摘要
目的观察化疗方案加芩部丹片对复治肺结核患者改善临床症状及生存质量的影响。方法收集上海中医药大学附属龙华医院于2011年4月至2013年3月牵头开展的芩部丹治疗复治肺结核多中心、随机、双盲、安慰剂对照临床试验(临床试验注册号:NCT02313610)的复治结核病患者,共181例,采用随机数字表法分为观察组(2H-R-Z-E-S/6H-R-E+芩部丹片,93例)和对照组(2H-R-Z-E-S/6H-R-E+安慰剂,88例)。观察治疗前及治疗后中医证候积分(包括咳嗽、咳痰、胸痛、潮热、颧红、盗汗、口渴、咽干共8个临床症状积分)和SF-36评分(包括生理机能、生理职能、躯体疼痛、精力、社会功能、情感职能、精神健康、一般健康状况、健康变化共9个维度的评分)的差异。结果治疗结束时,观察组改善中医证候的有效率为91.4%(85/93),明显高于对照组的78.4%(69/88),差异有统计学意义(χ2=6.010,P=0.012)。治疗结束时,观察组的潮热、颧红、盗汗、咳痰、口渴、咽干6项症状积分改善的有效率分别为83.9%(78/93)、71.0%(66/93)、86.0%(80/93)、84.9%(79/93)、80.6%(75/93)、87.1%(81/93),均高于对照组[68.2%(60/88)、53.4%(47/88)、73.9%(65/88)、70.5%(62/88)、54.5%(48/88)、65.9%(58/88)],差异均有统计学意义(χ2=6.415,P=0.013;χ2=5.943,P=0.015;χ2=4.195,P=0.041;χ2=5.516,P=0.019;χ2=14.144,P<0.001;χ2=11.391,P=0.001)。治疗结束时,观察组的健康变化、生理机能、精力、一般健康状况的4项SF-36评分的平均秩次分别为98.58、99.03、102.27、100.47,均高于对照组的平均秩次(82.99、82.51、78.69、82.99),差异有统计学意义(U=3387.000,P=0.027;U=3345.000,P=0.028;U=3009.000,P=0.002;U=3211.000,P=0.012)。结论芩部丹片有助于改善复治肺结核患者的临床症状、提高生存质量。
Objective To observe the effect of chemotherapy regimen and Qinbudan Tablet on clinical symptoms and life quality of patients with retreated smear-positive pulmonary tuberculosis.Methods A total of 181 cases were collected from a multicenter,randomized,double-blind,placebo-controlled clinical trial of chemotherapy regimen and Qinbudan tablet on retreated pulmonary tuberculosis(Clinical trial registration number:NCT02313610)led by Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from April 2011 to March 2013.According to random number table,all cases were randomly divided into observation group(2H-R-Z-E-S/6H-R-E+Qinbudan tablets,93 cases)and the control group(2H-R-Z-E-S/6H-R-E+placebo,88 cases).Observe the differences in Traditional Chinese medicine(TCM)symptom score(including 8 single symptom scores of cough,expectoration,chest pain,hot flashes,cheeky red,night sweats,thirst and dry throat)and SF-36 scale(including physical function,role-physical,bodily pain,vitality,social functioning,role-emotional,mental health,general health and health transition)before and after treatment.Results At the end of treatment,the effective rate of TCM symptom improving for the observation group(91.4%,85/93)was obviously higher than that in the control(78.4%,69/88)group with a significant statistical difference(χ2=6.010,P=0.012).The effective rate of 6 clinical symptom scores including hot flashes,cheeky red,night sweats,phlegm,thirst and dry throat for the observation group(83.9%,78/93;71.0%,66/93;86.0%,80/93;84.9%,79/93;80.6%,75/93;87.1%,81/93)were higher than those in the control group(68.2%,60/88;53.4%,47/88;73.9%,65/88;70.5%,62/88;54.5%,48/88;65.9%,58/88),and the differences were statistically significant(χ2=6.415,P=0.013;χ2=5.943,P=0.015;χ2=4.195,P=0.041;χ2=5.516,P=0.019;χ2=14.144,P<0.001;χ2=11.391,P=0.001).At the end of treatment,the mean rank of the four SF-36 scores including health transition,physical function,vitality and general health in the observation group were 98.58,99.03,102.27,100.47 which were higher than those in the control group(82.99,82.51,78.69,82.99),the differences statistically significant(U=3387.000,P=0.027;U=3345.000,P=0.028;U=3009.000,P=0.002;U=3211.000,P=0.012).Conclusion Qinbudan tablet can help improve the clinical symptoms and life quality of the retreated pulmonary tuberculosis.
作者
邱磊
张少言
郭晓燕
付际游
田黎明
张惠勇
鹿振辉
QIU Lei;ZHANG Shao-yan;GUO Xiao-yan;FU Ji-you;TIAN Li-ming;ZHANG Hui-yong;LU Zhen-hui(Department of Respiration,Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China)
出处
《中国防痨杂志》
CAS
CSCD
2020年第2期108-114,共7页
Chinese Journal of Antituberculosis
基金
“十三五”国家科技重大专项(2018ZX10725509)
上海市科学技术委员会科研计划(18495810600)。
关键词
结核
肺
再治疗
抗结核药
医学
中国传统
药物疗法
联合
疗效比较研究
芩部丹片
Tuberculosis
pulmonary
Retreatment
Antitubercular agents
Medicine
Chinese traditional
Drug therapy
combination
Comparative effectiveness research
Qinbudan tablet
