中药复方LC09颗粒泡洗联合尿素软膏治疗抗肿瘤靶向药物多激酶抑制剂致手足皮肤反应的随机对照双盲临床研究  

Study on Traditional Chinese Medicine Compound LC09 Granule Soaking Combined with Urea Ointment in the Treatment of Hand-Foot Skin Reactions Caused by Anti-tumor Targeted Drug Multikinase Inhibitors:a Randomized-Controlled Double-Blind Clinical Trial

作　　者：于然[1,2] 贾立群 裴育莹[1] 高宇 李园[2] 万冬桂[2] 李学[2] 李利亚[2] 娄彦妮[2] YU Ran;JIA Liqun;PEI Yuying;GAO Yu;LI Yuan;WAN Donggui;LI Xue;LI Liya;LOU Yanni(Beijing University of Chinese Medicine,Beijing,100029;China-Japan Friendship Hospital,Beijing,100029)

机构地区：[1]北京中医药大学,北京市100029 [2]中日友好医院

出　　处：《中医杂志》2020年第23期2078-2081,共4页Journal of Traditional Chinese Medicine

基　　金：北京市科技计划首都临床特色应用研究与成果推广项目(Z171100001017207)。

摘　　要：目的观察中药复方LC09颗粒泡洗治疗抗肿瘤靶向药物多激酶抑制剂引起的手足皮肤反应的临床疗效。方法采用随机对照试验方法,将66例手足皮肤反应患者随机分为治疗组(44例)与对照组(22例),治疗组给予中药复方LC09颗粒溶解后40℃温水泡洗手足部皮肤,对照组给予安慰剂溶解后泡洗,均每次20 min,每日2次,共7天。同时两组患者在泡洗后用尿素软膏涂抹,每日2次。治疗后比较两组患者有效率、靶向药物完成率;治疗前后进行毒性事件分级(NCI分级),采用数字评分法(NRS评分)评价疼痛程度,进行手足皮肤反应生活质量量表(QOL)评分。结果对照组脱落2例,治疗组脱落1例,最终纳入分析治疗组43例、对照组20例。治疗组有效率81.4%(35/43),靶向药物完成率72.1%(31/43),对照组有效率45.0%(9/20),靶向药物完成率25.0%(5/20),治疗组有效率和靶向药物完成率明显高于对照组(P<0.01)。治疗组治疗后NRS评分、QOL评分均较治疗前明显降低(P<0.01),NCI分级情况改善,对照组治疗后仅QOL评分降低(P<0.05)。治疗后两组间比较,治疗组在降低NRS评分,改善NCI分级方面优于对照组(P<0.05或P<0.01)。结论中药复方LC09颗粒泡洗联合尿素软膏可明显提高手足皮肤反应有效率,缓解疼痛,提高生活质量,降低靶向药物停药率和毒性事件分级。Objective To observe the clinical efficacy of traditional Chinese medicine(TCM)compound LC09 granule soaking in the treatment of hand-foot skin reactions(HFSR)caused by anti-tumor targeted drug multikinase inhibitors.Methods A randomize-controlled trial method was used.A total of 66 cases of HFSR were randomly divided into a treatment group(44 cases)and a control group(22 cases).The treatment group was treated with LC09 granule to dissolve and soak the skin of hands and feet at 40℃.The control group was given placebo soaking after dissolution,20 minutes each time,2 times a day for 7 days.Meanwhile,both groups were smeared with urea ointment after soaking,twice a day.After treatment,the effective rate and targeted drugs completion rate were compared between groups.Toxic event classification(NCI classification)before and after treatment,numerical rating scale(NRS)was used to evaluate pain degree,and HSFR quality of life scale(QOL)was scored.Results There were 2 cases drop off in the control group,1 case in the treatment group,and finally 43 cases were included in the treatment group and 20 cases were in the control group.The effective rate of the treatment group was 81.4%(35/43),the targeted drug completion rate was 72.1%(31/43),the effective rate of the control group was 45.0%(9/20),and the targeted drug completion rate was 25.0%(5/20).The effective rate and targeted drug completion rate of the treatment group were significantly higher than those of the control group(P<0.01).After treatment,NRS,QOL score of the treatment group was significantly decreased(P<0.01),and the NCI level was improved;while only QOL score was decreased in the control group(P<0.05).Compared between groups,the treatment group was supperior in decreasing NRS and improving NCI level(P<0.05 or P<0.01).Conclusion The TCM compound LC09 granule soaking combined with urea ointment can significantly improve the effective rate of HFSR,relieve pain,improve quality of life,reduce the rate of drug withdrawal of targeted drugs and the level of NCI.

关 键 词：手足皮肤反应 中药复方LC09颗粒 肿瘤 靶向药物 中药泡洗 随机对照试验 

分 类 号：R730.5[医药卫生—肿瘤]