The anti-infective action of a new steroid-base combination (fluclorolone acetonide in FAPG base) without conventional antimicrobial substances

Summary

A double-blind trial comparing 0.025% fluclorolone acetonide in FAPG base with 0.1% betamethasone-17-valerate plus 0.5% neomycin has been carried out in 54 patients suffering from skin disease which, in the physician's opinion, required treatment with a topical steroid plus anti-infective agent. Clinical and bacteriological equivalency of the two products has been demonstrated.     

醋酸戈舍瑞林缓释植入剂联合腹腔镜手术治疗子宫内膜异位症效果

目的:探讨醋酸戈舍瑞林缓释植入剂联合腹腔镜手术治疗子宫内膜异位症的临床疗效。方法:选择本院就诊的子宫内膜异位症患者80例,随机分为两组各40例,根据r-AFS分期进行腹腔镜手术,在术后1周内观察组醋酸戈舍瑞林缓释植入剂3.6mg皮下注射,每4周1次,连用6个月;对照组口服孕三烯酮2.5mg,每周2次,连用6个月。比较两组临床疗效,术前和术后6个月测定血清血管内皮生长因子(VEGF)、基质金属蛋白酶-9/组织金属蛋白酶抑制物-1(MMP-9/TIMP-1),评定患者视觉模拟评分法(VAS)和健康生活质量调查问卷(SF-36),随访3年术后不良反应和复发情况。结果:治疗有效率对照组(75.0%)低于观察组(92.5%)(P<0.05)。术后6个月时,对照组和观察组血清VEGF(158.41±56.28 ng/L、119.63±47.13ng/L),MMP-9/TIMP-1(1.35±0.25、1.14±0.23),生理健康评分(64.20±12.81分、78.53±13.23分),心理健康评分(69.14±13.26分、80.35±14.59分),VAS评分(1.21±0.46分、0.84±0.39分)比较均有差异(P<0.05);观察组无不良反应发生,术后3年复发率对照组(27.5%)高于观察组(10.0%)(P<0.05)。结论:醋酸戈舍瑞林缓释植入剂联合腹腔镜手术治疗子宫内膜异位症疗效确切,可降低术后血管侵袭指标及复发率,提高生活质量,安全性高。     

Comparison of serum levels of two sustained- release preparations of lithium carbonate

Summary

Concentrations of lithium in serum were compared during treatment of 18 chronic schizophrenic patients with 2 sustained-release forms of tablet containing lithium carbonate (‘Priadel’ and Lithium'Phasal’). Doses were given once daily at 7pmor8am. ‘Priadel’ gave higher concentrations at 9?pm after dosage at 7?pm, and higher at 12 noon when the drugs were given at 8 am. When the drugs were given at 7?pm mean values between 9 am and 6?pm were similar for the two formulations.

In general, the two preparations were satisfactory sustained-release forms of a lithium salt. ‘Phasal’ might have been slightly less likely to give side-effects than ‘Priadel’, but this disadvantage with the latter drug might be avoided by giving it later at night. The findings supported the view that for once-a-day administration it is better to give sustained-release forms of lithium salts at night rather than in the morning, so that any peaks in serum concentration should be during sleep, but twice-a-day dosage would be preferable.     

Extended‐release antiepileptic drugs: A comparison of pharmacokinetic parameters relative to original immediate‐release formulations

Many antiepileptic drugs (AEDs) have short half‐lives with large fluctuations in peak‐to‐trough plasma concentrations. Consequences of these pharmacokinetic (PK) properties may include adverse events (AEs) and breakthrough seizures, potentially leading to poor adherence. To address these challenges, newer formulations of these AEDs have been developed using unique extended‐release (ER) technologies. These technologies extend the dosing interval such that dosing frequency can be minimized, which may improve patient adherence. Available ER formulations have the potential to minimize the spikes in maximum plasma concentrations (C_max) at steady‐state that often contribute to AEs during treatment with immediate‐release (IR) products. In so doing, tolerability advantages may lead to increased AED effectiveness by improving adherence and allowing higher doses if clinically indicated. Direct PK comparison studies of IR and ER formulations (e.g., carbamazepine, divalproate sodium, lamotrigine, oxcarbazepine, levetiracetam, and phenytoin) have found that dose‐normalized ER formulations may or may not be bioequivalent to their IR counterparts, but most ER formulations have a lower fluctuation index ([C_max–C_min]/C_avg) compared with the IR versions. This results in flatter concentration‐time plots. Not all ER preparations improve the various PK parameters to the same extent, and PK nuances may impact the effectiveness, tolerability, and adherence rates of various ER formulations.     

头孢哌酮钠及其复方制剂的配伍禁忌

目的了解头孢哌酮钠及其复方制剂的配伍禁忌，供临床用药参考，避免其不良反应的发生。方法通过检索2009—2011年期间公开发表的头孢哌酮钠及其复方制剂配伍禁忌文献，进行总结归纳。鳍果头孢哌酮钠及其复方制剂与很多药物配伍试验均存在不同程度的配伍反应。结论头孢哌酮钠及其复方制剂的配伍禁忌较多，联合应用时应该谨慎，促进用药合理有效。     

紫外分光光度法测定阿替洛尔缓释微囊含量

目的：建立以紫外分光光度法测定阿替洛尔缓释微囊含量的方法。方法：将阿替洛尔缓释微囊研磨破碎,转移至容量瓶中,稀释后,在224nm处进行含量测定。结果：阿替洛尔在224nm处有最大吸收,辅料对测定无干扰。标准曲线方程：A=0.0355C+0.0014,线性范围为2.5～20.0μg·ml-1。回收率98.81%～99.36%,精密度和稳定性RSD均在2%以内,符合《中国药典》的要求。     

2004—2019年河南省雷公藤制剂不良反应分析

目的 分析2004—2019年河南省雷公藤制剂不良反应/事件（ADR/ADE）,分析雷公藤制剂不良反应/事件的发生特点,为雷公藤制剂的临床合理应用提供参考依据。方法 收集河南省内2004年1月—2019年5月有关雷公藤制剂不良反应报告203例。回顾性分析此203例患者ADR/ADE的时间、性别、年龄、既往史分布、用药原因及合并用药情况、剂型、累及系统及临床表现、结局。结果 203例发生ADR/ADE的患者中,以2017年比例最高（13.30%）,其次为2018年（10.34%）;季度分布上1～3月发生率最低,年度/季节分布差异有统计学意义（P<0.05）。男、女构成比分别为56.39%、46.31%,以45～64岁年龄层发生率最高（47.29%）,但性别与年龄分布差异无统计学意义。203例患者中,4例既往有过敏史、8例有吸烟史、3例有肾病病史、2例为妊娠期女性、4例饮酒史。片剂剂型比例最高（90.15%）。ADR/ADE发生时间以用药后2～6 h比例最高,其次为用药后6 h～1 d。药物使用时长<1周、1～3周、＞3周的构成比分别为71.43%、17.24%、11.33%。类风湿性关节炎、风湿性关节炎的比例（25.12%、24.14%）最高,其中91.13%为单药治疗,8.87%为联合用药。胃肠损害比例（54.68%）最高,其次为皮肤及其附件损害（10.84%）,用药部位损害、免疫功能紊乱和感染、内分泌紊乱罕见,构成比分别为0.49%;在临床表现上,以恶心、呕吐出现频次最高。203例患者中181份报告类型为一般,22例为严重;其中结局为痊愈、好转患者构成比分别为58.13%、39.41%,仅1例未好转,构成比为0.49%;未见ADR/ADE所致的死亡事件。结论 医务人员应重视雷公藤制剂的不良反应观察,了解雷公藤制剂所致的ADR/ADE的临床规律及特点,严格遵循说明书适应症及剂量操作,最大限度降低雷公藤制剂ADR/ADE相关风险。     

喹硫平与丙戊酸钠缓释片在双相情感障碍躁狂发作治疗中的疗效比较

目的 对比分析喹硫平与丙戊酸钠缓释片在双相情感障碍躁狂发作治疗中的临床疗效。方法 52例双相情感障碍躁狂发作患者,采用随机数字表法分为A组和B组,每组26例。A组患者采用喹硫平治疗, B组患者采用丙戊酸钠缓释片治疗。比较两组患者临床疗效及贝克-拉范森躁狂量表(BRMS)评分降低1/2时间、治疗前后炎症因子水平、不良反应发生情况。结果 A组患者总有效率为96.15%,与B组的92.31%比较差异无统计学意义(χ^2=0.354, P=0.552>0.05)。A组患者BRMS评分降低1/2时间为(2.32±0.57)周,短于B组的(3.87±0.67)周,差异具有统计学意义(t=8.985, P=0.000<0.05)。治疗前,两组患者白细胞介素-1(IL-1)、白细胞介素-10(IL-10)、肿瘤坏死因子-α(TNF-α)水平比较差异无统计学意义(P>0.05);治疗后,两组患者IL-1、TNF-α水平低于本组治疗前, IL-10水平高于本组治疗前,且A组患者IL-1、TNF-α水平低于B组, IL-10水平高于B组,差异具有统计学意义(P<0.05)。A组患者不良反应发生率为3.85%,低于B组的30.77%,差异具有统计学意义(χ^2=6.584, P=0.010<0.05)。结论 喹硫平与丙戊酸钠缓释片治疗双相情感障碍躁狂发作疗效相当,但喹硫平的起效时间更快,能够显著改善炎症因子水平,且不良反应更少,这对于控制病情发展具有更高的临床应用价值。