A sixteen-year-old girl with neuropsychological dysfunction after cerebral encephalopathy came to our hospital for evaluation of her cognitive impairment and ability to acquire compensatory skills for communicative dysfunction. Neuropsychological examinations revealed low scores on FSIQ, VCI, WMI and PSI by WISC-Ⅳ. We intervened using a process-orientated speech-language-hearing therapy to improve her cognitive, language and communicative skills for a year. After that, we evaluated her cognitive ability by WISC-Ⅳ and LCSA. As a result of our intervention, her word knowledge, idiom and mental expression, sentence expression and reading social condition and expression scores in LCSA performance were improved but each IQ by WISC-Ⅳ was preserved. In ST intervention for pediatric neuropsychological dysfunction, the patient evaluation should be made not only using IQ by WISC-IV but also by measuring other communicative skills such as by LCSA.

This study investigated the population prevalence of chronic arterial occlusion (CAO) using the ankle pressure index (API) of patients with lower back pain in an acupuncture clinic. The API was measured in 60 lumbago patients ≥ 50 years old at the Meiji College of Oriental Medicine Acupuncture Center. There were 19 patients (31.7%) with unilateral or bilateral API < 0.9, which was presumed to indicate CAO. Thirty-four patients had symptoms in the lower limbs, and 17 of 34 patients showed an API below 0.9. In all but 4 patients (13 of 17, or 76.5%), laterality of the lower API and the symptoms were noted. In conclusion, API measured noninvasively might be useful as a predictor of CAO in acupuncture clinics.

Over 40 years, Post-maketing surveillance (PMS) studies have been conducted as a legal obligation in Japan. Though the contribution of these studies to the better use of the drug has been acknowledged, there are criticisms that these PMS studies have been stereotyped and need to be improved. The ICH-E2E guideline entitled as "Pharmcovigilance Planning", agreed in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has been implemented in the concerned countries. The legislation of the guideline in Japan in 2005 seems to have urged drug companies and regulatory agency to review the current PMS practices in contrast with the today's highest scientific standard. We investigated the theoretical and practical aspects of pharmacoepidemiology required when the drug company evaluates safety specification prior to developing the pharmacovigilance plan and designs a PMS study along the lines stipulated in the ICH-E2E guideline. To meet this end, we evaluated the profiles of the drug, summarized "Important identified risks", "Important potential risks" and "Important missing information" to be identified and examined the pharmacovigilance plan suggested by the regulatory agency and that proposed and implemented by the drug company. We examined those aspects for 6 new products selected from 168 drugs newly approved during the period between January 2004 and October 2006. In 5 of 6 cases, we judged that the use of a comparator group would have been appropriate to asses the association between the drug and adverse events of interest. In addition, in one half (3) of 6 cases, it would have been preferable to use the database for the patient registration and/or other types of databases. The issues of relevant legislation and the infrastructure and funding for the investigations needed to develop a desirable study design and conduct a good pharmacoepidemiology study are however beyond a single company's capacity and should be set as a national strategy. The issues of post-marketing safety in the nation is becoming more and more important as the data in the countries outside Japan are being used more often for the processes of marketing authorization application of a new drug and its approval. It is urgent to secure the practice of pharmacoepidemiology to achieve the effective post-approval pharmacovigilance studies.

Essential thrombocythemia (ET) is an uncommon type of myeloproliferative disorder, characterized by both thrombotic and hemorrhagic diatheses. No clear guidelines exist for the pre- or post-operative management of patients with ET undergoing cardiac surgery. Here, we present a rare case of a patient with essential thrombocythemia and severe aortic stenosis, who needed an aortic valve replacement on cardiopulmonary bypass and who suffered no complications.

A 5-year-old boy with tricuspid atresia who underwent the Björk procedure died due to right atrial thrombus and left pulmonary embolus 37 days after operation. It is suggested that thromboembolism may be a frequent complication after the Björk procedure due to the turbulent blood flow at the right atrio-ventricular anastomosis and also due to congestive blood flow. Anticoagulation therapy seems to be essential for postoperative management.

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.

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.

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.

Background: Several systematic reviews have reported on the conservative treatment of full-thickness rotator cuff tears; however, clinical results of this treatment still remain determined. Methods: PubMed, Cochrane Library, PEDro, and CINAHL databases were systematically searched for randomized clinical trials and observational studies. Two independent researchers reviewed a total of 2,981 articles, 28 of which met the criteria for inclusion in the study. Clinical outcome measures included Constant score, visual analog scale score for pain, range of motion, and short-form 36. The meta-analysis used a linear mixed model weighted with the variance of the estimate. Results: The meta-analysis showed a significant improvement after surgery. Pain score is 26.2 mm (1 month) to 26.4 mm (3 months) and 24.8 mm (12 months) (P<0.05); active abduction: 153.2º (2 months), 159.0º (6 months), 168.1º (12 months) (P<0.05); Constant score: 67.8 points (2 months) to 77.2 points (12 months) (P<0.05); short-form 36 “vitality” section: 57.0 points (6 months) and 70.0 points (12 months) (P<0.05). Conclusions Our data confirmed the effectiveness of conservative treatment in patients with full-thickness rotator cuff tears 12 months post-intervention. The results suggest that conservative treatment for patients with full-thickness rotator cuff tears should be the first line of treatment before considering surgery.