摘要
目的评价中药灵芝补肺汤治疗支气管哮喘(简称哮喘)的疗效及安全性。方法选择符合标准的哮喘患者552例,随机分为观察组277例和对照组275例,观察组采用常规治疗+灵芝补肺汤每日1剂,对照组采用常规治疗+安慰剂,疗程12周,按中药新药研究指导原则于治疗前后进行临床症状、体征、各种理化检查从而进行安全性检测以及疗效评估。结果观察组有12例、对照组有3例患者出现轻度腹胀、胃部不适,经过对症治疗未影响观察,所有患者未发现其他与该中药治疗相关的不良反应,患者血常规、尿常规及肝、肾功能、心电图均无异常;治疗后患者症状、体征评分、肺功能以及各种理化指标均有明显改善,治疗前后比较差异有统计学意义;观察组明显优于对照组,两组比较在多项指标上差异有统计学意义(P<0.05)。根据疗效判断标准,观察组总有效率为95.7%,对照组为93.1%,两组比较差异无统计学意义(P>0.05)。但从两组的临床控制及无效例数比较,观察组明显优于对照组,两组比较差异有统计学意义(P<0.05)。结论中药灵芝补肺汤对于哮喘之肺气亏虚,内有蕴热证的治疗效果良好、安全性高,是哮喘慢性持续期良好的补充和辅助治疗。
Objective To evaluate the efficacy and safety of Chinese herbal medicine：＂Ganoderma tonifying lung decoction＂ on patients with bronchial asthma （asthma）.Methods A total of 552 patients with asthma were randomly assigned into 2 groups：277 patients received the conventional therapy plus ＂Ganoderma tonifying lung decoction＂ once a day,the 275 patients received the conventional therapy plus placebo. According to the guideline of new Chinese herbal medicine, their clinical symptoms, signs, and each of the parameters examined in the clinical laboratories were caparisoned before and 12 weeks after the therapy.Results Twelve patients who received the ＂Ganoderma tonifying lung decoction＂ and 3 ones received placebo reported to have slightly abdominal distention and stomach discomfort. The symptoms were alleviated after symptomatic treatment. No abnormal parameter was reported in the routine examination on blood urine, hepatic function, renal function, and electrocardiogram. The clinical symptoms, sign scores, pulmonary function and other physical index of the patients after treatment showed significantly improvement in the two groups, with 95.7% effective rate in the group of patients who received the decoction and 93.1% effective rate in the group of patients who received placebo （P〉0.05）.However, some indexes in the patients who received conventional therapy plus ＂Ganoderma tonifying lung decoction＂ was significantly better than that of the patients who received conventional therapy plus placebo （P〈0.05）.Conclusions Conventional therapy plus ＂Ganoderma tonifying lung decoction＂ is safe and effective to treat the asthmatic patients with lung Qi asthenia and inner fever.This decoction might be useful as a supplementary therapy for asthmatic patients in the chronic persistent period.
出处
《中华哮喘杂志（电子版）》
CAS
2012年第4期22-25,共4页
Chinese Journal of Asthma(Electronic Version)
关键词
哮喘
中药
灵芝补肺汤
治疗
Asthma； Chinese herbal medicine； ＂Ganoderma tonifying lung decoction＂； Therapy；
