103例藥物性肝損傷的臨床分析
發(fā)布時間：2018-12-17 17:29
【摘要】：我們于臨床用藥的過程里,因藥物自身成分及/或經(jīng)其代謝產(chǎn)生的物質(zhì),或者因機體本身體質(zhì)的原因?qū)е碌母呙舾行曰蜉^低的耐受性而引起的肝功能異�；蚪Y(jié)構(gòu)改變稱為藥物性肝損傷(DILI)�，F(xiàn)如今,在我國由于大量藥物的頻繁使用,藥物性肝損傷(DILI)已經(jīng)成為一種重要的肝臟疾病,正日益加深的影響著人類的身心健康。然而,DILI無特異性的臨床癥狀及生化學指標改變,診斷仍面臨困難,漏診及誤診率較高。針對該難題,中華醫(yī)學會肝病學分會于2015年發(fā)布我國第一個藥物性肝損傷診治指南,為藥物性肝損傷的診斷治療提供了依據(jù)。目的:依據(jù)藥物性肝損傷診斷指南,對山東省立醫(yī)院既往診斷為藥物性肝損傷病例行重新診斷,分析符合診斷標準者臨床特點,明確可引起肝損害的具體藥物種類,引起肝損害的類型,對于以后臨床用藥、防止再次發(fā)生藥物不良事件提供依據(jù)。方法:搜索山東大學附屬山東省立醫(yī)院2014年1月1日至2016年12月31日肝病科診治的診斷為"藥物性肝損傷"、"藥物性肝炎"、"中毒性肝病"、"中毒性肝炎"病例128例,依據(jù)診斷指南對其再次診斷,排除掉RUCAM評分6分者25例,納入依據(jù)診斷標準評定為極可能或很可能為藥物性肝損傷者103例,進行回顧性研究,就其一般情況(如年齡、性別、職業(yè))、臨床特點(包括體征、輔助檢查、臨床分型)、導致肝功能異常的藥物、治療方法、治療轉(zhuǎn)歸等情況進行統(tǒng)計研究。結(jié)果:1.納入研究的病例中RUCAM評分8分所占比例最大(25.2%),其次為 7 分23.3%,9 分 22.3%,6分21.4%,10 分4.9%,12 分 1.9%,11 分 1.0%。2.藥物性肝損傷發(fā)病率逐年增高。3.發(fā)病平均年齡為46.75 ± 16.11。其中41-60歲所占比例最大(44.7%)。4.導致藥物性肝損傷的藥物中,中藥52例(43.7%),抗生素17例(14.3%),抗結(jié)核藥9例(7.6%),減肥及保健品4例(3.4%),抗甲狀腺藥3例(2.5%),非甾體抗炎藥3例(2.5%),保胃藥5例(4.2%)。5.臨床表現(xiàn)以惡心、納差,厭油,腹痛、腹瀉等消化道癥狀57例(43.8%),皮膚、鞏膜黃染及/或小便發(fā)黃45例(34.6%),乏力12例(9.2%),皮疹、皮膚瘙癢2例(1.5%),無癥狀14例(10.8%)。6.臨床分型:根據(jù)病程,急性藥物性肝損傷94例(91.2%),慢性藥物性肝損傷9例(8.8%);根據(jù)靶細胞類型,肝細胞型90例(87.4%),膽汁淤積型7例(6.8%),混合型6例(5.8%)。肝細胞型DILI ALT、AST水平較高,膽汁淤積性DILI GGT、ALP水平較高(P0.05)。7.臨床轉(zhuǎn)歸:治療好轉(zhuǎn)出院92例(89.3%),未見明顯好轉(zhuǎn)自動出院9例(8.8%),死亡2例(1.9%)。結(jié)論:藥物性肝損傷(DILI)的發(fā)病率正一年高于一年,現(xiàn)已經(jīng)成為主要的肝功能及結(jié)構(gòu)損害原因之一。以女性及中老年人多見,臨床表現(xiàn)中以消化癥狀最多見�？梢砸鹚幬镄愿螕p傷的藥物為:中藥,抗生素,抗結(jié)核藥,減肥藥及保健品,抗甲狀腺藥,非甾體抗炎藥,保胃藥。急性DILI以及肝細胞型DILI最常見�；颊叽蠖囝A(yù)后良好。
[Abstract]:In the course of clinical use of drugs, the substances produced by the drug's own components and / or by its metabolism, Or liver dysfunction or structural change caused by high sensitivity or low tolerance due to the body's own physical condition is called drug-induced liver injury (DILI). Nowadays, due to the frequent use of a large number of drugs in China, drug-induced liver injury (DILI) has become an important liver disease, which is increasingly affecting the physical and mental health of human beings. However, DILI has no specific clinical symptoms and biochemical indicators, so the diagnosis is still difficult, and the rate of missed diagnosis and misdiagnosis is high. In order to solve this problem, the Chinese Society of Hepatology issued the first guidelines for the diagnosis and treatment of drug-induced liver injury in 2015, which provides a basis for the diagnosis and treatment of drug-induced liver injury. Objective: according to the guidelines for the diagnosis of drug-induced liver injury, we rediagnosed the patients with drug-induced liver injury in Shandong Provincial Hospital, analyzed the clinical characteristics of those who met the diagnostic criteria, and determined the specific drugs that could cause liver injury. The types of liver damage may provide evidence for clinical use of drugs to prevent the recurrence of adverse drug events. Methods: from January 1, 2014 to December 31, 2016, the Department of Hepatology of Shandong Provincial Hospital affiliated to Shandong University diagnosed as "drug-induced liver injury", "drug-induced hepatitis", "toxic liver disease", and "toxic hepatitis" in 128 cases. According to the diagnostic guidelines, 25 patients with RUCAM score 6 were excluded, and 103 patients who were assessed as most likely or most likely to be drug-induced liver injury according to the diagnostic criteria were included in a retrospective study on the general situation (such as age, sex, etc.) Clinical features (including signs, adjuvant examinations, clinical typing), drugs leading to abnormal liver function, treatment methods, outcome of treatment, etc. Results: 1. The RUCAM score of 8 was the largest (25.2%), followed by 7: 23.3and 9: 22.3. The incidence of drug-induced liver injury increased year by year. The mean age of onset was 46.75 鹵16.11. 41-60 years of age accounted for the largest proportion (44.7%). Among the drugs causing drug-induced liver injury, 52 cases (43.7%) were Chinese medicine, 17 cases (14.3%) were antibiotics, 9 cases (7.6%) were anti-tuberculosis drugs, 4 cases (3.4%) were slimming and health products. Antithyroid drugs were found in 3 cases (2.5%), non-steroidal anti-inflammatory drugs in 3 cases (2.5%), gastric preservatives in 5 cases (4.2%) and non-steroidal anti-inflammatory drugs in 5 cases (4.2%). The clinical manifestations were nausea, anorexia, oil, abdominal pain and diarrhea in 57 cases (43.8%), skin, yellowish sclera and / or urine yellowing in 45 cases (34.6%), fatigue in 12 cases (9.2%) and rash in 12 cases. There were 2 cases (1.5%) of pruritus and 14 cases (10.8%) of asymptomatic pruritus. Clinical classification: according to the course of disease, 94 cases (91.2%) were acute drug-induced liver injury, 9 cases (8.8%) were chronic drug-induced liver injury. According to target cell type, 90 cases (87.4%) were hepatocyte type, 7 cases (6.8%) were cholestasis type, 6 cases (5.8%) were mixed type. The level of hepatocyte DILI ALT,AST was higher, and the level of cholestatic DILI GGT,ALP was higher (P0.05). The clinical outcome: 92 cases (89. 3%) were cured, 9 cases (8. 8%) were left hospital without obvious improvement, 2 cases (1. 9%) died. Conclusion: the incidence of drug-induced liver injury (DILI) is more than one year and has become one of the main causes of liver function and structure damage. Most of them were female and middle aged, and digestive symptoms were most common in clinical manifestations. Drugs that can cause drug-induced liver injury are: traditional Chinese medicine, antibiotics, anti-tuberculosis drugs, diet and health products, anti-thyroid drugs, non-steroidal anti-inflammatory drugs, stomach protection drugs. Acute DILI and hepatocyte DILI are the most common. Most patients have a good prognosis.
【學位授予單位】：山東大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R575
[Abstract]:In the course of clinical use of drugs, the substances produced by the drug's own components and / or by its metabolism, Or liver dysfunction or structural change caused by high sensitivity or low tolerance due to the body's own physical condition is called drug-induced liver injury (DILI). Nowadays, due to the frequent use of a large number of drugs in China, drug-induced liver injury (DILI) has become an important liver disease, which is increasingly affecting the physical and mental health of human beings. However, DILI has no specific clinical symptoms and biochemical indicators, so the diagnosis is still difficult, and the rate of missed diagnosis and misdiagnosis is high. In order to solve this problem, the Chinese Society of Hepatology issued the first guidelines for the diagnosis and treatment of drug-induced liver injury in 2015, which provides a basis for the diagnosis and treatment of drug-induced liver injury. Objective: according to the guidelines for the diagnosis of drug-induced liver injury, we rediagnosed the patients with drug-induced liver injury in Shandong Provincial Hospital, analyzed the clinical characteristics of those who met the diagnostic criteria, and determined the specific drugs that could cause liver injury. The types of liver damage may provide evidence for clinical use of drugs to prevent the recurrence of adverse drug events. Methods: from January 1, 2014 to December 31, 2016, the Department of Hepatology of Shandong Provincial Hospital affiliated to Shandong University diagnosed as "drug-induced liver injury", "drug-induced hepatitis", "toxic liver disease", and "toxic hepatitis" in 128 cases. According to the diagnostic guidelines, 25 patients with RUCAM score 6 were excluded, and 103 patients who were assessed as most likely or most likely to be drug-induced liver injury according to the diagnostic criteria were included in a retrospective study on the general situation (such as age, sex, etc.) Clinical features (including signs, adjuvant examinations, clinical typing), drugs leading to abnormal liver function, treatment methods, outcome of treatment, etc. Results: 1. The RUCAM score of 8 was the largest (25.2%), followed by 7: 23.3and 9: 22.3. The incidence of drug-induced liver injury increased year by year. The mean age of onset was 46.75 鹵16.11. 41-60 years of age accounted for the largest proportion (44.7%). Among the drugs causing drug-induced liver injury, 52 cases (43.7%) were Chinese medicine, 17 cases (14.3%) were antibiotics, 9 cases (7.6%) were anti-tuberculosis drugs, 4 cases (3.4%) were slimming and health products. Antithyroid drugs were found in 3 cases (2.5%), non-steroidal anti-inflammatory drugs in 3 cases (2.5%), gastric preservatives in 5 cases (4.2%) and non-steroidal anti-inflammatory drugs in 5 cases (4.2%). The clinical manifestations were nausea, anorexia, oil, abdominal pain and diarrhea in 57 cases (43.8%), skin, yellowish sclera and / or urine yellowing in 45 cases (34.6%), fatigue in 12 cases (9.2%) and rash in 12 cases. There were 2 cases (1.5%) of pruritus and 14 cases (10.8%) of asymptomatic pruritus. Clinical classification: according to the course of disease, 94 cases (91.2%) were acute drug-induced liver injury, 9 cases (8.8%) were chronic drug-induced liver injury. According to target cell type, 90 cases (87.4%) were hepatocyte type, 7 cases (6.8%) were cholestasis type, 6 cases (5.8%) were mixed type. The level of hepatocyte DILI ALT,AST was higher, and the level of cholestatic DILI GGT,ALP was higher (P0.05). The clinical outcome: 92 cases (89. 3%) were cured, 9 cases (8. 8%) were left hospital without obvious improvement, 2 cases (1. 9%) died. Conclusion: the incidence of drug-induced liver injury (DILI) is more than one year and has become one of the main causes of liver function and structure damage. Most of them were female and middle aged, and digestive symptoms were most common in clinical manifestations. Drugs that can cause drug-induced liver injury are: traditional Chinese medicine, antibiotics, anti-tuberculosis drugs, diet and health products, anti-thyroid drugs, non-steroidal anti-inflammatory drugs, stomach protection drugs. Acute DILI and hepatocyte DILI are the most common. Most patients have a good prognosis.
【學位授予單位】：山東大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R575
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