两种甘草酸制剂治疗慢性乙型肝炎疗效比较

目的：比较异甘草酸镁注射液与复方甘草酸苷注射液治疗慢性乙型肝炎的临床疗效和安全性。方法：62例慢性乙型肝炎患者随机分为两组,观察组32例给予异甘草酸镁注射液150 mg加入5%～10%葡萄糖注射液250 ml中,ivd qd;对照组给予复方甘草酸苷注射液120 mg加入5%～10%葡萄糖注射液250 ml中,ivd qd。疗程均为4周。观察两组症状、体征、肝功能等指标的变化及药品不良反应。结果：治疗后两组患者的症状、体征、肝功能指标均有明显改善,组间比较差异无统计学意义（P〉0.05）。观察组与对照组有效率分别为90.63%、83.33%,差异同样无统计学意义（P〉0.05）。两组均未见严重不良反应。结论：异甘草酸镁注射液治疗慢性乙型肝炎疗效确切,安全性好,与复方甘草酸苷注射液临床疗效差异不明显。     

联合应用复方甘草酸苷与恩替卡韦对慢性重型乙型肝炎的临床疗效

目的分析并评价联合使用复方甘草酸苷与恩替卡韦对慢性重型乙型肝炎患者的临床疗效。方法选择江苏镇江解放军第三五九医院自2007年至2009年期间收治的慢性重型乙型肝炎患者36例作为观察组;选择2004年至2006年期间收治的慢性重型乙型肝炎32例作为对照组。对照组患者采取复方甘草酸苷(20ml/支)加综合治疗;观察组给予复方甘草酸苷(20ml/支)加恩替卡韦(0.5 mg/片)加综合治疗。结果两组患者经治疗后,在主要临床症状改善、TB及凝血酶原活动度、疸酶分离、并发症、抢救成功率、病死率以及住院时间方面比较,两组之间差异均显著(P<0.01或P<0.05),均具有统计学意义;随访或治疗2年后,观察组HBV-DNA与HBeAg转阴率均明显高于对照组,两组之间比较差异均显著(P<0.01),均具有统计学意义;2年后通过B超和/或肝组织活检证实肝硬变者,观察组明显少于对照组,两组比较差异显著(P<0.01),具有统计学意义。结论恩替卡韦在治疗慢性重型乙型肝炎患者方面具有较高的安全性,其与复方甘草酸苷联合使用能够发挥协同作用,提高临床疗效和抢救成功率,长期服用能够有效抑制病毒复制,延缓肝硬变进程。     

glycyrrhizin as a potential treatment for chronic hepatitis C

Chronic hepatitis C is a slowly progressive liver disease that may evolve into cirrhosis with its potential complications of liver failure or hepatocellular carcinoma. Current therapy with α-interferon is directed at viral clearance, but sustained response is only achieved in 20–40% of patients without cirrhosis, and less than 20% in patients with cirrhosis who have the greatest need for therapy. Treatment for those who do not respond to anti-viral therapy is highly desirable.
In Japan glycyrrhizin has been used for more than 20 years as treatment for chronic hepatitis. In randomized controlled trials, glycyrrhizin induced a significant reduction of serum aminotransferases and an improvement in liver histology compared to placebo. Recently, these short-term effects have been amplified by a well-conducted retrospective study suggesting that long-term usage of glycyrrhizin prevents development of hepatocellular carcinoma in chronic hepatitis C.
The mechanism by which glycyrrhizin improves liver biochemistry and histology are undefined. Metabolism, pharmacokinetics, side-effects, and anti-viral and hepatoprotective effects of glycyrrhizin are discussed.     

异甘草酸镁注射液治疗慢性乙型肝炎疗效研究

目的 探讨异甘草酸镁注射液在慢性乙型肝炎治疗中抗炎保肝作用.方法 120例慢性乙型肝炎患者随机分为治疗组和对照组,对照组采用甘利欣注射液治疗,治疗组给予异甘草酸镁注射液(商品名天晴甘美)治疗.治疗两周后观察疗效.结果 治疗组患丙氨酸氨基转移酶(ALT)、天门冬氨酸转氨酶(AST)、血清总胆红素(TBiL)的恢复速度治疗组明显优于对照组(P<0.05).两组治疗过程中均未出现明显副反应.结论 异甘草酸镁治疗慢性乙型肝炎在改善肝功能指标(ALT、AST、TBiL)方面速度快,优于甘利欣.     

复方甘草酸苷治疗慢性乙型肝炎肝纤维化疗效观察

目的:观察复方甘草酸苷治疗慢性乙型肝炎肝纤维化的疗效。方法:146例慢性乙型肝炎肝纤维化患者应用复方甘草酸苷注射液40ml～100ml,加入5%葡萄糖注射液250ml中静脉滴注,1次/d,连用4wk,然后改为序贯疗法,即口服复方甘草酸苷片50mg,3次/d,连用3mo。结果:注射4wk、序贯治疗后总有效率分别为67.12%、81.51%(P<0.05);治疗前、后症状与体征、肝功能及肝纤维化指标比较有显著性差异(P<0.05或P<0.01)。结论:复方甘草酸苷能有效地改善肝功能,抗肝纤维化,且疗效稳定、持久。     

复方甘草酸苷治疗慢性乙型肝炎临床研究

目的：观察复方甘草酸苷注射液治疗慢性乙型肝炎的疗效。方法：将136例慢性乙型肝炎患者随机分为治疗组及对照组,各68例。在综合治疗基础上治疗组予复方甘草酸苷注射液100ml加入5%～10%葡萄糖注射液中静脉滴注,对照组为甘草酸二胺150mg静脉滴注,疗程均为1个月。结果：治疗组总有效率为94.1%,对照组总有效率为77.9%,组间差异有统计学意义（P〈0.05）;治疗组肝功能改善情况明显好于对照组,差异有统计学意义（P〈0.05）;两组治疗过程中均未出现明显不良反应。结论：复方甘草酸苷治疗慢性乙型肝炎疗效确切,优于甘草酸二胺。     

丹红注射液联合治疗慢性乙型肝炎黄疸的疗效

目的：探讨丹红注射液联合复方甘草酸苷治疗慢性乙型肝炎黄疸患者的临床疗效。方法：选取96例慢性乙型肝炎黄疸患者,随机分为两组,治疗组48例用丹红注射液联合复方甘草酸苷注射液治疗,对照组48例单用复方甘草酸苷注射液。观察治疗前后患者肝功能主要指标变化及临床疗效比较两组疗效。结果：治疗组肝功能主要指标明显改善,与对照组相比差异显著（P〈0．05）。结论：丹红注射液联合复方甘草酸苷治疗慢性乙型肝炎黄疸患者,可有效改善肝功能。     

不同剂量复方甘草酸苷注射液治疗重型肝炎的疗效比较

目的:比较不同剂量复方甘草酸苷注射液治疗重型肝炎的疗效。方法:将62例重型肝炎患者随机分为高剂量治疗组(30例)和低剂量治疗组(32例),分别给予复方甘草酸苷注射液100ml或40ml,均加入10%葡萄糖注射液250ml中静脉滴注,1次/d,连用4wk。结果:高剂量组在症状、体征的改善方面及药品不良反应发生方面与低剂量组比较无显著性差异(P>0.05),而高剂量组在肝功能和凝血酶原活动度改善方面与低剂量组比较有显著性差异(P<0.05)。结论:高剂量复方甘草酸苷治疗重型肝炎效果显著。     

Pharmaceutical evaluation of liquorice before and after roasting in mice

Liquorice has been used for allergic-inflammatory and liver disorders in both traditional Chinese and modern medicine. In traditional Chinese formulations, it is mainly roasted liquorice that has been used rather than un-roasted liquorice. We have compared the pharmaceutical characteristics of liquorice before and after roasting to clarify the pharmaceutical significance of the roasting. Although roasted liquorice contained less glycyrrhizin (an anti-allergic component) than un-roasted liquorice, the inhibitory potency of roasted liquorice extract (200 mg x kg(-1)) on immunoglobulin E (IgE)-mediated triphasic ear swelling in mice was much greater compared with un-roasted liquorice. To search for additional active ingredients, roasted liquorice extract was subjected to gel-chromatography to give an anti-allergic fraction (Fa) of molecular weight ranging from 15000 to 200000 or more, in which glycyrrhizin was not detected. By testing the activity of the various fractions, it was proved that the anti-allergic effect of roasted liquorice was due to glycyrrhizin, its metabolite glycyrrhetic acid, and the Fa fraction. The inhibitory potency of the Fa fraction (15 and 75 mg x kg(-1)) prepared from roasted liquorice was stronger than that prepared from un-roasted liquorice. Therefore, a pharmaceutical implication of roasting the liquorice seems to be associated with an increase in the anti-allergic property of the Fa fraction. It is notable that oral administration of the high molecular mass fraction (Fa) significantly inhibited IgE-mediated ear swelling six days after challenge at doses as low as 3, 15 or 75 mg x kg(-1).     

异甘草酸镁与复方甘草酸苷治疗慢性乙型肝炎的疗效比较

目的探讨异甘草酸镁与复方甘草酸苷治疗慢性乙型肝炎的临床疗效。方法将168例慢性乙型肝炎患者随机分为观察组（84例）和对照组（84例）,观察组给予异甘草酸镁注射液治疗,对照组给予复方甘草酸苷注射液治疗。结果观察组总有效率为92.9%,对照组总有效率为91.7%,两组总有效率比较差异无统计学意义（P〉0.05）;两组患者治疗后丙氨酸氨基转移酶（ALT）、天门冬酸氨基转移酶（AST）、总胆红素（TBIL）均较治疗前有明显降低,差异均有统计学意义（P〈0.05）;但观察组的ALT、AST、TBIL的恢复情况明显优于对照组,两组间比较差异均有统计学意义（P〈0.05）。结论应用异甘草酸镁治疗慢性乙型肝炎疗效显著,较之复方甘草酸苷能更显著地改善患者的肝功能,且无不良反应发生,是一种治疗慢性乙型肝炎合理、安全、有效的方法 。     

复方甘草酸苷注射液联合前列地尔治疗病毒性肝炎重度淤胆的临床观察

目的:探讨复方甘草酸苷注射液联合前列地尔治疗病毒性肝炎重度淤胆的疗效。方法:采用随机对照、单盲的方法进行前瞻性试验。70例病毒性肝炎合并重度淤胆患者随机分为治疗组与对照组,2组均用复方甘草酸苷注射液治疗,治疗组加用前列地尔,疗程4wk。结果:治疗组总有效率为83%,显著优于对照组的60%(P<0·05),治疗组TBIL、DBIL、ALT、AST、GGT、PTA的下降幅度,与对照组比较有显著性差异(P<0·01)。结论:复方甘草酸苷注射液联合前列地尔可有效治疗病毒性肝炎合并重度淤胆。     

复方甘草酸苷联合用丹参治疗慢性乙型肝炎110例疗效观察

目的观察复方甘草酸苷联合丹参治疗慢性乙型肝炎的疗效。方法治疗组110例:复方甘草酸苷60ml和丹参20ml分别加入5～10%葡萄糖注射液250ml中静脉滴注,1次/d。对照组:甘草酸二铵30ml和门冬氨酸钾镁20ml分别加入5～10%葡萄糖注射液250ml中静脉滴注,1次/d,疗程均为1个月。治疗结束后进行疗效分析。结果两组比较,治疗组在患者症状、体征、丙氨酸氨基转移酶(ALT)、草氨酸氨基酸转移酶(AST)、血清胆红素(TBil)方面均优于对照组。结论复方甘草酸苷联合丹参可明显改变慢性乙肝炎的临床症状和肝功能损害,是治疗慢性乙型肝炎的有效联合。     

复方甘草甜素与还原型谷胱甘肽治疗慢性乙型肝炎的成本-效果分析

目的 　对复方甘草甜素和还原型谷胱甘肽治疗慢性乙型肝炎进行经济学评价 ,为临床提供最佳用药方案。 方法 　采用随机分组对照进行临床实验观察 ,分析比较复方甘草甜素与还原型谷胱城肽的治疗成本和治疗效果。 结果 　复方甘草素和干扰素α-1b治疗慢性乙型肝炎的总有效率分别为 70 .67%和 66.67% ( P>0 .0 5 ) ;成本 -效果比分别为 46.42和 76.44 ( P<0 .0 5 ) ;经敏感度分析所得的成本 -效果比分别为 3 9.45和64 .97。 结论 　复方甘草甜素与还原型谷胱甘肽均能有效治疗慢性乙型肝炎 ,但复方甘草甜素比还原型谷胱甘肽更经济 ,更符合药物经济学原则。     

慢肝汤联合复方甘草酸苷治疗慢性乙型肝炎的疗效观察

目的:观察慢肝汤联合复方甘草酸苷治疗慢性乙型肝炎的疗效。方法:将46例中度慢性乙型肝炎患者随机均分为治疗组和对照组,治疗组应用自拟慢肝汤治疗6mo,同时应用复方甘草酸苷治疗3mo;对照组应用甘草酸二铵、维生素、复方氨基酸注射液等常规治疗6mo。结果:治疗结束时治疗组肝功能及肝纤维化指标水平均显著好于对照组(P<0.05);治疗结束时治疗组HBV-DNA阴转10例,HBeAg阴转9例,ALT复常/HBV-DNA和HBeAg阴转9例,均显著好于对照组(P<0.05)。结论:慢肝汤联合复方甘草酸苷治疗慢性乙型肝炎有较好的疗效。     

Inhaled insulin for diabetes mellitus.

PURPOSE: Pharmacokinetic and safety data related to the use of inhaled insulin for the management of diabetes mellitus are discussed. The various pulmonary insulin delivery systems under development are also reviewed. SUMMARY: Several pharmaceutical companies are developing pulmonary insulin delivery systems. These products fall into two main groups: solution and drug powder formulations, which are delivered through different patented inhaler systems. Exubera, a rapid-acting insulin in powder form, has been studied extensively in patients with type 1 and type 2 diabetes mellitus. The AERx Insulin Diabetes Management System delivers a liquid form of human insulin. Preliminary data indicate that patients converting from insulin injections to this system showed higher compliance to therapy, demonstrated by improved glycemic control. Other pulmonary insulin delivery systems, including ProMaxx, AIR, Spiros, and Technosphere, are also under investigation. In humans, inhaled regular insulin is more rapidly absorbed than insulin from the subcutaneous injection site. The efficiency of inhaled insulin is lower than that of subcutaneous injection because pulmonary delivery of insulin involves some loss of drug within the inhaler or mouth during inhalation. A concern of many clinicians is the possibility of long-term effects from the intraalveolar deposition of insulin within the lung, since insulin is known to have growth-promoting properties. The long-term safety of these products has not been established. CONCLUSION: Several inhaled insulin products are under development. If these products receive marketing approval, the pulmonary delivery of insulin may offer patients with diabetes an alternative to repeated insulin injections.     

Chronic methamphetamine increases fighting in mice

A propensity for violent behaviors to develop in chronic methamphetamine (METH) abusers has been noted. The idea that increased aggressiveness might result from chronic METH administration was tested in mice after chronic (long-term intermittent, 8 weeks) or single exposures to the drug. A single injection of METH (6 mg/kg) did not augment fighting. In contrast, chronic METH administration significantly increased the number of animals that initiated bite attacks. This regimen also shortened the latency before the first attack. Latency before the first attack was shorter at 20 h after the METH injection than at 15 min after injection. Locomotor activity was not different at 20 h after METH injection, indicating that increased fighting was not secondary to METH-induced hyperactivity. METH-induced increases in fighting were not related to the duration of persistent sniffing after the initial encounter with an intruder since the duration of this behavior was significantly increased at 15 min after METH but not at 20 h post drug. These results indicate that repeated injections of METH can increase fighting behaviors and also alter social interactions in mice. Thus, intermittent administration of METH might be useful as a pharmacological model to study the biochemical and molecular bases of aggressiveness.     

复方甘草酸苷辅助西替利嗪治疗慢性荨麻疹疗效观察

目的观察复方甘草酸苷注射液辅助西替利嗪治疗慢性荨麻疹的疗效。方法80例慢性荨麻疹患者随机均分为对照组和治疗组,前者口服西替利嗪片10mg/d,后者在此基础上静脉滴注复方甘草酸苷注射液40ml/d,均治疗2wk,评价其疗效。结果对照组和治疗组总有效率分别为65.0%、92.5%,2组比较具有显著性差异(P<0.05)。结论复方甘草酸苷可辅助西替利嗪治疗慢性荨麻疹。     

复方甘草酸苷相关横纹肌溶解合并低钾血症

1例37岁男性患者因慢性乙型肝炎病毒感染再活动单独应用复方甘草酸苷注射液60 ml（含甘草酸苷120 mg）静脉滴注。治疗12 d,症状明显改善,改为口服复方甘草酸苷片（含甘草酸苷150 mg,2片/次,3次/d）和水飞蓟素（140 mg,3次/d）。服药2周,患者出现下肢无力,症状逐渐加重。服药25 d,双下肢肌力3级、肌张力减低,肌酸激酶（ CK）8378 U/L,血钾2.2 mmol/L。当日停用复方甘草酸苷片和水飞蓟素,结合腓肠肌活检,诊断为横纹肌溶解合并低钾血症。予氯化钾、还原型谷胱甘肽和螺内酯。治疗10 d,肌力恢复至5级,肌张力正常,CK 459 U/L,血钾5.1mmol/L。3个月后,体格检查示双下肢正常,CK 156 U/L,血钾4.8 mmol/L。     

复方甘草酸苷联合熊去氧胆酸治疗慢性乙型肝炎的疗效观察

目的:观察复方甘草酸苷联合熊去氧胆酸治疗慢性乙型肝炎的疗效。方法:87例慢性乙型肝炎患者均为抗病毒治疗失败或肝功能长期异常者,随机分为治疗组(47例)和对照组(40例),分别给予复方甘草酸苷+熊去氧胆酸和复方甘草酸苷+维生素C治疗,疗程均为8wk。结果:治疗组在肝功能、免疫功能改善方面优于对照组(P<0.05);治疗组与对照组总有效率分别为89.4%、67.5%(P<0.01)。结论:复方甘草酸苷联合熊去氧胆酸治疗抗病毒失败或肝功能长期异常者有效。     

Quantitation of poloxamers in pharmaceutical formulations using size exclusion chromatography and colorimetric methods

Poloxamers have been used as functional excipients in pharmaceutical products. They function as surfactants, emulsifying agents, solubilizing agents, dispersing agents, and in vivo absorbance enhancer. Despite their wide range of applications, limited analytical techniques have been reported in literature for characterizing poloxamers and few are targeted to quantify poloxamer contents in formulations with desired sensitivity and accuracy. In this paper, two distinct analytical methods for quantifying low levels of poloxamers in pharmaceutical formulations have been developed and optimized: a colorimetric method and a size exclusion chromatography method. The colorimetric method is based on the formation of a colored complex between poloxamers and cobalt(II) thiocyanate in aqueous medium, which has a maximum UV absorbance at 624 nm. The feasibility of this method is product specific. In this report, adequate specificity and sensitivity was demonstrated for only one of the several products tested. The size exclusion chromatography (SEC) method utilizes size exclusion columns with THF as mobile phase and refractive index detection. The SEC method provides a limit of quantitation (LOQ) of 0.005 mg/mL (0.0005%, w/w) and at least three orders of magnitudes of linear range. We applied the SEC method to pharmaceutical products containing 0.3–10% poloxamer 188 or poloxamer 407, such as Avapro, Neurontin, Sudafed and other developmental formulations. The results obtained with the SEC method agreed very well with literature and theoretical values with 97–102% recovery. The SEC method was proven to be widely applicable, accurate, precise and simple to use.