1.Great attention should be paid to the adverse drug reactions associated with the use of molecular targeted anticancer drugs.
Zheng-tang CHEN ; Yu-zhong DUAN ; Jian-cheng XU
Chinese Journal of Oncology 2009;31(12):881-884
Antineoplastic Agents
;
adverse effects
;
therapeutic use
;
Diarrhea
;
chemically induced
;
Drug Delivery Systems
;
methods
;
Exanthema
;
chemically induced
;
Humans
;
Leukopenia
;
chemically induced
;
Lung Diseases, Interstitial
;
chemically induced
;
Myocardial Infarction
;
chemically induced
;
Neoplasms
;
drug therapy
;
Tumor Lysis Syndrome
;
etiology
2.Influence of fiberform on defecation condition after surgery for benign anorectal lesion.
Chao LEI ; Ye-huang WANG ; Su-min ZHANG ; Ping JIANG ; Xue-xin JIAO ; He-gen HUANG
Chinese Journal of Gastrointestinal Surgery 2011;14(12):938-940
OBJECTIVETo explore the influence of fiberform on the defecation condition after surgery for benign anorectal lesion.
METHODSA total of 121 cases undergoing surgery for benign anorectal lesion at the Third Affiliated Hospital of Nanjing University of Traditional Chinese Medicine from October 2009 to February 2010 were randomly divided into the treatment group (n=61) and the control group (n=60) according to random number table. Patients in the treatment group received fiberform granule for 2 weeks while patients in the control group did not receive any medication to promote defecation. Postoperative defecation symptom scores and patient satisfaction were compared between the two groups.
RESULTSOn postoperative day 7, patients in the treatment group had a lower defecation smoothness score (62.1% decrease), lower fecal character score (74.3% decrease), lower defecation interval score (80.2% decrease), lower defecation pain score (77.5% decrease), the differences were statistically significant. On postoperative day 14, the degree of decrease of the abovementioned score were 58.3%, 88.5%, 82.8% and 83.1%, respectively. Postoperative patient satisfaction rate in the treatment group was significantly higher than that in the control group(P<0.05). No patient in the treatment group experienced any adverse events such as abdominal pain, diarrhea, and drug dependence.
CONCLUSIONFiberform can effectively prevent defecation disorders such as dry stool, unsmooth defecation, and anorectal pain.
Abdominal Pain ; chemically induced ; Anal Canal ; surgery ; Defecation ; drug effects ; Diarrhea ; chemically induced ; Dietary Fiber ; administration & dosage ; Humans ; Treatment Outcome
3.Antibiotics-associated Diarrhea and Other Gastrointestinal Abnormal Responses Regarding Helicobacter pylori Eradication.
Soon Beom KWON ; Kook Lae LEE ; Joon Suk KIM ; Jae Kyung LEE ; Won KIM ; Yong Jin JUNG ; Ji Bong JEONG ; Ji Won KIM ; Byeong Gwan KIM
The Korean Journal of Gastroenterology 2010;56(4):229-235
BACKGROUND/AIMS: Helicobacter pylori (H. pylori) is closely related with a wide range of gastrointestinal disease. One-week triple therapy is currently considered as the golden standard for the treatment of H. pylori infection. However, gastrointestinal abnormal responses are major pitfalls in such regimen. The aim of this study was to identify symptoms, frequency and severity of antibiotics-associated gastrointestinal abnormal responses during H. pylori eradication therapy. METHODS: Sixty-seven patients with H. pylori infection between September 2005 and March 2006 were included. After 1 week of H. pylori eradication triple therapy (rabeprazol 10 mg, clarithromycin 500 mg, amoxicillin 1 g bid), we evaluated gastrointestinal abnormal responses (diarrhea, bloating, constipation, abdominal pain, borborygmus, flatulence, stool frequency, belching, and nausea) and severities every week for 4 weeks. RESULTS: The incidence of diarrhea was the highest in week 1, which was 41.28% (n=28) and the lowest in week 4, which was 9.52% (n=6) and decreased from week 1 to week 4 with statistical significance (p<0.0001). The most common gastrointestinal abnormal responses were associated with flatulence in week 1 (n=21, 31.34%), week 2 (n=21, 33.33%) and abdominal distention in week 3 (n=16, 25.40%), week 4 (n=15, 23.81%). Most of gastrointestinal abnormal responses were mild, and the most common symptom with higher than moderate grade was abdominal pain (n=4, 40.00%) in week 1. Alcohol consumption and coexisting medical illness were not associated with diarrhea (p=0.0852, 0.9009 respectively). CONCLUSIONS: H. pylori eradication therapy is commonly associated with antibiotics-associated gastrointestinal abnormal responses, which may result in antibiotics intolerance and H. pylori eradication failure. Even though those symptoms are not so severe, we have to consider the gastrointestinal abnormal responses associated with H. pylori eradication, especially diarrhea.
Abdominal Pain/chemically induced
;
Adult
;
Alcohol Drinking
;
Anti-Bacterial Agents/*adverse effects/therapeutic use
;
Diarrhea/*chemically induced
;
Female
;
Flatulence/chemically induced/etiology
;
Gastrointestinal Diseases/*chemically induced
;
Helicobacter Infections/*drug therapy
;
*Helicobacter pylori
;
Humans
;
Male
;
Middle Aged
;
Young Adult
4.Clinical manifestation and influential factors in patients with acute arsenic poisoning.
Wei-Wei LIU ; Zhi-Qian YANG ; Cheng ZHANG ; Yi-Li ZHANG ; Wen-Zhong JIANG ; Yi-Xing WU ; Yi-Min LIU ; Li-Cheng GU
Chinese Journal of Industrial Hygiene and Occupational Diseases 2008;26(11):645-648
OBJECTIVETo investigate the clinical characteristics of acute arsenic poisoning and its influential factors.
METHODSClinical data of 47 cases of arsenic poisoning were collected and analyzed. Two cases of observation, 40 cases of mild acute poisoning, and 5 severe acute poisoning were investigated in this group.
RESULTSMyocardial enzyme activity was correlated with age and urine arsenic concentrations. Myocardial enzyme, the liver ALT, total bilirubin (TBil) and indirect bilirubin (IBil) were negatively correlated with vomiting frequency, with statistical significance (P < 0.05). Urine arsenic concentration was correlated with vomiting frequency and amount of soup drunk, with statistically significant difference (P < 0.05). Despite no statistical significance in age and amount of soup drunk, the patients with more vomiting or diarrhea had less urine arsenic concentrations, cardiac enzymes and liver enzyme concentration.
CONCLUSIONAcute arsenic poisoning can lead to multiple organ damage. The damage is relevant with amount of arsenic intake, vomiting, diarrhea and urinary frequency arsenic concentration. So early use of gastric lavage, vomiting, poison discharges, and adequate application of effective antidote (Na-DMPS) as soon as possible, symptomatic treatment and the reinforced monitoring, are the rescue key for patients with acute arsenic poisoning.
Acute Disease ; Adolescent ; Adult ; Arsenic ; urine ; Arsenic Poisoning ; physiopathology ; Diarrhea ; chemically induced ; Female ; Food Contamination ; Humans ; Liver ; enzymology ; Male ; Middle Aged ; Vomiting ; chemically induced ; Young Adult
5.Influence of stir-baked with sand on active ingredients, diarrhea and hepatoprotection of Herpetospermum caudigerum.
Juan-juan LI ; Gang SHEN ; Rong-li YIN ; Cheng-ying SHEN ; Ling CHENG ; Ling QIU ; Jin HAN ; Hai-long YUAN
China Journal of Chinese Materia Medica 2015;40(2):236-239
To study the influence of stir-baked with sand on active ingredients, diarrhea and hepatoprotection of Herpetospermum caudigerum, the contents of herperione and herpetin in H. caudigerum before and after stir-baking with sand were analyzed by HPLC. The effect of stir-baked with sand on diarrhea of H. caudigerum TL was evaluated using the mean stool rate (MSR) and mean diarrheal index ( MDI) and the influence of stir-baked with sand on hepatoprotective effect of H. caudigerum TL was examined using a mouse model of CCl4-induced liver injury based on the analysis of serum ALT and AST activities. The results of HPLC analysis showed the content of herperione in H. caudigerum after stir-baking with sand decreased by 40.9% (P < 0.01) and the content of herpetin had no change. Pharmacodynamic results showed that the MSR and MDI of high-dose and middle-dose group of H. caudigerum TL after stir-baking with sand were significantly lower than that of high-dose and middle-dose group of H. caudigerum TL without stir-baking with sand; The high-dose and middle-dose of H. caudigerum TL with/without stir-baking with sand significantly alleviated liver injury as indicated by the decreased levels of serum ALT and AST, but the ALT and AST levels of high-dose and middle-dose group of H. caudigerum TL after stir-baking with sand were higher than that of H. caudigerum TL without stir-baking with sand. The results revealed that the stir-baking with sand could effectively relieve diarrhea effect of H. caudigerum TL, while it also reduces the hepatoprotection of H. caudigerum TL.
Animals
;
Chromatography, High Pressure Liquid
;
Cooking
;
Cucurbitaceae
;
chemistry
;
Diarrhea
;
chemically induced
;
Female
;
Liver
;
drug effects
;
Male
;
Mice
;
Protective Agents
;
pharmacology
6.Bi-weekly Chemotherapy of Paclitaxel and Cisplatin in Patients with Metastatic or Recurrent Esophageal Cancer.
Sang Hee CHO ; Ik Joo CHUNG ; Sang Yun SONG ; Deok Hwan YANG ; Jeong Rae BYUN ; Yeo Kyeoung KIM ; Je Jung LEE ; Kook Joo NA ; Hyeoung Joon KIM
Journal of Korean Medical Science 2005;20(4):618-623
Although various combinations of chemotherapy regimens have been tried for patients with esophageal cancer, their duration of survival is extremely poor. In this study, we investigated the safety and clinical efficacy of paclitaxel and cisplatin chemotherapy in metastatic or recurrent esophageal cancer. 32 patients enrolled in this study and the median age was 60 yr. Of all the 32, 28 patients (88%) had been treated previously, 22 of them with chemotherapy or radiation therapy. All patients in the study received biweekly paclitaxel (90 mg/m2) followed by cisplatin (50 mg/m2). One patient (3%) responded completely, and 12 patients (38%) showed a partial response; in 9 patients (28%) the disease remained stable, and in 10 patients (31%) it progressed. The objective response rate was 41%. The median duration of response was 4.8 months, and the median overall survival in all patients was 7 months. The 1-yr and 2-yr survival rates were 28.1% and 7.1%, respectively. Grade 3 or 4 of neutropenia and anemia were observed in 6 (19%) and 5 (16%) patients, respectively. The major non-hematologic toxicity was fatigue, but most of them could manageable. In conclusion, biweekly paclitaxel and cisplatin is effective in patients with metastatic or recurrent esophageal cancer.
Aged
;
Anemia/chemically induced
;
Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
;
Bone Neoplasms/drug therapy/secondary
;
Cisplatin/administration & dosage/adverse effects
;
Diarrhea/chemically induced
;
Esophageal Neoplasms/*drug therapy/pathology
;
Fatigue/chemically induced
;
Humans
;
Liver Neoplasms/drug therapy/secondary
;
Lung Neoplasms/drug therapy/secondary
;
Lymphatic Metastasis
;
Male
;
Middle Aged
;
Nausea/chemically induced
;
Neoplasm Recurrence, Local
;
Paclitaxel/administration & dosage/adverse effects
;
Survival Analysis
;
Thrombocytopenia/chemically induced
;
Time Factors
;
Treatment Outcome
;
Vomiting/chemically induced
7.Factors Predictive of Treatment-Emergent Adverse Events of Prucalopride: An Integrated Analysis of Four Randomized, Double-Blind, Placebo-Controlled Trials.
Somchai LEELAKUSOLVONG ; Meiyun KE ; Duowu ZOU ; Suck Chei CHOI ; Jan TACK ; Eamonn M M QUIGLEY ; Andy LIU ; Jinyong KIM
Gut and Liver 2015;9(2):208-213
BACKGROUND/AIMS: This integrated analysis aimed to identify the factors associated with the most frequently reported treatment-emergent adverse events (TEAEs) in Asian and non-Asian patients with chronic constipation (CC) who receive prucalopride or placebo over 12 weeks. METHODS: Pooled data from four randomized, double-blind, placebo-controlled, multicenter, phase III studies (NCT00488137, NCT00483886, NCT00485940, and NCT01116206) on patients treated with prucalopride 2 mg or placebo were analyzed. The associations between predictors and TEAEs were evaluated based on a logistic regression model. RESULTS: Overall, 1,821 patients (Asian, 26.1%; non-Asian, 73.9%) were analyzed. Prucalopride treatment was significantly associated with diarrhea, headache, and nausea (p<0.001), but not with abdominal pain, compared with placebo. Differences in the prevalence of TEAEs between prucalopride and placebo decreased greatly after the first day of treatment. Compared with non-Asians, Asians were more likely to experience diarrhea and less likely to develop abdominal pain, headache, and nausea. Prior laxative use, CC duration, and body weight were not predictive of any of these TEAEs. CONCLUSIONS: Prucalopride treatment was positively associated with diarrhea, headache, and nausea. Asian patients tended to have a higher frequency of diarrhea but lower frequencies of headache, abdominal pain, and nausea compared with non-Asians.
Abdominal Pain/*chemically induced
;
Adult
;
Aged
;
Aged, 80 and over
;
Asian Continental Ancestry Group/statistics & numerical data
;
Benzofurans/*adverse effects
;
Clinical Trials, Phase III as Topic
;
Constipation/*drug therapy/ethnology
;
Diarrhea/*chemically induced
;
Double-Blind Method
;
Female
;
Headache/*chemically induced
;
Humans
;
Male
;
Middle Aged
;
Multicenter Studies as Topic
;
Nausea/chemically induced
;
Randomized Controlled Trials as Topic
;
Regression Analysis
8.Factors Predictive of Treatment-Emergent Adverse Events of Prucalopride: An Integrated Analysis of Four Randomized, Double-Blind, Placebo-Controlled Trials.
Somchai LEELAKUSOLVONG ; Meiyun KE ; Duowu ZOU ; Suck Chei CHOI ; Jan TACK ; Eamonn M M QUIGLEY ; Andy LIU ; Jinyong KIM
Gut and Liver 2015;9(2):208-213
BACKGROUND/AIMS: This integrated analysis aimed to identify the factors associated with the most frequently reported treatment-emergent adverse events (TEAEs) in Asian and non-Asian patients with chronic constipation (CC) who receive prucalopride or placebo over 12 weeks. METHODS: Pooled data from four randomized, double-blind, placebo-controlled, multicenter, phase III studies (NCT00488137, NCT00483886, NCT00485940, and NCT01116206) on patients treated with prucalopride 2 mg or placebo were analyzed. The associations between predictors and TEAEs were evaluated based on a logistic regression model. RESULTS: Overall, 1,821 patients (Asian, 26.1%; non-Asian, 73.9%) were analyzed. Prucalopride treatment was significantly associated with diarrhea, headache, and nausea (p<0.001), but not with abdominal pain, compared with placebo. Differences in the prevalence of TEAEs between prucalopride and placebo decreased greatly after the first day of treatment. Compared with non-Asians, Asians were more likely to experience diarrhea and less likely to develop abdominal pain, headache, and nausea. Prior laxative use, CC duration, and body weight were not predictive of any of these TEAEs. CONCLUSIONS: Prucalopride treatment was positively associated with diarrhea, headache, and nausea. Asian patients tended to have a higher frequency of diarrhea but lower frequencies of headache, abdominal pain, and nausea compared with non-Asians.
Abdominal Pain/*chemically induced
;
Adult
;
Aged
;
Aged, 80 and over
;
Asian Continental Ancestry Group/statistics & numerical data
;
Benzofurans/*adverse effects
;
Clinical Trials, Phase III as Topic
;
Constipation/*drug therapy/ethnology
;
Diarrhea/*chemically induced
;
Double-Blind Method
;
Female
;
Headache/*chemically induced
;
Humans
;
Male
;
Middle Aged
;
Multicenter Studies as Topic
;
Nausea/chemically induced
;
Randomized Controlled Trials as Topic
;
Regression Analysis
9.Dose escalation of domestic nedaplatin used in concurrent chemoradiotherapy for cervical cancer.
Wei-Guo ZHU ; Chang-Hua YU ; Tao LI
Chinese Journal of Oncology 2011;33(7):525-526
Adult
;
Aged
;
Antineoplastic Agents
;
administration & dosage
;
adverse effects
;
therapeutic use
;
Carcinoma, Squamous Cell
;
therapy
;
Chemoradiotherapy
;
Diarrhea
;
chemically induced
;
Dose-Response Relationship, Drug
;
Female
;
Humans
;
Leukopenia
;
chemically induced
;
Middle Aged
;
Organoplatinum Compounds
;
administration & dosage
;
adverse effects
;
therapeutic use
;
Radiotherapy, Conformal
;
Thrombocytopenia
;
chemically induced
;
Uterine Cervical Neoplasms
;
therapy
;
Vomiting
;
chemically induced
10.Therapeutic efficacy and prognostic factors of sorafenib treatment in patients with unresectable primary hepatocellular carcinoma.
Lan ZHANG ; Zheng-gang REN ; Yu-hong GAN ; Yan-hong WANG ; Bo-heng ZHANG ; Yi CHEN ; Xiao-ying XIE ; Nin-ling GE ; Sheng-long YE
Chinese Journal of Oncology 2010;32(8):630-633
OBJECTIVETo evaluate the efficacy and analyze the prognostic factors of sorafenib treatment in patient with unresectable primary hepatocellular carcinoma (HCC).
METHODSDuring the period from December 2005 to March 2009, 50 patients with unresectable primary HCC of Child-Pugh status A were treated with sorafenib (400 mg, Bid). The tumor response was evaluated with CT or MRI imaging every 6 - 8 weeks according to the RECIST criteria. The overall survival (OS) and time to progression (TTP) were defined as the time from administration of sorafenib to the death or the last follow up and were evaluated by Kaplan-Meier method.
RESULTSThere was no PR or CR, but 28 patients (56.0%) achieved stable disease. The median follow up time was 15 months with a median OS of 14 months and median TTP of 4 months. The common adverse events were dermal reaction (68.0%, 34/50), diarrhea (52.0%, 26/50), hypertension (4.0%, 2/50), hair loss (14.0%, 7/50), myelosuppression (16.0%, 8/50), and liver dysfunction (20.0%, 10/50). However, most of the drug-related adverse events were grade I-II and reversible. The patients with lower tumor burden and without distant metastasis had better prognosis.
CONCLUSIONSoafenib is effective for unresectable primary HCC with tolerable toxicity. Tumor stage is a predominant prognostic factor.
Adult ; Aged ; Alopecia ; chemically induced ; Antineoplastic Agents ; adverse effects ; therapeutic use ; Benzenesulfonates ; adverse effects ; therapeutic use ; Carcinoma, Hepatocellular ; drug therapy ; Chemoembolization, Therapeutic ; methods ; Diarrhea ; chemically induced ; Disease Progression ; Follow-Up Studies ; Humans ; Hypertension ; chemically induced ; Liver Neoplasms ; drug therapy ; Male ; Middle Aged ; Neoplasm Staging ; Niacinamide ; analogs & derivatives ; Phenylurea Compounds ; Pyridines ; adverse effects ; therapeutic use ; Skin Diseases ; chemically induced ; Survival Rate