摘要
背景 药物性肝损伤是仅次于病毒性肝炎和脂肪性肝病的第 3 大肝脏疾病,及时诊断并给予有效治疗是阻断疾病进展、提高治愈率的关键.苦黄制剂已被广泛应用于治疗各种原因导致的急慢性肝炎,尤其是伴有黄疸的患者,其临床疗效及安全性确切.但是,尚缺乏对急性药物性肝损伤患者保肝退黄疗效和安全性的循证医学证据.目的 评价苦黄注射液序贯苦黄颗粒治疗药物性肝损伤的疗效及安全性.方法 采用随机、阳性对照、非劣效性试验设计,选择 2021 年 11 月—2023 年 9 月在首都医科大学附属北京佑安医院诊断为急性药物性肝损伤患者 93 例,采用单中心随机化的方法,将患者随机分配到试验组(49 例)和对照组(44 例).在常规保肝治疗 4 周的基础上,试验组和对照组分别应用苦黄注射液/注射用丁二磺酸腺苷蛋氨酸治疗 2 周,再改用苦黄颗粒/丁二磺酸腺苷蛋氨酸肠溶片治疗 2周.比较两组患者入组时、治疗 2 周、治疗 4 周的退黄有效率、主要肝功能指标[丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)、碱性磷酸酶(ALP)、谷氨酰转移酶(GGT)、总胆红素(TBIL)、总胆汁酸(TBA)]水平变化及其复常率.结果 治疗期间共脱落 4 例患者,其中试验组 3 例,对照组 1 例.两组治疗 2、4 周后退黄有效率比较,差异均无统计学意义(P＞0.05).两组治疗 2、4 周时ALT、AST、ALP、GGT、TBIL、TBA比较,差异均无统计学意义(P＞0.05).两组治疗2、4周时ALT、AST、ALP、GGT、TBIL复常率比较,差异均无统计学意义(P＞0.05).结论 苦黄注射液序贯苦黄颗粒治疗药物性肝损伤疗效确切,安全性良好,非劣效于注射用丁二磺酸腺苷蛋氨酸序贯丁二磺酸腺苷蛋氨酸肠溶片.
Abstract
Background Drug-induced liver injury is the third major liver disease,following viral hepatitis and fatty liver disease.Timely diagnosis and effective treatment are crucial in halting disease progression and improving cure rates.Kuhuang preparation has been widely used in treating acute and chronic hepatitis stemming from various causes,particularly in patients manifesting jaundice,demonstrating clear clinical efficacy and safety.Nonetheless,there remains a dearth of evidence-based medical data concerning the efficacy and safety of hepatoprotective measures in patients with acute drug-induced liver injury.Objective To evaluate the efficacy and safety of Kuhuang injection sequential Kuhuang granules in the treatment of drug-induced liver injury.Methods Using a randomized,positive-controlled,non-inferiority trial design,93 patients diagnosed with acute drug-induced liver injury at Beijing Youan Hospital,Capital Medical University,between November 2021 and September 2023 were selected.These patients were allocated through single-center randomization,with 49 cases assigned to the experimental group and 44 cases to the control group.After receiving conventional hepatoprotective therapy for 4 weeks,the experimental group and the control group were treated with Kuhuang injection/adenosylmethionine butanedisulfonate for injection for 2 weeks,followed by Kuhuang granules/enteric-coated tablets of adenosylmethionine butanedisulfonate for another 2 weeks.The efficacy rates of jaundice regression,as well as changes in key liver function parameters[alanine aminotransferase(ALT),aspartate aminotransferase(AST),alkaline phosphatase(ALP),gamma-glutamyltransferase(GGT),total bilirubin(TBIL),total bile acid(TBA)]at baseline,2 weeks,and 4 weeks of treatment,along with their normalization rates,were compared between the two groups.Results A total of 4 patients fell off during treatment,including 3 patients in the experimental group and 1 patient in the control group.Following 2 and 4 weeks of treatment,there was no significant difference observed in the efficient rate of jaundice regression between the two groups(P＞0.05).Similarly,no significant differences were detected in the levels of ALT,AST,ALP,GGT,TBIL,and TBA between the two groups at the 2-week and 4-week marks of treatment(P＞0.05).Additionally,there were no notable variations in the recurrence rates of ALT,AST,ALP,GGT,TBIL,and TBA between the two groups following 2 and 4 weeks of treatment(P＞0.05).Conclusion Kuhuang Injection Sequential Kuhuang Granules has definite efficacy and good safety in the treatment of drug-induced liver injury,and is not inferior to adenosylmethionine butyldisulfonate for injection sequential enteric-coated tablets of adenosylmethionine butanedisulfonate.
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