• Title/Summary/Keyword: Clinical safety

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Trans-arterial Chemo-Embolization in Treating Elderly Patients with Hepatocellular Carcinoma

  • Zhang, Jian-Feng;Liu, Jun-Mao;Zhang, Nin;Du, Chao;Zheng, Qin
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.16
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    • pp.7201-7204
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    • 2015
  • Background: This analysis was conducted to evaluate the efficacy and safety of Trans-arterial Chemo-Embolization (TACE) in treating Elderly patients with Hepatocellular Carcinoma (EHPC). Methods: Clinical studies evaluating the efficacy and safety of TACE on response and safety for patients with EHPC were identified by using a predefined search strategy. Pooled response rate of treatment were calculated. Results: In TACE based regimen, clinical studies which including patients with EHPC were considered eligible for the evaluation of response. And, in these TACE based treatments, pooled analysis suggested that, in all 288 patients whose response could be assessed, the pooled reponse rate was 29.5%(85/288) in TACE based treatment. The most commonly encountered TACE-related morbidity was liver function impairment. No grade III or IV renal or liver toxicity were observed. No treatment related death occurred in EHPC patients with TACE based treatments. Conclusion: This evidence based analysis suggests that TACE based treatments are associated with mild response rate and accepted toxicities for treating patients with EHPC.

Systematic Analysis of Pemetrexed-based Chemoradiotherapy for Patients with Locally Advanced or Metastatic Esophageal Cancer

  • Tian, Guang-Yu;Miu, Min;Huang, Xin-En
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.19
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    • pp.8475-8478
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    • 2014
  • Purpose: This systematic analysis was conducted to evaluate the efficacy and safety of pemetrexed-based chemoradiotherapy in treating patients with locally advanced or metastatic esophageal cancer. Methods: Clinical studies evaluating the efficacy and safety of pemetrexed based regimens on response and safety for relevant patients were identified using a predefined search strategy. Pooled response rates (RRs) were calculated. Results: For pemetrexed-based regimens, 4 clinical studies including 47 patients with locally advanced or metastatic esophageal cancer were considered eligible for inclusion. Systematic analysis showed that, in all patients, the pooled RR was 51% (24/47). Major adverse effects of grade III/IV were esophagitis, neutropenia, thrombocytopenia, anemia anorexia, fatigue, diarrhea, dysphagia and vomiting. No treatment related death occurred with pemetrexed-based treatment. Conclusion: This systematic analysis suggests that pemetrexed based radiotherapy is associated with reasonable activity and good tolerability in treating patients with locally advanced or metastatic esophageal cancer.

Pemetrexed is Mildly Active with Good Tolerability for Treatment of Patients with Colorectal Cancer

  • Zhang, Hui-Qing;Lian, Chang-Hong;Ping, Yao-Dong;Song, Wen-Bin;Lu, Qing-Pu;Xie, Shu-Zhe;Lin, Tao;Cheng, Lin-Zhong
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.19
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    • pp.8391-8394
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    • 2014
  • Purpose: This systematic analysis was conducted to evaluate the efficacy and safety of pemetrexed based salvage chemotherapy for treatment of patients with metastatic colorectal cancer. Methods: Clinical studies evaluating the efficacy and safety of pemetrexed based regimens on response and safety for patients with colorectal cancer were identified using a predefined search strategy. Pooled response rates (RRs) were calculated. Results: For pemetrexed based regimens, 4 clinical studies including 201 patients with advanced colorectal cancer were considered eligible for inclusion. The analysis suggested that, in all patients, pooled RR was 20.4% (41/201). Major adverse effects were neutropenia, anorexia, fatigue, and anemia. No treatment related death occurred with pemetrexed based treatment. Conclusion: This systematic analysis suggests that pemetrexed based regimens are associated with mild activity with good tolerability in treating patients with metastatic colorectal cancer.

A Study on Subchronic Inhalation Toxicity of 1-Chloropropane

  • Chung, Yong Hyun;Han, Jeong Hee;Lee, Yong-Hoon
    • Toxicological Research
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    • v.31 no.4
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    • pp.393-402
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    • 2015
  • This study was conducted to measure toxicity of 1-chloropropane (CAS No. : 540-54-5). According to the OECD Test Guideline 413 (Subchronic inhalation toxicity: 90-day study), SD rats were exposed to 0, 310, 1,250, and 5,000 ppm of 1-chloropropane for 6 h/day, 5 day/week for 13 weeks via whole-body inhalation. Mortality, clinical signs, body weights, food consumption, motor activity, ophthalmoscopy, hematology, serum chemistry, urinalysis, organ weights, gross and histopathological findings were compared between control and all tested groups. No mortality or remarkable clinical signs were examined during the study. No gross lesions or adverse effects on body weight, food consumption, motor activity, ophthalmoscopy, urinalysis, hematology, organ weights were observed in any of male or female rats in all tested groups. In serum biochemistry, glucose was significantly decreased in males of 1,250 and 5,000 ppm groups compared to control group in dose-dependent relationship. In histopathological examination, vacuolation of acinar cells was observed in pancreas of all male and female groups exposed to 1-chloropropane. In conclusion, no observable adverse effect level (NOAEL) was considered to be below 310 ppm/6 h/day, 5 day/week for rats.

Evidence Based Analysis of Cisplatin for Treating Patients with Cutaneous Squamous Cell Carcinoma

  • Shao, Xiao-Hong;Xu, Yun-Sheng;Zhang, Xue-Qi;Li, Wen-Feng
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.22
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    • pp.9813-9815
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    • 2014
  • Background: This analysis was conducted to evaluate the efficacy and safety of cisplatin based chemotherapy for treating patients with cutaneous squamous cell carcinoma. Methods: Clinical studies evaluating the efficacy and safety of cisplatin based regimens on response and safety for patients with cutaneous squamous cell carcinoma were identified using a predefined search strategy. Pooled response rates (RR) of treatment were calculated. Results: In cisplatin based regimens, 4 clinical studies which including 50 patients with advanced cutaneous squamous cell carcinoma were considered eligible for inclusion. Regimens included cisplatin, doxorubicin, or vindesine. Pooled analysis suggested that, in all patients, the pooled RR was 60% (30/50) in cisplatin based regimens. Nausea and vomiting were the main side effects. No grade III or IV renal or liver toxicity were observed. No treatment related death occurred with the cisplatin based treatments. Conclusion: Evidence based analysis suggests that cisplatin based regimens are associated with a good response rate and acceptable toxicity for treating patients with cutaneous squamous cell carcinoma.

A Pooled Analysis on Crizotinib in Treating Chinese Patients with EML4-ALK Positive Non-small-cell Lung Cancer

  • Li, Yang;Huang, Xin-En
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.11
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    • pp.4797-4800
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    • 2015
  • Background: This analysis was conducted to evaluate the efficacy and safety of crizotinib based regimens in treating Chinese patients with EML4-ALK positive non-small-cell lung cancer. Materials and Methods: Clinical studies evaluating the efficacy and safety of crizotinib based regimens on response and safety for Chinese patients with EML4-ALK positive non-small-cell lung cancer were identified by using a predefined search strategy. Pooled response rate (RR) of treatment were calculated. Results: In crizotinib based regimens, 3 clinical studies which including 128 Chinese patients with EML4-ALK positive non-small-cell lung cancer and treated with crizotinib based regimen were considered eligible for inclusion. Pooled analysis suggested that, in all patients, the pooled RR was 59.3% (76/128) in crizotinib based regimens. ALT/AST mild visual disturbances, nausea, and vomiting were the main side effects. No treatment related death occurred in these crizotinib based treatments. Conclusions: This pooled analysis suggests that crizotinib based regimens are associated with good response rate and accepted toxicities in treating Chinese patients with EML4-ALK positive non-small-cell lung cancer.

Nursing Problems in Oriental Nursing Practice Based on Nursing Documentation (간호기록을 이용한 한방 간호 실무에서의 간호 문제에 대한 조사 연구)

  • Hwang, Jee-In
    • Journal of East-West Nursing Research
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    • v.17 no.1
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    • pp.66-70
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    • 2011
  • Purpose: The aim of this study was to examine the types of nursing problems in oriental nursing practice. Methods: This study employed a descriptive survey design. Nursing documentation was retrospectively reviewed for patients discharged from an oriental medicine hospital during three months. Nursing diagnoses documented were mapped into the Clinical Care Classification System. Data were summarized using descriptive statistics. Results: Data were collected from 110 patients using nursing documentation. The number of nursing diagnoses documented was 204 with a mean of 1.9 per patient. The frequently occurring nursing diagnoses were 'risk for trauma' (48.0%), 'pain' (13.7%), and 'urinary elimination alteration' (7.8%). According to the Clinical Care Classification system, the safety component (51.5%) was the most common nursing problem in oriental nursing practice. Conclusion: The study finding suggested that major nursing problems in oriental nursing practice were related to patient safety. Therefore, oriental nursing education on patient safety should be emphasized to improve the quality of nursing care in oriental medicine hospitals.

Applications of Genetically Modified Tools to Safety Assessment in Drug Development

  • Kay, Hee-Yeon;Wu, Hong-Min;Lee, Seo-In;Kim, Sang-Geon
    • Toxicological Research
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    • v.26 no.1
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    • pp.1-8
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    • 2010
  • The process of new drug development consists of several stages; after identifying potential candidate compounds, preclinical studies using animal models link the laboratory and human clinical trials. Among many steps in preclinical studies, toxicology and safety assessments contribute to identify potential adverse events and provide rationale for setting the initial doses in clinical trials. Gene modulation is one of the important tools of modern biology, and is commonly employed to examine the function of genes of interest. Advances in new drug development have been achieved by exploding information on target selection and validation using genetically modified animal models as well as those of cells. In this review, a recent trend of genetically modified methods is discussed with reference to safety assessments, and the exemplary applications of gene-modulating tools to the tests in new drug development were summarized.

Lenalidomide in Treating Patients with Castration-Resistant Prostate Cancer

  • Xing, Dong-Liang;Song, Dong-Kui;Zhang, Li-Rong
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.9
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    • pp.3969-3972
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    • 2015
  • Background: This analysis was conducted to evaluate the efficacy and safety of lenalidomide based regimen in treating patients with castration-resistant prostate cancer. Materials and Methods: Clinical studies evaluating the efficacy and safety of lenalidomide based regimens on response and safety for patients with castration-resistant prostate cancer were identified using a predefined search strategy. A pooled response rate (rate of PSA level decline of ${\geq}50%$) to treatment was calculated. Results: In lenalidomide based regimen, 3 clinical studies which including 98 patients with castration-resistant prostate cancer were considered eligible for inclusion. These lenalidomide based regimens included cisplatin, doxorubicin, or GM-CSF. Pooled analysis suggested that, in all patients, the pooled PSA level decline of ${\geq}50%$ was 13.3% (13/98) in lenalidomide based regimens. Fatigue, nausea and vomitting were the main side effects. No grade III or IV renal or liver toxicity were observed. No treatment related death occurred in patients with lenalidomide based regimens. Conclusions: This evidence based analysis suggests that lenalidomide based regimens are associated with mild response rate and acceptable toxicities for treating patients with castration-resistant prostate cancer.

Pemetrexed in Treating Patients with Metastatic Bladder Cancer

  • Li, Qing;Li, Jian-Zhang;Xu, Wan-Hai;Gao, Lin
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.9
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    • pp.3839-3841
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    • 2015
  • Background: This pooled analysis was conducted to evaluate the efficacy and safety of pemetrexed based chemotherapy in treating patients with metastatic bladder cancer as salvage chemotherapy. Methods: Clinical studies evaluating the efficacy and safety of pemetrexed based regimens on response and safety for patients with bladder cancer were identified by using a predefined search strategy. Pooled response rate (RR) of treatment were calculated. Results: In pemetrexed based regimens, 3 clinical studies which including 105 patients with advanced transitional cell cancer of the urothelium were considered eligible for inclusion. Pooled analysis suggested that, in all patients, pooled RR was 26.7% (28/105) for pemetrexed based regimens. Major adverse effects were neutropenia, anorexia, fatigue, and anemia in pemetrexed based treatment. Two treatment related deaths occurred with pemetrexed based treatment. Conclusion: This pooled analysis suggests that pemetrexed based regimens are associated with mild activity and good tolerability in treating patients with metastatic bladder cancer.