氧化苦参碱治疗慢性乙型肝炎：一项随机双盲安慰剂对照多中心试验。
Oxymatrine therapy for chronic hepatitis B: a randomized double-blind and placebo-controlled multi-center trial.
作者信息
Lu Lun-Gen, Zeng Min-De, Mao Yi-Min, Li Ji-Qiang, Wan Mo-Bin, Li Cheng-Zhong, Chen Cheng-Wei, Fu Qing-Chun, Wang Ji-Yao, She Wei-Min, Cai Xiong, Ye Jun, Zhou Xia-Qiu, Wang Hui, Wu Shan-Ming, Tang Mei-Fang, Zhu Jin-Shui, Chen Wei-Xiong, Zhang Hui-Quan
机构信息
Shanghai Institute of Digestive Disease, Renji Hospital, Shanghai Second Medical University, Shanghai 200001, China.
出版信息
World J Gastroenterol. 2003 Nov;9(11):2480-3. doi: 10.3748/wjg.v9.i11.2480.
AIM
To evaluate the efficacy and safety of capsule oxymatrine in the treatment of chronic hepatitis B.
METHODS
A randomised double-blind and placebo-controlled multicenter trial was conducted. Injection of oxymatrine was used as positive-control drug. A total of 216 patients with chronic hepatitis B entered the study for 24 weeks, of them 108 received capsule oxymatrine, 36 received injection of oxymatrine, and 72 received placebo. After and before the treatment, clinical symptoms, liver function, serum hepatitis B virus markers, and adverse drug reaction were observed.
RESULTS
Among the 216 patients, six were dropped off, and 11 inconsistent with the standard were excluded. Therefore, the efficacy and safety of oxymatrine in patients were analysed. In the capsule treated patients, 76.47% became normal in ALT level, 38.61% and 31.91% became negative both in HBV DNA and in HBeAg. In the injection treated patients, 83.33% became normal in ALT level, 43.33% and 39.29% became negative both in HBV DNA and in HBeAg. In the placebo treated patients, 40.00% became normal in ALT level, 7.46% and 6.45% became negative both in HBV DNA and in HBeAg. The rates of complete response and partial response were 24.51% and 57.84% in the capsule treated patients, and 33.33% and 50.00% in the injection treated patients, and 2.99% and 41.79% in the placebo treated patients, respectively. There was no significance between the two groups of patients, but both were significantly higher than the placebo. The adverse drug reaction rates of the capsule, injection and placebo were 7.77%, 6.67% and 8.82%, respectively. There was no statistically significant difference among them.
CONCLUSION
Oxymatrine is an effective and safe agent for the treatment of chronic hepatitis B.
目的
评估复方苦参素胶囊治疗慢性乙型肝炎的疗效和安全性。
方法
进行一项随机双盲、安慰剂对照的多中心试验。以苦参素注射液作为阳性对照药。共有216例慢性乙型肝炎患者进入研究，为期24周，其中108例接受复方苦参素胶囊治疗，36例接受苦参素注射液治疗，72例接受安慰剂治疗。治疗前后观察临床症状、肝功能、血清乙肝病毒标志物及药物不良反应。
结果
216例患者中，6例脱落，11例不符合标准被排除。因此，对苦参素在患者中的疗效和安全性进行分析。胶囊治疗组患者中，76.47%的谷丙转氨酶（ALT）水平恢复正常，38.61%的乙肝病毒脱氧核糖核酸（HBV DNA）和31.91%的e抗原（HBeAg）转阴。注射治疗组患者中，83.33%的ALT水平恢复正常，43.33%的HBV DNA和39.29%的HBeAg转阴。安慰剂治疗组患者中，40.00%的ALT水平恢复正常，7.46%的HBV DNA和6.45%的HBeAg转阴。胶囊治疗组患者的完全缓解率和部分缓解率分别为24.51%和57.84%，注射治疗组分别为33.33%和50.00%，安慰剂治疗组分别为2.99%和41.79%。两组患者之间无显著差异，但均显著高于安慰剂组。胶囊、注射剂和安慰剂的药物不良反应发生率分别为7.77%、6.67%和8.82%。它们之间无统计学显著差异。
结论
苦参素是治疗慢性乙型肝炎的一种有效且安全的药物。
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