Arizona Research and Education, Phoenix, AZ 85253, USA.
Clin Interv Aging. 2012;7:127-37. doi: 10.2147/CIA.S30884. Epub 2012 Jun 11.
This study aimed to determine the safety of diclofenac sodium topical solution 1.5% (w/w) in 45.5% dimethyl sulfoxide (TDiclo) for the treatment of knee or hand osteoarthritis in persons aged 75 years or older.
A pooled analysis of safety data from seven multicenter, randomized, blinded, Phase III clinical trials (4-12 weeks' duration) of TDiclo was conducted. The analysis focused on a subset of patients (n = 280) aged 75 years or older with a primary diagnosis of osteoarthritis of the knee (six trials) or hand (one trial). Patients received one of three topical treatments: TDiclo (n = 138); placebo (2.33% or 4.55% dimethyl sulfoxide, n = 39); or control (45.5% dimethyl sulfoxide, n = 103). Treatment groups were compared using Chi-square analysis, Fisher's Exact test, or analysis of variance.
The most common adverse events involved the skin or subcutaneous tissue, primarily at the application site. The incidence of dry skin was higher in the TDiclo (36.2%; P < 0.0001) and dimethyl sulfoxide control (18.4%; P = 0.0142) groups than in the placebo group (2.6%); the incidence of other skin or subcutaneous tissue adverse events was similar between the groups. Relatively few patients (<18%) experienced gastrointestinal adverse events, and group differences were not detected. In the TDiclo group, constipation (3.6%), diarrhea (3.6%), and nausea (3.6%) were the most common gastrointestinal adverse events. Cardiovascular and renal/ urinary adverse events were rare, and group differences were not detected. There was one case (0.7%) each of hypertension, spider veins, and vasodilation in the TDiclo group. Changes from baseline to the final visit in blood pressure and hepatic/renal enzyme levels were also similar between the groups.
TDiclo appears to be well tolerated for the treatment of osteoarthritis in persons aged 75 years or older.
本研究旨在确定 1.5%（w/w）双氯芬酸钠 topical solution 在 45.5%二甲基亚砜（TDiclo）中治疗 75 岁或以上膝或手骨关节炎患者的安全性。
对 7 项多中心、随机、双盲、III 期临床试验（持续 4-12 周）的安全性数据进行了汇总分析。该分析重点关注了一组年龄在 75 岁或以上、主要诊断为膝（6 项试验）或手（1 项试验）骨关节炎的患者（n=280）。患者接受了以下三种局部治疗之一：TDiclo（n=138）；安慰剂（2.33%或 4.55%二甲基亚砜，n=39）；或对照（45.5%二甲基亚砜，n=103）。使用卡方检验、Fisher 确切检验或方差分析比较治疗组。
最常见的不良事件涉及皮肤或皮下组织，主要发生在应用部位。TDiclo（36.2%；P<0.0001）和二甲基亚砜对照（18.4%；P=0.0142）组的皮肤干燥发生率高于安慰剂组（2.6%）；其他皮肤或皮下组织不良事件的发生率在各组之间相似。很少有患者（<18%）出现胃肠道不良事件，且组间无差异。在 TDiclo 组中，最常见的胃肠道不良事件是便秘（3.6%）、腹泻（3.6%）和恶心（3.6%）。心血管和肾脏/泌尿系统不良事件罕见，且组间无差异。TDiclo 组有 1 例（0.7%）高血压、蜘蛛静脉和血管扩张。各组间血压和肝/肾功能酶水平从基线到最后一次就诊的变化也相似。
TDiclo 似乎可耐受良好，用于治疗 75 岁或以上膝或手骨关节炎患者。
