盐酸阿扎司琼防治恶性淋巴瘤化疗所致恶心呕吐的临床研究

目的:探讨盐酸阿扎司琼和昂丹司琼治疗63 例恶性淋巴瘤化疗所致恶心、呕吐的疗效和安全性。方法:采用随机对照的临床研究方法,其中盐酸阿扎司琼组33 例,昂丹司琼组30 例。结果:盐酸阿扎司琼组总有效率为93. 9%(31/33),昂丹司琼组为70. 0%(21/30)。两组不良反应差异无统计学意义,但盐酸阿扎司琼组未出现锥体外系反应。结论:盐酸阿扎司琼防治化疗所致恶心、呕吐具有高效、安全的优势。     

Clinical usefulness of oral granisetron hydrochloride for alleviation of delayed nausea and vomiting induced by CPT-11

This open label pilot study evaluated the safety and efficacy of the oral 5-HT3 receptor antagonist granisetron for prophylaxis of delayed chemotherapy-induced nausea and vomiting (CINV) in 30 patients with advanced or recurrent colorectal cancer. Patients were studied during two cycles of a 5-week regimen with irinotecan (CPT-11) and UFT. Patients received prophylactic anti-emetic therapy that included intravenous granisetron. If Grade 1 or higher severity gastrointestinal symptoms occurred during 6 days after CPT-11 administration in Cycle 1, then oral granisetron was administered daily for the following 5 days of CPT-11 in Cycle 2. Sixteen patients (53.3%) experienced delayed CINV in Cycle 1. The incidence of Grade 2 or higher vomiting was 32.1% and 27.7% in Cycles 1 and 2 in males (P = 0.554) respectively, and 54.6% and 32.4% in females (P = 0.001) respectively. Granisetron is effective against delayed Grade 2 or higher vomiting induced by CPT-11/UFT in female patients, although granisetron alone may not sufficiently control nausea induced by this regimen.     

Clinical evaluation of granisetron hydrochloride for nausea and vomiting induced by oral anticancer drugs

We investigated the antiemetic effect, safety and usefulness of granisetron hydrochloride tablets on nausea and vomiting induced by oral anticancer drugs used in chemotherapy for gastric cancer and colorectal cancer. In the present trial, oral administration of granisetron hydrochloride was performed during 5 days after nausea or vomiting. 1) Clinically, the effective rate of granisetron hydrochloride (the percentage of cases in which the drug was assessed as "Remarkably effective" or "Effective") was more than 75% on each day of administration. There were no adverse events or abnormal laboratory tests. 2) In terms of usefulness, granisetron hydrochloride was rated "Extremely useful" or "Useful" in 17 out of 23 cases (78.2%). The above results have shown that granisetron hydrochloride tablets, administrated orally once daily at a dose of 2 mg, have an excellent antiemetic effect, and that this is a safe and useful drug.     

Clinical evaluation of sulpiride against nausea and vomiting during cancer chemotherapy compared with domperidone--envelope method

Sulpiride, which has been utilized as an antipeptic ulcer and antidepressant in Japan, is one of the dopamine antagonists, and is considered to have anti vomiting activity. We designed a comparative controlled study of Sulpiride and Domperidone, against nausea and vomiting during cancer chemotherapy. A total of 69 cases were entered into this study, 34 cases being treated with Sulpiride at a dose of 100 mg i.v. or i.m. (S group), and 35 cases being treated with Domperidone at a dose of 10 mg i.v. (D group), before and after chemotherapy. Three cases from the S group and 4 cases from the D group were excluded from this study because of differences in the administration schedule. There was no difference in patient characteristics between the two groups, such as age, sex, original disease and antitumor agents. According to our criteria 27 of 31 cases in the S group showed effectiveness of the agent against nausea and vomiting (87%), while in the D group, 24 cases showed effectiveness (77%). There was no statistical difference between them, and no side effects were found in either group.     

Prophylactic effect of tropisetron hydrochloride against nausea and vomiting in patients receiving chemotherapy for hematological malignancies

To establish the effectiveness of oral 5-HT(3) antagonist, oral 5 mg tropisetron was introduced in the 21 cases with hematological malignancies for the prevention of chemotherapy-induced nausea and vomiting. Nausea and vomiting did not develop in 81% of patients receiving the tropisetron in this study. The results suggested that oral tropisetron is effective for the control of acute, and to a lesser extent, delayed, nausea and vomiting. The drug enhanced patients' quality of life and reduced the clinical cost. In conclusion, tropisetron is effective for the prevention of chemotherapy-induced nausea and vomiting in treatment for hematological malignancies. It is suitable as first-line therapy for outpatients.     

帕洛诺司琼和恩丹西酮预防化疗诱发恶心呕吐的临床对比研究

目的:对比观察帕洛诺司琼和恩丹西酮预防化疗诱发恶心和呕吐的作用及其不良反应。方法:采用随机自身对照方法对36例接受中～高度致吐化疗药物的恶性肿瘤患者使用帕洛诺司琼进行止吐治疗,并与恩丹西酮作对照,于化疗第1个周期或第2个周期使用帕洛诺司琼止吐,同一患者于另1个周期使用恩丹西酮作自身对照。结果:帕洛诺司琼于急性呕吐期(化疗后24h内)止吐完全有效率为94.4%,恩丹西酮组为83.3%,帕洛诺司琼控制急性呕吐的疗效优于恩丹西酮,但两组比较差异无统计学意义,P>0.05。帕洛诺司琼于延迟呕吐期(化疗后d2～d5)止吐的有效率(完全有效率+部分有效率)均高于恩丹西酮,但两组差异均无统计学意义,P>0.05。帕洛诺司琼的不良反应主要为头痛和便秘,与恩丹西酮比较,两组主要不良反应发生率差异无统计学意义,P>0.05。结论:帕洛诺司琼能有效预防中、高度致吐化疗药物所致的恶心和呕吐反应,对于急性和延迟性呕吐反应相比恩丹西酮有较好疗效。     

Cinnarizine for prevention of nausea and vomiting during platin chemotherapy

The antiemetic efficacy of cinnarizine was assessed in 17 cancer patients receiving platin-based chemotherapy (cisplatin dose-range 30-160 mg, or carboplatin 270-600 mg) in a randomised, cross-over study. The patients were prophylactically given oral metoclopramide 3 x 1 mg/kg and lorazepam 2 x 1 mg with or without cinnarizine 3 x 75 mg. The antiemetic combination with cinnarizine prevented emesis completely on 51% of 35 days with chemotherapy and less than 3 emetic episodes occurred on 86% of the days, compared with 43% and 57% (p less than 0.01) without cinnarizine respectively. Severe nausea was significantly less frequent with cinnarizine and 59% of the chemotherapy days were without nausea, compared to 46% of the days without cinnarizine (p less than 0.05). Side-effects were uncommon and minor with both antiemetic regimens. The study suggests that addition of cinnarizine to metoclopramide and lorazepam improves antiemetic prophylaxis in low to medium dose platin-based chemotherapy.     

福沙匹坦三联用药预防高致吐化疗方案所致恶心呕吐疗效的临床观察

目的:评估福沙匹坦、盐酸托烷司琼、地塞米松三联方案预防高致吐化疗方案致恶心呕吐的效果及安全性。方法:采取回顾性分析的方法,选择2013年1月至2018年4月空军军医大学唐都医院肿瘤科收治的乳腺癌接受高致吐性化疗方案初次化疗的患者81例,根据预防化疗相关性恶心呕吐(chemotherapy-induced nausea and vomiting,CINV)方案的不同设置为观察组和对照组。对照组42例给予盐酸托烷司琼、地塞米松二联方案预防CINV。观察组39例,在对照组治疗基础上加用福沙匹坦。对比两组化疗后急性期(0～24 h)及延迟期(24～120 h)预防恶心呕吐的效果及不良反应的发生情况。结果:观察组患者化疗后恶心控制率显著高于对照组（87.2% vs 69.0%,P＜0.05);急性期观察组呕吐有效控制率为87.2%,显著高于对照组的66.7%(P＜0.05);呕吐延迟期内观察组和对照组的有效控制率分别为74.4%和57.1%,差异有统计学意义(P<0.05) 。两组不良反应发生率比较差异无统计学意义(P＞0.05),且不良反应均较轻微,患者可耐受。结论:福沙匹坦三联方案对高致吐化疗方案蒽环类药物联合环磷酰胺化疗致乳腺癌患者的恶心呕吐疗效显著,且不良反应轻微,患者可耐受。     

Investigation of anti-emetic effect of ondansetron tablet in multiple doses on nausea and emesis associated with cisplatin]

The anti-emetic effects, safety and usefulness of ondansetron, a 5-HT3 receptor antagonist, given orally once daily for 3-5 consecutive days, were investigated in patients receiving a high single dose (greater than or equal to 50 mg/m2 or 75 mg/body) or lower multiple doses (greater than or equal to 15-20 mg/m2/day for 3-5 consecutive days) of cisplatin. Ondansetron 4 mg was administered orally once daily for 3-5 consecutive days. Efficacy rates in controlling nausea and emesis over the 3-5 days were 77.3% (17/22 cases) and 66.7% (6/9 cases) in patients receiving a high single dose and lower multiple doses of cisplatin, respectively. Side effects were observed in 2 cases (headache and elevation of blood pressure in one case and only headache in the other case.). Abnormality in clinical laboratory findings was observed in 1 case. From the above, ondansetron, showing high efficacy by oral administration 4 mg once daily for 3-5 consecutive days, without any problem in safety, was considered to be a useful anti-emetic agent.     

沙利度胺联合昂丹司琼预防肺癌化疗所致恶心呕吐的临床研究

目的:探讨沙利度胺联合昂丹司琼对肺癌患者接受含顺铂双药方案化疗所致恶心呕吐的有效性和安全性。方法:将 2014年2月至2016年2月我院肿瘤科收治的60 例肺癌患者随机分成试验组(30例)和对照组(30例),均采用含顺铂25mg/m2 d1~3双药方案化疗。对照组用昂丹司琼注射液8mg qd d1~3化疗前30min 静脉滴注,试验组在对照组基础上加用沙利度胺片100mg口服 d1~5。结果:试验组和对照组急性恶心控制的有效率为 90% vs 80%,完全缓解率为73% vs 67%,差异均无统计学意义(P均＞0.05)。试验组和对照组第2~5天延迟性恶心控制的有效率分别为:87% vs 53%（P=0.011）,80% vs 47%（P=0.016）,80% vs 50%（P=0.030）,87% vs 74%（P=0.331）。试验组和对照组第2~5天延迟性恶心完全缓解率分别为:67% vs 37%（P=0.039）,57% vs 27%（P=0.036）,60% vs 23%（P=0.009）,67% vs 40%（P=0.070）。试验组和对照组急性呕吐控制的有效率为93% vs 90%,完全缓解率为84% vs 77%,差异均无统计学意义(P均 ＞0.05)。试验组和对照组第2~5天延迟性呕吐控制的有效率分别为:90% vs 73%（P=0.182）,83% vs 70%（P=0.360）,87% vs 73%（P=0.333）,94% vs 80%（P=0.255）。试验组和对照组第2~5天延迟性呕吐完全缓解率分别为:76% vs 46%（P=0.034）,66% vs 33%（P=0.020）,70% vs 40%（P=0.038）,73% vs 50%（P=0.110）。试验组和对照组的不良反应均可耐受,镇静、嗜睡、乏力、便秘、头痛和皮疹的发生率差异均无统计学意义(P均＞0.05)。结论:沙利度胺联合昂丹司琼能有效预防肺癌患者含顺铂双药化疗引起的恶心呕吐,能提高延迟性恶心呕吐的控制率,未增加特殊不良反应,安全性较好,是可供选择的止吐药物。     

格拉司琼对恶性肿瘤化疗所致恶心、呕吐的疗效观察

目的:探讨格拉司琼和昂丹司琼防治恶性肿瘤化疗所致恶心、呕吐的疗效和安全性.方法:采用随机对照的研究方法,124例患者分为格拉司琼组(治疗组)64例,昂丹司琼组(对照组)60例.结果:格拉司琼组总有效率96.88%(62/64);昂丹司琼组为80.00%(48/60),差异有统计学意义(P<0.01).而两组不良反应差异无统计学意义(P>0.05).结论:格拉司琼防治恶性肿瘤化疗所致恶心、呕吐具有高效、安全的优点.     

格拉司琼对恶性肿瘤化疗所致恶心、呕吐的疗效观察

目的：探讨格拉司琼和昂丹司琼防治恶性肿瘤化疗所致恶心、呕吐的疗效和安全性。方法：采用随机对照的研究方法,124例患者分为格拉司琼组（治疗组）64例,昂丹司琼组（对照组）60例。结果：格拉司琼组总有效率96．88％（62／64）;昂丹司琼组为80．00％（48／60）,差异有统计学意义（P〈0．01）。而两组不良反应差异无统计学意义（P〉0．05）。结论：格拉司琼防治恶性肿瘤化疗所致恶心、呕吐具有高效、安全的优点。     

Examination of anti-emetic effect, safety and usefulness of single oral dose of ondansetron tablet in nausea and emesis induced by anti-cancer drugs--dose-finding study of ondansetron tablet in patients receiving non-platinum anti-cancer drugs]

Inhibitory effects on acute nausea and emesis, safety and usefulness of a single oral dose of Ondansetron tablet were evaluated in 3 different dose levels for comparison by telephone registration system, in patients receiving non-platinum anti-cancer drugs. A single dose of ondansetron at 4 mg, 8 mg or 12 mg was given orally at 2 hrs before the initial administration of anti-cancer drugs. The patients were observed for 24 hours after administration of anti-cancer drugs, for occurrence of nausea and emesis. Efficacy rates of inhibitory effects on nausea and emesis were 83.3% (10/12 cases) in 4 mg dose group, 78.6% (11/14 cases) in 8 mg dose group and 84.6% (11/13 cases) in 12 mg dose group, without statistically significant difference. Side effects were observed in 3 cases (headache, cold feeling and trembling in limbs, sleepiness) in 12 mg dose group, but these symptoms were not severe and disappeared after several hours or several days. No abnormality in clinical laboratory findings attributable to Ondansetron was observed. From the above, it was considered that Ondansetron was a clinically useful anti-emetic for nausea and emesis induced by non-platinum anti-cancer drugs and that 4 mg once daily was the optimal dose.     

格拉司琼与恩丹西酮防治食管癌术后化疗所致恶心呕吐的疗效对比

目的：比较格拉司琼与恩丹西酮防治食管癌术后患者化疗引起恶心、呕吐的作用及毒副反应。方法：回顾性研究439例食管癌术后化疗患者的临床资料，比较格拉司琼和恩丹西酮的治疗效果及毒副反应。结果：吻合VI位于颈部患者比位于胸内患者易发生恶心、呕吐。格拉司琼对化疗后急性（1d）恶心、呕吐有效率为81．6％，延迟性恶心呕吐（2—5d）的有效率分别为75．0％、64．2％、60．8％、56．1％。恩丹西酮对化疗后急性恶心、呕吐有效率为71．4％，延迟性恶心、呕吐的有效率分别为68．7％、57．7％、52．0％、47．1％，两组差异显著（P〈0．05），格拉司琼治疗效果优于恩丹西酮。两者不良反应基本相似。结论：格拉司琼对于防治食管癌术后患者化疗所致恶心、呕吐效果较好。     

格拉司琼与恩丹西酮防治食管癌术后化疗所致恶心呕吐的疗效对比

目的:比较格拉司琼与恩丹西酮防治食管癌术后患者化疗引起恶心、呕吐的作用及毒副反应。方法:回顾性研究439例食管癌术后化疗患者的临床资料,比较格拉司琼和恩丹西酮的治疗效果及毒副反应。结果:吻合口位于颈部患者比位于胸内患者易发生恶心、呕吐。格拉司琼对化疗后急性(1d)恶心、呕吐有效率为81.6%,延迟性恶心呕吐(2～5d)的有效率分别为75.0%、64.2%、60.8%、56.1%。恩丹西酮对化疗后急性恶心、呕吐有效率为71.4%,延迟性恶心、呕吐的有效率分别为68.7%、57.7%、52.0%、47.1%,两组差异显著(P<0.05),格拉司琼治疗效果优于恩丹西酮。两者不良反应基本相似。结论:格拉司琼对于防治食管癌术后患者化疗所致恶心、呕吐效果较好。     

The efficacy and safety of indisetron hydrochloride for the management of nausea/vomiting caused by chemotherapy for gynecologic cancer

This clinical trial was designed to evaluate the efficacy and safety of indisetron hydrochloride an oral 5-HT3 receptor antagonist, for the management of nausea/vomiting caused by chemotherapy for gynecologic cancer with paclitaxel/ carboplatin or docetaxel/carboplatin. Indisetron hydrochloride(8 mg)was administered orally to 46 gynecologic cancer patients at 0.5 hours before administration of the above chemotherapy agents. Number of patients who showed nausea or vomiting for 24 hours was counted. The complete vomiting inhibition rate at 24 hours after chemotherapy was 89.1%(41/46), and nausea inhibition rate was 71.7%(33/46). No serious adverse events were observed. These findings indicate that prophylactic administration of indisetron hydrochloride is safe and useful for inhibition of nausea/vomiting caused by cancer chemotherapy.     

A randomized study of aprepitant, ondansetron and dexamethasone for chemotherapy-induced nausea and vomiting in Chinese breast cancer patients receiving moderately emetogenic chemotherapy

Objectives This is a single center, randomized, double-blind placebo-controlled study to evaluate the NK(1)-receptor antagonist, aprepitant, in Chinese breast cancer patients. The primary objective was to compare the efficacy of aprepitant-based antiemetic regimen and standard antiemetic regimen for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients who received moderately emetogenic chemotherapy. The secondary objective was to compare the patient-reported quality of life in these two groups of patients. Patients and Methods Eligible breast cancer patients were chemotherapy-naive and treated with adjuvant AC chemotherapy (i.e. doxorubicin 60 mg/m² and cyclophosphamide 600 mg/m²). Patients were randomly assigned to either an aprepitant-based regimen (day 1, aprepitant 125 mg, ondansetron 8 mg, and dexamethasone 12 mg before chemotherapy and ondansetron 8 mg 8 h later; days 2 through 3, aprepitant 80 qd) or a control arm which consisted of standard regimen (day 1, ondansetron 8 mg and dexamethasone 20 mg before chemotherapy and ondansetron 8 mg 8 h later; days 2 through 3, ondansetron 8 mg bid). Data on nausea, vomiting, and use of rescue medication were collected with a self-report diary, patients quality of life were assessed by self-administered Functional Living Index-Emesis (FLIE). Results Of 127 patients randomized, 124 were assessable. For CINV in Cycle 1 AC, there was no significant difference in the proportion of patients with reported complete response, complete protection, total control, ‘no vomiting’, ‘no significant nausea’ and ‘no nausea’. The requirement of rescue medication appears to be lesser in patients treated with the aprepitant-based regimen compared to those with the standard regimen (11% vs. 20%; P = 0.06). Assessment of FLIE revealed that while there was no difference in the nausea domain and the total score between the two groups; however, patients receiving standard antiemetic regimen had significantly worse quality of life in the vomiting domain (mean score [SD] = 23.99 [30.79]) when compared with those who received the aprepitant-based regimen (mean score [SD] = 3.40 [13.18]) (P = 0.0002). Both treatments were generally well tolerated. Patients treated with the aprepitant-based regimen had a significantly lower incidence of neutropenia (53.2% vs. 35.5%, P = 0.0468), grade ≥ 3 neutropenia (21.0% vs. 45.2, P = 0.0042) and delay in subsequent cycle of chemotherapy (8.1% vs. 27.4%, P = 0.0048). Conclusion The aprepitant regimen appears to reduce the requirement of rescue medication when compared with the control regimen for prevention of CINV in patients receiving both an anthracycline and cyclophosphamide, and is associated with a better quality of life during adjuvant AC chemotherapy.     

阿瑞匹坦预防胃癌术后化疗恶心呕吐反应68例临床观察

目的探讨阿瑞匹坦预防胃癌术后患者行含奥沙利铂化疗方案所致的恶心呕吐的临床疗效及不良反应。方法选取2014年4月至2016年6月江苏省肿瘤医院收治的接受含奥沙利铂方案化疗2周期的胃癌术后患者68例为研究对象。化疗第一周期使用帕洛诺司琼+地塞米松二联方案预防呕吐,第二周期使用阿瑞匹坦+帕洛诺司琼+地塞米松三联方案预防呕吐。记录患者化疗开始后7天的恶心呕吐情况;使用视觉模拟评分法(VAS)进行生活质量评估。结果化疗第一周期后有67.6%患者呕吐达到完全缓解,化疗第二周期后有85.3%的患者呕吐达到完全缓解(P0.01)。在延迟性呕吐预防效果的比较中,二联方案呕吐控制率为70.6%,加入阿瑞匹坦后提高到92.6%(P0.01)。第二周期化疗后VAS评分(92.3)明显高于第一周期化疗后的89.2(P0.01)。结论胃癌术后患者使用阿瑞匹坦+帕洛诺司琼+地塞米松预防含奥沙利铂化疗方案化疗所致恶心呕吐的疗效良好,能提高患者的生存质量。     

奥氮平治疗化疗所致恶心、呕吐疗效及副反应的关系研究

目的:研究不同奥氮平单次给药剂量疗效及不良反应,探讨最佳用药剂量。方法:75例接受中、高度致吐性化疗药物的患者随机分为5组:对照组和4个不同奥氮平剂量组(A、B、C、D奥氮平用药剂量分别为2.5,5,7.5,10mg)。用药时间与化疗时间一致,观察恶心、呕吐的发生率及不良反应。结果:对照组恶心、呕吐的发生率最高,随奥氮平剂量递增,恶心、呕吐发生率递减,但不良反应亦递增。结论:奥氮平对化疗所致恶心、呕吐的缓解存在剂量依赖,增加剂量可以提高疗效,但不良反应亦随着增加。治疗时应对患者的焦虑、抑郁、睡眠质量进行评估,个体化用药。     

Clinical usefulness of oral aprepitant for alleviation of delayed nausea and vomiting induced by mFOLFOX6--report of a case

A 50-year-old-woman underwent high anterior resection for sigmoid colon adenocarcinoma. Modified oxaliplatin/l / -LV/ 5-FU(mFOLFOX6)was started as adjuvant treatment due to final-stage III b. Granisetron 3 mg and dexamethasone 8 mg for prophylaxis chemotherapy-induced nausea and vomiting (CINV) were administered intravenously 30 min before oxaliplatin administration. Grade 3 delayed CINV was observed at course 4. CINV could not be controlled by any rescue medications. We adopted a neurokinin-1 receptor antagonist (aprepitant) that alleviated the emetic effects of substance P. The oral aprepitant dose was 125 mg on day 1 and 80 mg on days 2 and 3. Afterward, delayed vomiting was completely controlled and chemotherapy could be continued to course 12. Aprepitant is a very active antiemetic drug for the prevention of delayed nausea and vomiting induced by mFOLFOX6 regimen.