龙胆泻肝汤治疗胆腑郁热型慢性鼻—鼻窦炎的随机对照研究
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摘要
目的：
本实验采用随机对照(RCT)设计,结合鼻窦炎患者生存质量量表(QOL),客观评价龙胆泻肝汤治疗胆腑郁热型慢性鼻-鼻窦炎的临床疗效。
方法：
采用随机双盲、安慰剂对照的研究方法,将符合西医慢性鼻-鼻窦炎及中医诊断标准属鼻渊胆腑郁热证的患者,随机分为治疗组和对照组。治疗组予以龙胆泻肝汤水煎剂口服,每日1剂,2周为1疗程；对照组为中药安慰剂,每日1剂,2周为1疗程。治疗前后两组分别评价其患者主观指标(采用MOS SF-36量表、VAS量表、SNOT-20量表)和客观指标(包括Lund-Kennedy内镜黏膜形态评分系统、鼻腔分泌物IL-8水平),以及患者的不良反应。全部数据以SPSS13.0统计软件进行统计学分析。
结果：
1.基线比较：将治疗前两组患者的年龄、病程等基线数据进行比较,经统计学处理无显著性差异,有可比性。
2.中医证候积分变化：两组患者治疗后中医证候积分均有下降,治疗组下降明显,有统计学意义(P<0.05)；组间比较,治疗后治疗组比对照组改善更为明显,统计学处理有显著性差异(P 3.Lund-Kennedy内镜黏膜形态评分变化：两组患者治疗后Lund-Kennedy内镜黏膜形态评分均有下降,组间比较,治疗后治疗组与对照组体征改善差异不明显,无统计学意义(P>0.05)。
4.鼻腔分泌物IL-8水平变化：两组患者治疗后鼻腔分泌物IL-8水平均有下降,组间比较,治疗后治疗组与对照组IL-8水平差异明显,统计学处理有显著性差异(P<0.05)。
5.患者生存质量变化：①SF-36量表：治疗组患者治疗后SF-36评分下降,对照组也有下降；组间比较,差异不明显,无统计学意义(P>0.05)。②VAS量表：治疗组患者治疗后VAS评分下降,对照组也有下降；组间比较,治疗后治疗组比对照组改善更为明显,有统计学意义(P<0.05)。③SNOT-20量表：治疗组患者经治疗后SNOT-20评分下降,对照组也有下降；组间比较,治疗后治疗组比对照组改善更为明显,有统计学意义(P<0.05)。
6.总疗效比较：治疗组总有效率为86.7%;对照组总有效率为26.7%,经卡方检验,两者差异有统计学意义(P<0.05)。
7.安全性指标：治疗组出现1例腹泻；对照组未出现不良反应。
结论：
从初步临床研究来看,龙胆泻肝汤治疗胆腑郁热型鼻-鼻窦炎,能有效改善疼痛、流脓涕、头痛等症状,降低鼻腔IL-8水平,为延缓慢性鼻-鼻窦炎的发展起到了一定的治疗作用。由于受临床观察期限2周为一个疗程的限制,尚未进一步观察其长期疗效。同时,其治疗机制也值得进一步深入研究。
Purpose:The randomized controlled clinical study is conducted to observe the the clinical curative effect and safety of longdan xiegan decoction in the treatment of chronic rhinosinusitis in patients with depressed gall-bladder with phlegm-heat through Quality of Life Scale.
Method:60patients of chronic rhinosinusitis with depressed gall-bladder with phlegm-heat were randomly divided into treatment group and the control group.Subjects received either longdan xiegan decoction daily for2weeks or decoction placebo.Outcome measures included the Sinonasal Outcome Test-20(SNOT-20), VAS scale,SF-36scale,measurements of Lund-Kennedy endoscopic scoring,and nasal lavage assays for interleukin-8. All statistical data is Statistical analysis was performed using the SPSS software. Data are expressed as mean standard error of mean. An intention-to-treat analysis was used. The Mann-Whitney U test was applied to the patient response scale data. The Wilcoxon signed rank test was applied to the remaining data. P values<0.05were considered significant.
Results:There were statistically significant improvements in SNOT-20score and VAS scale as well as IL-8levels in lavage fluid (P<0.05) in the longdan xiegan decoction group. No significant improvements were noted for Lund-Kennedy endoscopic scoring, SF-36scale.
Conclusion:Through the preliminary clinical study, longdan xiegan decoction plays a significant role in the improvement of clinical symptoms to reduce the pain index, lower inflammatory activity, enhance the quality of life, Additional studies are required to assess their place in clinical practice.
本实验采用随机对照(RCT)设计,结合鼻窦炎患者生存质量量表(QOL),客观评价龙胆泻肝汤治疗胆腑郁热型慢性鼻-鼻窦炎的临床疗效。
方法：
采用随机双盲、安慰剂对照的研究方法,将符合西医慢性鼻-鼻窦炎及中医诊断标准属鼻渊胆腑郁热证的患者,随机分为治疗组和对照组。治疗组予以龙胆泻肝汤水煎剂口服,每日1剂,2周为1疗程；对照组为中药安慰剂,每日1剂,2周为1疗程。治疗前后两组分别评价其患者主观指标(采用MOS SF-36量表、VAS量表、SNOT-20量表)和客观指标(包括Lund-Kennedy内镜黏膜形态评分系统、鼻腔分泌物IL-8水平),以及患者的不良反应。全部数据以SPSS13.0统计软件进行统计学分析。
结果：
1.基线比较：将治疗前两组患者的年龄、病程等基线数据进行比较,经统计学处理无显著性差异,有可比性。
2.中医证候积分变化：两组患者治疗后中医证候积分均有下降,治疗组下降明显,有统计学意义(P<0.05)；组间比较,治疗后治疗组比对照组改善更为明显,统计学处理有显著性差异(P
4.鼻腔分泌物IL-8水平变化：两组患者治疗后鼻腔分泌物IL-8水平均有下降,组间比较,治疗后治疗组与对照组IL-8水平差异明显,统计学处理有显著性差异(P<0.05)。
5.患者生存质量变化：①SF-36量表：治疗组患者治疗后SF-36评分下降,对照组也有下降；组间比较,差异不明显,无统计学意义(P>0.05)。②VAS量表：治疗组患者治疗后VAS评分下降,对照组也有下降；组间比较,治疗后治疗组比对照组改善更为明显,有统计学意义(P<0.05)。③SNOT-20量表：治疗组患者经治疗后SNOT-20评分下降,对照组也有下降；组间比较,治疗后治疗组比对照组改善更为明显,有统计学意义(P<0.05)。
6.总疗效比较：治疗组总有效率为86.7%;对照组总有效率为26.7%,经卡方检验,两者差异有统计学意义(P<0.05)。
7.安全性指标：治疗组出现1例腹泻；对照组未出现不良反应。
结论：
从初步临床研究来看,龙胆泻肝汤治疗胆腑郁热型鼻-鼻窦炎,能有效改善疼痛、流脓涕、头痛等症状,降低鼻腔IL-8水平,为延缓慢性鼻-鼻窦炎的发展起到了一定的治疗作用。由于受临床观察期限2周为一个疗程的限制,尚未进一步观察其长期疗效。同时,其治疗机制也值得进一步深入研究。
Purpose:The randomized controlled clinical study is conducted to observe the the clinical curative effect and safety of longdan xiegan decoction in the treatment of chronic rhinosinusitis in patients with depressed gall-bladder with phlegm-heat through Quality of Life Scale.
Method:60patients of chronic rhinosinusitis with depressed gall-bladder with phlegm-heat were randomly divided into treatment group and the control group.Subjects received either longdan xiegan decoction daily for2weeks or decoction placebo.Outcome measures included the Sinonasal Outcome Test-20(SNOT-20), VAS scale,SF-36scale,measurements of Lund-Kennedy endoscopic scoring,and nasal lavage assays for interleukin-8. All statistical data is Statistical analysis was performed using the SPSS software. Data are expressed as mean standard error of mean. An intention-to-treat analysis was used. The Mann-Whitney U test was applied to the patient response scale data. The Wilcoxon signed rank test was applied to the remaining data. P values<0.05were considered significant.
Results:There were statistically significant improvements in SNOT-20score and VAS scale as well as IL-8levels in lavage fluid (P<0.05) in the longdan xiegan decoction group. No significant improvements were noted for Lund-Kennedy endoscopic scoring, SF-36scale.
Conclusion:Through the preliminary clinical study, longdan xiegan decoction plays a significant role in the improvement of clinical symptoms to reduce the pain index, lower inflammatory activity, enhance the quality of life, Additional studies are required to assess their place in clinical practice.
引文
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