• Clinical and Experimental Reproductive Medicine
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• v.8 no.2
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• pp.45-55
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• 1981

Clomiphene citrate. antiestrogen, was given to 39 infertile males whose spermatogenesis were disturbed and the efficacy of the drug was evaluated at the Department of Urology in 1980. (Table 1). Patients were divided into 3 clinical observation groups such as group I composed of 19 cases of idiopathic azoospermia, group II consisted of 15 cases of oligospermia following the vasovasostomy, and group III comprised 5 cases of testicular azoospermia. (Table 2). Clinical characteristics of these patients were as follows: Age of the patients ranged from 26 to 43 years old with mean of 34, and that of their wives ranged from 24 to 41 years old with mean of 31. Duration of marital life ranged from 1 to 21 years with mean of 5 years. Sizes of testis ranged from 6 to 25 ml with mean of 16 ml. Coital frequency ranged from 0.5 to 6 per week with mean of 2.4 per week. Levels of plasma FSH ranged from 3.15 to 23.06 lU/1 with mean of 8.15 lU/1, those of LH ranged from 2.98 to 19.89 lU/1 with mean of 8.18 lU/1 and those of testosterone ranged from 3.09 to 9.97 ng/ml with mean of 6.48 ng/ml. (Table 3). Clomiphene citrate was given in dosage of 50 mg per day (in d.) orally to 31 patients for 3 to 9 months and in dosage of 100 mg per day (b.i.d.) orally to 8 patients for 3 to 9 months. (Table 8). Semen samples were analysed monthly on each patient by routine analysis techniques. For the assessment of the efficacy of Clomiphene citrate on faulty spermatogenesis following empirical criteria were used: For semen quality: Improvement (I) represents that semen parameter increased more than 25% from basal level after the treatment, Unchange (U) expresses that semen parameter increased less than 25% of basal level or not changed after the treatment and Deterioration (D) means that semen parameter decreased from basal level after the treatment. For fertility unit (total counts ${\times}$ motility ${\times}$ morphology ${\div}10^6$): Improvement (I) represents that fertility unit increased more than 10 units after the treatment, Unchange (U) expresses that fertility unit increased less than 10 units or not changed after the treatment, and Deterioration (D) means that fertility unit decreased after the treatment. (Table 4). Results obtained from the Clomiphene therapy were as follows: Changes of spermiograme before and after the Oomiphene therapy shown in the Table 5. Sperm counts increased from 23 to 31 ${\times}10^6$/ml in group I, from 17 to 29 ${\times}10^6$/ml in group II. Other parameters of spermiogramme were not changed significantly after the treatment. Fertility units increased from 14 to 18 units after the treatment in group I, and from 16 to 18 units after the treatment in group II. Effectiveness of Clomiphene citrate on spermatogenesis was summarised in the Tables 6 and 7. After the treatment, sperm count increased in 11 patients, motility increased in 6 patients, morphology increased in 4 patients and fertility units increased in 9 patients. No sperm could be produced by Clomiphene citrate in group III of testicular azoospermia. Dosage of 50 mg of Clomiphene citrate per day for 3 to 6 months was proved to be the most effective in the present series. (Table 8). Pregnancy occurred in 2 patients after the treatment. No particular side effects were noted by the treatment. Pharmacologic compounds used for male infertility were shown in the Table 9. Reported results of Clomiphene citrate were shown in the Table 10.

• The Korean Society of Law and Medicine
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• v.21 no.2
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• pp.209-244
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• 2020

TMS and tDCS are non-invasive devices that treat the diseases of patients or individual users, and manage or improve their health by applying stimulation to a brain through magnetism and electricity. The effect and safety of these devices have proved to be valid in several diseases, but research in this area is still much going on. Despite increasing cases of their application, legislations directly regulating TMS and tDCS are hard to find. Legal regulation regarding TMS and tDCS in the United States, Germany and Japan reveals that while TMS has been approved as a medical device with a moderate risk, tDCS has not yet earned approval as a medical device. However, the recent FDA guidance, European MDR changes, recalls in the US, and relevant legal provisions of Germany and Japan, as well as recommendations from expert groups all show signs of tDCS growing closer to getting approved as a medical device. Of course, safety and efficacy of tDCS can still be regulated as a general product instead of as a medical device. Considering multiple potential impacts on a human brain, however, the need for independent regulation is urgent. South Korea also lacks legal provisions explicitly regulating TMS and tDCS, but they fall into the category of the grade 3 medical devices according to the notifications of the Korean Ministry of Food and Drug Safety. And safety and efficacy of TMS are to be evaluated in compliance with the US FDA guidance. But no specific guidelines exist for tDCS yet. Given that tDCS devices are used in some hospitals in reality, and also at home by individual buyers, such a regulatory gap must quickly be addressed. In a longer term, legal system needs to be in place capable of independently regulating non-invasive brain stimulating devices.

• Korean Journal of Health Education and Promotion
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• v.2 no.1
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• pp.31-61
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• 2000

Introduction. Despite the fact that half of premature deaths are caused by unhealthy lifestyles such as smoking tobacco, sedentary lifestyle, alcohol and drug abuse and poor nutrition, there are no theoretical models which accurately explain these health promotion related behaviors. This study tests a new model of health behavior called the Model of Health Promotion Behavior. This model draws on elements and frameworks suggested by the Health Belief Model, Social Cognitive Theory, the Theory of Planned Action and the Health Promotion Model. This model is intended as a general model of behavior but this first test of the model uses amount of exercise as the outcome behavior. Design. This study utilized a cross sectional mail-out, mail-back survey design to determine the elements within the model that best explained intentions to exercise and those that best explained amount of exercise. A follow-up questionnaire was mailed to all respondents to the first questionnaire about 10 months after the initial survey. A pretest was conducted to refine the questionnaire and a pilot study to test the protocols and assumptions used to calculate the required sample size. Sample. The sample was drawn from 2000 eligible participants at two blue collar (utility company and part of a hospital) and two white collar (bank and pharmaceutical) companies located in Southeastern Michigan. Both white collar site had employee fitness centers and all four sites offered health promotion programs. In the first survey, 982 responses were received (49.1％) after two mailings to non-respondents and one additional mailing to secure answers to missing data, with 845 usable cases for the analyzing current intentions and 918 usable cases for the explaining of amount of current exercise analysis. In the follow-up survey, questionnaires were mailed to the 982 employees who responded to the initial survey. After one follow-up mailing to non-respondents, and one mailing to secure answers to missing data, 697 (71.0％) responses were received, with 627 (63.8％) usable cases to predict intentions and 673 (68.5％) usable cases to predict amount of exercise. Measures. The questionnaire in the initial survey had 15 scales and 134 items; these scales measured each of the variables in the model. Thirteen of the scales were drawn from the literature, all had Cronbach's alpha scores above .74 and all but three had scores above .80. The questionnaire in the second mailing had only 10 items, and measured only outcome variables. Analysis. The analysis included calculation of scale scores, Cronbach's alpha, zero order correlations, and factor analysis, ordinary least square analysis, hierarchical tests of interaction terms and path analysis, and comparisons of results based on a random split of the data and splits based on gender and employer site. The power of the regression analysis was .99 at the .01 significance level for the model as a whole. Results. Self efficacy and Non-Health Benefits emerged as the most powerful predictors of Intentions to exercise, together explaining approximately 19％ of the variance in future Intentions. Intentions, and the interaction of Intentions with Barriers, with Support of Friends, and with Self Efficacy were the most consistent predictors of amount of future exercise, together explaining 38％ of the variance. With the inclusion of Prior Exercise History the model explained 52％ of the variance in amount of exercise 10 months later. There were very few differences in the variables that emerged as important predictors of intentions or exercise in the different employer sites or between males and females. Discussion. This new model is viable in predicting intentions to exercise and amount of exercise, both in absolute terms and when compared to existing models.

• The Korea Journal of Herbology
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• v.27 no.2
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• pp.1-16
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• 2012

Objective : To investigate the current status of prescription drugs in Oriental medical institutes and to draw up a future plan for the revitalization of Oriental medical health insurance, this survey has been performed. Method : The survey has been made with 321 doctors working at Oriental medical institutes in Daegu and Kyungbuk areas for a period of 3 month from June 1, 2010 until September 1, 2010. Result : 1. When it comes to the current status of the use of herbal drugs in Oriental Health insurance, most of doctors surveyed prescribe insurance drugs, and they prescribe insurance drugs to patients, who are less than 20% of total patients visiting their clinics. 2. The awareness of Herbal Health Care Drugs is investigated. When it comes to the understanding of the difference between insurance drugs(powder type drugs) and granular type drugs, doctors admit that they differ only in one aspect, whether or not their being covered by health insurance. Based on the survey results on the understanding of insurance coverage of granular type drugs, doctors, even though they long for granular type drugs to be accepted as insurance drugs, are worrying whether the number of outpatients might dwindle due to increased insurance co-payments. They also point out that the biggest obstacles in the expansion of the granular type drugs as insurance drugs are the lack of understanding of the government and the objection of the Health Insurance Review and Assesment service (HIRA) for fear of increased insurance claims. 3. Upon investigation on Oriental medicine doctors' understandings of herbal pharmaceutical industry, it is found that doctors' responses on pharmaceutical industry are not all positive ones('new product development and neglect of R&D infrastructure' and 'smallness of industry'). When it is investigated what area needs the greatest improvement in herbal pharmaceutical industry, 'securing sufficient capital, good manufacturing, and strengthening quality control', is the highest. 4. When it is asked what are the most needed in order to improve herbal health insurance medicine, responses such as 'the increase in the accessibility to and the utilization of Oriental medical clinics through the diversification of the means of prescriptions', 'the improvement of insurance benefits(cap adjustments)', 'increase the proportion of high quality medicinal plants', 'the ceiling of co-payments(deductible) at 20,000 won or more', 'expansion of the choices of formulations', 'formulational expansions of tablets and pills', and finally 'admittance and expansion of granular type drug as insurance drug' are the highest. 5. Upon investigating the general characteristics of the current status of the usage of Oriental health care herbal drugs, the followings are observed. First, the frequency of use of health insurance drugs by the doctors who use health insurance with general characteristics shows similar differences in case of total monthly sales amount (p<0.001), average number of daily patients (p<0.05). Secondly, as to the willingness of the expanded usage of insurance drugs, similar differences are observed in case of total monthly sales amount (p<0.05). 6. Upon investigating the general characteristics of the perception of Herbal health care drugs, the followings are observed. First, inspecting general characteristics and insurance claims due to increased co-payments(deductible amount) reveals similar differences in case of working period (p<0.01) and in case of total monthly sales amount (p <0.01). Secondly, inspecting general characteristics and the obstacles that hinder granular type drugs from being accepted as health care insurance drugs shows similar differences in case of working period (p<0.05). 7. Upon investigating the general characteristics of the understanding of Oriental Herbal pharmaceutical companies, the followings are observed. First, opinions on the general characteristics of pharmaceutical companies, when examined with variance analysis, shows similar differences in case of total monthly sales amount (p<0.05). Secondly, when opinions are examined on general characteristics and the problems of herbal pharmaceutical companies, similar differences are found in case of working period (p<0.01) and in case of total monthly sales amount (p<0.001). Lastly, opinions on the general characteristics and reforms of pharmaceutical companies, similar differences are observed in case of working period (p<0.001). 8. Upon investigating the general characteristics of the improvement of insurance Herbal drugs, the followings are observed. First, regarding general characteristics and insurance benefits, similar differences are observed in case of working period (p<0.05), in case of total monthly sales amount (p<0.05), and in case of average number of daily patients (p<0.01). Secondly, opinions on the general characteristics and the needs for the improvement of Herbal insurance drugs are examined in 5 different aspects, which are the approval of granular type drugs as insurance drugs, the expanded practices of the number of prescription insurance drugs, the needs of a variety of formulations, the needs of TFT of which numbers of Oriental medical doctors are members for the revision of the existing system, and the needs of adjusting the current ceiling of the fixed amount and the fixed rate. When processed by the analysis of variance, the results show similar differences in case of average number of daily patients (p<0.01). Conclusion : From the results of this study the first measures to take are, to reform overall insurance benefit system, including insurance co-payment system(fixed rate cap adjustment), to expand the number of the herbal drugs to be prescribed matching with insurance benefit accordingly, and to revitalize herbal medicine insurance system through the change of various formulations. In addition, it is recommended to improve the effectiveness of herbal medicine by making plans to enhance the efficacy of herbal medicine and by enabling small pharmaceutical companies to outgrow themselves.

• Tuberculosis and Respiratory Diseases
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• v.58 no.5
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• pp.498-506
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• 2005

Background : This study compared the bronchodilator efficacy and safety of tiotropium inhalation capsules ($18{\mu}g$ once daily) with a ipratropium metered dose inhaler (2 puffs of $20{\mu}g$ q.i.d.) in patients with chronic obstructive pulmonary disease (COPD). Method : After the initial screening assessment and a two-week run-in period, patients received either tiotropium $18{\mu}g$ once daily or ipratropium $40{\mu}g$ four times daily over a period of 4 weeks in a double blind, double dummy, parallel group study. The outcome measures were the lung function, the daily records of the peak expiratory flow rate (PEFR), the patients' questionnaire, and the use of concomitant salbutamol. The forced expiratory volume in one second ($FEV_1$) and the forced vital capacity (FVC) were measured 5 minutes before inhalation, and 0.5, 1, 2 and 3 hours after inhaling the study drug on days 0, 14 and 28. Result : In 16 centers, 134 patients with a mean (SD) age of 66 (7) years and a predicted $FEV_1$ of 42 (12)% were analyzed. The trough $FEV_1$ response was significantly higher in the tiotropium group than in the ipratropium group after a four-week treatment period. The weekly mean morning PEFR of the tiotropium group was consistently higher than that of the ipratropium group during the 4-week treatment period with differences ranging from 12.52 to 13.88 l/min, which were statistically significant. Tiotropium was well tolerated by the COPD patients during the 4-week treatment period and had a similar safety profile to ipratropium. Conclusion : This study shows that tiotropium administrated once daily has a superior bronchodilator effect with a similar safety profile in treating COPD patients compared with ipratropium, inhaled four times daily.

• Tuberculosis and Respiratory Diseases
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• v.62 no.5
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• pp.406-416
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• 2007

Background: Single nucleotide polymorphisms (SNPs), which consist of a substitution of a single nucleotide pair, are the most abundant form of genetic variations occurring with a frequency of approximately 1 per 1000 base pairs. SNPs by themselves do not cause disease but can predispose humans to disease, modify the extent or severity of the disease or influence the drug response and treatment efficacy. Single nucleotide polymorphisms (SNPs), particularly those within the regulatory regions of the genes often influence the expression levels and can modify the disease. Studies examining the associations between SNP and the disease outcome have provided valuable insight into the disease etiology and potential therapeutic intervention. Traditionally, the genotyping of SNPs has been carried out using polymerase chain reaction-restriction fragment length polymorphism(PCR-RFLP), which is a low throughput technique not amenable for use in large-scale SNP studies. Recently, TaqMan real-time PCR chemistry was adapted for use in allelic discrimination assays. This study validated the accuracy and utility of real-time PCR technology for SNPs genotyping Methods: The SNPs in promoter sequence (-37 and -524) of lung cancer suppressor gene, RRM1 (ribonucleotide reductase M1 subunit) with the genomic DNA samples of 89 subjects were genotyped using both real-time PCR and PCR-RFLP. Results: The discordance rates were 2.2% (2 mismatches) in -37 and 16.3% (15 mismatches) in -524. Auto-direct sequencing of all the mismatched samples(17 cases) were in accord with the genotypes read by real-time PCR. In addition, 138 genomic DNAs were genotyped using real-time PCR in a duplicate manner (two separated assays). Ninety-eight percent of the samples showed concordance between the two assays. Conclusion: Real-time PCR allelic discrimination assays are amenable to high-throughput genotyping and overcome many of the problematic features associated with PCR-RFLP.

• Tuberculosis and Respiratory Diseases
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• v.44 no.4
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• pp.836-843
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• 1997

Background : The prevalence of Gastro-esophageal reflux(GER) in patients with asthma is estimated to be 50~60% and treatment of GER has been shown to improve asthma symptoms in Western. But GER has been known to be less common in Eastern and GER prevalence rates in asthmatics are not available in Korea. Method : We compared the prevalence rate of GER in 42 patients with asthma to that in 20 healthy normal controls and examed the efficacy of new prokinetic drug, cisapride(40mg/day, 8weeks) in patients with GER and asthma. For acid GER to be considered pathological, 24 hour esophageal pH monitoring should reveal values exceeding upper limit of 95 percentile for at least one of 6 parameter of DeMesseter's table. Result : The results showed GER was more common in patients with asthma(11/42, 26.2%) than normal controls(3/20, 15%) and asthmatics group showed a significant longer supine time pH<4(%) and total time pH<4(%), and more reflux episodes as compared with normal control group. After 4 asthmatics with GER were treated with cisapride, their asthma symtom scores, FEV1 and composite scores of pH monitoring were improved. Conclusion : GER is more common in asthmatics than in normal controls in Korea and prepulsid reduces asthma symptoms in patients with GER and asthma.

• Clinical and Experimental Pediatrics
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• v.49 no.12
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• pp.1315-1323
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• 2006

Purpose : This study was conducted to compare the efficacy and safety of ibuprofen and indomethacin in the treatment of patent ductus arteriosus (PDA) in preterm infants and to determine whether ibuprofen can be an alternative drug. Methods : A total of 32 preterm infants with symptomatic PDA were enrolled in the study. Twelve infants received intravenous ibuprofen 10 mg/kg, followed by 5 mg/kg after 24 and 48 hours. As a comparative group, twenty premature infants received three doses of indomethacin 0.1-0.2 mg/kg every 12 hours. Results : PDA was closed in 11 of 12 infants of the ibuprofen group (92 percent) and in 18 of 20 infants of the indomethacin group (90 percent). Serum sodium concentration decreased along with time significantly (P<0.0001) and to its lowest level at 48 hours after administration of the third dose (P=0.0011) in both groups, but showed no significant difference between two groups. Serum BUN and creatinine concentrations were not changed significantly before or after treatment in each group and showed no difference between thetwo groups. The amount of urine output did not change along with time significantly in both groups (P=0.0725), and showed no significant difference between two groups. Conclusion : Ibuprofen has similar effects to indomethacin in the rate of PDA closure and complication when compared. It has similar changes in serum sodium level and complications when compared to indomethacin for the treatment of PDA in preterm infants. Therefore, intravenous ibuprofen may be used as an alternative agent in the treatment of symptomatic PDA in preterm infants.

• Tuberculosis and Respiratory Diseases
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• v.60 no.2
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• pp.171-179
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• 2006

Background : Despite the emerging danger of MDR-TB to human beings, there have only been a limited number of drugs developed to treat MDR-TB since 1970. This study investigated the cross-resistance rate between rifampicin (RFP) and rifabutin (RBU) in order to determine the efficacy of rifabutin in treating MDR-TB. In addition, the results of rifabutin were correlated with the rpoB mutations, which are believed to be markers for MDR-TB and RFP resistance. Methods : The MICs of RBU were tested against 126 clinical isolates of MDR-TB submitted to the clinical laboratory of National Masan TB Hospital in 2004. Five different concentrations ($10-160{\mu}g/ml$) were used for the MICs. The detection of the rpoB mutations was performed using a RFP resistance detection kit with a line probe assay(LiPA), which contains the oligonucleotide probes for 5 wide type and 3 specific mutations (513CCA, 516GTC, and 531TTG) The rpoB mutation was determined by direct sequencing. Results : The rate of cross-resistance between RFP and RBU was 70.5%(74/105) at $20{\mu}g/ml$ RBU(ed note: How much RFP?) Most mutations (86.3%) occurred in the 524~534 codons. The His526Gln, His526Leu, Leu533Pro, Gln513Glu, and Leu511Pro mutations(Ed note: Is this correct?) were associated with the susceptibilty to RBU. Conclusion : Based on the cross-resistance rate between RFP and RBU, RBU may be used effectively in some MDR-TB patients. Therefore, a conventional drug susceptibility test for RBU and a determination of the critical concentration are needed. However, rpoB gene mutation test may be have limited clinical applications in detecting RBU resistance.

• Tuberculosis and Respiratory Diseases
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• v.41 no.5
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• pp.531-536
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• 1994

Background: The intrapleural instillation of tetracycline for pleural sclerosis had been most commonly used in patients with symptomatic malignant pleural effusion or recurrent pneumothorax for a long time. Unfortunately, at a time of expanding use of this agent, the production of injectable tetracycline hydrochloride used for pleurodesis was discontinued by its sole manufacturer in mid-1991 because the manufacturer was unable to meet US Food and Drug Administration purity standards. So we performed a preliminary study of doxycycline, as a alternative pleural sclerosant on rabbit pleura and compared its efficacy with that of tetracycline. Method: Eighteen New Zealand white rabbits weighing 2 to 3kg(mean 2.6kg) were devided into three groups. In each groups, one tetracycline(20 mg/ml/kg) and two doxycycline solutions(7 mg/ml/kg and 20 mg/ml/kg) instillated into the right pleural space through an 18-gauge angiocath with care to prevent pneumothorax. All rabbits were sacrificed after 28 days. Results: 1) In the group of tetracycline 20 mg/ml/kg(six rabbits), five rabbits showed partial pleural symphysis with several fibrous bands, and one rabbit died on 22th day. 2) In the group of doxycycline 7 mg/ml/kg(six rabbits), three rabbits showed partial pleural symphysis and the other three rabbits showed complete pleural symphysis without necrosis of underlying parenchymal lung tissue. 3) In the group of doxycycline 20 mg/ml/kg(six rabbits), two rabbits showed complete pleural symphysis without lung necrosis, another two rabbits showed complete pleural symphysis with lung necrosis, and the other two rabbits died on 4th and 13th day, respectively. Conclusion: We concluded that doxycycline is a highly effective sclerosing agent having stronger pleurodesis effect with that of tetracycline by dose base and its optimal dosage was considered as 7 mg/ml/kg with minimal complications.