摘要
【目的】观察健脾养胃膏干预易感冒人群的临床疗效及安全性。【方法】将120例患者随机分为对照组和试验组,每组各60例。对照组采用生活方式干预,试验组在对照组生活方式干预基础上加用健脾养胃膏口服治疗,干预疗程为12周。评价2组患者在干预前、干预后12周和干预后1年的感冒情况及在试验过程中的安全性。【结果】(1)试验组脱落9例,共51例完成试验;对照组脱落8例,共52例完成试验。(2)干预后,2组患者12周内的感冒情况视觉模拟量表(VAS)评分均较干预前明显下降(P<0.01),而感冒次数均较干预前有所减少,但差异无统计学意义(P>0.05);干预后组间比较,差异均无统计学意义(P>0.05)。(3)干预后1年,试验组患者1年中的感冒次数明显减少,感冒情况VAS评分明显降低,差异均有统计学意义(P<0.01);对照组患者仅感冒次数明显减少(P<0.01),而感冒情况VAS评分虽有所下降,但差异无统计学意义(P>0.05);干预后组间比较,差异均无统计学意义(P>0.05)。(4)干预后,试验组患者的健康调查简表评分较干预前略有升高,差异有统计学意义(P<0.05),而对照组无明显变化(P>0.05);试验组患者对健康调查简表评分的升高作用明显优于对照组,组间干预前后差值比较,差异有统计学意义(P<0.05)。(5)在试验过程中,2组患者的血常规、肝肾功能等实验室指标均未发现明显异常。试验组出现不良反应的比例为19.2%(10/51),且大部分为轻度不良反应,经调理后症状可缓解、消失。【结论】健脾养胃膏对改善易感冒人群的易感冒情况安全有效,能使易感冒人群的感冒次数减少,感冒的严重程度减轻,生活质量提高。
Objective To observe the clinical curative effect and therapeutic safety of Jianpi Yangwei Soft Extract on the population susceptible to common cold. Methods A total of 120 subjects were randomly divided into control group and trial group,60 cases in each group. The control group adopted lifestyle intervention,while the trial group was given oral use of Jianpi Yangwei Soft Extract on the basis of lifestyle intervention in the control group.The course of intervention lasted for 12 weeks. The frequency of common cold attack as well as the scores of common cold manifestations of the subjects was evaluated before intervention,after 12 weeks of intervention and one year after intervention, and the safety during the intervention was also monitored. Results(1)During the trial,9 cases from the trial group and 8 cases from the control group dropped out,and 51 cases of the trial group and 52 cases of the control group completed the trial.(2)After 12 weeks of the intervention,the scores of visual analogue scale(VAS)for common cold manifestations were decreased in the two groups in comparison with those before treatment(P<0.01),and the frequency of common cold attack tended to reduce in the two groups but the difference was insignificant(P>0.05). The intergroup comparison showed that the differences of VAS scores and the frequency of common cold attack between the two groups were insignificant after intervention(P > 0.05).(3)One year after intervention,the frequency of common cold attack and VAS scores for common cold manifestations in the trial group were decreased in comparison with those before intervention(P < 0.01);in the control group,the frequency of common cold attack was much reduced(P<0.01), and the VAS scores for common cold manifestations tended to decrease but the difference was insignificant(P>0.05). The intergroup comparison showed that the differences of VAS scores and the frequency of common cold attack between the two groups were insignificant after intervention(P > 0.05).(4)After 12 weeks of the interventi
作者
雷静
吴翠萍
李海
陈欣燕
林嬿钊
LEI Jing;WU Cui-Ping;LI Hai;CHEN Xin-Yan;LIN Yan-Zhao(Guangzhou University of Chinese Medicine,Guangzhou 510405 Guangdong,China;Qingyuan Hospital of Traditional Chinese Medicine,Qingyuan 5115003 Guangdong,China;Guangdong Provincial Hospital of Traditional Chinese Medicine,Guangzhou 510120 Guangdong,China)
出处
《广州中医药大学学报》
CAS
2020年第8期1455-1460,共6页
Journal of Guangzhou University of Traditional Chinese Medicine
基金
国家中医药管理局2015年度中医药行业科研专项(编号:201507003)。
关键词
随机对照试验
易感冒
健脾养胃膏
感冒次数
生活质量
randomized controlled trial
susceptible to cold
Jianpi Yangwei Soft Extract
frequency of common cold attack
quality of life
