0.21g、赋形剂0.14g,对照组服用抗骨质增生胶囊5粒,每日3次,每粒含药物0.35g。所有治疗药物均采用双盲、双模拟法完整封装;医院2为随机、西药软骨保护剂氨基葡萄糖对照。患者分为2组,每组30例。治疗组服用养血软坚胶囊3粒,每日3次,每粒含药物0.35g;对照组服用氨基葡萄糖胶囊2粒,每日3次,每粒0.375g。所有患者在停用既往非甾类抗炎药(NSAID)或止痛治疗后2～7d以及服用受试药物治疗后0、2、4周,采用西安大略和麦克马斯特大学骨关节炎调查量表(WOMAC)调查问卷,根据标准疗效判定方法进行评估。结果养血软坚胶囊在改善OA的症状和体征上有显著效果。最大抗炎和镇痛作用出现在2~4周。对骨关节炎临床症状和体征的改善与市售中成药抗骨质增生胶囊及西药维骨力相当。养血软坚胶囊及各对照组均有良好的耐受性。治疗前后,二家医院患者疼痛积分分别下降50%和62%,僵硬积分下降54%和67%,功能积分改善52%和63%。结论养血软

Efficacy study on Yangxue ruanjian jiaonang in the management of osteoarthritic knee with randomized controlled trial

Objective The purpose of this study was to investigate the efficacy of Yangxue ruanjian jiaonang (blood-nourishing and hard-softening capsules) as an adjunctive therapy relieving pain and dysfunction in elderly patients with knee osteoarthritis (OA).Methods Two hospitals participated in this clinical trial with 60 patients in each. Sixty patients with symptomatic knee OA were randomly and double-blindly assigned to treatment of blood-nourishing and hard-softening capsules,or control treatment of another traditional Chinese drug in one hospital.The other hospital designed to use western medicine (viartril-S;glucosamine) as control. A 4-week prospective two-center study with blood-nourishing and hard-softening capsules 3.15 g daily in 120 male and female outpatients with painful osteoarthritis flares of the knee was made.On the day 1, patients were all switched from their previous drugs to blood-nourishing and hard-softening capsules,followed by continuous daily treatment with blood-nourishing and hard-softening capsules in a dosage of 3.15 g daily over 4 weeks. Further endpoints included changes in selfreported pain, stiffness and functional ability as measured by the WOMAC index (Western Ontario McMaster Universities Osteoarthritis Index).Patients′ report of general health status and overall assessment of pain intensity, as measured by visual analogue scale (VAS), was related with physicians′ and patients′ assessment of the efficacy of blood-nourishing and hard-softening capsules treatment.Results Disease specific symptoms measured by the WOMAC questionnaire were significantly improved under the blood-nourishing and hard-softening capsules treatment after 4 weeks: as assessed by the WOMAC index, pain decreased by 50% and 62% (P<0.001), stiffness by 54% and 67%(P<0.001) and functional ability increased by 52% and 63% (P<0.001) respectively in centers 1 and 2 over the course of the study.No matter using western medicine or TCM herb, there was no significant difference between the treatment and control groups.No severe adverse effects of blood-nourishing and hard-softening capsules were reported.Conclusion Blood-nourishing and hard-softening capsules, as a traditional Chinese medicine,significantly relieved pain,stiffness, and improved function, as assessed by the WOMAC questionnaire.