羌月乳膏治疗儿童亚急性和慢性湿疹的随机对照、多中心临床研究  

Qiangyue cream in treatment of subacute and chronic eczema in children:a randomized controlled,multicentre clinical study

作　　者：胡思源[1] 李新民[2] 钟成梁[1] 晋黎[2] 郭素香[3] 李邻峰[4] 张云峰[5] 李云玲 程宏斌[7] 张理涛[8] 周春晶[9] 钱华[10] 孙丽萍 柏志芳[12] 常成荣 郑艳梅[14] 段昕所[15] 王宏东[16] 张永宁 迪里拜尔·热夏提 刘素文 高学敏 孙媛媛 徐小景 HU Si-yuan;LI Xin-min;ZHONG Cheng-liang;JIN Li;GUO Su-xiang;LI Lin-feng;ZHANG Yun-feng;LI Yun-ling;CHENG Hong-bin;ZHANG Li-tao;ZHOU Chun-jing;QIAN Hua;SUN Li-ping;BAI Zhi-fang;CHANG Cheng-rong;ZHENG Yan-mei;DUAN Xin-suo;WANG Hong-dong;ZHANG Yong-ning;DILIBAIER-Rexiati;LIU Su-wen;GAO Xue-min;SUN Yuan-yuan;XU Xiao-jing(Department of CLinicdl Trails Centre,the First Tetwhing Hospital of Tianjin University of Tnulitional Chinese Medicine,Nalional Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion,Turnjin 300193,China)

机构地区：[1]天津中医药大学第一附属医院临床试验中心、国家中医针灸临床医学研究中心,天津300193 [2]天津中医药大学第一附属医院儿科,天津300193 [3]天津中医药大学第二附属医院儿科,天津300150 [4]首都医科大学附属北京友谊医院皮肤性病科,北京100050 [5]吉林大学第二医院儿科,吉林长春130041 [6]浙江医科大学附属儿童医院皮肤科,浙江杭州310003 [7]成都中医药大学附属医院皮肤科,四川成都610072 [8]天津市中医药研究院附属医院皮肤科,天津300131 [9]辽宁中医药大学附属第四医院儿科,辽宁沈阳110000 [10]苏州大学附属儿童医院皮肤科,江苏苏州215000 [11]陕西中医药大学附属医院皮肤科,陕西咸阳712000 [12]江苏省第二中医院皮肤科,江苏南京210017 [13]陕西省核工业二一五医院皮肤科,陕西咸阳712021 [14]太原市妇幼保健院儿科,山西太原030000 [15]承德医学院附属医院皮肤科,江西承德067000 [16]延安大学附属医院皮肤科,陕西延安716000 [17]渭南市妇幼保健院皮肤科,陕西渭南714000 [18]乌鲁木齐儿童医院皮肤科,新疆维吾尔自治区830000 [19]襄阳市中医院儿科,湖北襄阳441000 [20]中国中药协会药物研究评价技术中心,北京100061 [21]北京康派特医药科技开发有限公司项目部,北京100101

出　　处：《临床皮肤科杂志》2022年第2期103-107,共5页Journal of Clinical Dermatology

基　　金：国家卫计委药政司“中药儿童用药相关政策建议”课题示范项目(CATCM-EKKT201405)资助项目。

摘　　要：目的:评价羌月乳膏治疗儿童亚急性和慢性湿疹的临床有效性及安全性。方法:采用多中心、分层区组随机、双盲、安慰剂平行对照的设计方法。以中心为分层因素,计划入选240例,按1∶1随机分为试验组和对照组。试验组采用羌月乳膏,对照组采用基质乳膏,均涂敷于患处,每日3次,疗程4周。以靶皮损形态疗效、面积疗效、瘙痒疗效的有效率为主要有效性评价指标。结果:治疗2周及4周后,试验组靶皮损形态的有效率(46.96%、60.87%)均高于对照组(29.66%、44.91%);试验组靶皮损面积有效率(37.39%、55.65%)均高于对照组(22.03%、38.14%);试验组瘙痒疗效的有效率(48.65%、67.57%)均高于对照组(42.24%、51.72%),2组比较差异均有统计学意义(P<0.05),且优效性检验均成立。随访3个月,2组痊愈患者的复发率比较,试验组(2.38%)低于对照组(17.24%),差异有统计学意义(P<0.05)。试验组与对照组不良事件发生率分别为3.42%和8.47%,组间比较差异无统计学意义(P>0.05)。结论:羌月乳膏局部治疗儿童亚急性和慢性湿疹,能显著改善皮损形态,缩小皮损面积,缓解瘙痒症状,且复发率低,具有较好的疗效和安全性。Objective: To evaluate the efficacy and safety of Qiangyue cream in the treatment of children with subacute and chronic eczema. Methods: That was a randomized, double-blind, single-simulated, multicenter, stratified group, matrix cream parallel controlled clinical trial. Taking the center as the stratified factor, 240 cases were randomly divided into trial group and control group according to a1∶1 ratio. The trail group received Qiangyue cream and the control group received placebo for 4 weeks : local application on the affected areas, 3 times per day. Lesion shape, size and itching severity were used as main evaluation indexes. Results: After 2 weeks and4 weeks, the total effective rate for lesion shape in the trial group(46.96%, 60.87%) was higher than that in the control group(29.66 %,44.91%). The total effective rate for lesion size was higher in the trial group(37.39%, 55.65%) than in the control group(22.03%,38.14%). The total effective rate for pruritus in the trial group(48.65%, 67.57%) was higher than that in the control group(42.24 %,51.72 %). All differences were significant(P < 0.05), and the superior validity tests were all valid. All the cured cases were followed up for 4 weeks, and the recurrence rate in the trial group(2.38%) was lower than that in the control group(17.24%)(P<0.05). The incidences of adverse events in the trial group and the control group were 3.42 % and 8.47 %, but without significant difference(P > 0.05). Conclusion:Qiangyue cream exerts positive effects on the shape and size of skin lesions, and significantly relieves itching. After treatment, the recurrence rate is low.

关 键 词：湿疹 羌月乳膏 随机对照 多中心 儿童 

分 类 号：R758.23[医药卫生—皮肤病学与性病学]