• Title, Summary, Keyword: hematologic toxicity

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A Study on Subchronic Inhalation Toxicity of 2-Methylpentane (2-Methylpentane 아만성 흡입독성 연구)

  • Chung, Yong Hyun;Lim, Cheol Hong;Han, Jeong Hee
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.24 no.2
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    • pp.169-181
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    • 2014
  • Objectives: The purpose of this study was to obtain information regarding classification and health hazards that may result from a 13-week inhalation exposure to 2-methylpentane by Sprague-Dawley rats. Materials: The testing method was conducted in accordance with OECD guidelines for the testing of chemicals No. 413. The rats were divided into four groups(ten male and ten female rats in each group) and exposed to 0 ppm, 290 ppm, 1,160 ppm, 4,640 ppm 2-Methylpentane in each exposure chamber for six hours per day, five days per week, for 13 weeks. Results: No death or particular clinical presentation including weight change and change of feed rate was observed. The relationships between dose, gender and response were also not significantly changed in urinalysis, hematologic examination, or biochemical examination of blood(except for total cholesterol being up, total protein being up, and chloride ion being down in males), and blood coagulation time. For the relative weight measurement of organs, in the male group the weight change of both kidney and liver were increased in proportion to dose. In histopathological examination, nephropathy in the kidney(cystic change of renal tubules, regenerative tubule, inflammatory cell infiltration and necrosis in the interstitial tissue) was increased in a dose-dependent manner in the male group(290 ppm, 1,160 ppm, 4,640 ppm). However, other organs were not affected by the test substance. Conclusions: 2-methylpentane was estimated as a chemical causing nephropathy in the male group. NOAEL(No Observable Adverse Effect Level) in the female group is more than 4,640 ppm, while inthe male group it is less than 290 ppm.

Subacute Oral Toxicity Evaluation of Freeze-Dried Powder of Locusta migratoria

  • Kwak, Kyu-Won;Kim, Sun Young;An, Kyu Sup;Kim, Yong-Soon;Park, Kwanho;Kim, Eunsun;Hwang, Jae Sam;Kim, Mi-Ae;Ryu, Hyeon Yeol;Yoon, Hyung Joo
    • Food Science of Animal Resources
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    • v.40 no.5
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    • pp.795-812
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    • 2020
  • Novel food sources have enormous potential as nutritional supplements. For instance, edible insects are considered as an alternative food source due to their higher protein content; moreover, they are economically efficient reproducers and have high in nutritional value. In this study, we investigated the toxicity of the freeze-dried powder of Locusta migratoria (fdLM), known to contain rich proteins as well as fatty acids. The objective of the present study was to evaluate the subacute toxicity of fdLM in male and female Sprague-Dawley (SD) rats. The SD rats were divided into four groups based on the dosage of fdLM administered: dosage of 0 (vehicle control), 750, 1,500, and 3,000 mg/kg/day were administered for 28 days. Toxicological assessments including observations on food consumption, body and organ weights, clinical signs, mortality, ophthalmologic tests, urinalyses, hematologic tests, clinical chemistry tests, gross findings, and histopathology tests were performed. Clinical signs, urinalyses, hematology, serum biochemistry tests, and organ weight examinations revealed no fdLM-related toxicity. The no-observed-adverse-effect level for fdLM was higher than 3,000 mg/kg/day in rats of both sexes; therefore, fdLM, in conclusion, can be considered safe as an edible alternative human and animal food source material.

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 Changes of Quality of Life in Cancer Patients Treated with Chemotherapy (화학치료를 받는 암 환자 '삶의 질'의 변화에 관한 연구)

  • Kim, Byung-Soo;Choi, In-Keun;Park, Kyeung-Hwa;Yoon, So-Young;Oh, Sang-Chul;Seo, Jae-Hong;Choi, Chul-Won;Shin, Sang-Won;Kim, Yeul-Hong;Kim, Jun-Suk
    • The Korean Journal of Hospice and Palliative Care
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    • v.4 no.2
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    • pp.130-136
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    • 2001
  • Purpose : It is very important to endow the cancer patients underwent chemotherapy with satisfactory quality of life (QOL). However, little is known about the factors influencing QOL during chemotherapy. Therefore, we designed this study to find out the factors influencing QOL in the cancer patients who underwent chemotherapy. Methods : Ninety-seven cancer patients were studied, prospectively. The patients' characteristics were as follows; median age(range): 48(19{\sim}83) years, male:female; 57:40, PS:0,1/2,3;55/42 patients, diagnosis(number): lymphoma (28), lung cancer (22), gastrointestinal cancer (18), sarcoma (12), breast cancer (12), gynecological cancer (5), Stage: I,II/III.IV;37/60 patients. We used EORTC QLQ-C30 questionnaires to evaluate QOL. EORTC QLQ-C30 scores were performed before the onset of chemotherapy and after the end of 3 cycles of chemotherapy. The correlation of these scores with performance status (PS), diagnosis, disease stage, response to chemotherapy, and regimen related toxicity was evaluated. Results : The responder group (CR, PR) demonstrated marked improvement of social functional and emotional scales to non-responder group (SD,PD) (P=0.024, 0.045). Non-hematologic regimen related toxicity such as mucositis, nausea and vomiting was significantly correlated with pain scale change (P=0.043). Other factors had no notable correlation with QOL changes. Conclusion : Our preliminary study results may suggest as follows. The response to chemotherapy is associated with the change of social functional and emotional scales and the severity of non-hematologic regimen related toxicity is associated with pain scale change.

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26-Week Repeated Dose Oral Toxicity Study of KCHO-1 in Sprague-Dawley Rats

  • Yang, Muhack;Lee, Seongjin;Wang, Tingting;Cha, Eunhye;Jang, Jongwon;Kim, Dongwoung;Song, Bong-Keun;Son, Ilhong;Kim, Joonyup;Kang, Hyung Won;Kim, Sungchul
    • Journal of Pharmacopuncture
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    • v.22 no.3
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    • pp.192-199
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    • 2019
  • Objectives: KCHO-1(Mecasin), also called Gamijakyakgamchobuja-tang originally, is a combination of some traditional herbal medicines in East Asia. This medicine has been used mainly for alleviating neuropathic pains for centuries in Korean traditional medicine. KCHO-1 was developed to treat pain, joint contracture and muscular weakness in patients with amyotrophic lateral sclerosis. This study was carried out to investigate the chronic toxicity of KCHO-1 oral administration in rats for 26 weeks. Methods: Sprague-Dawely rats were divided into four groups and 10 rats were placed in the control group and the high-dose group, respectively. Group 1 was the control group and the remaining groups were the experimental groups. In the oral toxicity study, 500 mg/kg, 1,000 mg/kg, and 2,000 mg/kg of KCHO-1 were administered to the experimental group, and 10 ml/kg of sterile distilled water was administered to the control group. Survival rate, body weight, feed intake, clinical signs, and visual findings were examined. Urinalysis, ophthalmologic examination, necropsy, organ weight, hematologic examination, blood chemical examination and histopathologic examination were performed. Results: Mortality and toxicological lesions associated with the administration of test substance were not observed in all groups. Conclusion: NOAEL(No observed adverse effect level) of KCHO-1 is higher than 2000 mg/kg/day. And, the above findings suggest that treatment with KCHO-1 is relatively safe.

A 14-day Repeated Dose Oral Toxicity Study of HT042 in Sprague-Dawley Rats (Sprague-Dawley계 흰쥐를 이용한 HT042의 14일 반복 경구투여 독성연구)

  • Song, Jungbin;Lee, Donghun;Kim, Young-Sik;Lee, Seunggyeong;Bae, Jin-Sook;Kim, Hocheol
    • The Korea Journal of Herbology
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    • v.32 no.1
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    • pp.63-68
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    • 2017
  • Objectives : HT042 is a combination of three herbal extracts from the roots of Astragalus membranaceus, the stems of Eleutherococcus senticosus and the roots of Phlomis umbrosa, which has been demonstrated to increase longitudinal bone growth rate. The aim of this study was to assess the safety of HT042 after repeated oral administration. Methods : A 14-day repeated oral dose toxicity study was conducted using male and female Sprague-Dawley rats. HT042 was administered orally at repeated doses of 500, 1,000 and 2,000 mg/kg/day for 14 days. Clinical signs and mortality were observed daily, whereas body weight and food consumption were recorded weekly throughout the experiment. At the end of the study, blood was taken from the posterior vena cava for hematology and serum biochemistry. All organs of the body surface, subcutis, head, thoracic cavity, and abdominal cavity were observed grossly. Then, the internal organs were removed and weighed. Results : No death occurred and no significant changes in clinical sign, body weight, food consumption and serum biochemistry parameters were observed in male and female rats over the study period. Although there were some alterations in hematologic and necropsy findings, and organ weights, these changes were not considered toxicologically significant. Conclusions : These results suggest that the 14-day repeated administration of HT042 does not produce any significant oral toxicity at doses of up to 2,000 mg/kg/day in male and female rats under the present experimental conditions.

Subacute Transdermal Toxicity Study of Syndella gel, Topical Drug Containing Deproteinised Dialysate of Calf's Blood and Micronomicin sulfate, in Rats (흰쥐에서 신델라 겔 (송아지 제단백혈액추출물 : 황산미크로노마이신=20:1 복합제제)의 30일간 반복투여 경피독성시험)

  • Nam, Suk-Woo;Sung, Dae-Suk;Yoo, Se-Keun;Chang, Man-Sik;Choi, Wahn-Soo;Chung, Young-Kuk;Kim, Kyu-Bong;Han, Jeung-Whan;Hong, Sung-Youl;Lee, Hyang-Woo
    • YAKHAK HOEJI
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    • v.41 no.2
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    • pp.203-211
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    • 1997
  • This study was conducted to investigate the subacute transdermal toxicity of Syndella gel, a new topical drug containing deproteinized dialysate of calf's blood and micronomicin sulfate in Sprague-Dawley rats. Three doses (1.97, 3.94, 7.88 g/kg) of Syndella gel was daily treated transdermally to male and female rats for 30 days. No death was occurred in either control or treated rats. No significant toxic clinical signs and body weight change were not observed at any doses in the male or female rats treated. There were no significant alterations in hematologic and biochemical parameters in both sexes, however slight increase of potassium concentration was observed in 3.94g/kg and 7.88 g/kg female groups. No significant necrotic changes were not observed in examined organs. This study showed that up to 7.88g/kg Syndella gel did not induce subacute transdermal toxicity.

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Single-dose Intramuscular-injection Toxicology Test of Water-soluble Carthami-flos and Cervi cornu parvum Pharmacopuncture in a Rat Model

  • Park, Sunju;Sun, Seung-Ho
    • Journal of Pharmacopuncture
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    • v.18 no.3
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    • pp.42-48
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    • 2015
  • Objectives: The aim of the study is to investigate both the single-dose intramuscular injection toxicity and the approximate lethal dose of water-soluble Carthami-flos and Cervi cornu parvum pharmacopuncture (WCFC) in male and female Sprague-Dawley (SD) rats. Methods: The study was conducted at Biotoxtech Co. according to the Good Laboratory Practice (GLP) regulation and the toxicity test guidelines of the Ministry of Food and Drug Safety (MFDS) after approval of the Institutional Animal Care and Use Committee. Dosages for the control, high dose, middle dose and low dose groups were 0.5 mL/animal of saline and 0.5, 0.25 and 0.125 mL/animal of WCFC, respectively. WCFC was injected into the muscle of the left femoral region by using a disposable syringe (1 mL, 26 gauge). The general symptoms and mortality were observed 30 minutes, 1, 2, 4, and 6 hours after the first injection and then daily for 14 days after the injection. The body weights of the SD rats were measured on the day of the injection (before injection) and on the third, seventh, and fourteenth days after the injection. Serum biochemical and hematologic tests, necropsy examinations, and histopathologic examinations at the injection site were performed after the observation period. Results: No deaths, abnormal clinical symptoms, or significant weight changes were observed in either male or female SD rats in the control or the test (0.125, 0.25, and 0.5 mL/animal) groups during the observation period. No significant differences in hematology and serum biochemistry and no macroscopic abnormalities at necropsy were found. No abnormal reactions at injection sites were noted on the topical tolerance tests. Conclusion: The results of this single-dose toxicity study show that WCFC is safe, its lethal doses in male and female SD rats being estimated to be higher than 0.5 mL/animal.

Low-Dose Docetaxel/Cisplatin - Leucovorin and 46 Hour Infusional Fluorouracil in Metastatic Gastric Carcinoma

  • Alici, Suleyman;Buyukberber, Suleyman;Alkis, Necati;Benekli, Mustafa;Ozkan, Metin;Bilici, Ahmet;Demirci, Umut;Karaca, Halit;Arpaci, Erkan;Gumus, Mahmut;Altunbas, Mustafa;Dane, Faysal;Turk, H. Mehmet;Anatolian Society of Medical Oncology
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.1
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    • pp.423-427
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    • 2013
  • Background: Phase II and III trials of docetaxel, cisplatin and fluorouracil (DCF) have shown superior efficacy versus cisplatin and fluorouracil alone but with high rates of hematologic toxicity in metastatic gastric cancer cases. To reduce toxicity while maintaining the efficacy of DCF, we investigated low dose docetaxel (D), cispatin (C) - leucovorin and fluorouracil (De Gramont regimen). Patient and methods: Chemotherapy-naïve patients with metastatic gastric cancer (MGC) received D 60 mg/$m^2$ on day 1 and cisplatin 30 mg/$m^2$ on day 1-2 and the De Gramont regimen (Folinic acid 400 mg/m2 on day 1 and 5-FU 2400 mg/$m^2$/46h continuous infusion) every 3 weeks. The primary endpoint was response rate. Results: One hundred twenty patients with a median age of 52.5 years (range, 32-78) received a median of 6 cycles (range, 2-12 cycles). Of the 120 evaluable patients, 4 showed complete remission and 36 achieved a partial response. The overall response rate was 56.6%. Twenty eight patients (23.3%) showed stable disease and 52 (43.3%) progression. The median time to progression was 7 months (95%CI 6-7.9). The median overall survival was 15 months (95%CI 13.7-16.2). The most frequent hematological toxicity was leucopenia, which occurred at grade 3/4 intensity in 24 patients (20%). Conclusions: Low-dose DC-De Gramont regimen is active in MGC with a tolerable toxicity profile.

Studies on Combined Usage of Combined Preparation of Crude Drugs and Anti-neoplastic Drugs (I) -Alleviative Effect of Combined Usage of Gamisamryungbaekchool-San and cis-Platin on the Side Actions of cis-Platin- (생약복합제제(生藥複合製劑)와 항암제(抗癌劑)의 병용투여(倂用投與)에 관한 연구(硏究) (제1보)(第1報) -가미삼령백출산(加味蔘笭白朮散)과 cis-Platin 병용투여(倂用投與)에 의한 부작용(副作用) 경감(輕減) 효과(效果)-)

  • Kim, Nam-Jae;Hong, Nam-Doo;Cho, Chong-Kwan;Kim, Jin-Sik;Baek, Seung-Hak
    • Korean Journal of Pharmacognosy
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    • v.22 no.3
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    • pp.197-206
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    • 1991
  • The water extract of Gamisamryungbaekchool-San increased the lifespan of mice implanted intraperitoneally with sarcoma 180. Significant depression of lethal toxicity of cis-platin $(45{\mu}M/kg,\;s.c)$ and renal toxicity (indicated by an increase in blood urea nitrogen value and creatinine value) of cis-platin $(35{\mu}M/kg,\;s.c)$ were observed in mice and rats treated with Gamisamryungbaekchool-San. RBC and WBC were significantly decreased in rats treated with cis-platin, and significant depression of hematologic toxicities of cis-platin $(35{\mu}M/kg,\;s.c)$ in rats treated with Gamisamryungbaekchool-San. After all, alleviative effect of the side actions of cis-platin was acknowledged by combined usage of Gamisamryungbaekchool-San and cis-platin.

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