新癀片治疗吉非替尼痤疮样皮疹的临床疗效观察及相关机制探讨

Clinical observation of Xinhuang pills on the treatment of gefitinib acne-like rash and its mechanism study

目的观察新癀片治疗吉非替尼痤疮样皮疹的临床疗效,探讨其可能的作用机制。方法将40例吉非替尼痤疮样皮疹患者随机分为2组。治疗组20例,予新癀片治疗;对照组20例,予安慰剂治疗。2组均治疗4周后统计疗效,比较2组治疗前后皮损分级情况及白细胞介素1β(IL-1β)水平变化,以及治疗后对患者肿瘤病情的影响。结果治疗组总有效率95.0%,对照组30.0%,治疗组总有效率优于对照组(P<0.05);2组治疗后治疗组皮损分级情况比较差异有统计学意义(P<0.05),治疗组皮损程度轻于对照组;治疗组治疗后IL-1β水平与本组治疗前及对照组治疗后比较差异均有统计学意义(P<0.05),IL-1β水平降低,对照组IL-1β水平治疗前后比较差异无统计学意义(P>0.05);2组治疗后肿瘤病情比较差异无统计学意义(P>0.05),2组肿瘤病情情况相当。结论新癀片治疗吉非替尼痤疮样皮疹疗效确切,可明显改善患者临床症状,减轻皮损程度,且安全可靠,无明显不良反应,对患者肿瘤病情无影响,降低IL-1β水平,抑制炎症反应,可能是其治疗吉非替尼痤疮样皮疹的作用机制之一。

Objective To observe the clinical effects of Xinhuang pills on the treatment of gefitinib acne - like rash and to study its possible mechanism. Methods 40 patients gefitinib acne- like rash were randomly divided into two groups. 20 cases in treatment group were treated by Xinhuang pills, and 20 cases in control group were treated by placebo. The curative effect was evaluated after 4 weeks treatment in two groups, The skin lesion grading state and interleukin - 1β （ IL - 1β） before and after treatment were compared. The influence of tumor after treatment Was observed. Results The total effective rate in treatment group （95.0%） was superior to that in control group （P 〈 0.05 ）. The skin lesion grading state after treatment in treatment group was lower than that in control group, with statistical differences （P 〈 0.05）. The IL - 1β after treatment in treatment group was decreased, with statistical differences （P 〈 0. 05 ）. There were no statistical differences on IL - 1β in control group between before and after treatment （P 〉 0.05）. There were no statistical differences on the condition of tumor between before and after treatment in two groups （P 〉 0.05）, two group had same condition. Conclusion Xinhuang pills have exact effects on the treatment of gefitinib ache - like rash, can relief skin lesion grading, safe and reliable without adverse reaction, have no influence on tumor condition, and decrease IL - 1β, inhibit inflammation reaction, which may be one of the mechanism on treating gefitinib acne- like rash.