The relationship between body mass index, thickness of subcutaneous fat, and the gluteus muscle as the intramuscular injection site

An intramuscular injection (IMI) is an injection given directly into the central area of a specific muscle. Certain medicines need to be administered by the gluteal route for these to be effective. The aim of this study was to determine the influence of body mass index (BMI), subcutaneous fat, and muscular thickness of the dorsogluteal IMI site among healthy Japanese women. There were 39 healthy female subjects who volunteered and met the criteria. Their ages ranged from 40s to 60s (50.82 ± 6.04). With the data collected using the B-mode ultrasound images of the dorsogluteal site, it was found that the distance from the epidermis to the under-fascia (DEUF) of the gluteus maximus was dissimilar between the subject’s right and left buttocks. It was found that the distance from the epidermis to the iliac bone (DEI) was significantly more on the right than on the left buttocks. In the case of an adult Japanese woman with a BMI of 21 or more, the DEUF of the gluteus medius was found to be about 30 mm, and the DEI was approximately 50 mm or more. Based on these findings, it is recommended that a needle length of 38 mm (1.5 inches) can be safely used to administer IMIs to the gluteus medius muscle to effectively and efficiently deliver medications through the IMI route.

Sleep conditions and quality of life among patients with ischemic heart disease after elective percutaneous coronary intervention

In Japan, percutaneous coronary intervention (PCI) is a major therapeutic intervention for ischemic heart disease (IHD). Previous studies suggested that an association of the risk of IHD caused by sleep duration was related to factors closely associated with daily activities. However, in Japan, there is no study about this relationship objectively measured using the actigraphy in patients with IHD. Moreover, there is little reported data about sleep condition and early outcomes of patient’s Health-Related Quality of Life (QOL) after PCI. This study determines the correlations between sleep conditions and QOL (measured by SF36 version 2) of 25 patients with IHD who underwent elective PCI. Data were collected seven days after PCI using night-sleep condition. Using Spearman’s rank test, the results revealed positive correlation between vitality score and longest sleep duration (ρ = 0.43, p = 0.031): social functioning (SF) score and duration of night-time sleep (ρ = 0.42, p = 0.037);total sleep duration (ρ = 0.45, p = 0.026), and longest sleep duration (ρ = 0.44, p = 0.024);mental health score and longest sleep duration (ρ = 0.54, p = 0.006). However, negative correlation was found between physical functioning score and arousal during sleep (ρ = -0.44, p = 0.027). Sleep condition was significantly correlated with QOL. In particular, SF score was positively related to night-time sleep. This seems to indicate that SF score might be related to night-time sleep condition. Moreover, the longest sleep durations were correlated with the mental component summary. The results of the study suggest that not only the length of whole sleep durations leads to better QOL, but also the increase the amount of uninterrupted sleep.

Comparison of Gluteal Muscle Intramuscular Injection Sites of Japanese Healthy Subjects: Considerations for Optimal Insertion of Injection Needle Length

Long Acting Injectable (LAI) medications for patients with schizophrenia is commonly administered to relieve their symptoms. Through shared decision-making and clinical evidence-based, psychiatrists should systematically offer LAIs to all patients requiring long-term antipsychotic treatment as a first-line treatment. Gluteal intramuscular (IM) injection requires accurate insertion of needles into the specific muscle area, often the outer upper quadrant of the buttocks, in order to achieve the required blood concentration. The purposes of this study were to compare the “Distance from the Epidermis to the Under-Fascia (DEUF)” and “Distance from the Epidermis to the Iliac Bone (DEB)” of the buttocks IM injection sites at the dorsogluteal and ventrogluteal sites among healthy Japanese volunteer subjects, and to identify the optimal insertion injection needle length. The DEUF and DEB at the gluteal regions were measured by ultrasonography. Welch’s one-way analysis of variance was used to compare the DEUF and the DEB at the gluteal IM injection regions. There was no statistically significant difference observed between the right and left mean values of DEUF for Hochstetter and Clark’s point at the ventrogluteal sites, and the Four and Three-way split or Double Cross point at the dorsogluteal sites. However in the DEB, the Hochstetter’s point (P < 0.01) at ventrogluteal site on the right side, and Clark’s point (P < 0.05) were significantly shorter than the Double Cross point at dorsogluteal sites (F = 4.38). The left buttocks Hochstetter’s point was significantly shorter than the Double Cross point (F = 4.38, P < 0.01). These results, however, did not establish a statistically significant difference in the DEUF among injection sites. It was considered that the difference in the DEB depended on muscle volume and thickness in the gluteal injection sites.

A Phase II Trial of Preoperative Chemoradiotherapy with Oral DPD-Inhibitory Fluoropyrimidines in Patients with Advanced Rectal Cancer

Background: Preoperative chemoradiotherapy (CRT) with 5-FU has been widely used to improve local control of disease and to preserve anal sphincter in the treatment of rectal cancer. UFT and S-1 as oral dihydropyrimidine dehydrogenase (DPD)-inhibitory fluoropyrimidines enhance the therapeutic effect of 5-FU by modulating its metabolic pathways. The purpose of this study was to evaluate the efficacy and toxicity of CRT using UFT versus S-1 in patients with locally advanced rectal cancer. Methods: Fifty-nine patients who received preoperative CRT (40 Gy radiotherapy) were randomly assigned to either UFT or S-1 groups. UFT and S-1 were administered during the radiotherapy course. Response to CRT was determined using a histopathologic examination and RECIST of surgically resected specimens and classified as responders (CR, PR and grade 2, 3) or nonresponders (SD, PD and grade 0, 1). Results: All patients were randomly allocated to S-1 group (n = 30) or UFT group (n = 29). Pathological response rate (Grade2 and Grade3) was 57% in the S-1 group and 45% in the UFT group (p = 0.36). Pathological complete response (CR) rate (Grade3) was 7% in the S-1 group and 4% in the UFT group (p = 0.98). There was no statistically significant difference between the two groups in regard to the response rate of RECIST (p = 0.52). There was no statistically significant difference between the groups based on the downstaging rate, resection of tumor, sphincter preservation and marginal invasion. The incidence of Grade 3 diarrhea was significantly more frequent in the S-1 group (7%) compared with the UFT group (0%) (p = 0.02). Conclusion: The results supported the conclusion that CRT using UFT or S-1 is effective and feasible for patients with locally advanced rectal cancer.

Efficacy and Safety in Intramuscular Injection Techniques Using Ultrasonographic Data

Delivered by intramuscular (IM) injections, Long Acting Injections (LAI), offering comparatively long term medicinal effects from several weeks to several months, are gaining much attention. The aim of this article was to indicate a safe and effective IM injection technique based on evidenced data derived from ultrasonographic data. Accurate anatomical knowledge is necessary in order to administer IM injections. It is possible to gain an adequate understanding of injection site anatomical structures by using ultrasound diagnostic devices. In particular, ultrasonography offers real-time diagnostic data allowing for observation of injection site, subcutaneous tissues, fat layers, muscle membrane, muscles and bones. To deliver the drug accurately into the muscle is essential, to achieve maximum drug efficacy and prevent injection site reactions. Therefore, when administering IM injections to the buttocks area, a suitable injection needle between 23G 25 mm to 21G or 22G 38 mm must be chosen depending on physique and drug characteristics. Needles determined as safe and effective through ultrasonographic evidence are needed such as in the case of a deltoid injection site, in which a 23G 25 mm injection needle is used in the absence of notable obesity. Not only the needle type is essential, but also the IM procedure itself. It is important to stretch the skin, inserting the needle at 90 degree angle to ensure depth of needle insertion to the muscle. Until new con-firmed evidence becomes available, it is necessary to increase the understanding of injection site selection methods, needle insertion depth, needle angle, and established IM injection techniques. The application of ultrasound devices in the development of next-generation techniques for IM injection is promising. Importantly, these techniques provide critical information from a risk management perspective.

Optimal needle insertion length for intramuscular injection of risperidone long-acting injectable (RLAI)

Risperidone long-acting injectable (RLAI) is approved for the treatment of schizophrenia in many countries. The suggested site is the gluteal muscle with a needle length of two inches (50 mm) in Japan, which is longer than the ordinarily used needle for intramuscular injections. The aim of this study was to determine the optimal needle insertion length for accurate delivery of RLAI procedure among subjects who have normal body mass index (BMI: 18 to 25) and high BMI (>25). Thirty-seven patients with schizophrenia were administered RLAI intramuscularly into the dorsogluteal muscle. The standard procedure required inserting 80% of the two inch needle. By using data collected by ultrasonography, the findings confirmed that the median needle insertion lengths for subjects with normal and high BMI were 39.0 and 45.5 mm, respectively. To deliver RLAI effectively and safely, the authors strongly recommend that a specialized needle be used that is “marked” at the 40 mm point from the tip of the needle to the base. In this way regardless of subcutaneous fat content, the RLAI can be safely delivered into the muscle without causing untoward or side effects.

Effects of Depth of Needle Insertion with Risperidone Long-Acting Injectable in Persons with Schizophrenia: A Randomized Double-Blind Study

In some cases, if the insertion depth is shallower than expected, intramuscular (IM) injection of risperidone long-acting injectable (RLAI) may not penetrate the muscle fascia. However, if needle insertion depth is deeper than anticipated, needle penetration may cause damage to nerves, arteries and veins. Few clinical studies were done to evaluate the depth of needle length insertion reaching the intended gluteal muscle. The aim of this study was to evaluate the suitable depth of injecting RLAI. Twenty-six patients with schizophrenia were treated with RLAI, and randomly divided into two groups: 50 mm needle inserted group (Group-D, deep insertion, n = 13) and 20 mm needle insertion group (Group-S, shallow insertion, n = 13). For Group-S, the needle length was marked with a spacer at exactly 20 mm. Injections were performed by the psychiatrist or nurse, alternating between the two gluteal sites by double-cross method every two weeks. Clinical psychotic symptoms and injection site reactions were recorded throughout the study period. Experienced psychologists who were blinded from the needle-length experimental variable evaluated patients’ psychotic symptoms using the Positive and Negative Syndrome Scale (PANSS) every two weeks. The plasma 9-hydroxyrisperidone (9-OH-RIS) concentrations were measured every two weeks;comparison data were determined on the 8th week and the 14th week. No significant difference was observed in 9-OH-RIS concentrations, psychotic symptoms, injection site skin reactions of subjects in both groups. However, in Group-D, injection site adverse reactions were confirmed in two subjects (15%). In Group-S, injection site reactions were confirmed in six subjects (46%). Although effective 9-OH-RIS concentrations were obtained with the insertion using both depth, it was concluded that the 50 mm insertion length was more suitable for dorsogluteal IM injections in adult patients with schizophrenia as demonstrated by the incidence of local adverse skin reactions.

Intramuscular Diffusion Status of Risperidone and Aripiprazole Long Acting Injectable (LAI) by Ultrasonography

The aim of this study was to consider the characteristics of intramuscular diffusion status of risperidone and aripiprazole long acting injectable (LAI) by ultrasonography. Subjects were 40 adult subjects diagnosed with schizophrenia and treated with LAI [32 patients were risperidone LAI (RLAI) and 8 patients were aripiprazole LAI (ALAI)]. However, in this paper, only three cases (one RLAI case and 2 ALAI cases) were selected to illustrate the diffusion effects of both LAI. Dorsogluteal intramuscular (IM) injection sites were measured at prone position using the “double cross” method. Before LAI injection, the distance from the epidermis to the under-fascia (DEUF), and distance from the epidermis to the iliac bone (DEI) at the IM injection site were assessed by using ultrasonography: 1) the injection needle was inserted to the gluteus medius, and 2) observed the diffusion status within the muscle injected RLAI and ALAI were confirmed using the B-mode ultrasonography. Both RLAI and ALAI were depicted as high echogenicity with acoustic shadowing. It was considered that the diffusion states of LAIs by ultrasonography were important time course evaluations providing objective evidence.

雷莫芦单抗用于经乐伐替尼治疗后进展的不可切除肝细胞癌的治疗效果

背景:在日本,乐伐替尼可用于不可切除原发性肝癌的一线、二线或三线治疗。本研究评估新近研发的雷莫芦单抗用于经乐伐替尼治疗后进展的不可切除的原发性肝癌的疗效。方法:2018年5月至2020年1月间在日本16家中心接受乐伐替尼治疗的385例不可切除原发性肝癌患者中,我们将其中接受雷莫芦单抗作为下一线治疗的28例患者纳入研究,对其治疗效果进行回顾性分析。结果:28例患者中位年龄70岁,中位白蛋白-胆红素(ALBI)评分为2.19。28例患者中,23例为男性;21例为Child-Pugh A级,7例为Child-Pugh B级;3例为BCLC B期,25例为BCLC C期。雷莫芦单抗用于二线、三线和四线治疗的病例分别为14例、9例和5例患者。26例患者获得疗效评估,客观缓解率为3.8%(1/26),疾病控制率为42.3%(11/26);中位疾病进展时间为2个月。未继续接受雷莫芦单抗治疗的原因包括16例出现疾病进展和2例出现3级不良反应(消化道出血和腹水)。结论:我们的初步研究显示,对于乐伐替尼治疗进展的不可切除原发性肝癌,雷莫芦单抗并没有获得预期的治疗效果。