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1.
Aprepitant, a selective high-affinity antagonist of human substance P/neurokinin 1 (NK1) receptors, is the active ingredient of EMEND which has recently been approved by the FDA for the prevention of chemotherapy-induced nausea and vomiting (CINV). Aprepitant undergoes extensive metabolism, primarily via CYP3A4 mediated oxidation. It is eliminated primarily by metabolism and is not renally excreted. The apparent terminal half-life in humans ranged from 9 to 13 hours. Early development studies led to the development of a nanoparticle formulation to enhance exposure and minimize food effects. Two large randomized trials accruing 1099 patients studied the effect in patients receiving cisplatin of adding aprepitant to ondansetron and dexamethasone on day 1 then to dexamethasone on days 2 and 3 to control delayed emesis. The complete response of no vomiting and no rescue medication overall from days 1 to 5 improved from 48% to 68% (p<0.001), a 13% improvement in acute emesis but a 21% improvement in delayed emesis with the improvement from 51% to 72% (p<0.001). Similarly, 866 patients treated with cyclophosphamide plus either doxorubicin or epirubicin, received either ondansetron, dexamethasone, and aprepitant on day 1 followed by aprepitant on days 2 and 3 or ondansetron and dexamethasone on day 1 and dexamethasone on days 2 and 3. The overall complete response rate over 5 days was better for the aprepitant group 50.8% vs 42.5% (p=0.015). Complete responses were reported in more patients taking aprepitant in both the acute (76% vs 69%, p=0.034) and delayed (55% vs 49%, p=0.064) phases of vomiting. There were no clinically relevant differences in toxicity by adding aprepitant and improvements in the quality of life of patients on chemotherapy were recorded.  相似文献   

2.
Perhaps the most unpleasant experience following outpatient plastic surgery procedures is postoperative nausea and vomiting. Postoperative nausea and vomiting often results in delayed recovery time and unintended admission, and it can be a contributing factor to the formation of hematoma following rhytidectomy. Ondansetron (Zofran) has proven benefit in preventing postoperative nausea and vomiting if given before general anesthesia in a variety of surgical procedures. Its utility in cases performed under conscious sedation has not been determined. The purpose of this study was (1) to test the ability of prophylactic ondansetron to prevent postoperative nausea and vomiting in plastic surgery cases performed under conscious sedation, and (2) to determine relative risk factors for postoperative nausea and vomiting and a selection policy for the administration of antiemetic prophylaxis. This was a prospective, randomized, double-blind study. One hundred twenty patients were enrolled after giving informed consent. Patients received a single dose of either placebo or ondansetron (4 mg intravenously) before administration of sedation. Sedation administration followed a standardized institutional protocol, using midazolam and fentanyl. Data were recorded from a series of three questionnaires: preoperatively, immediately postoperatively, and at the time of the first office return. Data were confirmed by means of telephone interview, chart analysis, and nursing documentation. Multivariate analysis was conducted. Nausea and emesis occurred with an overall frequency of 33 percent and 22 percent, respectively. Postoperative nausea and vomiting was associated with statistically longer recovery periods. The incidence of emesis was statistically higher among women, among those undergoing facial rejuvenation, and among those with a history of opioid-induced emesis or postoperative nausea and vomiting following a previous operation (p < 0.05). The incidence of postoperative nausea and vomiting paralleled increases in case duration; the incidence of emesis was zero in cases less than 90 minutes in duration. Ondansetron significantly reduced the incidence of emesis overall (placebo, 30 percent; ondansetron, 13 percent; p < 0.05). Postoperative perception of nausea was significantly lower among those who had received ondansetron (p < 0.05). These results confirm the efficacy of ondansetron for the prevention of postoperative nausea and vomiting in plastic surgery cases under conscious sedation. In those who are at increased risk, prophylaxis should be considered. Such risks include female gender, facial rejuvenation procedures, and a patient history of opioid-induced emesis or postoperative nausea and vomiting following a prior operation. The zero incidence of emesis in cases less than 90 minutes does not support the routine use of prophylaxis in such cases. Patient satisfaction in plastic surgery is derived from the overall subjective experience of the event as much as by the final result. By remaining attentive to patient concerns and optimizing perioperative care, we can improve the subjective experience for our patients.  相似文献   

3.
OBJECTIVE--To determine how many patients were deprived of treatment by being given placebo as comparator in trials of ondansetron for postoperative nausea and vomiting. DESIGN--Review of published trials of ondansetron during 1991 to July 1994. SETTING--Medline search in a university department of anaesthesia. SUBJECTS--8806 patients who had been included in 18 indexed placebo controlled trials of ondansetron as prophylaxis against or treatment of postoperative nausea and vomiting. RESULTS--Five studies (1236 patients) had been published by July 1992. All were placebo controlled trials. By July 1994, 8806 patients had been included in 18 indexed placebo controlled studies of prophylaxis or treatment. Only 462 patients had been in studies that compared ondansetron with other drugs, and there were no indexed comparative trials of treatment of nausea and vomiting. Roughly 2180 patients had been given placebo as prophylaxis and 440 had been given placebo when already experiencing postoperative nausea or vomiting. CONCLUSIONS--Around 2620 patients in the reviewed studies were denied existing drugs, which, though not completely effective or without side effects, do bring some relief from postoperative nausea and vomiting. Drug regulatory bodies should collaborate with drug companies to ensure better comparison of new with established drugs. This would avoid placebos being given to more than the fewest patients necessary to confirm effect and would allow doctors to be informed more quickly about relative efficacies.  相似文献   

4.
Postoperative nausea and vomiting frequently complicate outpatient anesthesia and surgery. The duration of treatment for this complication must occasionally extend beyond discharge from the hospital. In this study, we evaluated the commonly used anti-emetic promethazine for its efficacy in the post-discharge period. Adult outpatient surgical patients who had excessive postoperative nausea and vomiting in the recovery room, or who were at risk for postoperative nausea and vomiting following discharge were given two promethazine suppositories (25 mg) for home use. All patients were contacted by our recovery room nurses on the first business day after their surgery and questioned as to their use of the suppositories and, if used, their efficacy. We found that 55 percent of patients given promethazine suppositories for home use had nausea and vomiting in the post-discharge period. Of the patients given promethazine, 89 percent used the suppositories. All of these patients reported improvement in their symptoms following use of the suppositories. None reported adverse effects from the promethazine suppositories. In conclusion, we found promethazine suppositories to be an inexpensive and efficacious treatment for nausea and vomiting in adult outpatient surgical patients following discharge from the hospital. Side-effects were minimal, and our patients voiced no complaints about this mode of therapy. We recommend this therapy for treatment of nausea and vomiting after hospital discharge following adult outpatient surgery.  相似文献   

5.
OBJECTIVE--To determine the contribution of dexamethasone to the efficacy of the 5-hydroxytryptamine antagonist ondansetron in control of cisplatin induced nausea and vomiting. DESIGN--Randomised double blind crossover study. SETTING--Two cancer centres in teaching hospitals, one in the United Kingdom and the other in Germany. SUBJECTS--100 patients (53 men and 47 women) new to cisplatin chemotherapy, 84 of whom completed two consecutive courses of chemotherapy. INTERVENTIONS--Patients were given intravenous dexamethasone (20 mg) or physiological saline with intravenous ondansetron 8 mg before cisplatin, then ondansetron 1 mg/h for 24 hours. Oral ondansetron 8 mg was taken three times daily on days 2-6. MAIN OUTCOME MEASURES--Incidence of complete or major control of emesis (0-2 episodes in the 24 hours after chemotherapy). RESULTS--Complete or major control was obtained in 49 out of 71 (69%) of patients after receiving ondansetron plus dexamethasone compared with 40 out of 71 (56%) when they were given ondansetron alone (p = 0.012). This effect was most pronounced in the first 12 hours after chemotherapy. Patients receiving the combination also had significantly less nausea. Of the 53 patients who expressed a preference, 38 (72%) preferred the combination treatment (p = 0.002) to ondansetron alone. The effect of ondansetron on delayed emesis was less pronounced. CONCLUSIONS--Dexamethasone makes a significant contribution to the efficacy of ondansetron in the control of acute platinum induced emesis.  相似文献   

6.
Approximately one half of cancer patients experience nausea or vomiting during chemotherapy containing high-dose cisplatin, despite the use of a corticosteroid and 5-hydroxytryptamine(3) (5-HT(3)) receptor antagonists. The addition of aprepitant, a neurokinin 1 receptor antagonist, improves control of emesis by a further 15-20%, and improves late phase symptoms (>24 h after chemotherapy). The cornerstone of standard first line lung cancer chemotherapy is high-dose cisplatin. Our experience with aprepitant in the chemotherapy of 10 lung cancer patients is described, who reported more than one episode of vomiting caused by chemotherapy despite the use of ondansetron previously. Aprepitant prevented acute and late phase oncoming vomiting in all 10 patients and acute and late phase nausea in 9 of the 10 patients. According to our experience on a limited number of patients, aprepitant may be of clinical benefit in the supportive treatment of lung cancer, in achieving better quality of life during chemotherapeutic cycles in these patients.  相似文献   

7.
余琼  刘咏辉  张洁  朱伟强  梁伟民 《生物磁学》2014,(26):5068-5071
目的:分析地塞米松对接受乳癌根治术的患者术后恶心呕吐、血糖、皮质醇、出血和感染的影响,明确其临床使用的有效性和安全性。方法:将160 例择期全麻下行单侧乳癌改良根治术的女性患者随机分为实验组(地塞米松组,n=80)和对照组(生理盐水组,n=80)。检测两组患者术后第1 天和第3 天血糖和血清皮质醇水平,记录术后1~3天恶心呕吐次数和抗呕吐药物的使用量,比较两组术后1 周内出血和感染的发生情况。结果:实验组患者术后第1 天的恶心发生率显著低于对照组,术后1~2 天的呕吐发生率均显著低于对照组,术后第1 天血清皮质醇较对照组显著降低(P〈0.05)。两组患者术后血糖水平比较无统计学差异(P〉0.05)。术后1 周内,两组患者出血和感染的发生情况比较均无显著性差异(P〉0.05)。结论:地塞米松可有效地预防乳癌改良根治术患者术后恶心呕吐,短暂抑制术后内源性皮质醇水平,不增加患者术后高血糖、出血和感染的风险。  相似文献   

8.
目的:观察腹式子宫全切术后硬膜外镇痛应用舒芬太尼复合吗啡时两种药物不同剂量的镇痛效果和不良反应,以寻找其最佳剂量配伍。方法:选择90例美国麻醉医师协会(ASA)标准Ⅰ-Ⅱ级、年龄20-60岁拟行腹式子宫全切术的病人,均实施腰硬联合麻醉。随机分成3组,每组30例:Ⅰ组:舒芬太尼10μg+吗啡2 mg+氟哌利多1 mg+1%罗哌卡因20 mg;Ⅱ组:舒芬太尼15μg+吗啡1.5 mg+氟哌利多1 mg+1%罗哌卡因20 mg;Ⅲ组:舒芬太尼20μg+吗啡1 mg+氟哌利多1 mg+1%罗哌卡因20mg。术中监测生命体征,记录术后24小时内的镇痛效果、不良反应及辅助镇痛药物的使用情况。镇痛效果评价采用视觉模拟评分(visual analogue scale,VAS)标准。结果:2组各个时间点VAS评分均明显低于1组(P〈0.05),在术后6 h,8 h,12 h,18 h,24 h与3组有统计学差异(P〈0.05),3组在2 h,4 h,6 h的VAS评分低于1组(P〈0.05);2组恶心评分与3组相比明显较低(P〈0.05),其他不良反应三组间没有统计学差异;各组患者在术后24h内辅助镇痛药物使用情况比较无统计学差异(P〉0.05)。结论:舒芬太尼15μg复合吗啡1.5 mg用于腹式子宫全切术后硬膜外镇痛效果优于其他常用剂量配伍,镇痛效果平稳确切且不良反应少,具有临床应用价值。  相似文献   

9.
目的:了解舒芬太尼联合昂丹司琼静脉术后镇痛应用妇科手术的临床效果。方法:对我院2012年3月至2014年3月收治的全麻术后患者进行随机抽样,选取80例患者随机分成两组,对照组予以1.0 mg芬太尼联合8 mg昂丹司琼镇痛,实验组予以100μg舒芬太尼联合8 mg昂丹司琼镇痛。观察并比较两组患者的镇痛效果及不良反应的发生状况。结果:对比恶心、呕吐等临床症状,实验组患者的临床情况明显优于对照组,经统计学分析,差异具有统计学意义(P0.05),且镇静评分、疼痛评分亦优于对照组,经统计学分析,差异具有统计学意义(P0.05)。结论:术后持续静脉予以舒芬太尼联合昂丹司琼,能降低术后恶心、呕吐发生率,减轻患者疼痛程度,提升患者临床治疗效果。  相似文献   

10.

Background

We carried out a systematic review and meta-analysis to evaluate the impact of prophylactic dexamethasone on post-operative nausea and vomiting (PONV), post-operative pain, and complications in patients undergoing thyroidectomy.

Methods

We searched Pubmed, Embase, and Cochrane Library databases for randomized controlled trials (RCTs) that evaluated the prophylactic effect of dexamethasone versus placebo with or without other antiemetics for PONV in patients undergoing thyroidectomy. Meta-analyses were performed using RevMan 5.0 software.

Results

Thirteen RCTs that considered high quality evidence including 2,180 patients were analyzed. The meta-analysis demonstrated a significant decrease in the incidence of PONV (RR 0.52, 95% CI 0.43 to 0.63, P<0.00001), the need for rescue anti-emetics (RR 0.42, 95% CI 0.30 to 0.57, P<0.00001), post-operative pain scores (WMD –1.17, 95% CI –1.91 to –0.44, P = 0.002), and the need for rescue analgesics (RR 0.65, 95% CI 0.50–0.83, P = 0.0008) in patients receiving dexamethasone compared to placebo, with or without concomitant antiemetics. Dexamethasone 8–10mg had a significantly greater effect for reducing the incidence of PONV than dexamethasone 1.25–5mg. Dexamethasone was as effective as other anti-emetics for reducing PONV (RR 1.25, 95% CI 0.86–1.81, P = 0.24). A significantly higher level of blood glucose during the immediate post-operative period in patients receiving dexamethasone compared to controls was the only adverse event.

Conclusions

Prophylactic dexamethasone 8–10mg administered intravenously before induction of anesthesia should be recommended as a safe and effective strategy for reducing the incidence of PONV, the need for rescue anti-emetics, post-operative pain, and the need for rescue analgesia in thyroidectomy patients, except those that are pregnant, have diabetes mellitus, hyperglycemia, or contraindications for dexamethasone. More high quality trials are warranted to define the benefits and risks of prophylactic dexamethasone in potential patients with a high risk for PONV.  相似文献   

11.
摘要 目的:研究昂丹司琼联合泮托拉唑对宫颈癌同步放化疗所致恶心呕吐的临床疗效。方法:选择2018年1月~2020年1月我院收治的79例宫颈癌患者,均采取同步化疗,将其随机分为两组。对照组在当天化疗前30 min和随后的6 d连续静脉注射昂丹司琼,每次8 mg,1次/d;同时给予地塞米松磷酸钠注射液10 mg,1次/d。观察组在昂丹司琼的基础上静脉注射泮托拉唑,每次40 mg,1次/d,给药的时间与昂丹司琼相同。比较两组宫颈癌患者恶心呕吐的完全缓解率、癌因性疲乏评分和不良反应的发生情况。结果:两组化疗第1、2 d恶心呕吐的完全缓解率比较差异无明显统计学意义(P>0.05),观察组化疗第3、4、5、6 d恶心呕吐的完全缓解率分别为76.92 %、79.49 %、87.18 %、87.18 %,均明显高于对照组(P<0.05);观察组的癌因性疲乏评分为(45.39±7.29)分,明显低于对照组的(67.24±8.36)分(P<0.05);两组的乏力嗜睡、便秘、椎体外系反应、失眠/不安、腹泻、轻度头痛的发生率比较无明显统计学差异(P>0.05)。结论:昂丹司琼联合泮托拉唑对宫颈癌同步放化疗所致恶心呕吐的疗效显著优于单用昂丹司琼治疗,并能明显减轻癌因性疲乏,且安全性高。  相似文献   

12.
目的:比较两种不同途径注射地塞米松磷酸钠对吗啡硬膜外术后镇痛的影响。方法:选择200例(ASAⅠ-Ⅱ)在腰硬联合麻醉下行腹式子宫切除术的患者,随机分为A、B、C、D四组(n=50),各组均给以硬膜外注射2.5 mg吗啡作为术后镇痛治疗的同时,A组静脉注射安慰剂(生理盐水),B组静脉注射地塞米松磷酸钠10 mg,C组静脉注射地塞米松磷酸钠5 mg,D组硬膜外注射地塞米松磷酸钠5 mg及静脉注射安慰剂(生理盐水),以上均以5 mL作为注射容积。观察和比较术后24 h内各组恶心和呕吐(PONV)、皮肤瘙痒、补救镇痛、呼吸抑制的发生率、排气时间和补救镇痛时间。结果:B、C、D三组的PONV总发生率显著低于A组(P0.0083),而B、C、D三组之间比较无显著差异(P0.0083);A、B、C、D四组间恶心的发生率无显著差异(P0.05),而D组呕吐的发生率明显低于A组(P0.0083);B组皮肤瘙痒的发生率明显低于A组(P0.0083);四组患者的VAS评分比较无显著差异,均达到满意的镇痛效果(P0.05)。四组患者补救镇痛的发生率、补救镇痛药量和排气时间比较无明显差异(P0.05),而C、D组的补救镇痛时间明显比A组延长(P0.0083),四组患者均未出现呼吸抑制。结论:地塞米松磷酸钠可降低吗啡硬膜外术后恶心和呕吐的发生率,延长补救镇痛时间;硬膜外注射地塞米松磷酸钠对降低呕吐的发生率更有效;静脉注射地塞米松磷酸钠10 mg可降低瘙痒的发生率,且无明显的不良反应。  相似文献   

13.
An analytical method based upon liquid chromatography coupled to ion trap mass spectrometry (MS) detection with electrospray ionization interface has been developed for the simultaneous identification and quantification of droperidol and ondansetron in human plasma. The two drugs were isolated from 0.5 mL of plasma using a basic liquid-liquid extraction with diethyl ether/heptane (90/10, v/v) and tropisetron and haloperidol as internal standards, with satisfactory extraction recoveries. They were separated on a 5-μm C(18) Highpurity column (150 mm×2.1 mm I.D.) maintained at 30°C. The elution was achieved isocratically with a mobile phase of 2 mM HCOONH(4) pH 3.8 buffer/acetonitrile (60/40, v/v) at a flow rate of 200 μL/min. Data were collected either in full-scan MS mode at m/z 100-450 or in full-scan MS-MS mode, selecting the [M+H] (+) ion at m/z=294.0 for ondansetron, m/z=285.2 for tropisetron, m/z=380.0 for droperidol and m/z=376.0 for haloperidol. The most intense daughter ion of ondansetron (m/z=212.0) and droperidol (m/z=194.0) were used for quantification. Retention times for tropisetron, ondansetron, droperidol and haloperidol were 2.50, 2.61, 3.10 and 4.68 min, respectively. Calibration curves were linear for both compounds in the 0.50-500 ng/mL range. The limits of detection and quantification were 0.10 ng/mL and 0.50 ng/mL, respectively. The intra- and inter-assay precisions were lower than 6.4% and intra- and inter-assay recoveries were in the 97.6-101.9% range for the three 3, 30 and 300 ng/mL concentrations. This method allows simultaneous and rapid measurement of droperidol and ondansetron, which are frequently co-administrated for the prevention of postoperative nausea and vomiting.  相似文献   

14.
ObjectiveLike other inhalational anesthetics xenon seems to be associated with post-operative nausea and vomiting (PONV). We assessed nausea incidence following balanced xenon anesthesia compared to sevoflurane, and dexamethasone for its prophylaxis in a randomized controlled trial with post-hoc explorative analysis.Methods220 subjects with elevated PONV risk (Apfel score ≥2) undergoing elective abdominal surgery were randomized to receive xenon or sevoflurane anesthesia and dexamethasone or placebo after written informed consent. 93 subjects in the xenon group and 94 subjects in the sevoflurane group completed the trial. General anesthesia was maintained with 60% xenon or 2.0% sevoflurane. Dexamethasone 4mg or placebo was administered in the first hour. Subjects were analyzed for nausea and vomiting in predefined intervals during a 24h post-anesthesia follow-up.ResultsLogistic regression, controlled for dexamethasone and anesthesia/dexamethasone interaction, showed a significant risk to develop nausea following xenon anesthesia (OR 2.30, 95% CI 1.02–5.19, p = 0.044). Early-onset nausea incidence was 46% after xenon and 35% after sevoflurane anesthesia (p = 0.138). After xenon, nausea occurred significantly earlier (p = 0.014), was more frequent and rated worse in the beginning. Dexamethasone did not markedly reduce nausea occurrence in both groups. Late-onset nausea showed no considerable difference between the groups.ConclusionIn our study setting, xenon anesthesia was associated with an elevated risk to develop nausea in sensitive subjects. Dexamethasone 4mg was not effective preventing nausea in our study. Group size or dosage might have been too small, and change of statistical analysis parameters in the post-hoc evaluation might have further contributed to a limitation of our results. Further trials will be needed to address prophylaxis of xenon-induced nausea.

Trial Registration

EU Clinical Trials EudraCT-2008-004132-20ClinicalTrials.gov NCT00793663  相似文献   

15.
A double blind trial was conducted in 477 mothers in labour to compare the antiemetics metoclopramide 10 mg and promethazine 25 mg and placebo when added to the first dose of pethidine. Metoclopramide and promethazine were equally effective, and both better than placebo, in reducing the incidence of nausea and vomiting after the administration of pethidine. Seventy seven per cent of mothers were drowsy, and 8% slept in the hour after the pethidine injection, with no difference between the groups. The sedative effect was more persistent in the promethazine group, 66% of whom were still drowsy after delivery. One third of the mothers in each group needed further analgesia, with 77% of these ultimately requesting an epidural. The reduction in pain half an hour and one hour after pethidine, assessed by a visual analogue scale, were, respectively, 22% and 22% for placebo; 26% and 23% for metoclopramide; 13% and 9% for promethazine. Analgesia after metoclopramide was significantly better than that after promethazine in terms of pain score, duration of first injection, and need for Entonox. Metoclopramide is therefore to be preferred to promethazine as an antiemetic in labour.  相似文献   

16.
目的:观察三重措施预防为基础,联合非阿片镇痛药复合静脉全麻在行鼾症手术患者术后恶心呕吐的应用效果。方法:选择择期行鼾症手术男性病人80例,随机分为两组:吸入麻醉组(inhalation group, IHLA组)和静脉麻醉组(intravenous group, TIVA组),每组40例,两组均采用三重措施预防恶心呕吐,IHLA组采用以舒芬太尼为基础复合七氟烷吸入麻醉,TIVA组以氯胺酮和右美托咪定镇痛基础上丙泊酚全凭静脉麻醉。评估两组病人恶心呕吐危险系数,采用李克特量表(Likert scale),记录并分析两组患者术后6~8 h在麻醉后监测治疗室(post anesthesia care unit, PACU)及病房24 h恶心呕吐发生情况及补救用药用量。结果:两组患者一般临床资料、恶心呕吐风险评分、手术时间、术后恢复期补救用药量人数无显著差异(P>0.05);IHLA组在PACU恶心呕吐发生率为39.5%,TIVA组发生率为18.9%,两者相比有显著性差异(P<0.05);IHLA组病房24 h恶心呕吐严重程度高于TIVA组,两组术后需要补救应用抗呕吐药物用量无显著差异(P>0.05)。结论:以三重措施预防为基础,与吸入麻醉相比,非阿片类镇痛药复合静脉麻醉可以减少肥胖病人鼾症手术术后恶心呕吐发生率和严重程度,降低围术期风险,有利于患者早期恢复。  相似文献   

17.
Efficiency of anti-emetic properties of metoclopramide and dexamethasone was compared. Both drugs were administered to 22 patients with newly diagnosed untreated previously Hodgkin's disease during ABVD therapy. Number of vomiting episodes, nausea intensity and everyday patients' activity on the day of cytostatics administration were evaluated. Metoclopramide prevented vomiting in 55% of patients while dexamethasone in 65%. This difference was statistically insignificant. Patients' everyday activity was statistically significantly more frequently normal in patients receiving dexamethasone in comparison with placebo and decreased in patients receiving metoclopramide. Therefore, patients preferred dexamethasone.  相似文献   

18.
19.
OBJECTIVE: To quantify the impact of duplicate data on estimates of efficacy. DESIGN: Systematic search for published full reports of randomised controlled trials investigating ondansetron''s effect on postoperative emesis. Abstracts were not considered. DATA SOURCES: Eighty four trials (11,980 patients receiving ondansetron) published between 1991 and September 1996. MAIN OUTCOME MEASURES: Percentage of duplicated trials and patient data. Estimation of antiemetic efficacy (prevention of emesis) of the most duplicated ondansetron regimen. Comparison between the efficacy of non-duplicated and duplicated data. RESULTS: Data from nine trials had been published in 14 further reports, duplicating data from 3335 patients receiving ondansetron; none used a clear cross reference. Intravenous ondansetron 4 mg versus placebo was investigated in 16 reports not subject to duplicate publication, three reports subject to duplicate publication, and six duplicates of those three reports. The number needed to treat to prevent vomiting within 24 hours was 9.5 (95% confidence interval 6.9 to 15) in the 16 non-duplicated reports and 3.9 (3.3 to 4.8) in the three reports which were duplicated (P < 0.00001). When these 19 were combined the number needed to treat was 6.4 (5.3 to 7.9). When all original and duplicate reports were combined (n = 25) the apparent number needed to treat improved to 4.9 (4.4 to 5.6). CONCLUSIONS: By searching systematically we found 17% of published full reports of randomised trials and 28% of the patient data were duplicated. Trials reporting greater treatment effect were significantly more likely to be duplicated. Inclusion of duplicated data in meta-analysis led to a 23% overestimation of ondansetron''s antiemetic efficacy.  相似文献   

20.
目的:探讨术前应用对乙酰氨基酚和加巴喷丁对电视辅助胸腔镜肺叶切除患者术后阿片类药物使用、恶心呕吐的影响。方法:收集2016年1月至2018年12月因非小细胞肺癌就诊于我科行电视辅助胸腔镜肺叶切除的患者,收集患者临床资料包括年龄、性别、BMI、合并症、美国麻醉医师协会麻醉分级、肿瘤分级、肿瘤部位、手术时间,术中和术后阿片类药物使用情况、术后止吐药使用情况,阿片类药物使用均换算为口服吗啡当量,根据术前是否采用对乙酰氨基酚和加巴喷丁超前镇痛方案将患者分为两组,比较两组患者术前基本情况及术中术后阿片类药物使用情况,分析对乙酰氨基酚和加巴喷丁超前镇痛方案对阿片类药物使用情况的影响。结果:共有241例患者纳入研究,有78例患者术前采用对乙酰氨基酚和加巴喷丁超前镇痛方案,163例患者没有采用该镇痛方案,超前镇痛组患者术中及术后阿片类药物使用剂量、术后24小时呕吐次数、术后止吐药使用剂量均低于没有采用超前镇痛方案的患者,两组患者术后NSAIDs使用和镇静状态没有统计学差异。结论:术前采用对乙酰氨基酚和加巴喷丁超前镇痛方案可减少行电视辅助胸腔镜肺叶切除患者术中及术后阿片类药物使用剂量,降低术后恶心呕吐的发生。  相似文献   

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