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小青龙汤治疗表寒里饮证慢性阻塞性肺疾病急性加重期的临床观察

Using Xiaoqinglong Decoction to Treat Acute Exacerbation of Chronic Obstructive Pulmonary Disease Presenting External Cold and Internal Fluid Retention Syndrome: Observation of the Clinical Efficacy

  • 摘要:
    目的  分析小青龙汤联合基础西药治疗表寒里饮证慢性阻塞性肺疾病急性加重期(acute exacerbation of chronic obstructive pulmonary disease, AECOPD)的临床疗效,并评估其对患者短期预后的影响。
    方法  将124例表寒里饮证AECOPD患者使用随机数字表法分为观察组(62例)与对照组(62例),对照组给予支气管舒张剂、糖皮质激素及抗菌药物等基础西药治疗,观察组在对照组治疗方案的基础上给予小青龙汤治疗,每日1剂,连续治疗10 d。主要结局指标为总有效率、治疗前及治疗10 d后主要中医证候积分。次要结局指标:治疗前、治疗10 d后感染及炎症指标〔白细胞计数(WBC)、降钙素原(PCT)、白细胞介素(IL)-6、C-反应蛋白(CRP)〕、动脉血气〔动脉血氧分压(PaO2)、动脉血二氧化碳分压(PaCO2)、动脉血氧饱和度(SaO2)〕,治疗期间药物不良反应,出院后1个月随访呼吸困难程度〔改良英国医学研究委员会呼吸困难量表(mMRC)〕。
    结果  与本组治疗前比较,治疗后两组各项主要中医证候积分及总分均降低(P<0.05);治疗后与对照组比较,观察组患者咳嗽、恶寒、鼻塞、流涕证候积分及总积分降低(P<0.05)。观察组与对照组总有效率分别为94.91%、82.76%,观察组总有效率明显高于对照组(P<0.05)。与本组治疗前比较,两组患者治疗10 d后PaCO2、WBC及PCT、IL-6、CRP水平均明显降低(P<0.05);治疗后与对照组比较,观察组患者PaCO2、WBC及PCT、IL-6、CRP水平降低(P<0.05)。与本组治疗前比较,两组患者治疗10 d后PaO2、SaO2明显升高(P<0.05);治疗后与对照组比较,观察组患者PaO2、SaO2升高(P<0.05)。治疗期间两组患者均未出现肝肾功能异常等严重不良反应,也并未观察到与小青龙汤治疗相关的不良反应。两组患者出院后1个月随访时均无mMRC4级病例,与本组治疗前比较,出院后1个月两组患者mMRC分级均降低(P<0.05);出院后1个月与对照组比较,观察组患者mMRC分级更低(P<0.05)。
    结论  小青龙汤联合基础西药治疗表寒里饮证AECOPD患者临床疗效较好,可有效改善中医证候,缓解呼吸困难症状,减轻炎症反应,促进感染消退,延缓病情进展,改善短期预后,安全性良好。

     

    Abstract:
    Objective To study the clinical efficacy of Xiaoqinglong decoction combined with the conventional protocol of western medicine in the treatment of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) presenting with exterior cold and interior fluid retention syndrome, and to evaluate its effect on the short-term prognosis of patients.
    Methods A total of 124 AECOPD patients presenting exterior cold and interior fluid retention syndrome were divided into an observation group (62 cases) and a control group (62 cases) using a random number table. Patients in the control and observation groups were managed with conventional western medicine treatment protocols consisting of bronchodilators, glucocorticoids, and antibacterial drugs. In addition, patients in the observation group were also given Xiaoqinglong decoction at one dose per day for 10 days in succession. The primary outcome indicators included the total effective treatment rate and the main traditional Chinese medicine (TCM) syndrome scores before treatment and after 10 days of Xiaoqinglong decoction treatment. The secondary outcome indicators included infection and inflammatory indicators, including white blood cell count (WBC), procalcitonin (PCT), interleukin (IL)-6, C-reactive protein (CRP), and arterial blood gas indicators, including arterial partial pressure of oxygen (PaO2), arterial partial pressure of carbon dioxide (PaCO2), and arterial oxygen saturation (SaO2), measured before treatment and after 10 days of treatment, adverse drug reactions during treatment, and the severity of dyspnea assessed by the modified Medical Research Council (mMRC) dyspnea scale at the 1-month follow-up after discharge.
    Results Compared with baseline findings for the same group before treatment, the main TCM syndrome scores and the total score were reduced in both groups after treatment (P < 0.05). After treatment, compared with those of the control group, the syndrome scores for cough, aversion to cold, nasal congestion, and runny nose, and the total score in the observation group were lower (P < 0.05). The total effective treatment rate in the observation group (94.91%) was significantly higher than that in the control group (82.76%) (P < 0.05). After 10 days of treatment, the levels of PaCO2, WBC, PCT, IL-6, and CRP in both groups were significantly reduced compared with those before treatment (P < 0.05). After treatment, the levels of PaCO2, WBC, PCT, IL-6, and CRP in the observation group were lower than those in the control group (P < 0.05). Compared with those before treatment, PaO2 and SaO2 levels in both groups increased significantly after 10 days of treatment (P < 0.05). During the course of treatment, no severe adverse reactions, such as liver or kidney dysfunction, occurred in either group. No adverse reactions associated with Xiaoqinglong decoction were observed. No patients in either group reached mMRC grade 4 at the 1-month follow-up after discharge. The mMRC grades in both groups declined at the 1-month follow-up after discharge compared to those before treatment (P < 0.05). At the 1-month follow-up after discharge, the mMRC grades of patients in the observation group were lower than those of the control group (P < 0.05).
    Conclusion Xiaoqinglong decoction combined with the conventional protocol of western medicine deminstrates good clinical efficacy in treating patients with AECOPD of exterior cold and interior fluid retention syndrome, and can effectively improve the TCM syndromes, relieve the symptoms of dyspnea, reduce the inflammatory response, promote the resolution of infection, delay disease progression, improve short-term prognosis, and shows better safety.

     

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