RevMate®is one of risk minimization activities in Japanese RMPs of Revlimd®and Pomalyst®, of which indications are hematological malignancy including multiple myeloma. This is a proper management procedure approved by Japanese health authorities in order to prevent exposure to pregnant women because these agents are derivatives of thalidomide. RevMate® was revised in 2015 after the discussion in MHLW's Taskforce and its operation started from April 2016. Due to this revision of version 5.0, the manufacture no longer receives the patient name, and this and other information must be managed by the hospital. In addition, with regard to the same objective in the format used in the management procedure（TERMS®）of thalidomide drug products, unification was attempted concerning the name of the format andthe notation of confirmation items. Physician becomes to make judgment to omit explanation of some RevMate® requirements based on the patient's level of their understandings to RevMate®. Periodical survey sheet regarding compliance with RevMate® requirement filled by a patient is to be submitted directly to a physician on his/her visit instead of sending it to the manufacturer by mail under previous procedures. A representative person of the manufacture is required to visit the hospital periodically and confirm filing condition of the survey sheets and compliance check lists of RevMate® for every prescription as well appropriately at the hospital. Furthermore, RevMate® was revised to add clear role description of relevant pharmacists and nurses for in-patients and its strict drug-handling procedures at bedside as version 5.1, as we received four reports from hospitals of medication error of our drug to the another patient in the hospital within 2016. After getting approval of additional indications for Revlimid® from March 2017, RevMate® of version 5.2 started. In the view of implement RevMate® as strict “risk minimization activities” to prevent pregnant women from exposure, we will continue to solve each problem recognized from the actual operation, constantly keep basics in mind by providing necessary training to our employees about thalidomide drug problem etc. In addition, we appreciate the understanding and support from the patient, patient family, Healthcare Professional, etc. involved in this procedure without incompleteness as well as non-compliance with procedures caused by habituation. Including all these, we consider it is important to endeavor as a manufacture continuously in the future.

This report describes a case of cluster headaches that was successfully treated with Senkito. The patient was a 46-year-old female. She had been having attacks of cluster headaches that had continued for 3 days at the change of seasons since she was 30 years old. During an attack, she took a triptan preparation and non-steroid anti-inflammatory drug (NSAID), but they were not effective. Recently, the attacks had been increasing in frequency and continued for 1-2 weeks. She visited our hospital for Kampo treatment. We diagnosed her as having oketsu and kiutsu ; therefore, we prescribed tsudosan, and the frequency and strength of the attacks decreased. Even if NSAIDs were effective for headaches, they were not consistently effective. We re-examined her and found she had inside biryokotsu, which is tenderness in the orbital part of the frontal bone. We diagnosed her headache as including biryokotsu pain. We prescribed Senkito as required for her biryokotsu pain. It was very effective and the headache vanished after only 30 min. Generally, the potency of Kampo medicines with few structural components is higher than that of those with many structural components. Senkito has only five structural components ; therefore, we concluded that Senkito is effective not only for everyday use but also for use when required. Senkito is one of the most effective formulations for treatment of biryokotsu pain,especially the patient with inside of biryokotsu tenderness.

Background: New onset fever is a common symptom among hospitalized patients and it may be a manifestation of fatal illnesses such as infection. However, its epidemiology and predictors for mortality have not been fully determined in a Japanese teaching hospital.
Methods: We investigated adult patients with new onset elevated temperature of 37.5 degrees Celsius or greater the 3^rd day after admission during a 4-month study period. Only the first, single episode per patient was analyzed. We determined the causes of fever among these patients with new onset fever. We also analyzed predictors for in-hospital mortality among these patients. These predictors were based on multivariable adjusted logistic regression using demographics, vital signs at the time of fever onset, baseline diseases, and basic laboratory data.
Results: From a total of 2,271 admitted patients, 126 patients (5.6%) developed fever. Among these febrile patients, 98 (78%) had infectious diseases with a prevalence of 4.3% in all admitted patients. The most common cause of infection among those patients was respiratory tract infection, followed by urinary tract infection. Causes for non-infectious fever included neoplastic diseases, inflammatory diseases, and drug fever. In-hospital mortality was associated with lower mean blood pressure <60 mmHg with odds ratio (OR) of 12.7 (95% CI, 1.3–121), tachycardia >90/min with OR 4.1 (95% CI, 1.2–13.5), tachypnea >20/min with OR 10.0 (95% CI, 2.8–35.2), and neoplastic disease with OR 4.1 (95% CI, 1.3–13.1). Infection as a cause of fever was not associated with mortality.
Conclusion: The majority of inpatients with new onset fever had infectious diseases, however fever was also caused by neoplastic diseases, inflammatory diseases and drug fever. Abnormality of vital signs and neoplastic disease were related to in-hospital mortality.

Case reports of drug-induced liver injury caused by Kampo medicines are on the rise, but most of them are noted for related symptoms such as jaundice. Usually, severe liver injury is detected by chance upon routine medical checkup. Recently, we noted 3 cases of suspected drug-induced liver injury caused by orengedokuto, saikokeishikankyoto and bofutsushosan. In these 3 cases, maximum ALT was under 100 IU/l and no symptoms related to liver injury were observed. Early detection by blood test was useful, and appropriate treatment quickly improved and normalized the abnormal values associated with liver injury. We should always be alert for drug-induced liver injury caused by Kampo medicines, especially when prescribing formulations that include Scutellariae Radix. We also emphasize the importance of scheduling blood tests when prescribing these formulations.

The patient was a 45-year-old woman who began suffering from pain in her extremities 1 year and 6 months previously, and who received Oketsu-reducing Kampo. Her pain disappeared in a year. Six months after her treatment ended, she visited our hospital again complaining of the same symptom. Due to strong signs of Oketsu, we prescribed her a Kampo that reduces Oketsu, but her pain largely persisted. On re-examination, we noticed that her condition had occurred during the rainy season on both instances and speculated that high humidity and strong ‘wind' may be the reason. Therefore, Byakujutsubushito was prescribed for her, and her pain disappeared in 2 weeks. However, in the following rainy season, she visited us again complaining of the same pain, and Byakujutsubushito was again administered, and that relieved her from pain in 11 days. Although it is stated that Byakujutsubushito is useful for the treatment of pain resulting from dampness and ‘wind', there are very a few reports on this in the Kinkiyoryaku text. Nowadays, we live in air-conditioned spaces, and high humidity results in ‘cool wind’ and exterior dampness. Frequent movement in and out of such spaces worsens extremity pain, and we believe that the incidence of this condition is increasing. And we believe that Byakujutsubushito is one of the most useful formulations for the treatment of this condition that occurs during rainy season.

Case 1 was a 24-year-old female suffered from the feeling that her throat was obstructed ; this occurred after she had to talk loudly in front of many people. Case 2 was a 51-year-old female who complained of a palpitation attack ; this occurred after she underwent a hysterectomy. We diagnosed these symptoms as “hontonki.” Hontonki is a case of symptoms rising from the lower abdomen into the chest and throat with feelings of anxiety. When these symptoms appeared, the patients felt as if death were upon them, but when they disappeared, the patients soon felt healthy. There are certain medicines that can be used to treat hontonki. We administered Kinkiyoryaku hontonto (i.e. hontonto as described in Kinkiyoryaku) to them, and it was very effective.
We undertook a retrospective analysis of these two cases, along with 8 other cases successfully treated with Kinkiyoryaku hontonto at our hospital over the last 11 years. We found the common clinical characteristics of hontonki events were paroxysmal symptoms with feelings of anxiety. There are some differences between the clinical characteristics of Kinkiyoryaku hontonto from those of Chugobikyuho hontonto (hontonto as described in Chugobikyuho). The cases of Kinkiyoryaku hontonto are not kyosho (hypofunction) as those of Chugobikyuho hontonto are. Either they have heat symptoms or they do not have coldness, and they have shoulder stiffness or headache as some of the other oketsu symptoms.

Mengen is an acute symptom that sometimes occurs after administration of a Kampo formula. It is a shortterm phenomenon and its onset indicates that the patient's clinical course will improve rapidly. It is important to distinguish it from other adverse events, which are not temporary. However, to date, detailed analysis of mengen characteristics such as its frequency, time of onset after Kampo administration, and duration have not been reported. Therefore, we report a precise analysis of mengen characteristics through a literature review of case reports published between 1945 and 2009 in Japan, and retrospective analyses of the cases in our institute.
The literature review revealed that 42% patients developed symptoms of mengen within a day of administration, and 79% developed symptoms within 3 days. In terms of mengen duration, the symptoms persisted for 1 day in 35% cases and 3 days in 63% cases. A diagnosis of mengen proved difficult in 39% cases that presented with atypical symptoms.
Overall, the retrospective analysis of the cases in our institute revealed that 11 patients (7.7%) developed mengen, among 143 patients treated with Kampo between May 2010 and November 2011.