Food Craving and Symptoms of Premenstrual Syndrome among University Students

@#Introduction: Food craving was one of the common symptoms of premenstrual syndrome (PMS) among women. This study aimed to examine level of food craving during pre-menstruation and PMS symptoms; its association and predictor of PMS symptoms on food craving during pre-menstruation among university students. Methods: A cross-sectional study was conducted among female undergraduate students from International Islamic University Malaysia, Kuantan Campus. Screening phase for eligibility was conducted. Three questionnaires consisted of Health History Questionnaire, Food Craving Questionnaire-Trait-reduced and Premenstrual Tension Syndrome Rating Scale were distributed among eligible students. Descriptive analysis, Pearson correlation test and multiple linear regression were performed using SPSS version 22.0. P value was set at p<0.05 as statistically significant. Results: 129 students were eligible as study respondents. A total of 48% of the respondents showed clinically relevant traits of food craving. The highest food craving among respondents were sweet foods (45.7%) followed by fatty (18.6%), spicy (10.9%), salty (8.5%) and sour (2.3%) food. 60% respondents had moderate to severe PMS symptoms level. There was a significant association between food craving and PMS symptoms (p=0.001). PMS symptoms significantly predicted food craving (p=0.002). Conclusion: This study is at the forefront in reporting food craving and PMS symptoms among undergraduate students which were prevalent during pre-menstruation. Food craving was significantly associated with PMS symptoms. This research provides further insight related to food craving among women particularly the role of PMS symptoms as predictor. Strategies in preventing substantial calories intake during pre-menstruation is therefore required in this population.

The relationship between PMS and jump performance in female track and field athletes / 体力科学

Premenstrual syndrome (PMS) that occur during late luteal phase is a problem for many female athletes. Many studies reported that subjective condition is affected by PMS in female athletes. Moreover, female athletes with PMS have higher stress and/or anxiety levels during luteal phase compared with non-PMS athletes. However, the relationship between PMS and physical performance in female athletes are not clarified yet. The purpose of this study was to investigate the relationship between premenstrual syndrome (PMS) and jump performance in female track and field athletes. Sixteen participants who has natural basal body temperature pattern with the menstrual cycle (observed low-temperature and high-temperature phase), were participated in this study. PMS was assessed by ACOG’s premenstrual syndrome questionnaire. As physical performance, counter movement jump (CMJ) and rebound jump (RJ) were evaluated in low-temperature phase and high-temperature phase. The result of this study, no significant differences were observed in body composition and physical performance between low-temperature phase and high-temperature phase. However, compared with participants who had non-symptom, participants who had a breast tenderness of PMS showed larger decreases in jump height of CMJ (p = 0.038) and RJ index (p = 0.015) in high-temperature phase. Therefore, PMS may have a negative effect on physical performance during high-temperature phase in female athletes.

Aplicación del método bioquímico-colorimétrico para identificar agentes trypanocidas / Application of the biochemical-colorimetric method to identify trypanocidal agents

La tripanosomiasis americana es una enfermedad infecciosa desatendida, causada por el parásito protozoo Trypanosoma cruzi, que no cuenta con tratamiento en la fase crónica de esta enfermedad mortal, uno de los desafíos es encontrar terapias efectivas para esta compleja enfermedad, dado que no presenta síntomas asociables a la parasitosis por lo que es desconocida entre los médicos tradicionales. Nuestra Facultad está evaluando la medicina tradicional tacana como fuente de agentes antiparasitarios potenciales. El objetivo de este trabajo fue identificar productos naturales trypanocidas utilizando el método colorimétrico XTT-PMS. Para ello, se realizaron curvas de crecimiento de epimastigotes de T. cruzi y determinamos el tiempo óptimo de realización de los ensayos. Se seleccionó la población inicial de trabajo (3x106 parásitos/mL), las condiciones de incubación (medio LIT, 27ºC, 72 horas) y revelado (XTT-PMS, 4 horas). Con el protocolo optimizado, se realizaron evaluaciones de actividad de drogas control, controles naturales y 20 extractos crudos de plantas medicinales de la amazonía. La actividad se basó en cálculos de concentración inhibitoria media y se consideraron activos las sustancias con CI50<50µg/mL. De los 20 extractos evaluados, el 40% fueron activos. Las plantas más interesantes fueron Sipu sipu (CI50=8.9±1.7µg/mL), Ejije bid'u (CI50=9.1±1.5µg/mL) e Id'ene eidhue (CI50=10.8±1.1µg/mL) con valores de CI50 cercanos a los controles, confirmando la utilidad y potencial del protocolo desarrollado

American trypanosomiasis is listed among the unattended infectious disease, is caused by the protozoan parasite Trypanosoma cruzi, and has no treatment in the chronic phase of this deadly disease. One of the challenges is finding effective therapies for this complex disease, given that it does not present any associated symptoms to the parasitism and is unknown among traditional doctors. Our Faculty is evaluating tacana traditional medicine as a source of potential antiparasitic agents. The objective of this work was to identify trypanocidal natural products using the XTTPMS colorimetric method. For this, growth curves of T. cruzi epimastigotes were made to determine the optimal time to carry out the tests. The initial work population (3x106 parasites/mL), the incubation conditions (medium LIT, 27ºC, 72 hours) and revealed process (XTT-PMS, 4 hours) were selected. With the optimized protocol, activity evaluations of control drugs, natural controls and 20 crude extracts of medicinal plants of the Amazon were carried out. The activity was based on calculations of mean inhibitory concentration and substances with IC50 <50µg/mL were considered active. Of the 20 extracts evaluated, 40% were active. The most interesting plants were Sipu sipu (IC50=8.9±1.7µg/mL), Ejije bid'u (IC50=9.1±1.5µg/mL) and Id'ene eidhue (IC50=10.8±1.1µg/mL) with values of IC50 close to the controls, confirming the usefulness and potential of the developed protocol.

The Effect of Anaemia on PMS Patients

Objectives: In this study our main aim is to evaluate the effectof anaemia on PMS patients.Methods: This cross-sectional observational study was donein the department of Physiology, Chittagong Medical College,over one-year period from July, 2015 to June, 2016. Total 90subjects between 18-22 years were selected by purposivesampling according to inclusion and exclusion criteria from the1st year female medical students. They were divided inanaemic (Group A) and non anaemic (Group B) on the basis ofhaemoglobin concentration.Result: Mean (±SD) haemoglobin of the subjects were 11.70± 0.26 gm/dl and 14.26 ± 1.31 gm/dl in anaemic and nonanaemic group respectively. Mean (±SD) PMS score of thesubjects was 7.59 ± 3.6 and 7.08 ± 2.9 in anaemic and nonanaemic group respectively. Anaemic subjects showed morePMS score than non anaemic subjects though it wasinsignificant. On Pearson’s correlation, PMS score showedvery weak positive correlation with haemoglobin and nocorrelation with BMI.Conclusion: From our study we can conclude that, theanaemic subjects had higher PMS scores than non anaemicsubjects. There was a weak positive correlation betweenanaemia and PMS. Further study is needed for better outcome.

Impact of dietary and lifestyle choices on menstrual patterns in medical students

Background: The aim of the study was to evaluate average age of menarche, the pattern and types of menstrual disorders and their relation with BMI, dietary habits, physical exercise and stress.Methods: A cross sectional prospective study was conducted on female medical students during the academic year 2018-2019 at Mallareddy medical college for women, Suraram, Hyderabad, India. The various life style factors including BMI, junk food consumption and physical exercise were factored. Prevalence of each different menstrual abnormality were identified and analyzed by Chi-squire test and p value <0.005 was considered as statistically significant.Results: Study included 255 medical students who had attained menarche without known medical problems. Mean age of menarche was 12.81years. The most frequent menstrual disorders were premenstrual syndrome 192 (75 %), dysmenorrhoea 146 (57 %), and irregular cycle 97(38%). Statistically significant association of Body mass index (BMI) related to premenstrual syndrome (PMS) and dysmenorrhoea was reported (both p<0.05). Similarly, statistically significant association of lack of physical activity had greater risk of premenstrual syndrome and dysmenorrhoea (both p<0.0001). Unhealthy dietary patterns had statistically significant higher risk for dysmenorrhoea (p<0.0001).Conclusions: In conclusion premenstrual symptoms, dysmenorrhoea and menstrual irregularities were more prevalent. Majority of symptoms were stress, pain abdomen, irritability, mood swings. Comprehensive education programs on lifestyle modifications like regular physical activities, promoting healthy eating habits should be emphasised to prevent menstrual abnormalities of young students as early as at school level.

Effects of radices paeoniae alba extract on erp and sert in hippocampus of rat model of pms liver-qi inverse syndrome / 中国药理学通报

Aim To investigate the effect of Radices Paeoniae Alba extract on estrogen receptor (3 ( ERp ) and serotonin transporter(SERT) in the hippocampus of rat model of premenstrual syndrome( PMS) liver-qi inverse syndrome. Methods The rats were randomly divided into the normal group, the model group, the Radices Paeoniae Alba extract group, the fluoxetine group and the ER(3 agonist group by the vaginal smear microscopy and the open field score. The model group rats were prepared by electrical stimulation to prepare PMS liver-qi inverse syndrome. After five days of administration, the hippocampal tissues of each group were separated. ERp and SERT mRNA and protein expression in each group were determined by RT-PCR and immunofluorescence histochemical method. Results During the estrous reception period, there was no significant difference in the behavior score of the open- field test and the expression of ERp and SERT mRNA and protein in the hippocampus of each group. Estrous non-reception period; compared with normal rats, the total distance of open field test in model rats increased significantly. The expression of ER(3 mRNA in hippocampus significantly decreased and SERT mRNA significantly increased. In model group, the pyramidal cells in hippocampal CA1 and CA3 brain areas of rats were irregularly arranged, and the number of ERp positive cells and protein expression decreased. The number of SERT positive cells and protein expression were significantly up-regulated. After the Radices Paeoniae Alba extract was given, the above indexes were significantly improved, and no significant difference was found between them and fluoxetine group and ER agitator group. Conclusions Radices Paeoniae Alba extract may adjust the PMS card of diseases with inverse nega-tive emotions possibly by improving the hippocampus ER|3 and SERT mRNA and protein expression.

Expression and clinical significance of MMR protein and MLH1 promoter methylation testing in endometrial cancer / 中华妇产科杂志

Objective To explore the expression and clinical significance of mismatch repair (MMR)protein and MLH1 promoter methylation testing in endometrial cancer(EC). Methods A total of 420 cases with EC diagnosed by the surgical pathology examination from the Department of Pathology of PLA General Hospital, MLH1,MSH2,MSH6 and PMS2 protein in EC were detected by immunohistochemistry and methylation-specific multiplex ligation-dependent probe amplification(MS-MLPA) testing. Results (1)Of the 420 tumor cases, the total expression loss rate of MMR protein was 34.5%(145/420), the expression loss rates of MLH1,MSH2,MSH6 and PMS2 protein were respectively 17.1%(72/420), 8.1% (34/420), 7.4%(31/420), 26.2%(110/420)and loss rates of MLH1 and PMS2,MSH2 and MSH6 were 16.7%(70/420), 6.2%(26/420). When there was a loss of MMR protein expression, any one or more protein expression deletions in MLH1, PMS2, MSH2 and MSH6, it could be Lynch syndrome related endometrial carcinoma(LS-EC). The expression loss rate of MMR protein in the poorly differentiated endometrioid adenocarcinoma was higher than that in the well differentiated endometrioid adenocarcinoma(P<0.05).(2) The expression loss rate of MMR and PMS2 protein had statistically significant between the endometrioid adenocarcinoma and non-endometrioid adenocarcinoma(P<0.01). The expression loss rate of MSH2 protein had statistically significant in the stage Ⅲ(P<0.01). Moreover, there were also significant differences in depth of myometrial invasion and lymph node metastasis between the expression loss rate of MMR protein (P<0.05).(3)The expression loss rate of MLH1 protein was 72 cases and 57 cases had MLH1 promoter methylation testing(excluding those who were not qualified for DNA testing). The positive rate was 47.4% (27/57). Therefore, these patients were sporadic endometrial cancer, not non-LS-EC. Conclusions MMR protein may be play an important role in the development of endometrial cancer and be indicated poor prognosis. Immunohistochemical staining and MLH1 promoter methylation detection may be play an important role in the screening of the LS-EC.

Relationship between premenstrual syndrome and type D personality in female college students / 中国心理卫生杂志

Objectives:To understand the current situation of premenstrual syndrome (PMS) and type D personality in female college students,and to explore the relationship between them.Methods:Totally 856 female college students were assessed with the Premenstrual Syndrome Scale (PMSS,those with total score of 6 or higher as having PMS) and Type D Personality Scale 14 (DS-14,those negative emotion and social inhibition factor with total score of 10 or higher as having type D personality).Result:A total of 280 students were detected with PMS,and the rote was 32.7％.Totally 272 students were detected with the type D personality,and the rote was 31.8％.The total score of DS-14 and the score of 2 factors were higher in PMS group than in non-PMS group (Ps ＜0.001).The rate of PMS was lower in type D personality group than in non-type D personality group (11.76％ vs.25.34％,P ＜ 0.001).Conclusions:The occurrence of premenstrual syndrome may be related to the type D personality.The evaluation of personality characteristics should be taken into consideration when formulating the intervention program.

Scrapping therapy combined withDecoction for perimenopausal syndrome with pattern of fire excess fromdeficiency / 中国针灸

<p><b>OBJECTIVE</b>To observe the efficacy difference between scrapping therapy combined withDecoction and the single application ofDecoction for perimenopausal syndrome (PMS) with pattern of fire excess fromdeficiency.</p><p><b>METHODS</b>Eighty patients were assinged into an observation group and a control group, 40 cases in each one. Patients in the control group were treated with oral administration ofDecoction to clear heart heat and nourish kidney. One dose of the decoction was taken by two times within one day. Based on the treatment of the control group, patients in the observation group were additionally treated with scrapping therapy along the urinary bladder meridian of foot-, heart meridian of hand-and kidney meridian of foot-; the scrapping therapy was performed at Back-points, Shenmen (HT 7), Yongquan (KI 1), Taixi (KI 3), Zhaohai (KI 6), Sanyinjiao (SP 6), Zusanli (ST 36), etc.; the treatment was given once every week. Four weeks of treatment were taken as one course in two groups, and totally 2 courses were given. The modified Kupperman score, menopausal quality of life (MENQOL), level of serum estrogen (E), follicle stimulating hormone (FSH) and luteinizing hormone (LH) before and after treatment as well as the clinical efficacy were valuated between the two groups.</p><p><b>RESULTS</b>After treatment, each item score and total score of modified Kupperman were reduced apparently in the two groups (<0.01,<0.05) except dyspareunia score in the control group. The score of hot flash and sweating, paresthesia, depression, fatigue, arthralgia, palpitation, formication, urinary symptoms and total score in the observation group were superior to those in the control group (<0.01,<0.05). After treatment, the total score and each dimension score of MENQOL were obviously decreased in the two groups (all<0.01), and the scores of vasomotor symptoms, psychosocial condition and physical condition in the observation group were significantly lower than those in the control group (<0.01,<0.05). There were no significant differences of serum hormone levels before and after treatment between the two groups (all>0.05), however, after treatment, the serum Elevel had the tendency to raise and serum LH, FSH levels had the tendency to decrease in the observation group. The total effective rate was 97.4% (37/38) in the observation group, which was higher apparently than 81.1% (30/37) in the control group (<0.01).</p><p><b>CONCLUSIONS</b>The scrapping therapy combined withDecoction or the simple application ofDecoction can both improve PMS symptoms and the quality of life, delay the ovary recession; the combination of scrapping therapy andDecoction achieve superior efficacy on PMS syndrome to the simple application ofDecoction.</p>

<b>A Comparative Study on the Effectiveness of Acupuncture in Treating Psychiatric Symptoms of Premenstrual Syndrome</b> / 日本東洋医学雑誌

<p><b>Introduction </b>: Premenstrual syndrome (PMS) is a constellation of symptoms that occurs 3-10 days before menses, and irritability is the most common mental symptom of PMS.<br> <b>Subjects </b>: Subjects were 52 women who were seen for irritability prior to menses. Thirty of the women received acupuncture (the treatment group) while the remaining 22 women were untreated (the control group).<br><b>Methods </b>: The Stress Response Scale-18 (SRS-18) was used to measure the extent of mental symptoms. The treatment group underwent 1 session of acupuncture per week for a total of 6 sessions (1 round of acupuncture). Mental symptoms were measured in the control group over 4 consecutive menstrual cycles. Patients with a total score on the SRS-18 of 20 to 40 points were identified in the 2 groups, and the SRS-18 scores of these selected patients were compared over consecutive menstrual cycles.<br><b>Results </b>: There was a statistically significant (P = 0.0080) difference between the percent improvement in the SRS-18 score for 17 selected patients from the treatment group and the percent change in that 21 score or 7 selected patients from the control group. There was a statistically significant (P = 0.00025) difference in the SRS-18 scores of the 30 patients in the treatment group before and after acupuncture. Of the 30 patients, 73.3% (22/30) satisfied with the treatment was effective. All mental symptoms of PMS, including irritability, were alleviated an average of 43% in those patients.<br><b>Conclusion </b>: Acupuncture alleviated the mental symptoms of PMS.</p>

Mismatch repair protein deficient endometrioid adenocarcinomas, metastasizing to adrenal gland and lymph nodes: Unusual cases with diagnostic implications.

Recently, certain endometrial carcinomas have been found to be associated with mismatch repair (MMR) protein defects/deficiency. A 39-year-old female presented with cough, decreased appetite and significant weight loss since 2 months. Earlier, she had undergone total abdominal hysterectomy with bilateral salpingo-oophorectomy (TAH-BSO) for endometrioid adenocarcinoma. Imaging disclosed an 8 cm-sized adrenal mass that was surgically excised. Histopathology of the adrenal tumor, endocervical tumor, and endometrial biopsy revealed Federation of Gynecology and Obstetrics (FIGO) Grade II to III endometrioid adenocarcinoma. By immunohistochemistry, tumor cells were positive for cytokeratin 7, epithelial membrane antigen, PAX8, MLH1 and PMS2 while negative for estrogen receptor (ER), progesterone receptor (PR), MSH2 and MSH6. She underwent adjuvant radiotherapy and chemotherapy. A 34-year-old lady presented with vaginal bleeding since 9 months. She underwent TAH-BSO, reported as FIGO Grade III endometrioid adenocarcinoma. By immunohistochemistry, tumor cells were negative for ER, PR, MLH1, and PMS2 while positive for MSH2 and MSH6. She underwent adjuvant radiotherapy and chemotherapy. However, she developed multiple nodal and pericardial metastases and succumbed to the disease within a year post-diagnosis. Certain high-grade endometrioid adenocarcinomas occurring in younger women are MMR protein deficient and display an aggressive clinical course. Adrenal metastasis in endometrial carcinomas is rare.

Post marketing surveillance of sublingual buprenorphine naloxone combination tablets.

Background & Objectives : A combination of buprenorphinenaloxone (Addnok-N) tablets has been recently introduced in India as treatment for Opioid dependence. This study was undertaken to evaluate the possible adverse consequences following use of the buprenorphinenaloxone tablets through post marketing surveillance. Methods : National Drug Dependence Treatment Centre (NDDTC), AIIMS, India, monitored all patients receiving buprenorphine-naloxone combination tablets from the centre over a period of two and half years. Evaluation included subjective and objective side effect checklist, physical examination, and laboratory investigation. Results : Data was obtained from 1132 observations among 158 patients. Commonly reported medication effects, like muscle aches (44.0%), sleepiness (44.0%), relief from pain (41.3%), etc; are expected in opioid substitution treatment. Laboratory investigations were mostly normal except for liver enzyme abnormalities (52.2% of cases). Eight adverse events were reported in the study. No dangerous event or mortality was reported during the study.

Results of a Post-marketing Surveillance Study on a Switch OTC Product and Information Providing for Appropriate Use / 医薬品情報学

<b>Objective: </b>To investigate frequency of adverse drug reactions (ADR) on HIGURD ®<br>, a switch OTC product of azelastine hydrochloride, in a three-year post-marketing surveillance study.<br><b>Methods: </b>We conducted two surveys in this study a solicited survey with a questionnaire and a survey of spontaneous ADR reports.<br><b>Results: </b>A total of 183 cases with 293 ADRs were reported in the solicited survey on 3,453 consumers and a total of 29 cases with 37 ADRs were reported from spontaneous sources.  No serious ADRs were reported.  Most frequently reported ADRs were somnolence, thirst, malaise, and dysgeusia, all of which are common on azelastine hydrochloride.  This study indicated that HIGURD ®<br>is well tolerated.<br><b>Conclusion: </b>This study suggested that efficacy and safety of HIGURD ®<br>depend on how much consumers understand the contents of “Precautions for Use” section of package insert.  It is considered to be effective for safety assurance in an early post-marketing phase that pharmacists inform consumers about appropriate use of HIGURD ®<br>and ask for the occurrence of ADRs.

O setor de telefonia móvel do Brasil após o SMP: as estratégias das operadoras e a convergência fixa-móvel / The mobile telephony sector in Brazil after PMS: operators' strategies and landline-mobile convergence

Este artigo analisa como a regulação do Serviço Móvel Pessoal (SMP), implementada pela Anatel em 2001, alterou a estrutura do mercado e as estratégias das operadoras do setor de telefonia móvel no Brasil, entre 2002 e 2007. Foi realizada uma pesquisa qualitativa e um estudo de caso múltiplo acerca das maiores operadoras do setor: Vivo, Tim, Claro e Oi. Diante da análise setorial e da influência de fatores externos sobre a estrutura do mercado, adotou-se o referencial teórico clássico de estratégia competitiva a fim de se entender as estratégias das operadoras. Adotou-se também um referencial mais específico do setor de telecomunicações, com destaque para trabalhos que discutem a convergência entre as telefonias fixa e móvel. Entre as conclusões do trabalho estão os efeitos de caráter deliberado das mudanças na regulação sobre as estratégias empresariais do setor, entre elas a adoção generalizada de estratégias de custo até o lançamento de serviços inovadores no mercado nacional, caracterizados pela integração entre as operadoras de telefonias fixa e móvel, promovendo estratégias de diferenciação, claramente representadas pela formação de dois grupos estratégicos: um com serviços convergentes do tipo bundle e relações de quase integração vertical entre operadoras fixas e móveis e outro com serviços convergentes entre operações de telefonia fixa e móvel verticalmente integradas.

This article analyzes how PMS (Personal Mobile Service) regulation made by Anatel in Brazil in 2001 changed the market structure and the operators' strategies for the telephony sector between 2002 and 2007. It was carried out a quantitative research and a multiple case study about the main operators in Brazil: Vivo, Tim, Claro and Oi. According to this sector analysis and the influence of external factor as regards the market structure, the classic theoretical reference of competitive strategy was used to better understand the operators' strategies. It was also used a more specific reference for the telecommunications sector featuring the works related to the convergence between the landline and mobile telephony. Within the conclusions of this paper, there are the effects related to cost strategy until the rollout of innovative service on a marketwide basis. They are deemed by the integration between the operators of landline and mobile telephony by promoting strategies of differentiation clearly presented by the formation of two strategic groups: the former related to convergent services bundle type and relations of quasi-vertical integration between the landline and mobile operators and the latter related to convergent services between vertically integration landline and mobile operators.

A Report from Task Force on Pharmacoepidemiology and Pharmaceutical Industory / 薬剤疫学

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.

Prevalence and severity of dysmenorrhea : A problem related to menstruation, among first and second year female medical students.

Dysmenorrhea is the most common of gynecologic complaints. It affects half of all female adolescents today and represents the leading cause of periodic college/school absenteeism among that population. To evaluate the menstrual problem specially dysmenorrhea and its severity in female medical students and its effect on their regular activities. This is a cross-sectional descriptive study; conducted on 107 female medical students, all participants were given a questionnaire to complete; questions were related to menstruation elucidating variations in menstrual patterns, history of dysmenorrhea and its severity, pre-menstrual symptom and absenteeism from college and /or class; to detect the severity of dysmenorrhea we used the verbal multi-dimensional scoring system, participants were given 20 minutes to complete the questionnaire. The mean age of subjects at menarche was 12.5 (±1.52) years, with a range of 10-15 years. The prevalence of dysmenorrhea was 73.83%; approximately 4.67%of dysmenorrhic subjects had severe dysmenorrhea. The average duration between two periods and the duration of menstrual flow were 28.34 (±7.54) days and 4.5 (±2.45) days respectively. Prevalence of other menstrual disorders like irregularity, prolonged menstrual bleeding, heavy menstrual bleeding and PCOD were 7.47%, 10.28%, 23.36% and 3.73% respectively. Among female medical students who reported dysmenorrhea; 31.67% and 8.68% were frequently missing college & classes respectively. Premenstrual symptom was the second most (60.50%) prevalent disorder and 67.08% reported social withdrawal. Dysmenorrhea and PMS is highly prevalent among female medical students, it is related to college/class absenteeism, limitations on social, academic, sports and daily activities. Maximum participants do not seek medical advice and self treat themselves with prostaglandin inhibitors; like Ibuprofen.

Safety and tolerability of fluvastatin XL in the treatment of hyper-cholesterolemia : a postmarketing surveillance conducted in Indonesia.

Fluvastatin XL 80 mg tablet has been marketed in Indonesia since December 2002. This post-marketing surveillance (PMS) was conducted between May 2004 and April 2005 involving 98 general physicians to observe the safety and tolerability of fluvastatin XL 80 mg once daily at bedtime for 8 weeks in the treatment of outpatients with hypercholesterolemia. The efficacy of the drug in lowering LDL-cholesterol and other lipid parameters was also observed in daily clinical practice in this PMS. A total of 740 patients were eligible for safety analyses. There were 32 patients (4.32%) with 39 adverse events that were considered related to fluvastatin XL therapy. The most common adverse reactions were dizziness (2.03%), nausea (1.22%), and myalgia (0.68%). No serious adverse event (SAE) was found in this PMS, and no patient discontinued due to adverse event. According to physician’s global evaluation, the safety and tolerability of treatment was good in 91.9% of patients. For efficacy analyses, only 566 patients were eligible. At week 8, fluvastatin XL caused decreases in LDL-cholesterol (LDL-C), total cholesterol (TC) and triglyceride (TG) levels by 28.6%, 30.2% and 24.5%, respectively, and an increase in HDL-cholesterol (HDL-C) by 14.3%. In 74 patients with baseline TG > 300 mg/dL, the decrease in TG was 38.1% and the increase in HDL-C was 18.1%. Reduction in LDL-C of > 40% occurred in 19.6% of the patients. In conclusion, treatment with fluvastatin XL 80 mg once daily for 8 weeks in this PMS was shown to be safe and well tolerated, and also effective in reducing LDL-C, TC and TG, and raising HDL-C in daily clinical practice.

Clinical symptom of premenstrual syndrome in Korean women acorrding to tissue mineral concentration / 대한산부인과학회지

OBJECTIVE: Premenstrual syndrome (PMS) is a disease with specific psychologic and physical symptoms on luteal phase. Its incidence is variable in 20~80%, but its cause is not definitely proved. Because progesterone and estrogen affect the balance of the body mineral, the alteration of progestorone and estrogen in the patients with PMS may effect the imbalance of tissue mineral, that can induce the specific symptoms of PMS. This study examines the relationship between symptoms of PMS and mineral count by tissue mineral test. METHODS: Women who volunteered for the tissue mineral test completed MMDQ questionnaire and checked blood test for Ca, Mg, Na, K, Cu, Zn. The tissue mineral test used the hair not treated within 3 weeks and not washed within 3 hours. The hair was send to TEI for the analysis. We used SPSS (14.0) for statistical analysis. RESULTS: The MMDQ score of the normal Mg group is significantly higher than the high Mg group (22.5+/-17.8 vs. 13.9+/-11.1), and the behavioral disorder score of the normal Na group is significantly lower than the low Na group (2.2+/-1.7 vs. 3.4+/-2.2). The MMDQ score of the normal Cu group is significantly lower than abnormal group (15.7+/-11.9 vs. 24.9+/-16.9). CONCLUSIONS: Total score of MMDQ showed difference according to magnesium and copper concentrations in tissue, and scores of behavioral disorder was affected by sodium concentration of tissue. Additional study about cause and effect relationship is required.

Pharmacovigilance as a New Discipline / 薬剤疫学

In last ten years or more, the term pharmacovigilance has been often used instead of post-marketing surveillance (PMS) or drug monitoring. However, this term, pharmacovigilance, is not just another term for PMS but should be understood as a new discipline, namely, science for the benefit-risk evaluation of medicinal products on humans with the final aim of individualization of medical therapy. It will be more clearly understood why nowadays this term pharmacovigilance has been used, when one considers the historical development of the safety issue of medicinal products. Pharmacovigilance as a new discipline should evaluate constantly safety and efficacy of medicinal products in daily practice considering all available data from non-clinical data, clinical data, pharmacoepidemiological data, post-marketing clinical data, risk-benefit evaluation and applied pharmacologies such as gender-specific pharmacology, pharmacogenetics, graviduspharmacology etc. in order to collect, evaluate and disseminate systematically necessary information and data on the safety and efficacy of medicinal products.<BR>In addition, one should realize the presence of two different aspects of pharmacovigilance, namely obligatory duty of care and voluntary duty of care. The former aspect is defined by regulatory authorities and each pharmaceutical industry should carry out all necessary countermeasures and studies defined by regulatory authorities in order to keep the optimal standard on the efficacy, safety and effectiveness of the company's medicinal products. The latter aspect can also be considered as ethical duty of care for pharmaceutical industries, and refers to more detailed studies in particular patients such as children, pregnant women, aged patients, ethnically different patients, etc.

Safety and tolerability of moxifloxacin in the treatment of respiratory tract infections: a post-marketing surveillance conducted in Indonesia.

Moxifloxacin 400 mg tablet has been marketed in Indonesia for several indications, i.e. acute exacerbation of chronic bronchitis (AECB), community-acquired pneumonia (CAP), and acute bacterial sinusitis (ABS). To assess the safety and tolerability of moxifloxacin, a post-marketing surveillance study was conducted in the year 2001 involving 589 physicians. Clinical efficacy was also evaluated, both by physicians and patients, using a 6-symptom total score, which was scaled 0-12. A total of 1715 patients with acute sinusitis, CAP, AECB, and other infections were treated with oral moxifloxacin 400 mg once daily. There were 151 (8.8%) patients with adverse events (AEs) and 5 (0.29%) patients with serious adverse events (SAEs) that were considered related to moxifloxacin treatment. The most common adverse reactions were nausea (4.96%), dizziness (1.52%), vomiting (0.64%), headache (0.47%), and weakness (0.47%). Twenty three (1.34%) patients discontinued treatment due to adverse events. Tolerance to treatment was rated very good and good by 647 (37.7%) and 919 (53.6%) of patients, respectively. Based on physicians’ clinical assessment, 57.7% of patients were cured and 39.9% were improved at the end of treatment. Mean total symptom score, as assessed by the patients, decreased from 6.43 on day-1 to 2.76 on day-3. Totally, 95.3% of patients felt better after receiving moxifloxacin and 97.6% of patients had good impression on moxifloxacin treatment. In conclusion, treatment of respiratory tract infections, mainly AECB, CAP and ABS, with moxifloxacin 400 mg once daily in this post-marketing surveillance was shown to be safe and well tolerated. Moxifloxacin was also shown to be highly effective in the treatment of these infections with rapid improvement of symptoms.