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目的:研究重组α-2a干扰素(酵母)局部注射治疗尖锐湿疣的疗效及安全性。方法:以α-2a干扰素(大肠杆菌)作对照,进行了随机、双盲、多中心、对照平行试验。试验组用2%利多卡因1ml溶解α-2a干扰素 100万 U,于患者皮损基底部皮内注射,每次100万U,每周3次,连续3周,共9次;对照组用同类药α-2a干扰素,使用方法与试验组相同。其中试验组入组112例,失访1例,可评价病例111例,对照组入组111例,失访2例,因不符合标准淘汰2例,可评价病例107例。结果:试验组111例,其中痊愈38例,显效33例,进步 29例,无效 11例,痊愈率 34.23%,总有效率 63.96%;对照组 107例,其中痊愈25例,显效32例,进步32例,无效18例,痊愈率23.36%,总有效率53.27%。两组疗效比较,统计学处理无显著性差异。两组药物不良反应发生率经统计学处理,P>0.05,无显著性差异。结论:提示α-2a干扰素(酵母)治疗尖锐湿疣疗效与对照药α-2a干扰素(大肠杆菌)相似。
Objective: To study the efficacy and safety of local injection of recombinant interferon α-2a (yeast) in the treatment of condyloma acuminatum. Methods: Randomized, double-blind, multicenter and controlled parallel experiments were performed with α-2a interferon (E. coli) as a control. The experimental group with 1% 2% lidocaine α-2a interferon dissolved 1 million U, intradermal injection at the base of the skin lesions in patients with 1 million U, 3 times a week for 3 consecutive weeks, a total of 9 times; control group With similar drugs α-2a interferon, using the same method with the test group. Among them, 112 cases were enrolled in the trial group, 1 case was lost to follow-up, 111 evaluable cases, 111 cases in the control group and 2 cases lost to follow-up. Results: The experimental group of 111 cases, of which 38 cases cured, effective in 33 cases, 29 cases improved, 11 cases ineffective, the cure rate was 34.23%, the total effective rate was 63.96%; control group of 107 cases, of which 25 cases cured, effective 32 cases, 32 cases improved, 18 cases ineffective, the cure rate was 23.36%, the total effective rate was 53.27%. There was no significant difference between the two groups in the statistical treatment. Two groups of adverse drug reactions incidence by statistical analysis, P> 0.05, no significant difference. CONCLUSIONS: It is suggested that the efficacy of alpha-2a interferon (yeast) in the treatment of condyloma acuminatum is similar to that of the control interferon alpha-2a (E.coli).