1.Survey on the Attitudes of Citizens toward Genetic Analysis Studies Associated with Clinical Trials Planned by the Pharmaceutical Industry
Kenji Momo ; Takeshi Yamada ; Hideo Tsurushima ; Yoshihiro Arakawa
Japanese Journal of Drug Informatics 2017;19(2):59-63
Objective: Owing to the recent advances in genetic analysis technology, its application in drug development is expected to increase, although there are concerns regarding the leakage of personal information. This study aimed to assess the attitudes of community citizens toward genetic analysis studies associated with clinical trials planned by the pharmaceutical industry.
Methods: A questionnaire survey was conducted after an educational seminar on drug development at a university campus festival. Answers were obtained from 47 citizens (16 males and 31 females, ages ranging from teens to fifties).
Results: Attitudes toward providing genome samples were assessed using a 100-mm visual analogue scale, and the data revealed significant differences in the conditions of sample use (A, limited to specific genes during the trial, 89±14 mm; B, limited to genes related to the test drug or target disease, 81±23 mm; C, unlimited, 71±33 mm, p<0.01). Twenty-seven citizens (57%) consistently expressed acceptance toward all three conditions. The remaining 38% (n=18) expressed denial as the analysis targets widened. Regarding the acceptable period for sample storage, 17 citizens (36%) allowed “indefinite storage” but 14 citizens (30%) requested “immediate disposal after analysis.” A feedback on the accidental findings of abnormalities was requested by 43 citizens (91%).
Conclusion: The results demonstrated a wide variety of attitudes toward providing samples. On the other hand, most citizens requested a feedback on the findings of abnormalities for disease-related genes. These results suggest that it is necessary to improve the study protocol to reflect these fears and expectations.
2.Indomethacin spray for radiation oral mucositis -A report of five cases-
Kiyoka Ebina ; Yoshiyuki Kizawa ; Masato Homma ; Tetsuro Wada ; Kenji Momo ; Hiroyuki Hosono ; Yukinao Kohda
Palliative Care Research 2007;2(1):301-305
We report that a case of maxillary sinus carcinoma with severe pain for radiation oral mucositis was successfully managed by using indomethacin spray. Fifty three-year-old male who was treated with radiation and chemotherapy including 5-FU for his maxillary sinus carcinoma developed oral mucositis with severe pain. Several medications such as diclofenac sodium (tablet), oxycodone hydrochloride (sustained-release tablet), morphine sulfate (fine granule), fentanyl (patch), azulene (gargle) and lidocaine (viscous) did not provide satisfactory effects on the pain control. We, therefore, tried to use indomethacin spray (0.2 mg/0.08 mL/push) with the daily dose of 9.6±5.2 mg (2-10 push/once, 1-11 times daily). Indomethacin spray provided dramatic effects on his pain relief with the significant reduction of pain score (face scale) from 2.4±0.4 to 1.0±0.1 (p<0.01). Mean time for pain relief was 8.7±2.2 min. after applying indomethacin spray. The effects of indomethacin spray on the radiation oral mucositis were evaluated by pain score in five patients with head-and-neck carcinoma. The pain score was improved in all cases after introducing indomethacin spray (before vs. after: 3.2±0.5 vs. 1.6±0.6, p<0.01) with the 8.1±3.8 mg/day. There was no adverse events associated with the use of indomethacin spray. The results suggest that the use of indomethacin spray is an alternative approach to control the pain for radiation oral mucositis in patients under radiation therapy for head-and-neck carcinoma.