OBJECTIVE: Rikkunshito, an herbal medicine, is widely prescribed in Japan for the treatment of anorexia and functional dyspepsia, and has been reported to recover reductions in food intake caused by cisplatin. We investigated whether rikkunshito could improve chemotherapy-induced nausea and vomiting (CINV) and anorexia in patients treated with cisplatin. METHODS: Patients with uterine cervical or corpus cancer who were to receive cisplatin (50 mg/m² day 1) and paclitaxel (135 mg/m² day 0) as first-line chemotherapy were randomly assigned to the rikkunshito group receiving oral administration on days 0–13 with standard antiemetics, or the control group receiving antiemetics only. The primary endpoint was the rate of complete control (CC: no emesis, no rescue medication, and no significant nausea) in the overall phase (0–120 hours). Two-tailed p<0.20 was considered significant in the planned analysis. RESULTS: The CC rate in the overall phase was significantly higher in the rikkunshito group than in the control group (57.9% vs. 35.3%, p=0.175), as were the secondary endpoints: the CC rate in the delayed phase (24–120 hours), and the complete response (CR) rates (no emesis and no rescue medication) in the overall and delayed phases (63.2% vs. 35.3%, p=0.095; 84.2% vs. 52.9%, p=0.042; 84.2% vs. 52.9%, p=0.042, respectively), and time to treatment failure (p=0.059). Appetite assessed by visual analogue scale (VAS) appeared to be superior in the rikkunshito group from day 2 through day 6. CONCLUSION: Rikkunshito provided additive effect for the prevention of CINV and anorexia.
Administration, Oral ; Anorexia* ; Antiemetics ; Appetite ; Cisplatin* ; Drug Therapy ; Dyspepsia ; Eating ; Herbal Medicine* ; Humans ; Japan ; Nausea* ; Paclitaxel* ; Time-to-Treatment ; Vomiting*

PURPOSE: To investigate the prevalence of paralytic ileus after spinal operation in the supine or prone operative position and to determine the efficacy of prophylactic gastrointestinal motility medications in preventing symptomatic paralytic ileus after a spinal operation. MATERIALS AND METHODS: All patients received spinal surgery in the supine or prone operative position. The study period was divided into two phases: first, to analyze the prevalence of radiographic and symptomatic paralytic ileus after a spinal operation, and second, to determine the therapeutic effects of prophylactic gastrointestinal motility medications (postoperative intravenous injection of scopolamine butylbromide and metoclopramide hydrochloride) on symptomatic paralytic ileus after a spinal operation. RESULTS: Basic demographic data were not different. In the first phase of this study, 27 patients (32.9%) with radiographic paralytic ileus and 11 patients (13.4%) with symptomatic paralytic ileus were observed. Radiographic paralytic ileus was more often noted in patients who underwent an operation in the prone position (p=0.044); whereas the occurrence of symptomatic paralytic ileus was not different between the supine and prone positioned patients (p=0.385). In the second phase, prophylactic medications were shown to be ineffective in preventing symptomatic paralytic ileus after spinal surgery [symptomatic paralytic ileus was observed in 11.1% (4/36) with prophylactic medication and 16.7% (5/30) with a placebo, p=0.513]. CONCLUSION: Spinal surgery in the prone position was shown to increase the likelihood of radiographic paralytic ileus occurrence, but not symptomatic paralytic ileus. Unfortunately, the prophylactic medications to prevent symptomatic paralytic ileus after spine surgery were shown to be ineffective.
Adjuvants, Anesthesia/*administration & dosage/pharmacology ; Adult ; Aged ; Antiemetics/*administration & dosage/pharmacology ; Female ; Gastrointestinal Motility/*drug effects/physiology ; Humans ; Injections, Intravenous ; Intestinal Pseudo-Obstruction/drug therapy/epidemiology/*prevention & control ; Lumbar Vertebrae/radiography/*surgery ; Male ; Metoclopramide/*administration & dosage/pharmacology ; Middle Aged ; Postoperative Complications/epidemiology ; Prevalence ; Prone Position ; Prospective Studies ; Republic of Korea ; Scopolamine Hydrobromide/*administration & dosage/*pharmacology ; Spinal Fusion/*adverse effects ; Supine Position ; Treatment Outcome

PURPOSE: Postoperative nausea and vomiting (PONV) is a common problem after general anesthesia. Although 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists have significantly reduced PONV, over 35% of patients treated with ondansetron can experience PONV. In this study, we investigated whether the Y129S and -100_-102AAG deletion polymorphisms of the 5-HT3B receptor gene affect the efficacy of ondansetron in preventing PONV. MATERIALS AND METHODS: Two hundred and forty-five adult patients who underwent laparoscopic cholecystectomy were enrolled. Ondansetron 0.1 mg/kg was intravenously administered 30 minutes before the end of surgery. Genomic DNA was prepared from blood samples using a nucleic acid isolation device. Both the Y129S variant and the -100_-102AAG deletion variant were screened for using a single base primer extension assay and a DNA direct sequencing method, respectively. The relationship between genetic polymorphisms and clinical outcomes of ondansetron treatment was investigated. RESULTS: Among the 5-HT3B AAG deletion genotypes, the incidence of PONV was higher in patients with the homomutant than with other genotypes during the first 2 hours after surgery (p=0.02). There were no significant differences in the incidence of PONV among genotypes at 2-24 hours after surgery. In the Y129S variants of the 5-HT3B receptor gene, there were no significant differences in the incidence of PONV among genotypes during the first 2 hours and at 2-24 hours after surgery. CONCLUSION: The response to ondansetron for PONV was significantly influenced by the -100_-102AAG deletion polymorphisms of the 5-HT3B gene. Thus, the -100_-102AAG deletion variants may be a pharmacogenetic predictor for responsiveness to ondansetron for PONV.
Adult ; Aged ; Anesthesia, General ; Antiemetics/administration & dosage/*pharmacology ; Cholecystectomy, Laparoscopic ; Female ; Genome, Human ; Genotype ; Humans ; Incidence ; Injections, Intravenous ; Male ; Middle Aged ; Ondansetron/administration & dosage/*pharmacology ; Polymorphism, Genetic ; Postoperative Nausea and Vomiting/chemically induced/*drug therapy/epidemiology ; Receptors, Serotonin, 5-HT3/*drug effects/*genetics ; Time Factors

OBJECTIVE: There is no research regarding the appropriate antiemetic agents for female patients, especially those receiving moderately emetogenic chemotherapy (MEC). We evaluated the antiemetic efficacy of a combination of 5-HT3 receptor with/without aprepitant in patients with gynecological cancer treated with the TC (paclitaxel and carboplatin) regimen of MEC. METHODS: We enrolled 38 patients diagnosed with gynecologic cancer and scheduled to receive the TC regimen. The patients were randomly assigned to receive a 5-HT3 receptor antagonist, either palonosetron in the first cycle followed by granisetron in the second cycle or vice versa. In the third cycle, all patients received a combination of the 5-HT3 receptor and dexamethasone with/without aprepitant. RESULTS: When three drugs were administered, palonosetron consistently produced an equivalent complete response (CR) rate to granisetron in the acute phase (89.5% vs. 86.8%, p=0.87) and delayed phase (60.5% vs. 65.8%, p=0.79). With regard to the change in dietary intake, palonosetron exhibited similar efficacy to granisetron in the acute phase (92.1% vs. 89.4%, p=0.19) and delayed phase (65.7% vs. 68.4%, p=0.14). However, in the delayed phase, the addition of aprepitant therapy with a 5-HT3 receptor antagonist and dexamethasone produced a higher CR rate than a 5-HT3 receptor antagonist with dexamethasone (93.3% vs. 47.8%, p<0.001) and allowed the patients to maintain a higher level of dietary intake (93.3% vs. 56.5%, p<0.001). CONCLUSION: The addition of aprepitant therapy was more effective than the control therapy of a 5-HT3 receptor antagonist, and dexamethasone in gynecological cancer patients treated with the TC regimen.
Adult ; Aged ; Antiemetics/*administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Carboplatin/administration & dosage/adverse effects ; Cross-Over Studies ; Diet ; Drug Administration Schedule ; Female ; Genital Neoplasms, Female/*drug therapy ; Granisetron/administration & dosage ; Humans ; Isoquinolines/administration & dosage ; Middle Aged ; Morpholines/administration & dosage ; Nausea/chemically induced/*prevention & control ; Paclitaxel/administration & dosage/adverse effects ; Quinuclidines/administration & dosage ; Serotonin 5-HT3 Receptor Antagonists ; Vomiting/chemically induced/*prevention & control

PURPOSE: We evaluated the incidence and risk factors of postoperative nausea and vomiting (PONV) in patients with fentanyl-based intravenous patient-controlled analgesia (IV-PCA) and single antiemetic prophylaxis of 5-hydroxytryptamine type 3 (5 HT3)-receptor antagonist after the general anesthesia. MATERIALS AND METHODS: In this retrospective study, incidence and risk factors for PONV were evaluated with fentanyl IV-PCA during postoperative 48 hours after various surgeries. RESULTS: Four hundred-forty patients (23%) of 1878 had showed PONV. PCA was discontinued temporarily in 268 patients (14%), mostly due to PONV (88% of 268 patients). In multivariate analysis, female, non-smoker, history of motion sickness or PONV, long duration of anesthesia (>180 min), use of desflurane and intraoperative remifentanil infusion were independent risk factors for PONV. If one, two, three, four, five, or six of these risk factors were present, the incidences of PONV were 18%, 19%, 22%, 31%, 42%, or 50%. Laparoscopic surgery and higher dose of fentanyl were not risk factors for PONV. CONCLUSION: Despite antiemetic prophylaxis with 5 HT3-receptor antagonist, 23% of patients with fentanyl-based IV-PCA after general anesthesia showed PONV. Long duration of anesthesia and use of desflurane were identified as risk factors, in addition to risk factors of Apfel's score (female, non-smoker, history of motion sickness or PONV). Also, intraoperative remifentanil infusion was risk factor independent of postoperative opioid use. As the incidence of PONV was up to 50% according to the number of risk factors, risk-adapted, multimodal or combination therapy should be applied.
Adult ; Aged ; Analgesia, Patient-Controlled/*adverse effects ; Analgesics, Opioid/*adverse effects/therapeutic use ; Antiemetics/administration & dosage/therapeutic use ; Female ; Fentanyl/*adverse effects/therapeutic use ; Humans ; Incidence ; Isoflurane/adverse effects/*analogs & derivatives/therapeutic use ; Male ; Middle Aged ; Piperidines/*adverse effects/therapeutic use ; Postoperative Nausea and Vomiting/chemically induced/*epidemiology ; Retrospective Studies ; Risk Factors

PURPOSE: Opioid-based intravenous patient-controlled analgesia (IV PCA) is popular method of postoperative pain control, but many patients suffer from IV PCA-related postoperative nausea and vomiting (PONV). In this retrospective observational study, we have determined independent predictors of IV PCA-related PONV and predictive values of the Apfel's simplified risk score in pursuance of identifying high-risk patients. MATERIALS AND METHODS: We analyzed 7000 patients who received IV PCA with background infusion after elective surgery. Patients who maintained IV PCA for a postoperative period of 48 hr (completion group, n=6128) were compared with those who have discontinued IV PCA within 48 hr of surgery due to intractable PONV (cessation group, n=872). Patients, anesthetics, and surgical factors known for predicting PONV were evaluated by logistic regression analysis to identify independent predictors of IV PCA related intractable PONV. RESULTS: In a stepwise multivariate analysis, weight, background infusion dose of fentanyl, addition of ketolorac to PCA, duration of anesthesia, general anesthesia, head and neck surgery, and Apfel's simplified risk score were revealed as independent risk factors for intractable PONV followed by the cessation of IV PCA. In addition, Apfel's simplified risk score, which demonstrated the highest odds ratio among the predictors, was strongly correlated with the cessation rate of IV PCA. CONCLUSION: Multimodal prophylactic antiemetic strategies and dose reduction of opioids may be considered as strategies for the prevention of PONV with the use of IV PCA, especially in patients with high Apfel's simplified risk scores.
Adult ; Analgesia, Patient-Controlled/*adverse effects ; Anesthetics, Intravenous/administration & dosage/adverse effects/therapeutic use ; Antiemetics/administration & dosage/therapeutic use ; Female ; Fentanyl/administration & dosage/adverse effects/therapeutic use ; Humans ; Male ; Middle Aged ; Multivariate Analysis ; Odds Ratio ; Postoperative Nausea and Vomiting/*drug therapy ; Retrospective Studies ; Risk Assessment/methods ; Risk Factors

OBJECTIVETo evaluate the efficacy and toxicity of palonosetron for prevention of vomiting induced by high dose cisplatin-based chemotherapy.

METHODSOne-hundred and twenty-eight patients received tropisetron 5 mg plus dexamethasone 10 mg at the first cycle or palonosetron 0.25 mg plus dexamethasone 10 mg, respectively, each administered 30 min before the initiation of high dose cisplatin-based chemotherapy. To observe the remission rate of acute emetic episodes and delayed emetic episodes, adverse effects and daily food-intake in the patients after the chemotherapy.

RESULTSThe complete response (CR) rates for acute vomiting were not significantly different between the tropisetron and palonosetron cycles (75.8% vs. 79.7%, P>0.05). The complete control rate of delayed vomiting in the palonosetron cycle was significantly higher than that in the tropisetron cycle (70.3% vs. 50.8%, P<0.01). The food-intake decrease rate of palonosetron cycle was 18.8%, significantly lower than the 53.1% of the tropisetron cycle (P<0.05). The toxicity in the two cycles was similar and no grade 3-4 toxicity was observed.

CONCLUSIONSPalonosetron is superior to tropisetron with a lower remission rate of delayed emesis induced by high dose cisplatin-based chemotherapy and with tolerable toxicity. Moreover, the apparent emesis control of palonosetron treatment seems to provide an adequate food-intake in these patients.

Aged ; Antiemetics ; therapeutic use ; Antineoplastic Agents ; administration & dosage ; adverse effects ; therapeutic use ; Cisplatin ; administration & dosage ; adverse effects ; therapeutic use ; Eating ; drug effects ; Female ; Humans ; Indoles ; therapeutic use ; Isoquinolines ; therapeutic use ; Male ; Middle Aged ; Neoplasms ; drug therapy ; Quinuclidines ; therapeutic use ; Vomiting ; chemically induced ; prevention & control

OBJECTIVETo observe the effect of thalidomide in preventing nausea and vomiting induced by emetogenic cisplatin (CDDP) chemotherapy in patients with advanced non-small cell lung cancer.

METHODSThis study was carried out as a prospective, randomized control clinical trial. 61 patients with advanced non-small cell lung cancer were scheduled to receive chemotherapy (gemcitabin 1000 mg/m(2) i.v. gtt d1, 8 and CDDP 75 mg/m(2) i.v. gtt d1, GP regimen). The patients were randomly divided into a treatment and control groups. All patients in both groups received ramosetron 0.3 mg intravenously (i.v.) and metoclopramide 20 mg intramuscularly (i.m.) 30 min prior to chemotherapy to prevent nausea and emesis on day 1. In the treatment group, addition of thalidomide (50 mg p.o. bid) were administered on days 1 to 5 after the start of chemotherapy.

RESULTSAcute nausea was effectively controlled in 74.2% of the patients in the control group and in 90.0% of treatment group. Acute vomiting was effectively controlled in 90.3% of the patients in the control group and in 93.3% of treatment group. No statistically significant differences showed in effective control of acute nausea and vomiting between the 2 groups (P = 0.108; P = 1.000). Delayed nausea was effectively controlled in 19.4% of the patients in control group and in 56.7% in the treatment group. Delayed vomiting was effectively controlled in 48.4% of the patients in control group and 76.7% in treatment group. Statistically there was a significant differences in effective control of delayed nausea and vomiting between the 2 groups (P = 0.003, P = 0.023). Both antiemetic regimens were well tolerated, and no significant difference was observed in adverse events between the 2 groups (P > 0.05).

CONCLUSIONOur results demonstrate that thalidomide is highly effective in controlling delayed nausea and vomiting episodes in patients induced by moderately emetogenic chemotherapy. Moreover, no serious toxic effects are induced by this treatment.

Antiemetics ; therapeutic use ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; pathology ; Cisplatin ; administration & dosage ; Deoxycytidine ; administration & dosage ; analogs & derivatives ; Female ; Humans ; Lung Neoplasms ; drug therapy ; pathology ; Male ; Middle Aged ; Nausea ; chemically induced ; prevention & control ; Neoplasm Staging ; Prospective Studies ; Thalidomide ; therapeutic use ; Vomiting ; chemically induced ; prevention & control

PURPOSE: The purpose of this study was to compare the effects of ondansetron combined with dexamethasone on Post-Operative Nausea and Vomiting (PONV) and pain with ondansetron alone in patients with laparoscopy assisted vaginal hysterectomy under general anesthesia. METHODS: Data were collected from April 1 through September 30, 2005 using a double blind method. Ondansetron 4 mg and dexamethasone 10 mg were administered to the experimental group (25 patients), and ondansetron 4 mg only to the control group (25 patients). The medications were administered through an intravenous line at the beginning peritoneum suture. PONV by Index of Nausea Vomiting and Retching (INVR), nausea by Visual Analogue Scale (VAS), and pain (VAS) were assessed at postoperative 1 hr, 3 hr, 6 hr, 24 hr, and 48 hr. Data were analyzed using repeated measures ANOVA, and Bonferroni methods. RESULTS: The experimental group that received ondansetron combined with dexamethasone had less PONV (p=.048), and nausea (p=.012) than control group that received ondansetron alone. However, there was no difference in pain (p=.557) between the patients in the two groups. CONCLUSION: We conclude that the administration of ondansetron combined with dexamethasone is more effective than the administration of ondansetron alone to reduce PONV in patients with laparoscopic hysterectomy.
Adult ; Analgesia, Patient-Controlled ; Analysis of Variance ; Anesthesia, General ; Antiemetics/*administration & dosage ; Data Interpretation, Statistical ; Dexamethasone/*administration & dosage ; Double-Blind Method ; Drug Therapy, Combination ; Female ; Humans ; *Hysterectomy, Vaginal ; Laparoscopy ; Middle Aged ; Ondansetron/*administration & dosage ; Pain/*drug therapy ; Postoperative Nausea and Vomiting/*drug therapy ; Postoperative Period ; Time Factors

OBJECTIVETo observe therapeutic effect of acupuncture combined with antiemetic on cisplatin-induced nausea and vomiting.

METHODSBy using paired, cross-controlled trial design, 66 cases of chemotherapy were divided into group A and B, 33 cases in each group. For the group A, chemotherapy, tropisetron and acupuncture therapy were adopted in the first chemotherapy cycle and the same chemotherapy program, tropisetron and sham acupuncture were used in the next cycle. For the group B, chemotherapy, tropisetron and sham acupuncture were given in the first chemotherapy cycle and the same chemotherapy program, tropisetron and acupuncture therapy were applied in the next cycle. Zusanli (ST 36), Neiguan (PC 6) and Gongsun (SP 4) and auricular point Wei (stomach) were selected for acupuncture therapy, and the points at 3 cm lateral to Zusanli (ST 36) , Neiguan (PC 6) and Gongaun (SP 4) and auricular point corresponding to scapha level were selected for sham acupuncture. Acupuncture treatment or sham-acupuncture was given for 6 consecutive days, once each day and antiemetic tropisetron 5 mg was given to the two groups as basic antiemetic prophylaxis for 6 days, once daily. The therapeutic effects on nausea and vomiting in the 6 days were compared between the acupuncture group and the sham-acupuncture group in the two chemotherapeutic cycles.

RESULTSThe effective rates for nausea in the 2nd day and the 4th day were 87.1% and 79.0% in acupuncture group, which were superior to 59.4% and 57.8% in the sham-acupuncture group, respectively (both P < 0.05); and the therapeutic effects on vomiting in the 3rd-6th day in the acupuncture group were better than those in the sham-acupuncture group (P < 0.05).

CONCLUSIONAcupuncture combined with antiemetic can effectively decrease the incidence and degree of cisplatin-induced delayed nausea and vomiting. The effect of acupuncture is better than that of sham acupuncture.

Acupuncture Points ; Acupuncture Therapy ; Adolescent ; Adult ; Aged ; Antiemetics ; administration & dosage ; Breast Neoplasms ; complications ; drug therapy ; Cisplatin ; adverse effects ; therapeutic use ; Female ; Humans ; Lung Neoplasms ; complications ; drug therapy ; Male ; Middle Aged ; Nausea ; drug therapy ; etiology ; therapy ; Vomiting ; drug therapy ; etiology ; therapy