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甲基強的松龍靜脈沖擊及眼眶放射治療甲狀腺相關(guān)眼病的系統(tǒng)評價

發(fā)布時間:2018-06-14 22:47

  本文選題:甲狀腺相關(guān)眼病 + 甲基強的松龍 ; 參考:《第二軍醫(yī)大學》2012年碩士論文


【摘要】:目的 甲狀腺相關(guān)眼。═hyroid-associated ophthalmopathy, TAO)是自身免疫性甲狀腺疾病在眼部的一種炎癥表現(xiàn),部分患者會出現(xiàn)嚴重的眼部癥狀和體征而需要積極治療,主要治療方法有免疫抑制劑、眼眶放射治療、外科手術(shù)、生長抑素類似物及免疫球蛋白治療等,其中較常見的是甲基強的松龍靜脈沖擊、眼眶放射治療和眼眶減壓術(shù)。但是,甲基強的松龍靜脈沖擊和眼眶放射治療的有效性及安全性,以及甲基強的松龍靜脈沖擊聯(lián)合應用眼眶放療的有效性均需要進行深入的研究。雖然既往已經(jīng)發(fā)表近百篇關(guān)于TAO治療的隨機對照臨床試驗,但結(jié)果并不一致,甚至自相矛盾。我們通過對以往發(fā)表的所有關(guān)于甲基強的松龍靜脈沖擊和眼眶放射治療的隨機對照臨床試驗進行系統(tǒng)評價和Meta分析,以明確兩者治療TAO的有效性和安全性。 資料和方法 根據(jù)預先設計的研究方案進行系統(tǒng)評價。通過系統(tǒng)全面的檢索,獲取既往發(fā)表的關(guān)于甲基強的松龍靜脈沖擊和眼眶放射治療TAO的隨機對照臨床試驗。電子檢索數(shù)據(jù)庫包括PubMed、Embase、Cochrane臨床對照試驗注冊中心、中國生物醫(yī)學文獻數(shù)據(jù)庫、相關(guān)期刊論文、中文科技期刊全文數(shù)據(jù)庫和萬方數(shù)據(jù)庫,檢索截止日期為2011年5月31日,并手工檢索紙質(zhì)雜志及參考文獻作為補充。研究對象包括:未經(jīng)其他方法治療的中或重度活動期TAO患者。干預措施包括:甲基強的松龍靜脈沖擊、眼眶放射治療或兩者聯(lián)合治療。有效性指標為:治療后患者眼部癥狀、體征、輔助檢查結(jié)果和主觀感受中的1項較治療前好轉(zhuǎn)。安全性指標為:副作用的發(fā)生率。通過嚴格的篩選流程,總計納入12項隨機對照臨床試驗:甲基強的松龍靜脈沖擊治療7項、眼眶放射治療5項。采用Jadad量表或Cochrane Handbook for Systematic Reviewsof Interventions5.0.2質(zhì)量評價標準進行定量化的質(zhì)量評估。采用意向性分析原則進行臨床終點的評估。Meta分析采用Cochrane系統(tǒng)評價軟件RevMan5.0和RevMan5.1,統(tǒng)計方法選擇DerSimonian-Laird法隨機效應模型;二分類變量采用相對危險度(RR)或比值比(OR)及其95%可信區(qū)間(confidence interval,CI),連續(xù)性變量則采用加權(quán)均數(shù)差(weighted mean difference,WMD)及其95%CI。 結(jié)果 ①甲基強的松龍靜脈沖擊:總計360例患者,平均年齡45.3歲,男女性別比1∶3.14,,包括79例甲基強的松龍靜脈沖擊聯(lián)合眼眶放射治療、100例甲基強的松龍靜脈沖擊、78例強的松口服聯(lián)合眼眶放射治療、88例強的松口服、9例安慰劑和6例眼眶減壓術(shù)。根據(jù)Jadad量表的評分標準所有被納入文獻的評分結(jié)果為:1項試驗為5分、3項試驗為4分、1項試驗為3分,1項試驗為1分,1項試驗為0分。 甲基強的松龍靜脈沖擊與安慰劑相比的RR(95%CI)為7.50[1.14,49.26],與眼眶減壓術(shù)相比的RR(95%CI)為3.33[0.51,21.89],與口服糖皮質(zhì)激素相比的合并RR(95%CI)為1.48[1.18,1.87]。甲基強的松龍靜脈沖擊聯(lián)合眼眶局部放療與口服糖皮質(zhì)激素聯(lián)合眼眶局部放療相比的合并RR(95%CI)為1.42[1.11,1.81]。 ②眼眶放射治療:總計289例患者,平均年齡46.7歲,男女性別比1∶2.94。包括165例眼眶放射治療、50例強的松口服和116例假放療。根據(jù)Cochrane Handbookfor Systematic Reviews of Interventions5.0.2質(zhì)量評價標準所有被納入文獻的評分結(jié)果為:1項試驗為A級質(zhì)量,4項試驗為B級質(zhì)量。 眼眶放射治療與假放療相比的OR(95%CI)為0.32[0.16,0.64],眼眶放射治療與口服糖皮質(zhì)激素相比的OR(95%CI)為0.89[0.40,1.94],眼眶放療對突眼癥狀改善的合并均數(shù)差(95%CI)為-0.30[-0.69,0.10]。 結(jié)論 ①大劑量甲基強的松龍靜脈沖擊治療是中或重度活動性TAO的有效治療方法,聯(lián)合應用眼眶局部放射治療可提高療效。Meta分析的結(jié)果顯示,無論糖皮質(zhì)激素靜脈沖擊或口服,經(jīng)過治療后,臨床活動積分均明顯下降,與治療前有明顯的差異,對TAO的臨床癥狀均有明顯緩解,說明糖皮質(zhì)激素治療是一個有效的手段,但是糖皮質(zhì)激素靜脈沖擊的治療作用更優(yōu)于口服。 糖皮質(zhì)激素治療的副作用和并發(fā)癥在靜脈沖擊或口服后均能見到,主要是類庫欣綜合征、糖耐量減低、消化道癥狀、高血壓、精神異常等。類庫欣綜合征是發(fā)生率較高的并發(fā)癥之一,尤以口服治療多見,兩組間差異有顯著性。 ②眼眶放療可以有效治療中或重度活動性TAO,與假放療相比有明顯統(tǒng)計學差異;眼眶放療的治療效果與口服糖皮質(zhì)激素相當,二者無明顯差異;眼眶放療對突眼癥狀的改善無明顯效果。 綜上所述,甲基強的松龍靜脈沖擊是中或重度活動性TAO目前較有效的治療,作用顯著優(yōu)于糖皮質(zhì)激素口服,聯(lián)合應用眼眶局部放射治療可提高療效。而且,甲基強的松龍靜脈沖擊的耐受性高,安全性好。因此,甲基強的松龍靜脈沖擊可以作為治療中或重度活動性TAO的首選。
[Abstract]:objective
Thyroid associated ophthalmopathy (Thyroid-associated ophthalmopathy, TAO) is an inflammatory manifestation of autoimmune thyroid disease in the eye. Some patients have serious ocular symptoms and signs and need to be treated actively. The main treatment methods are immunosuppressive, orbital radiotherapy, surgery, somatostatin analogues and immunity. Globulin therapy, among which the most common is methylprednisolone, orbital radiotherapy and orbital decompression. However, the effectiveness and safety of methylprednisolone and orbital radiotherapy, as well as the effectiveness of methylprednisolone venous impact combined with orbital radiotherapy, need to be studied in depth. However, nearly a hundred randomized controlled clinical trials of TAO therapy have been published in the past, but the results are inconsistent and even contradictory. We have made systematic evaluation and Meta analysis of all the previously published randomized controlled clinical trials of methylprednisolone venous impact and orbital radiotherapy to clarify the effectiveness of both treatment of TAO. Sex and safety.
Information and methods
A systematic review is conducted according to a pre designed study. Through systematic and comprehensive retrieval, a randomized controlled randomized controlled trial of methylprednisolone venous impact and orbital radiotherapy for TAO is obtained. The electronic retrieval database includes the PubMed, Embase, Cochrane clinical alignment center, and Chinese biomedical literature data The Chinese journal full text database, the full text database of Chinese sci-tech periodicals and the Wanfang database, the search cut-off date is May 31, 2011, and the manual retrieval of paper magazines and references is supplemented. The study includes: TAO patients in the medium or severe active period without other methods. Intervention includes: methylprednisolone Pulse shock, orbital radiotherapy, or combination of the two. The effectiveness index is: 1 items of eye symptoms, signs, auxiliary examination results and subjective feelings after treatment. Safety index is the incidence of side effects. Through a strict screening process, a total of 12 randomized controlled clinical trials are included: methylprednisone 7 items of dragon vein impact therapy, 5 cases of orbital radiotherapy. Quantitative evaluation was performed using Jadad scale or Cochrane Handbook for Systematic Reviewsof Interventions5.0.2 quality evaluation criteria. The clinical end point assessment was evaluated by intention analysis principle. Cochrane system evaluation software RevMan5.0 and RevMan5.1 were used. The statistical method selects the DerSimonian-Laird random effect model; the two classification variables use the relative risk degree (RR) or the ratio Ratio (OR) and the 95% confidence interval (confidence interval, CI), and the continuity variables use the weighted mean number difference (weighted mean difference, WMD) and its 95%CI.
Result
(1) methylprednisolone venous impact: a total of 360 patients, with an average age of 45.3 years of age, and sex ratio of 1 to 3.14, including 79 cases of methylprednisolone intravenous shock combined with orbital radiotherapy, 100 cases of methylprednisolone venous shock, 78 prednisone oral orbital radiotherapy, 88 prednisone oral, 9 placebos and 6 cases of orbital subtraction. According to the Jadad scale, all the scores included in the literature were 5 points, 3 trials for 4, 1 for 3, 1 for 1, 1 for 0.
RR (95%CI) of methylprednisolone compared with placebo was 7.50[1.14,49.26], RR (95%CI) compared with orbital decompression was 3.33[0.51,21.89], combined with oral glucocorticoid, RR (95%CI) combined with 1.48[1.18,1.87]. methylprednisolone intravenous impact combined orbital radiotherapy with oral glucocorticoid combined orbital part of orbit. RR (95%CI) was 1.42[1.11,1.81]. compared with radiotherapy
(2) orbital radiotherapy: a total of 289 patients, the average age of 46.7 years old, and sex ratio 1: 2.94. including 165 cases of orbital radiotherapy, 50 cases of prednisone oral and 116 case of false radiotherapy. According to the Cochrane Handbookfor Systematic Reviews of Interventions5.0.2 quality evaluation standard all included in the literature score results: 1 trials of A Grade quality, 4 tests for grade B.
The OR (95%CI) of orbital radiotherapy compared with that of false radiotherapy was 0.32[0.16,0.64], and OR (95%CI) of orbital radiotherapy compared with oral glucocorticoid (95%CI) was 0.89[0.40,1.94], and the combination of orbital radiotherapy for improvement of exophthalmos (95%CI) was -0.30[-0.69,0.10]..
conclusion
(1) high dose methylprednisolone intravenous impact therapy is an effective treatment for moderate or severe active TAO. Combined application of orbital local radiation therapy can improve the efficacy of.Meta analysis. The clinical symptoms of TAO were significantly relieved, indicating that glucocorticoid therapy was an effective means, but the therapeutic effect of glucocorticoid on venous impact was better than that of oral administration.
The side effects and complications of glucocorticoid treatment can be seen in both venous impact or after oral administration, mainly such as Cushing syndrome, impaired glucose tolerance, digestive tract symptoms, hypertension, and psychosis. One of the higher incidence of complications is Cushing syndrome, especially oral treatment. The difference between the two groups is significant.
(2) orbital radiotherapy can effectively treat moderate or severe active TAO, and there is significant difference compared with that of false radiotherapy. The therapeutic effect of orbital radiotherapy is similar to that of oral glucocorticoid. There is no significant difference between the two cases. The improvement of orbital radiotherapy has no obvious effect on the improvement of the exophthalmos.
To sum up, methylprednisolone venous impact is a more effective treatment of moderate or severe active TAO, which is significantly better than glucocorticoid oral administration. Combined use of orbital local radiation therapy can improve the efficacy. Moreover, methylprednisolone venous impact is well tolerated and safe. Therefore, the methylprednisolone venous impact can be used as a result. It is the first choice for the treatment of moderate or severe active TAO.
【學位授予單位】:第二軍醫(yī)大學
【學位級別】:碩士
【學位授予年份】:2012
【分類號】:R771.3

【參考文獻】

相關(guān)期刊論文 前1條

1 劉理,馮曉莉,徐靜,陳衛(wèi),鄭宏廷,方芳;甲狀腺眼病球后放射治療結(jié)合不同給藥途徑的糖皮質(zhì)激素聯(lián)合治療比較研究[J];實用醫(yī)學雜志;2005年11期



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