Clinical Effectiveness of Erlova in EGFR-Mutated Non-Small Cell Lung Cancer: An Affordable Price with Clinical Benefit

Background: Thyrosin kinase inhibitors (TKIs) is approved for the first line treatment of non-small cell lung cancer (NSCLC) patients with  epidermal growth factor receptor (EGFR) mutation. This study performed to assess clinical effectiveness and safety of Erlova (generic form of Erlotinib). Methods: Somatic mutations of EGFR gene were studied in tumor tissue by polymerase chain reaction (PCR) and bi-directional sequencing in 513 chemonaive and histologically verified lung adenocarcinoma Iranian patients. Patients  with EGFR mutation received Erlova at 150 mg/day  as first line treatment. Primary endpoint was progression free survival (PFS). Results: About 21% (n=109) cases had EGFR mutation. Most EGFR mutations were  occurred at exon 19. Among them, sixty nine patients treated with Erlova. Median PFS was 11.4 months and objective response rate (ORR) was about  88%. Most frequent treatment related adverse events was  skin rash. Conclusion: Our findings showed Erlova had remarkable effectiveness. In  mutation-positive patients with EGFR, Erlova can be used  safely instead of  other tyrosine-kinase inhibitors.     

健脾生血片治疗慢性心力衰竭伴贫血的临床效果

目的:探索健脾生血片治疗慢性心力衰竭伴贫血的疗效、安全性和作用机制。方法:选取2016年5月至2017年2月同济医院收治的慢性心力衰竭贫血患者144例,按照随机数字表法分为观察组和对照组,每组72例。观察组给予健脾生血片治疗,3片/次,3次/d,疗程3个月;对照组给予生血宝合剂治疗,15 m L/次,3次/d,3个月为1个疗程。比较2组患者治疗前与治疗后血红蛋白、红细胞计数、网织红细胞、血清铁、转铁蛋白饱和度、血清铁蛋白、血清铁调素(Hepcidin)、血清IL-1β、血清肿瘤坏死因子-α(TNF-α)、血清C反应蛋白(CRP)、左室射血分数(LVEF)、6 min步行距离、明尼苏达心力衰竭生命质量量表(MLHFQ)和不良事件。并随访2组心血管事件次数,住院次数与全因死亡率。结果:观察组72例患者完成了前3个月的治疗,随访期间脱失2例;对照组治疗期间1例患者退出研究,随访期间脱失4例。2组一般资料比较,差异无统计学意义(P 0. 05),具有可比性。观察组贫血有效率98. 6%,对照组有效率11. 3%,差异有统计学意义(P0. 05)。治疗后观察组红细胞计数和网织红细胞、均显著高于对照组(P 0. 05)。观察组血清铁、转铁蛋白饱和度水平均高于对照组,差异有统计学意义(P 0. 05),但血清铁调素水平显著低于对照组,差异有统计学意义(P 0. 05),血清铁蛋白水平2组差异无统计学意义(P 0. 05)。观察组IL-1β、血清TNF-α、血清CRP均显著低于对照组,差异有统计学意义(P 0. 05)。观察组LVEF、6 min步行距离、明尼苏达心力衰竭生命质量量表(MLHFQ)均显著高于对照组,差异有统计学意义(P 0. 05)。2组不良事件总发生率比较,差异无统计学意义(P 0. 05),但对照组4例患者出现血清肌酐、尿素氮水平异常,发生率高于观察组,差异有统计学意义(P 0. 05)。经1年随访,观察组心血管事件人均发生次数显著少于对照组(P 0. 05),但2组住院次数和全因死亡率比较,差异无统计学意义(P 0. 05)。结论:健脾生血片可有效治疗心力衰竭伴贫血,减少心血管发生次数,并且安全性良好,其作用机制与提供准确足量铁元素、抑制铁调素表达,抑制慢性炎性反应有关。     

金水宝片联合依诺肝素对维持性血液透析患者血脂代谢的影响

目的：探究金水宝片联合依诺肝素对维持性血液透析患者血脂代谢的影响。方法：选取2018年12月至2019年3月马鞍山十七冶医院血液净化中心进行透析的患者154例作为研究对象，根据用药不同分为对照组和观察组,每组77例。对照组常规应用依诺肝素抗凝，观察组在对照组抗凝基础上加用金水宝片，各组均干预3个月，比较2组患者血脂变化及持续血液透析并发症发生情况。结果：治疗后，观察组患者三酰甘油、总胆固醇及低密度脂蛋白胆固醇水平下降，高密度脂蛋白胆固醇升高，与治疗前比较差异均有统计学意义（P<0.05），与对照组治疗后比较，差异有统计学意义（P<0.05）；观察组总并发症发生率明显低于对照组，2组比较差异有统计学意义（P<0.05）；2组患者维持性血液透析不良反应发生率均较低，组间比较差异无统计学意义（P>0.05）。结论：金水宝片联合依诺肝素有助于改善维持性血液透析患者血脂代谢水平，降低维持性血液透析相关并发症，值得临床推广应用。     

静脉注射美托洛尔、地尔硫卓治疗快速心房纤颤的临床疗效观察

目的:观察美托洛尔注射液和地尔硫卓注射液治疗快速房颤的有效性和安全性。方法:105例符合入选标准的快速房颤患者被随机分为3组,美托洛尔组39例:5mg美托洛尔缓慢静脉注射,观察5min,如无效重复一次,连续用药3次,总量15mg;地尔硫卓35例:地尔硫卓15mg稀释后静脉注射,观察15min,如无效重复1次,继以15mg/h维持。西地兰组31例:西地兰0.2～0.4mg稀释后静脉注射,观察10min,如无效追加0.2～0.4mg,连续用药3次;总量0.6～1.0mg。记录用药前、后心室率和血压变化,并比较在各观察时间点上的有效率。结果:与西地兰相比,美托洛尔和地尔硫卓起效更快[(36.9±11.6)min∶(8.2±4.5)min∶(9.1±3.8)min,P<0.05],心室率下降幅度更明显(25.22%∶33.32%∶37.50%,P<0.05),治疗有效率更高(71.0%∶89.7%∶91.4%,P<0.05)。而美托洛尔组和地尔硫卓组之间无显著性差异。三组均无严重不良反应发生。结论:美托洛尔注射液和地尔硫卓注射液均能快速、安全、有效控制快速房颤的心室率。     

降糖益肾方合二甲双瓜治疗2型糖尿病50例

目的:观察中药降糖益肾方合二甲双胍片治疗2型糖尿病的临床疗效.方法:治疗组50例口服降糖益肾方、二甲双胍片.对照组45例口服二甲双胍片.两组均连续用药3个月,监测两组治疗前后空腹及餐后2h血糖(FPG、PG2h)、空腹胰岛素(Fins)血脂(TC、TG)及血液流变学指标变化,并计算胰岛素敏感指数(IAI).结果:治疗组临床症状改善、FPG、PG2h、Fins、TC、TG以及血浆粘比度、红细胞压积、纤维蛋白原与对照组比较明显降低,IAI明显提高(P＜0.01、P＜0.05).结论:中药降糖益肾方合二甲双胍片治疗2型糖尿病疗效确切.     

In vitro/in vivo correlation of prolonged release dosage forms containing diltiazem HCl

Six preparations were considered: three multiple unit dosage forms (micropellets in capsules) (D, E and G) and one matrix tablet (B) were experimental prolonged release formulations, two non-disintegrating tablets (A and C) were commercial products. The in vitro dissolution behaviour of the differing formulations was investigated using the USP XXII paddle apparatus. The in vivo study was effected on a panel of 12 healthy volunteers. The two commercial tablets (A and C) showed mean dissolution time (MDT) of 1.34 and 1.44 h and t_d of 91 and 92 min, respectively; for prolonged release formulations (B, E, D, and G) MDT ranged between 2.28 and 4.23 h and t_d between 149 and 291 min. The mean residence time (MRT) was 8.68 and 6.47 h for tablets A and C, respectively; it ranged between 9.62 and 10.24 h for the multiple unit formulations E, D, and G and was 11.27 h for matrix B. Formulation B also showed the higher apparent elimination half-life t_1/2 (7.12 h), while apparent t_1/2 for all the other formulations were very similar, ranging between 5.04 and 5.28 h. High variability between the various formulations was found for C_max and AUC values, and no relationships could be established with the type of formulation. An in vitro/in vivo correlation was found for all the formulations examined on the basis of analogous parameters (MDT and MRT); (r = 0.83, p <0.05). In a few cases the Wagner-Nelson deconvolution method was applied to individual plasma level versus time curves and the corresponding absorption curves were obtained. In these cases the in vitro/in vivo correlation was tested on the basis of the comparison of the in vivo absorption curves with the in vitro dissolution profiles. This was accomplished using the ‘Levy's plot’ (per cent released versus per cent absorbed) approach and provided further support for the correlation found.     

Elevation of carbamazepine plasma levels by diltiazem in rabbits: a potentially important drug interaction

The effect of diltiazem on the plasma level of carbamazepine (CBZ) was investigated in rabbits. The animals were given either CBZ alone or in combination with diltiazem and plasma samples were collected at different time intervals. The concentration of CBZ was detected using an HPLC method. Diltiazem significantly increased the area under the curve (AUC), the maximum plasma concentration (Cmax), and the elimination half-life (t1/2) of CBZ (p less than 0.05). These results suggest that a potentially harmful drug-drug interaction may occur if CBZ and diltiazem are administered concurrently.     

地尔硫卓联合地高辛治疗心力衰竭并慢性快速房颤分析

目的观察地尔硫卓联合小剂量地高辛对心力衰竭并慢性快速房颤患者血压、心室率和心功能的影响。方法 :心功能Ⅱ～Ⅲ级慢性房颤患者 10 6例 ,随机分为二组 ,对照组 5 0例 ,单用地高辛 ,治疗组 5 6例 ,地尔硫卓与地高辛联用 ,其余治疗二组相同 ,7～ 10d为一疗程 ,观察治疗前后血压、心率、左室射血分数 (LVEF)、心输出量 (CO)。结果 :治疗组较对照组心室率明显下降 ,控制满意 ,血压、LVEF及CO变化二组相似。结论 :地尔硫卓联合小剂量地高辛治疗心衰并慢性快速房颤患者心室率较单用地高辛效果更好 ,且较为安全。     

不同血管保存液对人桡动脉血管移植物的抗痉挛作用

目的 研究不同的血管保存液对人离体桡动脉痉挛的缓解与预防能力。方法 非体外循环冠状动脉旁路手术(OPCAB)19例患者,应用“无接触(No Touch)”外科技术获取自体桡动脉,保留未处理的远段0.8～1.5cm。应用血管环灌流技术(Organ Bath)比较不同保存液的抗痉挛作用和预防痉挛作用。结果 血管环灌流实验显示,在对痉挛状态桡动脉的舒张能力方面,PS、VG、DG、NG溶液均可以在10min内100％舒张血管,舒张曲线显示舒张能力依次为VG、DG、NG、PS,但差异无显著性(P>0.05),在预先浸泡处理桡动脉45～60min后,除对照组(Ringer's Solution)外,所有血管保存液均可以有效地预防离体桡动脉的痉挛,各组间差异无显著性(P>0.05)。结论 罂粟碱溶液、VG、DG、NG溶液均有较好的抗血管痉挛作用,单从抗血管痉挛角度考虑可以用作CABG手术中桡动脉的准备液。     

妇科恶性肿瘤术后骨质疏松症的防治

为探讨妇科恶性肿瘤术后骨质疏松症的预防措施,采用补充紫竹爱维和乐力胶囊来预防骨质疏松的发生,分别与未服药的妇科恶性肿瘤及良性肿瘤术后作对照,并对其对骨代谢指标血清骨性碱性磷酸酶(BALP)及血清抗酒石酸酸性磷酸酶(TRAP)的影响进行了临床观察.结果发现恶性肿瘤术后较良性肿瘤术后患者的BALP降低,TRAP增高,服用紫竹爱维与乐力胶囊的患者TRAP均低于未服药的恶性肿瘤术后患者,P＜0.05,均有显著性差异.表明妇科恶性肿瘤术后患者较良性肿瘤更易患骨质疏松症,服用紫竹爱维与乐力胶囊均能有效防治骨质疏松症,前者效果更佳,但应掌握性激素补充治疗(HRT)的应用指征.