Ciccolunghi S N, Chaudri H A, Schubiger B I
Rheumatol Rehabil. 1979;Suppl 2:100-15.
The results of 940 patients treated with diclofenac for 3 to 24 months in comparative and non-comparative trials are presented. Maximal improvement tended to occur in the first 3 to 6 months of treatment and was generally maintained. Diclofenac was at least as effective as equivalent doses of indomethacin and naproxen and, when treatment lasts more than 3 months, may be more effective. The majority of patients reporting unwanted effects or discontinuing treatment did so in the first 6 months. Unwanted effects (similar to those in short-term trials) were mainly gastrointestinal. Central nervous system, cardiovascular and dermatological side-effects were reported in 1% or less of patients. The long-term laboratory tolerability of diclofenac was good, with no changes in the nature, frequency or severity of abnormal tests with increasing duration of treatment. During the development of diclofenac sodium (Voltarol) various types of long-term investigation were conducted (Table I). This paper presents the results, covering a total of 940 patients treated for 3-24 months, and discusses their significance.
本文呈现了940例患者在对照和非对照试验中接受双氯芬酸治疗3至24个月的结果。最大改善往往出现在治疗的前3至6个月，且通常得以维持。双氯芬酸至少与等效剂量的吲哚美辛和萘普生一样有效，并且当治疗持续超过3个月时，可能更有效。大多数报告有不良反应或停止治疗的患者是在最初6个月内。不良反应（与短期试验中的类似）主要是胃肠道方面的。中枢神经系统、心血管和皮肤方面的副作用在1%或更少的患者中被报告。双氯芬酸的长期实验室耐受性良好，随着治疗时间延长，异常检查的性质、频率或严重程度均无变化。在双氯芬酸钠（扶他林）的研发过程中进行了各类长期研究（表I）。本文呈现了总计940例患者接受3至24个月治疗的结果，并讨论了其意义。
