目的　研究健康志愿者口服双环醇片剂的药代动力学。方法　 30名健康志愿者 ,随机分成 2 5、 5 0、10 0mg3个剂量组 ,分别给予单一剂量、多次剂量、餐前、餐后给药 ,用HPLC测定血药浓度 ,用3p97软件进行药代动力学分析。结果　药代动力学符合一房室模型及一级动力学消除规律 ,3个剂量单次给药代动力学参数分别为t( 1/2 )ka(0 .84±0 .6 8)、(0 .33± 0 .0 9)、(1.19± 10 .9)h。t( 1/2 )ke为(6 .2 6± 6 .2 4 )、(6 .17± 2 .0 1)、(4.6 6± 1.2 1)h。Vd/F 为 (45 5 .0 2± 13

目的 :评估双环醇治疗慢性乙型肝炎的疗效和安全性。方法 :慢性乙型肝炎病人随机分成双环醇组 (2 69例 )和联苯双酯组 (1 3 8例) ,分别服用双环醇或联苯双酯 2 5mg,tid,共 2 4wk。结果 :经双环醇治疗后 ,临床症状有较大程度的改善。ALT和AST的复常率分别为 5 3 .5 %和 48.7% ,停药 1 2wk后分别为 40 .2 %和 48.7%。与联苯双酯组(61 .6%和 44.2 % ;45 .7%和 5 0 .0 % )比较 ,P 0 .0 5。治疗结束和停药 1 2wk后 ,双环醇组血清HBeAg阴转率分别为 2 0 .8%和 2 9.0 % ,HBeAg/抗HBe血清转换率分别为 1 5 .6%和 2 0 .8% ,HBV DNA阴转率分别为 3 9.0 %和 45 .7% ,上述指标均高于联苯双酯组。双环醇组治疗前ALT水平≥ 2 0 0U·L-1者 ,在停药 1 2wk时HBeAg阴转率和血清转换率分别为 48%和 3 8% ,显著高于联苯双酯组 (2 2 %和 1 2 % ) ,(P 0 .0 5 )。病人在治疗期间未出现明显不良反应。结论 :双环醇对改善乙肝病人临床症状和降低转氨酶有很好的疗效 ,不良反应少 ,病人耐受性好

目的:通过Ⅳ期临床试验评估双环醇片治疗慢性乙型肝炎和慢性丙型肝炎的安 全性和疗效.方法:随机选择12～65 a的2 200例慢性乙型肝炎和慢性丙型肝炎病人接受治疗,每日口服双环醇片75 mg,观察连续用药24 wk(近期)及停药12 wk后(远期)的安全性和疗效,以血清丙氨酸转氨酶(ALT)作为主要疗效评估指标.结果:试验过程中未发生严重不良事件,不良事件发生率为 10.87%.意向性分析(ITT)统计显示,慢性乙型肝炎和慢性丙型肝炎病人治疗24 wk末的ALT复常率分别为60.37%和54.0%,停药12 wk后的ALT持续复常率分别为71.88%和65%.结论:双环醇片75 mg·d-1治疗慢性乙型肝炎和慢性丙型肝炎安全,对改善肝功能有效.

双环醇片（Bicyclol，商品名：百赛诺）是我国首个上市的 具有国际自主知识产权的治疗肝脏炎症1.1类化学新药。于2001年11月在中国上市。双环醇片已被纳入《国家基本医疗保险、工伤保险和生育保险药品目录 （2009年版）》、《慢性乙型肝炎防治指南（2010年版）》[1]、《非酒精性脂肪性肝病诊疗指南（2010年修订版）》[2]、《酒精性肝病诊疗指 南（2010年修订版）》[3]，被列为抗炎保肝治疗药物。上市10余年来，双环醇片积累了用于多种病因肝病的抗炎保肝治疗的循证医学证据，已在国内外发 表研究论文380篇，其中中文核心期刊和中国科技核心期刊151篇，SCI收录期刊38篇。2004年8月，经国内肝病专家充分研讨后形成的《双环醇片临 床应用专家意见》（以下简称“意见”），在过去的10年里，为临床医生科学、合理、正确使用双环醇片提供了理论依据和指导。近年来随着双环醇片循证医学证 据的积累，国内相关专家在原“意见”基础上，参照肝病诊疗各项指南和共识，结合肝病治疗发展趋势，讨论并撰写本文，以期为临床医生提供具有科学性、严谨性 和实用性的药物使用参考依据。

Abstract Top of page Abstract Materials and Methods Results Discussion Acknowledgements References Abstract: The aim of this study was to determine the effect of bicyclol against cisplatin-induced hepatotoxicity and the influence on the antitumour capacity of cisplatin in hepatocarcinoma 22 (H22) tumour-bearing mice. ICR mice were treated with bicyclol (250mg/kg, orally) 2hr before the injection of cisplatin (5mg/kg, intraperitoneally) for 5 days (once daily) after H22 tumour cells were implanted. All animals were killed on the fifth day after cisplatin treatment and tumour weight of each animal was measured. Liver pathological changes were examined by light microscopy and biochemical assay. The expressions of liver inducible nitric oxide synthase (iNOS and nitric oxide synthase 2) and 3-nitrotyrosine were assessed by Western blotting. Bicyclol showed a significant protection as evidenced by the decrease of elevated serum aminotransferases and lactate dehydrogenase, and improvement of histopathological injury induced by cisplatin. The formation of liver malondialdehyde with a concomitant reduction of reduced glutathione was also inhibited by bicyclol, while the activities of liver superoxide dismutase, catalase and glutathione peroxidase were all increased, respectively. In addition, the over expressions of liver iNOS and 3-nitrotyrosine were suppressed by bicyclol. The administration of bicyclol had no affect on the anti-tumour capacity of cisplatin in mice bearing H22 tumour. The hepatoprotective action of bicyclol provides a new approach for preventing the hepatotoxicity induced by cisplatin in the clinic.

目的研究双环醇对慢性乙型病毒性肝炎(乙肝)肝纤维化的治疗作用.方法以双环醇治疗慢性乙肝患者20例,疗程6个月.分别于治疗前后检测患者血清丙氨酸氨基转移酶(ALT)、γ-谷氨酰转肽酶(GGT)及血清纤维化指标层粘连蛋白(LN)、Ⅳ型胶原(C-Ⅳ)、Ⅲ型前胶原肽(PⅢP)和透明质酸(HA)水平.同时经皮肝活检观察治疗前后肝脏组织病理学变化.结果双环醇可以显著降低慢性乙肝患者血清ALT和GGT水平,复常率分别达95%和70%,同时可以明显降低慢性乙肝患者血清LN、C-Ⅳ和PⅢP水平,尤其PⅢP 和C-Ⅳ水平与肝组织纤维化程度呈明显正相关(相关系数分别为0.653和0.530,P<0.01).结论双环醇可以减轻慢性乙肝患者肝脏炎症反应,保护肝细胞和抑制肝纤维化.

目的:探讨减轻体重联合百赛诺治疗非酒精性脂肪性肝病(NAFLD)的疗效.方法:120例NAFLD患 者,体重指数(BMI)均大于24 kg/m2,随机分为4组,每组30例.慢速减肥组(A组),每月体重减轻3～5 kg;快速减肥组(B组),每月体重减轻大于5 kg;百赛诺组(C组),口服百赛诺25 mg每d 3次;慢速减肥组+百赛诺组(D组),具体方法同A、C组.均治疗半年.治疗前后用图像定量测量软件测定面罩式覆盖的CT图像,得到肝脏脂肪浸润指数 (MIFI),并同时检测多项肝功能指标,BMI和腰围臀围比值(W/H).结果:B组治疗后虽有BMI、W/H、ChE和MIFI的改善,但ALT和 AST治疗前后没有差别.C组治疗前后BMI、W/H和MIFI没有变化,转氨酶降低.A、D组治疗后指标均有改善,D组效果最好.结论:减轻体重联合百 塞诺治疗非酒精性脂肪性肝病疗效较好.

篇首： 药物性肝损害是抗肿瘤药物常见的不良反应之一.其发生不仅可影响患者生活质量,并可导致化疗延期、剂量调整而影响抗肿瘤疗效,因而及时保肝治疗、预防再次肝损害发生有重要临床意义.

针对真实世界中苦碟子注射液(KDZ)治疗冠心病和脑梗死的联合用药进行分析,获得关联关系,为临床用药和下一步的深入分析提供借鉴和参考.运用数据挖掘方法中的关联规则对来自18家医院电子病历数据进行回顾性分析.针对使用KDZ的6 032例冠心病患者和3 468例脑梗死患者,获得其联合使用扩血管西药和抗血小板西药人群的相关性信息,如获得不同人群在年龄、用药疗程;年龄、单次用药剂量;年龄、死亡率;年龄、好转率之间的联合关系和对比直观图.本研究分析虽然获得了一些比较积极且符合临床相关性的结果,但还不具有强关联性以及因果推断关系,因此有必要进行下一步的探索和分析.

该研究对17家三级甲等医院HIS数据库中4 497例帕金森综合征住院患者的诊断信息、临床用药特点进行了分析,结果显示帕金森综合征患者最常见的合并疾病为脑梗死、高血压病、冠心病、糖尿病和肺部感染,其中脑梗塞、高血压病在男性的合并发生率分别达到33.46％,30.05％,女性较此略低.男性合并冠心病者高于女性,女性合并糖尿病和骨病者高于男性.合并疾病发生率随年龄升高,血管性因素占据重要地位.90岁以上老年人最常见的合并病是冠心病、肺部感染,常伴有营养代谢紊乱及急症、危重症.便秘、抑郁及焦虑、睡眠障碍、认知障碍是常见的非运动症状.与帕金森综合征核心症状治疗相关的药物种类约占临床用药20％ ～ 30％,其他药物主要用于治疗合并疾病,临床用药与疾病谱吻合.活血化瘀剂高居中药应用频率首位,达到44.52％;通便药占11.66％;清热解毒剂占9.46％.应用频率前20位的中药品种使用率合计达到56.07％,其中12种属于中药注射剂,占60％.研究提示在帕金森综合征诊疗中,合并疾病的治疗非常重要,应重视本病的血管性因素,中医药更应关注非运动症状的改善,充分发挥中医药多靶点、整体调节的优势,中西医结合,改善患者的生存质量.

Background and Aims:Thrombocytopenia is a relatively common extrahepatic manifestation of hepatitis c,even in the absence of cirrhosis.Also, thrombocytopenia has been reported in chronic HBV infection. The aims of present study were to evaluate the prevalence of thrombocytopenia in chronic HCV and HBV infection in the absence of cirrhosis and to assess the relationship between HBV and HCV infection and frequency of thrombocytopenia.Methods: 438 patients (219 patients with chronic active hepatitis B and 123 inactive carriers of HBV and 96 patients with chronic HCV infection) were enrolled in this study. Thrombocytopenia was defined as platelet counts below 150,000/碌l.Results: The prevalence of thrombocytopenia was 17.7% in patients with chronic active hepatitis B and 10.6% in HBV inactive carriers, 13.3% in patients with chronic hepatitis C and 5.3% in control group. The prevalence of thrombocytopenia in chronic hepatitis B and C was significantly more than control group.Conclusions: These results in Iran, with 2-3 million people with chronic HBV infection and around 400,000 with chronic HCV infection shows that HBV and HCV infections, even in the absence of cirrhosis, may be two causes of thrombocytopenia.

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目的 研究双环醇片抗病毒治疗慢性乙型肝炎的临床疗效.方法 选择70例慢性乙型肝炎病人随机分两组接受治疗,试验组35例,每日服用双环醇片75mg;对照组35例,给予每日口服复方甘草酸苷150mg.两组均连 续用药12周.观察治疗前后血清氨基转移酶水平的改变.结果 两组血清氨基转移酶均得到明显下降,试验组更为显著(P<0.05,P<0.01).两组均未发生严重的不适反应.结论 双环醇片治疗慢性乙型肝炎在生物化学方面取得较好疗效,且安全性好,使用方便,很值得在临床推广应用.

目的　观察双环醇对缺血 再灌注诱发肾损伤的保护作用。方法　在大鼠肾动脉缺血 再灌注模型上观察双环醇对肾缺血 再灌注引起的血清丙二醛 (MDA)、尿素氮 (BUN) ,肾脏还原型谷胱甘肽 (GSH)、谷胱甘肽巯基转移酶 (GST)及肾线粒体膜流动性改变的影响。结果　双环醇ig 5 0及 2 0 0mg·kg- 1 可剂量依赖性保护缺血 再灌注引起的血清MDA及BUN升高、肾GSH含量降低 ,同时可诱导GST活性 ,缓解由于缺血 再灌注损伤引起的线粒体膜流动性降低。结论　双环醇对肾缺血 再灌注损伤有保护作用

AIM: To evaluate the efficacy and safety of bicyclol for chronic hepatits B(CHB). METHODS: CHB patients were randomly divided into bicyclol group and bifendate group on the ratio of 2 1. Each group of patients received bicyclol or bifendate 2 mg tid for 24 wk, then stopped treatment and followed up 12 wk. Investigating items included clinical symptoms, liver function tests, serum hepatitis B (HBV) markers and safety profile. Efficacy evaluation was based on Intent To Treat (ITT) principle. RESULTS: Bicyclol or bifendate were given to two hundred and sixty nine and one hundred and thirty eight patients, respectively. The demographic and baseline features were similar in both groups. After bicyclol therapy, both clinical symptoms and serum ALT, AST levels were improved markedly. The normalization rates of ALT and AST were 53.5 % and 48.7 % at wk 24, and kept sustained normal in 40.2 % and 48.7 % at 12 wk after stop of treatment. In bifendate group, the ALT and AST normalization rates were 61.6 % and 44.2 % at wk 24, and 45.7 % and 50.0 % at 12 wk after stop of the treatment, respectively. The improvement of serum ALT and AST showed no statistical difference between two groups ( P 0.05). Regarding the HBV markers, in bicyclol group the negativity of HBeAg, HBeAg/Anti HBe seroconversion and negativity of HBV DNA at wk 24 were 20.8 % 15.6 % and 39.0 %, respectively, and then 29.0 %, 20.8 % and 45.7 % and 12 wk after stop of treatment. Whereas in bifendate group, those parameters were 15.2 %, 9.4 % and 37.7 % at wk 24, and 21.0 %, 14.5 % and 38.4 % at 12 wk after stop of treatment. These results between bicyclol and bifendate groups showed no significant statistical difference. However, in patients whose baseline ALT levels were higher than 5 times of upper limit of normal (200 U L -1 ), the HBeAg negative rates and seroconversion rates at 12 wk after stop of treatment were significant higher in bicyclol group than those in bifendate group, those were 48 % versus 22 %( P = 0.015) and 38 % versus 12 % ( P =0.01). The adverse reactions of bicyclol group were mild and uncommon, only skin rash and dizzeness were occurred in one patient each; and skin rashes occurred in two and loss of appetite and nausea occurred in one patient who received bifendate. CONCLUSION: Bicyclol is effective for the improvement of the clinical symptoms and serum ALT and AST. Bicyclol is superior to bifendate on the clearance of serum HBeAg and seroconversion. It is well tolerated and safety throughout the course of trial.

目的 探讨双环醇治疗婴儿肝炎综合征的疗效.方法 104例婴儿肝炎随机分为两组,治疗组52例予以双环醇片口服,对照组52例予以联苯双酯口服.两组在治疗前、治疗后3、6个月及停药后3个月分别进行血 清丙氨酸转氨酶(ALT)和天冬氨酸转氨酶(AST)的测定.结果 两组治疗后3、6个月血清ALT复常率对比无显著性差异(P>0.05),AST复常率对比有显著性差异(P<0.05);停药后3个月两组 ALT、AST的复常率对比均有显著性差异(P<0.01).结论 双环醇治疗婴儿肝炎疗效肯定且停药后不易反弹.

双环醇（百赛诺），是在五味子素的基础上人工合成的一类新药，具有明显的肝细胞保护作用和一定的抗肝炎病毒作用。近年来，已广泛用于治疗病毒性肝炎和其他慢性肝病，取得了较好的疗效。现就其药理作用和临床应用状况作一综述。

正 1 双环醇具有抗肝炎病毒和抗肝细胞损伤两方面的药理作用 1.1 对小鼠CCl4急性肝损伤的研究结果表明,双环醇不同剂量组均使ALT明显降低,剂量-效应关系明显,200mg/kg组还使AST亦明显降低。而联苯双酯200mg/kg只能降ALT,对AST无影响。肝脏病理损伤如炎症和坏死,双环醇组明显减

目的研究不同剂量的双环醇片治疗慢性乙型肝炎(CHB)的疗效和安全性. 方法随机选择139例CHB患者分2组接受治疗,口服双环醇片150 mg/d(治疗组)或75 mg/d(对照组),观察连续用药24周后的疗效和安全性.结果2组血清氨基转移酶均得到明显下降,且治疗组更为明显(P＜0.05);治疗24周后治疗 组与对照组HBeAg阴转率分别为36.1%和20.9%(P＜0.05),均未发生明显的不良反应.结论双环醇片150 mg/d治疗CHB在降低血清氨基转移酶及HBeAg阴转方面优于75 mg/d,安全性好.