Maheu E, Mazières B, Valat J P, Loyau G, Le Loët X, Bourgeois P, Grouin J M, Rozenberg S
Hôpital Cochin, Paris, France.
Arthritis Rheum. 1998 Jan;41(1):81-91. doi: 10.1002/1529-0131(199801)41:1<81::AID-ART11>3.0.CO;2-9.
To assess the efficacy and safety of avocado/soybean unsaponifiables (ASU) in the treatment of patients with symptomatic osteoarthritis (OA) of the knee or hip, as well as the potential residual effects of ASU after stopping treatment, to determine whether ASU might be a symptomatic slow-acting drug for the treatment of OA.
One hundred sixty-four patients with regular, painful, primary OA of the knee (n = 114) or hip (n = 50) entered a prospective, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial with a 6-month treatment period and a 2-month posttreatment followup. A 15-day washout period for nonsteroidal antiinflammatory drugs (NSAIDs) preceded the study. Efficacy was judged according to 1) Lequesne's functional index (LFI) and 2) pain on Huskisson's visual analog scale (VAS; 100-mm scale), intake of NSAIDs/analgesics, and overall disability score (by 100-mm VAS).
Eighty-five patients received ASU; 79 received placebo. One hundred forty-four patients were evaluable at month 6 (75 taking ASU; 69 taking placebo). The mean +/- SEM LFI score decreased from 9.7 +/- 0.3 to 6.8 +/- 0.4 in the ASU group and from 9.4 +/- 0.3 to 8.9 +/- 0.4 in the placebo group (P < 0.001 for intergroup difference at month 6). Pain decreased from 56.1 +/- 1.6 mm to 35.3 +/- 2.3 in the ASU group and from 56.1 +/- 1.8 mm to 45.7 +/- 2.6 in the placebo group (P = 0.003 at month 6). NSAID consumption was slightly lower in the ASU group. Fewer patients in the ASU group required NSAIDs (48%, versus 63% in the placebo group; P = 0.054). The success rate was 39% in the ASU group and 18% in the placebo group. Overall functional disability was significantly reduced in the ASU group. Improvement appeared more marked in patients with hip OA. A residual effect was observed at month 8. Tolerance was good to excellent for most patients.
ASU treatment showed significant symptomatic efficacy over placebo in the treatment of OA, acting from month 2 and showing a persistent effect after the end of treatment.
评估鳄梨/大豆不皂化物（ASU）治疗膝关节或髋关节症状性骨关节炎（OA）患者的疗效和安全性，以及停药后ASU的潜在残留效应，以确定ASU是否可能是一种治疗OA的症状性慢作用药物。
164例膝关节（n = 114）或髋关节（n = 50）原发性、规律性疼痛的OA患者进入一项前瞻性、随机、双盲、安慰剂对照、平行组、多中心试验，治疗期为6个月，治疗后随访2个月。在研究前有15天的非甾体抗炎药（NSAIDs）洗脱期。疗效根据以下指标判断：1）勒凯斯内功能指数（LFI）；2） 赫斯基森视觉模拟量表（VAS；100毫米量表）上的疼痛、NSAIDs/镇痛药的摄入量以及总体残疾评分（通过100毫米VAS）。
85例患者接受ASU治疗；79例接受安慰剂治疗。144例患者在第6个月可进行评估（75例服用ASU；69例服用安慰剂）。ASU组的平均±标准误LFI评分从9.7±0.3降至6.8±0.4，安慰剂组从9.4±0.3降至8.9±0.4（第6个月组间差异P<0.001）。ASU组的疼痛从56.1±1.6毫米降至35.3±2.3，安慰剂组从56.1±1.8毫米降至45.7±2.6（第6个月P = 0.003）。ASU组的NSAIDs消耗量略低。ASU组需要NSAIDs的患者较少（48%，而安慰剂组为63%；P = 0.054）。ASU组的成功率为39%，安慰剂组为18%。ASU组的总体功能残疾显著降低。在髋关节OA患者中改善似乎更明显。在第8个月观察到残留效应。大多数患者的耐受性良好至极佳。
在OA治疗中，ASU治疗比安慰剂显示出显著的症状性疗效，从第2个月起起效，治疗结束后仍有持续效果。
