Objective: In Japan, perioperative prophylaxis of pulmonary embolism (PE) in gynecologic cancer patients with preoperative asymptomatic venous thromboembolism (VTE) has not been well established yet. The GOTIC-VTE trial was a prospective, multi-center, single-arm clinical trial to investigate the prevention of postoperative symptomatic PE onset by seamless anticoagulant therapy from the preoperative period to 4 weeks after surgery instead of using intermittent pneumatic compression. Methods: Anticoagulant therapy was started immediately after asymptomatic VTE diagnosis and stopped preoperatively according to the rules of each institution. Unfractionated heparin administration was resumed within 12 hours postoperatively, and this was followed by the switch to low-molecular-weight heparin and subsequently, edoxaban; this cycle was continued for 28 days. Primary outcome was the occurrence of symptomatic PE in 28 days postoperatively. Secondary outcomes were the incidence of VTE-related events in 28 days and 6 months postoperatively and protocol-related adverse events. Results: Between February 2018 and September 2020, 99 patients were enrolled; of these, 82patients were assessed as the full analysis set, including 58 for ovarian cancer, fallopian tube, or peritoneal cancer; 21 for endometrial cancer; and 3 for cervical cancer. No symptomatic PE was observed within 28 days postoperatively; two patients had bleeding events (major bleeding and clinically relevant nonmajor bleeding) and three had grade 3 adverse events (increased alanine transaminase, aspartate aminotransferase, or gamma-glutamyl transferase). Conclusion The multifaceted perioperative management for gynecologic malignancies with asymptomatic VTE effectively prevented postoperative symptomatic PE.Trial Registration: JRCT Identifier: jRCTs031180124

Objective: In Japan, perioperative prophylaxis of pulmonary embolism (PE) in gynecologic cancer patients with preoperative asymptomatic venous thromboembolism (VTE) has not been well established yet. The GOTIC-VTE trial was a prospective, multi-center, single-arm clinical trial to investigate the prevention of postoperative symptomatic PE onset by seamless anticoagulant therapy from the preoperative period to 4 weeks after surgery instead of using intermittent pneumatic compression. Methods: Anticoagulant therapy was started immediately after asymptomatic VTE diagnosis and stopped preoperatively according to the rules of each institution. Unfractionated heparin administration was resumed within 12 hours postoperatively, and this was followed by the switch to low-molecular-weight heparin and subsequently, edoxaban; this cycle was continued for 28 days. Primary outcome was the occurrence of symptomatic PE in 28 days postoperatively. Secondary outcomes were the incidence of VTE-related events in 28 days and 6 months postoperatively and protocol-related adverse events. Results: Between February 2018 and September 2020, 99 patients were enrolled; of these, 82patients were assessed as the full analysis set, including 58 for ovarian cancer, fallopian tube, or peritoneal cancer; 21 for endometrial cancer; and 3 for cervical cancer. No symptomatic PE was observed within 28 days postoperatively; two patients had bleeding events (major bleeding and clinically relevant nonmajor bleeding) and three had grade 3 adverse events (increased alanine transaminase, aspartate aminotransferase, or gamma-glutamyl transferase). Conclusion The multifaceted perioperative management for gynecologic malignancies with asymptomatic VTE effectively prevented postoperative symptomatic PE.Trial Registration: JRCT Identifier: jRCTs031180124

Objective: In Japan, perioperative prophylaxis of pulmonary embolism (PE) in gynecologic cancer patients with preoperative asymptomatic venous thromboembolism (VTE) has not been well established yet. The GOTIC-VTE trial was a prospective, multi-center, single-arm clinical trial to investigate the prevention of postoperative symptomatic PE onset by seamless anticoagulant therapy from the preoperative period to 4 weeks after surgery instead of using intermittent pneumatic compression. Methods: Anticoagulant therapy was started immediately after asymptomatic VTE diagnosis and stopped preoperatively according to the rules of each institution. Unfractionated heparin administration was resumed within 12 hours postoperatively, and this was followed by the switch to low-molecular-weight heparin and subsequently, edoxaban; this cycle was continued for 28 days. Primary outcome was the occurrence of symptomatic PE in 28 days postoperatively. Secondary outcomes were the incidence of VTE-related events in 28 days and 6 months postoperatively and protocol-related adverse events. Results: Between February 2018 and September 2020, 99 patients were enrolled; of these, 82patients were assessed as the full analysis set, including 58 for ovarian cancer, fallopian tube, or peritoneal cancer; 21 for endometrial cancer; and 3 for cervical cancer. No symptomatic PE was observed within 28 days postoperatively; two patients had bleeding events (major bleeding and clinically relevant nonmajor bleeding) and three had grade 3 adverse events (increased alanine transaminase, aspartate aminotransferase, or gamma-glutamyl transferase). Conclusion The multifaceted perioperative management for gynecologic malignancies with asymptomatic VTE effectively prevented postoperative symptomatic PE.Trial Registration: JRCT Identifier: jRCTs031180124

The establishment of enhanced surveillance systems for mass gatherings to detect infectious diseases that may be imported during an event is recommended. The World Health Organization Regional Office for the Western Pacific contributed to enhanced event-based surveillance for the Tokyo 2020 Olympic and Paralympic Games (the Games) by using Epidemic Intelligence from Open Sources (EIOS) to detect potential imported diseases and report them to the National Institute of Infectious Diseases (NIID), Japan. Daily screening of media articles on global infectious diseases was conducted using EIOS, which were systematically assessed to determine the likelihood of disease importation, spread and significant impact to Japan during the Games. Over 81 days of surveillance, 103 830 articles were screened by EIOS, of which 5441 (5.2%) met the selection criteria for initial assessment, with 587 (0.6%) assessed as signals and reported to NIID. None of the signals were considered to pose a significant risk to the Games based on three risk assessment criteria. While EIOS successfully captured media articles on infectious diseases with a likelihood of importation to and spread in Japan, a significant manual effort was required to assess the articles for duplicates and against the risk assessment criteria. Continued improvement of artificial intelligence is recommended to reduce this effort.

Objective: To assess the efficacy of the FIGO 2018 classification system for nodal-specific classifications for early-stage cervical cancer; specifically, to examine the impact of nodal metastasis on survival and the effect of postoperative treatments, according to histological subtypes. Methods: This society-based retrospective observational study in Japan examined 16,539 women with the 2009 FIGO stage IB1 cervical cancer who underwent primary surgical treatment from 2004 to 2015. Associations of cause-specific survival (CSS) with nodal metastasis and postoperative adjuvant therapy were examined according to histology type (squamous cell carcinoma [SCC], n=10,315; and non-SCC, n=6,224). Results: The nodal metastasis rate for SCC was higher than that for non-SCC (10.7% vs. 8.3%, p<0.001). In multivariable analysis, the impact of nodal metastasis on CSS was greater for non-SCC tumors (adjusted-hazard ratio [HR], 3.11; 95% confidence interval [CI], 2.40–4.02) than for SCC tumors (adjusted-HR, 2.20; 95% CI, 1.70–2.84; p<0.001). Propensity score matching analysis showed significantly lower CSS rates for women with pelvic nodal metastasis from non-SCC tumors than from SCC tumors (5-year CSS rate, 75.4% vs. 90.3%, p<0.001). The CSS rates for women with nodal metastasis in SCC histology were similar between the postoperative concurrent chemoradiotherapy/radiotherapy and chemotherapy groups (89.2% vs. 86.1%, p=0.42), whereas those in non-SCC histology who received postoperative chemotherapy improved the CSS (74.1% vs. 67.7%, p=0.043). Conclusion The node-specific staging system in the 2018 FIGO cervical cancer classification is applicable to both non-SCC tumors and SCC tumors; however, the prognostic significance of nodal metastases and efficacy of postoperative therapies vary according to histology.

We experienced a case of palmoplantar pustulosis in which the patient's dermatological symptoms im­proved after treatment with a combination of bofutsushosan and keishibukuryogan. The patient was a 42-year-old woman. She had been prescribed biotin and a steroid ointment, but her condition did not improve. At her first visit to our Kampo clinic, we observed impetigo, cracks, and scaling on both palms and plantar surfaces. We determined that the patient was of the poisoned organ (zodoku) and stagnant blood (oketsu) constitutions,as outlined in the Ikkando school of medical thought. We prescribed bofutsushosan and keishibukuryogan as fundamental treatment and then in a few days, the patient's dermatological symptoms resolved. The patient later developed hyperthyroidism, which caused her symptoms to worsen again, we therefore switched to shofusan and eppikajutsuto as local and symptomatic treatment, and then she once again improved. Soon after, we returned to keishibukuryogan and bofutsusho for her to maintain remission. Since poisoned organ and stagnant blood constitutions contribute greatly to the Kampo pathology of palmoplantar pustulosis, we believe bofutsushosan and keishibukuryogan are effective formulations for the treatment of this condition. As far as we searched, there were no papers that selected bofutsushosan or blood stasis agents as the main cure from the viewpoint of the poisoned organ constitution and the stagnant blood constitution. Therefore, this case was considered to be a valuable case.

We conducted a questionnaire survey on shift and on-call system targeting under-forty cardiovascular surgeons and obtained responses from 35 surgeons. We report the questionnaire results.

Although evidence of Western therapy for heart failure has been established, evidence of treatment for heart failure with chronic kidney disease (CKD) has still not been established. The efficacy of additional Oriental medicine to standard therapy for heart failure with CKD is unclear. To address this issue, we retrospectively evaluated 20 consecutive heart failure patients with CKD (≧stage 3) who were orally administered goreisan (7.5 g/day) due to insufficient efficacy of standard therapy in our hospital from November 2015 to December 2017. We assessed symptoms, chest X-ray, BNP concentration, serum electrolytes, eGRF, plasma osmolality, and side effects. Goreisan improved heart failure in 11 of 20 patients, did not significantly deteriorate renal function, plasma osmolality, and did not clinically affect electrolytes. In conclusion, the present study suggested that additional use of goreisan to Western standard therapy is safe and useful for heart failure with CKD.

This report describes 20 women who underwent in vitro fertilization or microinsemination while receiving a regimen of herbal medicine, of which contents varied according to the treatment stage. Until the ova were harvested, in order to promote maturation, patients were treated with hachimijiogan for reinforcing kidney yang, and keishibukuryogan for removing blood stasis. Following this, during the period between harvesting and implantation, they were treated either exclusively with unkeito for warming meridians, dissipates cold, and replenishes blood, or with unkeito in combination with keishibukuryogan. Following implantation, they were treated with tokishakuyakusan to induce uterine relaxation. The treatment regimen was determined based on traditional herbal evidence of infertile patient's blood stasis and kidney deficiency. We adjusted applied dose depending on the conditions of patients. Fourteen of the 20 women tested positive for pregnancy; 10 of them carried to term, whereas in 4 of them, the pregnancy ended in abortion or miscarriage. Anti-Müllerian hormone concentration, endometrial thickness, estimated follicle count, recovered ova count, fertilized ova count, and numbers of ova to reach the early-embryo stage and blastocyst stage were compared between the continuing pregnancy and the non-pregnancy groups. Improvements were observed in all values after combined use of traditional herbal medicines, except in the case of endometrial thickness, and significant differences appeared in recovered ova count and fertilized ova count. These observations suggest that a regimen of herbal medicine adapted to the various stages of in vitro fertilization may be a useful complementary therapy during pregnancy.

ART (Assisted Reproductive Technology) is making impressive advancements. However, not all patients will successfully conceive even with this technique. Patients undergoing infertility treatment are predominantly in a state of mental stress for being unable to conceive, and the importance of stress care in treating infertility has been reported. This time, to investigate the relationship between infertility, mental stress and Kampo treatment, we have conducted a retrospective study on 7 patients who achieved conception by a combination treatment of Kampo medicine and ovulation day prediction. Patients'occupation, menstruation history, pregnancy history, premenstrual symptoms, and oriental medical examination findings were extracted from their medical records. The clinical background were age (mean age: 36 [29-39]), time to pregnancy (mean: 6 months [2-9 months]), and outcome (normal vaginal delivery [3 cases], caesarean section [2 cases], abortion [1 case], transfer to other facility [1 case]). The oriental medical diagnosis in all cases found stagnation of liver qi. Two cases had only stagnation of liver qi. As comorbidities, kidney deficiency (3 cases), blood stasis syndrome (1 case), and blood stasis syndrome with syndrome of dual deficiency of qi and blood (1 case) were found. The Kampo prescriptions were as follows: nyoshinsan (2), kamishoyosan (2), tsudosan (1), shigyakusan (1) and kyukichoketsuin (1). Stagnation of liver (TM) qi was considered to play a role in infertility and is one of the important factors in Kampo prescriptions.