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Volume 39 Issue 1
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ZHU Zhanhui, LI Jun, SHENG Guorong. Effects of Yinlian Qufeng decoction on chronic urticaria and the level of IgE and T cell subsets[J]. Journal of Pharmaceutical Practice and Service, 2021, 39(1): 82-85, 93. doi: 10.12206/j.issn.1006-0111.202003107
Citation: ZHU Zhanhui, LI Jun, SHENG Guorong. Effects of Yinlian Qufeng decoction on chronic urticaria and the level of IgE and T cell subsets[J]. Journal of Pharmaceutical Practice and Service, 2021, 39(1): 82-85, 93. doi: 10.12206/j.issn.1006-0111.202003107

Effects of Yinlian Qufeng decoction on chronic urticaria and the level of IgE and T cell subsets

doi: 10.12206/j.issn.1006-0111.202003107
  • Received Date: 2020-03-16
  • Rev Recd Date: 2020-06-04
  • Publish Date: 2021-01-25
  •   Objective  To study the clinical effects of Yinlian Qufeng decoction in the treatment of chronic urticaria (CU) and the effects on the changes of serum IgE and T cell subsets (CD4+, CD8+).  Methods  96 patients were randomly divided into two groups, treatment group and control group, with 48 cases in each group. The treatment group was treated with Yinlian Qufeng decoction, while the control group was treated with desloratadine dispersible tablets for 8 weeks. The clinical symptom score, TCM syndrome score and quality of life [skin disease quality of life index (DLQI)] of the two groups were evaluated before and after treatment. The serum levels of IgE and CD4+ and CD8+ were measured by ELISA and flow cytometry. Clinical effect was observed and the rate of adverse reactions was counted.  Results  There was no statistically difference between two groups in clinical symptom scores, TCM syndrome scores, DLQI, the levels of IgE, CD4+, CD8+, and the ratio of CD4+/CD8+ before treatment (P>0.05). After treatment, the clinical symptoms, TCM syndromes and DLQI were reduced in both groups. The treatment group had lower scores than that in control group with statistical significance(P < 0.05). CD4+ level and ratio of CD4+/CD8+ were increased, while IgE and CD8+ levels were decreased in both groups after treatment with statistical significance (P < 0.01). The changes of above indexes in the treatment group were better than those in the control group with statistical significance (P < 0.01). The effective rates of the two groups were 91.67% and 77.08% and rates of adverse reactions were 6.25% and 20.83% separately with statistical difference (P < 0.05).  Conclusion  Yinlian Qufeng decoction can effectively regulate the cellular immune function, alleviate the disease symptoms and improve life quality with few adverse reactions. This decoction deserves the promotion for clinical application.
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    [19] 林中方, 何斌, 熊超. 枸地氯雷他定片联合匹多莫德分散片治疗慢性荨麻疹的疗效及对T细胞亚群的影响[J]. 实用医学杂志, 2014, 30(15):2490-2492. doi:  10.3969/j.issn.1006-5725.2014.15.049
    [20] 张蕾, 卜晓琳, 谷金鹏, 等. 西替利嗪联合卡介菌多糖核酸对慢性荨麻疹患者细胞免疫功能及TNF-α、IgE、IFN-γ的影响[J]. 贵州医药, 2018, 42(12):1424-1426. doi:  10.3969/j.issn.1000-744X.2018.12.006
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    [22] 王远志, 蒙秉新, 谭茜. 氯雷他定联合白芍总苷对慢性湿疹患者免疫功能及细胞因子的影响[J]. 中国中西医结合皮肤性病学杂志, 2018, 17(1):9-11. doi:  10.3969/j.issn.1672-0709.2018.01.003
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Effects of Yinlian Qufeng decoction on chronic urticaria and the level of IgE and T cell subsets

doi: 10.12206/j.issn.1006-0111.202003107

Abstract:   Objective  To study the clinical effects of Yinlian Qufeng decoction in the treatment of chronic urticaria (CU) and the effects on the changes of serum IgE and T cell subsets (CD4+, CD8+).  Methods  96 patients were randomly divided into two groups, treatment group and control group, with 48 cases in each group. The treatment group was treated with Yinlian Qufeng decoction, while the control group was treated with desloratadine dispersible tablets for 8 weeks. The clinical symptom score, TCM syndrome score and quality of life [skin disease quality of life index (DLQI)] of the two groups were evaluated before and after treatment. The serum levels of IgE and CD4+ and CD8+ were measured by ELISA and flow cytometry. Clinical effect was observed and the rate of adverse reactions was counted.  Results  There was no statistically difference between two groups in clinical symptom scores, TCM syndrome scores, DLQI, the levels of IgE, CD4+, CD8+, and the ratio of CD4+/CD8+ before treatment (P>0.05). After treatment, the clinical symptoms, TCM syndromes and DLQI were reduced in both groups. The treatment group had lower scores than that in control group with statistical significance(P < 0.05). CD4+ level and ratio of CD4+/CD8+ were increased, while IgE and CD8+ levels were decreased in both groups after treatment with statistical significance (P < 0.01). The changes of above indexes in the treatment group were better than those in the control group with statistical significance (P < 0.01). The effective rates of the two groups were 91.67% and 77.08% and rates of adverse reactions were 6.25% and 20.83% separately with statistical difference (P < 0.05).  Conclusion  Yinlian Qufeng decoction can effectively regulate the cellular immune function, alleviate the disease symptoms and improve life quality with few adverse reactions. This decoction deserves the promotion for clinical application.

ZHU Zhanhui, LI Jun, SHENG Guorong. Effects of Yinlian Qufeng decoction on chronic urticaria and the level of IgE and T cell subsets[J]. Journal of Pharmaceutical Practice and Service, 2021, 39(1): 82-85, 93. doi: 10.12206/j.issn.1006-0111.202003107
Citation: ZHU Zhanhui, LI Jun, SHENG Guorong. Effects of Yinlian Qufeng decoction on chronic urticaria and the level of IgE and T cell subsets[J]. Journal of Pharmaceutical Practice and Service, 2021, 39(1): 82-85, 93. doi: 10.12206/j.issn.1006-0111.202003107
  • 慢性荨麻疹(CU)是外周毛细血管扩张致渗透性增加,皮肤出现的一种水肿反应,临床表现以风团、瘙痒为主,病程均在6周以上。对患者生活质量造成严重影响[1]。CU发病原因不明,普遍认为与免疫功能改变有关[2]。西医以抗组胺药物对症治疗为主[3],但抗组胺药物不良反应发生率较高,且停药易复发。本研究用中药银连祛风汤治疗CU患者48例,观察其临床治疗效果,检测治疗前后患者血清免疫球蛋白E(IgE)、T细胞亚群(CD4+、CD8+)水平的变化情况,报告如下。

  • 96例CU患者均来自于2018年7月~2019年10月期间本院皮肤科门诊,按就诊顺序随机分成治疗组48例和对照组48例,治疗组:男20例,女28例,年龄18~62岁,平均(36.42±10.83)岁,病程6个月至4.3年,平均(21.43±12.41)个月;对照组:男21例,女27例,年龄19~64岁,平均(35.06±11.65)岁,病程4个月至5年,平均(20.27±13.68)个月。在性别、年龄、病程方面,治疗组和对照组比较均无统计学差异(P>0.05),具有可比性。病例纳入标准:①符合西医[4]及中医[5]CU诊断标准;②1周内未服用抗组胺药和治疗CU的中药制剂者;③1个月内未服用糖皮质激素者;④妇女不在妊娠期或哺乳期;⑤无心、肝、肾功能障碍者;⑥无严重系统性疾病者;⑦对本试验药物成分无过敏史者。30例正常对照组来自于本院门诊体检健康者,男13例,女17例,年龄22~56岁,平均(33.25±9.67)岁。在性别及年龄方面,正常对照组与治疗组和对照组分别比较均无统计学差异(P>0.05)。

  • 治疗组内服银连祛风汤,其处方为:银花10 g,土茯苓30 g,生地30 g,连翘10 g,生石膏30 g(先煎),丹皮10 g,白蒺藜20 g,地肤子15 g,茵陈30 g,地骨皮15 g,生甘皮5 g,炒僵蚕15 g。以上饮片加水浸泡,过药面2 cm,大火煮开后小火慢炖至200 ml,早晚各1次口服,每次100 ml。对照组给予地氯雷他啶分散片(海南普利制药股份有限公司;国药准字H20040972;规格:5 mg/片)1片口服,每日1次。两组均连续用药8周。

  • 内容包含瘙痒程度、风团大小、风团数量、持续时间、风团水肿程度等5项,每一项目均在0~3分之间进行评估,分数越高说明患者症状越严重。

  • 内容包含口渴少饮、肢体困重、舌质红、苔黄腻、脉滑等5项,每一项目均在0~3分之间进行评估,分数越高说明患者症状越严重。

  • 对临床症状、心理感受、躯体感受、临床治疗、工作、锻炼、日常活动、社交娱乐、朋友关系、家庭关系、衣物选择、性生活12个条目进行CU生活质量评价,在0~3分之间进行逐项评估,生活质量随分数降低而提高。

  • 痊愈:治疗后,临床体征与症状完全消失,疗程结束后1个月内无复发;显效:临床症状基本消失,疗程结束后1个月内无复发或仅复发1次,对复发者继续使用实验药物症状控制;有效:临床症状明显缓解,皮疹范围和风团直径均变小,数量大大减少,持续时间也明显缩短,但需继续服药治疗才能控制症状;无效:临床症状没有改善或改善不明显,皮疹、瘙痒等症状基本无变化。有效率=(痊愈例数+显效例数)/病例总数×100%[10]。治疗结束后1个月的月末记录临床有效率,治疗期间观察不良反应发生情况。

  • 观察正常组和两组患者IgE、CD4+、CD8+水平的变化情况。实验前,两组患者和正常组均在早晨8:00空腹抽取静脉血3 ml;疗程结束后次日,两组患者早晨8:00空腹再次抽取静脉血3 ml,1500 r/min离心30 min取血清,−80 ℃冻存备用。IgE含量用ELISA法测定,CD4+、CD8+含量用流式细胞仪测定,严格按试剂盒说明书提供的方法进行操作。所用主要试剂和仪器:IgE ELISA试剂盒、藻红蛋白(CD8-PE)标记抗人CD8抗体试剂盒、异硫氰酸荧光素(FITC)标记抗人CD4抗体试剂盒(上海蓝基生物科技有限公司);Elx-800型酶标仪(美国宝特);FACS Calibur型流式细胞仪(美国BD公司)。

  • 运用SPSS20.0软件分析处理,计量资料以($\bar x \pm s$)表示,采用单因素方差分析,记数资料采用卡方检验,P<0.05为差异有统计学意义。

  • 治疗前,两组患者的临床症状积分、中医证候积分、DLQI评分分别比较,差异均无统计学意义(P>0.05)。治疗后,两组患者的临床症状积分、中医证候积分、DLQI评分均较治疗前明显下降,差异均有统计学意义(P<0.01),治疗组下降程度均优于对照组,差异均有统计学意义(P<0.01),见表1

    组别症状积分中医证候积分DLQI评分
    对照组(48例)
    治疗前12.46±4.9314.11±4.5821.88±6.79
    治疗后5.16±1.46*7.49±2.83*10.18±3.33*
    治疗组(48例)
    治疗前12.17±4.8113.62±4.3722.31±6.69
    治疗后3.56±1.03*#4.86±1.23*#6.25±1.67*#
    *P<0.01,与同组治疗前比较;#P<0.01,与对照组治疗后比较。
  • 治疗前,患者血清IgE、CD4+、CD8+水平与正常组比较,差异均有统计学意义(P<0.01),而治疗组和对照组比较则无统计学意义(P>0.05)。治疗后,治疗组与对照组患者CD4+水平和CD4+/CD8+比值均明显升高,IgE、CD8+水平均明显降低,与治疗前比较,差异均有统计学意义(P<0.01);治疗组改变程度优于对照组,各指标差异均有统计学意义(P<0.05,P<0.01),见表2

    组别IgE(pg/ml)CD4+(%)CD8+(%)CD4+/CD8+
    正常组(30例)32.78±4.6741.69±6.8522.07±3.081.93±0.52
    对照组(48例)
    治疗前110.92±16.23**29.65±3.79**27.89±3.21**1.07±0.28**
    治疗后42.79±6.31**#35.84±4.05**#25.43±3.11**#1.51±0.32**#
    治疗组(48例)
    治疗前112.65±15.29**30.11±3.65**28.34±3.57**1.07±0.25**
    治疗后35.15±4.28*#△△38.43±5.05*#△△23.66±2.78*#△1.71±0.41*#△△
    *P<0.05,**P<0.01,与正常组比较;#P<0.01,与同组治疗前比较;P<0.05,△△P<0.01,与对照组治疗后比较。
  • 疗程结束后1个月的月末统计,治疗组有效率91.67%(44/48),对照组有效率77.08%(37/48),差异有统计学意义(P<0.05),见表3

    组别痊愈显效有效无效有效率(%)
    对照组(48例)211610177.08
    治疗组(48例)2618 4091.67*
    *P<0.05,与对照组比较。
  • 在整个治疗过程中,对两组患者用药后发生的不良反应情况进行了观察记录,治疗组48例患者中有3例分别出现轻微恶心、腹泻症状,不良反应发生率为6.25%;对照组48例患者中有10例分别出现轻微嗜睡、头晕、头痛、恶心等症状,不良反应发生率为20.83%。两组比较,差异有统计学意义(P<0.05),见表4。以上不适症状均未作特殊处理,继续用药,不适症状均在1周内逐渐消失。

    组别嗜睡头晕、头痛恶心腹泻总发生率(%)
    对照组(48例)541020.83
    治疗组(48例)00216.25*
    *P<0.05,与对照组比较。
  • 中医学上将CU归属瘾疹范畴[11],认为因汗出当风,风邪侵袭,气血不足,卫外不固,湿热蕴结,进而复感湿邪,兼寒湿热邪,发于肌肤见风团瘙痒而发病[12-13]。因此,治疗CU应以疏风散邪为根本,配以调和营卫进行治疗[14]。本院自制中药银连祛风汤协定方是在长期临床实践基础上发展而成,处方中银花、土茯苓合用具有清热除湿作用,生地、丹皮合用具有凉血养阴作用,连翘、石膏合用具有清热泻火作用,地肤子、茵陈、炒僵蚕合用具有清热、解毒、止痒作用,白蒺藜具有熄风和止痒作用,地骨皮具有清肺降火作用,生甘皮具有理气降逆作用。该处方诸药合用,在祛风清热解表止痒的同时,又辅以调和气血之效,还兼顾润燥通里之功。在长期的皮肤科临床实践中,用银连祛风汤治疗慢性荨麻疹,能有效控制临床症状,做到标本兼顾,提高疗效。

    本文进行了银连祛风汤治疗CU的临床应用研究,并与地氯雷他啶分散片进行了临床疗效对比观察,两组患者临床症状积分、中医证候积分和DLQI评分均较治疗前明显下降,治疗组下降程度更优于对照组,差异均有统计学意义(P<0.01)。治疗组的临床疗效明显高于对照组,不良反应发生率明显低于对照组,差异均有统计学意义(P<0.05)。表明银连祛风汤能有效改善CU患者的生活质量,明显减轻CU患者炎症反应和临床症状,大大提高机体的防御功能。

    研究表明,IgE介导的I型变态反应是CU发病的主要原因[15],患者自身机体形成抗体[16],与亲和力较高的IgE受体相结合,通过免疫应答使得嗜碱性粒细胞与肥大细胞释放大量组胺等介质,进而诱发风团、皮疹、瘙痒等CU特有的临床症状。CU患者血清IgE水平明显高于正常人,其水平的高低与CU的严重程度呈正相关性[16-18]。因此监测血清中IgE的表达水平在CU的诊断和治疗中具有重要的临床价值。研究表明[19],细胞免疫功能受损在CU的发病中起重要作用,其中CD4+、CD8+是一类反映机体细胞免疫状态的T细胞亚群,CD4+/CD8+比值可准确反映机体的细胞免疫调节水平。近年来的研究[20-21]进一步认识到慢性荨麻疹患者体内存在CD4+和CD8 + T细胞比例失调,CD4+/CD8+比值的降低是慢性荨麻疹发病的重要因素。所以,选择适当的干预药物调节失调的CD4+/CD8+比值,对CU的治疗具有临床实际价值。

    西医治疗CU常采用抗组胺药物,但此类药物仅暂时阻断H1受体,无明显抗5-羟色胺和抗胆碱作用,也无明显修复和调节免疫功能。抗组胺类药物治疗CU虽见效快,但药效保持时间较短,大多只能控制临床症状,病情容易复发[22]。传统中医中药具有标本兼治的优点,延长药效时间,起到缓解、消除CU症状的作用。

    笔者通过对银连祛风汤治疗CU后IgE和T细胞亚群(CD4+、CD8+)表达水平影响的临床实验研究,认为银连祛风汤治疗CU疗效确切,临床症状积分、中医证候积分和DLQI均明显下降,随着以上分值的降低,血清CD4+含量及CD4+/CD8+比值明显上调,IgE、CD8+含量也得到相应下降,说明银连祛风汤的临床治疗效果与血清中上述指标值的变化有关。推测银连祛风汤治疗CU能发挥良好临床治疗效果,可能是通过增强CD4+,抗原提呈T细胞亚群的功能,并同步下调IgE、CD8+的效应,使得血液中的炎症细胞因子产生被抑制,细胞因子网络也同步受到影响,进而全身CD4+/CD8+的比值由治疗前的紊乱逐渐恢复至正常所致。而银连祛风汤是通过什么途径调节CU患者的细胞免疫功能,减轻皮肤炎症深层机制是什么,是本课题将要继续深入探讨的问题。

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