1.Additive effect of rikkunshito, an herbal medicine, on chemotherapy-induced nausea, vomiting, and anorexia in uterine cervical or corpus cancer patients treated with cisplatin and paclitaxel: results of a randomized phase II study (JORTC KMP-02).
Shunsuke OHNISHI ; Hidemichi WATARI ; Maki KANNO ; Yoko OHBA ; Satoshi TAKEUCHI ; Tempei MIYAJI ; Shunsuke OYAMADA ; Eiji NOMURA ; Hidenori KATO ; Toru SUGIYAMA ; Masahiro ASAKA ; Noriaki SAKURAGI ; Takuhiro YAMAGUCHI ; Yasuhito UEZONO ; Satoru IWASE
Journal of Gynecologic Oncology 2017;28(5):e44-
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*
2.The Effect of Metoclopramide on the Time from Disapprearance of 1 Hz Single Twitch Height to Reappearance of that following injection of Succinylcholine.
Sung Sook OH ; Po Sun KANG ; Il Ok LEE ; Nan Suk KIM ; Suk Min YOON ; Sang Ho LIM ; Young Suk CHOI
Korean Journal of Anesthesiology 1990;23(6):979-983
Although it has been accepted that metoclopramide provides the effects of antiemetics, enhance- ment of intestinal motility and acts as antagonist on dopamine receptor, there is still controversy over inhibitory action of plasma cholinesterase. We examined the effect of preoperative intravenous administration of metoclopramide 10mg (group 2,4) on the duration of neuromuscular block induced by an intubating dose (1 mg/kg) of succinylcholine. Forty female adult patients were devided into four groups, scheduled for cesarean section (group 3,4) or other elective operations (group 1,2). The 1 H2single twitch height of the adductor pollicis muacle was recorded on paper to 1 H2single twitch stimulus by a nerve stimulator (Accelograph). The patients in group 2 and 4 received metoclopramide 10 mg i.v followed by succinylcholine 1mg/kg, and the patients in group 1 and 3 received succinylcholine 1mg/kg alone. The time from disappearance of 1 H, single twitch height to reappearance of that did not significantly differ between group l and 3. However, there was significant prolongation of the time from disappearance of 1H2single twitch height to reappearance of that in patients who received metoclopramide followed by succinylcholine in group 2 and 4. Also, we examined the effect of preoperative intravenous administration of metoclopramide 10mg on the duration of neuromuscular block by 0.5mg/kg of succinylcholine in twenty female patients for elective operations (group 5,6). There was no significant prolongation of the time from disappearance of 1 H, single twitch height to reappearance of that.
Administration, Intravenous
;
Adult
;
Antiemetics
;
Cesarean Section
;
Cholinesterases
;
Female
;
Gastrointestinal Motility
;
Humans
;
Metoclopramide*
;
Neuromuscular Blockade
;
Plasma
;
Pregnancy
;
Receptors, Dopamine
;
Succinylcholine*
3.Effects of Metoclopramide and Ranitidine on Preoperative Gastric Contents in Day-Case Surgery.
Yonsei Medical Journal 2006;47(3):315-318
This prospective, randomized, double-blinded study was performed to evaluate the effects of intravenous metoclopramide and ranitidine on preoperative gastric contents in outpatients receiving intravenous anesthesia for laparoscopic gynecologic surgery. Fifteen minutes before the induction of anesthesia, the Z-M group (n=20) received 50mg ranitidine and 10mg metoclopramide intravenously and the control group (n=20) received the same volume of normal saline. Before the surgery, a 14-F multiorifice nasogastric tube was inserted to aspirate the gastric contents of patients under sedation with propofol and midazolam. The mean pH values of the gastric fluid were 2.7+/-2.0 (SD) [median 1.6 (range: 1.2-7.2)] in the control group, and 6.1+/-1.9 [median 6.8 (range 1.4-7.8)] in the Z-M group. The mean aspirated volumes (mL) were 15.3+/-10.4 (SD) [median 11.0 (range: 5.0-44.0)] in the control group, and 6.9+/-10.0 (SD) [median 4.5 (range: 0-38.0)] in the Z-M group. There were significantly more high-risk (gastric fluid volumes > 25mL and pH < 2.5) patients in the control group (4/20, 20%) than in the Z-M group (1/20, 5%). In conclusion, intravenous prophylactic ranitidine and metoclopramide may be an easy and useful method to decrease the volume while increasing the pH of gastric contents, and therefore may reduce the number of patients at risk for aspiration pneumonitis in ambulatory laparoscopic procedures who receive an anesthesia.
Stomach/*drug effects
;
Risk Factors
;
Ranitidine/*administration & dosage
;
Preoperative Care
;
Pneumonia, Aspiration/epidemiology/*prevention & control
;
Metoclopramide/*administration & dosage
;
Injections, Intravenous
;
Humans
;
Antiemetics/*administration & dosage
;
Anti-Ulcer Agents/*administration & dosage
;
Ambulatory Surgical Procedures
;
Adult
4.Effects of Metoclopramide and Ranitidine on Preoperative Gastric Contents in Day-Case Surgery.
Yonsei Medical Journal 2006;47(3):315-318
This prospective, randomized, double-blinded study was performed to evaluate the effects of intravenous metoclopramide and ranitidine on preoperative gastric contents in outpatients receiving intravenous anesthesia for laparoscopic gynecologic surgery. Fifteen minutes before the induction of anesthesia, the Z-M group (n=20) received 50mg ranitidine and 10mg metoclopramide intravenously and the control group (n=20) received the same volume of normal saline. Before the surgery, a 14-F multiorifice nasogastric tube was inserted to aspirate the gastric contents of patients under sedation with propofol and midazolam. The mean pH values of the gastric fluid were 2.7+/-2.0 (SD) [median 1.6 (range: 1.2-7.2)] in the control group, and 6.1+/-1.9 [median 6.8 (range 1.4-7.8)] in the Z-M group. The mean aspirated volumes (mL) were 15.3+/-10.4 (SD) [median 11.0 (range: 5.0-44.0)] in the control group, and 6.9+/-10.0 (SD) [median 4.5 (range: 0-38.0)] in the Z-M group. There were significantly more high-risk (gastric fluid volumes > 25mL and pH < 2.5) patients in the control group (4/20, 20%) than in the Z-M group (1/20, 5%). In conclusion, intravenous prophylactic ranitidine and metoclopramide may be an easy and useful method to decrease the volume while increasing the pH of gastric contents, and therefore may reduce the number of patients at risk for aspiration pneumonitis in ambulatory laparoscopic procedures who receive an anesthesia.
Stomach/*drug effects
;
Risk Factors
;
Ranitidine/*administration & dosage
;
Preoperative Care
;
Pneumonia, Aspiration/epidemiology/*prevention & control
;
Metoclopramide/*administration & dosage
;
Injections, Intravenous
;
Humans
;
Antiemetics/*administration & dosage
;
Anti-Ulcer Agents/*administration & dosage
;
Ambulatory Surgical Procedures
;
Adult
5.The Preventive Effect on Postoperative Nausea and Vomiting According to Dosages of Intraoperative Intravenous Ondansetron in Cesarean Section Patients under Patient-Controlled Epidural Analgesia.
Korean Journal of Anesthesiology 2004;47(4):516-520
BACKGROUND: Ondansetron is a specific 5-hydroxytrypamine (HT3) receptor antagonist, sodium channel blocker and mu-opioid receptor agonist. Prophylactic intravenous administration of ondansetron has an antiemetic effect in general and epidural anesthesia. This study is designed to evaluate the antiemetic effect of intravenous ondansetron in patient-controlled epidural analgesia (PCEA) patients. METHODS: Sixty ASA physical status I-II patients undergoing elective cesarean section under epidural anesthesia using 0.75% ropivacaine and fentanyl 50microgram were received intravenous fentanyl 50microgram plus ondansetron 2 mg (group 2 mg: n = 20), 4 mg (group 4 mg: n = 20) or 8 mg (group 8 mg: n = 20) after delivery of baby. PCEA was started using 0.15% ropivacaine and 50microgram/ml butorphanol (total volume: 300 ml, 4 ml of bolus dose, and 10 min of lockout interval). The intraoperative and postoperative incidence and severity of nausea and vomiting were recorded using 4 point scale (0: none, 1: mild, 2: moderate, 3: severe) for postoperative 24 hours. RESULTS: There were no significantly lower incidence and severity of nausea and vomiting in group 8 mg (10%, 5%) than group 2 mg (25%, 10%), and group 4 mg (20%, 10%) during postoperative 24 hours. CONCLUSIONS: Prophylactic intravenous ondansetron 8 mg injection with PCEA drug has no superior antiemitic effect than 2 mg or 4 mg in cesarean section patients under PCEA without significant side effects.
Administration, Intravenous
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Analgesia, Epidural*
;
Anesthesia, Epidural
;
Antiemetics
;
Butorphanol
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Cesarean Section*
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Female
;
Fentanyl
;
Humans
;
Incidence
;
Nausea
;
Ondansetron*
;
Postoperative Nausea and Vomiting*
;
Pregnancy
;
Sodium Channels
;
Vomiting
6.Palonosetron versus granisetron in combination with aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with gynecologic cancer.
Satoe FUJIWARA ; Yoshito TERAI ; Satoshi TSUNETOH ; Hiroshi SASAKI ; Masanori KANEMURA ; Masahide OHMICHI
Journal of Gynecologic Oncology 2015;26(4):311-319
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
7.Combination of Antiemetics for the Prevention of Postoperative Nausea and Vomiting in High-Risk Patients.
Eun Jin KIM ; Justin Sang KO ; Chung Su KIM ; Sang Min LEE ; Duck Hwan CHOI
Journal of Korean Medical Science 2007;22(5):878-882
It was previously reported that the Korean predictive model could be used to identify patients at high risk of postoperative nausea and vomiting (PONV). This study investigated whether PONV in the high-risk and very high-risk patients identified by the Korean predictive model could be prevented by multiple prophylactic antiemetics. A total of 2,456 patients were selected from our previous PONV study and assigned to the control group, and 374 new patients were recruited consecutively to the treatment group. Patients in each group were subdivided into two risk groups according to the Korean predictive model: high-risk group and very high-risk group. Patients in the treatment group received an antiemetic combination of dexamethasone 5 mg (minutes after induction) and ondansetron 4 mg (30 min before the end of surgery). The incidences of PONV were examined at two hours after the surgery in the postanesthetic care unit and, additionally, at 24 hr after the surgery in the ward, and were analyzed for any differences between the control and treatment groups. The overall incidence of PONV decreased significantly from 52.1% to 23.0% (p< or =0.001) after antiemetic prophylaxis. Specifically, the incidence decreased from 47.3% to 19.4% (p< or =0.001) in the high-risk group and from 61.3% to 28.3% (p< or =0.001) in the very high-risk group. Both groups showed a similar degree of relative risk reductions: 59.0% vs. 53.8% in the high-risk and very high-risk groups, respectively. The results of our study showed that the antiemetic prophylaxis with the combination of dexamethasone and ondansetron was effective in reducing the occurrence of PONV in both high-risk and very high-risk patients.
Adult
;
Anesthetics/adverse effects
;
Antiemetics/*pharmacology
;
Dexamethasone/administration & dosage
;
Female
;
Humans
;
Incidence
;
Korea
;
Middle Aged
;
Ondansetron/administration & dosage
;
Postoperative Complications/prevention & control
;
Postoperative Nausea and Vomiting/*prevention & control
;
Postoperative Period
;
Risk
;
Risk Factors
;
Treatment Outcome
8.Paralytic Ileus and Prophylactic Gastrointestinal Motility Medication after Spinal Operation.
Chang Hyun OH ; Gyu Yeul JI ; Seung Hwan YOON ; Dongkeun HYUN ; Hyeong Chun PARK ; Yeo Ju KIM
Yonsei Medical Journal 2015;56(6):1627-1631
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
9.Therapeutic effect of acupuncture on cisplatin-induced nausea and vomiting.
Chinese Acupuncture & Moxibustion 2009;29(1):3-6
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
10.Risk Assessment of Postoperative Nausea and Vomiting in the Intravenous Patient-Controlled Analgesia Environment: Predictive Values of the Apfel's Simplified Risk Score for Identification of High-Risk Patients.
Shin Hyung KIM ; Yang Sik SHIN ; Young Jun OH ; Jeong Rim LEE ; Sung Chan CHUNG ; Yong Seon CHOI
Yonsei Medical Journal 2013;54(5):1273-1281
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