• Title/Summary/Keyword: clinical efficacy

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Low Dose Cisplatin as a Radiation Sensitizer in Management of Locally Advanced Scluamous Cell Carcinoma of the Uterine Cervix : Evaluation of Acute Toxicity and Early Response (국소 진행된 자궁경부암의 방사선치료와 저용량 cisplatin 항암요법 동시치료시 급성독성 밀 초기반응 평가)

  • Kim Hunjung;Cho Young Kap;Kim Chulsu;Kim Woo Chul;Lee Sukho;Loh J K
    • Radiation Oncology Journal
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    • v.17 no.2
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    • pp.113-119
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    • 1999
  • Purpose : To evaluate possible acute toxicity and early response of concurrent radiation therapy and low dose daily cisplatin as a radiosensitizer in patients with locally advanced uterine cervical carcinomas. Materials and Method : From December 1996 to January 1999, 38 previously untreated Patients with locally advanced squamous cell carcinoma of the uterine cervix (from stage IIB to stage IIIB) were treated at Inha University Hospital. All patients underwent standard pretreatment staging Procedures after the initial evaluation by gynecologists and radiation oncologists. Sixteen Patients with huge cervical mass (>4 cm) were submitted to the group treated with concurrent radiation therapy and low dose daily cisplatin while the remainder was treated with radiation therapy alone. Radiation therapy consisted of 4500 cGy external beam irradiation to whole pelvis (midline block after 3000 cGy), 900$\~$1000 cGy boost to involved parametrium, and high dose-rate intracavitary brachytherapy (a total dose of 3000$\~$3500 cGy/500 cGy per fraction to point A, twice per week). In the group treated with low dose cisplatin concurrently, 10 mg of daily intravenous cisplatin was given from the 1st day of radiation therapy to the 20th day of radiation therapy. Acute toxicity was measured according to expanded common toxicity criteria of the NCI (C) Clinical Trials. Early response data were analyzed at minimum 4 weeks' follow-up after completion of the treatment protocol. Results: Hematolgic toxici쇼 was more prominent in patients treated with radiation therapy and cisplatin. Six of 16 patients (37.5$\~$) treated with radiation therapy and cisplatin and one of 22 patients (4.5$\~$) treated with radiation therapy alone experienced grade 3 leukopenia. In Fisher's exact test, there was statistically significant difference between two groups regarding leukopenia (P=0.030). There was no apparent difference in the frequency of gastrointestinal and genitourinary toxicity between two groups (P=0.066). Three of 16 patients (18.7$\~$) treated with radiation therapy and cisplatin and two of 22 patients (9.1$\~$) treated with radiation therapy alone experienced more than 5 kg weight loss during the treatment. There was no statistically significant difference on weight loss between two groups (P=0.63). Two patients on each group were not evaluable for the early response because of incomplete treatment. The complete response rate at four weeks' follow-up was 80$\~$(16/20) for the radiation therapy alone group and 78$\~$ (11/14) for the radiation therapy and cisplatin group. There was no statistically significant difference in early response between two treatment groups (P=0.126). Conclusion : This study led to the conclusion that the hematologic toxicity from the treatment with concurrent radiation therapy and low dose daily cisplatin seems to be more prominent than that from the treatment of radiation therapy alone. There was no grade 4 hematologic toxicity or mortality in both groups. The hematologic toxicity in both treatment groups seems to be well managable modically. Since the risk factors were not balanced between two treatment groups, the direct comparison of early response of both groups was not possible. However, preliminary results regarding early response for patients with bulky cervical tumor mass treated with radiation therapy and low dose daily cisplatin was encouraging. Longer follow-up is necessary to evaluate the survival data. A phase III study is needed to evaluate the efficacy of concurrent daily low dose cisplatin with radiation therapy in bulky cervical cancer.

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The impact of early detection through school urinary screening tests of membranoproliferative glomerulonephritis type I (학교집단뇨검사를 통한 1형 막증식성 사구체신염의 조기진단의 효과)

  • Chung, Sung-Hoon;Park, Sung-Sin;Kim, Sung-Do;Cho, Byoung-Soo
    • Clinical and Experimental Pediatrics
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    • v.50 no.11
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    • pp.1104-1109
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    • 2007
  • Purpose : Since 1998, school urinary screening tests have been performed on Korean school children. We could detect and treat so many asymptomatic chronic renal disease in early stage. We investigated the efficacy of school urinary screening tests from children with membranoproliferative glomerulonephritis (MPGN) type I. Methods : We analyzed the characteristics and prognosis of 18 patients with MPGN type I who admitted after 1996 and received steroid therapy with or without cyclosporine. These patients were divided into two groups. Group A (asymptomatic patients detected by school urinary screening tests) consisted of 7 patients; Group S (symptomatic patients) consisted 11 patients. Results : Mean follow-up duration was 6.3 years (from 2 to 11 years). Urinary protein excretion was 1.1 g/day in group A and 6.6 g/day in group S. 24 hour creatinine clearance (mL/min/$1.73m^2$) was 134.3 in group A and 82.3 in group S. No patients in group A had renal insufficiency, but three patients in group S had renal insufficiency and one patient required peritoneal dialysis. Conclusion : Early detection by school urinary screening tests improves prognosis of MPGN type I.

Effect of Submucosal Formalin Injection on Bladder Wall in Rats (백서에서 Formalin의 방광점막하주사가 방광벽에 미치는 영향)

  • Lee, Dong-Heon;Park, Tong-Choon
    • Journal of Yeungnam Medical Science
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    • v.4 no.2
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    • pp.113-120
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    • 1987
  • The effect of intravesical formalin instillation as a therapeutic modality for intractable bladder hemorrhage is well known. And despite clear evidence of therapeutic efficacy of intravesical cytotoxic drugs and/or BCG immunotherapy, there have been substantial recurrences during followup after transurethral resection for superficial bladder tumor. If formalin injected at the bed of superficial bladder tumor is able to coagulate and necrotize the tumor, it will be greatly helpful to the patients With recurrent bladder tumor developed during followup. Since this technique is applicable on outpatient basis, an economical as well as a psychological burden of the patients can be reduced considerably. The purpose of this study is to evaluate the effect of submucosal formalin injection on rat bladder wall, 36 healthy adult male Sprague-Dawley rats (weighing 350gm in average) were divided into 3 groups: In Group I (control group), 0.01ml of normal saline was injected submucosally at the left posterolateral wall of the bladder opened under intraperitoneal Nembutal anesthesia ; In Group II and III, 0.01 ml of 10% and 4% formalin, respectively, were administered at the same site as in the Group I, two rats in each group were sacrificed at day 1, 2, and 3, and week 1, 2 and 4 after injection, respectively. Gross and microscopic examination of the cystectomized specimen were done in each group. In the Group II, bladder stones were formed at week I, and in both the Group I and III, stones were seen at week 2 post injection. There was no significant difference III histologic findings of the bladder between the group II and III. Mucosal ulcer and/or prominent mucosal disruption was observed at 24 hours after injection in both Group II and III. Epithelial regeneration began at day 2, and was marked at day 3, and epithelial lining was almost normalized one week after injection. Subepithelial edema, telangiectasia and inflammatory reaction were prominent at 24 hours post formalin injection. Subepithelial edema persisted in moderate degree for 1 week. Telangiectasia and inflammatory reaction were noted for 4 weeks. Mild degree of these findings also appeared In the control group. Fibroblastic proliferation appeared at day 2 and persisted in moderate degree for 4 weeks. There has been no mortality or bladder perforation. These results suggest that clinical application of this technique is feasible for the selected cases of recurrent, solitary superficial bladder tumor. However, optimal dosage of formalin in relation to the size of the lesion remains to be investigated.

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The Role and Efficacy of Diagnostic Laparoscopy to Detect the Peritoneal Recurrence of Gastric Cancer (복막 전이가 의심되는 위암 환자에서 진단적 복강경 검사의 의의와 역할)

  • Song, Sun-Choon;Lee, Sang-Lim;Cho, Young-Kwan;Han, Sang-Uk
    • Journal of Gastric Cancer
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    • v.9 no.2
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    • pp.51-56
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    • 2009
  • Purpose: Peritoneal recurrence has been reported to be the most common form of recurrence of gastric cancer. Peritoneal recurrence can generally be suggested by several types of image studies and also if there is evidence of ascites or Bloomer's rectal shelf. It can be confirmed by explorative laparotomy, but diagnostic laparoscopy is a good alternative method and laparoscopic surgery has also been widely used. We reviewed and analyzed the ability of diagnostic laparoscopy to detect peritoneal recurrence or carcinomatosis, and especially for gastric cancer. Materials and Methods: We performed a retrospective review the 45 gastric cancer patients who were operated via diagnostic laparoscopy between 2004. 2. and 2009. 3. We analyzed the perioperative clinical characteristics and the accuracy of the diagnostic methods. Results: The study groups included 14 patients who had confirmed gastric cancer, but they suspected to have carcinomatosis, and 31 patients who had previously underwent gastric resection, but they suspected to have recurrence. The mean operation time was $44.1\pm26.9$ minutes and the mean postoperative hospital stay was $2.7\pm2.8$ days. There was one case of operation-related complication and no postoperative mortality occurred. The sensitivities for detecting peritoneal recurrence or carcinomatosis were 92.1% for diagnostic laparoscopy, 29.7% for detecting ascites and rectal shelf on the physical examination, 86.5% for abdominal computed tomography, 69.2% for PET CT and 18.8% for CEA. Conclusion: Diagnostic laparoscopy does not require a long operation time or a long hospital stay, and it showed a low complication rate in our study. It has high sensitivity for detecting peritoneal recurrence of gastric cancer. It can be an alternative diagnostic confirmative method and it is useful for deciding on further treatment.

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A STUDY ON THE CHANGE OF SALIVARY FLUORIDE CONCENTRATION WITH TIME AFTER VARIOUS TOPICAL FLUORIDE TREATMENTS (각종 불소처치 이후 시간변화에 따른 타액내 불소농도 변화에 관한 연구)

  • Park, Soo-Jin;Kim, Hyung-Doo;Kim, Chong-Chul
    • Journal of the korean academy of Pediatric Dentistry
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    • v.26 no.2
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    • pp.262-274
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    • 1999
  • Several alternatives for increasing the fluoride concentration in the mouth, such as water fluoridation, ingestion of fluoride supplements, fluoride paste, fluoride mouthrinse, application of fluoride gel are available. There is an impressive body of evidence that the topically deliverd fluorides are clinically effective in inhibiting the progression of dental caries. Recent studies on the cariostatic action of fluoride have indicated the importance of fluoride in the fluid environment of the teeth. The fluoride levels in unstimulated whole saliva can be considered indicative of F in the aqueous phase available for interaction with the tooth surface at a given time. The retention of F in the mouth after topical fluoride treatment is considered to be an important factor in the clinical efficacy of F. The aim of this study was to determine the elevation and clearance of fluoride in whole saliv after the following topical flouride treatments using HMDS-diffusion technique and fluoride ion electrode. The obtained results were as follow: 1. Average salivary fluoride concentration in the unstimulated whole saliva was $0.0152ppm{\pm}0.0091ppm$. Unstimulated salivary flow rate was between 0.34-0.36ml/min and there was no statistically significant difference among the groups(p>0.05). 2. Except for the immediate time after treatment, fluoride levels followed as APF gel>neutral gel>F-rinse>F-paste. There was no statistical difference between the salivary F concentration of F-paste group and that of control group after 2 hours. In case of F-rinse group, after 3 hours the concentration had dropped to baseline value. But there was statistically significant difference among the F concentraion of F gel groups and that of control group(p<0.05). 3. The mean $AUC_{0-120min}$ values were followed as neutral gel>APF gel>F-rinse>F-paste, and the values of the two former groups were significantly higher than those of the two latter groups(p<0.05).

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Phase II Study of Concurrent Chemotherapy with Etoposide and Cisplatin (EP) and Radiation Therapy for Unresectable Stage III Non-small Cell Lung Cancer (수술이 불가능한 제 III기 비소세포폐암에서 Cisplatin 및 Etoposide(EP)의 화학요법과 방사선요법의 병행요법(2상 임상연구))

  • Hur, Nam-Hyun;Lee, Choon-Taek;Kim, Jae-Hag;Jang, Jae-Jin;Nam, Seung-Mo;Park, Yeon-Hee;Ryoo, Baek-Yeol;Kim, Tae-You;Im, Young-Hyuck;Kang, Yoon-Koo;Kim, Mi-Sook;Yoo, Seong-Yul;Lee, Jhin-Oh;Kang, Tae-Woong
    • Tuberculosis and Respiratory Diseases
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    • v.44 no.4
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    • pp.776-784
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    • 1997
  • Background : Various combinations of treatment modalities have been reported in stage III non-small cell lung cancer (NSCLC). however, the standard treatment modality has not established yet. Recently, the efficacy of concurrent chemotherapy and radiation therapy has been reported in locally advanced lung cancer. We evaluate the response rate, toxicity, and survival of concurrent chemotherapy with etoposide and cisplatin(EP) and radiation therapy for unresectable stage III NSCLC. Method : Between October 1995 and December 1996, 32 patients with histologically proven unresectable stage III NSCLC without malignant pleural effusion were entered into this study. Twenty-nine patients were eligible for the response, survival, and toxicity analysis. Induction was two cycles of chemotherapy with etoposide and cisplatin plus concurrent chest RT to 4500cGy. Resection was attempted if the clinical response offered surgical resectability. Boost radiation therapy upto 5940cGy and one cycle of EP were performed if the disease were stable or responsive but still unresectable. Results : Of 29 eligible patients, 22(75.9%) showed partial response(PR). The progression free interval was 6.3months(range 1.1 to 19.5months). Surgical resection was performed in one patient. The median survival was 12.1months and one-year survival rate was 50.6%. The major toxicity was leukopenia($\geq$ grade 3, 46%). Thrombocytopenia over grade 3 was found in 11%. Radiation pneumonitis occurred in 13 patients(46%). Conclusion : Concurrent chemotherapy(EP) plus radiotherapy was effective and tolerable in the treatment of unresectable stage III NSCLC.

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Surgical Treatment for Metastatic Spinal Tumor (전이성 척추 종양의 수술적 치료)

  • Han, Chung-Soo;Kim, Ki-Tack;Soh, Jae-Ho;Lee, Jung-Hee;Shin, Dong-Jun
    • The Journal of the Korean bone and joint tumor society
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    • v.6 no.1
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    • pp.1-9
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    • 2000
  • Purpose : Spine is one of the most common sites of the metastatic bone tumors. Conservative management such as chemotherapy or radiotherapy has been preferred in most cases. However, the neurologic deficit has not been usually improved, and the quality of life was poor. The purpose of this study was to show the efficacy of the surgical treatments for metastatic spinal tumors in terms of postoperative improvements of neurologic deficit and survival time. Materials and Methods : Authors have reviewed the literatures and analyzed 14 patients of metastatic spinal tumors who were received operative treatments between August 1991 and June 1999 at the our department of orthopaedic surgery. Results : The most frequent primary tumor was breast cancer in women and lung cancer in men. The thoracic region was the most common site. There was a preponderance of females over males, and the age ranged between 4th and 8th decade. The indications of surgical treatment comprised instability, progressive neurologic findings, resistance to radiotherapy, pathological fracture, long life expectancy( >6weeks), isolated metastasis and need for pathological diagnosis. The degree of preoperative neurological deficit might influence on the improvement of clinical symptoms after surgery. Conclusion : The surgical treatment reduced the neurological deficit and pain regardless of the operative methods. In the early stage of neurological deficit, the surgical treatment was important for better prognosis. Recently early active operative treatment was performed for metastatic spinal tumor to minimize the intractable pain and to prevent the progression of the neurologic deficit. Early intervention can improve the quality of life and long term survival.

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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
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    • v.18 no.2
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    • pp.353-358
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    • 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.

Strategic Direction and Road Map of Expanding Prevention of Winter Disease in the Summer (동병하치 확산을 위한 전략적 방향과 이행방안)

  • Song, Ho-Sueb
    • Journal of Acupuncture Research
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    • v.27 no.3
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    • pp.147-157
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    • 2010
  • Objectives : The purpose of this study was to propose appropriate strategic directions and road maps for successful achievement of programs preventing winter disease in the summer. Methods : Details on programs preventing winter disease in the summer such as clear concept, theoretical basis, current status, intervention or available prescriptions and indication/contraindication/caution were prepared through the related journal review, upon which an observational study was devised and done for simulation to find out even a trivial problem and to guarantee the safety beforehand. The experimental group was divided into 5 groups by the size of pill and the way ginger is treated; 1cm pill with ginger group, 3cm pill group without ginger, 3cm pill group dipped into ginger, 3cm pill group applying ginger to acupoints and 3cm pill group with ginger Results 1. program preventing winter disease in the summer was defined as representative winter diseases such as common cold, influenza, chronic asthma, chronic bronchitis, allergic rhinitis, emphysema, chronic gastritis and rheumatoid arthritis, and preventive care in the summer, reinforcing deficient yang qi of five viscera by using exuberant yang qi from summer heat. 2. It was based upon historically established theories which is 'nourishing yang qi in the spring and summer', 'long summer, namely rainy spell in the summer overwhelms the winter, because of earth winning water according to the five phases theory' and 'To replenish yang qi is major principle to treat winter diseases, which can be most appropriately and timely applied to the patient with deficient yang qi of five viscera inherently, especially in the three dog days of the summer, because of exuberant exterior yang qi and deficient interior yang qi in the five viscera'. 3. In the adjacent China and Taiwan, acupoint applying method in the three dog days named 'San Fu Tie' have been stirring a boom throughout the nation, in which Xiaochuan Gao was used as a basic prescription and it mainly was applied at bilateral $BL_{13}$, $_{15}$ and $_{17}$ for about 4 hours. As far as domestic current status, the necessity of adopting the above method prior to Herbal formula was also recognised, because not a few koreans have apprehension for the safety of it including medicinal herbs and are reluctant to take it any more due to negative advertisement of narrow minded doctors' association. 4. Indication of acupoint applying method in the three dog days included most of winter diseases such as common cold, influenza, chronic asthma, chronic bronchitis, allergic rhinitis, emphysema, chronic gastritis. contraindication was pregnant woman and the weak such as infants and the old. More attention was paid to grasp firmly the normal reaction following the treatment for preventing side effect and teasing blister. recommendation was also given to abstain from food inducing phlegm and dampness such as meat, shrimp and crab as well as cold drinks and foods 5. In the simulation observational study based upon the above findings following review the related articles, no blister was shown on the acupoints icluding bilateral $BL_{13}$, $_{15}$ and $_{17}$ in every experimental group during 24hr observation following the acupoint applying treatment with pills made by modified and devised prescription. At 4 hr, the effectiveness of it reached a peak showing redness and mild tenderness and there is little difference between groups 3cm pills groups regardless of the way ginger was treated. abdominal distention and growling was found in all the volunteers during the treatment at CV 8. Strategic directions and road maps : Through successful fulfillment of the program preventing winter disease in the summer, Korean traditional medicine should be integrated into mainstream national health care services. Cultural access was thought to be as important as Scientific EBM approach. First of all, To evoke potential cultural homogeneity from campaigns and press advertisement was needed for promoting public awareness about preventing winter disease in the summer by enhancing immunity via acupoint applying treatment in the three dog days, and then indigenous name as Sambokcheop, protocol, Clinical Research Form for data collection of it should be developed and prepared. Once the first step was taken this summer, through a thorough data collection and scrutinized scientific evaluation, drawbacks should be compensted for and the efficacy and safety should be substantiated.

Combined Therapy of Alfa-Interferon and Thymodulin on Children with Chronic Active Hepatitis B (소아의 B형 만성 활동성 간염에서 저용량 ${\alpha}$-Interferon과 Thymodulin의 병용 치료 효과)

  • Choe, Byung-Ho;Ko, Cheol-Woo
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.1 no.1
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    • pp.79-89
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    • 1998
  • Purpose: Though many antiviral or immunomodulatory agents have been used in patients with chronic HBV hepatitis, interferon is considered to be the only effective therapeutic agent so far. Among immunomodulatory agents, thymodulin, the oral form of thymosin, is currently in clinical trial. We compared the efficacy of alfa-interferon therapy alone with a combined therapy of alfa-interferon and thymodulin in children with chronic active hepatitis B. Method: Twenty three children aged 4.4~13.7 years who were known to be positive for HBsAg and HBeAg in serum for at least 6 months and who had biopsy-proven chronic active hepatitis were given either combined therapy of alfa-interferon and thymodulin or alfa-interferon alone, and all children were HBV DNA positive in their serum at the beginning. Follow-ups have been done for at least 1 year after a 6 month course of therapy and clearance of viral replication markers has been evaluated. Results: 1) During follow up period, 11 (48%) children were seroconverted to anti-HBe and were cleared of HBV DNA from their serum. However, 2 of them relapsed after discontinuance of interferon therapy. 2) Seroconversion occurred more frequently among those who had not been vertically transmitted, had elevated serum ALT levels and low HBV DNA levels before interferon therapy. 3) There was no significant advantage of the combined therapy with thymodulin compared to interferon therapy alone. Conclusion: Combined therapy of alfa-interferon and thymodulin failed to demonstrate synergistic effect. We think that combination therapies of alfa-interferon with other antiviral or immunomodulatory agents need to be studied in order to achieve better therapeutic responses.

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