本文選題：復(fù)方板藍(lán)根顆粒 + 祛毒消炎膠囊�。� 參考：《吉林大學(xué)》2017年碩士論文

【摘要】：祛毒消炎膠囊屬于中藥第5類新藥。本次研究為祛毒消炎膠囊治療感冒(風(fēng)熱證)有效性和安全性的隨機(jī)、對照、臨床研究。祛毒消炎膠囊是從板藍(lán)根中提取的有效部位制成的制劑,祛毒消炎膠囊臨床前小鼠急性毒性及犬長毒研究結(jié)果未見明顯毒性反應(yīng);臨床前一般藥理研究顯示祛毒消炎膠囊對麻醉犬的血壓、心率、心電、呼吸頻率和幅度無明顯影響。本次觀察的感冒(風(fēng)熱證)患者,將接受為期3天的治療期,隨分到3組,——研究組、陽性對照組和安慰劑組。研究組:祛毒消炎膠囊3粒+復(fù)方板藍(lán)根模擬顆粒1袋/次,每日3次;陽性對照:祛毒消炎模擬膠囊3粒+復(fù)方板藍(lán)根顆粒1袋/次,每日3次;安慰劑組:祛毒消炎模擬膠囊3粒+復(fù)方板藍(lán)根模擬顆粒1袋/次,每日3次。本次臨床研究的陽性對照組定為復(fù)方板藍(lán)根顆粒,依據(jù)為:與研究用藥的藥理作用一致;復(fù)方板藍(lán)根顆粒的功能主治為清熱解毒,為臨床治療感冒的有效藥物;研究過程中發(fā)熱的患者治療前測體溫一次。體溫升高者首次服藥后每小時(shí)測體溫一次,連續(xù)4次。此后,每日10:00、14:00、20:00各測體溫一次。體溫正常者,每日下午14:00測體溫一次。給藥前、給藥后每次訪視研究者要記錄中醫(yī)證侯評分和讓患者各進(jìn)行1次實(shí)驗(yàn)室檢查。所納患者用藥后生命體征(收縮壓、舒張壓、呼吸和心率)未見異常。祛毒消炎膠囊組各實(shí)驗(yàn)室檢查結(jié)果的異常率與復(fù)方板藍(lán)根顆粒組、安慰劑組相當(dāng)。用藥后3天后的主要療效指標(biāo)——祛毒消炎膠囊組有效率高于復(fù)方板藍(lán)根顆粒組和安慰劑組,其癥狀總評分低于其他兩組。祛毒消炎膠囊組身熱和咽痛的清除率高于安慰劑組。祛毒消炎膠囊組流黃濁涕和汗出的清除率高于復(fù)方板藍(lán)根顆粒組。祛毒消炎膠囊組起效時(shí)間及解熱時(shí)間低于安慰劑組。綜上,根據(jù)主要療效指標(biāo)(臨床療效有效率判定),祛毒消炎膠囊優(yōu)于復(fù)方板藍(lán)根顆粒及安慰劑。祛毒消炎膠囊安全性與復(fù)方板藍(lán)根顆粒和安慰劑對照相當(dāng)。
[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.
【學(xué)位授予單位】：吉林大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R259

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