Real-world clinical outcomes of treatment with casirivimab-imdevimab among patients with mild-to-moderate coronavirus disease 2019 during the Delta variant pandemic

BackgroundMutations of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) may reduce the efficacy of neutralizing monoclonal antibody therapy against coronavirus disease 2019 (COVID-19). We here evaluated the efficacy of casirivimab-imdevimab in patients with mild-to-moderate COVID-19 during the Delta variant surge in Fukushima Prefecture, Japan. MethodsWe enrolled 949 patients with mild-to-moderate COVID-19 who were admitted to hospital between July 24, 2021 and September 30, 2021. Clinical deterioration after admission was compared between casirivimab-imdevimab users (n = 314) and non-users (n = 635). ResultsThe casirivimab-imdevimab users were older (P < 0.0001), had higher body temperature ([≥] 38{degrees}C) (P < 0.0001) and greater rates of history of cigarette smoking (P = 0.0068), hypertension (P = 0.0004), obesity (P < 0.0001), and dyslipidemia (P < 0.0001) than the non-users. Multivariate logistic regression analysis demonstrated that receiving casirivimab-imdevimab was an independent factor for preventing deterioration (odds ratio 0.448; 95% confidence interval 0.263-0.763; P = 0.0023). Furthermore, in 222 patients who were selected from each group after matching on the propensity score, deterioration was significantly lower among those receiving casirivimab-imdevimab compared to those not receiving casirivimab-imdevimab (7.66% vs 14.0%; p = 0.021). ConclusionThis real-world study demonstrates that casirivimab-imdevimab contributes to the prevention of deterioration in COVID-19 patients after hospitalization during a Delta variant surge. SummaryThis real-world retrospective study demonstrates the contribution of treatment with casirivimab-imdevimab to the prevention of deterioration in patients with mild-to-moderate coronavirus disease 2019 (COVID-19) even during the Delta variant pandemic.

Development and external validation of the DOAT and DOATS scores: simple decision support tools to identify disease progression among nonelderly patients with mild/moderate COVID-19

BACKGROUNDDue to the dissemination of vaccination against severe acute respiratory syndrome coronavirus 2 in the elderly, the virus-susceptible subjects have shifted to unvaccinated non-elderlies. The risk factors of COVID-19 deterioration in non-elderly patients without respiratory failure have not yet been determined. This study was aimed to create simple predicting method to identify such patients who have high risk for exacerbation. METHODSWe analyzed the data of 1,675 patients aged under 65 years who were admitted to hospitals with mild-to-moderate COVID-19. For validation, 324 similar patients were enrolled. Disease progression was defined as administration of medication, oxygen inhalation and mechanical ventilator starting one day or longer after admission. RESULTSThe patients who exacerbated tended to be older, male, had histories of smoking, and had high body temperatures, lower oxygen saturation, and comorbidities such as diabetes/obesity and hypertension. Stepwise logistic regression analyses revealed that comorbidities of diabetes/obesity, age [≥] 40 years, body temperature [≥] 38{degrees}C, and oxygen saturation < 96% (DOATS) were independent risk factors of worsening COVID-19. As a result two predictive scores were created: DOATS score, which includes all the above risk factors; and DOAT score, which includes all factors except for oxygen saturation. In the original cohort, the areas under the receiver operating characteristic curve of the DOATS and DOAT scores were 0.789 and 0.771, respectively. In the validation, the areas were 0.702 and 0.722, respectively. CONCLUSIONWe established two simple prediction scores that can quickly evaluate the risk of progression of COVID-19 in non-elderly, mild/moderate patients. SummaryThe risk stratification models using independent risks, namely comorbidity of diabetes or obesity, age [≥] 40 years, high body temperature [≥] 38{square}, and oxygen saturation < 96%, DOATS and DOAT scores, predicted worsening COVID-19 in patients with mild-to-moderate cases.

Case reports on adverse effects of acupuncture and moxibustion:a review of papers published between 2007 and 2011 / 全日本鍼灸学会雑誌

[Objective]To analyze and understand cases of adverse effects of acupuncture and moxibustion published in medical journals between 2007 and 2011.<BR>[Methodology]We searched relevant articles with the Web of Japan Medical Abstracts Society and PubMed. We used keywords for acupuncture, moxibustion and related adverse events.<BR>[Results]We located 39 papers reporting 39 cases that occurred in Japan:infection (7 cases), organ injury (11), foreign body or needle breakage (8), neurological damage (6), cutaneous disease (1), adverse effects of moxibustion (4), and others (2). As for cases published in foreign countries, we located 60 relevant papers:infection (19 cases including 2 outbreaks), organ injury (13), foreign body or needle breakage (5), neurological damage (9), cutaneous disease (5), adverse effects of moxibustion (2), and others (7).<BR>[Conclusion]Although causal relationship has not been established in some cases, occurrences of infection, organ injury, and needle breakage/foreign body are still as high as they were before. This suggests that continual feedback to acupuncturists of information on safety is necessary.

Ideas for Safer Acupuncture Practice (2) / 全日本鍼灸学会雑誌

Continued from the previous year's theme of our workshop, we collected various information and ideas for safer acupuncture practice. Subjects and presentations of the present workshop were as follows:<BR>1. Literature review of papers on adverse events published between 2003and 2006<BR> 1) Papers in domestic journals (by Ishizaki and Egawa)<BR> 2) Papers in foreign journals (by Yamashita and Umeda)<BR>2. Debate on wearing sterilized fingerstall or glove<BR> 1) Present status of the use of fingerstall in acupuncture practice (by Katai and Minowa)<BR> 2) Practical side of clinical education of acupuncture using fingerstall (by Hatakeyama and Furuya)<BR> 3) Problem of using individual fingerstalls in acupuncture practice (by Handa and Miyamoto)<BR>We will continue to provide information and discuss solutions in order to reach a common understanding and specific methods for safer acupuncture practice.

Ideas for Safer Acupuncture Practice (1) / 全日本鍼灸学会雑誌

We have been collecting various ideas on safer acupuncture practice from participants in our workshop as well as members of the committee. Subjects and presentations of the present workshop were as follows:<br>1. Forgotten needles<br>  1) Ideas of prevention based on a questionnaire survey (Egawa and Ishizaki)<br>  2) Effect of incident reporting system (Yamashita)<br>2. Cleaner method of needle insertion and Oshide (needle-supporting fingers)<br>  1) Merits and demerits of sterilized fingerstall and glove (Miyamoto)<br>  2) History of the clean needle development (Umeda)<br>  3) A novel clean acupuncture needle device (Imai and Ishizaki)<br>Although there was not enough time for discussion, we collected some useful ideas from the participants. A novel clean needle invented by Imai gave a strong impression to the audience. We should continue to discuss a diverse impact when such new devices and concepts become widespread in traditional acupuncture practices. We welcome more ideas and opinions from relevant facilities, clinics and fields in order to further improve safety of acupuncture.

Evidence in Safety Issue of Acupuncture (2) / 全日本鍼灸学会雑誌

We continued reviewing published evidence and information regarding the safety of acupuncture. Subjects in 2005 were as follows : <BR>1. Safety during acupuncture stimulation<BR>2. Quality and strength of acupuncture needle<BR>3. Sterilization and storage of equipments<BR>4. Hygienic handling of equipments<BR>5. Relevant notices from the Government<BR>6. Standards of notification regarding hygienic practice and contaminated wastes<BR>We hope that the information here will influence the future school education, clinical practice, manual editing and research activities.

Evidence in Safety Issue of Acupuncture (1) / 全日本鍼灸学会雑誌

Knowledge and procedures regarding safe acupuncture practices often include conjecture and anecdotes lack-ing scientific evidence. In order to improve the safety standards of acupuncture, we should collect, scrutinize, and apply evidence on the safe management of acupuncture. We, the Committee for Safe Acupuncture, have commenced collecting and reviewing relevant evidence published. Subjects in 2004 were as follows : <BR>1. The present situation of safety education and damages (by Katai) <BR>2. Hand washing and finger disinfection (by Ishizaki) <BR>3. Disinfection of the needle insertion area (by Umeda) <BR>4. Procedures of needle insertion and removal (by Miyamoto) <BR>5. Safe insertion depth (by Yamashita) <BR>6. Environmental sanitation (by Egawa) <BR>We hope that the knowledge and questions which come to light through the present work will influence school education, clinical practice, manual editing and research activities.

Effect of Wiping Acupuncture Needles with Cotton on Removing Hepatitis C Viruses Contaminating the Needle Surface / 全日本鍼灸学会雑誌

We examined whether wiping acupuncture needles with cotton could remove Hepatitis C viruses (HCV) adhering to the needles. The needles were incubated in the serum from patients infected with HCV, then the needles were wiped with dry cotton or cotton soaked in 80% ethanol. RNA was extracted from these needles and the HCV genome was amplified by reverse transcription-polymerase chain reaction (RT-PCR). The results indicated that the HCV genome was not detected when the needles were wiped with dry cotton. However, in one of two experiments, the HCV genome was detected after wiping the needles with cotton soaked in ethanol. We also examined the HCV contamination on the needles extracted from patients infected with HCV. The HCV genome was detected on extracted needles that were not wiped with cotton, but the genome was not found on needles wiped with cotton at the time of extraction. Therefore, wiping acupuncture needles with cotton might effectively remove HCV on the contaminated needles, but the viruses could not always be re-moved by simply wiping the needles with cotton.

Update of Adverse Events Associated with Acupuncture and Moxibustion in Japan (1998-2002) and Controversy over Infection Control in Acupuncture Treatment / 全日本鍼灸学会雑誌

We updated safety information on acupuncture and moxibustion, focusing on adverse events. Case reports published between 1998 and 2002 were searched, using “Ichushi Web” (Web version of <I>Japana Centra Medio Medicina</I>) and “PubMed”. Thirtysix cases of acupunctureassociated adverse events (13 infections, 11 dermatological problems, 6 organ injuries or foreign bodies, 5 nerve injuries etc.) and nine cases of moxibustionassociated adverse events (6 dermatological problems etc.) were located. Most cases were published in academic journals in the field of modern Western medicine, which clinical acupuncturists usually do not read. Therefore, our committee should play a role of collecting safety information and performing the feedback for the acupuncturists.<BR>We also summarize the contents of the Workshop held by our committee on June 6, 2003. The most controversial issue was determining an appropriate method of needle insertion in terms of infection control. More evidence is needed for establishing a good manual for safety acupuncture.

Randomized Controlled Trials (RCTs) of Acupuncture and Moxibustion in Japan at the Present and the Future Issues / 全日本鍼灸学会雑誌

The results of multi-center RCT of acupuncture and moxibustion for the prevention of the symptoms of common cold conducted by the financial support of the foundation for training and licensure examination in anma-massage-acupressure, acupuncture and moxibustion were briefly reviewed. Traditional acupuncture manipulation to the throat induced significant positive effects, however, more common indirect moxibustion to the neck for longer period did not induce the significant effect compared with no-treatment control. Several issues to be resolved were discussed and the shortage of duration of intervention was pointed out as one of the major issues. Then four pilot studies with long-lasting intervention of acupuncture or moxibustion were con-ducted. The effects tended to be more positive, however, they were still unclear. The selection of subjects (students in the acupuncture school) will be the next important issue to be examined.

Hepatitis B Virus is Detected on the Surface of Acupuncture Needles / 全日本鍼灸学会雑誌

We have detected Hepatitis B viral DNA on the surface of needles after removing acupuncture needles. Using a polymerase chain reaction we confirmed a band specific for Hepatitis B virus in one out of two patients who are known carriers. Our study indicates that acupuncture needles represent one possible sources of viral infection.

The Effect of the Weight Reduction on the Salivary Cortisol Levels of Judo Players

The purpose of this study was to investigate the effect of weight reduction prior to a competition on the salivary cortisol level for first-rate judo players. Subjects were divided into three groups by the weight reduction rate. On the day before the competition, the cortisol levels of the low- and high-weight reduction group showed a tendency to decrease and were significantly lower than that of the non-weight reduction group (p<0.05). However, with regard to the change in the stress indices, there was a difference between the high- and low-weight reduction groups. In the high-weight reduction group alone, there was a significant increase in the stress indices on the day before the competition (p<0.05). These findings suggest that the HPA axis is affected during the relatively early stage of weight reduction and mental stress is increased at the higher weight reduction rate.

The Unique Correlation between Anti-Mutagenicity of Human Saliva and Change in Body Weight

The purpose of this study was to investigate the effect of weight reduction on the anti-mutagenicity of human saliva. Subjects were 16 male college judo players. The anti-mutagenicity of the saliva was measured using the umu test. There was an inhibiting effect of the saliva on the mutagenicity of AF-2. However, a modifying effect of the saliva on Trp-P-1 was not observed. On the day before a competition and 7 days after the competition, the inhibiting capacity of the saliva for the mutagenicity of AF-2 decreased and increased in two non-weight reduction and two weight reduction groups, respectively. However, on the day before the competition, the changed body weights (r=−0.77, p<0.01) and BMI (r=−0.77, p<0.01) were significantly correlated with that of the inhibiting capacity of the saliva for the mutagenicity of AF-2. In addition, the BMI at 20 days before the competition was not significantly but markedly correlated with it (r=0.50, p=0.057). At 7 days after the competition, however, these correlations were not found. These findings suggest a unique correlation between the anti-mutagenicity of human saliva and body weight or BMI.