清热化痰法治疗急性气管—支气管炎合并SIRS患者的临床研究及相关Meta分析

发布时间：2018-07-15 07:24

【摘要】：目的:1.探讨清热化痰法治疗急性气管-支气管炎合并全身炎症反应综合征患者(痰热壅肺证)的临床疗效。2.通过Meta分析探究国内外研究文献关于痰热清注射液治疗全身炎症反应综合征患者的临床疗效以及临床安全性。方法:1.选取天津市南开医院急诊科和呼吸科2014年11月至2015年11月期间收治的急性气管-支气管炎合并SIRS患者(痰热壅肺证)60例,随机分为对照组、治疗组各30例;上述患者均给予西医常规治疗以及抗SIRS治疗,治疗组患者再加用清热化痰中成药。对两组患者的治疗前后的中医证候积分、体温(T)、心率(HR)、呼吸频率(RR)、白细胞计数(WBC)、前降钙素原(PCT)、C-反应蛋白(CRP)、活化部分凝血活酶时间(APTT)、血浆凝血酶时间(TT)、血浆凝血酶原时间(PT)的变化情况以及临床疗效,统计后进行对比分析;同时观察两组患者的并发症及死亡情况。2.应用计算机与手工检索,查找国内外的大型数据库,包括中国知网(CNKI)、维普期刊资源整合服务平台(VIP)、中国生物医学文献数据库、万方医学网、Ovid/Pubmed以及Embase等,以“痰热清注射液/Tanreqing injection”、“全身炎症反应综合征/systemic inflammatory response syndrome/SIRS”、“Meta分析/Meta-analysis”、“临床研究/clinical research”为检索词,从2000-1-1至2015-5-30公开发表的关于痰热清注射液对SIRS患者疗效的临床随机对照试验(RCT),文献语种为中文或英文,选用Jadad质量评分标准对文献实施质量评估,并且应用软件Rv Man5.3对所有纳入的研究文献给予评估分析。结果:1.治疗组患者治疗前后的中医证候积分、HR、T、WBC、CRP、PCT、APTT、PT的改善明显优于对照组,消化道出血的发生率、麻痹性肠梗阻的发生率较对照组更低,临床总有效率明显高于对照组;且上述比较差异均具有统计学意义(P0.05)。2.本次研究11篇文献共811例SIRS患者最终纳入,其中对照组患者396例,治疗组患者415例。两组患者均给予西医常规抗SIRS治疗,治疗组患者在此基础上加用痰热清注射液。最终的Meta分析结果显示:治疗组患者的临床总有效率明显高于对照组,WBC水平、CRP水平、PCT水平、TNF-a水平、IL-6水平、T值较对照组下降更为明显,且上述比较差异均具有统计学意义(P0.05);所有纳入文献中均未报告有不良反应的发生。结论:1.清热化痰法治疗急性气管-支气管炎合并全身炎症反应综合征患者的临床疗效明显,不仅能够降低患者的中医证候积分、稳定患者的生命体征、改善患者的炎症反应、血凝指标,提高临床总有效率,尚能够降低急性气管-支气管炎合并SIRS患者并发症的发生率。2.Meta分析结果显示:痰热清注射液能够减轻全身炎症反应综合征患者体内的炎症反应,提高临床总有效率,效果良好、可靠,并且无临床不良反应发生,安全性较高。3.痰热清注射液是中成药清热化痰法的典型代表,能够治疗多种疾病伴随的全身炎症状态,方便快捷、安全有效。
[Abstract]:Purpose 1. To explore the clinical effect of clearing heat and removing phlegm in treating acute tracheobronchial bronchitis complicated with systemic inflammatory response syndrome (phlegm-heat obstruction of lung syndrome). To explore the clinical efficacy and safety of Tanreqing injection in treating patients with systemic inflammatory response syndrome by meta-analysis. Method 1: 1. From November 2014 to November 2015, 60 patients with acute trachea bronchitis complicated with Sirs (phlegm-heat obstructing lung syndrome) were randomly divided into control group (n = 30) and treatment group (n = 30). All the patients were treated with routine western medicine and anti-Sirs. The patients in the treatment group were treated with traditional Chinese medicine for clearing heat and resolving phlegm. The TCM syndromes integral before and after treatment for the two groups of patients, Changes of body temperature (T), heart rate (HR), respiratory rate (RR), leukocyte count (WBC), procalcitonin (PCT) C-reactive protein (CRP), activated partial thromboplastin time (APTT), plasma thrombin time (TT), plasma prothrombin time (PT) and clinical efficacy were observed. At the same time, the complications and death of the two groups were observed. Large databases at home and abroad were searched by computer and manual search, including CNKI, VIP, Chinese Biomedical Literature Database, Ovid / Pubmed and Embase, etc. "Tanreqing injection", "systemic inflammatory response syndrome / Sirs", "Meta-analysis / meta-analysis", "clinical study / clinical research" as the key words. A randomized controlled trial (RCT) on the efficacy of Tanreqing injection in patients with Sirs was published from January 1, 2000 to May 30, 2015.The literature was conducted in Chinese or English. Jadad quality scoring criteria were used to evaluate the quality of the literature. And the software Rv Man5.3 is applied to evaluate and analyze all the research literature involved. The result is 1: 1. The improvement of TCM syndrome score before and after treatment in the treatment group was significantly better than that in the control group. The incidence of gastrointestinal hemorrhage and the incidence of paralytic intestinal obstruction were lower and the total clinical effective rate was significantly higher than that in the control group. The differences were statistically significant (P0.05). A total of 811 Sirs patients were included in this study, including 396 patients in the control group and 415 patients in the treatment group. Both groups were treated with routine anti-Sirs therapy, and the patients in the treatment group were treated with Tanreqing injection. The results of Meta-analysis showed that the total effective rate of the patients in the treatment group was significantly higher than that in the control group. The levels of CRP and PCT, TNF-a and IL-6 levels were significantly lower in the treatment group than in the control group. The differences were statistically significant (P0.05), and no adverse reactions were reported in all the literatures. Conclusion 1. The treatment of acute tracheobronchial bronchitis with systemic inflammatory response syndrome by clearing heat and removing phlegm has obvious clinical effect. It can not only reduce the TCM syndromes of the patients, stabilize the vital signs of the patients, but also improve the inflammatory reaction of the patients. The results of Meta analysis showed that Tanreqing injection could reduce the inflammatory reaction in patients with systemic inflammatory response syndrome (Sirs), and could reduce the incidence of complications in patients with acute trachea bronchitis and Sirs. 2. The results of Meta analysis showed that Tanreqing injection could alleviate the inflammatory reaction in patients with systemic inflammatory response syndrome (Sirs). Improve the total clinical effective rate, good effect, reliable, and no clinical adverse reactions, the safety is high. 3. Tanreqing injection is a typical representative of traditional Chinese patent medicine to clear away heat and dissipate phlegm. It can treat systemic inflammation accompanied by many diseases, which is convenient, quick, safe and effective.
【学位授予单位】：天津医科大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R259

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