奈西雅注射剂预防化疗药物所致胃肠反应的临床研究

目的　观察奈西雅注射剂预防顺铂或 (和 )阿霉素引起的胃肠反应作用和毒副作用 ,并与康泉比较。方法　采用开放、多中心 ,中心内均衡随机 ,自身交叉对照方法。入选患者随机分为AB组或BA组 ,AB组第 1周期给予奈西雅 ,第 2周期给予康泉 ,BA组则相反。结果　收治患者 111例 ,可评价疗效 98例 ,其中顺铂组 6 1例 ,阿霉素组 37例。在化疗后 0～ 6h ,奈西雅对食欲不振、恶心、呕吐的控制率与康泉相似 ,但在 0～ 2 4h ,奈西雅对食欲不振的完全控制率 (38.8% )明显优于康泉(2 5 .5 % )。在 0～ 12h、0～ 18h、0～ 2 4h对恶心的改善作用 (73.6 %、71.4%、6 7.3% )也明显优于康泉(6 5 .3%、6 1.2 %、48% ,P <0 .0 5 ) ,提示奈西雅作用时间较康泉长。奈西雅在 0～ 2 4h对呕吐的抑制作用虽与康泉比较差异无显著性 ,但有效率前者 73.5 %高于后者 6 1.2 %。对顺铂组或阿霉素组化疗药所致食欲不振、恶心及呕吐的抑制作用 ,两药效果相似 ,差异无显著性。奈西雅不良反应轻 ,主要为头重感、头痛、口干、便秘等 ,其发生率与康泉相似。结论　奈西雅能有效预防化疗药物所致胃肠反应 ,其疗效与康泉相似 ,但作用时间较康泉长 ,不良反应轻 ,是良好的化疗止吐药。     

奈西雅预防治疗化疗所致胃肠道反应的临床研究

目的：观察奈西雅防治化疗药物引起的胃肠道反应的疗效及其不良反应。方法：采用开放式的研究，对86例患者化疗同时给予奈西雅(0．3mg，静脉推注，d1～d3)，观察化疗不同时间其对食欲不振、恶心、呕吐等的预防和治疗作用。结果：奈西雅防治化疗药物尤其是顺铂和(或)表阿霉素的胃肠道不良反应有较好疗效，有效率分别为53．5％～90．6％；对顺铂引起的迟发性呕吐亦有一定的防治作用；不良反应轻，主要为便秘、头痛、口干、头重、发热感等。结论：奈西雅能有效防治化疗药物所致的胃肠道反应，疗效维持时间长，不良反应轻，为较好的化疗止吐剂。     

雷莫司琼预防化疗药物所致胃肠反应的临床结果

目的 观察雷莫司琼（奈西雅）预防化疗药物〔顺铂和（或）阿霉素〕所致胃肠反应的作用，并与格拉司琼（康泉）对比，观察两药的疗效和安全性。方法 采用随机，交叉，自身对照方法，入选病人随机分为ＡＢ组或ＢＡ组。ＡＢ组第１周期给予奈西雅，第２周期给予康泉；ＢＡ组第１、２周期给药顺序则相反。结果 可评价疗效４０例。在化疗后１２小时内奈西雅对食欲缺乏的控制率（７０％）及２４小时内对恶心的抑制作用（５７．５％）明显     

奈西雅预防治疗化疗所致胃肠道反应的临床研究

目的:观察奈西雅防治化疗药物引起的胃肠道反应的疗效及其不良反应。方法:采用开放式的研究,对86 例患者化疗同时给予奈西雅(0. 3 mg,静脉推注,d1~d3),观察化疗不同时间其对食欲不振、恶心、呕吐等的预防和治疗作用。结果:奈西雅防治化疗药物尤其是顺铂和(或)表阿霉素的胃肠道不良反应有较好疗效,有效率分别为53 .5%~90 .6%;对顺铂引起的迟发性呕吐亦有一定的防治作用;不良反应轻,主要为便秘、头痛、口干、头重、发热感等。结论:奈西雅能有效防治化疗药物所致的胃肠道反应,疗效维持时间长,不良反应轻,为较好的化疗止吐剂。     

甲磺酸托烷司琼预防顺铂和阿霉素所致胃肠道反应的临床研究

目的 观察甲磺酸托烷司琼控制顺铂、阿霉素所致胃肠道反应的作用及其不良作用。并与胃复安和欧必亭对照。方法 采用开放、多中心、中心内均衡随机、自身交叉对照方法。292例随机分为AB、BA组，39例分为AC、CA组。AB组第1个周期给予甲磺酸托烷司琼，第2个周期给予胃复安，BA组则相反。AC组第1个周期给予甲磺酸托烷司琼，第2个周期给予欧必亭、控制顺铂、阿霉素化疗所致的食欲不振、恶心、呕吐的疗效优于胃复安，与欧必亭相近。甲磺酸托烷司琼的不良反应轻微、与欧必亭相似，未见有锥体外系症状。结论 甲磺酸托烷司琼能有效预防顺铂、阿霉素所致胃肠道反应，疗效明显优于胃复安，与进口药物欧必亭相似，不良反应轻，是安全有效的化疗止吐药。     

奈西雅预防化疗所致恶心呕吐的临床观察

目的观察奈西雅预防化疗所致恶心呕吐反应的作用及毒副作用,并与欧必亭对比.方法对72例病人采用随机平行对照方法分成奈西雅组36例和欧必亭组36例,对各种恶性肿瘤均给予五日化疗方案.方案中大部分含有顺铂,其余含有表阿霉素.在化疗的1、3、5日化疗前给予止吐药物,观察1～7日止恶心、呕吐的疗效及副反应.结果在1、3、5日给止吐药时,奈西雅的止恶心、止呕吐有效率高于欧必亭组,但无统计学差异(P＞0.05),在2、4日奈西雅组止恶心呕吐有效率高于欧必亭组,但P＞0.05,在6、7日奈西雅组止恶心有效率显著高于欧必亭组(P＜0.05);虽然在6、7日两组止呕吐有效率P＞0.05,但奈西雅组明显高于欧必亭组;而且,奈西雅组的副反应更轻微,尤其是腹胀,便秘发生率明显低于欧必亭组(P＜0.05).结论在临床五日化疗方案中,仅在第1、3、5日化疗前应用奈西雅即能起到很好的止恶心呕吐作用,且疗效优于同样价位的欧必亭.止恶心,呕吐有效率高,持续时间长,副作用小.     

电子止吐仪联合托烷司琼防治顺铂化疗所致呕吐的疗效观察

目的:观察电子止吐仪联合托烷司琼预防顺铂化疗所致呕吐的疗效。方法:采用随机、自身交叉对照的方法,将120例接受两周期含顺铂联合化疗的患者,随机分为AB组60例、BA组60例。AB组第1周期应用电子止吐仪联合托烷司琼止吐,第2周期单用托烷司琼止吐;BA组第1周期单用托烷司琼止吐,第2周期应用电子止吐仪联合托烷司琼止吐。观察和记录两组患者化疗后恶心、呕吐的控制情况。结果:AB组化疗第1周期（A方案）和第2周期（B方案）恶心的有效控制率分别为93.1%、79.3%,呕吐有效控制率分别为86.2%、70.7%,差异有统计学意义(P<0.05);BA组化疗第1周期（B方案）和第2周期（A方案）恶心的有效控制率分别为71.7%、93.3%,呕吐有效控制率分别为70.0%、86.7%,差异有统计学意义(P<0.05)。两种方案的主要不良反应为头痛、眩晕、腹泻、便秘、心悸、口干等,不良反应发生率比较差异无统计学意义（P>0.05）。结论:电子止吐仪联合托烷司琼预防顺铂化疗所致呕吐优于单用托烷司琼,不良反应可以耐受,可作为防治顺铂化疗所致呕吐的常规措施。     

奈西雅预防化疗引起胃肠道反应的临床观察

目的 观察奈西雅注射剂(盐酸雷莫司琼)预防顺铂引起的胃肠道反应的疗效及其毒副作用,并与格拉司琼注射液进行比较.方法 采用随机对照法,入选病例随机分为奈西雅组和格拉司琼组.结果 收治患者120例,奈西雅组60例和格拉司琼组60例,在化疗后0-12 h,奈西雅对恶心的控制率虽然与格拉司琼比较差异无显著意义,但有效率前者96.7﹪,高于后者93.3﹪;而0-18 h、0-24 h,奈西雅对恶心的有效率及完全控制率均高于格拉司琼,差异有显著意义,P＜0.05;第2天、第3天奈西雅对恶心的有效率及完全控制率分别为73.3﹪和58.3﹪,明显高于格拉司琼48.3﹪和41.7﹪;差异有显著意义,P＜0.05,说明奈西雅对化疗引起的延迟恶心有明显的疗效.在化疗后0-12 h,奈西雅止吐的有效率98.3﹪,高于格拉司琼90.0﹪,虽然统计学上无显著性,但奈西雅却优于格拉司琼.而0-18 h、0-24 h,均有显著性差异,P＜0.05,提示奈西雅作用时间较格拉司琼长.第2天、第3天奈西雅止吐的有效率明显高于格拉司琼,P＜0.005,迟发性呕吐的疗效尤为明显.奈西雅的不良反应轻,主要为头重感、头痛、口干、便秘等.结论 奈西雅能有效地预防化疗药物所致的胃肠道反应,其疗效明显优于格拉司琼,是很好的化疗止吐药.     

奈达铂同期放化疗治疗中晚期宫颈癌前瞻性临床研究

目的探讨顺铂同期放化疗与奈达铂同期放化疗治疗中晚期宫颈癌的疗效和不良反应。方法180例中晚期宫颈癌患者随机分为奈达铂同期放化疗组（奈达铂组90例）和顺铂同期放化疗组（顺铂组90例）,观察并比较2组的近期疗效及不良反应。结果奈达铂组近期有效率、1年无复发生存率、1年无转移生存率、2年无复发生存率、2年无转移生存率分别为98．85％、89．66、86．21％、85．06％和80．46％,顺铂组近期有效率、1年无复发生存率、1年无转移生存率、2年无复发生存率、2年无转移生存率分别分别为97．60％（χ2=3．07,P〉0．05）、81．93％（χ2=3．07,P〉0．05）、83．13％（χ2=0．31,P〉0．05）、78．31％（χ2=1．30,P〉0．05）和80．72％（χ2=0．00,P〉0．05）,两组间差异无统计学意义。顺铂组恶心呕吐总发生率及Ⅲ-Ⅳ级发生率分别为52．27％、12．50％,明显高于奈达铂组的27．27％、6．82％（χ2=12．18,P=0．01）,而贫血、白细胞减少、血小板减少、腹泻等不良反应两组间无明显差异。结论奈达铂同期放化疗疗效与顺铂同期放化疗相同,不良反应可以耐受。     

恩丹西酮预防化疗所致呕吐Ⅲ期临床研究

作观察了经顺铂类和非顺铂类药物化疗的95例患应用恩丹西酮的止吐作用。顺铂组共68例。顺铂40mg／次×3天(23例)，50mg／次×3天(27例)。80mg／次×2天(18例)；非顺铂组27例．均系接受含环磷酰胺和／或阿霉素联合方案化疗用胃复安后出现呕吐患，A组后接受同一方案治疗。结果显示，恩丹西酮对控制顺铂不同剂量组所致急性呕吐的CR率依次为87.0％，85.2％和66.7%，总有效率分别为91．3％，96．3％和94．4％;而对非顺铂组控制急性呕吐的CR率为88．9%。有效率为96.3％。上述结果表明恩丹西酮对控制顺铂类和非顺铂类药物所致的呕吐反应均有较强的止吐作用。     

雷莫司琼崩解片防治化疗所致恶心呕吐的临床研究

目的：观察比较雷莫司琼崩解片与盐酸托烷司琼治疗含顺铂或蒽环类方案化疗所致恶心呕吐的疗效及不良反应。方法：将４５例接受含顺铂或蒽环类方案化疗的患者随机分为ＡＢ、ＢＡ组。ＡＢ组第１周期静脉用盐酸托烷司琼;第２周期以雷莫司琼崩解片口服代替盐酸托烷司琼。ＢＡ组第１周期以雷莫司琼崩解片治疗;第２周期静脉用盐酸托烷司琼治疗。结果：可评价疗效的３９例患者中,含雷莫司琼崩解片止呕方案和含盐酸托烷司琼止呕方案对急性恶心的有效率分别为８９.７％和９４.９％,迟发性恶心有效率分别为６６.７％ ～８２.１％和７９.５％ ～８９.７％。对急性呕吐的有效率分别为８９.７％和９２.３％,迟发性呕吐分别为８７.２％ ～８９.７％和８４.６％ ～８９.７％。两组疗效差异均无统计学上意义。两组不良反应亦无显著性差异。结论：雷莫司琼崩解片与盐酸托烷司琼在控制急性、迟发性恶心呕吐的有效率和毒副反应均相近,高效低毒,值得临床推广应用。     

苏罗同预防化疗引起的恶心呕吐的临床效果

观察苏罗同预防含顺铂或阿霉素方案化疗引起的恶性心呕吐的临床疗效和不良反应。方法对３０例患者采用随机自身对照研究的方法，分别在第１周期化疗前用苏罗同、第２周期笔康泉预防呕吐，或第１周期化疗前用康泉、第２周期和苏罗同预防呕吐。结果苏罗同和康泉第１天预防呕吐的有效率均为９６．７％，患者第１天平均呕吐次数分别为１．３次和１次。     

Clinical evaluation of granisetron as an inhibitor of nausea and vomiting induced by oral anticancer drugs

In order to inhibit the nausea and vomiting induced by oral anticancer drugs, granisetron was administered orally at a dose of 2 mg once a day, and its usefulness and safety were evaluated. The subjects were 26 outpatients with gastric or colon cancer receiving chemotherapy with oral anticancer drugs and complaining of gastrointestinal symptoms. A record sheet was handed to the patients. In comparison with the condition before treatment, the patients were instructed to indicate on the record sheet the severity of nausea (4 grades), presence or absence of vomiting, and degree of appetite (4 grades) after treatment, and thereby to evaluate the clinical efficacy or antiemetic effect every day in accordance with clinical efficacy evaluation criteria of 4 grades (very effective, effective, slightly effective, and ineffective). i) Nausea disappeared in 47.8% of the patients on the 1st day of treatment and in 65.2% on the 5th day of treatment. ii) Vomiting was observed in 2 and 3 patients on the 1st and 3rd day, respectively, but not on the 4th day of treatment or thereafter. iii) The efficacy rate, comprising both very effective and effective, was 69.5% on the 1st day of treatment, and increased gradually to reach 78.2% on the 5th day of treatment. iv) There was no adverse reaction or abnormality of laboratory test values attributable to granisetron. Granisetron was safe and effective against nausea and vomiting induced by oral anticancer drugs.     

Evaluation of efficacy of ramosetron orally disintegrating tablets and patient preference as to the dosage form in gynecological cancer chemotherapy

The efficacy of an oral 5-HT3 antagonist, ramosetron orally disintegrating tablet (ODT), in the treatment of chemotherapy-induced emesis was investigated in 21 female patients with cancer. Patient preference for the dosage form was also investigated. Eighteen (85.7%) of 21 patients answered that ODT is easy to take. Eleven (68.8%) of 16 patients who had previously taken granisetron tablets preferred ramosetron ODT to conventional tablets. The complete suppression rate of nausea or vomiting was more than 90% for 6 days. No adverse drug reactions associated with ramosetron were observed. As ambulatory or home chemotherapy becomes frequent, the use of oral 5-HT3 antagonists rather than intravenous agents will be increased. Chemotherapy for elderly cancer patients is becoming frequently used. Considering these circumstances, it is suggested that ramosetron ODT is a palatable and useful treatment of chemotherapy-induced emesis.     

Efficacy of an ondansetron orally disintegrating tablet: a novel oral formulation of this 5-HT(3) receptor antagonist in the treatment of fractionated radiotherapy-induced nausea and emesis. Emesis Study Group for the Ondansetron Orally Disintegrating Tablet in Radiotherapy Treatment

A significant number of patients who are receiving radiotherapy experience the distressing side effects of emesis and nausea. Although prophylactic antiemetics are often given to patients who are receiving single-fraction, high-dose radiotherapy to the abdomen, a survey has revealed that antiemetic prophylaxis is not routinely offered to those receiving fractionated radiotherapy. Hence there is a need for an effective treatment of emesis for use in this group of patients. Ondansetron is an effective and well-tolerated antiemetic, which is used for the prevention of both chemotherapy and radiotherapy-induced emesis and nausea. This agent has been developed as a novel freeze-dried oral formulation. Ondansetron orally disintegrating tablets (ondODT) disperse rapidly when placed on the tongue. As the tablet does not need to be swallowed with water, it is a particularly useful formulation for patients who have difficulty with swallowing or who do not feel able to drink. This study was undertaken to investigate the efficacy of ondODT in the treatment of established emesis and nausea induced by radiotherapy. Two doses of ondODT, 8 mg and 16 mg, were compared with placebo in patients who developed emesis and/or moderate/severe nausea after receiving fractionated radiotherapy to sites located between the thorax and the pelvis. The study showed that ondODT was clinically superior to placebo in treating emesis and nausea successfully over a 12-hour period after taking the medication. There were no statistically significant differences between the two doses of ondODT. In the 2 hours after taking the study medication, patients who received ondODT (8 mg and 16 mg) had significantly fewer emetic episodes compared with those who received placebo. They also experienced significantly less nausea. In conclusion, ondODT 8 mg is effective in the treatment of radiotherapy-induced emesis and nausea and provides an effective alternative to the conventional ondansetron tablet.     

雷莫司琼治疗恶性肿瘤化疗所致胃肠道反应的随机对照研究

目的观察雷莫司琼治疗恶性肿瘤化疗所致的食欲不振、恶心、呕吐等胃肠道反应的疗效和安全性.方法60例恶性肿瘤患者,采用随机交叉对照的方法,间隔3～4周的两次相同方案的化疗前30 min静脉注射雷莫司琼0.3 mg或昂丹司琼8 mg,观察化疗后3 d内食欲、恶心、呕吐情况,以及其引起的不良反应,比较两种止吐药的疗效.结果化疗后0～6 h雷莫司琼对胃肠道反应的完全控制率为70.0%,与昂丹司琼56.7%的控制率差别无统计学意义(P＞0.05);6～48 h间雷莫司琼完全控制率53.3%～56.7%,高于昂丹司琼30.0%～38.3%的控制率(P＜0.05).120例次的化疗中共出现便秘28例次(23.3%),肝功能异常13例次(10.8%),头痛9例次(6.7%),颜面潮红、发热感4例次(3.3%),无其他严重不良反应发生,均未中止治疗.结论与昂丹司琼相比,雷莫司琼是高效率、作用时间持久、安全性高的止吐药.     

伊立替康联合顺铂方案治疗复发性晚期小细胞肺癌23例临床观察

Objective:To evaluate the efficacy and safety of the irinotecan and cisplatin combination in relapsed advanced small cell lung cancer (SCLC).Methods:Eligible patients with SCLC who had progressed or relapsed after therapy were treated with cisplatin and irinotecan.The regimen consisted of irinotecan 60 mg/m2 on days 1,8,15 and cisplatin 60 mg/m2 on day 1;the plan was given every 28 days.Results:In 23 evaluable patients,responses included 5 complete remissions and 7 partial remissions (overall response rate,43.4%),6 patients had stable disease and 7 had progressive disease.Median time to progression and median survival were 4.6 and 8.3 months.The main toxicities were the hematologic toxicity,nausea and vomiting.Grade Ⅲ,Ⅳ leukopenia were seen in 15 patients (65.2%),thrombocytopenia was seen in 8 patients (34.8%);Nausea and vomiting were seen in 19 patients (82.6%);Grade Ⅲ,Ⅳ nausea and vomiting were seen in 4 patients (65.2%)and diarrhea was seen in 20 patients (87.0%).There were no treatment-related deaths.Conclusion:The combination of irinotecan and cisplatin is highly active and tolerable in patients with relapsed SCLC when it is administered as second-line treatment.