薬理と治療

Objectives　In this study, we aimed to investigate the effects of pharmacist intervention on potential medical cost reduction in pharmacies associated with the sale of non-prescription drugs. Methods　Sales records of non-prescription drugs from WIN Pharmacy Yokohama Nishiguchi Store, Yokohama, Japan, during October 1st, 2016 to May 31st, 2017, were collected. The data were classified into four groups:“ cold”,“ vasomotor rhinitis”,“ allergic rhinitis by pollen”, and “others”, based on the International Statistical Classification of Diseases and Related Health Problems 10th Revision（ICD-10）. Results　A total of 953 drug sales records were analyzed. The data showed that 60％ of users （n＝570）took non-prescription drugs after consulting the pharmacist. Although in 91％（n＝866）cases, the use of non-prescription drugs was appropriate, 2％（n＝16）of users required consultation recommendation. The potential medical cost reduction estimated from non-prescription drug sales trends during the survey period was 0.89 million yen for“colds”, 90,000 yen for“vasomotor rhinitis”, 0.46 million yen for“allergic rhinitis by pollen”, and 2.83 million yen for“others”, totaling 4.26 million yen; on the basis of this estimate, the annual potential medical cost reduction was 6.40 million yen. Considering this estimated cost reduction, we predicted that if there were 10,000 health support pharmacies in Japan, the savings towards potential medical expenses would be approximately 64 billion yen annually. Conclusions　The increase in the number of pharmacies that actively support self-medication through the sale of non-prescription drugs suggests further reduction in medical costs in the future.

Objective　To investigate the safety and efficacy of esomeprazole（Nexium® capsules）for preventing the recurrence of gastric╱duodenal ulcers in patients receiving continuous low-dose aspirin to prevent thrombosis or embolism in the real world. Methods　This post marketing surveillance study（observation period of 2 years）was conducted using a central registration method. The main safety outcomes were rates of adverse drug reactions（ADRs）, infections, and serious adverse events（SAEs）. Efficacy was assessed in terms of the recurrence of gastric╱duodenal ulcers and disappearance of subjective symptoms. We also analyzed whether patient background characteristics or treatment regimens were associated with safety or efficacy outcomes. Results　Overall, 2295 patients were included in the safety analysis. ADRs occurred in 63 （2.7％）patients. ADRs in three or more patients were constipation（8 patients, 0.3％）, diarrhea （5 patients, 0.2％）, death（4 patients, 0.2％）, and anemia, abdominal distension, dyspepsia and pruritus（3 patients each, 0.1％）. Seventeen SAEs occurred in 14 patients. This included seven ADRs in five patients who died and a causal relationship with esomeprazole was not ruled out. The rates of ADRs and SAEs did not increase with long-term administration of esomeprazole. The non-recurrence rates of gastric╱duodenal ulcers were 98.5％, 97.8％, 97.4％, 96.4％, and 92.7％ at 12, 24, 36, 52, and 104 weeks, respectively. The disappearance rates of subjective symptoms at the final evaluation were 83.9％, 76.7％, 80.2％, 86.1％, 88.6％, 88.7％, and 79.7％ for epigastric pain, anorexia, abdominal distension, heartburn, nausea, vomiting, and belching, respectively. Conclusion　This post marketing surveillance of long-term use of esomeprazole found no new safety problems and confirmed its long-term efficacy.

Objectives　Chronic inflammation is thought to be a significant factor for various diseases including Alzheimerʼs, arthritis, cancer, diabetes, and heart disease. Although there are several anti-inflammatory drugs, these drugs show severe side-effects. Therefore, it is important to find new food materials with anti-inflammatory effects instead of drugs. In this study, we investigated the anti-inflammatory effect of the sea alga Petalonia binghamiae（P. binghamiae） in vivo and in vitro. Methods　P. binghamiae was extracted with methanol（PBE）. The anti-inflammatory effect of PBE（1000 and 2000 mg╱kg body weight）was evaluated on a carrageenan-induced paw edema model in mice. The levels of nitric oxide（NO）production stimulated by lipopolysaccharides （LPS）were measured in RAW264.7 macrophages with or without PBE. Results　We found that oral treatment with 2000 mg╱kg body weight of PBE had a significant inhibitory effect in carrageenan-induced paw edema model mice. We also found that the treatment of PBE（6.25, 12.5 25, 50, 100, and 200μg╱mL）decreased the levels of NO production stimulated by LPS in RAW264.7 macrophages without being cytotoxic. Conclusion　Our results suggest that P. binghamiae potentially has a role in an anti-inflammatory effect, and it could be useful as a functional food for prevention of chronic inflammatory disease.

Background and Objective　The bodyʼs flexibility, muscular strength, peripheral circulation blood flow, which the athlete improved with warm-up, declines over time. Long standby time after warm-up might prevent full performance and increase the possibility of injury. Since cocoa flavanol can improve peripheral circulation, we examined whether it can sustain the effect of warm-up. Methods　A randomized placebo-controlled, double-blind, crossover comparative study was conducted in 5 healthy young adult male people aged 20.6±1.14 years. The trial drink contained 200 mg of cocoa flavanols, while the placebo drink was a cocoa-flavored beverage with a similar taste and the same level of energy as the trial drink. Participants ingested 200 g of their drink 30 minutes prior to a warm-up. Then, the effects from their warm-up were assessed using indexes of flexibility, muscle strength, explosiveness, performance, body temperature and muscle hardness. Results　Flexibility, muscular strength, explosiveness, performance, body temperature（deep body temperature, skin surface temperature）and muscle hardness were improved by warm-up. In other indexes excluding deep body temperature, the decrease in measured values from 30 minutes to 90 minutes after warm-up was suppressed by ingesting 200 mg of cocoa flavanol-containing beverages. There was no change in BMI and body fat percentage during the test period. Conclusion　Ingestion of cocoa flavanol elongated the effect of warm-up, by the improvement of peripheral blood circulation observed as suppression of decrease in skin surface tem-perature.

Objectives　We evaluated the effect of Kaempferia parviflora extract for 8 weeks on physical activity in Japanese healthy elderly subjects. Methods　We performed a randomized, double-blind, placebo-controlled parallel-group trial to evaluate the effect of the test food contained Kaempferia parviflora extract on physical activity. The subjects were 34 healthy elderly volunteers, and they were divided into two groups. They took a placebo food or active food contained Kaempferia parviflora extract for 8 weeks. Twenty nine subjects were eligible for analysis because 5 subjects were withdrawn from the study. 6-minute walk test was evaluated as the primary outcome. Additionally, Timed up and go test, chair stand test, handgrip strength, long seat forward bending were evaluated as secondary outcomes. The safety assessments were also performed by physical measurements, blood parameter measurements, urine analysis, and interview as secondary outcomes. Results　The distance of 6-minute walk test was increased significantly in active food group compared with those in placebo group. There were no significant differences in any other parameters related to physical activity. No adverse effects associated with Kaempferia parviflora extract were observed. Conclusion　The present study suggests that daily consumption of Kaempferia parviflora extract could maintain and╱or improve walking function in healthy elderly.

Objectives　The aim of this study was to evaluate the effects of administration of Lactobacillus curvatus CP2998 on physical function, body composition and health-related quality of life （HR-QOL）in the older adults. Methods　We performed a randomized, double-blind, placebo-controlled, parallel-group trial. A total of 130 subjects aged from 65 to 79 without excessive exercise habits were randomly divided into two groups and were administered CP2998（5*10 11 cells╱day）（n＝65）or placebo （n＝65）once a day for 12 weeks. Physical function, body composition and HR︱QOL（SF-36） were assessed at 0, 6, and 12 weeks. Results　In the CP2998 group, gait speed, cadence, surface electro-myography, SF-36（mental health and vitality）were increased significantly at 12 weeks compared with those in the placebo group（P＜0.05）. No significant changes in body composition were observed with CP2998 intake. Conclusions　The present study shows that the 12 weeks of continuous ingestion of CP2998 is effective in improving the gait function and mental health of the older adults.

Objectives　This randomized, double-blind, placebo-controlled, cross-over study aimed to evaluate the effect of a functional food containing Terminalia bellirica extract on postprandial serum triglyceride levels in healthy subjects. Methods　Ninety healthy subjects with fasting plasma triglyceride levels＜150 mg╱dL were enrolled and randomly divided into two groups: those receiving test food items containing Terminalia bellirica extract（containing 20.8 mg gallic acid）and those receiving a placebo, before initiation of the loading diet. Serum triglyceride levels were measured before and 2, 3, 4, and 6 h after ingestion. Results　Upon area under the curve analysis, the test food yielded a significant reduction in postprandial serum triglyceride and serum triglyceride levels 6 h after the loading diet compared to the control diet（P＜0.05）. In addition, serum triglyceride levels decreased 4 h after ingestion（P＜0.1）. No adverse events attributable to the test food were observed throughout the study period. Conclusions　These results indicate that consumption of food containing Terminalia bellirica extract inhibits postprandial elevation in serum triglyceride levels in healthy subjects

Background and Objective　Osteoarthritis（OA）is a representative cause of knee pain in the elderly. The estimated number of Japanese patients with knee OA is approximately 25 million. Glucosamine and chondroitin are used as a supplement to relief the symptoms of knee pain, based on the clinical trials with knee OA patients. However, there is essentially no study reporting on the action of glucosamine and chondroitin-containing supplement on healthy individuals. The aim of this study was to investigate the effects of glucosamine and chondroitin sulfate on gait of healthy volunteer. Methods　We conducted a randomized, placebo-controlled, double-blind, clinical trial using 60 healthy participants with weak gait ability aged 40 to 68. They were administered with a glucosamine and chondroitin-containing supplement （glucosamine hydrochloride 1200 mg╱day and chondroitin sulfate 60 mg╱day）or a placebo for 12 weeks. The primary outcome was evaluated with the screening score of locomotive syndrome as well as JKOM（Japanese Knee Osteoarthritis Measure）. Results　Among gait ability indicators, the two-step test（one of the screening score of locomotive syndrome）was significantly improved at 8 weeks after the intervention in the test supplement group compared with the placebo group. Moreover, when the subjects with JKOM score≥30 and ≥average body weight were analyzed, the score of two-step test was further improved in the test supplement group. These observations suggest that a test supplement improves a gait ability of the subjects with weak gait ability. Conclusions　Glucosamine and chondroitin-containing supplement improves the gait ability of healthy individuals with weak gait ability. Furthermore, gait ability was improved in the subjects with high JKOM score and heavy body weight.

Objective　Andrographis paniculata（Burm.f.）Nees is used to treat a wide range of diseases traditionally. We have evaluated the safety in consecutive intake of 700 mg╱day of Andrographis paniculata（A. paniculata）extract for 12weeks, and showed no adverse clinical changes in the trial. This study aimed to verify the safety on excessive consumption of supplement containing A. paniculata extract in healthy subjects. Methods　Non-randomized, open-label trial was conducted with 11 healthy Japanese subjects. All subjects were given test product for 4 wk. Daily intake of the test product was contained 3500 mg of A. paniculata extract. Safety was evaluated every 2 weeks by interview, physical examination, hematology and urinalysis. Results　The elevation of liver functions（ALT, AST and╱or γ-GT）and╱or generalized rash were observed in 3 subjects. Two out of 3 subjects were withdrawn the study. The lymphocyte stimulation test associated with test product was positive in 1 subject withdrawn the study. These adverse events had resolved by the end of observation. One subject was also withdrawn the study by difficulty swallowing test product. Although 1 subject indicated stomachache due to dosage form of the test product, she completed the study. Conclusions　It is possible that consecutive intake of 3500 mg╱day of A. paniculata extract for 4weeks causes allergic reaction or other physical symptoms.