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目的观察外用止痒平肤液治疗表皮生长因子受体抑制剂(epidermal growth factor receptor inhibitors,EGFRIs)相关痤疮样皮疹、皮肤瘙痒、皮肤干燥、指甲改变的疗效,并评价药物的安全性、患者的满意度。方法选择经病理学诊断明确的、应用EGFRIs后出现痤疮样皮疹患者201例,采用随机数字表法分为试验组和对照组。试验组(131例)在西医标准处理原则基础上加用自拟中药止痒平肤液,对照组(70例)外用空白药物及西医标准处理原则,连续14天。观察治疗前后2组患者皮疹分级、皮肤瘙痒、皮肤干燥、指甲改变的变化以及血常规、肝肾功等安全性指标,并随访无进展生存期(progression-free survival,PFS)。结果 185例完成临床观察,试验组脱落10例,对照组6例。试验组治疗皮疹分级、皮肤瘙痒、皮肤干燥、指甲改变的有效率分别为90.1%(109/121)、57.9%(70/121)、57.9%(70/121)、16.5%(20/121);对照组分别为14.1%(9/64)、6.3%(4/64)、1.6%(1/64)、0.0%(0/64)。两组比较皮疹分级、皮肤瘙痒、皮肤干燥的差异有统计学意义(χ2分别为105.1022,51.3312,59.1777,P<0.05)。临床观察过程中未出现与药物相关的严重不良事件,安全性较好,试验组与对照组患者满意度分别为95.4%(125/131)、57.1%(40/70)。两组无进展生存期比较,差异无统计学意义(χ2=2.006,P>0.05)。结论止痒平肤液治疗EGFRIs相关皮肤不良反应的疗效显著,且无明显的不良反应,但仍需要更多的随机对照试验进一步加以证实。
Objective To observe the efficacy of topical antipruritic skin lotion for the treatment of acne-like rash associated with epidermal growth factor receptor inhibitors (EGFRIs), pruritus, dry skin and nails, and evaluate the safety of the drug. Patients Satisfaction. Methods Totally 201 patients with acne-like rash who were diagnosed by pathology were divided into test group and control group by random number table. The experimental group (131 cases) was treated with self-made Chinese medicine Anti-itching and Pingfu liquid on the basis of the standard treatment of western medicine, blank control of the control group (70 cases) and Western standard treatment principle for 14 consecutive days. The changes of rash grading, pruritus, dry skin and nails before and after treatment were observed. The safety indexes such as blood routine, liver and kidney function were observed and followed up for progression-free survival (PFS). Results 185 cases completed the clinical observation, test group shed 10 cases, control group 6 cases. The effective rates of the treatment group were 90.1% (109/121), 57.9% (70/121), 57.9% (70/121), 16.5% (20/121), respectively. ; Control group were 14.1% (9/64), 6.3% (4/64), 1.6% (1/64) and 0.0% (0/64) respectively. The difference between the two groups was statistically significant (χ2 = 105.1022,51.3312,59.1777, P <0.05) compared with the rash grading, pruritus and dry skin. There were no serious drug-related adverse events in the course of clinical observation, and the safety was good. Satisfaction of patients in trial group and control group were 95.4% (125/131) and 57.1% (40/70), respectively. There was no significant difference in progression-free survival between the two groups (χ2 = 2.006, P> 0.05). Conclusion Antipruritic skin lotion treatment of EGFRIs related skin adverse reactions with significant effect, and no obvious adverse reactions, but still need more randomized controlled trials to be further confirmed.