Subcutaneous injection pain with C.E.R.A., a continuous erythropoietin receptor activator,compared with darbepoetin alfa

ABSTRACT

Objective: This study assessed injection site pain following subcutaneous (SC) administration with a continuous erythropoietin receptor activator (C.E.R.A.), compared with darbepoetin alfa in healthy adults.

Methods: In a randomized, placebo-controlled, single-centre, single-blind, three-way crossover study, subjects received one of six treatment sequences (ABC/ACB/BAC/BCA/CBA/CAB) involving SC injection of (A) C.E.R.A. 50?μg, (B) darbepoetin alfa 50?μg, or (C) placebo on days 1, 29, and 57. An initial pilot phase (n = 12) was used to determine the sample size for the confirmatory phase (n = 72), and data were combined for the final analysis (n = 84).

Main outcome measures: The primary endpoint was pain on the 100?mm visual analog scale (VAS) immediately after dosing. Secondary endpoints included VAS at 1 hour after dosing and pain on the six-point verbal rating scale (VRS) immediately and at 1 hour after dosing.

Results: C.E.R.A. was associated with significantly less pain immediately after SC injection compared with darbepoetin alfa: least squares mean VAS 21.5 (95% confidence interval [CI]: 17.5, 25.5) versus 33.4 (95% CI: 28.4, 38.4) (?p < 0.0001). Incidence of pain on the VRS was lower with C.E.R.A. compared with darbepoetin alfa immediately after dosing (?p < 0.0001). One hour after administration, most subjects had no VRS pain. A study limitation is the small sample size and the findings need to be confirmed in a large trial of chronic kidney disease patients.

Conclusions: SC injection with C.E.R.A. is significantly less painful than SC darbepoetin alfa in healthy adults. Treatment of anemia in chronic kidney disease with SC injection of C.E.R.A. may provide a lower pain burden compared with darbepoetin alfa.     

炎琥宁联合更昔洛韦治疗小儿轮状病毒感染性腹泻的临床疗效

目的：观察炎琥宁联合更昔洛韦治疗小儿轮状病毒感染性腹泻的疗效。方法选取2010年5月-2013年12月延安市人民医院确诊的小儿轮状病毒感染性腹泻患儿235例，随机分为治疗组（120例）和对照组（115例）。对照组在常规治疗基础上静脉滴注更昔洛韦注射液，5 mg/（kg·d）加入5%葡萄糖注射液150 mL，15滴/min，1次/d。治疗组静脉滴注炎琥宁注射液，10 mg/（kg·d）加入250 mL葡萄糖注射液中，1次/d；其他治疗同对照组。两组患者均持续治疗5 d。治疗结束后比较两组患儿临床治疗总有效率、症状消失时间、人轮状病毒抗原（RV-Ag）转阴率及不良反应情况。结果治疗后，治疗组和对照组的总有效率分别为91.7%、71.3%，两组比较差异有统计学意义（P＜0.05）。治疗组体温恢复时间、呕吐消失时间、腹泻改善时间、住院时间均明显短于对照组，两组比较差异有统计学意义（P＜0.05）。治疗3 d后，治疗组患儿大便RV-Ag转阴率为85.8%，对照组转阴率为71.3%，两组比较差异有统计学意义（P＜0.05）；治疗5 d后，治疗组转阴率为100.0%，对照组转阴率为91.3%，两组比较差异有统计学意义（P＜0.05）。两组均未发生严重不良反应。结论炎琥宁联合更昔洛韦治疗小儿轮状病毒感染性腹泻有较好的临床疗效，不良反应轻微，值得临床推广应用。     

“I felt like a superhero”: The experience of responding to drug overdose among individuals trained in overdose prevention

BackgroundOverdose prevention programs (OPPs) train people who inject drugs and other community members to prevent, recognise and respond to opioid overdose. However, little is known about the experience of taking up the role of an “overdose responder” for the participants.MethodsWe present findings from qualitative interviews with 30 participants from two OPPs in Los Angeles, CA, USA from 2010 to 2011 who had responded to at least one overdose since being trained in overdose prevention and response.ResultsBeing trained by an OPP and responding to overdoses had both positive and negative effects for trained “responders”. Positive effects include an increased sense of control and confidence, feelings of heroism and pride, and a recognition and appreciation of one's expertise. Negative effects include a sense of burden, regret, fear, and anger, which sometimes led to cutting social ties, but might also be mitigated by the increased empowerment associated with the positive effects.ConclusionFindings suggest that becoming an overdose responder can involve taking up a new social role that has positive effects, but also confers some stress that may require additional support. OPPs should provide flexible opportunities for social support to individuals making the transition to this new and critical social role. Equipping individuals with the skills, technology, and support they need to respond to drug overdose has the potential to confer both individual and community-wide benefits.     

A型肉毒素内括约肌侧方注射+病灶扇形小切口切扩引流术治疗Ⅱ、Ⅲ期肛裂的临床研究

目的评价A型肉毒素内括约肌侧方注射+病灶扇形小切口切扩引流术治疗Ⅱ、Ⅲ期肛裂的安全性和有效性,探索其手术操作步骤及要点,介绍一种治疗肛裂的新手术方式。方法采用随机、平行、对照的临床试验方法,将纳入病例随机分为试验组和对照组,试验组行A型肉毒素内括约肌侧方注射+病灶扇形小切口切扩引流术,对照组行肛裂切除扩创术加部分内括约肌侧方切断术。将2组安全性指标(包括肛门狭窄、肛门失禁、急性尿潴留、术后疼痛的发生及直肠肛管测压结果)和有效性指标(包括痊愈率、手术时间、切口创面愈合时间、切口愈合分级、切口愈合后瘢痕面积大小)进行比较。结果 2组均无肛门狭窄和急性尿潴留发生;对照组肛门失禁评分高于试验组,但差异无统计学意义(P>0.05)。试验组术后(术后24 h、术后第1次排便及术后1周)疼痛评分明显低于对照组(P<0.01)。术前、术后直肠肛管测压结果 2组间比较差异无统计学意义(P>0.05)。试验组痊愈率高于对照组(P<0.05),手术时间及切口创面愈合时间均明显短于对照组(P<0.01),切口愈合优于对照组(P<0.05),切口愈合后瘢痕面积小于对照组(P<0.01)。结论 A型肉毒素内括约肌侧方注射+病灶扇形小切口切扩引流术具有治愈率高、切口愈合时间短、切口愈合后瘢痕面积小、操作快捷、手术微创化等优点;且在肛门外形和功能保护方面优于对照组,本术式具有较好的临床疗效和安全性。     

Heparin-Induced Thrombocytopenia and Vascular Surgery

Heparin-induced thrombocytopenia (HIT) is of special interest to vascular surgeons as heparin is the predominant anticoagulant used before, during, and after vascular surgery. Further, the prothrombotic nature of this antibody-mediated disorder leads to a high frequency of limb ischemia due to large arterial occlusion by platelet-rich (“white”) clots or because of extensive venous thrombosis involving large veins and small venules. This latter syndrome has been associated with coumarin anticoagulation of HIT-associated deep-vein thrombosis (coumarin-induced venous limb gangrene). Non-heparin anticoagulants, such as the direct thrombin inhibitors (lepirudin, argatroban), may be needed for intraoperative management of a patient with suspected acute HIT who requires vascular surgery. The transience of HIT antibodies provides a rationale for intraoperative use of heparin in a patient who has recovered from HIT and in whom HIT antibodies are no longer detectable.     

伤科接骨片联合双氯芬酸钠治疗闭合性足踝部骨折早期肿胀的疗效观察

目的探讨伤科接骨片联合双氯芬酸钠注射液治疗闭合性足踝部骨折早期肿胀的临床疗效。方法选取2016年12月—2017年12月天全县中医医院收治的100例闭合性足踝部骨折患者,按随机数字法分为对照组和治疗组,每组各50例。对照组患者肌肉注射双氯芬酸钠注射液,50 mg/次,2～3次/d。治疗组在对照组治疗的基础上以温开水或温黄酒送服伤科接骨片,4片/次,3次/d。两组患者均连续治疗4d。观察两组的临床疗效,比较两组的临床症状改善情况和视觉模拟评分法(VAS)评分。结果治疗后,对照组和治疗组的总有效率分别为82.00%、90.00%,两组比较差异具有统计学意义(P0.05)。治疗后,治疗组踝关节背伸、踝关节屈曲均明显大于对照组,消肿止痛时间、住院时间均明显短于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组患者VAS评分均显著降低,同组治疗前后比较差异具有统计学意义(P0.05);且治疗后治疗组患者VAS评分均明显低于对照组,两组比较差异具有统计学意义(P0.05)。结论伤科接骨片联合双氯芬酸钠注射液治疗闭合性足踝部骨折早期肿胀具有较好的临床疗效,可改善临床症状,缓解疼痛,具有一定的临床推广应用价值。     

灯盏细辛注射液联合丁苯酞治疗急性脑梗死的临床研究

目的探讨灯盏细辛注射液联合丁苯酞氯化钠注射液治疗急性脑梗死的临床疗效。方法选取2017年3月—2018年11月洛阳市第三人民医院收治的90例急性脑梗死患者为研究对象,按照随机数字表法将患者分为对照组和治疗组,每组各45例。对照组静脉滴注丁苯酞氯化钠注射液,25 mg/次,2次/d。治疗组在对照组治疗的基础上静脉滴注灯盏细辛注射液,30 mL加入到250 mL生理盐水中充分稀释,30 mL/次,1次/d。两组患者均连续治疗14 d。观察两组患者的临床疗效,同时比较两组治疗前后的神经功能缺损评分(NIHSS)、日常生活活动能力评定量表(ADL)评分和血管内皮功能指标。结果治疗后,对照组和治疗组的总有效率分别为75.56%、91.11%,两组比较差异具有统计学意义(P0.05)。治疗后,两组NIHSS评分显著降低,ADL评分显著升高,同组治疗前后比较差异具有统计学意义(P0.05);治疗后,治疗组NIHSS评分显著低于对照组,ADL评分显著高于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组的内皮素-1(ET-1)、血管生成素(Ang-1)、血管内皮生长因子(VEGF)水平明显降低,一氧化氮(NO)明显升高,同组治疗前后比较差异具有统计学意义(P0.05);治疗后,治疗组血管内皮功能指标水平显著优于对照组,两组比较差异具有统计学意义(P0.05)。结论灯盏细辛注射液联合丁苯酞氯化钠注射液治疗急性脑梗死具有较好的临床疗效,能改善患者的神经功能和血管内皮功能指标,具有一定的临床推广应用价值。     

加味四妙勇安汤联合前列地尔注射液治疗下肢动脉闭塞90例临床研究

目的:观察加味四妙勇安汤联合前列地尔注射液治疗下肢动脉闭塞疗效。方法:将90例下肢动脉闭塞症患者随机分为治疗组和对照组,各45例。治疗组给予加味四妙勇安汤联合前列地尔注射液治疗,加味四妙勇安汤每日1剂,水煎服,连用3周;对照组给予前列地尔注射液治疗。其它情况处理,两组同样对待。前列地尔注射液2 m L+生理盐水10 m L缓慢静注,连续治疗两周为1个疗程,每20天1个疗程,共治疗4个疗程,其他治疗两组相同。观察两组患者治疗结束后临床疗效、血浆血脂及两组病人治疗前后症状变化。结果:治疗组患者总有效率为97.8%,高于对照组的88.9%,比较两组患者的总有效率,经检验后得出差异有统计学意义(χ2=4.94,P=0.026)。两组患者治疗结束后的总胆固醇、低密度脂蛋白均较治疗前有所降低,而高密度脂蛋白较治疗前则有所升高,与对照组相比差异具有统计学意义(P<0.05)。两组患者的ABI值也较治疗前有所升高,但治疗组ABI升高值明显大于对照组,差异具有统计学意义(P<0.03)。两组患者症状体征积分比较,差异具有统计学意义(P<0.001)。结论:加味四妙勇安汤联合前列地尔注射液治疗下肢动脉闭塞症临床疗效肯定,可能通过降低患者的血浆血脂而起作用。