仿制药一致性评价国内外研究进展

在我国药品市场中仿制药占据绝大部分市场份额,然而仿制药的质量参差不齐,严重影响了广大患者的用药安全,因此,如何提升仿制药的质量在政府、学术界以及整个医药行业中一直备受关注。本文整理了国内外学者们针对仿制药一致性评价问题的研究,从我国仿制药的发展现状,仿制药一致性评价原则与方法,仿制药一致性评价对医药行业的影响,完善仿制药一致性评价体系的对策等角度细致展开,以期为开展仿制药一致性评价研究提供参考.     

不同镇痛方式用于股骨颈骨折老年患者硬膜外麻醉穿刺时的作用

目的比较不同镇痛方式用于老年股骨颈骨折患者硬膜外麻醉穿刺时的作用。方法选择行人工股骨头置换的股骨颈骨折患者90例,男35例,女55例,年龄65~90岁,体重48~78kg,ASAⅡ或Ⅲ级。按随机数字表法分为三组:股神经阻滞组(FNB组)、髂筋膜腔隙阻滞组(FIC组)和静脉注射芬太尼镇痛组(IV组),每组30例。硬膜外穿刺前30min,FNB组在神经刺激仪引导下行股神经阻滞,FIC组在超声引导下行髂筋膜腔隙阻滞,两组按患者体重给予相应容量的罗哌卡因(50kg,20ml;50~70kg,25ml;70kg,30ml);IV组于穿刺前3 min时静脉注射芬太尼0.5μg/kg。三组穿刺期间VAS评分≥4分时,静脉注射芬太尼0.25μg/kg,VAS评分4分后摆放体位。采取患侧在上、L1~2硬膜外穿刺,硬膜外导管置入完成后改平卧位。记录入室后(T0)、硬膜外麻醉前(T1,FNB组和FIC组阻滞30min后,IV组静脉注射首剂芬太尼3min后)、硬膜外穿刺前变换体位时(患侧在上,T2)、麻醉穿刺成功改为平卧位即刻(T3)和改为平卧位后3 min(T4)的VAS评分;记录硬膜外穿刺时间、穿刺期间芬太尼用量和心血管事件、低氧血症的发生情况。结果与IV组比较,T1、T2时FNB组和FIC组芬太尼用量明显减少[(38±9)μg、(38±11)μg vs.(110±18)μg],硬膜外穿刺时间明显缩短[(9±4)min、(9±4)min vs.(17±5)min],心血管事件和低氧血症发生率明显降低(10%、7%vs.37%)(P0.05或0.01);FNB组和FIC组上述各指标差异无统计学意义。结论股神经阻滞和髂筋膜腔隙阻滞对老年股骨颈骨折患者硬膜外麻醉穿刺期间有明显的芬太尼节俭效应,并能减少心血管事件和低氧血症的发生。     

秘剂四联疗法与序贯疗法治疗幽门螺杆菌感染的Meta分析

目的 系统评价10天秘剂四联疗法和10天序贯疗法治疗中国患者幽门螺旋杆菌(Hp)感染的疗效和安全性。方法 利用中英文数据库,查找使用两种方案治疗中国患者Hp感染患者的随机对照实验(RCT)。根据纳入排除标准选取研究,提取资料,并使用Jadad量表评价研究质量,采用STATA12统计软件进行Meta分析。结果 纳入14项RCT研究,1518名患者,秘剂四联疗法和序贯疗法的Hp清除率按意向分析(ITT)分别为82.75%和84.13 %(RR = 0.99(0.95,1.04),P=0.658),两种疗法Hp根除率方面的差异无统计学意义。秘剂四联疗法与序贯疗法的不良反应发生率分别是14.19%和12.45 %(RR = 1.30(0.99,1.69),P=0.056),不良反应发生率差异也无统计学意义。结论 当前证据表明,10天铋剂四联疗法和10天序贯疗法治疗中国患者Hp感染的疗效和安全性相当,可以作为中国患者的一线治疗方案。     

右美托咪啶对舒芬太尼抑制甲状腺切除术患者切皮时体动反应半数有效效应室靶浓度的影响

目的 评价右美托咪啶对舒芬太尼抑制甲状腺切除术患者体动反应的半数有效效应室靶浓度(EC50)的影响.方法 择期行甲状腺双叶次全切除术患者,性别不限,ASA分级Ⅰ或Ⅱ级,年龄20～64岁,体重指数20～2.5 kg/m2,采用随机数字表法,将其随机分为2组,D组经10 min静脉输注右美托咪啶0.6 μg/kg,C组给予等容量生理盐水,停止给药后5 min时开始靶控输注异丙酚,血浆靶浓度为3.0 μg/ml,输注10 min时,2组开始靶控输注舒芬太尼,第1例患者的效应室靶浓度为0.20ng/ml,输注舒芬太尼3 min时置入喉罩,保留自主呼吸,待舒芬太尼达到目标靶浓度后,开始手术.根据切皮时是否发生体动反应确定下一例患者舒芬太尼的靶浓度,相邻靶浓度比值为1.2.采用序贯法计算舒芬太尼抑制切皮时体动反应的EC50及其95%可信区间(95%CI).结果 C组和D组样本数分别为19和20,舒芬太尼抑制切皮时体动反应的EC50分别为0.1454 ng/ml(95%CI 0.1339～0.1580 ng/ml)和0.1148 ng/ml(95%CI 0.1055～0.1249 ng/ml),D组EC50低于C组(P＜0.05).结论 术前静脉注射右美托咪啶0.6 μg/kg可降低舒芬太尼抑制甲状腺切除术患者切皮时体动反应的EC50.

Abstract：

Objective To investigate the effect of dexmedetomidine on median effective target effect-site concentration ( EC50) of sufentanil inhibiting body movement evoked by skin incision in patients undergoing bilateral subtotal thyroidectomy. Methods Thirty-nine ASA I or II patients of both sexes aged 20-64 yr with a body mass index of 20-25 kg/m2 undergoing bilateral subtotal thyroidectomy were randomly divided into 2 groups: control group (group C) and dexmedetomidine group (group D). The patients were premedicated with intramuscular phenobarbital 0.1 g and scopolamine 0.3 mg. In group D dexmedetomidine 0.6 μg/kg was injected iv over 10 min at S min before induction of anesthesia. Anesthesia was induced with target-controlled infusion (TCI) of propofol and sufentanil. The target plasma concentration of propofol was set at 3.0 μg/ml which was maintained until the end of operation. TCI of sufentanil was started at 10 min after initiation of propofol TCI. The initial target effect-site concentration was set at 0.20 ng/ml and decreased/increased by 20% in the next patient according to whether the patient's body moved or not within 1 min after skin incision. Laryngeal mask airway was inserted at 3 min after initiation of sufentanil TCI. Spontaneous breathing was maintained. Skin incision was made at 10 min after initiation of sufentanil TCI. The EC50 and 95% confidence interval (CI) of sufentanil inhibiting skin incision-evoked body movement were calculated with sequential method. Results EC50, of sufentanil was 0.1148 ng/ml (95% CI 0.1055-0.1249 ng/ml) in group D and 0.1454 ng/ml (95% CI 0.1339-0.1580 ng/ml) in group C, and was significantly lower in group D than in group C. Conclusion Dexmedetomidine 0.6 μg/kg infused iv before operation can reduce the EC50 of sufentanil inhibiting body movement evoked by skin incision in patients undergoing bilateral subtotal thyroidectomy.