Fioravanti A, Cicero M R, Nerucci F, Manopulo R, Marcolongo R
Institute of Rheumatology, University of Sienna, Italy.
Drugs Exp Clin Res. 1999;25(5):235-40.
To evaluate the efficacy and tolerability of the new diclofenac-N-(2-hydroxyethyl)-pyrrolidine lecithin gel (DHEP lecithin gel, with 1.3% DHEP and 2.4% lecithin) compared with the efficacy and tolerability of diclofenac-N-(2-hydroxyethyl)-pyrrolidine gel (DHEP gel) in peri and extraarticular inflammatory states, a controlled, randomized, double-blind clinical study was conducted. Two groups of 50 patients each were enrolled and were given one of the two different formulations with a slight massage on the painful area three times a day for 10 consecutive days. Patients received a self-evaluation notebook in which to record daily assessment of spontaneous pain (Huskisson's visual analogue scale). On days 0, 3 and 10, the patients were visited by the investigator. All patients completed the study. The assessment of spontaneous pain showed that although pain decreased in both groups, the decrease was more marked in patients taking DEHP lecithin gel and that it reached a statistically significant difference at days 5, 6, 7 and 8. This decrease was also confirmed by assessments on the ordinal scale. Although periarticular swelling disappeared in both groups, swelling severity decreased sooner in patients taking DHEP lecithin gel. The efficacy and safety of both treatments was judged to be good or excellent by 70% of the patients in each group. The efficacy of the active principle, pyrrolidine salt, is confirmed. Moreover, the formulation containing lecithin passes through the skin lipid barrier more easily than the formulation without lecithin and is as valid as the other in the therapy of rheumatic disorders. Finally, DHEP lecithin gel preparation has a quicker therapeutic action on symptoms, such as spontaneous pain and local swelling, than DHEP gel.
为评估新型双氯芬酸 - N -（2 - 羟乙基）- 吡咯烷卵磷脂凝胶（DHEP卵磷脂凝胶，含1.3% DHEP和2.4%卵磷脂）与双氯芬酸 - N -（2 - 羟乙基）- 吡咯烷凝胶（DHEP凝胶）在关节周围和关节外炎症状态下的疗效及耐受性，开展了一项对照、随机、双盲临床研究。每组招募50名患者，连续10天每天3次在疼痛部位轻轻按摩并给予两种不同制剂中的一种。患者收到一本自我评估笔记本，用于记录每日自发疼痛的评估情况（采用Huskisson视觉模拟量表）。在第0、3和10天，研究者对患者进行访视。所有患者均完成了研究。自发疼痛评估显示，虽然两组疼痛均有减轻，但服用DEHP卵磷脂凝胶的患者疼痛减轻更为明显，且在第5、6、7和8天达到统计学显著差异。这种减轻在序数量表评估中也得到了证实。虽然两组关节周围肿胀均消失，但服用DHEP卵磷脂凝胶的患者肿胀严重程度减轻得更快。每组70%的患者认为两种治疗的疗效和安全性良好或极佳。活性成分吡咯烷盐的疗效得到了证实。此外，含卵磷脂的制剂比不含卵磷脂的制剂更容易穿透皮肤脂质屏障，在风湿性疾病治疗中与另一种制剂同样有效。最后，DHEP卵磷脂凝胶制剂对自发疼痛和局部肿胀等症状的治疗作用比DHEP凝胶更快。
