本文選題：尋常痤瘡　切入點(diǎn)：肺胃蘊(yùn)熱型　出處：《成都中醫(yī)藥大學(xué)》2012年碩士論文

【摘要】：目的：通過本次研究進(jìn)一步評價凱悅欣軟膏治療肺胃蘊(yùn)熱型尋常痤瘡在改善皮損及相關(guān)癥狀等方面的有效性及安全性。 方法：1、總體設(shè)計(jì)：陽性藥平行對照(迪康粉刺霜)、隨機(jī)、雙盲、多中心臨床試驗(yàn)的方法。2、治療：溫水潔面后,將所領(lǐng)藥品(雙盲、隨機(jī))均勻外用于患處,1-1.5g/次,3次/日,2周為1個療程,連用4周。3、觀察：受試者在初診及治療后2周、4周分別填寫觀察表格,記錄皮疹類型、數(shù)量、形態(tài)、癢痛等中醫(yī)證候的改善情況,詢問用藥依從性,記錄不良反應(yīng)。4、療效評價：參照2002年版《中藥新藥臨床指導(dǎo)原則(試行)》中“中藥新藥治療尋常痤瘡的臨床研究指導(dǎo)原則”制定的療效判定標(biāo)準(zhǔn)進(jìn)行療效觀察,分別對治療前、中、后受試者的中醫(yī)證候、不良反應(yīng)等情況進(jìn)行如實(shí)記錄并按照評分標(biāo)準(zhǔn)進(jìn)行積分,每2周一次,揭盲后根據(jù)記錄對治療組及對照組進(jìn)行療效評價及安全性評價。 結(jié)果：1、兩組之間受試者性別、年齡、病程、治療前中醫(yī)證候主癥及次癥積分比較,差異均無統(tǒng)計(jì)學(xué)意義(P＞0.05),基線均衡,具有可比性。 2、綜合療效評價：兩組組內(nèi)在不同療程(2周、4周)治療前后的比較均有明顯改善(P=0.00)；兩組之間綜合療效在不同療程的比較,差異均無統(tǒng)計(jì)學(xué)意義(P＞0.05),FAS(全分析數(shù)據(jù)集)與PPS(符合方案數(shù)據(jù)集)療效結(jié)果一致。 3、中醫(yī)證候療效評價：兩組組內(nèi)在不同療程(2周、4周)治療前后的比較均有明顯改善,(P=0.00)；兩組之間中醫(yī)證候改善情況在不同療程的比較,差異均無統(tǒng)計(jì)學(xué)意義(P0.05),FAS與PPS療效結(jié)果一致。 4、單項(xiàng)皮損癥狀(皮疹類型、數(shù)量、形態(tài)、癢痛等)療效評價：兩組組內(nèi)在不同療程(2周、4周)的比較均有明顯改善；兩組之間各皮損癥狀改善情況在不同療程的比較,差異均無統(tǒng)計(jì)學(xué)意義(P0.05),FAS與PPS療效結(jié)果一致。 結(jié)論：1、凱悅欣軟膏與迪康粉刺霜治療肺胃蘊(yùn)熱型尋常痤瘡在改善皮損及相關(guān)癥狀等方面的有效性及安全性相當(dāng),無顯著性差異。 2、凱悅欣軟膏治療肺胃蘊(yùn)熱型尋常痤瘡在改善皮損及相關(guān)癥狀等方面療效確切,臨床安全有效。
[Abstract]:Objective: to evaluate the efficacy and safety of Kaiyuexin ointment in the treatment of febrile acne vulgaris.Method 1, overall design: parallel control of positive drugs (Dickon acne cream, randomized, double-blind, multicenter clinical trial method .2.Therapeutic: warm water after facial cleaning, the drug was obtained (double-blind, double-blind, double-blind).The subjects were given a course of treatment for 2 weeks, followed by 4 weeks. Observation: the subjects filled out the observation form 2 weeks after the first visit and 2 weeks after treatment, and recorded the type, quantity and shape of the rash.The improvement of TCM syndromes, such as itching pain, asking about drug compliance,Record adverse reactions .4. curative effect evaluation: according to the guidelines for Clinical Research of New Chinese Medicine for the treatment of Acne Vulgaris, 2002 edition of the "Clinical guidelines for the treatment of Acne vulgaris", we observed the curative effect before treatment, respectively.The TCM syndromes and adverse reactions of the subjects were recorded truthfully and scored according to the scoring standard. Once every 2 weeks, the treatment group and the control group were evaluated for efficacy and safety according to the records.Results there was no significant difference between the two groups in sex, age, course of disease, the scores of main syndrome and secondary symptom of TCM before treatment (P > 0.05), and the baseline was balanced and comparable.2, comprehensive curative effect evaluation: the comparison between the two groups before and after different courses of treatment (2 weeks and 4 weeks) was significantly improved, and the comprehensive curative effect was compared between the two groups in different courses of treatment.There was no significant difference (P > 0.05) between FASs and PPSs.3. Evaluation of TCM syndromes: there were significant improvements in the two groups before and after treatment, and the improvement of TCM syndromes between the two groups was compared in different courses of treatment, and there was no significant difference between the two groups in the improvement of TCM syndromes in different courses of treatment, and the improvement of TCM syndromes was compared between the two groups in different courses of treatment.There was no significant difference between P0.05 and PPS.4, the curative effect evaluation of single lesion symptom (rash type, quantity, shape, itching pain, etc.): there was significant improvement in the two groups in different course of treatment, and the improvement of each lesion symptom in different course of treatment was compared between the two groups.There was no significant difference between P0.05 and PPS.ConclusionThe efficacy and safety of Kaiyuexin ointment and Dekang acne cream in improving skin lesions and related symptoms were comparable, but there was no significant difference between them in the treatment of feverish acne vulgaris with heat accumulation in lung and stomach.2. Kaiyuexin ointment is safe and effective in the treatment of acne vulgaris with heat accumulation in lung and stomach.
【學(xué)位授予單位】：成都中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2012
【分類號】：R758.733

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