Neoadjuvant chemotherapyeoadjuvant chemoradiotherapy (NAC/NACRT) can be performed in patients with pancreatic cancer to improve survival. We aimed to clarify the clinical outcomes of biliary drainage with a metal stent (MS) or a plastic stent (PS) during NAC/NACRT. Between October 2013 and April 2016, 96 patients with pancreatic cancer were registered for NAC/NACRT. Of these, 29 patients who underwent biliary drainage with MS or PS before NAC/NACRT and a subsequent pancreatoduodenectomy were retrospectively analyzed with regard to patient characteristics, preoperative recurrent biliary obstruction rate, NAC/NACRT delay or discontinuation rate, and operative characteristics. The median age of the patients was 67 years. NAC and NACRT were performed in 14 and 15 patients, respectively, and MS and PS were used in 17 and 12 patients, respectively. Recurrent biliary obstruction occurred in 6% and 83% of the patients in the MS and PS groups, respectively (p<0.001). NAC/NACRT delay was observed in 35% and 50% of the patients in the MS and PS groups, respectively (p=0.680). NAC/NACRT discontinuation was observed in 12% and 17% of the patients in the MS and PS groups, respectively (p=1.000). The operative time in the MS group tended to be longer than that in the PS group (625 minutes vs 497 minutes, p=0.051), and the operative blood loss volumes and postoperative adverse event rates were not different between the two groups. MS was better than PS from the viewpoint of preventing recurrent biliary obstruction, although MS was similar to PS with regards to perioperative outcomes.

　　Epidermal growth factor receptor (EGFR) gene mutation examination is now performed in most medical institutions in order to select the molecular targeted medicine for lung cancer. It became clear that the positive rate of the biopsy material was lower than that of the surgical sample in this hospital. The cause was attributed to false negatives due to low tumor cell content in biopsy specimens. We investigated the presence of the mutation using surgical samples and preoperative biopsy specimens from the same patients in 13 cases. Furthermore, we investigated the tumor cell content of the biopsy specimens by cell counting. Results showed that 3 of 6 biopsy specimens that were associated with positive surgical samples were judged to be negative. The tumor cell content was less than 5% in all negative cases. Regarding EGFR gene mutation examination, we should carefully determine tumor cell content when using biopsy specimens.

MHLW released a guideline for Risk Management Plan (RMP) in April 2012, in order to manage the risk of pharmaceutical products from the development stage towards post marketing period. The guideline suggests to determine Safety Specification and to develop Pharmacovigilance Plan (PVP) and Risk Minimization Plan aligned to the ICH E2E guideline. However, in some of the RMPs, which had been published online (as of August 2014), conventional (Special) Drug Use Results Surveys are planned as a “universal” PVP regardless of the impact, severity and characteristics of the risks. Our JPMA taskforce (Data Science Expert Committee) summarized report and published in August 2014. In this report, we explained how to evaluate safety events based on evidence level for safety specification and how to develop PVP. Also, we would like to propose KAIZEN activities for RMP improvement as follows:
1. In order to clarify the research question, rationale and evidence for safety specification should be evaluated carefully.
2. It is essential to be considered in advance how to collect and analyze the safety data for detecting safety specification during clinical development.
3. Safety profiles should be discussed thoroughly on DSUR development among stakeholders in order to clarify safety specification at NDA. Research questions for each different risk and missing information should be established according to PECO, which will flow into appropriate PVP planning.
4. Continuous PDCA cycling is critical for RMP. The first survey or research will bring you next research question (s).
We expect all stakeholders, including clinical development specialists in industry, regulatory authorities, and academia, to have better understating of RMP principle and to manage and implement it more appropriately in a scientific manner.

We administered a Kampo decoction containing bushi (prepared aconiti tuber) or uzu (un-prepared aconiti tuber) to two children in Aso Iizuka hospital. Case 1 was a thirteen year-old girl with atopic dermatitis that worsened after her topical steroid was stopped. When her itching sensation was reduced following a bath, we considered that she was suffering from coldness. Therefore we administered a half dose of bukuryoshigyakuto.The next morning her old skin flaked off and her skin appeared healthy. We administered bukuryoshigyakuto before every meal and there was rapid improvement in her dermatitis. Case 2 was a twelve year-old girl with orthostatic dysregulation who was unable to attend school. She had become aware of coldness the previous autumn and had not been able to go to school, nor even sit up, since the previous winter because of severe fatigue. We diagnosed her with severe coldness and so started sekiganryo administration, and included 2 g of uzu. We gradually increased the uzu. At a result, her severe fatigue improved to the extent that she could eat breakfast and go to school inside the hospital. Children may have severe coldness if they suffer from a long-term illness. Moreover, particular attention should be given to toxicity caused by aconiti tuber.

Background: Complementary medicine and alternative medicine have been included in the curricula of many medical schools and colleges; however, teaching methods have not been standardized. We gave lectures and practical instruction on acupuncture and moxibustion medicine to medical students during their clinical clerkship in anesthesiology. We used a questionnaire to evaluate the usefulness of small-group teaching.
Methods: The subjects were 93 fifth-year medical students doing clinical clerkships in anesthesiology. The clinical clerkship consists of small-group learning with 2 or 3 students per group. After a lecture and practical instruction on acupuncture and moxibustion were given, students were asked to fill out a questionnaire about their interest in and basic knowledge of acupuncture and moxibustion and whether they would like to master the technique.
Results: All 93 students answered the questionnaire （response rate, 100%）. After the small-group teaching, students became more interested in acupuncture and moxibustion and learned that the costs of treatment were covered by health insurance. Most students were interested mastering acupuncture and moxibustion in the future.
Discussion: Our results suggest that lectures and practical instruction during clinical clerkship are useful for getting medical students interested in acupuncture and moxibustion medicine.

A 51-year-old male with cyclic neutropenia, on whom we previously reported, was admitted to our hospital with severe abdominal pain and diarrhea four years and seven months after his last hospitalization. Since then, he has received Kampo treatment at our hospital every three weeks, with good clinical results. This time, he was at first treated with Kampo daikenchuto combined with bushikobeito, which had been effective during his last hospitalization, although this time the remedy had no effect. From the viewpoint of Japanese traditional (Kampo) medicine, it was considered that the patient had severe cold syndrome. He was given uzukeishito three times a day (at 10.00, 15.00 and 20.00 hours). The dose of uzu in uzukeishito was gradually increased. Daiuzusen, in which the dose of uzu (an aconite) was 1g or 2g, was also administered five times a day due to the patient's very severe abdominal pain. On the fourth day of uzukeishito administration, the patient felt very hot and still had severe abdominal pain, although this pain was different from the previous pain, thirty minutes after daiuzusen (with 2g dose of uzu) was administered. This reaction can better be explained as mengen rather than uzu poisoning. Very soon he had a good appetite, his abdominal pain was reduced and the cycle of neutropenia was normalized. The case suggests that in cases of very severe cold syndrome, frequent and high-dose administration of aconite component medicine can be effective.

Recently, the number of athletes who receive acupuncture therapy is increasing. However, most of these athletes receive acupuncture therapy with single-acupuncture and/or electro-acupuncture to a local point, or a trigger point. We experienced two water polo athletes who were improved using acupuncture and moxibustion therapy with “zuisho” therapy. Case 1 was 16 year old man. He became aware of pain in his right thumb after training, which continued with extended training time, a numbness in his left hand appeared more, and he received acupuncture and moxibustion therapy. These symptoms disappeared immediately with acupuncture and moxibustion therapy using the standard traditional methods, such as contact needling to a yuan point, and in situ acupuncture to a back shu point, etc. Case 2 was 17 year old man. He received acupuncture and moxibustion therapy for lumbago and stiffness of the neck. These symptoms disappeared immediately after acupuncture and moxibustion therapy using the standard traditional methods such as contact needling to a yuan point, and inserting needles into a back shu point, an extra meridian, etc. In these two cases, symptoms were improved with “zuisho” therapy, and both could continue with longer and more strenuous training. This suggests that acupuncture and moxibustion therapy using the standard traditional methods are useful for athletes.
Acupuncture ; Therapeutic procedure ; symptoms <1> ; Training ; Water

Sho-syndrome was analyzed by cluster analysis of answers to a set of questionnaire presented to first-visit patients at a hospital of Japanese-Oriental (Kampo) medicine. The answers from 270 new patients were classified into 3 groups by hierarchical cluster analysis, with a total of 202 non-female related items. We looked at which Sho-syndromes of metabolic (Mb: “Kan-” _??_-), gastrointestinal (Gi: “Hi” _??_-), respiratory (Rp: “Hai-” _??_-), or water and mineral-balance (Wm: “Zin-” _??_-) deficiency (“Kyo” _??_) disorders were included, in one of the groups at high frequencies. Water and mineral-balance deficiency disorders were in Group II and III, while metabolic deficiency disorders were in Group III. We conclude that the results of this analysis support the rationale for the empirical determination of Sho-syndrome, in addition to pulse diagnosis by Kampo-clinicians who examine patients.

The objective of this study was to investigate whether isometric resistance exercise (IRE) can attenuate musculoskeletal atrophy during unloading and accelerate its recovery during reloading. Twenty-six female Fischer 344 rats, aged 16 weeks, had their hindlimbs suspended for 3 weeks (unloading) ; 12 of these rats were allowed subsequent cage activity (reloading) for 3 weeks with or without IRE. IRE (stationary support on a cylindrical grid inclined 60 or 80 degrees) was done for 30 min/day, 6 days/week, with an additional load of 30% or 50% body mass attached to the tail during the unloading and reloading periods. The tibial bone and hindlimb skeletal muscles from four experimental and two age-matched control groups were evaluated with dual-energy X-ray absorptiometry, mechanical testing, and muscle mass measurement. Bone mineral density (BMD) was measured in the whole tibia and in 7 regions divided equally along the long axis of the epiphysis from proximal (R1) to distal (R7) . After unloading, fat-free dry mass (FFDM), bone mineral content (BMC), and BMD of the whole tibia decreased by 8%, 10%, and 6%, respectively. FFDM and BMC, but not BMD, returned to the levels of age-matched controls during reloading. Unloading-induced decreases in BMD were observed in the regions from the proximal epiphysis to the diaphysis (R1 to R4) and the distal epiphysis (R7) . The rate of decrease in BMD was regionally specific and was particularly pronounced (12%) in the most proximal region (R1) . These findings indicate regional variations in responses of BMD to skeletal unloading. The BMD in R2 to R4 remained less than that in age-matched control after reloading. No significant changes were observed in maximum breaking load, energy, and deformation after unloading and reloading. Hindlimb-unloading induced loss of mass in the soleus (38%), plantaris (14%), gastrocnemius (25%), tibialis anterior (8%), extensor digitorum longus ( 8%), and rectos lemons (17%) muscles, but the mass of muscles, except for the soleus muscle, recovered during reloading. IRE ameliorated the loss of mass in the soleus and gastrocnemius muscles during unloading but did not promote the recovery of mass in any muscles during reloading. Moreover, IRE showed no effect on bone responses after unloading and reloading. This lack of beneficial effects of IRE on osteopenia may be due, in part, to insufficient exerciseinduced load. We concluded that 1) regional analysis of BMD can be used to assess local bone metabolism, 2) the response of BMD to altered loading conditions does not necessarily depend on the response of muscle mass, 3) recovery from osteopenia progresses more slowly than that from sarcopenia, and a longer time than the unloading period is required to restore BMD. Further studies are needed to develop more effective countermeasures against osteopenia and sarcopenia.