利肺胶囊联合四联抗结核方案治疗结核性胸膜炎临床研究

Clinical Study on Lifei Capsules Combined with Quadruple Anti-Tuberculosis Regimen for Tuberculous Pleurisy

目的:观察利肺胶囊联合四联抗结核方案治疗结核性胸膜炎(TBP)的临床疗效及对胸膜厚度、血清趋化因子的影响。方法:采用随机数字表法将98例TBP患者分为观察组与对照组各49例。对照组给予常规四联抗结核方案治疗,观察组给予利肺胶囊联合常规四联抗结核方案治疗,2组均连续治疗2个月。比较2组胸痛消失时间、胸水消失时间;比较2组治疗前后中医证候积分、胸膜厚度、白细胞介素-10 (IL-10)、转化生长因子-β (TGF-β)、单核细胞趋化蛋白-1 (MCP-1)、调节性T细胞(Treg)、辅助性T细胞(Th17)、白细胞介素-17 (IL-17)水平及Th17/Treg,并评估2组临床疗效及不良反应发生情况。结果:治疗2个月后,观察组总有效率95.92%,高于对照组81.63%(P<0.05);胸痛消失时间和胸水消失时间均短于对照组(P<0.05)。2组中医证候积分、胸膜厚度及血清IL-10、IL-17、MCP-1、Th17、TGF-β水平及Th17/Treg均较治疗前降低(P<0.05);Treg水平升高(P<0.05),且观察组治疗后中医证候积分、胸膜厚度及血清IL-10、IL-17、MCP-1、Th17、TGF-β水平及Th17/Treg均低于对照组(P<0.05),Treg水平高于对照组(P<0.05)。2组均未出现不良反应。结论:利肺胶囊联合四联抗结核方案治疗TBP疗效确切,能够降低患者胸膜厚度,改善免疫功能和调节趋化因子水平,安全性较高。

Objective:To observe the clinical effect of Lifei Capsules combined with quadruple antituberculosis regimen for tuberculous pleurisy(TBP),and its effect on pleural thickness and chemotactic factors in serum.Methods:A total of 98 TBP patients were divided into the observation group and the control group according to the random number table method,with 49 cases in each group.The control group was treated with conventional quadruple anti-tuberculosis regimen,and the observation group was treated with Lifei Capsules combined with conventional quadruple anti-tuberculosis regimen.Both groups were treated continuously for two months.The disappearance time of chest pain and pleural effusion was compared between the two groups.The traditional Chinese medicine(TCM)syndrome scores,pleural thickness,and interleukin-10(IL-10),transforming growth factorβ(TGF-β),monocyte chemotactic protein 1(MCP-1),regulatory T cells(Treg),helper T cells(Th17),interleukin-17(IL-17),and Th17/Treg were compared between the two groups before and after treatment.The clinical effects and incidence of adverse reactions were evaluated in the two groups.Results:After two months of treatment,the total effective rate was 95.92%in the observation group,higher than that of 81.63%in the control group(P<0.05).The disappearance time of chest pain and pleural effusion in the observation group was shorter than that in the control group(P<0.05).The TCM syndrome scores,pleural thickness,and serum levels of IL-10,IL-17,TGF-β,MCP-1,Th17,and Th17/Treg,in the two groups were decreased when compared with those before treatment(P<0.05);and Treg levels were increased(P<0.05).After treatment,TCM syndrome scores,pleural thickness,and serum levels of IL-10,IL-17,TGF-β,MCP-1,Th17 and Th17/Treg,in the observation group were lower than those in the control group(P<0.05),and the Treg level was higher than that in the control group(P<0.05).No adverse reaction was observed in both groups.Conclusion:The combination of Lifei Capsules and quadruple anti-tuberculosis regimen has a definite curative effect on TBP,which can reduce pleural thickness,improve immune function,and regulate levels of chemotactic factors,with high safety.