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- 2017
0.03%他克莫司软膏主动维持治疗儿童和青少年慢性唇炎的疗效及安全性评价
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Abstract:
摘要 目的:采用主动维持疗法,观察0.03%他克莫司软膏治疗儿童和青少年慢性唇炎的疗效,并对其安全性进行评价。方法:本试验共分为2个阶段:治疗阶段(第一阶段)与主动维持阶段(第二阶段)。在试验第一阶段,将40例慢性唇炎患者随机分为2组,试验组25例,对照组15例。试验组首先湿敷复方氯己定溶液,再涂用0.03%他克莫司软膏。对照组仅湿敷复方氯己定,每天2次,连续2周。试验组中痊愈和显效的患者进入第二阶段,并随机分配至试验组或对照组,试验组采用间歇性主动维持疗法,对照组在本阶段不进行间歇维持治疗,如病损复发时采用常规治疗,两组的观察期均为6个月。结果:第一阶段,他克莫司组痊愈21例,显效3例,总有效率为96%,明显高于对照组(60%),差异有统计学意义(P<0.05)第一阶段试验结束后,试验组24例患者进入第二阶段,并随机分为试验组和对照组各12例。第二阶段试验组有效率为100%,对照组的有效率为91.7%,差异无统计学意义。试验组首次出现复发的时间均值为(95.5±9.2) d,对照组均值为(26.6±10.0) d,差异具有统计学意义。试验组患者复发率16.7%明显低于对照组患者58.3%,差异有统计学意义(P<0.05)。结论: 0.03%他克莫司软膏采用主动维持疗法能显著降低儿童和青少年慢性唇炎的复发,疗效好且安全
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