本文選題：息風(fēng)止痛顆粒 + 血虛風(fēng)動(dòng)證��； 參考：《湖北中醫(yī)藥大學(xué)》2016年碩士論文

【摘要】：目的:觀察并客觀分析評(píng)價(jià)息風(fēng)止痛顆粒治療偏頭痛血虛風(fēng)動(dòng)證的臨床有效性及安全性。方法:本臨床試驗(yàn)采用隨機(jī)、安慰劑平行對(duì)照法,將56例中醫(yī)證型屬于血虛風(fēng)動(dòng)證的偏頭痛患者隨機(jī)分組,其中試驗(yàn)組42例,對(duì)照組14例。試驗(yàn)組給以息風(fēng)止痛顆粒(由廣西強(qiáng)壽藥業(yè)集團(tuán)有限公司提供),每次1袋(每袋10克),溫開(kāi)水沖服,每天3次。對(duì)照組給以息風(fēng)止痛顆粒模擬劑(由廣西強(qiáng)壽藥業(yè)集團(tuán)有限公司提供),每次1袋(每袋10克),溫開(kāi)水沖服,每天3次�？勺们榭诜�(yīng)急備用藥品布洛芬緩釋膠囊,以緩解偏頭痛患者劇烈難以忍受的頭痛。兩組患者治療的療程均為28天,觀察時(shí)間點(diǎn)為入組的第1天(基線)、治療第14天(訪視1)、治療第28天(訪視2)和停藥后的第28天(隨訪),每次觀察時(shí)間點(diǎn)進(jìn)行一次臨床觀察。觀察患者的頭痛評(píng)分、頭痛VAS評(píng)分、中醫(yī)證候積分、臨床療效、中醫(yī)證候療效、止痛藥使用情況等有效性指標(biāo);檢測(cè)生命體征,觀察肝腎功能、血尿常規(guī)、心電圖、不良事件等安全性指標(biāo)。觀察期間所有患者禁止應(yīng)用偏頭痛的其他治療藥物。依據(jù)觀察指標(biāo)進(jìn)行統(tǒng)計(jì)學(xué)數(shù)據(jù)處理,然后加以分析和評(píng)價(jià)。結(jié)果:1.頭痛癥狀評(píng)分:治療4周后兩組的頭痛癥狀評(píng)分各均值和標(biāo)準(zhǔn)差均較基線時(shí)降低,兩組分別與基線比較差異有統(tǒng)計(jì)學(xué)意義(P0.05)。治療4周后兩組的頭痛癥狀評(píng)分組間比較,差異有統(tǒng)計(jì)學(xué)意義(P0.05)。停藥4周后,兩組患者的頭痛癥狀評(píng)分的均值、標(biāo)準(zhǔn)差均有增加,但仍低于基線,對(duì)兩組的頭痛癥狀評(píng)分進(jìn)行組間、組內(nèi)對(duì)比,差異均無(wú)統(tǒng)計(jì)學(xué)意義(P0.05)。2.頭痛VAS評(píng)分:治療4周后兩組治療前后頭痛VAS評(píng)分較基線均有減少,P0.01,差異有統(tǒng)計(jì)學(xué)意義。組間比較,治療后治療組與對(duì)照組之間頭痛VAS評(píng)分評(píng)分,差異具有顯著性(P0.05)。3.單項(xiàng)中醫(yī)證候積分:在治療4周后兩組患者的單項(xiàng)中醫(yī)癥狀積分的均值和標(biāo)準(zhǔn)差均比基線時(shí)低,差異有統(tǒng)計(jì)學(xué)意義(P0.05)。組間比較,試驗(yàn)組降低比對(duì)照組降低明顯(P0.05)。停藥4周后,對(duì)兩組的各種單項(xiàng)中醫(yī)癥候積分進(jìn)行組間、組內(nèi)對(duì)比,差異均無(wú)統(tǒng)計(jì)學(xué)意義(P0.05)。4.使用止痛藥情況:兩組在治療4周時(shí)止痛藥使用的次數(shù)、劑量均較基線時(shí)減少(P0.05)。對(duì)兩組患者治療4周后進(jìn)行組間比較,發(fā)現(xiàn)兩組患者止痛藥使用情況差異不明顯(P0.05)。5.臨床療效:試驗(yàn)組的臨床有效率為83.33%,對(duì)照組為42.86%,試驗(yàn)組高于對(duì)照組,經(jīng)秩和檢驗(yàn)差異有統(tǒng)計(jì)學(xué)意義(P0.05)。6.中醫(yī)臨床療效:試驗(yàn)組的中醫(yī)證候有效率為85.71%,對(duì)照組為57.14%,試驗(yàn)組高于對(duì)照組,經(jīng)秩和檢驗(yàn)差異有統(tǒng)計(jì)學(xué)意義(P0.05)。7.安全指標(biāo):試驗(yàn)研究期間,兩組患者的肝腎功能、血常規(guī)、尿常規(guī)等安全性觀察指標(biāo)均良好;兩組患者的生命體征在訪視和隨訪期均無(wú)明顯波動(dòng),平穩(wěn)良好;且兩組所有患者均未見(jiàn)明顯不良反應(yīng)。結(jié)論:息風(fēng)止痛顆�？梢园踩⒂行У闹委熎^痛血虛風(fēng)動(dòng)證,能明顯降低偏頭痛血虛風(fēng)動(dòng)證患者的頭痛癥狀評(píng)分、頭痛VAS評(píng)分、中醫(yī)證候積分;可有效減少患者止痛藥的使用次數(shù)和劑量;具有良好的臨床療效和中醫(yī)證候療效。本臨床研究期間所有患者均未見(jiàn)明顯不良反應(yīng),也未見(jiàn)肝腎功能損害現(xiàn)象。
[Abstract]:Objective: To observe and objectively evaluate the clinical effectiveness and safety of xanfeng Zhitong granule in the treatment of migraine blood deficiency syndrome. Methods: This clinical trial was randomized into a randomized, placebo parallel control method. 56 cases of migraine were randomly divided into 42 cases in the experimental group and 14 cases in the control group. Feng Zhitong granule (provided by Guangxi Qiang Shou Pharmaceutical Group Co., Ltd.), 1 bags (10 grams per bag) each time, warm boiled water, 3 times a day. The control group is provided with interest wind analgesic granule simulant (provided by Guangxi Qiang Shou Pharmaceutical Group Co., Ltd.), 1 bags (10 grams per bag) each time, warm boiled water, 3 times a day. The sustained release capsule was used to relieve the severe headache of migraine patients. The treatment course of the two groups was 28 days, the observation time was first days (baseline), the treatment fourteenth days (visit 1), the twenty-eighth days (visit 2) and the twenty-eighth days after the withdrawal (follow up), each observation time point was observed. The headache score of the patients was observed. Headache VAS score, TCM syndrome score, clinical efficacy, TCM syndrome effect, analgesic use and other effective indicators, detection of vital signs, observation of liver and kidney function, hematuria routine, electrocardiogram, adverse events and other safety indicators. During the observation period, all patients are prohibited from using migraine other treatment drugs. According to the observation index to carry out statistics. Data processing, and then analyzed and evaluated. Results: 1. headache symptom score: after 4 weeks of treatment, the mean and standard deviation of the two groups of headache symptoms were lower than the baseline, and the difference between the two groups and the baseline was statistically significant (P0.05). The difference between the two groups of headache symptom scores after 4 weeks was statistically significant (P0.05). After 4 weeks of drug withdrawal, the mean value of the headache symptom score of the two groups increased, but still lower than the baseline. The headache symptom score of the two groups was between groups, and the difference was not statistically significant (P0.05).2. headache VAS score: 4 weeks after treatment, the two groups had less VAS score than the baseline, P0.01, the difference was statistically significant. The difference of VAS score between the treatment group and the control group was significant (P0.05).3. score of TCM syndrome: the mean and standard deviation of the symptom score of the single Chinese medicine symptom in the two groups were lower than that of the baseline after 4 weeks of treatment, and the difference had the significance (P0.05). The comparison between the groups was lower than the control group. The group decreased significantly (P0.05). After 4 weeks of withdrawal, the scores of the various TCM syndrome scores in the two groups were between groups, and the differences were not statistically significant (P0.05).4. used painkillers: the number of painkillers used in the two group at 4 weeks was less than that in the baseline (P0.05). The comparison between the two groups after 4 weeks of treatment was found. The two groups of patients with pain medication were not significantly different (P0.05).5. clinical efficacy: the clinical efficacy of the experimental group was 83.33%, the control group was 42.86%, the test group was higher than the control group, and the difference between the test group and the control group was statistically significant (P0.05) the clinical efficacy of the TCM syndrome in the experimental group was 85.71%, the control group was 57.14%, and the test group was higher than the control group. There were statistically significant (P0.05).7. safety indicators in the control group (P0.05): during the trial study, the liver and kidney function, blood routine, and urine routine were all well observed in the two groups of patients; the two groups of patients had no obvious fluctuations in the visit and follow-up period, and the two groups had no obvious adverse reactions. Conclusion: xanfeng Zhitong granule can be safe and effective in the treatment of migraine blood deficiency syndrome. It can obviously reduce the score of headache symptoms, VAS score of headache and TCM syndrome, which can effectively reduce the use and dose of painkillers, and have good clinical curative effect and TCM syndrome curative effect. This clinical effect. No obvious adverse reactions were observed in all patients during the study period, nor did the liver and kidney function damage occur.
【學(xué)位授予單位】：湖北中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2016
【分類號(hào)】：R277.7

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