【摘要】：目的： 觀察中藥內(nèi)服加消斑膜外用配合耳穴壓豆治療黃褐斑的臨床療效；通過觀察其對(duì)患者血清SOD、MDA的影響,探討其可能的治療機(jī)制；通過觀察其可能出現(xiàn)的不良事件,對(duì)其安全性做出評(píng)價(jià)。通過以上的研究,為黃褐斑的臨床治療提供一種安全、有效的治療方案。 方法： 1臨床部分 1.1研究設(shè)計(jì)方法 采用隨機(jī)對(duì)照方法。用密閉信封法,參照隨機(jī)數(shù)字表按照2：1產(chǎn)生試驗(yàn)組和對(duì)照組的隨機(jī)安排。將對(duì)應(yīng)的治療分配信箋密封入信封,形成隨機(jī)信件。按納入病例的先后順序?qū)⒒颊唠S機(jī)分配到試驗(yàn)組或?qū)φ战M。最后納入研究165例患者,其中試驗(yàn)組112例,對(duì)照組53例。 1.2治療方法 試驗(yàn)組112例,肝郁血滯型內(nèi)服中藥消斑1號(hào)方及中藥?kù)畎吣?號(hào)方外用配合耳穴壓豆治療；腎虛型內(nèi)服消斑2號(hào)方及中藥?kù)畎吣?號(hào)方外用配合耳穴壓豆治療。對(duì)照組53例,維生素C片和維生素E膠丸口服,0.1%維A酸乳膏外用治療,治療12周后進(jìn)行療效判定。 1.3觀察方法 所有患者于初診、治療第4周、第8周、第12周復(fù)診時(shí),記錄皮損面積、皮損顏色、皮損嚴(yán)重程度評(píng)分等觀察指標(biāo),并于初診及治療12周結(jié)束時(shí)進(jìn)行血尿常規(guī)、肝腎功能等安全指標(biāo)檢測(cè)。詢問用藥依從性,記錄合并用藥及不良反應(yīng)。 1.4療效判定方法 ①黃褐斑皮損改變?cè)u(píng)分方法和標(biāo)準(zhǔn)：根據(jù)中國(guó)中西醫(yī)結(jié)合皮膚性病學(xué)會(huì)色素性疾病分會(huì)2003年制定的標(biāo)準(zhǔn)。 ②療效評(píng)價(jià)標(biāo)準(zhǔn)：按四級(jí)療效標(biāo)準(zhǔn)評(píng)定(尼莫地平法)。 評(píng)分下降指數(shù)計(jì)算方法： 下降指數(shù)=(治療前總積分一治療后總積分)/治療前總積分。 1.5安全性評(píng)價(jià)方法： 所有患者于試驗(yàn)前后分別檢測(cè)血常規(guī)、尿常規(guī),肝功能、腎功能,記錄兩組不良事件發(fā)生率,臨床全過程觀察。 2實(shí)驗(yàn)部分 2.1研究對(duì)象：為第二部分中用“中藥內(nèi)服及外用面膜配合耳穴壓豆聯(lián)合治療”試驗(yàn)組的40例患者；健康對(duì)照組10例。 2.2分別抽取受試者治療前、治療后及健康志愿者空腹外周靜脈血5ml,注入試管中,離心(2000r/min,10min)吸取上層血清注入EP管中,加蓋塞緊,置于-87℃冰箱保存待檢,避免反復(fù)凍融。 2.3血清SOD和MDA的檢測(cè)：采用酶聯(lián)免疫分析試劑盒檢測(cè),嚴(yán)格按照說明書操作。 3統(tǒng)計(jì)學(xué)方法 比較兩組的療效、不良反應(yīng)采用t檢驗(yàn)；多組間的比較采用方差分析；不同療效及安全性評(píng)價(jià)采用Ridit分析；有效率的比較采用x2檢驗(yàn)。P0.05具有顯著性差異。統(tǒng)計(jì)軟件為SAS8.1。 結(jié)果： 1.兩組各項(xiàng)癥狀改善情況的比較：治療前后兩組總評(píng)分及下降指數(shù)比較有顯著性差異(P0.05)。 2.兩組療效比較：試驗(yàn)組總有效率87.50%,對(duì)照組總有效率66.04%,兩組比較差異有統(tǒng)計(jì)學(xué)意義(P0.05)。 3.安全性比較： 試驗(yàn)組治療前后實(shí)驗(yàn)室檢查無異常,試驗(yàn)組和對(duì)照組的安全性比較,無顯著性差異(P0.05)。 4.血清SOD和MDA的水平變化：黃褐斑患者與健康人比較,血清中SOD的水平明顯降低,MDA水平明顯升高,且差異有統(tǒng)計(jì)學(xué)意義(P0.05)：試驗(yàn)組治療后血清SOD水平比治療前升高,MDA水平比治療前降低,且差異均有統(tǒng)計(jì)學(xué)意義(P0.05)；肝郁血滯組與腎虛組比較,腎虛組患者的血清SOD、 MDA水平變化更為顯著。 結(jié)論： 1.中醫(yī)藥“內(nèi)外合治”黃褐斑的臨床療效肯定。 2.中醫(yī)藥“內(nèi)外合治”黃褐斑能升高患者血清SOD水平,降低血清MDA水平。 3.中醫(yī)藥“內(nèi)外合治”黃褐斑是一種安全有效的值得推廣的治療方案。 基于以上結(jié)果,本研究初步證實(shí)了中醫(yī)藥“內(nèi)外合治”黃褐斑,療效肯定,安全性高,值得臨床推廣應(yīng)用。同時(shí)初步證實(shí)中醫(yī)藥“內(nèi)外合治”黃褐斑可能是通過抗氧化機(jī)制發(fā)揮作用的。
[Abstract]:Purpose: To observe the clinical curative effect of traditional Chinese medicine oral and anti-plaque membrane combined with the traditional Chinese medicine pressed bean for the treatment of melalma; observe the effect of its influence on the serum SOD and MDA of the patients, discuss its possible treatment mechanism; observe the possible adverse events, and make it safe to the patients. Evaluation. Through the above research, it provides a safe and effective treatment for the clinical treatment of melmelia. Programme. METHODOLOGY: 1 Clinical part 1. 1 Study set The method adopts a randomized controlled method. With closed envelope method, the reference to the random number table is 2: 1. The randomization schedule for the test group and the control group was generated. The corresponding treatment was assigned The letterhead is sealed into the envelope to form a random letter. The order in which the case is incorporated will Patients were randomized to either the test group or the control group. Finally, 165 patients were enrolled in the study, of which 112 cases of test group In the control group, there were 112 cases of control group, 1. 2 treatment method test group, 1 prescription of traditional Chinese medicine Xiaoyan No.1 and the traditional Chinese medicine spot removing film No. 1 for external use. Prescription and traditional Chinese medicine spot removing film No. 2 for external use in combination with pressed bean treatment. In control group, 53 cases, vitamin C tablets and vitamin E gel pill were taken orally, 0. 1% dimensional A Application of acid cream for external use After 12 weeks of treatment, after 12 weeks of treatment, all patients were treated for the first week, the 4th week, the 8th week and the 12th week, and the lesion area, the color of the lesions, the severity of the lesions were recorded and other observation indexes were recorded. At the end of 12 weeks of treatment, blood urine routine, liver and kidney function, etc. were performed. Safety index detection. Query Medication compliance, record of concomitant medications and adverse reactions. 1. 4 Methods of evaluation of efficacy determination methods and criteria for the change of skin lesions: According to the Chinese traditional Chinese and western medicine combined with the dermatology of dermatology, the branch of the disease branch 200 The standard developed in 3 years. Evaluation criteria for clinical efficacy: assessed by four levels of efficacy criteria (NiNimethod). Calculation method of score reduction index: fall index = (total integral after treatment-total score after treatment)/ total score before treatment. 1. 5 Method of evaluation of safety: There is a patient in the trial blood routine and urine routine are respectively detected before and after the test, Liver function, renal function, record two groups of adverse event rates, Pro whole-course observation of the bed. Experimental part 2. 1 Study object: In the second part, 40 patients in the test group were treated with "Chinese medicine oral administration and external facial mask", and 10 cases of healthy control group. centrifuging (2000r/ min, 10min) sucking the upper layer serum into the EP tube, capping, placing in-87 鈩，

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