本文選題：Graves病 + 甲亢寧膠囊　； 參考：《北京中醫(yī)藥大學》2017年碩士論文

【摘要】：Graves病(GD)也稱毒性彌漫性甲狀腺腫伴甲狀腺功能亢進癥,臨床表現(xiàn)并不限于甲狀腺,而是一種多系統(tǒng)的綜合征,包括高代謝癥候群,彌漫性甲狀腺腫,眼征,皮損和甲狀腺肢端病。目前,西醫(yī)治療Graves病的方法主要有3種:①抗甲狀腺藥物治療,停藥復發(fā)率高,改善癥狀與體征困難,有加重肝損傷、造血系統(tǒng)功能障礙、小血管炎和周期性麻痹等副作用;②1311治療后甲減比例較高;③手術治療并非人人皆宜。中醫(yī)藥在本病的治療方面積累了豐富的經(jīng)驗,在改善癥狀與體征、抗復發(fā)、縮短療程等方面具有顯著的優(yōu)勢。本研究依托北京市科技計劃課題"甲狀腺功能亢進癥病證結合診療方案推廣驗證"(編號:Z121107001012010)。本研究對廣安門醫(yī)院應用于臨床38年的院內(nèi)制劑甲亢寧膠囊治療Graves病的減毒增效、縮短療程作用,進行了系統(tǒng)臨床觀察。本論文分為文獻綜述和臨床研究兩部分:第一部分文獻綜述通過查閱古代文獻、檢索中外數(shù)據(jù)庫,回顧總結近年中西醫(yī)治療甲狀腺功能亢進癥的現(xiàn)狀。Graves病是甲亢的常見類型,以甲狀腺毒癥、甲狀腺腫、突眼等為主要臨床表現(xiàn)。中醫(yī)認為甲亢屬本虛標實證,本虛主要為氣虛、陰虛,標實主要為氣滯、火旺、痰凝、血瘀。陰虛陽亢是甲亢早期的主要證型,痰瘀、熱毒是主要兼證。中醫(yī)治療以辨證論治、分期論治、專方專藥及對癥治療為主,滋陰潛陽,軟堅散結,活血解毒是最常用治法。中藥可達到"減毒增效"的作用,即改善癥狀和體征、減少西藥用量、減少并發(fā)癥、降低復發(fā)率、縮短療程等。西醫(yī)治療方式有3種,包括抗甲狀腺藥物治療、1311治療、手術治療等,但是這些治療手段均存在一些不良反應和局限性。第二部分臨床觀察.目的:觀察甲亢寧膠囊治療Graves病的減毒增效作用。方法:采用隨機、盲法、對照的方法,共納入332例Graves病(GD)患者,治療組270例,對照組62例,觀察24周,每4周隨訪一次,觀察結束后,跟蹤隨訪2年。治療組:甲亢寧膠囊+標準劑量1/2的抗甲狀腺藥物;對照組:安慰劑+標準劑量抗甲狀腺藥物。主要觀察比較:(1)增效作用:兩組癥狀和體征的改善時間和改善率、兩組甲狀腺功能主要指標改善比例和恢復正常率、兩組6個月、12個月、24個月復發(fā)情況和復發(fā)率。(2)減毒作用:兩組抗甲狀腺藥物劑量、兩組肝損害指標變化情況和恢復正常率、兩組造血功能變化情況和改善正常率、兩組安全性指標變化情況等。研究病例以Excel 2010建立數(shù)據(jù)庫,進行數(shù)據(jù)分析采用SPSS 22.0軟件。計量資料用±S表示,計量資料兩組間比較各指標比較采用t檢驗,率的比較用χ2檢驗。結果:1增效作用(1)中醫(yī)癥狀:治療組改善癥狀快,4周內(nèi)即改善,對照組8周～12周才達到治療組4周的改善水平。治療組多個時間節(jié)點優(yōu)于對照組(P0.05)。(2)甲狀腺腫大:兩組以輕度甲狀腺腫大恢復快,治療組8周內(nèi)即改善,對照組24周尚未達到治療組4周的改善水平,治療組在16周～24周優(yōu)于對照組(P0.05)。中度甲狀腺腫占比例最高,治療組8周即改善,對照組24周才達到16周改善水平,治療組在16周～24周優(yōu)于對照組(P0.05)。重度甲狀腺腫變化不大,兩組無顯著性差異(P0.05)。(3)突眼度:治療組4周內(nèi)即改善,對照組12周以后才達到治療組4周的改善水平。治療組各時間節(jié)點均優(yōu)于對照組(P0.05)。(4)甲亢指數(shù):甲亢指數(shù)4周即有改善,對照組8周～12周才達到治療組4周的改善水平。治療組在8周～12周均優(yōu)于對照組(P0.05),16周～24周兩組沒有顯著性差異(P0.05)。(5)甲狀腺功能:兩組各指標4周內(nèi)均改善,對照組TSH水平8周～12周才達到治療組4周的改善水平,8周以后各時間節(jié)點均優(yōu)于對照組(P0.05);兩組TT3、TT4指標的均數(shù)變化在各時間節(jié)點均沒有顯著性差異(P0.05);FT3指標4周時治療組低于對照組,對照組在4周～8周達到治療組4周水平,4周～16周兩組沒有顯著性差異(P0.05),20周、24周時治療組高于對照組,兩組有統(tǒng)計學差異(P0.05);FT4指標均數(shù)在8周后兩組存在統(tǒng)計學差異(P0.05),治療組高于對照組;治療組a-TG均數(shù)4周內(nèi)即下降,對照組20周～24周才達到治療組4周的改善水平,治療組各時間節(jié)點(除24周)均優(yōu)于對照組(P0.05);治療組a-TP04周內(nèi)即指標下降,對照組24周才達到治療組4周的改善水平,治療組各時間節(jié)點均優(yōu)于對照組(P0.05)。(6)甲狀腺功能恢復情況甲狀腺功能主要指標:治療8周時,FT3、FT4均正常例數(shù)者,兩組均超過50.00%,兩組無顯著性差異(P0.05);FT3、FT4、TSH均正常例數(shù)者,治療組4周即增多,且治療組在4周優(yōu)于對照組(P0.05),16周～24周對照組優(yōu)于治療組(P0.05)。(7)復發(fā)情況和復發(fā)率:6個月兩組復發(fā)率無差異(P0.05),隨訪12個月、24個月治療組復發(fā)率均低于對照組(P0.05)。2減毒作用(1)抗甲狀腺藥物用量:治療組甲巰咪唑的劑量低于對照組,且對照組12周～16周才降至治療組4周的劑量水平。治療組各時間節(jié)點劑量均低于對照組(P0.05)。治療組丙基硫氧嘧啶的劑量低于對照組,且對照組12周才降至治療組4周的劑量水平。治療組各時間節(jié)點劑量均低于對照組(P0.05)。(2)肝損害:治療組ALT異常率低,4周內(nèi)即降低,對照組24周尚未達到治療組4周的改善水平。治療組各時間節(jié)點均優(yōu)于對照組(P0.05)。(3)白細胞減少癥:治療組白細胞減少例數(shù)少,4周內(nèi)即改善,對照組8周～12周才達到治療組4周的改善水平。治療組4周～8周白細胞減少例數(shù)優(yōu)于對照組(P0.05),8周～24周低于對照組(P0.05)。(4)不良反應:治療組不良反應發(fā)生率低于對照組(P0.05)。結論:甲亢寧膠囊對Graves病的治療優(yōu)勢主要表現(xiàn)在改善癥狀、改善甲功;可減少西藥劑量、減少肝損害、改善造血功能;有抗復發(fā)作用。具有顯著的減毒增效作用。
[Abstract]:Graves's disease (GD), also known as toxic diffuse goiter with hyperthyroidism, is not limited to thyroid, but a multisystem syndrome, including high metabolic syndrome, diffuse goiter, eye sign, skin lesions and acromegaly. Currently, there are 3 main methods for treating Graves disease in western medicine: (1) antithyroid drug treatment Relapse rate is high, symptoms and signs are difficult to improve, liver injury, hematopoietic system dysfunction, small vasculitis and periodic paralysis and other side effects; (2) the proportion of hypothyroidism after 1311 treatment is higher; (3) surgical treatment is not suitable for everyone. Chinese medicine has accumulated rich experience in the treatment of this disease, in improving symptoms and signs, anti recurrence This study is based on the Beijing science and technology program "hyperthyroidism syndrome combined diagnosis and treatment scheme" (number: Z121107001012010). This study was used in the hospital for 38 years in Guanganmen hospital for the treatment of Graves's disease with hyperthyroidism capsule to reduce the effect and shorten the course of treatment. This paper is divided into two parts: literature review and clinical research: the first part of the literature review, through consulting ancient literature, retrieving Chinese and foreign databases, review and summarize the current status of.Graves disease in the treatment of hyperthyroidism in Chinese and Western medicine, which is the common type of hyperthyroidism, with thyrotoxicosis, goiter, and exophthalmos. It is the main clinical manifestation. Traditional Chinese medicine believes that hyperthyroidism is a virtual standard. The deficiency is mainly Qi deficiency and yin deficiency. The main body is Qi stagnation, fire flourishing, phlegm coagulation and blood stasis. Yin deficiency and yang hyperactivity is the main syndrome type in the early stage of hyperthyroidism. Phlegm and stasis, heat toxin is the main syndrome. Traditional Chinese medicine can improve symptoms and signs, reduce the dosage of Western medicine, reduce complications, reduce the recurrence rate, and shorten the course of treatment. There are 3 kinds of treatment in western medicine, including anti thyroid medicine treatment, 1311 treatment and surgical treatment, but these treatments all have some bad methods. The second part of the clinical observation. Objective: To observe the attenuated and synergistic effect of hyperthyroidism capsule in the treatment of Graves's disease. Methods: a total of 332 cases of Graves's disease (GD) were randomly, blinded and controlled, 270 cases in the treatment group and 62 cases in the control group, followed up for 24 weeks, followed up for 2 years after the observation. The treatment group: Hyperthyroidism Ningxia capsule + standard dose 1/2 antithyroid drug; control group: placebo + standard dose antithyroid drugs. The main observation and comparison: (1) synergistic effect: two groups of symptoms and signs of improvement time and improvement rate, the two groups of main indicators of thyroid function improvement ratio and recovery of normal rate, two groups 6 months, 12 months, 24 months of recurrence and recurrence (2) antitoxic effect: two groups of anti thyroid drug dosage, two groups of liver damage indexes and recovery normal rate, two groups of hematopoietic function changes and improvement of normal rate, two groups of safety index changes, and so on. Study cases with Excel 2010 to establish a database, data analysis using SPSS 22 software. Measurement data in + S, to count Comparison of the two groups compared each index with t test, the comparison of the rate compared with the x 2 test. Results: 1 synergistic effect (1) of Chinese medicine symptoms: the treatment group improved the symptoms quickly, the improvement in 4 weeks, 8 weeks to 12 weeks in the control group to reach the improvement level of 4 weeks in the treatment group. The treatment group was better than the control group (P0.05). (2) the two groups were mild. The recovery of thyroid enlargement was faster, the treatment group was improved within 8 weeks, and the control group had not reached the improvement level of 4 weeks in the treatment group for 24 weeks. The treatment group was superior to the control group in 16 weeks to 24 weeks (P0.05). The moderate goiter accounted for the highest proportion, the treatment group was improved for 8 weeks, the control group reached 16 weeks for 24 weeks, and the treatment group was better than the control group for 16 weeks to 24 weeks (P0.05). There was no significant difference in severe goiter (P0.05). (P0.05) there was no significant difference (3) the degree of exophthalmos: the treatment group was improved within 4 weeks and the control group reached the level of improvement for 4 weeks after 12 weeks. All time nodes in the treatment group were better than the control group (P0.05). (4) hyperthyroidism index: the hyperthyroidism index was improved for 4 weeks, and the control group was 4 weeks from 8 to 12 weeks before the treatment group. The level of improvement in the treatment group was superior to the control group in 8 weeks to 12 weeks (P0.05), and there was no significant difference between the two groups in 16 weeks to 24 weeks (P0.05). (5) the thyroid function: the two groups of indexes were improved in 4 weeks, and the level of TSH in the control group was 8 weeks to 12 weeks to achieve the improvement of the group 4 weeks, after 8 weeks, the nodes were better than the control group (P0.05); two group TT3, TT4 There was no significant difference in the average number of indexes at all time nodes (P0.05), while the FT3 index was lower than the control group at 4 weeks, the control group reached the 4 week level in the treatment group from 4 weeks to 8 weeks, and there was no significant difference between the two groups in the 4 week to 16 weeks (P0.05), the treatment group was higher than the control group at 20 weeks and 24 weeks, and the two groups were statistically different (P0.05), and the FT4 index was in 8. There was a statistical difference between the two groups after the week (P0.05), and the treatment group was higher than the control group. The a-TG in the treatment group decreased within 4 weeks, and the control group reached the improvement level of the treatment group for 4 weeks for 20 weeks to 24 weeks. The treatment group was better than the control group (P0.05) at all time nodes (except 24 weeks). The treatment group was decreased in the a-TP04 week, and the control group was 24 weeks to reach 4 weeks in the treatment group. The time node of the treatment group was better than the control group (P0.05). (6) the thyroid function was the main index of thyroid function recovery: at 8 weeks, the normal cases of FT3 and FT4 were all normal, two groups were more than 50%, the two groups had no significant difference (P0.05); FT3, FT4, TSH were all normal cases, the treatment group increased for 4 weeks, and the treatment group was superior to the control in 4 weeks. Group (P0.05), 16 weeks to 24 weeks of control group was better than the treatment group (P0.05). (7) recurrence and recurrence rate: 6 months of two group recurrence rate no difference (P0.05), 12 months of follow-up, 24 months treatment group recurrence rate is lower than the control group (P0.05).2 antitoxic effect (1) antithyroid drug dosage: the treatment group is lower than the control group, and the control group is 12 weeks to 16. The dose level of the treatment group at 4 weeks was lower than that of the control group (P0.05). The dose of propyl sulfur in the treatment group was lower than the control group, and the control group was lower than the control group for 12 weeks. The dose of the treatment group was lower than the control group for 4 weeks. The dose of each node in the treatment group was lower than the control group (P0.05). (2) the liver damage: the ALT abnormality rate in the treatment group was low, 4 Within 24 weeks, the control group had not reached the improvement level of the treatment group for 4 weeks. All the time nodes in the treatment group were better than the control group (P0.05). (3) leuccytopenia: the number of leukocyte reduction in the treatment group was less, the treatment group was improved within 4 weeks, and the control group reached the improvement level of 4 weeks in the treatment group for 8 weeks to 12 weeks. The number of leukocyte reduction in the treatment group for 4 to 8 weeks was excellent. In the control group (P0.05), 8 to 24 weeks was lower than that of the control group (P0.05). (4) adverse reaction: the incidence of adverse reactions in the treatment group was lower than that of the control group (P0.05). Conclusion: the advantages of hyperthyroidism capsule for Graves disease are mainly manifested in improving the symptoms and improving the thyroid function; it can reduce the dose of Western medicine, reduce the liver damage and improve the hematopoiesis, and have the effect of anti recurrence. Attenuated and synergistic effects.

【學位授予單位】：北京中醫(yī)藥大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R259

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