薬理と治療
Volume 43, Issue 4, 2015
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扉・目次
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GUIDELINE
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TOPICS:第14 回CRC と臨床試験のあり方を考える会議2014 in 浜松
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- 4. シンポジウム/製造販売後調査のあり方を考える-患者さんの治療に活かせる製造販売後調査の実施に向けて
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ORIGINAL ARTICLES
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塩酸セベラマー低忍容透析患者におけるビキサロマーの忍容性―消化器症状に関する検討―
43巻4号(2015);View Description Hide DescriptionBackground Sevelamer hydrochloride(SH)is a non-calcium-containing phosphate binder effective in reducing the progression of arterial wall calcification in dialysis patients(Pts). Yet patients receiving SH frequently experience gastro-intestina(l GI)side effects. Bixalomer( Bix), a new non-calcium-containing phosphate binder, is expected to cause fewer GI symptoms than SH. Methods Five GI side effects of Bix(gastric juice reflux, gastric pain, abdominal fullness, constipation, and diarrhea)were evaluated by the Izumo-Scale Score(ISS)in 39 hemodialysis Pts with low acceptance of SH because of GI symptoms(either A type Pts, who were unable receive higher SH doses, or B type Pts who were recently forced to discontinue SH). A type Pts were switched from SH to 1500 mg╱day of Bix. B type Pts were given additional 1500 mg╱day of Bix. ISS was checked before Bix administration and at 4, 8, 12 weeks(w)after administration.Results Twenty-five Pts(64.1%)completed this study and 14 Pts(35.9%) stopped the study midway due to side effects(GI symptoms in 10 Pts). In Pts who completed the study, the ISS “constipation”score significantly decreased from 103 points(before)to 64(4 w), 53(8 w), and 69(12 w)points(P<0.05). In Pts who stopped the study, the“gastric juice reflux”and “abdominal fullness”scores were significantly(P<0.05)increased, and the“constipation” score was not significantly changed. Conclusion The improvement in constipation suggests that Bix may be tolerable for nearly two-thirds of Pts with low acceptance of SH. -
市販直後調査期間中に報告された副作用からみたダパグリフロジンの安全性評価
43巻4号(2015);View Description Hide DescriptionIn the present early post-marketing phase vigilance(EPPV)for 6 months, there was not seen any signals for ADRs which strongly suspected the causality with dapagliflozin and are considered to need the attention. In addition to urinary tract and genital infections, which were predicted from clinical studies, additional adverse drug reactions(ADRs), such as skin eruption related events or cerebral infarctions, have been raised as possible concern reported for SGLT2 inhibitors since their launch. EPPV was conducted from March 24, 2014(the dapagliflozin approval date)until November 22, 2014(6 months after launch)to examine the safety of dapagliflozin in actual clinical settings. Information on ADRs for which a causal relationship could not be ruled out was collected by prescribing physicians and for post-marketing clinical study. During this period, 588 ADRs were reported in 430 subjects. Of these ADRs, 91 events related to skin disorders in 85 subjects, and 18 cerebral and cardiac disease events in 16 subjects. There was no evidence of differences from non-Asian findings in any of the cases. Attention has been drawn to correlations between cerebral-cardiac events and dehydration for SGLT2 inhibitors. The correlation between cerebro-cardiac events and dehydration for dapagliflozin is unknown, and in clinical study data, there is no finding that dapagliflozin administration increases a risk of cerebro-cardiac events, including thromboembolic events and cerebral infarction patients who experienced cerebro-cardiac events in this EPPV were reported to have had confounding factors, such as concurrent dyslipidaemia, hypertension, arteriosclerosis, and preexisting primary disease. However, as common for all SGLT2 inhibitor class the package insert for dapagliflozin has been revised and warnings thoroughly communicated. Experience of dapagliflozin use in Japan is limited but surveillance will continue to be conducted over the long term to provide more appropriate recommendations. -
ビルベリー・ルテイン・ブラジル産プロポリス含有食品の「眼精疲労に対する」効果―ランダム化二重盲検プラセボ対照2 試験区クロスオーバー試験―
43巻4号(2015);View Description Hide DescriptionObjective The aim of this study was to evaluate the effect of bilberry, lutein and brazilian propolis contain diet(BLP)intake on eye fatigue in healthy adults. Methods Six men, six women ranging in age from 32 to 57 with eye fatigue were participated in this randomized controlled trial for 2 weeks. They ingested three capsules containing 270 mg bilberry extract, 9 mg lutein, 75 mg brazilian propolis ethanol extract, or placebo every day. Before and after ingestion, and VDT operation, we conduct VAS(visual analogue scale)test, Jikaku︱sho Shirabe, Schirmer test, and autonomic function by the acceleration pulse wave. Results Eye fatigue symptoms such as“eye fatigue”“, dry eye”“, listlessness”were significantly improved in the active group after two weeks ingestion. And parasympathetic function (High Frequency:HF)was higher in active group than placebo group. Conclusions The result of current study suggests that the BLP is suggested to improve eye fatigue and to alleviate disturbance in the balance of autonomic function. -
Significant Symptomatic Benefit of the Enzymolyzed Honeybee Larvae for Patients with Mild Self—perceived Tinnitus Handicap ―A Double—blind Placebo—controlled Trial―
43巻4号(2015);View Description Hide DescriptionObjectives Tinnitus interferes with the quality of life, however no drug has been effective in reducing the magnitude of tinnitus. We investigated whether lyophilized powder of enzymolyzed honeybee larvae as a complementary medicine can provide a therapeutic effect for mild tinnitus. Methods Sixty subjects with mild self-perceived tinnitus handicap participated in a double-blind, placebo-controlled trial using lyophilized powder of enzymolyzed honeybee larvae combined with γ-aminobutyric acid, Riboflavin and Cyanocobalamin(honeybee larvae group)or placebo(placebo group). A visual analog scale(VAS)to rate the severity of tinnitus(loudness, duration and frequency), the Tinnitus Handicap Inventory(THI)and Chalder fatigue scale(CFS) were measured upon entry into the study and after 12 weeks of follow-up. Results Total VAS score to rate the severity of self-perceived tinnitus(loudness, duration, frequency, and annoyance)was significantly improved by 12-week intervention in honeybee larvae group(P<0.05), and the score on the THI was reduced by 12-week intervention in both groups (P<0.05). The intervention with honeybee larvae tended to decrease total CFS score, especially physical component score of the CFS(P=0.06). The change ratio of the total VAS score by the intervention significantly correlated with the change ratio of the CFS in honeybee group(r=0.54, P<0.05). Conclusion Our results suggest that the lyophilized powder of enzymolyzed honeybee larvae represent an effective complementary medicine for subjects with mild self-perceived tinnitus handicap. -
The Beneficial Effects of Coffee on Stress and Fatigue can be Enhanced by the Addition of GABA ―A Randomized, Double‒blind, Placebo Controlled, Crossover‒designed Study―
43巻4号(2015);View Description Hide DescriptionBackground It is known that oral γ-aminobutyric acid(GABA)administration shows stress-reducing, fatigue-relieving, and relaxation-inducing effect on humans. As coffee is often drunk in expectation of relax, coffee added with GABA can be an effective functional food. In case of the commercial products containing GABA, the effect of GABA is not always displayed because of the influence of other components in the products. Based on these backgrounds, we aimed to investigate the effects of GABA added in coffee on stress and fatigue.Methods A randomized, double-blind, placebo controlled, crossover-designed study was conducted. Nineteen subjects took coffee and coffee added with 28 mg of GABA as test samples and carried out 17 min-arithmetic task to induce stress and fatigue. Salivary chromogranin A(CgA) was measured for evaluation of subjectsʼ stress before and after arithmetic task. A self-diagnostic questionnaire using visual analogue scale(VAS)was used for self-evaluation of subjectsʼ fatigue. Prior to this study, a study for baseline measurement in which subjects took water as a test sample was conducted. Results CgA in coffee added with GABA group reduced to 75% of initial value after 30 min and it was significantly lower than that in coffee group(P<0.01)and water group(P<0.01).Although CgA in coffee group increased to 107% of initial value after 30 min, it was significantly lower than that in water group(P<0.05). VAS questionnaire showed that coffee added with GABA significantly suppressed the accumulation of fatigue 60 min after compared to coffee group(P<0.05)and water groups(P<0.05). Conclusion GABA exhibited its stress-reducing and fatigue-relieving effect even in coffee. Coffee itself also showed stress-reducing effect, and the effects of coffee was enhanced by the addition of GABA. -
アスタキサンチンの単回摂取が間欠的自転車運動時の体温および血液性状に及ぼす影響
43巻4号(2015);View Description Hide DescriptionObjectives In this study, we examined the effects of single astaxanthin supplementation on body temperature and blood characteristics at intermittent cycling. Methods The subjects were 6 normally healthy male students. The subjects took astaxanthin (6 mg)or placebo capsule after breakfast. The intermittent cycling was carried out until complete exhaustion on a bicycle ergometer. Measurement items were body temperature, blood characteristics, blood pressure, heart rate, exercise time, exercise intensity and myalgia. Results and discussion Body temperature and NO in astaxanthin group were significant higher than placebo group before exercise. There is some possibility that single astaxanthin supplementation cause vasodilator action and elevation of body temperature. Blood characteristics in astaxanthin group were not significant lower than placebo group after exercise. It is suggested single astaxanthin supplementation does not have effects of reduction of muscular fatigue. -
納豆菌エキス含有食品の抗肥満効果の検討
43巻4号(2015);View Description Hide DescriptionObjective DC-15 is a strain of Bacillus subtilis var. natto used for producing Korean soybean pasteʻCheonggukjangʼ. The intake of its culture extracts reduces postprandial elevation of blood glucose levels via the inhibition of α-glucosidase. The aim of this study was to evaluate the effect of continuous consumption of DC-15 extract︱containing food on body weight, fats, and sizes in subjects with relatively higher levels of body mass index(BMI). Methods An open-labeled study was conducted on 16 Japanese subjects(7 males and 9 females aged from 20 to 64 years)with BMI of about 25 to 30 kg╱m2. During the12 weeks of test period, subjects comsumed test food containings 1 g of DC-15 extracts daily. Results After 4 to 12 weeks of test food consumption, body fat weight(25.71±4.18 vs. 24.98±4.03 kg, baseline vs. at 8th week), as well as sizes of the waist, calf, and hip, were significantly reduced compared to the baseline levels, while no difference was observed in body weight and BMI. No serious adverse event or clinically relevant abnormal change in the blood and urine parameters was observed. Conclusions Our findings suggest that continuous consumption of the DC-15 B. subtilis var. natto extract︱containing food reduces body fat and body sizes in humans with relatively higher levels of BMI. -
ニガウリエキス含有食品摂取の空腹時血糖値低減効果
43巻4号(2015);View Description Hide DescriptionObjective Momordica charantia var. pavel is a flowering vine in the family Cucurbitaceae. It is a tropical plant that is widely cultivated in Asia, India, East Africa, and South America. Previous studies in healthy or diabetic animal models have revealed that M. charantia var. pavel extract has potent hypoglycemic effect. However, clinical studies with human subjects are not sufficiently conducted to consolidate the evidence. The aim of this study was to evaluate the effect of the continuous consumption of M. charantia var. pavel extract-containing food on fasting blood glucose levels, as well as levels of insulin, glucoalbumin, HbA1c, homeostasis model assessment(HOMA)as an index of insulin resistance(HOMA︱IR), and HOMA of β cell function(HOMA-β)in subjects with relatively higher fasting glucose levels. Methods An open-labeled study was conducted with 15 Japanese subjects(9 males and 6 females aged from 20 to 64 years)with fasting glucose levels of 100-125 mg╱dL. During a 12-week of test period, subjects comsumed test food containings 1 g of M. charantia var. pavel extracts daily. The number of subjects analyzed for efficacy was 13(8 males and 5 females)after excluding deviants. Results HbA1c was improved with a statistically marginal significance(from 5.87±0.24% to 5.76±0.32%, P<0.1)after 6 weeks of test food intake. HOMA︱β was improved with a statistically marginal significance(from 35.13±26.99 to 52.83±55.53, P<0.1)after 12 weeks, while no difference was observed in the levels of insulin and HOMA-IR during the whole test period. Fasting blood glucose level was moderately lowered(-1.8 ±0.7% at week 6 and -4.6 ±0.9% at week 12). No serious adverse event or clinically relevant abnormal change in the blood and urine parameters was observed. Conclusions Our findings suggest that continuous consumption of M. charantia var. pavel extract modelately reduces fasting blood glucose level and slightly improves the levels of HbA1c and HOMA︱β in human subjects with relatively high fasting blood glucose levels. It is likely that the hypoglycemic effects of M. charantia var. pavel extract is attributable to increased insulin release, ultimately resulting fromlong︱term lowering of fasting blood glucose level. -
成人女性におけるグァバ葉エキス含有食品摂取による美白効果の検討
43巻4号(2015);View Description Hide DescriptionObjective The aim of this study was to evaluate the effect of guava leaf extract (GLE)intake as a dietary supplement on the improvement of skin condition in women. Methods Twenty eight women aged from 20 to 39 were divided into either control(n=14)or GLE group(n=14), where their median ages were equal. In this open︱labeled study, GLE group comsumed GLE-containing dietary supplements (600 mg of GLE per day)for 8 weeks. During and after the whole test period, skin parameters including melanin value, erythema index, and values for skin brightness(L*)and color(a*, red-green;b*, yellow-blue;C*, saturation)were evaluated. Results At the UV-irradiated skin area, some values representing clearness of the skin color(b* and C*)were significantly increased at 8 weeks after the intake of GLE-containing dietary supplement, while no change was observed in values of L*, a*, melanin value, and erythema index. The subpopulation analysis demonstrated that the effect of test article intake was significant with respect to L* value in women in their 20s. In addition, durability of makeup was improved after 4 and 8 weeks by the intake of GLE according to the questionnaire for the subjects. Conclusions The intake of GLE-containing dietary supplements at 600 mg╱day is suggested to increase skin color clearness by increasing yellowness and color saturation. In women in their 20s, the intake of GLE significantly increased skin brightness. Thus, daily consumption of GLE-containing food is suggested to be effective for the improvement of skin conditions in young women. -
酵母GNL24/497 による膝関節の違和感等改善効果
43巻4号(2015);View Description Hide DescriptionObjective The yeast strain GNL24╱497(GNL24╱497) is a dietary supplement containing S-adenosylmethionine(SAM-e)that has been reported to improve the symptoms of osteoarthritis(OA)for a long time. GNL24╱497 is expected to be effective for the discomfort of knee as with SAM-e. In this study, we set out to compare GNL24╱497 with placebo in terms of effects on the discomfort of knee in healthy adults who belong to border zone between patient with knee osteoarthritis and non-patient. Methods Placebo-controlled double-blind randomized clinical trial, comparing GNL24╱497 (SS16TM 500 mg per day)with placebo for 4 weeks to reduce the discomfort of knee. 36 Japanese healthy adults(range:40︱59 years old)were each measured the subjective sensation of knee on a 100 mm VAS and on a 10 point scale questionnaires against certain loads and everyday life once a week. Results Mean VAS scores and 10 point scale scores were significantly reduced in GNL24╱497 group compared with placebo at 4 weeks after ingestion(P<0.05). Conclusion Oral intake of GNL24╱497 reduced the subjective symptoms such as the senses of the discomfort of knee by certain loads and everyday life. It suggests that GNL24╱497 probably improved the discomfort of knee in healthy adults who belong to border zone between patient with knee osteoarthritis and non-patient.
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INFORMATION
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CONSORT 2010声明―ランダム化並行群間比較試験報告のための最新版ガイドライン―(薬理と治療2010;38:939-49. より再掲載)
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