Maobushisaishinto was given to 10 elderly female patients with stress urinary incontinence (SUI) for 4 weeks. Five patients showed SUI improvement with its herbs. The mean age for the effective group was higher than that for the non-effective group (73.2 vs 50.2 yrs old ; p = 0.08). In former group, 2 cases demonstrated a remarkable effect ; one with the number of pads used decreasing from 8 to 2 and the other decreasing from 4 to 1.
Because of the possibilities of urethral pressure elevation with ma huang (the mao component) and improvement of detrusor overactivity with Fu zi (the bushi component), maobushisaishinto may be applicable for the aged female suffering from SUI.

Four interstitial cystitis/chronic pelvic pain syndrome (IC/CPPS) patients presenting with pain and autonomic imbatances were improved by Kampo medicine. (Case 1) a 42 year old female : Her bladder and perinial pain were relieved by ryutanshakanto and her autonomic imbalances were improved by Kamishoyosan. (Case 2) a 51 year old female : She was given anchusan which warmed the internal organs. (Case 3) a 49 year old female : Her general hypothermia was relieved by shinbuto and ninjinto. (Case 4) a 27 year old female :She was given tokishigyakukagoshuyushokyoto which warmed the lower body half. These Kampo medicines for autonomic imbalance in IC/CPPS were drugs that adjusted general condition on the basis of diagnostic processes, and logic based on states of vital energy and blood.

Objective: In Japan, the Guideline on Drug Interaction for Drug Development and Appropriate Provision of Information (GL) was notified in 2018. In the GL and the associated document, it was determined that package inserts of drugs which need to be categorized as precaution due to the significant degree of drug interactions by CYP3A inhibition should describe possible perpetrator drugs using designated expressions, such as “strong CYP3A inhibitor.” For contraindication, it was decided that all drugs should be described individually. In 2021, as supplementary information to the GL, a list of CYP substrates, inhibitors and inducers, classified based on interaction strength and CYP isoenzymes (i.e., the drug list), was published. In this study, we aimed to survey the information on drug interactions by CYP3A inhibition described in the package inserts based on information in the drug list, and to clarify the status and issues.Methods: The package inserts of 24 substrate drugs of CYP3A with contraindications for itraconazole, a strong CYP3A inhibitor, were examined, and the descriptions of strong, moderate, and other CYP3A inhibitors were studied.Results: The frequencies of contraindication for strong CYP3A inhibitors were cobicistat (75%), grapefruit juice (0%), ritonavir (92%), voriconazole (67%), clarithromycin (50%), ceritinib (0%), and posaconazole (33%). On the other hand, some CYP3A substrate drugs was contraindicated with moderate CYP3A inhibitors but not with these strong CYP3A inhibitors. Furthermore, 19 CYP3A inhibitors, which were not on the drug list published in 2021, were identified as contraindications for co-administration. Majority of these were protease inhibitors, and some have been discontinued or not available in Japan.Conclusion: The findings of this study imply the necessity of organizing scientific description based on the GL strength classification. Moreover, it is important to disseminate the information and precautions for drug interactions provided in the package inserts to medical practice.

The package inserts revision regarding prescription drugs is an ongoing process. In this study, we examined the status of this revision and how the content of the information provided has been updated with the new instructions, including the rationale for contraindications for pregnant and breast-feeding women. A total of 407 prescription drugs for pregnant and breast-feeding women were contraindicated, accounting for approximately 15% of the 2,627 nonproprietary names. The number of contraindicated drugs for pregnant, breast-feeding, and both pregnant and breast-feeding women were 406, 44, and 43, respectively. The majority of the contraindications were based on nonclinical data, such as teratogenicity and fetotoxicity data in reproductive toxicity studies involving pregnant animals and pharmacokinetic information in breast-feeding animals. The overall revision rate for the new instructions was 16.2% after three years of revision work for each drug. The alert wording has been revised to provide more clarity and consistency, with three categories of statements: “should not be administered/avoid breastfeeding,” “advisable not to administer/breastfeed,” and “should be administered/breastfeed in consideration of the therapeutic benefit (benefit-risk consideration).” The statement indicating that the drug should not be administered to pregnant women remained in the revised instructions. Conversely, the revision of the description for breast-feeding women from “should be discontinued/avoided” to “benefit-risk consideration” may have improved the usefulness of the product, allowing healthcare professionals to make more informed decisions after considering the transfer of the drug into milk, its pharmacological effects, and other factors.

A woman in her 50s underwent abdominal total hysterectomy for uterine myoma. She was discharged from the hospital on postoperative day (POD) 6 following an uneventful postoperative course but returned to the outpatient clinic on POD 11 with chief complaints of fever and abdominal pain. Blood tests at presentation showed a C-reactive protein level of 22.95 mg/dL and a white blood cell count of 21300/μL, indicating an increased inflammatory response. Transvaginal ultrasonography and contrast-enhanced computed tomography (CT) revealed a small amount of ascites and a thickened pelvic peritoneum. Based on these findings, pelvic peritonitis was diagnosed and the patient was readmitted to the hospital. After admission, antimicrobial treatment with cefmetazole 3 g/day was started, but transvaginal ultrasonography on POD 13 (3 days after readmission) revealed an intra-pelvic abscess. The abscess was punctured under transvaginal ultrasonographic guidance and the puncture fluid was submitted for microbiological examination, followed by CT-guided drainage. At the same time, the antimicrobial regimen was changed to sulbactam/ampicillin 9 g/day and doxycycline (DOXY) 200 mg/day (100 mg/day from the following day). On POD 18 (8 days after readmission), Mycoplasma hominis was detected in the abscess culture, leading to the decision to increase the dose of DOXY to 200 mg. Subsequently, with improvement of subjective and objective symptoms and reduction of the abscess cavity, the patient was discharged from the hospital on POD 21 (11 days after readmission). Although M. hominis is a common urogenital commensal, it can be a potential pathogen in a patient with a pelvic abscess that occurs as a late postoperative complication and does not respond to beta-lactam antibiotics, so treatment decisions should be made with this organism kept in mind.

The patient was a 36-year-old primipara with no comorbidities such as diabetes or hypertension. At 35 weeks and 3 days of pregnancy, she was admitted for rupture of membranes. She vomited often during the expulsive stage of labor, so a vacuum extraction was performed. Her vital signs were normal throughout the delivery. She vomited repeatedly after the delivery but did not complain of headache or arm weakness and her level of consciousness was Japan Coma Scale I-1. Head CT revealed right caudate hemorrhage and cerebral ventricular rupture. Head MRI showed no obvious cerebrovascular abnormality, so she was followed up with symptomatic treatment. Recovery was uneventful, without neurological sequelae, and she was discharged on postpartum day 27. Cerebral hemorrhage during pregnancy is caused in many cases by comorbidities such as cerebral aneurysm, cerebral artery malformation, and pregnancyinduced hypertension syndrome. Cerebral hemorrhage may occur in pregnant women with no risk factors, even when their vital signs are stable. It is necessary to pay attention to the appearance of new symptoms, such as vomiting, around the time of delivery.