Objective: We investigated the efficacy and toxicity of tailored-dose chemotherapy with gemcitabine and irinotecan for platinum-refractory/resistant ovarian or primary peritoneal cancer. Methods: We enrolled patients with ovarian or primary peritoneal cancer who received ≥2 previous chemotherapeutic regimens but developed progressive disease during platinumbased chemotherapy or within 6 months post-treatment. All patients received gemcitabine (500 mg/m 2 ) and irinotecan (50 mg/m 2 ) on days 1 and 8 every 21 days at the starting dose. The dose was increased or decreased by 4 levels in subsequent cycles based on hematological or non-hematological toxicities observed. The primary endpoint was progression-free survival (PFS), and secondary endpoints were disease control rate (DCR), overall survival (OS), and adverse events. Results: We investigated 25 patients who received 267 cycles (median 8 cycles/patient) between October 2008 and May 2011. Tailored-dose gemcitabine was administered up to the 5th cycle as follows: 1,000 mg/m 2 in 1 (4%), 750 mg/m 2 in 16 (64%), 500 mg/m 2 in 6 (24%), and 250 mg/m 2 in 2 patients (8%). The median PFS and OS were 6.2 months (95% confidence interval [CI]=2.7–10.7) and 16.8 months (95% CI=9.4–30.7), respectively. The DCR was 76%, and PFS was >6 months in 12 of 25 patients (48%). Grade 3 hematological toxicities included leukopenia (9.4%), neutropenia (11.2%), anemia (9.8%), and thrombocytopenia (1.1%).Grade 3/4 non-hematological toxicities did not occur except for fatigue in one patient. Conclusions Tailored-dose chemotherapy with gemcitabine and irinotecan was effective and well tolerated in patients with platinum-refractory/resistant ovarian or primary peritoneal cancer.

STUDY DESIGN: Multicenter analysis of two groups of patients surgically treated for degenerative L4 unstable spondylolisthesis. PURPOSE: To compare the clinical and radiographic outcomes of posterolateral fusion (PLF) and posterior lumbar interbody fusion (PLIF) for degenerative L4 unstable spondylolisthesis. OVERVIEW OF LITERATURE: Surgery for lumbar degenerative spondylolisthesis is widely performed. However, few reports have compared the outcome of PLF to that of PLIF for degenerative L4 unstable spondylolisthesis. METHODS: Patients with L4 unstable spondylolisthesis with Meyerding grade II or more, slip of >10degrees or >4 mm upon maximum flexion and extension bending, and posterior opening of >5 degree upon flexion bending were studied. Patients were treated from January 2008 to January 2010. Patients who underwent PLF (n=12) and PLIF (n=19) were followed-up for >2 years. Radiographic findings and clinical outcomes evaluated by the Japanese Orthopaedic Association (JOA) score were compared between the two groups. Radiographic evaluation included slip angle, translation, slip angle and translation during maximum flexion and extension bending, intervertebral disc height, lumbar lordotic angle, and fusion rate. RESULTS: JOA scores of the PLF group before surgery and at final follow-up were 12.3+/-4.8 and 24.1+/-3.7, respectively; those of the PLIF group were 14.7+/-4.8 and 24.2+/-7.8, respectively, with no significant difference between the two groups. Correction of slip estimated from postoperative slip angle, translation, and maintenance of intervertebral disc height in the PLIF group was significantly (p<0.05) better than those in the PLF group. However, there was no significant difference in lumbar lordotic angle, slip angle and translation angle upon maximum flexion, or extension bending. Fusion rates of the PLIF and PLF groups had no significant difference. CONCLUSIONS: The L4-L5 level posterior instrumented fusion for unstable spondylolisthesis using both PLF and PLIF could ameliorate clinical symptoms when local stability is achieved.
Asian Continental Ancestry Group ; Follow-Up Studies ; Humans ; Intervertebral Disc ; Spondylolisthesis*

We report two cases of inchinkoto treatment for obstructive jaundice via autoimmune pancreatitis (AIP). Case 1 : A 38-year-old male. After completion of treatment for Mikulicz disease, obstructive jaundice developed. A diagnosis of AIP was based on a high IgG 4 blood level and image views. T-Bil stayed above 20 mg/dl and there was no improvement by oral administration of prednisolone (PSL), ursodeoxycholic acid, or bilirubin adsorption therapy. Upon inchinkoto administration, T-Bil promptly fell to 3 mg/dL. Case 2 : A 77-year-old male. He suffered from itching and constipation, and blood data showed a pattern of obstructive jaundice. Image views suggested AIP, but a duodenal papillary biopsy could not provide a definitive diagnosis. Inchinkoto was administered, and the itching and constipation had mostly disappeared within 1 week. However, these symptoms recurred after one month. A definitive diagnosis of AIP was then reached based on a pancreas biopsy, and a PSL regimen was initiated. From these two cases, we consider that inchinkoto is useful for improving the symptoms of obstructive jaundice induced by AIP.

The new practical use example of the JADER datasets from Japanese Adverse Drug Event Report database opened by Independent Administrative Agency Pharmaceuticals and Medical Devices Agency in April, 2012 and afterwards will be reported. The purpose of this study is to examine the evaluating method of medicine concomitant use risk by the frequency at which two or more medicines were reported simultaneously, being assumed the possibility of the influence of drug interactions to be the concomitant use risk in an adverse drug event onset. In order to estimate the potential degree of the safety risk at the time of the concomitant use, the methodology was estimated by the following procedures. 1) For considering that two suspicion medicine targeted is one medicine, the statistical signal index which means those of medicines with use in the case where they both are indicated in one report, the index of the concomitant use, is computed. 2) The statistical signal index about two target suspicion medicines is computed individually. 3) The case where the ratio of the index of the concomitant use to the index obtained individually exceeds 2 also in any of two suspicion medicines is judged as there being the concomitant use risk. The Proportional Reporting Ratio (PRR) and the Reporting Odds Ratio (ROR) were used as a statistical signal index. In order to check the validity of this method, Stevens-Jonson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) which are known for the adverse events of critical drug rash reported in JADER were taken up, and the causality of medical supplies limited to the medicine with which they were reported as a suspicion medicine. As for the combination of the suspicion medicine which fulfills the conditions of the concomitant use risk, 10 kinds of candidates out of 159 combinations for SJS and 22 kinds of candidates out of 111 combinations for TEN were detected, respectively. Although this approach for the concomitant use risk was considered to be an effective means in showing the above results, some issues about the ratio of the index of the concomitant use and criteria in the report numbers of the medicine to be chosen, the effective calculation method for combinations in more than 3 medicines, etc. will be required for the further examination.

Background: The glissonean pedicle approach was introduced by Couinaud and Takasaki in the early 1980s. The key of the glissonean pedicle approach is clamping the pedicle first, secondly confirming the territory, and finally dissecting the liver parenchyma. In this presentation, we introduced our recent refinements of glissonean pedicle approach for liver resection. “Approach to the glissonean pedicles at the hepatic hilus” Couinaud described three approaches to the hepatic hilus. 1) Intra-fascial access (Control method): The conventional dissection at the hilus or within the sheath is referred to as intrafascial access However, dissection performed under the hilar plate is dangerous and surgeons have to consider any variations of the hepatic artery and bile ducts. 2) Extra-fascial access (Glissonean pedicle approach): The glissonean pedicle is dissected from the liver parenchyma at the hepatic hilus before dissecting the liver parenchyma. This procedure prevents intrahepatic metastasis of HCC, which spreads along the portal vein and improves the overall survival after surgery. 3) Extra-fascial and transfissural access: If the main portal fissure or the left suprahepatic fissure is opened after dissecting the liver parenchyma, the surgeon can confirm the pedicles that arise from the hilar plate or the umbilical plate. “Operative techniques” 1) Preoperative 3D simulation of the precise anatomy of portal vein, hepatic artery and bile duct at hepatic hilus should be performed. 2) Right glissonean pedicle: The hilar plate is detached from the quadrate lobe. The assistant pulls the liver parenchyma cranially and the operator conversely pulls the hepatoduodenal ligament caudally. Mayo scissors are inserted along the liver parenchyma between the liver parenchyma and glissonean capsule (Fig.1). Then forceps are inserted in the same way and the right main pedicle is taped (Fig.2). The right anterior and posterior glissonean pedicles are taped as well. 3) Left glissonean pedicle: The hilar plate is detached from the liver parenchyma. Then, the Arantius duct is confirmed and the left pedicle is dissected along the left pedicle at the ventral side of the Arantius duct. “Pitfall of glissonean pedicle approach” The right pedicle should be dissected in the liver side as much as possible to prevent the injury of left hepatic duct. If possible, the right pedicle is recommended to be dissected at the level of the second branches separately (Fig.3). The right posterior hepatic duct sometimes branches from the left hepatic duct and the Arantius duct is confirmed and the left pedicle should be dissected along the left pedicle at the ventral side of the Arantius duct because the right posterior hepatic duct branches from the left hepatic duct at the dorsal side of Arantius’ duct. In addition, the intraoperative cholangiogram should be used in the case with the abnormal anatomy of bile duct. Conclusions: Any anatomical hepatectomy can be performed using “glissonean pedicle approach” which allows simple, safe and easy liver resection.

Introduction : As one of the strategies for the introduction of collaborative drug therapy management (CDTM) into a community healthcare system in Japan, we constructed a ‘positive list’ which was agreed by a family physician in advance, and subsequently validated the effects on healthcare insurance fees, the number of prescription question and the changes of utilization rate for generic drugs.
Methods : The items that replaced prescription questions with regard to ex post facto approval were defined as ‘Resolved Questions’ in our constructed positive list. By adopting the ‘Resolved Questions’, we then examined the effect on healthcare insurance fees, prescription questions and the changes of utilization rates for generic drugs.
Results : Among all prescription questions accepted from January through May 2012 inclusive, 178 (22.7%) were ‘Resolved Questions’, without there being change in the therapeutic strategies by the prescribing physicians. During this period, 17,455 healthcare insurance fees were reduced. In addition, the utilization rate for generic drugs were increased up to 46.6%.
Conclusion : The reduction of healthcare insurance fees, prescription questions and the increased utilization rates of generic drugs were facilitated by prudent pharmacist judgements based on ‘Resolved Questions’.

Objective: Adequate periconceptional intake of folic acid decreases the risk of neural tube defects.  The present study aimed to investigate pharmacists’ awareness of the importance of folic acid intake for the prevention of neural tube defects and to identify factors associated with pharmacists’ awareness.
Design: Questionnaire survey.
Methods: A self-administered questionnaire regarding the importance of folic acid intake for the prevention of neural tube defects was distributed to pharmacists who attended educational seminars offered by the Sendai City Pharmaceutical Association in December 2010.
Results: Among the 166 respondents, 104 (62.7%) pharmacists were aware that folic acid intake decreases neural tube defects.  After stratification for age and sex including history of delivery, female gender and history of delivery were significantly associated with the awareness of the importance of folic acid intake only among pharmacists younger than 40 years old. Of 104 pharmacists who recognized the importance of folic acid intake for the prevention of neural tube defects, 51.0% and 27.9% recognized that women should begin intake of folic acid before conception and should take about 400 μg of folic acid per day during pregnancy, respectively.
Conclusion: Although about 60% of pharmacists recognized that folic acid intake decreases the risk of neural tube defects, many did not know the intake level required to effectively prevent neural tube defects.  Therefore, more aggressive promotion of the awareness of the importance of folic acid intake among pharmacists is warranted.

Objective: To examine how best to provide information on over-the-counter (OTC) drugs in the future, the Japan Self-Medication Industry (JSMI) conducted an online survey on public attitudes toward changes in the system for controlling the sales of OTC drugs specified by the revised Pharmaceutical Affairs Act effective since June 2009.
Methods: A secure web-based questionnaire system was developed and linked to the JSMI website.  The survey was conducted between July 17 and August 31, 2009.
Results: Of the 4,257 people who responded to the questionnaire, 56.8% indicated they understood the provisions of the revised Pharmaceutical Affairs Act.  More than half of the responders had positive opinions of the revision.  They welcomed the improvement in convenience resulting from the availability of drugs at convenience stores, but “Druggists,” who are responsible for sales of the drugs, were not sufficiently represented among responders.  It was inferred that the general public feels that they should be able to purchase OTC drugs for self-medication after receiving sufficient information about the drugs from qualified sources.

A follow-up study of 98 patients undergoing abdominal aortic aneurysm (AAA) repair for 44 months, ranging 2 to 113 months, revealed no difference in 5-year actuarial survival between patients aged 75 or older and patients aged less than 75. The 5-year actuarial survival of ruptured and nonruptured AAA cases was 469% and 71.2%, respectively (p<0.01). Late deaths after the repair of ruptured AAA were all due to atherosclerotic diseases. During a follow-up period after AAA repair, 9 patients were diagnosed as having malignant diseases with a fatal outcome in 6. Careful attention to atherosclerotic and malignant diseases is indispensable for follow-up management after AAA repair.

The preoperative pulmonary arterial pressure of 38 patients aged over 50 undergoing surgical closure of a secundum atrial septal defect was studied. They were divided into three groups according to systolic pulmonary arterial pressure (PAP): Group A (PAP<30mmHg, n=14), Group B (30≤PAP<50mmHg, n=16), and Group C (PAP≥50mmHg, n=8). The mean age of group C patients was older than that of group A patients. With higher PAP, the Pp/Ps, Rp/Rs and cardiothoracic ratios increased, atrial fibrillation and heart failure (NYHA≥2) were more frequent, and PaO₂ levels declined. There were no differences in left to right shunt ratio and Qp/Qs among the three groups. The PAP and Rp/Rs were under 70mmHg and 0.30, respectively in all patients. High pulmonary blood flow seems to be the cause of pulmonary hypertension in most elderly patients because PAP and Rp/Rs decreased after surgery in all groups. Findings of cardiomegaly and heart failure also improved after surgery. Surgical intervention is recommended even in elderly patients with a ASD.