1.Comparison of Formulation Property and Therapeutic Safety of Paclitaxel between Generic Products
Hiroyuki Ono ; Yuhki Sato ; Nobuhiro Oyama ; Ryosuke Nakahara ; Masae Kuranari ; Hiroki Itoh
Japanese Journal of Drug Informatics 2016;18(1):7-12
Background: Because generic medicines reduce the financial burden on patients and medical insurance providers, they become more popular year after year. However, there are still few reports that analyze the efficacy and safety of generic medicines, especially in terms of their characteristics and side effects.
Methods: Paclitaxel is an antineoplastic frequently used with good results in the treatment of breast cancer, ovarian cancer, gastric cancer, and angiosarcoma, but fat solubility is high and various kinds of adverse events, such as myelosuppression and arthralgia, peripheral neuropathy, and alcohol hypersensitivity are known to develop. We investigated the efficacy, characteristics, and the incidence of adverse events for the generic product of paclitaxel.
Results: Differences were found for the generic version in terms of the characteristics and preparation time.
Conclusion: The incidence of adverse events was not significant, suggesting that the generic version could be a reasonable substitute.
2.Evaluation of Newspaper Stories on Drug Therapy with “Media Doctor” Instrument
Kyoko KITAZAWA ; Masae SATO ; Kiyotaka WATANABE ; Michiko YAMAMOTO
Japanese Journal of Drug Informatics 2019;21(3):109-115
Objective: The objective of this study was to examine information quality by quantitatively evaluating newspaper stories on drug therapy using the “Media Doctor” instrument.Methods: A database search was conducted to extract newspaper stories on drug therapy published between July 1, 2017 and December 31, 2017. Two evaluators independently evaluated each story using the “Media Doctor” instrument. Each of the 10 evaluation criteria were rated as “satisfactory” or “not satisfactory.” When the content of the story was not suitable for the evaluation criteria, it was regarded as “not applicable”.Results: Fifty-nine news stories (Asahi: 13, Mainichi: 8, Nikkei: 8, Sankei: 14, Yomiuri: 16) were included. The median number of evaluation criteria that the two evaluators judged as “satisfactory” was 5. The proportions of stories that the two evaluators judged as satisfactory were “1. availability,” 73%; “2. novelty,” 66%; “3. alternatives,” 39%; “4. disease mongering,” 58%; “5. evidence,” 32%; “6. quantification of benefits,” 31%; “7. harm,” 41%; “8. cost,” 22%; “9. sources of information/conflict of interest,” 12%; and “10. headline,” 66%. Conversely, the proportions of stories judged as “not satisfactory” were “1. availability,” 0%; “2. novelty,” 5%; “3. alternatives,” 12%; “4. disease mongering,” 8%; “5. evidence,” 24%; “6. quantification of benefits,” 29%; “7. harm,” 41%; “8. cost,”44%; “9. sources of information/conflict of interest,” 32%; and “10. headline,” 12%.Conclusion: These results suggest that the quality of newspaper stories are insufficient as drug information in terms of the validity of its scientific evidence.
3.The use of conization to identify and treat severe lesions among prediagnosed CIN1 and 2 patients in Japan.
Mikio MIKAMI ; Masae IKEDA ; Hidetaka SATO ; Haruko IWASE ; Takayuki ENOMOTO ; Yoichi KOBAYASHI ; Hidetaka KATABUCHI
Journal of Gynecologic Oncology 2018;29(4):e46-
OBJECTIVE: To evaluate the clinical efficiency of identifying patients with suspicious severe lesions by conization among prediagnosed cervical intraepithelial neoplasia (CIN) 1 and 2 patients in Japan. METHODS: The data in a Japanese nation-wide registry for cervical cancer (2009 and 2011) was collected to analyze the clinical efficacy of pre- and postdiagnosis for 13,215 Japanese women who underwent treatment by conization. Their preoperative and postoperative histologic findings and clinical outcomes were evaluated using standard statistical procedures including clinical and demographic characteristics. RESULTS: Almost half of 1,536 women who were treated by conization after the prediagnosis of CIN1 and 2 because the lesions showed no evidence of natural regression actually contained CIN1–2 (45.0%), CIN3 (47%), or invasive cancer (2.7%) in their cervical tissue. They underwent conization either for therapeutic (treatment) (78.5%) or diagnostic (21.5%) reasons. Invasive disease was diagnosed postoperatively more often in diagnostic cases (6.1%) than in therapeutic cases (2.8%). All the patients survived their diagnostic and therapeutic conization after approximately 30 months of follow up. CONCLUSION: Our study shows that the continuous observation of the prediagnosed CIN1 and 2 cases by the combination of cytology, colposcopy and histology in Japan has worked successfully to identify severe lesions by using conization as well in the process.
Asian Continental Ancestry Group
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Cervical Intraepithelial Neoplasia
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Colposcopy
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Conization*
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Female
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Follow-Up Studies
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Humans
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Japan*
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Treatment Outcome
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Uterine Cervical Neoplasms
4.Vaginal Double Circular Incision-Closure Method: A New Technique for Vaginal Cuff Dehiscence after Total Laparoscopic Hysterectomy
Koji SHIMABUKURO ; Takanori YOSHIDA ; Tamami ODAI ; Takafumi TSUKADA ; Reiko NAKAMURA ; Ikuno YAMAUCHI ; Tatsuya SATO ; Haruka MANEYAMA ; Shiori KOHRI ; Yukiko NUSHI ; Yasuko NISHIDA ; Rie KITANO ; Asami HIRATA ; Maiko ICHIKAWA ; Seiichi ENDO ; Masae SAKAMOTO
Journal of the Japanese Association of Rural Medicine 2017;66(1):91-94
We report a case of vaginal cuff dehiscence after total laparoscopic hysterectomy that was successfully managed by a newly developed vaginal double-layer circular incision-closure method through a transvaginal approach. The nulligravid postmenopausal patient with cervical cancer received a diagnosis of vaginal evisceration on postoperative day 24. The eviscerated small intestine was pushed back after vaginal douching with normal saline before the procedure. The vaginal mucosa was incised circularly in two layers at the levels of 10 mm and 15 mm from the vaginal stump, and the edges apposed with double-layer closures. She was discharged on postoperative day 3 and followed up for 5 years, with no recurrence of cancer or vaginal dehiscence. This operative method is especially useful for a nulligravida with a small vagina.