本文選題：仙方活命飲　切入點(diǎn)：痤瘡　出處：《廣州中醫(yī)藥大學(xué)》2017年碩士論文

【摘要】：目的仙方活命飲是治療瘡瘍腫毒陽證的常用方,臨床常用之治療痤瘡,療效頗佳,但至今未有循證醫(yī)學(xué)的證據(jù)證明其有效性及安全性。本研究通過對仙方活命飲治療痤瘡的RCT文獻(xiàn)行meta分析,并通過觀察仙方活命飲治療痰瘀互結(jié)型痤瘡的臨床療效,為仙方活命飲治療痤瘡的臨床應(yīng)用提供并補(bǔ)充循證醫(yī)學(xué)的依據(jù)。方法一、Meta分析:通過計(jì)算機(jī)檢索中外電子數(shù)據(jù)庫,檢索時(shí)間定為2016年12月31日以前,治療組以口服中藥方仙方活命飲為主要治療手段,對照組以西藥或中成藥為主要治療手段。嚴(yán)格按照納入標(biāo)準(zhǔn)及排除標(biāo)準(zhǔn)的要求對相關(guān)文獻(xiàn)進(jìn)行篩選,對最終的納入文獻(xiàn)進(jìn)行數(shù)據(jù)的提取及文獻(xiàn)質(zhì)量評價(jià),應(yīng)用Revman5.3軟件對其有效率、不良反應(yīng)發(fā)生率及治療后皮損評分進(jìn)行統(tǒng)計(jì)評價(jià)。二、臨床療效觀察:將符合研究條件的80例痰瘀互結(jié)型痤瘡的患者隨機(jī)分為治療組及對照組,治療組(40例)予仙方活命飲湯劑,對照組(40例)予鹽酸米諾環(huán)素膠囊口服,兩組均聯(lián)合火針外治,以4周為一個(gè)療程,共治療兩個(gè)療程。治療后對皮損評分、中醫(yī)癥候評分、綜合療效、不良反應(yīng)發(fā)生率進(jìn)行評定。結(jié)果一、Meta分析:本研究共納入13篇文獻(xiàn),實(shí)驗(yàn)組共納入研究對象711例,對照組共納入研究對象682例。Meta分析結(jié)果表明:1.有效率:仙方活命飲組治療痤瘡有效率高于抗生素組(OR=3.03,95%CI[1.90,4.83],P0.00001)及中成藥組(OR=2.22,95%CI[1.10,4.45],P=030.05),且中西醫(yī)結(jié)合治療痤瘡療效高于單純使用抗生素或維A酸類藥組治療(OR=3.34,95%CI[2.23,4.99],P0.00001),而與維A酸類藥物相比則療效相當(dāng)(OR=1.11,95%CI[0.51,2.43],P=0.790.05)。2.不良反應(yīng)發(fā)生率:仙方活命飲組不良反應(yīng)發(fā)生率低于西藥組(OR=0.33,95%CI[0.20,0.56],P0.0001),而仙方活命飲組與中成藥組對比不良反應(yīng)發(fā)生率相當(dāng)(OR=3.09,95%CI[0.31,30.40],P=0.33)。3.治療后皮損評分:只有2篇納入文獻(xiàn)對治療結(jié)束后皮損評分進(jìn)行了評定,且對照組干預(yù)措施均為中成藥,結(jié)果顯示仙方活命飲對患者皮損的改善優(yōu)于中成藥(MD=-4.44,95%CI[-6.33,-2.55],Z=4.60(P0.00001)。二、臨床療效觀察:80名痰瘀互結(jié)型痤瘡受試者中,實(shí)驗(yàn)組脫落3例,對照組脫落2例,最終共有可評價(jià)患者75例,其中實(shí)驗(yàn)組37例,對照組38例。1.基線比較:經(jīng)檢驗(yàn),兩組患者性別、年齡、病程、治療前皮損評分、中醫(yī)癥候評分差異無統(tǒng)計(jì)學(xué)意義,基線可比。2.皮損評分:兩組治療4周后組內(nèi)皮損評分比較,P值均小于0.05,差異具有顯著性;兩組治療4周后組間皮損評分比較,P=0.480(P0.05),差異不具有顯著性,兩組治療4周后的皮損評分差值比較,P=0.060(P0.05),差異不具有顯著性;兩組治療8周后組間皮損評分比較,P=0.002(P0.05),差異具有顯著性。治療8周后的皮損評分差值比較,P=0.010(P0.05),差異具有顯著性。說明兩種治療方案都是有效的,治療4周后兩組間皮損評分無顯著差異,而隨著療程延長,8周后仙方活命飲組對皮損的改善優(yōu)于鹽酸米諾環(huán)素組。3.中醫(yī)癥候評分:兩組治療4周后組內(nèi)中醫(yī)癥候評分比較,P值均小于0.05,差異具有顯著性;兩組治療4周后組間中醫(yī)癥候評分比較,P=0.002(P0.05),差異具有顯著性;組間治療4周后中醫(yī)癥候評分差值比較,P=0.002(P0.05),差異具有顯著性。兩組治療8周后組間中醫(yī)癥候評分比較,P=0.000,差異具有顯著性。兩組治療8周后的中醫(yī)癥候評分差值比較,P=0.000(P0.05),差異具有顯著性。說明兩種治療方法均能有效改善中醫(yī)癥候,而仙方活命飲組對中醫(yī)癥候的改善優(yōu)于鹽酸米諾環(huán)素組。4.綜合療效:治療8周后,實(shí)驗(yàn)組總有效率為97.30%,對照組總有效率為84.2%,P=0.006(P0.05),差異具有顯著性,說明仙方活命飲組綜合療效優(yōu)于鹽酸米諾環(huán)素組。5.不良反應(yīng)發(fā)生率:兩組不良反應(yīng)發(fā)生情況經(jīng)Fisher的精確檢驗(yàn),P=0.24,P0.05,差異無顯著性。結(jié)論一、Meta分析:本研究表明:仙方活命飲治療痤瘡有效率高于抗生素、中成藥,而與維A酸類藥物相比無顯著差異,且本方聯(lián)合西藥治療有效率高于單純西藥治療。仙方活命飲不良反應(yīng)發(fā)生率較西藥低,與中成藥相比無顯著差異。仙方活命飲對患者皮損的改善優(yōu)于中成藥。但鑒于本研究所納入的文獻(xiàn)數(shù)相對較少、納入文獻(xiàn)質(zhì)量普遍不高,可能影響結(jié)果的準(zhǔn)確性和可靠性。二、臨床療效觀察:通過對兩組皮損評分、中醫(yī)癥候評分、綜合療效、不良反應(yīng)發(fā)生率的比較,證實(shí)了兩組治療方案的有效性,且實(shí)驗(yàn)組對皮損評分、中醫(yī)癥候評分、綜合療效的改善優(yōu)于對照組,兩組不良反應(yīng)發(fā)生率無顯著差異。仙方活命飲是治療痰瘀互結(jié)型痤瘡的良方,值得臨床推廣應(yīng)用。
[Abstract]:Objective to Xianfang Huoming decoction is commonly used in treatment of sores Yang Syndrome, the clinical efficacy is quite commonly used in treatment of acne, but so far no evidence-based evidence of its effectiveness and safety. Through the analysis of the Xianfang Huoming Decoction in the treatment of acne RCT literature meta, and through the observation of Xian Fang a clinical curative effect of decoction for the treatment of phlegm and blood stasis type of acne, and provide evidence-based basis for the clinical application of Xianfanghuoming Decoction for the treatment of acne. Methods: a Meta analysis, Chinese and foreign electronic database through computer retrieval, retrieval time for before December 31, 2016, the treatment group were treated with oral medicine decoction for the treatment of Xianfang. Methods control group with western medicine or Chinese medicine as the main treatment. The related literatures were screened according to the inclusion criteria and exclusion criteria, the final literatures and extract data in the literature Quality evaluation, application of Revman5.3 software on the efficiency, rate and adverse reactions after treatment of skin lesions were statistically evaluated. Two. Clinical observation: 80 cases of phlegm and blood stasis will meet the conditions on the stasis type of acne patients were randomly divided into treatment group and control group, treatment group (40 cases) treated with Xianfanghuoming Yin decoction, the control group (40 cases) treated by oral administration of Minocycline Hydrochloride Capsules, the two groups were combined with acupuncture treatment, 4 weeks for a course of treatment, a total of two courses of treatment. Scores of lesions after treatment, TCM symptoms, comprehensive curative effect, the incidence of adverse reactions were evaluated. Results: This study, Meta analysis a total of 13 literatures were included in the study object, the experimental group 711 cases, control group were included in the study of 682 cases of.Meta analysis showed that: 1. efficiency: Xianfang Huoming Decoction group for the treatment of acne is more efficient than the antibiotics group (OR=3.03,95%CI, [1.90,4.83], P0.00001) and the traditional Chinese Medicine Group (OR=2.22,95%CI[1.10,4.45], P=030.05), and the combination is higher than that of simple antibiotics or vitamin A acid treatment group therapy is effective in treating acne (OR=3.34,95%CI[2.23,4.99], P0.00001), and compared with the similar efficacy with vitamin A acid drugs (OR=1.11,95%CI[0.51,2.43], P= 0.790.05.2.) the incidence of adverse reactions: Xianfang Huoming Decoction group adverse reaction rate is lower than western medicine group (OR=0.33,95%CI[0.20,0.56], P0.0001), and the occurrence of Xianfanghuoming Decoction group and traditional Chinese medicine group compared the rate of adverse reactions (OR=3.09,95%CI[0.31,30.40], P=0.33) is.3. after the treatment of skin lesions: only 2 literatures on after the treatment of skin lesions was evaluated, and the control group interventions are medicine, showed by xianfanghuomingyin on the skin lesions of patients with better medicine (MD=-4.44,95%CI[-6.33, -2.55], Z=4.60 (P0.00001). Two, 80: To observe the clinical curative effect of phlegm and blood stasis type Acne subjects, the experimental group 3 cases were lost and 2 in the control group. The cases, there were 75 evaluable cases, including 37 cases in the experimental group, 38 cases of the control group.1.: baseline examination, two groups of patients with gender, age, course of disease, before the treatment of skin lesions, no significant symptom score the difference, baseline score than.2. lesions: two groups after 4 weeks of treatment group lesions score comparison, P values were less than 0.05, the difference was significant; the two groups after 4 weeks of treatment between groups of skin lesions, P=0.480 (P0.05), the difference was not significant, compared with lesions score difference after 4 weeks two the treatment group, P=0.060 (P0.05), the difference was not significant between the two groups; after 8 weeks of treatment between groups of skin lesions, P=0.002 (P0.05), the difference was significant. Comparing the lesions after 8 weeks of treatment the score difference, P=0.010 (P0.05), the difference was significant. Two treatments are effective after 4 weeks of treatment, two No significant difference between the groups of skin lesions, and extend along with the course of 8 weeks, Houxian Huoming Decoction group score was better than that of the lesions of minocycline hydrochloride group.3. TCM syndrome: two groups after 4 weeks of treatment in the scores of TCM symptoms, P values were less than 0.05, the difference was significant; the two groups after 4 weeks of treatment group Chinese medicine symptom score, P=0.002 (P0.05), the difference was significant; comparison of TCM syndrome score difference between groups after 4 weeks of treatment, P=0.002 (P0.05), the difference was significant. The two group after 8 weeks of treatment group of Chinese medicine symptom score, P=0.000, the difference was significant between the two groups in 8. After weeks of TCM syndrome score, P=0.000 (P0.05), the difference was significant. Two kinds of methods of treatment can effectively improve the symptoms of traditional Chinese medicine, and by xianfanghuomingyin group of TCM symptoms was better than that of minocycline hydrochloride group.4. comprehensive curative effect: after 8 weeks of treatment, the experimental group The total effective rate was 97.30%, control group total effective rate was 84.2%, P=0.006 (P0.05), the difference was significant, indicating the Xianfang Huoming Decoction group comprehensive curative effect is better than that of minocycline hydrochloride group.5. the incidence rate of adverse reaction in two groups: the incidence of adverse reactions after the exact test, Fisher P=0.24, P0.05, no significant difference. Conclusion a Meta analysis, this study shows that: the Xianfang Huoming Decoction for the treatment of acne is more efficient than the traditional Chinese medicine, antibiotics, and vitamin A acid drugs showed no significant difference, and the recipe combined with western medicine treatment is more efficient than the pure Western Medicine treatment. Xian Fang live life to drink the adverse reaction rate is low compared with western medicine and traditional Chinese medicine, no significant the difference. The Xianfang Huoming Decoction on patients with lesions was better than that of traditional Chinese medicine. But given the relatively small number of documents this research into the literature, quality is not high, the accuracy could affect the results and reliability. Two, the clinical curative effect Study: the score for the two groups of lesions, TCM symptoms, comprehensive curative effect, adverse reaction rate comparison, confirmed the effectiveness of treatment group two, and experimental group of lesion score, TCM symptoms, comprehensive curative effect was better than the control group, two groups of adverse reactions was no significant difference between Xian. Huoming decoction is the cure of phlegm and blood stasis type of acne, it is worthy of clinical application.

【學(xué)位授予單位】：廣州中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R275.9

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本文編號：1702582