中西医结合综合治疗方案对肺心病急性发作期疗效和安全性评价及机制探讨

【作者】 徐学功；

【导师】 陈绍宏；

【作者基本信息】 成都中医药大学 ， 中医内科学， 2005， 博士

【摘要】 目的:通过多中心随机对照临床试验,对中西医结合综合方案治疗肺心病急性发作期疗效和安全性进行评价,并观察其对部分细胞因子及免疫状态的影响。试图找到适合中国国情的肺心病急性发作期治疗的优化方案。 研究方法:以肺心病急性发作期中医辨证属痰浊蕴肺、肺气郁闭患者为对象,随机分为治疗组（中西医结合综合治疗）和对照组（西医常规治疗）。治疗组采用中西医结合综合方案治疗,即在西医常规治疗基础上加以中药治疗,基本证型为痰浊蕴肺、肺气郁闭,采用宣肺平喘,化痰止咳为治法,方选三拗汤、瓜蒌薤白半夏汤及桔梗汤合方。兼肺脾两虚者,以宣肺平喘、化痰止咳、健脾益肺为治法,在基本方基础上加用香砂六君子汤。兼阳虚水泛者,以宣肺平喘、化痰止咳、温阳利水为治法,在基本方基础上加五苓散。西医常规治疗采用控制性氧疗,积极抗感染,保持呼吸道通畅,改善通气、纠正缺氧和二氧化碳潴留,纠正电解质紊乱及酸碱失衡,降低肺动脉压,纠正心衰,营养支持,预防及处理各种并发症。对照组予以西医常规治疗。两组均治疗14天。观察疗效性指标（总体疗效、中医主症及次症积分、西医体征积分、胸部X线、白细胞总数及分类、血气分析、肺功能、自我生活能力评分等）、机理性指标（IL-8、T细胞亚群、IgG、IgA、IgM等）、卫生经济学指标及安全性指标。 结果:治疗组在总体疗效、降低症状体征积分、缩短白细胞总数及分类异常的恢复时间、提高血氧分压和FEV₁/预测值及生活能力评分等方面明显优于对照组。住院总费用治疗组低于对照组。两组治疗后安全性分析均无明显异常。同时治疗组在降低血清IL-8水平、提高CD₃⁺、CD₄⁺、CD₄⁺/CD₈⁺、IgG、IgA、IgM水平等方面亦优于对照组。 结论:初步研究提示,针对肺心病急性发作期的中西医结合综合治疗方案可能具有提高总体疗效,改善症状体征,缩短疗程,降低医疗费支出,改善肺功能及生活能力等优势,且有较好的安全性。同时此方案对部分炎症因子及细胞和体液免疫功能状态有一定的调节作用。本研究可为进一步探索适合中国国情的肺心病急性发作期防治优化方案提供有益借鉴。更多还原

【Abstract】 Objective :To value the curative effect and security of the combination treatment project of Chinese and western medicine during the acute attack stage period of pulmonary heart disease by a multi-center, randomized controlled clinical trial. In addition, to fmd the effects on some cell factors and immune system under the remedial project. Try to study the optimized remedial project to adapt the China situation during the acute attack stage period of pulmonary heart disease.Method:The patients with acute attack stage period of pulmonary heart disease and basic pattern were divided randomly into 2 groups: treatment group and control group with routine treatment in modern medicine. The patients in treatment group were cured with combination treatment project of Chinese and western medicine (namely routine treatment in modern medicine and herbs). The basic Zheng pattern is accumulation of phlegm in the Lung and obstruction of Lung-Qi. Therapeutic methods are following: dispersing the Lung to relieve asthma, resolving phlegm and checking cough. Prescriptions used are San Ao Decoction, Gua Luo Xie Bai Ban Xia Decoction and Jie Geng Decoction. Modification: For patients with Lung and Spleen deficiency, Xiang Sha Liu Jun Zi Decoction was added to strengthen the Spleen and nourish the Lung. For patients with edema due to Yang deficiency, Wu Ling Decoction was added to warm Yang and induce diuresis. The routine therapeutic considerations in modern medicine include controlled Oxygen therapy, actively anti-infective treatment, smoothing respiratory tract, ameliorating ventilation, therapy of hypoxia and carbon dioxide retention, remedying electrolyte and acid-base disturbances, keeping pulmonary arterial pressure down, controlling congestive heart failure, nutritional support, prevention and treatment of complications. The patients were cured for 14 days. Indexes evaluated were following: effect indexes ( the whole effect, integra of main and secondary symptoms in TCM, signs integra in modern medicine, chest x-rays, leucocyte sum and classification, arterial blood gas analysis, pulmonary function, personal更多还原