1.Appendix 1
Masao IWAGAMI ; Kotonari AOKI ; Manabu AKAZAWA ; Chieko ISHIGURO ; Shinobu IMAI ; Nobuhiro OOBA ; Makiko KUSAMA ; Daisuke KOIDE ; Atsushi GOTO ; Norihiro KOBAYASHI ; Izumi SATO ; Sayuri NAKANE ; Makoto MIYAZAKI ; Kiyoshi KUBOTA
Japanese Journal of Pharmacoepidemiology 2018;23(2):124-124
2.Appendix 2
Masao IWAGAMI ; Kotonari AOKI ; Manabu AKAZAWA ; Chieko ISHIGURO ; Shinobu IMAI ; Nobuhiro OOBA ; Makiko KUSAMA ; Daisuke KOIDE ; Atsushi GOTO ; Norihiro KOBAYASHI ; Izumi SATO ; Sayuri NAKANE ; Makoto MIYAZAKI ; Kiyoshi KUBOTA
Japanese Journal of Pharmacoepidemiology 2018;23(2):125-130
3.Appendix 3
Masao IWAGAMI ; Kotonari AOKI ; Manabu AKAZAWA ; Chieko ISHIGURO ; Shinobu IMAI ; Nobuhiro OOBA ; Makiko KUSAMA ; Daisuke KOIDE ; Atsushi GOTO ; Norihiro KOBAYASHI ; Izumi SATO ; Sayuri NAKANE ; Makoto MIYAZAKI ; Kiyoshi KUBOTA
Japanese Journal of Pharmacoepidemiology 2018;23(2):131-139
4.Appendix 4
Masao IWAGAMI ; Kotonari AOKI ; Manabu AKAZAWA ; Chieko ISHIGURO ; Shinobu IMAI ; Nobuhiro OOBA ; Makiko KUSAMA ; Daisuke KOIDE ; Atsushi GOTO ; Norihiro KOBAYASHI ; Izumi SATO ; Sayuri NAKANE ; Makoto MIYAZAKI ; Kiyoshi KUBOTA
Japanese Journal of Pharmacoepidemiology 2018;23(2):140-143
5.Appendix 5
Masao IWAGAMI ; Kotonari AOKI ; Manabu AKAZAWA ; Chieko ISHIGURO ; Shinobu IMAI ; Nobuhiro OOBA ; Makiko KUSAMA ; Daisuke KOIDE ; Atsushi GOTO ; Norihiro KOBAYASHI ; Izumi SATO ; Sayuri NAKANE ; Makoto MIYAZAKI ; Kiyoshi KUBOTA
Japanese Journal of Pharmacoepidemiology 2018;23(2):144-146
6.Task Force Report on the Validation of Diagnosis Codes and Other Outcome Definitions in the Japanese Receipt Data
Masao IWAGAMI ; Kotonari AOKI ; Manabu AKAZAWA ; Chieko ISHIGURO ; Shinobu IMAI ; Nobuhiro OOBA ; Makiko KUSAMA ; Daisuke KOIDE ; Atsushi GOTO ; Norihiro KOBAYASHI ; Izumi SATO ; Sayuri NAKANE ; Makoto MIYAZAKI ; Kiyoshi KUBOTA
Japanese Journal of Pharmacoepidemiology 2018;23(2):95-123
Although the recent revision of the ministerial ordinance on Good Post-marketing Study Practice (GPSP) included the utilization of medical information databases for post-marketing surveillance, there has been limited research on the validity of diagnosis codes and other outcome definitions in Japanese databases such as administrative claims (“receipt”) database. This task force proposed how to conduct good validations studies, based on the narrative review on around 100 published papers around the world. The established check list consists of : (ⅰ) understanding the type of the database (e.g. administrative claims data, electronic health records, disease registry) ; (ii) understanding the setting of the validation study (e.g. “population-based” or not) ; (iii) defining the study outcome ; (iv) determining the way of linkage between databases ; (v) defining the gold standard ; (vi) selecting the sampling method (e.g. using the information of all patients in the database or a hospital, random sampling from all patients, random sampling from patients satisfying the outcome definition, random sampling from patients satisfying and not satisfying the outcome definition, “all possible cases” method) and sample size ; (vii) calculating the measures of validity (e.g. sensitivity, specificity, positive predictive value, negative predictive value) ; and (viii) discussing how to use the result for future studies. In current Japan, where the linkage between databases is logistically and legally difficult, most validation studies would to be conducted on a hospital basis. In such a situation, detailed description of hospital and patient characteristics is important to discuss the generalizability of the validation study result to the entire database. This report is expected to encourage and help to conduct appropriate validation studies.
7.Targeting hyaluronan for the treatment of pancreatic ductal adenocarcinoma.
Norihiro SATO ; Xiao-Bo CHENG ; Shiro KOHI ; Atsuhiro KOGA ; Keiji HIRATA
Acta Pharmaceutica Sinica B 2016;6(2):101-105
Progression of cancer is often associated with interactions between cancer cells and extracellular matrix (ECM) surrounding them. Increasing evidence has suggested that accumulation of hyaluronan (HA), a major component of ECM, provides a favorable microenvironment for cancer progression. Pancreatic ductal adenocarcinoma (PDAC) is characterized typically by a dense desmoplastic stroma with a large amount of HA, making this molecule as an attractive target for therapy. Several studies have shown efficacy of inhibitors of HA synthesis or signaling for the treatment of PDAC. Recent studies have also demonstrated substantial improvements in the effects of chemotherapy by a targeted depletion of stromal HA in PDAC using an enzymatic agent. Thus, targeting HA has been recognized as a promising therapeutic strategy to treat this highly aggressive neoplasm. In this review article, we summarize our current understanding of the role of HA in the progression of PDAC and discuss possible therapeutic approaches targeting HA.
8.A case of bronchial asthma improved by acupuncture therapy.
Masaaki SHINOHARA ; Norihiro YAMAUCHI ; Hiroaki NOBUHARA ; Toru SATO
Journal of the Japan Society of Acupuncture and Moxibustion 1990;40(4):383-389
A 73 year old female, who had suffered from serious bronchial asthma and had been taking prednisolone and theophylline, was treated with acupuncture and herbal medicine. Twenty points, which are so called effective points for bronchial asthma, were used for acupuncture, e. g. LU 1: Zhongij, LU 2: Yunmen, and CV 22: Tiantu, etc. As Ryoudouraku mesurments showed suppression of F3 (Kidny Meridian) and F5 (Gallbladder Meridian), the exciting points on those meridians (KI 7: Fuliu and GB 43: Xiaxi) were also mildly stimulated by acupuncture. The severity of asthmatic attack, the strength of cough and the amount of sputum were expressed by a scoring system, where the most sever one which had been experienced before was scored as 10.
At the initiation of acupuncture, the frequency of asthmatic attack was 5 times a day, the severity of asthmatic attack was 6/10, the strength of cough was 6/10 and the amount of sputum was 8/10. Recently prednisolone was successfully reduced from 20mg to 7.5mg per day with acupuncture and the severity of asthmatic attack, the strength of cough and the amount of sputum were improved to 2/10, 1/10 and 3/10, respectively.
On the other hand, % FVC, FEV 1.0% and blood gas analysis data were not improved.
In summary, we believe that acupuncture acts beneficially to reduce the subjective symptoms of asthma even when the dose of prednisolone were decreased.
9.Effects of electrical acupuncture on pain threshold.
Masaaki SHINOHARA ; Norihiro YAMAUCHI ; Koichi KAMIMURA ; Hiroaki NOBUHARA ; Toru SATO
Journal of the Japan Society of Acupuncture and Moxibustion 1989;39(3):300-305
On twenty patients and ten healthy adult volunteers, pain threshold was measured by a dolorimeter (Pain meter NYT-5) to clarify whether analgesic effects of electrical acupuncture on various body surface may be changed by acupuncture points or not.
Electrical acupuncture was performed to the traditional acupuncture points on the two meridians. A group is the combination of LI 10 (Shousanli) and LI 14 (Hoku) on the right side, the other is the combination of ST 36 (Tsusanli) and ST 40 (Liangchiu) on the right side.
Measured points of pain threshold are (1) face, (the point 2cm above from the center of both eyelids), (2) (3) left and right upper extremities (LI 11; Chuchih) and (4) (5) left and right lower extremities (ST 41; Chiehhsi).
In the Shousanli-Hoku group, pain thresholds of face, both upper extrimities increased significantly. However, those of both lower extremities were not significantly changed.
In the Tsusanli-Liangchiu group, pain thresholds of the upper and lower extremities on both sides increased significantly. However there were no significant changes in the forehead.
In comparison of two groups, increases of pain thresholds of both lower extremities were observed in significantly more cases with acupuncture to Tsusanli and Liangchiu points than those with Shousanli and Hoku points by the Chi-square test (p<0.01). From this fact, acupuncture of Tsusanli-Liangchiu points seems to be more effective on the lower extremities than that of the Shousanli-Hoku points.
Therefore, we conclude that effects on pain threshold by electrical acupuncture depend on various points on meridians and are not evenly shown on the whole body surface.
10.Effects of electrical acupuncture on the autonomic nervous system function after local anesthesia to the acupuncture points.
Masaaki SHINOHARA ; Yuriko IMAOKA ; Norihiro YAMAUCHI ; Koichi KAMIMURA ; Akira TANAKA ; Toru SATO
Journal of the Japan Society of Acupuncture and Moxibustion 1988;38(4):403-408
This study was performed to clarify whether local anesthesia or sympathetic ganglion block abolishes the effects of electrical acupuncture (EA) on the autonomic nervous system or not.
Twelve healthy adult volunteers and 24 patients are divided into the following three experimental groups of each 12. EA was performed to the traditional acupuncture points on the meridians (H7; SHENMEN and CX4; HSIMEN). (1) In control group, only EA was performed. (2) In stellate ganglion block (SGB) group, EA was performed after unilateral SGB. (3) In local anesthesia (LA) group, EA was performed after local anesthesia on the same acupuncture points. The measured parameters on the autonomic nervous system functions were heart rates, R-R intervals in ECG, blood pressure and deep tissue temperature.
Results are as follows; Means of heart rate decreased significantly by EA in both control and SGB groups. Systolic blood pressure, diastolic blood pressure and RR-CV showed no significant changes by EA in all groups. Deep tissue temperature of the anterior forearm ipsilateral to the stimulation side decreased significantly by EA in SGB group. Deep tissure temperature of the anterior forearm contralateral to the stimuli decreased significantly by EA in both control and SGB groups. In LA group, however, all parameters were not changed by EA.
In summary, the effects of electrical acupuncture on the autonomic nervous system were not much different between control and SGB groups. It seems that one side of stellate ganglion block dose not interfere with the effects of acupuncture. On the other hand, any changes on the autonomic nervous system by electrical acupuncture were not observed in LA group. The fact showed that local anesthesia abolishes the effects of acupuncture on site. Local anesthesia blocks peripheral nerves and nerve endings. Therefore, we conclude that the effects of acupuncture on the autonomic nervous system are transmitted through the peripheral nerves, especially through the sensory nerves.


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