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目的:观察不同剂量N-乙酰半胱氨酸(NAC)治疗重症肝病患者所致不良反应,探讨其安全使用。方法:2006年2月至2008年1月在我院应用NAC治疗的各种类型重症肝病患者173例纳入研究。173例患者分为3个剂量组:大剂量组(25例)、小剂量组(66例)及剂量增加组(82例)。大剂量组男16例,女9例,平均年龄(42.3±3.6)岁。小剂量组男42例,女24例,平均年龄(41.6±4.8)岁。剂量增加组男51例,女31例,平均年龄(45.2±5.2)岁。给药方法如下:大剂量组患者给予NAC8g溶于10%葡萄糖注射液250ml中静脉滴注,1次/d;小剂量组患者给予NAC4g溶于10%葡萄糖注射液250ml中静脉滴注,1次/d,同时给予法莫替丁20mg口服,2次/d,10%葡萄糖酸钙10ml加入50%葡萄糖注射液20ml中缓慢静脉推注;剂量增加组患者给予NAC起始剂量4g/d静脉滴注;如无不良反应,自第4天起剂量增至8g/d,给药方法及其他用药同小剂量组。所有患者至少观察2周。结果:大剂量组25例患者中16例(64%)出现不良反应,包括皮肤反应(9例,36%)、胸闷和头晕(2例,8%)、消化道反应(3例,12%)、过敏性休克(1例,4%),双下肢活动障碍(1例,4%)。该组中发生不良反应患者和未发生不良反应患者的终末期肝病(MELD)评分分别为(11.26±5.47)分和(18.38±5.71)分,差异有统计学意义(P<0.05),提示发生不良反应患者病情较轻。小剂量组66例患者中2例(3.03%)出现不良反应,其中皮疹1例和上腹部不适1例。小剂量组不良反应发生率显著低于大剂量组,差异有统计学意义(P<0.001)。皮疹患者和上腹部不适患者的MELD评分分别为11.38分和10.29分。剂量增加组有4例(4.88%)在用药3d内发生不良反应,其余78例中有7例(8.97%)在用药4d后出现不良反应,其发生率高于小剂量组而低于大剂量组(均P<0.001)。78例中,MELD评分>15者31例,发生胃肠反应和皮疹各1例;MELD评分<15者47例,发生胃肠道反应3例,头皮水肿和皮疹各1例。两者差异有统计学意义(P<0.001)。所有患者出现的不良反应经停药、对症处理后消失。结论:NAC小剂量或逐渐增加剂量与口服法莫替丁及静脉推注10%葡萄糖酸钙联用是一种较为安全的治疗重症肝病的方法,但对病情较轻的重症肝病患者用药时应加强监测以避免或减少不良反应的发生。
Objective: To observe the adverse reactions caused by different doses of N-acetylcysteine (NAC) in patients with severe liver disease and to explore its safe use. METHODS: A total of 173 patients with various types of severe liver diseases treated with NAC from February 2006 to January 2008 in our hospital were enrolled. 173 patients were divided into three dose groups: high-dose group (25 cases), low-dose group (66 cases) and dose-added group (82 cases). High-dose group of 16 males and 9 females, the average age (42.3 ± 3.6) years old. Small dose group of 42 males and 24 females, mean age (41.6 ± 4.8) years old. There were 51 males and 31 females with the average age (45.2 ± 5.2) years old. The administration method is as follows: The patients in the high-dose group were given intravenous drip of NAC8g dissolved in 250ml of 10% glucose injection once per day; patients in the low-dose group were given intravenous drip of NAC4g in 250ml of 10% glucose injection once, / d, while given famotidine 20mg orally, 2 times / d, 10% calcium gluconate 10ml 50% glucose injection 20ml slow intravenous injection; patients given dose NAC initial dose of 4g / d intravenous drip Note; If no adverse reactions, the dose from the 4th day increased to 8g / d, administration methods and other medication with a small dose group. All patients were observed for at least 2 weeks. RESULTS: Twenty-six (64%) of the 25 patients in the high-dose group experienced adverse reactions including skin reactions (9, 36%), chest tightness and dizziness (2, 8%), gastrointestinal reactions (3, 12% ), Anaphylactic shock (1 patient, 4%), and lower extremity dysfunction (1 patient, 4%). The patients with ADR and MELD score were (11.26 ± 5.47) and (18.38 ± 5.71) points respectively, the difference was statistically significant (P <0.05), suggesting that the occurrence Adverse reactions in patients with mild disease. Two of 66 patients (3.03%) in low dose group had adverse reactions, including 1 case of rash and 1 case of upper abdominal discomfort. The incidence of adverse reactions in the low-dose group was significantly lower than that in the high-dose group, the difference was statistically significant (P <0.001). MELD scores for patients with rash and those with upper abdominal discomfort were 11.38 and 10.29, respectively. There were 4 adverse reactions (4.88%) in the dose-increasing group and 3 (78%) in the remaining 78 patients. The adverse reactions occurred after 4 days of treatment, and the incidence rate was higher than that of the low dose group and lower than the high dose group Group (all P <0.001). Among the 78 cases, 31 cases had MELD score> 15, 1 case had gastrointestinal reaction and skin rash, 47 cases had MELD score <15, 3 cases had gastrointestinal reaction, 1 case had scalp edema and rash. The difference was statistically significant (P <0.001). Adverse reactions to all patients after withdrawal, symptomatic treatment disappeared. Conclusions: NAC is a safe and safe treatment for severe liver disease in combination with oral administration of famotidine and intravenous injection of calcium gluconate. However, for patients with less severe liver disease, Strengthen monitoring to avoid or reduce the occurrence of adverse reactions.