摘要
背景:研究表明,甲氨蝶呤直接外用治疗能使关节局部药物质量浓度提高,具有疗效好而全身毒副作用少的优点。目前的外用剂型有乳剂、涂膜剂、药膜等,但透皮吸收效果均不理想。研制具有优良透皮特性的载药纳米柔性脂质体,将会极大地拓宽适用于经皮给药的药物范围。目的:观察甲氨蝶呤柔性纳米脂质体局部外用治疗类风湿性关节炎的疗效,并对其不良反应进行评估。方法:40例类风湿性关节炎患者随机分为两组,在常规抗风湿治疗基础上分别局部外用甲氨蝶呤柔性纳米脂质体(治疗组)或口服甲氨蝶呤(对照组),共治疗12周;观察关节压痛指数、关节肿胀指数、关节功能障碍指数、晨僵时间和平均握力等各项临床指标,并对外用甲氨蝶呤柔性纳米脂质体的安全性进行评估。结果与结论:两组患者经治疗12周时,治疗组较对照组能明显缓解关节的疼痛和压痛症状(P<0.01);经治疗12周,治疗组和对照组的总有效率分别为90%和75%,两组比较差异无显著性意义(P>0.05);治疗组不良反应发生率低于对照组(P<0.01)。结果提示局部外用甲氨蝶呤柔性纳米脂质体和口服甲氨蝶呤均能明显改善类风湿性关节炎的多种临床症状和体征,但对改善关节疼痛、压痛和关节肿胀,前者明显优于后者,且不良反应低。
BACKGROUND：Studies have shown that external application of methotrexate can increase local drug concentration,with good efficacy and fewer systemic side effects.The current external formulations are creams,plastics,pellicles and so on,but the percutaneous absorption is not satisfactory.Developing a drug-laded flexible nanoliposome with excellent transdermal permeability,would greatly expand the applicable scope of transdermal drug delivery.OBJECTIVE：To investigate the effectiveness of flexible nanoliposomes of methotrexate for external application in the treatment of rheumatoid arthritis and to evaluate the adverse effect.METHODS：Based on routine rheumatoid arthritis therapy,44 patients with rheumatoid arthritis were divided into a treatment group with flexible nanoliposomes of methotrexate and a control group with methotrexate pill for 12 weeks.The clinical indices including joint tenderness index,joint swelling index,joint dysfunction index,morning stiffness time and average gripping strength were observed.The safety of flexible nanoliposomes of methotrexate was also assessed.RESULTS AND CONCLUSION：After 12 week of the therapy,flexible nanoliposomes of methotrexate could significantly reduce the joints pain and tenderness compared with methotrexate pills,and the effective rates in treatment group and control group were respectively 90% and 75% with no significant differences between two groups（P 0.05）.Further,the side effects of treatment group were significant lower than control group（P 0.01）.Both external application of flexible nanoliposomes of methotrexate and the oral administration of methotrexate pills could significantly improve the clinical signs and symptoms of rheumatoid arthritis patients.But the former is better than the latter in the aspect of improving the pain,tenderness and swelling of involved joints.Moreover,flexible nanoliposomes of methotrexate has nearly no side effects.
出处
《中国组织工程研究与临床康复》
CAS
CSCD
北大核心
2010年第47期8893-8896,共4页
Journal of Clinical Rehabilitative Tissue Engineering Research
