• Title/Summary/Keyword: Randomized Clinical Trial

Search Result 875, Processing Time 0.034 seconds

Nonpharmacologic Pain Relief with Oral 25% Dextrose or/and Pacifier for Newborn Infants (신생아에서 비약물적 통증조절을 위한 25% 경구 포도당과 인공 젖꼭지 사용의 효과)

  • Kim, Min-Kyung;Kim, In-Ah;Jung, Min-Hee;Han, Myung-Ki;Park, Kie-Young;Kim, Bong-Seong;Jin, Hyun-Seong
    • Neonatal Medicine
    • /
    • v.18 no.2
    • /
    • pp.353-358
    • /
    • 2011
  • Purpose: The goal of this study was to compare the efficacy of oral 25% dextrose treatment or/and pacifier for analgesia in healthy newborns during intramuscular injection of a hepatitis B vaccine. Methods: A prospective, randomized, partially blinded, clinical trial was performed in 132 healthy newborns. They were assigned randomly to 4 treatment groups: control group (2 mL distilled water), dextrose group (2 mL 25% dextrose), pacifier group, dextrose+pacifier group (pacifier coating with 25% dextrose) during intramuscular injection of hepatitis B vaccine. For all groups, Neonatal Infant Pain Scale (NIPS), Neonatal Facial Coding System (NFCS), Premature Infant Pain Profile (PIPP) scores were evaluated before the injection, during the injection, and at 2 minutes after the injection. Pain scores were compared among the 4 groups. Results: Maternal and neonatal characteristics were similar among the 4 groups. 25% dextrose treatment led to lower NIPS pain scores during injection (6.4${\pm}$0.9 vs. 5.5${\pm}$1.7, P=0.01) and after injection (1.6${\pm}$2.0 vs. 0.6${\pm}$0.9, P=0.01) and NFCS pain scores after injection (1.5${\pm}$2.3 vs. 0.7${\pm}$0.8, P=0.04) than control group. The number of neonates who feel the pain (indication of scores: NIPS${\geq}$4, NFCS${\geq}$3) decreased (9 (23.1%) vs. 0 (0%), P=0.04 via NIPS, 7 (17.9%) vs. 0 (0%), P=0.02 via NFCS). However, all treatment groups did not decreased PIPP scores, compared with the control group. Conclusion: Oral 25% dextrose is effective than distilled water or using pacifier with or without 25% dextrose in reducing pain during intramuscular injection of hepatitis B vaccinations. Further study based on this preliminary study need about nonpharmacologic management of pain in newborns.

Risk Factors Related to Uterine Leiomyoma in Korean Women - A Retrospective Study - (한국인 여성에서 자궁근종 발생에 관여하는 인자들에 대한 연구 - 후향적 연구 -)

  • Hong, D.G.;Chung, M.J.;Kim, B.S.;Lee, J.M.;Cho, Y.L.;Lee, T.H.;Chun, S.S.
    • Clinical and Experimental Reproductive Medicine
    • /
    • v.33 no.3
    • /
    • pp.159-170
    • /
    • 2006
  • Objective: The purpose of this study is to find out risk factors related to uterine leiomyoma in Korean women and to compare with the results of previous western studies. Methods: A retrospective analysis was carried out. All the cases of uterine leiomyoma (n=244) were diagnosed surgically or sonographically between Jannuary 1998 and December 2004. Total of 269 controls not having uterine leiomyoma were collected from patients who visited Kyungpook national university hospital for routine gynecologic check-up or treatment of their gynecologic or obstetric diseases other than uterine leiomyoma. Data were collected through review of medical records and interviews and analyzed with $x^2$ and logistic regression model. Results: In multivariate analysis, patient's age (OR 1.070; 95% CI 1.041~1.099), number of artificial abortion (OR 1.182; 95% CI 1.018~1.374) and alcohol drinking (OR 1.865; 95% CI 1.231~2.824) had significantly positive correlation with uterine leiomyoma. The duration of lactation was the only factor which had negative correlation (OR 0.985; 95% CI 0.972~0.998). BMI, parity, age at menarche, the duration and interval of menstruation, caffeine consumption and marital status did not show any correlations. Conclusion: In this study, patient's age, number of artificial abortion, and alcohol drinking were the risk factors of uterine leiomyoma in Korean women and the result was similar to that of western studies. Though we couldn't find out the specific risk factors related to the development of uterine leiomyoma in this study, but it has a great meaning to be the first trial in Korean women. The role of information bias should be carefully evaluated and further multicentered, randomized, controlled prospective studies will be needed to know the possible risk factors among Korean women.

Clinical Efficacy of Belotecan (CKD-602), Newly Developed Camptothecin Analog, in the 2nd Line Treatment of Relapsed Small Cell Lung Cancer (재발된 소세포폐암환자에서 이차 약제로 사용되는 Belotecan (CKD-602)의 임상적 효용성)

  • Ban, Hee-Jung;Oh, In-Jae;Kim, Kyu-Sik;Ju, Jin-Yung;Kwon, Yong-Soo;Kim, Yu-Il;Lim, Sung-Chul;Kim, Young-Chul
    • Tuberculosis and Respiratory Diseases
    • /
    • v.66 no.2
    • /
    • pp.93-97
    • /
    • 2009
  • Background: Belotecan (Camtobell, CKD-602, Chongkundang Pharm., Korea), a camptothecin derivative, has anticancer effects by inhibiting topoisomerase I such as topotecan. This study observed the response, survival and toxicity of belotecan monotherapy after the failure of etoposide and platinum (EP). Methods: Forty nine small cell lung cancer (SCLC) patients (M/F=41/8; age, 64.5${\pm}$7.6 (mean${\pm}$SD) years), who failed in their first line chemotherapy were enrolled in this study. Twenty one SCLC patients showed relapsed lung cancer more than 90 days after their priorEP chemotherapy (sensitive relapse group, SR) and 28 patients relapsed within 90 days (refractory relapse group, RR). Results: The response rate was 25%. Eleven patients showed partial responses and 5 patients could not be checked. The response rate of the SR and RR patients was similar. The relative dose intensity was lower in the responders (78${\pm}$15%) than non-responders (83${\pm}$13%, p=0.03). The median survival time (MST) was 10.3 months (290 days). The MST of the non-responders and responders was 186 days (95% CI; 67-305) and 401 days (95% CI; 234-568, p=0.07), respectively. The median progression free survival (MPFS) was similar in the SR (79 days) and RR (67 days) patients. Grade 3-4 neutropenia, anemia, and thrombocytopenia were observed in 59.6%, 12.8% and 23.4% of patients, respectively. Conclusion: The efficacy and survival were demonstrated in the second-line setting. However, a randomized comparative trial with topotecan will be needed.

The Effects of Functional Tea (Mori Folium, Lycii Fructus, Chrysanthemi Flos, Zizyphi Fructus, Sesamum Semen, Raphani Semen) Supplement with Medical Nutrition Therapy on the Blood Lipid Levels and Antioxidant Status in Subjects with Hyperlipidemia (고지혈증 환자에서 의학영양치료와 병행하여 섭취한 기능성차(상엽, 구기자, 국화, 대추, 참깨, 나복자)의 혈중 지질 농도 저하 및 항산화 효과)

  • Lim, Hyun-Jung;Cho, Kum-Ho;Choue, Ryowon
    • Journal of the Korean Society of Food Science and Nutrition
    • /
    • v.34 no.1
    • /
    • pp.42-56
    • /
    • 2005
  • Hyperlipidemia is one of the risk factors for coronary artery disease. Despite of epidemiological evidence that tea consumption is associated with the reduced risk of coronary heart disease, experimental studies designed to show that drinking tea affects blood lipid concentration or oxidative stress have been unsuccessful. The purpose of this study was to investigate whether functional tea (three servings/day) supplement with medical nutrition therapy (MNT) lead to a beneficial outcomes in mildly hyperlipidemic adults. From February to October, 2003, the 43 hyperlipidemic (23 men, 20 women) subjects (total cholesterol$\geq$200 mg/dL or triglyceride$\geq$150 mg/dL) admitted to K Medical Center were studied. Subjects were randomly divided into 3 groups; placebo tea (PT), half dose of functional tea (HFT), full dose of functional tea (FFT). During 12 weeks of study period, the subjects were given placebo or functional tea daily with MNT. Anthropometric measurements, blood chemical analysis including lipid levels, total superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px) levels, and dietary assessment were carried out at the beginning and end of experiment. The effects of functional tea were compared with the placebo in randomized clinical trial study. The placebo was prepared to match with the functional tea in color and taste. After the 12 weeks of MNT, the subjects had regular and balanced meal pattern. Consumption of foods high in cholesterol and saturated fat, salty foods, fried foods, and instant foods decreased significantly in all three groups (p<0.05). Intake of energy and cholesterol also decreased (p<0.05). Drinking three servings per day (390 mL/day) of functional tea significantly reduced the levels of blood triglyceride (HFT, 42.5%; FFT, 29.4%), total cholesterol (HFT, 8.5%; FFT, 13.7%), and atherogenic index (HFT, 14.6%; FFT, 21.7%). Whereas no changes were found in the LDL-, HDL-cholesterollevels, and LDL/HDL ratio. Plasma homocysteine (Hcy) concentration decreased significantly (p<0.05) in functional tea groups (HFT, 14.9%; FFT, 14.1%). SOD increased significantly (p<0.05) in HFT (8.3%). GSH-Px increased significantly (p<0.05) in FFT (12.8%). In conclusion, the MNT improved the dietary habits, in addition, functional tea supplement decreased blood lipid levels and Hcy, and increased SOD and GSH-Px levels. These results indicate that functional tea consumption may decrease the risk of cardiovascular disease via improving blood lipid levels and antioxidant status.

Combined Modality Therapy with Selective Bladder Preservation for Muscle Invading Bladder Cancer (침윤성 방광암 환자에서 방광 보존 치료)

  • Youn Seon Min;Yang Kwang Mo;Lee Hyung Sik;Hur Won Joo;Oh Sin Geun;Lee Jong Cheol;Yoon Jin Han;Kwon Heon Young;Jung Kyung Woo;Jung Se Il
    • Radiation Oncology Journal
    • /
    • v.19 no.3
    • /
    • pp.237-244
    • /
    • 2001
  • Purpose : To assess the tolerance, complete response rate, bladder preservation rate and survival rate in patients with muscle-invading bladder cancer treated with selective bladder preservation protocol. Method and Materials : From October 1990 to June 1998, twenty six patients with muscle-invading bladder cancer (clinical stage T2-4, N0-3, M0) were enrolled for the treatment protocol of bladder preservation. They were treated with maximal TURBT (transurethral resection of bladder tumor) and 2 cycles of MCV chemotherapy (methotrexate, crisplatin, and vinblastine) followed by $39.6\~45\;Gy$ pelvic irradiation with concomitant cisplatin. After complete urologic evaluation (biopsy or cytology), the patients who achieved complete response were planed for bladder preservation treatment and treated with consolidation cisplatin and radiotherapy (19.8 Gy). The patients who had incomplete response were planed to immediate radical cystectomy. If they refused radical cystectomy, they were treated either with TURBT followed by MCV or cisplatin chemotherapy and radiotherapy. The median follow-up duration is 49.5 months. Results : The Patients with stage T2-3a and T3b-4a underwent complete removal of tumor or gross tumor removal by TURBT, respectively. Twenty one out of 26 patients $(81\%)$ successfully completed the protocol of the planned chemo-radiotherapy. Seven patients had documented complete response. Six of them were treated with additional consolidation cisplatin and radiotherapy. One patient was treated with 2 cycles of MCV chemotherapy due to refusal of chemo-radiotherapy. Five of 7 complete responders had functioning tumor-free bladder. Fourteen patients of incomplete responders were further treated with one of the followings : radical cystectomy (1 patient), or TURBT and 2 cycles of MCV chemotherapy (3 patients), or cisplatin and radiotherapy (10 patients). Thirteen patients of them were not treated with planned radical cystectomy due to patients' refusal (9 patients) or underlying medical problems (4 patients). Among twenty one patients, 12 patients $(58\%)$ were alive with their preserved bladder, 8 patients died with the disease, 1 patient died of intercurrent disease. The 5 years actuarial survival rates according to CR and PR after MCV chemotherapy and cisplatin chemoradiotherapy were $80\%\;and\;14\%$, respectively (u=0.001). Conclusion : In selected patients with muscle-invading bladder cancer, the bladder preservation could be achieved by MCV chemotherapy and cisplatin chemo-radiotherapy. All patients tolerated well this bladder preservation protoco. The availability of complete TURBT and the responsibility of neoadjuvant chemotherapy and chemoradiotherapy were important predictors for bladder preservation and survival. The patients who had not achieved complete response after neoadjuvant chemotherapy and chemoradiotherapy should be immediate radical cystectomy. A randomized prospective trial might be essential to determine more accurate indications between cystectomy or bladder preservation.

  • PDF