Method of treating post operative nausea and vomiting

A postoperative, surgical technique applied in the field of postoperative nausea and vomiting and general vomiting, which can solve problems such as unsatisfactory prescription needs, expensive receptor competitive antagonists, and increased burden on the health care system

Inactive Publication Date: 2006-03-22
HELSINN HEALTHCARE SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] 5-HT 3 Receptor competitive antagonists are currently very expensive
As such, they do not meet prescription needs and these agents increase the burden on the health care system
[0016] One of the biggest challenges when it comes to drug dosing is finding a dose that is well tolerated and consistently effective

Method used

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  • Method of treating post operative nausea and vomiting

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0074] Example 1 : Prophylaxis of PONV with a single intravenous dose of palonosetron

[0075] A study aimed to test the efficacy and safety of 5 doses of palonosetron administered intravenously in preventing postoperative vomiting and nausea. A total of 381 women, aged 24-80 years, scheduled for abdominal or vaginal hysterectomy, were enrolled in the study with ASA physical fitness index I or II. All patients received balanced general anesthesia including N 2 O plus one opiate. The study drug, palonosetron, was administered over 30 seconds through the peripheral IV line at the time of the final skin closure during the surgical procedure.

[0076] placebo

0

(n=62)

0.1

μg / kg

(n=47)

0.3

μg / kg

(n=67)

1

μg / kg

(n=62)

3

μg / kg

(n=67)

30

μg / kg

(n=67)

with CR% *

p.value a

19％

-

34%

N / A b

34％

0.051

44％

0.004

30％

0.174

45％ ...

Embodiment 2

[0091] Example 2. Oral Palonosetron for PONV

[0092] The study was conducted to test the efficacy, safety and pharmacokinetics of 5 doses of palonosetron administered orally in the prevention of postoperative emesis and nausea. A total of 351 patients (308 women, 43 men) aged 19-75 were scheduled to undergo elective laparoscopy, and patients with ASA physical fitness index I and II were selected to participate in the study. All of the above patients received balanced general anesthesia including N 2 O plus one opiate.

[0093] The dose of palonosetron was determined by the patient's body weight at the time of screening diagnosis, rounded to the nearest kilogram. Dilute each dose to 25ml by adding sterile water to the measuring cup, then rinse the measuring cup with 25ml of sterile water, and the rinsed liquid is also given to the patient. Study drug was administered 2 hours before anesthesia for surgical procedures requiring nasogastric aspiration and 1 hour before anest...

Embodiment 3

[0107] Example 3. Dosage Forms for Intravenous Administration

[0108] Table 8: Representative IV Dosage Forms

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Abstract

Methods are provided to treat post-operative nausea and vomiting, as well as emesis generally, with 5-HT3 receptor antagonists. In particular, the invention discloses methods for reducing post-operative nausea and vomiting and other emetic events with palonosetron.

Description

technical field [0001] The present invention discloses the use of 5-HT 3 Methods of receptor antagonists for the treatment of postoperative nausea and vomiting and general vomiting. In particular, the present invention discloses methods of using palonosetron to relieve postoperative nausea and vomiting and other emesis-provoking events. Background technique [0002] Postoperative nausea and vomiting (PONV) is the most common sequelae of many anesthesia and surgical procedures. PONV can cause serious side effects such as dehydration, electrolyte imbalance, gastric hernia, wound rupture, esophageal tear, and muscle fatigue. In addition to medical complications, PONV can cause patient anxiety about further surgery. Due to delayed recovery and hospital discharge, as well as increased medical care, PONV adds significant costs to an already overburdened health care system. [0003] Typically, PONV occurs within 24 hours of surgery. At least 25-40% of surgical patients have PO...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4748A61P1/08
CPCA61K31/4745A61K31/4748A61P1/00A61P1/08A61P25/00
Inventor 路易吉·巴罗尼阿尔贝托·马乔基恩里科·布拉格里亚里卡尔多·布拉格里亚
Owner HELSINN HEALTHCARE SA
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