Ebner W, Poal Ballarin J M, Boussina I
Arzneimittelforschung. 1983;33(4A):660-3.
98 patients with reversible, definite, active ankylosing spondylitis were selected for this study. 49 patients were treated with N-(2,6-dichloro-m-tolyl)anthranilic acid, sodium salt (meclofenamate sodium, Meclomen) and 49 patients with indometacin. Following a single-blind baseline period on placebo, patients received either 200 mg meclofenamate sodium per day or 100 mg indometacin per day for one week, in the second week the doses were increased to 250 mg meclofenamate sodium and 125 mg indometacin and from the third through the eight week 300 mg meclofenamate sodium and 150 mg indometacin were given. The results of this double-blind study showed that similar improvement in mobility of the vertebral column and spondylitic pain could be achieved with meclofenamate sodium and indometacin in patients with ankylosing spondylitis. Although both treatments were well tolerated fewer meclofenamate sodium patients reported adverse reactions than did those who had received indometacin. It is concluded that meclofenamate sodium offers an effective and safe alternative to indometacin in the treatment of patients with ankylosing spondylitis.
本研究选取了98例患有可逆性、明确性、活动性强直性脊柱炎的患者。49例患者接受N-(2,6-二氯间甲苯基)邻氨基苯甲酸二钠盐(甲氯芬那酸钠,甲氯灭酸)治疗,49例患者接受吲哚美辛治疗。在安慰剂单盲基线期之后,患者每天接受200毫克甲氯芬那酸钠或100毫克吲哚美辛治疗一周,第二周剂量增加到250毫克甲氯芬那酸钠和125毫克吲哚美辛,从第三周到第八周给予300毫克甲氯芬那酸钠和150毫克吲哚美辛。这项双盲研究的结果表明,甲氯芬那酸钠和吲哚美辛在强直性脊柱炎患者中均可使脊柱活动度和脊柱炎疼痛得到相似程度的改善。虽然两种治疗的耐受性都良好,但报告不良反应的甲氯芬那酸钠治疗患者比接受吲哚美辛治疗的患者少。结论是,在治疗强直性脊柱炎患者时,甲氯芬那酸钠为吲哚美辛提供了一种有效且安全的替代药物。