1.Evaluation of Dermatological Disorders Caused by Anti-neoplastic Agents with an Adverse Event Spontaneous Reporting Database
Yuuki Hane ; Ryogo Umetsu ; Junko Abe ; Natsumi Ueda ; Yamato Kato ; Toshinobu Matsui ; Yumi Motooka ; Sayaka Sasaoka ; Haruna Hatahira ; Akiho Fukuda ; Misa Naganuma ; Siori Hasegawa ; Yasutomi Kinosada ; Mitsuhiro Nakamura
Japanese Journal of Drug Informatics 2016;18(3):201-208
Introduction: Dermatological disorders are one of the adverse events caused by cancer chemotherapy and are a dose-limiting factor for some anti-neoplastic agents. The severe symptoms associated with these disorders affect the patients’ quality of life (QOL). Early countermeasures for the onset of dermatological disorders associated with anti-neoplastic agent administration might be important.
Materials and Methods: We analyzed the occurrences of dermatological disorders after administration of an anti-neoplastic agent in the Food and Drug Administration Adverse Event Reporting System (FAERS), and compared the adverse event (AE) reporting ratio of the total reports. In addition, we studied the association between anti-neoplastic agents and dermatological disorders using cluster analysis. Reports for 15 anti-neoplastic agents (4 anti-neoplastic agents and 11 molecular target drugs) were analyzed.
Results: After excluding duplicate data in FAERS, 6,157,897 reports were analyzed. The number of reports that showed a dermatological disorder was 534,934. The reporting ratio of hand-foot syndrome with sorafenib and capecitabine was 11.20% and 7.05%, respectively.
Conclusions: We set the cluster number at six; cluster features obtained were as follows: (1) the reporting ratio of hand-foot syndrome was especially high, followed by the reporting ratio of rash, (2) the reporting ratio of rash and erythema was high. Similar anti-neoplastic agents may demonstrate similar occurrence tendencies of AEs and cluster features. Further studies are required to draw conclusions over these findings. Information services based on the feature of each cluster might be useful to improve patient QOL at the clinical site.
2.A blended learning program providing core competency in clinical research
Naoki Kakudate ; Yukio Tsugihashi ; Yoko Yokoyama ; Yosuke Yamamoto ; Hiroki Mishina ; Fumiaki Nakamura ; Norio Fukumori ; Misa Takegami ; Shinya Ohno ; Keiko Sato ; Takafumi Wakita ; Kazuhiro Watanabe ; Takuhiro Yamaguchi ; Shunichi Fukuhara
Medical Education 2012;43(3):205-210
In Japan, few health care professionals have a basic understanding(core competency)of the design of clinical research and statistical analysis. We developed a blended distance–learning program comprising face–to–face lectures with e–learning for busy health care professionals who work in the clinical settings to achieve core competency in clinical research. The purpose of this study was to examine the educational effects of this program.
1)Four months after the end of the program, 64% of the participants had started to conduct clinical research.
2)This program may increase the number of research colleagues that can discuss clinical research.
3)This program could enhance the confidence(self–efficacy)of health care professionals in clinical research.
3.Clinical outcome in patients with hand lesions associated with complex regional pain syndrome after arthroscopic rotator cuff repair
Takaki IMAI ; Masafumi GOTOH ; Keiji FUKUDA ; Misa OGINO ; Hidehiro NAKAMURA ; Hiroki OHZONO ; Naoto SHIBA ; Takahiro OKAWA
Clinics in Shoulder and Elbow 2021;24(2):80-87
Background:
Complex regional pain syndrome (CRPS)-related hand lesions are one of the complications following arthroscopic rotator cuff repair (ARCR). This study aimed to investigate the clinical outcomes of patients with CRPS-related hand lesions following ARCR.
Methods:
Altogether, 103 patients with ARCR were included in this study (mean age, 63.6±8.2 years; 66 males and 37 females; follow-up period, preoperative to 12 months postoperative). Clinical assessment included the Japanese Orthopaedic Association (JOA) score, University of California, Los Angeles (UCLA) score, Constant score, 36-item short form health survey (SF-36) score, and Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) score from preoperative to 12 months postoperatively. The patients were either assigned to the CRPS group or non-CRPS group depending on CRPS diagnosis until the final follow-up, and clinical outcomes were then compared between the groups.
Results:
Of 103 patients, 20 (19.4%) had CRPS-related hand lesions that developed entirely within 2 months postoperatively. Both groups showed significant improvement in JOA, UCLA, and Constant scores preoperatively to 12 months postoperatively (P<0.0001). Comparisons between the two groups were not significantly different, except for SF-36 “general health perception” (P<0.05) at 12 months postoperatively. At final follow-up, three patients had residual CRPS-related hand lesions with limited range of motion and finger edema.
Conclusions
CRPS-related hand lesions developed in 19.4% of patients following ARCR. Shoulder or upper-limb function improved in most cases at 12 months, with satisfactory SF-36 patient-based evaluation results. Patients with residual CRPS-related hand lesions at the last follow-up require long-term follow-up.
4.Clinical outcome in patients with hand lesions associated with complex regional pain syndrome after arthroscopic rotator cuff repair
Takaki IMAI ; Masafumi GOTOH ; Keiji FUKUDA ; Misa OGINO ; Hidehiro NAKAMURA ; Hiroki OHZONO ; Naoto SHIBA ; Takahiro OKAWA
Clinics in Shoulder and Elbow 2021;24(2):80-87
Background:
Complex regional pain syndrome (CRPS)-related hand lesions are one of the complications following arthroscopic rotator cuff repair (ARCR). This study aimed to investigate the clinical outcomes of patients with CRPS-related hand lesions following ARCR.
Methods:
Altogether, 103 patients with ARCR were included in this study (mean age, 63.6±8.2 years; 66 males and 37 females; follow-up period, preoperative to 12 months postoperative). Clinical assessment included the Japanese Orthopaedic Association (JOA) score, University of California, Los Angeles (UCLA) score, Constant score, 36-item short form health survey (SF-36) score, and Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) score from preoperative to 12 months postoperatively. The patients were either assigned to the CRPS group or non-CRPS group depending on CRPS diagnosis until the final follow-up, and clinical outcomes were then compared between the groups.
Results:
Of 103 patients, 20 (19.4%) had CRPS-related hand lesions that developed entirely within 2 months postoperatively. Both groups showed significant improvement in JOA, UCLA, and Constant scores preoperatively to 12 months postoperatively (P<0.0001). Comparisons between the two groups were not significantly different, except for SF-36 “general health perception” (P<0.05) at 12 months postoperatively. At final follow-up, three patients had residual CRPS-related hand lesions with limited range of motion and finger edema.
Conclusions
CRPS-related hand lesions developed in 19.4% of patients following ARCR. Shoulder or upper-limb function improved in most cases at 12 months, with satisfactory SF-36 patient-based evaluation results. Patients with residual CRPS-related hand lesions at the last follow-up require long-term follow-up.
5.Calcitonin induces connective tissue growth factor through ERK1/2 signaling in renal tubular cells.
Misa NAKAMURA ; Takashi OZAKI ; Aiko ISHII ; Masayoshi KONISHI ; Yuji TSUBOTA ; Toru FURUI ; Hayato TSUDA ; Ichiro MORI ; Kiichiro OTA ; Kennichi KAKUDO
Experimental & Molecular Medicine 2009;41(5):307-314
Calcitonin (CT), a polypeptide hormone, plays important roles in a variety of physiological processes. CT has been used clinically to treat osteoporosis and humoral hypercalcemia of malignancy. In order to clarify the pharmacological effects of CT in the kidney, we identified potential downstream genes induced by CT in the renal cells. Using a cDNA subtraction hybridization method, we identified connective tissue growth factor (CTGF) as a CT-induced gene in the porcine renal cell line, LLC-PK1. Furthermore, we found that CT-mediated induction of the gene was not inhibited by cycloheximide, which suggests that CTGF gene was not induced by an increased synthesis of regulating proteins. Therefore, CTGF is an immediate early gene. We further demonstrated that the regulation of CTGF gene expression by CT involved the ERK1/2 pathway, because PD98059, a MEK1 inhibitor, partially inhibited the mRNA expression of CTGF induced by CT. CT-induced CTGF protein expression was also observed in vivo. Our present findings suggest that CT induces the transcription of CTGF through ERK1/2 phosphorylation. We also identified twelve other genes induced by CT that, like CTGF, were related to wound healing. These results suggest that CT may have an effect on renal differentiation and wound healing in the kidney.
Animals
;
Calcitonin/*pharmacology
;
Cell Line
;
Connective Tissue Growth Factor/*genetics/metabolism
;
Female
;
Kidney Tubules, Proximal/*enzymology/metabolism
;
*MAP Kinase Signaling System
;
Mice
;
Mice, Inbred BALB C
;
Mitogen-Activated Protein Kinase 1/*metabolism
;
Mitogen-Activated Protein Kinase 3/*metabolism
;
Phosphorylation
;
Swine
6.Calcitonin induces connective tissue growth factor through ERK1/2 signaling in renal tubular cells.
Misa NAKAMURA ; Takashi OZAKI ; Aiko ISHII ; Masayoshi KONISHI ; Yuji TSUBOTA ; Toru FURUI ; Hayato TSUDA ; Ichiro MORI ; Kiichiro OTA ; Kennichi KAKUDO
Experimental & Molecular Medicine 2009;41(5):307-314
Calcitonin (CT), a polypeptide hormone, plays important roles in a variety of physiological processes. CT has been used clinically to treat osteoporosis and humoral hypercalcemia of malignancy. In order to clarify the pharmacological effects of CT in the kidney, we identified potential downstream genes induced by CT in the renal cells. Using a cDNA subtraction hybridization method, we identified connective tissue growth factor (CTGF) as a CT-induced gene in the porcine renal cell line, LLC-PK1. Furthermore, we found that CT-mediated induction of the gene was not inhibited by cycloheximide, which suggests that CTGF gene was not induced by an increased synthesis of regulating proteins. Therefore, CTGF is an immediate early gene. We further demonstrated that the regulation of CTGF gene expression by CT involved the ERK1/2 pathway, because PD98059, a MEK1 inhibitor, partially inhibited the mRNA expression of CTGF induced by CT. CT-induced CTGF protein expression was also observed in vivo. Our present findings suggest that CT induces the transcription of CTGF through ERK1/2 phosphorylation. We also identified twelve other genes induced by CT that, like CTGF, were related to wound healing. These results suggest that CT may have an effect on renal differentiation and wound healing in the kidney.
Animals
;
Calcitonin/*pharmacology
;
Cell Line
;
Connective Tissue Growth Factor/*genetics/metabolism
;
Female
;
Kidney Tubules, Proximal/*enzymology/metabolism
;
*MAP Kinase Signaling System
;
Mice
;
Mice, Inbred BALB C
;
Mitogen-Activated Protein Kinase 1/*metabolism
;
Mitogen-Activated Protein Kinase 3/*metabolism
;
Phosphorylation
;
Swine