摘要
目的:评价龙牡壮骨颗粒治疗小儿反复呼吸道感染(肺脾气虚证)的临床疗效及安全性。方法:本研究采用分层区组随机、双盲双模拟、阳性药(匹多莫德颗粒)平行对照、非劣效性检验、多中心临床研究的方法,计划纳入240例患儿,以1∶1比例分为观察组和对照组。疗程8周,随访12个月。观察指标为疾病痊愈率、呼吸道感染次数、平均病程、中医证候疗效、单项症状疗效、免疫指标疗效及安全性指标。结果:本次试验10家研究中心共入选受试者237例,其中,观察组118例,对照组119例。236例进入全分析集(FAS),210例进入符合方案数据集(PPS),236例进入安全性数据集(SS)。两组基线资料差异均无统计学意义,具有可比性。观察组疾病痊愈率为75.21%(88/117),对照组为73.95%(88/119),两组差值的95%置信区间(CI),FAS为1.26%(-9.85%,12.37%),PPS为3.81%(-6.28%,13.90%),在非劣界值为10%的条件下,治疗终点疾病痊愈率的非劣效检验成立,FAS,PPS分析结论一致。上呼吸道感染、支气管炎、肺炎次数及病程的组间比较,差异均无统计学意义。中医证候等级疗效,治疗4周两组间比较,差异无统计学意义,治疗8周两组间比较,差异有统计学意义(P<0.01)。单项症状消失率,治疗4周,各单项症状消失率(面色少华、形体消瘦、少气懒言、气短、食少、纳呆、多汗、大便稀溏)的组间比较,差异均无统计学意义;治疗8周,仅少气懒言、纳呆、多汗的消失率的组间比较,差异均有统计学意义(P<0.05);免疫指标基线及治疗后8周的组间比较,差异均无统计学意义;除观察组的CD8外(P<0.05),其余免疫指标,治疗前后的自身比较,差异均无统计学意义。两组不良反应发生率的组间比较,差异无统计学意义。结论:龙牡壮骨颗粒治疗小儿反复呼吸道感染(肺脾气虚证)改善疾病痊愈率非劣于匹多莫德颗粒,且药物安全性良好,具有临床推广价值。
Objective:To evaluate the clinical efficacy and safety of Longmu Zhuanggu granule for the treatment of children recurrent respiratory infection due to lung-spleen Qi deficiency.Method:This multicenter stratified,block-randomized,double-blind,double-dummy,positive drug(pidotimod granule)parallel controlled,and non-inferiority trail intended to included 240 children patients and divided them into the experimental group(n=120)and the control group(n=120)at the ratio of 1∶1.Patients in both groups were treated for eight successive weeks and followed up for 12 months.The cure rates,numbers of respiratory infections,average courses of disease,curative effects of traditional Chinese medicine(TCM)syndrome,curative effects of individual symptoms,curative effects of immune indexes,and safety indexes between the two groups were observed and compared.Result:A total of 237 subjects were collected from 10 research centers,including 119 cases in the control group and 118 in the experimental group.There were 236 cases enrolled into the full analysis set(FAS),210 into the per-protocol set(PPS),and 236 into the safety set(SS).The baseline data of the two groups were not significantly different from each other,indicating that they were comparable.The cure rates of the experimental group and control group were 75.21%(88/117)and 73.95%(88/119),respectively,with the 95%confidence interval(CI)of difference between the two groups being 1.26%(-9.85%,12.37%)for FAS and 3.81%(-6.28%,13.90%)for PPS.The 95%CI fell within the 10%noninferiority margin,implying that non-infertility test of the cure rate in the treatment of endpoint disease was valid,and the conclusions of FAS and PPS analysis were consistent.There was no significant difference in the number or course of upper respiratory infection,bronchitis,and pneumonia.The difference in curative effects of TCM syndrome between the two groups after four weeks of treatment was not remarkable.After eight weeks of treatment,the total effective rate of the experimental group was 84.62%(99/117),
作者
祝新璐
胡思源
钟成梁
罗红芳
张云峰
张月霞
高茉丽
冯海军
吴娟
丁樱
孟牛安
白玉华
易文龙
ZHU Xin-lu;HU Si-yuan;ZHONG Cheng-liang;LUO hong-fang;ZHANG Yun-feng;ZHANG Yue-xia;GAO Mo-li;FENG Hai-jun;WU Juan;DING Ying;MENG Niu-an;BAI Yu-hua;YI Wen-long(First Teaching Hospital of Tianjin University of Traditional Chinese Medicine(TCM),National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion,Tianjin 300193,China;The Second Affiliated Hospital of Guizhou Medical University,Kaili 556000,China;The Second Hospital of Jilin University,Changchun 130041.China;Luoyang Second Hospital of TCM,Luoyang 471003,China;Qian'an Hospital of TCM,Tangshan 064499,China;Daqing People's Hospital,Daqing 163711,China;Qiandongnan Miao and Dong Autonomous Prefecture Hospital of TCM,Kaili 556000,China;The First Affiliated Hospital of Henan University of Chinese Medcine,Zhengzhou 450099,China;Anyang Hospital of TCM,Anyang 4550001,China;Inner Mongolia International Mongolian Hospital,Hohhot 010020,China;Tianyou Hospital Affiliated to Wuhan University of Science&Technology,Wuhan,430070,China)
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2021年第23期111-117,共7页
Chinese Journal of Experimental Traditional Medical Formulae
基金
国家卫生计生委药政司“中药儿童用药相关政策建议”课题(CATCM-EKKT201404)。
关键词
龙牡壮骨颗粒
反复呼吸道感染
儿童
随机对照试验
Longmu Zhuanggu granule
recurrent respiratory infection
children
randomized controlled trial
