A 31-year-old healthy mother of twins developed Guillain-Barré syndrome in her fourth gestational week of pregnancy. Impaired motor coordination, sensation, and joint position sense were observed. Immunoglobulin therapy was not performed given the early stage of pregnancy. She received rehabilitation to accommodate changes in her body shape and movements necessary for pregnancy, childbirth, and childcare. The patient delivered a healthy baby by cesarean section. By 42 weeks postpartum, she was capable of almost all housework activities and childcare. Family support was important in this case. Patient-oriented intervention, which included periodic confirmation and establishment of goals in each phase and continuity of intervention, was also essential.

Objective: The purpose of this study is to identify the problems in the adverse drug report (ADR) system in early post-marketing vigilance phase (EPM phase) in Japan.
Methods: The incidence of all ADRs and the ratio of serious ADRs were compared between the new drug application phase (ND phase) and the EPM phase.  The target medicines were Moxifloxacin (Avelox®tablets, 400mg), Gatifloxacin (Gatiflo®tablets, 100mg) and Prulifloxacin (Sword®tablets, 100mg).
Results: The average incidence of all ADRs in the ND phase was 100-fold greater than that in the EPM phase.  There were also 2-fold differences in the ratio of serious ADRs of individual medicines.
Conclusion: There are several problems with the ADR system in the EPM phase in Japan.  It is currently possible that the implementation of EPM will vary between in individual medicines and companies.  This suggests that the present data cannot be applied universally.  Thus, there is an urgent need to standardize the implementation of EPM.

Objective: Opioid analgesics are normally administered as monotherapy. However, we experienced a patient in whom alleviations of cancer pain, coughing and dyspnea were successfully achieved with the combination therapy of morphine and a fentanyl patch (FP), and the case is reported herein. Case Report: A woman in her fifties, suffering from sigmoid colon cancer, liver and lung metastases, and associated pain complicated with coughing and dyspnea, manifested symptomatic alleviations following the facilitation of treatment with morphine sulphate. Taking into consideration that oral intake would become difficult at some time in the future, treatment switchover to FP was planned. However, in view of the efficacy of fentanyl against coughing and dyspnea having not yet been firmly established, a low dose of morphine sulphate for coughing and dyspnea continued and cancer pain was controlled with FP. Thus, through continued combined use of the two ingredients, morphine and fentanyl, until treatment end, symptomatic alleviations of pain, coughing and dyspnea were able to be achieved. Conclusion: For patients experiencing difficulty with oral intake and suffering from coughing and dyspnea in addition to cancer pain, combined use of a low dose of morphine and FP is considered useful in achieving a stable alleviation of such symptoms.

A correction of a coauthor's name from Chigusa Nakamura to Chigusa Nakagawa on the author list and the abstract.

Purpose: From shortly after the fentanyl patch became commercially available, we have been using it as part of our armamentarium for cancer therapy to produce a reliable analgesic effect from the active treatment period to the terminal stage in patients who are expected to develop resistance to oral analgesics. To confirm the usefulness of fentanyl patch, a retrospective study was conducted to determine its efficacy and safety. Method: A survey was conducted of 28 cancer patients who were undergoing pharmacological pain control. The following parameters were recorded: opioids administered prior to fentanyl patch use, reasons for switching to fentanyl patch, duration of administration and dosage of fentanyl patch, pain score before switching to fentanyl patch, adverse effects (nausea, vomiting, constipation and drowsiness), and the results of clinical tests. Results: The major reasons for switching to fentanyl patch were: "pain control with oral agents was expected to become difficult in future" and "adverse effects of chemotherapy were noted or were likely to develop". The mean duration of fentanyl patch use was 133 days, during which time the pain score and the constipation symptom were significantly reduced. No significant difference was found with nausea, vomiting, drowsiness or the results of clinical tests. Conclusion: It is concluded that fentanyl patch is a highly useful opioid for analgesia when administered during chemotherapy for cancer and continued to the terminal stage.

We controlled the hemodilution and electrolyte levels during coronary artery revascularization in chronic hemodialysis patients by hemofiltration during the period of extracorporeal circulation. Subjects comprised 7 chronic hemodialysis patients (males, average age 53) undergoing coronary artery revascularization in our department from January 1988 to December 1989. All patients had been undergoing hemodialysis for chronic renal failure and in one patient, after admission, continuous ambulatory peritoneal dialysis (CAPD) was additionally performed. During surgery, the dialyzer was equipped with an extracorporeal circulation circuit and the electrolyte level and hemodilution were adjusted using transfusion (1, 270±372ml). A large infusion volume (12, 657± 3, 966ml) was maintained and removal of water was carried out by ultrafiltration. After surgery, all patients underwent hemodialysis twice or more by the 3rd day of recovery. Concentrations of electrolytes were maintained at appropriate levels throughout the day of surgery except for one case of postoperative hypokalemia, but no marked changes in hemodynamics were observed during and after surgery. Hemofiltration during extracorporeal circulation is safe and useful in coronary surgery because it is simpler and requires less time than hemodialysis.

Objective: The practices pertaining to hereditary breast and ovarian cancer (HBOC) in Japan have been rapidly changing owing to the clinical development of poly(ADP-ribose) polymerase inhibitors, the increasing availability of companion diagnostics, and the broadened insurance coverage of HBOC management from April 2020. A questionnaire of gynecologic oncologists was conducted to understand the current status and to promote the widespread standardization of future HBOC management. Methods: A Google Form questionnaire was administered to the members of the Japan Society of Gynecologic Oncology. The survey consisted of 25 questions in 4 categories: respondent demographics, HBOC management experience, insurance coverage of HBOC management, and educational opportunities related to HBOC. Results: A total of 666 valid responses were received. Regarding the prevalence of HBOC practice, the majority of physicians responded in the negative and required human resources, information sharing and educational opportunities, and expanded insurance coverage to adopt and improve HBOC practice. Most physicians were not satisfied with the educational opportunities provided so far, and further expansion was desired. They remarked on the psychological burdens of many HBOC managements. Physicians reported these burdens could be alleviated by securing sufficient time to engage in HBOC management, creating easy-to-understand explanatory material for patients, collaboration with specialists in genetic medicine, and educational opportunities. Conclusion Gynecologic oncologists in Japan are struggling to deal with psychological burdens in HBOC practice. To promote the clinical practice of HBOC management, there is an urgent need to strengthen human resources and improve educational opportunities, and expand insurance coverage for HBOC management.

OBJECTIVE: To examine the surgical-pathological predictors of para-aortic lymph node (PAN) metastasis at radical hysterectomy, and for PAN recurrence among women who did not undergo PAN dissection at radical hysterectomy. METHODS: This is a retrospective analysis of a nation-wide cohort study of surgically-treated stage IB–IIB cervical cancer (n=5,620). Multivariate models were used to identify independent surgical-pathological predictors for PAN metastasis/recurrence. RESULTS: There were 120 (2.1%) cases of PAN metastasis at surgery with parametrial involvement (adjusted odds ratio [aOR]=1.65), deep stromal invasion (aOR=2.61), ovarian metastasis (aOR=3.10), and pelvic nodal metastasis (single-node aOR=5.39 and multiple-node aOR=33.5, respectively) being independent risk factors (all, p<0.05). Without any risk factors, the incidence of PAN metastasis was 0.9%, while women exhibiting certain risk factor patterns (>20% of the study population) had PAN metastasis incidences of ≥4%. Among 4,663 clinically PAN-negative cases at surgery, PAN recurrence was seen in 195 (4.2%) cases that was significantly higher than histologically PAN-negative cases (2.5%, p=0.046). In clinically PAN-negative cases, parametrial involvement (adjusted hazard ratio [aHR]=1.67), lympho-vascular space invasion (aHR=1.95), ovarian metastasis (aHR=2.60), and pelvic lymph node metastasis (single-node aHR=2.49 and multiple-node aHR=8.11, respectively) were independently associated with increased risk of PAN recurrence (all, p<0.05). Without any risk factors, 5-year PAN recurrence risk was 0.8%; however, women demonstrating certain risk factor patterns (>15% of the clinically PAN-negative population) had 5-year PAN recurrence risks being ≥8%. CONCLUSION: Surgical-pathological risk factors proposed in this study will be useful to identify women with increased risk of PAN metastasis/recurrence.
Cohort Studies ; Female ; Humans ; Hysterectomy ; Incidence ; Lymph Nodes ; Neoplasm Metastasis ; Odds Ratio ; Recurrence ; Retrospective Studies ; Risk Factors ; Uterine Cervical Neoplasms

OBJECTIVE: We aimed to propose a set of quality indicators (QIs) based on the clinical guidelines for cervical cancer treatment published by The Japan Society of Gynecologic Oncology, and to assess adherence to standard-of-care as an index of the quality of care for cervical cancer in Japan. METHODS: A panel of clinical experts devised the QIs using a modified Delphi method. Adherence to each QI was evaluated using data from a hospital-based cancer registry of patients diagnosed in 2013, and linked with insurance claims data, between October 1, 2012, and December 31, 2014. All patients who received first-line treatment at the participating facility were included. The QI scores were communicated to participating hospitals, and additional data about the reasons for non-adherence were collected. RESULTS: In total, 297 hospitals participated, and the care provided to 15,163 cervical cancer patients was examined using 10 measurable QIs. The adherence rate ranged from 50.0% for ‘cystoscope or proctoscope for stage IVA’ to 98.8% for ‘chemotherapy using platinum for stage IVB’. Despite the variation in care, hospitals reported clinically valid reasons for more than half of the non-adherent cases. Clinically valid reasons accounted for 75%, 90.9%, 73.4%, 44.5%, and 88.1% of presented non-adherent cases respectively. CONCLUSION: Our study revealed variations in pattern of care as well as an adherence to standards-of-care across Japan. Further assessment of the causes of variation and non-adherence can help identify areas where improvements are needed in patient care.
Guideline Adherence ; Humans ; Insurance ; Japan* ; Methods ; Patient Care ; Platinum ; Proctoscopes ; Qi ; Standard of Care ; Uterine Cervical Neoplasms*