Peng Yan-Mei, Cui Hui-Juan, Liu Zhel, Jing Fang-Fang, Chu Yu-Ping, Bai Yan-Ping, Liu Dai-Wei, Song Ya-Zhong, Duan Hua, Qiu Yu-Qin
Zhongguo Zhong Xi Yi Jie He Za Zhi. 2017 Feb;37(2):149-154.
Objective To observe the curative effect of Zhiyang Pingfu Lotion (ZPL) for its ex- ternal application in treatment of epidermal growth factor receptor inhibitors (EGFRIs)-related acneiform rash, cutaneous pruritus , xerosis cutis , and nail changes , as well as to evaluate its safety and patients' satisfaction. Methods Recruited were 201 patients with confirmed pathological diagnosis, who had acne- iform rash after using EGFRIs. They were assigned to the treatment group (131 cases) and the control group (70 cases) by random digit table. Patients in the treatment group were externally applied with self- formulated ZPL based on principles of Western medical standards, while those in the control group were externally applied with blank drugs plus conventional Western medicine standard. The therapeutic course for all was 14 days. Changes in rash degree, cutaneous pruritus, xerosis cutis, and nails were observed in both groups before and after treatment. Blood routines as well as liver and kidney function tests were performed in both groups before and after treatment. Follow-up visit was also conducted during progression-free survival (PFS). Results A total of 185 patients finished this clinical trial. Ten dropped out in the treatment group and 6 in the control group. The effective rates of rash degree, cutaneous pruritus, xerosis cutis, and nail changes were 90.1 % (109/121 ), 57.9% (70/121 ), 57. 9% (70/121 ), and 16. 5% (20/121) in the treatment group, respectively. They were 14. 1% (9/64), 6. 3% (4/64), 1. 6% (1164), and 0 (0/64) in the control group, respectively. Significant difference existed in all these indices between the two groups (X² = 105. 1022, 51. 3312, 59. 1777; P <0. 05). No serious drug-related adverse events occurred during clinical observation, with relatively better safety. The satisfaction was 95. 40% (125/131) in the treatment group and 57. 1 % (40/70) in the control group. No statistical difference in PFS was observed between the two groups (X² = 2. 006, P > 0. 05). Conclusions ZPL had significantly curative effect in treatment of EGFRIs-related skin adverse reactions, with no obvious adverse reactions. Howev- er, more randomized control trials are needed to verify these findings.
目的 观察止痒平肤洗剂外用治疗表皮生长因子受体抑制剂（EGFRIs）相关的痤疮样皮疹、皮肤瘙痒、皮肤干燥及指甲改变的疗效，并评价其安全性及患者满意度。方法 招募201例经病理确诊、使用EGFRIs后出现痤疮样皮疹的患者，采用随机数字表法分为治疗组（131例）和对照组（70例）。治疗组患者根据西医标准原则外用自拟的止痒平肤洗剂，对照组患者外用空白药物加西医常规标准治疗。两组疗程均为14天。观察两组治疗前后皮疹程度、皮肤瘙痒、皮肤干燥及指甲的变化。治疗前后两组均进行血常规及肝肾功能检查。在无进展生存期（PFS）期间进行随访。结果 共有185例患者完成本临床试验。治疗组脱落10例，对照组脱落6例。治疗组皮疹程度、皮肤瘙痒、皮肤干燥及指甲改变的有效率分别为90.1%（109/121）、57.9%（70/121）、57.9%（70/121）和16.5%（20/121）。对照组分别为14.1%（9/64）、（4/64）、1.6%（1/64）和0（0/64）。两组这些指标差异均有统计学意义（χ² = 105.1022、51.3312、59.1777；P <0.05）。临床观察期间未发生严重的药物相关不良事件，安全性相对较好。治疗组满意度为95.40%（125/131），对照组为57.1%（40/70）。两组PFS无统计学差异（χ² = 2.006，P >0.05）。结论 止痒平肤洗剂治疗EGFRIs相关皮肤不良反应疗效显著，无明显不良反应。然而，需要更多的随机对照试验来验证这些结果。
