Objective: The success rate of third-line treatment for Helicobacter pylori (H. pylori) infection has been reported to depend on the use of antibacterial agents, potassium-competitive acid blockers, and proton pump inhibitors. However, there is insufficient information on the success rate of H. pylori treatment due to the differences in the clinically used drugs. Here, the factors influencing the success rate of third-line treatment for H. pylori infection was investigated.

Methods: Patients aged 20 years or older, who had received third-line treatment for H. pylori infection from January 2013 to December 2021 at the Kameda Medical Center were included. The exclusion criteria were as follows: patients with unknown treatment results and discontinuation of treatment. The primary endpoint was treatment success rate, based on the differences in the treatment regimen and drug choice, which was retroactively investigated from medical records. Confounding factors were adjusted by multivariate logistic regression analysis.

Results: Treatment regimens containing sitafloxacin resulted in higher treatment success rates (p<0.05). Multivariate logistic regression analysis showed that the administration of sitafloxacin was the only statistically significant factor influencing treatment success. However, vonoprazan also tended to influence treatment success.

Conclusion: Treatment with sitafloxacin and vonoprazan increases the success rate of third-line treatment against H. pylori infection.

Objective: Pharmaceutical documents such as the common technical document, package inserts (PIs), and interview forms (IFs) are available at the website of the Pharmaceuticals and Medical Devices Agency. However, because these documents were created with an emphasis on human readability in paper form, it is difficult to use the information included and interoperate these documents with computers. Using IFs, we will investigate how to structure pharmaceutical documents in the AI era to achieve both human and machine readability.

Design/Methods: The IFs of arbitrary selected ten drugs were structured into Resource Description Framework (RDF) according to the Drug Interview Form Description Guidelines 2018 (updated version in 2019). The data were manually extracted from the IFs and entered into a spreadsheet before being converted to RDF by a written script. The PIs were converted to RDF in addition to the IFs. To examine the linkage with external databases, IDs in ChEMBL, which is a manually curated database of bioactive molecules with drug-like properties, were embedded in the RDF.

Results: We demonstrated that the conversion of IFs and PIs into RDF makes it possible to easily retrieve the corresponding part of the PIs cited in the IFs. Furthermore, we quickly obtained the relevant data from ChEMBL, demonstrating the feasibility of linking IFs with an external database. Our attempt to RDFization of IFs is expected to encourage the development of web applications for healthcare professionals and the development of datasets for AI development.

Conclusion: We could easily interoperate IFs with other pharmaceutical documents and an external database by converting IFs into RDF following the description guidelines. However, problems such as how to deal with items that were not described in the description guidelines were indicated. We hope that discussions will grow based on this effort and that related industries will move toward accomplishing effective use of these documents.

Objective: The placebo effect can enhance the response to treatment, even in the absence of pharmacological ingredients. One possible factor explaining the likelihood of the placebo effect in individuals is genetic polymorphisms in neurotransmitters. This study focused on gene polymorphisms in the catechol-O-methyltransferase (COMT) as an interindividual variable of the placebo effect.

Design・Methods: All 120 participants were explained the effects of caffeine, including its ability to ameliorate drowsiness and increase concentration, and then given a placebo (lactose). The onset of the placebo effect was measured in terms of the degree of caffeine-reduced sleepiness using subjective indices of the Stanford Sleepiness Scale (SSS) and a feeling of drowsiness-Visual Analogue Scale (VAS). The mechanism of the placebo effect was objectively examined in terms of changes in cerebral blood flow in the prefrontal cortex of the brain. In addition, we investigated participants’ susceptibility to the placebo effect by examining genetic polymorphisms in COMT.

Results: After taking the drug, sleepiness on the SSS and VAS was significantly improved (p＜0.001), although there was no change in prefrontal cortex activity. Among the 120 participants, 63 had a Val/Val-type polymorphism in COMT (52.5%), 45 had a Val/Met-type (37.5%), and 12 had a Met/Met-type (10.0%). There were no significant differences among COMT gene polymorphisms in the subjective measures of SSS and VAS. However, there was a tendency for the cerebral blood flow changes to be larger in the left hemisphere of the brain in individuals with the Met/Met type.

Conclusion: There seems to be a relationship between prefrontal cortex activity and genetic polymorphisms. In particular, there may be a correlation between the expression of a placebo effect and COMT gene polymorphisms.

Objective: In the instructions for package inserts (PI) of prescription drugs revised in June 2017, the section “persons with reproductive potential” was established under “precautions concerning patients with specific backgrounds.” The description rules associated with contraceptive duration were modified in these. In this study, we investigated descriptions of contraceptive duration in PI that were prepared based on the revised instructions, interview forms (IF), and other proper use materials (PM).

Methods: We collected PI, IF, and PM of prescription drugs containing a new active ingredient approved from April 2017 to March 2022 for which the PI were prepared based on the revised instructions and investigated descriptions of PI, contraceptive duration, and its evidence in each information material.

Results: Of the 181 drugs studied, 43.1 and 12.7% required females and males to use contraception during the period of drug consumption, respectively. Among these, the ratio of drugs that had descriptions of contraceptive duration were 15.4 and 0% for females and males at PI, respectively; 51.3 and 39.1% for female sand males at IF, respectively. Anticancer drugstended to describe contraceptive duration in the PM rather than PI or IF. For some drugs, there was no description of contraceptive duration in any of the materials. Contraceptive durations ranged from the period of administration of that drug to over a year for females and approximately one week to six months for males. The reasons for these contraceptive durations were diverse.

Conclusion: Contraceptive information in the PI based on revised instructions were not sufficient for use by healthcare workers, even when the IF and PM were confirmed. These results suggest that there is a need for standardizing the descriptions, types of materials to be described, and choice of evidence for contraceptive duration.