祛毒消炎胶囊治疗感冒（风热证）的临床观察及疗效评价

发布时间：2018-04-25 18:23

本文选题：复方板蓝根颗粒 + 祛毒消炎胶囊　；参考：《吉林大学》2017年硕士论文

【摘要】：祛毒消炎胶囊属于中药第5类新药。本次研究为祛毒消炎胶囊治疗感冒(风热证)有效性和安全性的随机、对照、临床研究。祛毒消炎胶囊是从板蓝根中提取的有效部位制成的制剂,祛毒消炎胶囊临床前小鼠急性毒性及犬长毒研究结果未见明显毒性反应;临床前一般药理研究显示祛毒消炎胶囊对麻醉犬的血压、心率、心电、呼吸频率和幅度无明显影响。本次观察的感冒(风热证)患者,将接受为期3天的治疗期,随分到3组,——研究组、阳性对照组和安慰剂组。研究组:祛毒消炎胶囊3粒+复方板蓝根模拟颗粒1袋/次,每日3次;阳性对照:祛毒消炎模拟胶囊3粒+复方板蓝根颗粒1袋/次,每日3次;安慰剂组:祛毒消炎模拟胶囊3粒+复方板蓝根模拟颗粒1袋/次,每日3次。本次临床研究的阳性对照组定为复方板蓝根颗粒,依据为:与研究用药的药理作用一致;复方板蓝根颗粒的功能主治为清热解毒,为临床治疗感冒的有效药物;研究过程中发热的患者治疗前测体温一次。体温升高者首次服药后每小时测体温一次,连续4次。此后,每日10:00、14:00、20:00各测体温一次。体温正常者,每日下午14:00测体温一次。给药前、给药后每次访视研究者要记录中医证侯评分和让患者各进行1次实验室检查。所纳患者用药后生命体征(收缩压、舒张压、呼吸和心率)未见异常。祛毒消炎胶囊组各实验室检查结果的异常率与复方板蓝根颗粒组、安慰剂组相当。用药后3天后的主要疗效指标——祛毒消炎胶囊组有效率高于复方板蓝根颗粒组和安慰剂组,其症状总评分低于其他两组。祛毒消炎胶囊组身热和咽痛的清除率高于安慰剂组。祛毒消炎胶囊组流黄浊涕和汗出的清除率高于复方板蓝根颗粒组。祛毒消炎胶囊组起效时间及解热时间低于安慰剂组。综上,根据主要疗效指标(临床疗效有效率判定),祛毒消炎胶囊优于复方板蓝根颗粒及安慰剂。祛毒消炎胶囊安全性与复方板蓝根颗粒和安慰剂对照相当。
[Abstract]:Quduxiaoyan capsule belongs to class 5 new medicine of Chinese medicine. This study is a randomized, controlled, clinical study on the efficacy and safety of Quduxiaoyan capsule in the treatment of cold (wind-heat syndrome). Quduxiaoyan capsule was made from the effective part of Radix Isatidis. The acute toxicity of Qduxiaoyan capsule was not found in mice before clinical application. General pharmacological studies showed that Quduxiaoyan capsule had no significant effect on blood pressure, heart rate, ECG, respiratory frequency and amplitude of anesthetized dogs. The observed cold (wind-heat syndrome) patients will be treated for 3 days, followed by three groups: study group, positive control group and placebo group. Study group: Qduxiaoyan capsule 3 compound Banlanganmimic granules 1 bag per day 3 times per day positive control: Qduxiaoyan simulated capsule 3 compound Banlangen granules 1 bag per day 3 times daily; Placebo group: Qduxiaoyan simulated capsule 3 compound Radix Isatis root simulated granules 1 bag, 3 times a day. The positive control group of this clinical study was defined as compound Banlangen granule, which was based on the pharmacological effect of the drug used in the study, the function of compound Banlangen granule was mainly for clearing away heat and detoxifying, and it was an effective drug for clinical treatment of colds. Patients with fever in the course of the study took their body temperature once before treatment. Patients with elevated body temperature took their body temperature once an hour after the first medication, 4 times in a row. Thereafter, 10: 00, 14: 00, 20: 00, each take his body temperature. If the body temperature is normal, take the temperature at 14:00 every day. Before and after administration, the researcher should record TCM syndromes and make one laboratory examination. The vital signs (systolic blood pressure, diastolic blood pressure, respiration and heart rate) were not abnormal after medication. The abnormal rate of Qduxiaoyan capsule group was similar to that of compound Banlangen granule group and placebo group. The effective rate of Quduxiaoyan capsule group was higher than that of compound Banlangen granule group and placebo group, and the total symptom score was lower than that of the other two groups. The clearance rate of body heat and pharynx pain in Qduxiaoyan capsule group was higher than that in placebo group. The clearance rate of runny snot and sweat in Qduxiaoyan capsule group was higher than that in compound Banlangen granule group. The effective time and antipyretic time of Quduxiaoyan capsule group were lower than that of placebo group. To sum up, according to the main curative effect index (clinical curative effect effective rate judgment, Quduxiaoyan capsule is superior to compound Banlangen granule and placebo. The safety of Quduxiaoyan capsule was similar to that of compound Banlangen granules and placebo.
【学位授予单位】：吉林大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R259

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