通过中西医结合疗法，观察中药溃疡油联合西药复方维生素B₁₂溶液外用防治放射性皮肤损伤的临床疗效。

选择2016年9月至2021年6月中日友好医院中西医结合肿瘤内科及其他科室收治的头颈及胸部恶性肿瘤且需要进行放射治疗的患者110例，单盲下随机分为观察组和对照组各55例。观察组从放疗开始每天外用溃疡油及复方维生素B₁₂溶液喷剂，早晚各1次；对照组只予复方维生素B₁₂溶液喷剂早晚各1次，2组患者均持续用药至放疗结束后1周。放疗第14、21、28天分别记录患者皮肤损伤发生时间、有无溃疡、美国肿瘤放射治疗协作组(RTOG)急性放射性损伤分级、疼痛情况(NRS评分)及用药安全性。放疗结束后1个月及6个月时分别进行随访。数据比较采用χ²检验、t检验、秩和检验。

(1)观察组放射性皮肤损伤出现时间为16.0(13.0，17.0)d，持续时间为33.0(28.0，34.0)d；对照组为10.0(8.0，12.0)d，持续时间为45.0(34.0，48.0)d。2组放射性皮肤损伤出现时间和持续时间比较，差异均有统计学意义(Z＝1.473、5.361，P<0.05)。(2)观察组放射性皮炎发生率为70.91%，显著低于对照组的85.45%(χ²＝8.338，P<0.05)；观察组皮肤溃疡发生率为30.91%，对照组为50.91%，2组比较差异有统计学意义(χ²＝9.575，P<0.05)。(3)观察组和对照组在放疗第14天及6个月随访时的RTOG急性放射性损伤分级总发生例数差异无统计学意义(χ²＝0.015、0.340，P>0.05)，在放疗第21、28天及1个月随访时，观察组RTOG急性放射性损伤分级总发生例数均少于对照组，差异有统计学意义(χ²＝4.677、5.006、3.757，P<0.05)。(4)2组患者在放疗不同时间点疼痛NRS评分差异无统计学意义(Z＝0.903、0.871、0.913，P>0.05)，1个月随访时观察组疼痛NRS评分0.5(0.3，1.0)分低于对照组4.0(2.5，6.0)分，差异有统计学意义(Z＝2.953，P<0.05)，6个月随访时2组疼痛NRS评分比较[0.5(0.2，1.5)分vs. 1.0(0.5，3.5)分]，差异无统计学意义(Z＝1.250，P>0.05)。(5)观察组在应用溃疡油期间未出现不良反应。

溃疡油联合复方维生素B₁₂溶液外用可延缓放射性皮肤损伤出现时间并缩短其持续时间，降低放射性皮炎和皮肤溃疡发生率，减轻疼痛症状，从而避免放疗疗程的延误。

To observe the clinical efficacy of traditional Chinese medicine ulcer oil combined with the western medicine compound vitamin B₁₂ solution in the prevention and treatment of radiation-induced skin injury.

Totally 110 patients with head, neck and chest malignant tumors requiring radiotherapy who were admitted to the Department of Integrated Traditional Chinese and Western Medicine Oncology and other departments, China-Japan Friendship Hospital from September 2016 to June 2021 were enrolled and divided into observation group and control group randomly under the condition of single-blind, with 55 patients in each group. The observation group was treated with ulcer oil and compound vitamin B₁₂ solution twice a day; the control group was only given compound vitamin B₁₂ solution twice a day until one week after the end of radiotherapy. On the 14th, 21st and 28th days, the time of skin injury occurrence, skin ulcer, Radiation Therapy Oncology Group (RTOG) grading, numerical rating scales, and drug safety were recorded. Clinical follow-up was conducted at 1 month and 6 months after the radiotherapy. Data were compared by χ² test, t test and rank-sum test.

(1)In the observation group, the occurrence time of radiation-induced skin injury was 16.0(13.0, 17.0)days, and the duration was 33.0(28.0, 34.0)days; in the control group, the occurrence time was 10.0(8.0, 12.0)days and the duration was 45.0(34.0, 48.0)days, which were significantly different between the two groups (Z=1.473, 5.361, P<0.05). (2)The incidence of radiation dermatitis in the observation group was 70.91%, significantly lower than 85.45% of the control group (χ²=8.338, P<0.05); the incidence of skin ulcer was 30.91% in the observation group and 50.91% in the control group with significant difference between the two groups (χ²=9.575, P<0.05). (3)No significant difference was found in total number of RTOG grading between the two groups at the 14th day of radiotherapy and the 6-month follow-up(χ²=0.015, 0.340, P>0.05). The total number of RTOG grading of the observation group was significantly less than that of the control group at the 21st, 28th days of radiotherapy and the 1-month follow-up (χ²=4.677, 5.006, 3.757, P<0.05). (4)There was no significant difference in NRS score between the two groups during radiotherapy(Z=0.903, 0.871, 0.913, P>0.05) and 6-month follow-up (Z=1.250, P>0.05). The NRS score was significantly lower in the observation group than in the control group at 1-month follow-up [0.5(0.3, 1.0) vs. 4.0(2.5, 6.0), Z=2.953, P<0.05]. (5)No adverse reaction was found in the observation group during the application of ulcer oil.

Ulcer oil combined with compound vitamin B₁₂ solution for external use can delay the occurrence of radiation-induced skin injury and shorten its duration, reduce the incidence of radiation dermatitis and skin ulcers, alleviate pain symptoms, and thereby can avoid delay in radiotherapy treatment.