Ease of use of two autoinjectors in patients with multiple sclerosis treated with interferon beta-1a subcutaneously three times weekly: results of the randomized,crossover REDEFINE study

Background: For interferon beta-1a subcutaneously three times weekly (IFN β-1a SC tiw), administration options include manually injected prefilled syringes; a preassembled, single-use autoinjector; and a reusable autoinjector. This study evaluated patient-perceived ease of use of two injection devices.

Research design and methods: REDEFINE, a Phase IV, multicenter crossover study, randomized patients with multiple sclerosis and ≥5 weeks’ IFN β-1a 44 μg SC tiw use to 4 weeks using a single-use autoinjector, then 4 weeks using a reusable autoinjector, or vice versa. The primary endpoint was the proportion rating each ‘easy’ or ‘very easy’, with/without regard to previous device experience.

Results: Of 97 randomized patients, 29 had most recent experience with manual injection; 23 with single-use autoinjector; and 45 with reusable autoinjector. 68.4% found using the single-use autoinjector very easy or easy, versus 77.9% for the reusable device (difference ?9.5%; p = 0.200). 40.0% versus 29.5% found the respective devices very easy (difference 10.5%; p = 0.203).

Conclusions: Most patients found both autoinjectors easy or very easy to use. Having two viable options may help accommodate patient preferences. Ease of administration and patient satisfaction relates to adherence; satisfied patients may more likely be adherent.

Trial registration: The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT02019550).     

ICSI联合IVM技术在卵巢低反应高龄患者中的应用

目的：探讨胞浆内单精子注射（ICSI）联合未成熟卵母细胞体外成熟（IVM）技术在卵巢低反应高龄患者中的应用价值。方法：回顾性分析2016年1月—2018年9月于郑州大学第一附属医院生殖医学中心行ICSI助孕治疗81个周期，年龄≥35岁，获卵数≤3个，且卵母细胞均未成熟。按促排卵方案分为微刺激方案组（n=37）和拮抗剂方案组（n=44），统计2组患者基础情况、实验室结果及妊娠结局。结果：①2组患者年龄、不孕时间、基础内分泌、基础窦卵泡数及抗苗勒管激素（AMH）比较，差异均无统计学意义（P＞0.05）；②拮抗剂方案组Gn总量较微刺激方案组高，差异有统计学意义（P＜0.05）；③微刺激方案组与拮抗剂方案组体外培养成熟率、2PN率、卵裂率、可利用胚胎率及优胚率比较差异均无统计学意义（P＞0.05）；④微刺激方案组与拮抗剂方案组的胚胎存活率、种植率和临床妊娠率比较差异无统计学意义（P＞0.05）。结论：对于卵巢低反应的高龄患者行ICSI联合IVM培养有利于提高卵母细胞成熟率及胚胎利用率，增加妊娠机会，微刺激方案Gn用量少对卵巢低反应患者是经济有效的选择。     

Ultrasound-guided facet joint injection to treat a spinal cyst

Lumbar spinal cysts often present with backache and may be accompanied by lower extremity weakness as well as radiation pain if root compression occurs. The treatment regimens include anti-inflammatory drugs, physical therapy, procedures guided by fluoroscopy or computed tomography, and surgery. We report the case of a patient with a symptomatic lumbar spinal cyst at the L4–L5 facet joint. The symptoms immediately remitted after ultrasound-guided steroid–lidocaine injection into the L4–L5 facet joint. Magnetic resonance imaging follow up 4 months after injection showed complete resolution of the cyst.     

奥沙利铂脱敏治疗及皮试的探索性研究

目的:探讨运用抗过敏药物预处理、奥沙利铂减慢速率输注或脱敏治疗进行奥沙利铂再化疗的可能性。尝试对奥沙利铂过敏的患者进行3个浓度梯度的皮试，同时分析奥沙利铂皮试结果与临床奥沙利铂过敏的符合率，了解皮试结果与临床奥沙利铂过敏的符合率。方法:对在本中心接受含奥沙利铂方案治疗的患者进行筛选，经临床医师根据临床症状和体征判断为奥沙利铂Ⅰ-Ⅲ度过敏反应的患者进入本研究。对Ⅰ-Ⅲ度奥沙利铂过敏的患者进行3个浓度梯度（0.01 mg/ml、0.1 mg/ml和5 mg/ml）的奥沙利铂皮试，并以5%葡萄糖水作为阴性对照。15~20分钟读取测试结果。如果皮疹最大径大于阴性对照3 mm判为阳性结果。之后根据奥沙利铂过敏反应的等级进行不同方式的干预措施。主要研究终点为奥沙利铂再次化疗3周期的完成率，次要终点为奥沙利铂皮试结果与临床医师判断之间的符合率。结果:2016年6月至2017年4月126例在本中心接受含奥沙利铂方案治疗的患者中，14例（11.1%）发生奥沙利铂过敏。发生奥沙利铂过敏反应的中位疗程数为第8疗程，过敏反应时患者已接受的奥沙利铂中位累积剂量为1 200 mg(600~1 500 mg),男性8例，女性6例，中位年龄51岁（43~73岁）。Ⅰ、Ⅱ度过敏反应10例，Ⅲ度过敏反应4例，无Ⅳ度过敏反应的患者。14例患者的皮试结果为:13例阳性。皮试结果与临床的符合率为92.9%。除1例Ⅲ度过敏反应的患者拒绝继续接受奥沙利铂治疗，其余13例均接受了奥沙利铂的再化疗。总体再化疗成功率为100%。 结论:本研究证实了本中心设计的奥沙利铂过敏的干预措施是可行的。奥沙利铂皮试与临床医师判断之间的符合率高。     

Influence of gender,BMI and body shape on theoretical injection outcome at the ventrogluteal and dorsogluteal sites

Aims and objectives

This study aimed to determine the influences of gender, BMI and observed body shape on subcutaneous fat and muscle thicknesses, and theoretical injection outcome, at the ventrogluteal and dorsogluteal intramuscular injection sites.

Background

Debate continues as to whether the dorsogluteal or ventrogluteal injection site is more reliable for a successful intramuscular injection outcome. Subcutaneous fat and muscle thicknesses at the injection site are direct determinants of intramuscular injection outcome. BMI and observed body shape influence gluteal subcutaneous fat and muscle thicknesses, and therefore injection outcome, with potentially distinct effects at the ventrogluteal and dorsogluteal sites.

Design

This was a cross‐sectional study.

Methods

Demographic data were collected, and subcutaneous fat and muscle thicknesses were quantified bilaterally at the dorsogluteal and ventrogluteal injection sites using ultrasound, for 145 participants (57% female).

Results

Subcutaneous fat and muscle were significantly thicker at the dorsogluteal than the ventrogluteal site, and 75% and 86% of participants would receive a successful intramuscular injection at these sites, respectively. There were significant effects of gender, BMI and observed body shape on subcutaneous fat thickness and theoretical injection outcome at both sites. Females, obese individuals and endomorph individuals had thicker subcutaneous fat and were more likely to have a subcutaneous injection outcome.

Conclusions

Gender, BMI and observed body shape could be used to guide site and needle length selection when administering gluteal intramuscular injections to increase the likelihood of a successful intramuscular injection outcome.

Relevance to clinical practice

Both gluteal injection sites should be avoided in obese individuals and endomorph individuals. An intramuscular injection will be successful: using a 32‐mm needle at the ventrogluteal site for all males and normal‐weight females and using a 38‐mm needle for all females at the ventrogluteal site, and for all males and at least 98% of females at the dorsogluteal site.     

奥沙利铂的治疗恶性胸腔积液的有效性和安全性

目的：探讨针对恶性胸腔积液使用奥沙利铂治疗的有效性和安全性.方法：在我院抽取由各种疾病引起恶性胸腔积液的病例32 例,临床治疗时给予分组,每组16 例,选择使用奥沙利铂的病例为一组,选择使用顺铂的病例为二组,用药方式均为胸腔注药,对比、探讨一组的用药有效性和安全性.结果：一组有效率75%,12 例有效病例中5 例改善（31.3%）、7 例缓解（43.7%）,比二组的有效性高（P＜0.05）;一组副反应发生率25%,4 例出现副反应的病例中1 例为肠胃不适（6.3%）,2 例为胸痛（12.4%）,1 例为肢端不适（6.3%）,比二组的安全性高（P＜0.05）.结论：针对恶性胸腔积液使用奥沙利铂为安全有效的治疗方法.     

Absorption kinetics of subcutaneously injected insulin

Summary The absorption of subcutaneously injected insulin was examined by injecting semisynthetic [³H] insulin in anaesthetized pigs and subsequently analysing the tissue excised from the injection site. Contrary to previously accepted views, a significant proportion of insulin was degraded at the injection site. The disappearance of intact [³H] insulin from the injection site followed a monoexponential function with a half-time of 59 min.