论文部分内容阅读
目的:观察评价辣椒碱搽剂对带状疱疹后遗神经痛(PHN)的临床疗效及安全性。方法:采用多中心、随机、双盲、安慰剂对照试验方法,于2005年9月至2007年12月期间选择符合入选标准的PHN患者240例,符合意向性分析并纳入疗效评价的患者231例,随机分为2组:治疗组(117例)和对照组(114例)。治疗组中男52例,女65例,平均年龄(59.23±10.12)岁,平均病程5(1,398)月;对照组中男53例,女58例(3例缺失性别资料),平均年龄(57.44±11.32)岁,平均病程5(1,110)月。治疗组用0.075%的辣椒碱搽剂,对照组用空白基质搽剂,分别涂擦于PHN部位,3次/d,疗程为2周,每周复诊1次。对2组的疗效、不良反应以及血常规、尿常规和肝肾功能的变化进行观察。结果:本试验中共脱落28例(治疗组3例、对照组6例无用药后的评价数据)。治疗组与对照组治疗PHN的总有效率分别为86.32%(101/117)和31.58%(36/114),2组间比较差异有统计学意义(P<0.05)。不良反应主要有皮肤烧灼感、局部刺激发红、肿胀等。治疗组和对照组不良反应的发生率分别为9.17%(11/120)和8.33%(10/120)。2组间差异无统计学意义(P>0.05)。结论:辣椒碱搽剂是治疗带状疱疹后遗神经痛的有效而较为安全的药物。
Objective: To observe and evaluate the clinical efficacy and safety of capsaicin liniment on postherpetic neuralgia (PHN). METHODS: A multicenter, randomized, double-blind, placebo-controlled trial was conducted. Between September 2005 and December 2007, 240 eligible PHN patients were selected. A total of 231 patients with intention-to-treat analysis and included in the efficacy evaluation Were randomly divided into two groups: treatment group (117 cases) and control group (114 cases). In the treatment group, there were 52 males and 65 females, with an average age of 59.23 ± 10.12 years and a mean duration of 5 months (1,398 months). The control group included 53 males and 58 females (3 males) with a mean age of 57.44 ± 11.32) years old, the average duration of 5 (1,110) months. The treatment group with 0.075% capsaicin liniment, the control group with a blank matrix liniment, were rubbed in the PHN site, 3 times / d, course of treatment for 2 weeks, weekly referral 1 time. The curative effect, side effects and changes of blood routine, urine routine and liver and kidney function were observed in the two groups. Results: A total of 28 cases were exfoliated in this experiment (3 in the treatment group and 6 in the control group after evaluation). The total effective rate of treatment of PHN in treatment group and control group were 86.32% (101/117) and 31.58% (36/114), respectively. The difference between the two groups was statistically significant (P <0.05). Adverse reactions are mainly burning sensation, local irritation redness, swelling and so on. The incidence of adverse reactions in the treatment and control groups was 9.17% (11/120) and 8.33% (10/120), respectively. There was no significant difference between the two groups (P> 0.05). Conclusion: Capsaicin liniment is an effective and safe drug for the treatment of postherpetic neuralgia.