㈼−2- 11
急性期治療において制吐薬の使用は有用か

 

1) Ellis GL, Delaney J, DeHart DA, Owens A. The efficacy of
　 metoclopramide in the treatment of migraine headache . Ann Emerg
　 Med. 1993 Feb;22(2):191-5.
論文抄録
STUDY OBJECTIVES: By evaluating the efficacy of metoclopramide alone and in combination with ibuprofen versus placebos, this study was designed to both evaluate the efficacy of metoclopramide and elucidate its mechanism of action in the treatment of migraine headache. DESIGN: The study was conducted over a two-year period and was a randomized, double-blind, placebo-controlled study. SETTING: An urban teaching hospital. PARTICIPANTS: Patients enrolled were at least 18 years old and had recurring headaches with one or more of the following characteristics: unilateral, preceded by neurologic symptoms, significant nausea and vomiting, or mood changes and photophobia. INTERVENTION: Ten milligrams of metoclopramide or an equal volume of IV normal saline was given and 600 mg of ibuprofen or identical-appearing placebo was given orally at time 0. Patients rated their pain and nausea at time 0, 30 minutes, and 60 minutes using visual-analog scales. RESULTS: The differences in pain and nausea scores for the metoclopramide + placebos group versus the other three groups were tested using exact nonparametric (Mann-Whitney) statistical procedures. The metoclopramide + placebos group had significantly better relief of pain compared with the placebos + ibuprofen and placebos + placebos groups. The metoclopramide + placebos group had significantly better relief of nausea than the ibuprofen + placebos group; nausea scores for the placebos + placebos group could not be analyzed due to excessive variance from the other groups at baseline. The differences between the metoclopramide + placebos group and the metoclopramide + ibuprofen group were not statistically significant with regard to either pain or nausea. CONCLUSION: Metoclopramide is efficacious in the treatment of both the pain and nausea of migraine headache. This is a direct action that is not dependent on the concomitant administration of another agent.
文献 PubMed−ID

PMID: 8427430

エビデンスレベル

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文献タイトル (日本語)

片頭痛治療におけるメトクロプラミドの効果

目的
制吐剤メトクロプラミド単独と鎮痛剤 イブプロフェンとの合剤の片頭痛治療効果を評価
研究デザイン
a randomized, double-blind, placebo-controlled study
研究施設
An urban teaching hospital
研究期間
２年間
対象患者
18 歳以上の片頭痛患者 40 人．
介入
片頭痛急性期に
Group1 メトクロプラミド 10mg 静注 + イブプロフェン 600 ｍｇ内服
Group2 メトクロプラミド 10mg 静注 + プラセボ内服
Group3 プラセボ静注 + イブプロフェン 600 ｍｇ内服
Group4 プラセボ静注 + プラセボ内服
主要評価項目とそれに用いた
統計学的手法
頭痛の程度，嘔気を投与時・ 30 分後・ 60 分後に記録
結果

頭痛の程度・嘔気とも Group2 （メトクロプラミド + プラセボ）は Group3 （プラセボ + イブプロフェン）， Group4 （プラセボ + プラセボ）よりも有意に改善した． Group3 （プラセボ + イブプロフェン）とは効果に差がみられなかった．
結論
メトクロプラミド 10mg 静注単独投与は片頭痛の程度・嘔気双方に有効であった．
備考
 Publication Types:
・ Clinical Trial
・Randomized Controlled Trial

MeSH Terms:
・Adolescent
・Adult
・Comparative Study
・Double-Blind Method
・Drug Synergism
・Drug Therapy, Combination
・Humans
・Ibuprofen/therapeutic use*
・Metoclopramide/therapeutic use*
・Migraine/drug therapy*
・Treatment Outcome

Substances:
・Ibuprofen
・Metoclopramide

作成者
井尻珠美

 

2) Jones EB, Gonzalez ER, Boggs JG, Grillo JA, Elswick RK Jr. Safety
　 and efficacy of rectal prochlorperazine for the treatment of migraine
　 in the emergency department. Ann Emerg Med. 1994 Aug;24(2):237-
　 41.

論文抄録
STUDY OBJECTIVE: To assess the safety and efficacy of rectal prochlorperazine in the treatment of acute migraines. DESIGN: Randomized, double-blinded, placebo-controlled study. SETTING: Emergency department of an inner-city university hospital. PARTICIPANTS: ED patients with documented diagnosis of migraines. INTERVENTIONS: Vital signs and level of alertness were monitored immediately before drug administration and 120 minutes after dosing. Pain intensity and adverse events were monitored immediately before drug administration and at 30, 60, and 120 minutes after dosing. RESULTS: A positive outcome was defined as a pain score less than or equal to 5 on a 10-point scale or a 50% reduction in pain intensity from baseline at 120 minutes after dosing. All patients treated with prochlorperazine suppositories experienced a positive treatment outcome; only 50% of patients treated with placebo experienced a positive result at 120 minutes after dosing (P = .016). Pain intensity scores were significantly lower in the prochlorperazine group at 120 minutes (P = .018). There were no adverse reactions in either group, and there were no significant differences in vital signs or levels of alertness between groups. Patients who failed therapy were given rescue medication 120 minutes after dosing. CONCLUSION: Prochlorperazine administered as a 25-mg rectal suppository provides excellent pain relief within 2 hours in patients with acute migraines.  

文献 PubMed−ID

PMID: 8037389

エビデンスレベル

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文献タイトル (日本語)

救急外来における片頭痛治療でのプロクロルペラジン経直腸投与の安全性と有効性

目的

制吐剤 プロクロルペラジン座薬の片頭痛急性期治療の効果と安全性を評価する．

研究デザイン

Randomized, double-blinded, placebo-controlled study

研究施設

Emergency department of an inner-city university hospital

対象患者

17 歳以上の片頭痛患者 20 人．

介入

片頭痛急性期に プロクロルペラジン座薬 25 ｍｇもしくはプラセボを投与

主要評価項目とそれに用いた統計学的手法

頭痛の程度，副作用を投与直後， 30 分後， 60 分後， 120 分後に記録， 120 分後の頭痛の程度が投与前より半減したものを有効とした．

結果

頭痛改善はプロクロルペラジン投与群は 100 ％，プラセボ群は 50 ％であった．プラセボ群と比較して有意に改善がみられた（ p=0.018 ）．
有害事象はみられなかった．

結論

プロクロルペラジン座薬は片頭痛急性期治療薬として有効でありかつ安全であった．

備考
Publication Types:
・Clinical Trial
・Randomized Controlled Trial

MeSH Terms:
・Acute Disease
・Administration, Rectal
・Adult
・Double-Blind Method
・Emergency Service, Hospital
・Female
・Humans
・Male
・Migraine/drug therapy*
・Pain Measurement
・Pilot Projects
・Prochlorperazine/therapeutic use*
・Research Support, Non-U.S. Gov't
・Treatment Outcome

Substances:
・Prochlorperazine  

作成者

井尻珠美

 

3) Tfelt-Hansen P, Olesen J, Aebelholt-Krabbe A, Melgaard B, Veilis B.
　 J Neurol Neurosurg Psychiatry. 1980 Apr;43(4):369-71.

論文抄録

One hundred and fifty patients with migraine attacks attending the Copenhagen acute migraine clinic were treated either with metoclopramide 10 mg i.m. metoclopramide 20 mg as suppository or placebo in a double blind trial. All patients simultaneously or 30 minutes later received paracetamol 1 g and diazepam 5 mg orally. The nausea was relieved in 71% of the patients by placebo and bed rest, but metoclopramide was significantly (p = 0.04) more effective and relieved nausea in 86% of the patients. Metoclopramide did not by itself reduce the pain, but enhanced the effect of the analgesic or sedative medication. This effect, however, just failed to be statistically significant (p = 0.06).  

文献 PubMed−ID

PMID: 7373338

エビデンスレベル

Ib

文献タイトル (日本語)

片頭痛発作治療におけるメトクロプラミド二重盲検法

目的

制吐剤 メトクロプラミド筋注が片頭痛急性期に有効かどうかを決定すること ．

研究デザイン

a randomized double-blind trial

研究施設

Copenhagen acute migraine clinic

対象患者

18 歳〜 74 歳（平均年齢 40.5 歳）の片頭痛患者 150 人．

介入

片頭痛急性期に
・メトクロプラミド 10mg 筋注 + プラセボ座薬
・プラセボ筋注 + メトクロプラミド 20mg 座薬
・プラセボ筋注 + プラセボ座薬　　　　　　　にて投与
その後全員がパラセタモル 1g とジアゼパム 5mg を内服

主要評価項目とそれに用いた統計学的手法

嘔気 ,頭痛の程度
統計学的計算にはメトクロプラミドの 2群をまとめて算出．

結果

メトクロプラミド投与群はプラセボよりも有意に悪心を改善（ p=0.04）．
メトクロプラミド単独では痛みの程度はプラセボと有意差はなかったが,鎮痛剤・鎮静剤の効果を高めている可能性がある(p=0.06)．

結論

メトクロプラミド筋注単独では 頭痛の改善はプラセボと差がなかったが，悪心を有意に改善した．

備考
MeSH Terms:
・Acetaminophen/therapeutic use
・Adolescent
・Adult
・Aged
・Diazepam/therapeutic use
・Double-Blind Method
・Drug Therapy, Combination
・Female
・Humans
・Male
・Metoclopramide/therapeutic use*
・Middle Aged
・Migraine/drug therapy*
・Nausea/drug therapy

Substances:
・Acetaminophen
・Metoclopramide
・Diazepam  

作成者

井尻珠美

 

4) Amery WK, Waelkens J . Prevention of the last chance:
　 an alternative pharmacologic treatment of migraine. Headache 1983;
　 23: 37 -8

論文抄録

The hypothesis that in migraine, cyclically, an internal environment is established which - beyond a certain point-of-no-return ? gives rise to the characteristic attacks in patients who experience “warning”symptoms several hours before the actual attack. To interfere with the typical vegetative disregulation during the attack the selective dopamine receptor blocker domperidone was used. In a double-blind cross-over study 30 mg domperidne, taken at the very first appearance of the warning signals, was clearly superior (p<0.001) to placebo in preventing attacks: the success rates were 66% and 5% respectively.
 

文献 PubMed−ID

PMID: 6337976

エビデンスレベル

㈼ a

文献タイトル (日本語)

最後の予防療法：片頭痛の代替薬理学的治療

目的

選択的ドパミン受容体拮抗薬ドンペリドンが片頭痛予兆時の内服で片頭痛予防が可能かどうか決定すること．

研究デザイン

A double-blind placebo-controlled cross-over study

対象患者

11 歳〜 64 歳 ( 平均年齢 34 歳 ) の予兆を有する前兆のある片頭痛患者 19 人．

介入

4 回の片頭痛発作のうち，ドンペリドン 30mg もしくはプラセボを予兆時に 2 回ずつ内服．

主要評価項目とそれに用いた統計学的手法

内服後に前兆・頭痛が出現するかどうか

結果

前兆・頭痛とも出現しなかったものはドンペリドン内服は 25人（66％），プラセボは2人（5％）であった．
ドンペリドン内服はプラセボより有意に改善がみられた (p<0.001)．
有害事象はみられなかった．

結論

制吐剤ドンペリドンは発作前に内服することにより頭痛発作を抑制することが可能であった．

備考

Publication Types:
・Clinical Trial


MeSH Terms:
・Adolescent
・Adult
・Child
・Clinical Trials
・Domperidone/therapeutic use*
・Double-Blind Method
・Female
・Human
・Male
・Middle Aged
・Migraine/prevention & control*
・Random Allocation

Substances:
・Domperidone 

作成者

井尻珠美

 

5) Coppola M, Yealy DM, Leibold RA . Randomized, placebo-controlled
　 evaluation of prochlorperazine versus metoclopramide for emergency
　 department treatment of migraine headache. Ann.Emerg.Med. 1995;
　 26: 541-6

論文抄録

STUDY OBJECTIVE: To determine the comparative efficacy of i.v. metoclopramide and prochlorperazine for the initial emergency department treatment of migraine headache. DESIGN: Prospective, randomized, double-blind, placebo-controlled trial. SETTING: Military community hospital ED with an annual census of 75,000. PARTICIPANTS: Seventy consenting adults from a convenience sample of patients presenting with migraine headache similar to that experienced in at least one prior episode. Exclusion criteria were pregnancy, fever, signs of meningismus, altered sensorium, drug or alcohol use, oxygen saturation less than 90%, recent trauma or seizure, "worst headache," abnormal blood pressure, recent (within 48 hours) use of metoclopramide or prochlorperazine, and allergy to metoclopramide or prochlorperazine. INTERVENTIONS: In a random manner, each subject received a 2-mL i.v. injection of identical-appearing fluid containing metoclopramide (10 mg), prochlorperazine (10 mg), or saline solution (placebo). No other analgesics or medications were administered during the initial study period; rescue agents were administered by the choice of the treating physician after all data were collected. MEASUREMENTS: Patients scored their nausea, pain, and sedation before receiving the 2-mL injections and at 30 minutes after injection. Ten-centimeter nonhatched visual analog scales were used for these measurements, with distance from the left end (zero) calculated for each use. Clinically important successful treatment was defined a priori as achievement of the following criteria: patient satisfaction and either a decrease of 50% or more in the 30-minute pain score (compared with the initial score) or an absolute pain score of 2.5 cm or less. Failure to achieve these criteria constituted treatment failure. Differences between groups were analyzed with the Kruskal-Wallis ANOVA and chi 2 tests. Data are reported as frequency percentages and median values, with a two-tailed P value of .05 or less considered significant. RESULTS: Nausea, pain, and sedation scores were similar in all three groups before therapy. Thirty minutes after treatment, pain scores differed among those treated with prochlorperazine (1.1 cm), with metoclopramide (3.9 cm), and with placebo (6.1 cm, P = .003). Clinical success occurred more commonly after treatment with prochlorperazine (82%) than after metoclopramide (46%) or placebo (29%, P = .03). However, metoclopramide and placebo scores did not differ (P = .14). Nausea tended to be improved after prochlorperazine, compared with metoclopramide or placebo, at 30 minutes (P = .64). Four patients (6%) returned to the ED for relapse of migraine headache within 24 hours (three in the placebo group and one in the metoclopramide group). CONCLUSION: i.v. prochlorperazine relieves the headache and tends to improve nausea better than metoclopramide in ED patients with acute migraine headache
 

文献 PubMed−ID

PMID: 7486359

エビデンスレベル

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文献タイトル (日本語)

片頭痛の救急診療におけるプロクロルペラジンとメトクロプロマイドの無作為プラセボ対照評価

目的

制吐剤プロクロペラジンとメトクロプロマイドが片頭痛頓挫薬として効果的かどうか決定すること．

研究デザイン

無作為プラセボ対照試験（ Randomized, placebo-controlled evaluation ）

対象患者

成人片頭痛患者 70人

介入

プロクロペラジン 10mg or メトクロプロマイド 10mg or プラセボ（生理食塩水）を片頭痛急性期に静注，30分後に悪心，頭痛の程度，鎮静効果などを評価．

主要評価項目とそれに用いた統計学的手法

痛みの程度，悪心，鎮静効果

結果

臨床症状の改善率は メトクロプロマイド 46%，プラセボ29%，プロクロルペラジン82%であり，プロクロルペラジンが最も有効であった．悪心も同様の結果であった．

結論

片頭痛急性期においてプロクロペラジンはメトクロプロマイドよりも頭痛を改善し悪心を軽減する傾向にあった．

備考

Publication Types:
・Clinical Trial
・Randomized Controlled Trial

MeSH Terms:
・Adolescent
・Adult
・Aged
・Analysis of Variance
・Comparative Study
・Dopamine Antagonists/therapeutic use*
・Double-Blind Method
・Emergency Service, Hospital
・Human
・Injections, Intravenous
・Metoclopramide/therapeutic use*
・Middle Aged
・Migraine/drug therapy*
・Pain Measurement
・Patient Satisfaction
・Prochlorperazine/therapeutic use*
・Prospective Studies
・Treatment Outcome

Substances:
・Dopamine Antagonists
・Metoclopramide
・Prochlorperazine  

作成者

井尻珠美，竹島多賀夫

 

6) Cameron JD, Lane PL, Speechley M . Intravenous chlorpromazine vs
　 intravenous metoclopramide in acute migraine headache.
　 Acad.Emerg.Med. 1995; 2: 597-602

論文抄録

OBJECTIVE: To compare the efficacy of IV chlorpromazine with that of IV metoclopramide in the treatment for acute migraine headache in the ED. METHODS: A prospective randomized double-blind trial was undertaken at two university-affiliated urban EDs with a combined annual census of more than 85,000 patients. Included in the study were patients presenting to the ED with a diagnosis of migraine headache. The subjects were randomized to receive 0.1 mg/kg/dose IV of either chlorpromazine (CPZ) or metoclopramide (MC), up to a total of three doses. RESULTS: Ninety-one patients completed the protocol; 44 received MC and 47 received CPZ. The demographics of the two groups were similar. Both drugs provided, for the majority of patients, adequate pain relief as measured on a visual analog scale (VAS) completed every 15 minutes from T = 0 minutes to T = 45 minutes. The average pain relief over 45 minutes (delta VAS) for CPZ was 4.87 cm, vs 4.34 cm for MC (p = 0.35). There also was no statistically significant difference in blood pressure (BP) changes (delta BP < 2 mm Hg for both systolic and diastolic BPs, p = 0.47 and 0.33) or numbers of patients reporting adverse effects (AEs) (CPZ: 16 of 35; MC: 13 of 29, p = 0.43). There was no severe AE with either study drug. CONCLUSIONS: Metoclopramide and chlorpromazine administered IV are both effective in the management of acute migraine headache. They are associated with similar minor side-effect profiles  

文献 PubMed−ID

PMID: 8521205

エビデンスレベル

Ib

文献タイトル (日本語)

片頭痛急性期におけるクロルプロマジン静注対メトクロプロマイド静注

目的

制吐剤クロルプロマジンとメトクロプロマイドの経静脈投与のどちらがが片頭痛頓挫薬として効果的かどうか決定し，副作用を評価すること．

研究デザイン

前向き無作為二重盲検試験（ prospective randomized double-blind trial ）

研究施設

St. Joseph 's Health Center ， Victoria Hospital in London ， Ontario

研究期間

1990 年から 1992 年（ over a 2.5 years from 1990 to 1992 ）

対象患者

18 歳〜 59 歳の片頭痛急性期患者 91 人．

介入

まず生理食塩水 5ml/kg を静注後，患者を 2 群に分ける．
47 人にクロルプロマジン 0.1ml/kg ， 44 人にメトクロプロマイド 0.1ml/kg 静注後，　 15 分おきにＶＡＳにて効果を評価　副作用を確認．
必要なら頓挫薬を追加．
その後電話にて 48 時間以内の副作用，頭痛再発の有無を調査．

主要評価項目とそれに用いた統計学的手法

群間の VAS score や血圧の検討； Unpaired t-test
治療前後の VAS の差の検討； 95 ％ CI

結果

クロルプロマジン投与群は 79 ％，メトクロプロマイド投与群は 66 ％で 70 ％以上の頭痛改善を認めた．またクロルプロマジン投与群は 53 ％，メトクロプロマイド投与群 52 ％で 90 ％以上の頭痛改善を認めた．
副作用は重篤なものはなし．

結論

静注ではメトクロプロマイドとクロルプロマジンはほぼ同等の有効性であった．重篤な副作用はみられず，安全な薬剤と考えられた．

コメント

比較試験の追試が必要．

備考

Publication Types:
・Clinical Trial
・Multicenter Study
・Randomized Controlled Trial


MeSH Terms:
・Acute Disease
・Adolescent
・Adult
・Aged
・Chlorpromazine/administration & dosage
・Chlorpromazine/adverse effects
・Chlorpromazine/therapeutic use*
・Comparative Study
・Dopamine Antagonists/administration & dosage
・Dopamine Antagonists/adverse effects
・Dopamine Antagonists/therapeutic use*
・Double-Blind Method
・Emergency Service, Hospital
・Female
・Human
・Injections, Intravenous
・Male
・Metoclopramide/administration & dosage
・Metoclopramide/adverse effects
・Metoclopramide/therapeutic use*
・Middle Aged
・Migraine/drug therapy*
・Prospective Studies
・Support, Non-U.S. Gov't
・Treatment Outcome

Substances:
・Dopamine Antagonists
・Metoclopramide
・Chlorpromazine  

作成者

井尻珠美，竹島多賀夫

 

7) Jones J, Pack S, Chun E . Intramuscular prochlorperazine versus
　 metoclopramide as single-agent therapy for the treatment of acute
　 migraine headache. Am.J.Emerg.Med. 1996; 14: 262-4

論文抄録

To compare the efficacy of intramuscular prochlorperazine and metoclopramide in the short-term treatment of migraine headache in the emergency department 86 eligible adult patients with moderate to severe migraine headache were evaluated prospectively at a university-affiliated community hospital. After randomization, each subject received a 2-mL intramuscular injection of sterile saline, prochlorperazine (10 mg), or metoclopramide (10 mg). No other analgesics were administered during the 60-minute study period; patient assessment of relief was followed using visual analog scales. Reduction in median headache scores was significantly better among those treated with prochlorperazine (67%) compared to metoclopramide (34%) or placebo (16%). Similarly, symptoms of nausea and vomiting were significantly relieved in the prochlorperazine group (chi 2 = 17.1, P < .001). However, rescue analgesic therapy was necessary in the majority of patients treated with prochlorperazine (16/28) and metoclopramide (23/29) after the 60-minute study period. Although intramuscular prochlorperazine appears to provides more effective relief than metoclopramide, these results do not recommend either drug as single-agent therapy for acute migraine headache  

文献 PubMed−ID

PMID: 8639197

エビデンスレベル

Ib

文献タイトル (日本語)

片頭痛急性期における単剤治療としてのプロクロルペラジン筋注とメトクロプロマイド筋注

目的

制吐剤プロクロルペラジンとメトクロプロマイド筋注のどちらが 片頭痛頓挫薬として効果的かどうか決定すること．

研究デザイン

Randomized Controlled Trial

研究期間

1991年2月〜1991年6月の6ヶ月間

対象患者

16 歳〜 60 歳の成人片頭痛患者 86 人．

介入

片頭痛急性期に プロクロルペラジン 10mg またはメトクロプロマイド 10mg またはプラセボ（生理食塩水）を筋注．
投与後 60 分間は他の鎮痛剤は使用しない．

主要評価項目とそれに用いた統計学的手法

VAS

結果

頭痛改善率は メトクロプロマイド 34% ，プラセボ 16% ，プロクロルペラジン 67% であり，プロクロルペラジンが有意に高率であった（ P < .001 ） ．また悪心・嘔吐の改善率も同様にプロクロルペラジンが有意に高率であった（ P < .001 ） ．しかし制吐剤以外の頓挫薬が大多数で必要であった．

結論

メトクロプロマイドよりもプロクロルペラジのほうが頭痛・悪心により有効であったが，制吐剤単独投与では痛みに対する効果が不十分であった．

備考

Publication Types:
・Clinical Trial
・Randomized Controlled Trial

MeSH Terms:
・Acute Disease
・Adult
・Analgesics, Opioid/therapeutic use
・Antiemetics/therapeutic use*
・Comparative Study
・Double-Blind Method
・Emergency Service, Hospital
・Female
・Human
・Injections, Intramuscular
・Male
・Metoclopramide/therapeutic use*
・Migraine/drug therapy*
・Pain Measurement
・Prochlorperazine/therapeutic use*
・Prospective Studies

Substances:
・Analgesics, Opioid
・Antiemetics
・Metoclopramide
Prochlorperazine  

作成者

井尻珠美，竹島多賀夫

 

8) Schulman E.A. and Dermott K.F. Sumatriptan plus metoclopramide in
　 triptan-nonresponsive migraineurs. Headache 2003;43: 729-733.

論文抄録

OBJECTIVES: We evaluated the effectiveness of combination treatment using sumatriptan plus metoclopramide versus sumatriptan alone for the treatment of acute migraine. The patients who were treated had failed to respond to triptans in the past despite adequate doses on at least 2 separate trials of the same triptan or 2 trials involving different triptans. BACKGROUND: There is limited evidence that dopaminergic antagonists may benefit the migraineur by relieving migraine pain and associated symptoms. The exact mechanism of action in migraine is unknown. The postulated action is the inhibition of dopaminergic overactivity. A dopaminergic antagonist, metoclopramide, may improve the efficacy of a 5-HT1B/1D agonist, sumatriptan. METHODS: In this double-blind, randomized, crossover study, 16 adult migraineurs fulfilling International Headache Society (IHS) criteria for migraine with or without aura who had failed to receive adequate relief from triptans treated one migraine with each treatment: sumatriptan 50 mg plus metoclopramide 10 mg or sumatriptan 50 mg plus placebo to match metoclopramide. Patients treated their migraines when they were moderate or severe in intensity and recorded pain severity and symptoms prior to treatment and 30, 60, 90, and 120 minutes and 24 hours after treatment. RESULTS: Thirteen women and 3 men (mean age, 40 years) completed the study; ie, treated 2 migraines (a total of 32 migraines), one attack with each treatment. Meaningful relief was attained in 10 (63%) of 16 migraines treated with the combination of sumatriptan 50 mg plus metoclopramide 10 mg compared with 5 (31%) of 16 migraines treated with sumatriptan 50 mg plus placebo. Headache response (moderate or severe to mild or no pain at 2 hours) was achieved in 7 (44%) of 16 migraines with the combination of sumatriptan 50 mg plus metoclopramide 10 mg compared with 5 (31%) of 16 migraines treated with sumatriptan 50 mg plus placebo. There did not appear to be a difference between treatment groups with respect to associated symptoms. The combination of sumatriptan 50 mg plus metoclopramide 10 mg was well tolerated. CONCLUSIONS: Combining sumatriptan with metoclopramide provided relief in some migraineurs who failed to achieve adequate relief with a triptan alone. It remains unknown whether initiating therapy when pain was mild or using a higher dose of sumatriptan (ie, 100 mg) would have provided additional benefit. Further studies are indicated  

文献 PubMed−ID

PMID: 12890127

エビデンスレベル

Ib

文献タイトル (日本語)

トリプタンノンレスポンダー片頭痛患者におけるスマトリプタン＋メトクロプロマイド

目的

トリプタンノンレスポンダーの片頭痛患者において制吐剤メトクロプロマイド追加が片頭痛頓挫薬として効果的かどうか決定すること．

研究デザイン

無作為二重盲検交差試験（ double-blind, randomized, crossover study ）

対象患者

国際頭痛学会の診断基準を満たす片頭痛患者 16人（平均年齢40歳） ．

介入

スマトリプタン 50mg 単独で治療効果が不十分であった片頭痛患者にメトクロプロマイド 10mg 又はプラセボを加えそれぞれ一度ずつ中等度‐重度片頭痛発作時に内服し，頭痛の程度を 治療後 30 ， 60 ， 90 ， 120 分， 24 時間に記録し 内服前 と比較した．

主要評価項目とそれに用いた統計学的手法

頭痛の程度

結果

メトクロプロマイド 併用では 16 人中 10 人 (63 ％ ) に頭痛改善がみられたが，プラセボでは 5 人 (31 ％ ) に過ぎなかった．
副作用はプラセボと差はなかった．

結論

スマトリプタンノンレスポンダーにおいて，スマトリプタンにメトクロプロマイド 10mgを併用することは有効な片頭痛急性期治療と考えられる．

コメント

対象を増やして追試が必要．

備考
Publication Types:
・Clinical Trial
・Randomized Controlled Trial

MeSH Terms:
・Adult
・Antiemetics/therapeutic use*
・Comparative Study
・Double-Blind Method
・Drug Combinations
・Female
・Human
・Male
・Metoclopramide/therapeutic use*
・Middle Aged
・Migraine/drug therapy*
・Pilot Projects
・Serotonin Agonists/therapeutic use*
・Sumatriptan/therapeutic use*
・Support, Non-U.S. Gov't
・Treatment Failure
・Treatment Outcome

Substances:
・Antiemetics
・Drug Combinations
・Serotonin Agonists
・Sumatriptan
・Metoclopramide  

作成者

井尻珠美，竹島多賀夫

 

9) Klapper JA, Stanton J . Current emergency treatment of severe
　 migraine headaches. Headache 1993; 33: 560-2

論文抄録

OBJECTIVE: To compare the efficacy of the combination of meperidine and hydroxyzine IM, versus dihydroergotamine and metoclopramide IV in the treatment of severe migraine headaches. DESIGN: This was a randomized double-blind, double-dummy study. SETTING: Established patients, whose headache had failed to respond to their usual abortive agent, were invited to an out-patient headache clinic for the study. PATIENTS: Twenty-eight patients, diagnosed as suffering from either migraine headache or chronic daily headache, were screened on arrival to exclude life-threatening causes. INTERVENTION: Group A (14 patients) received dihydroergotamine 1mg and metoclopramide 10mg IV and a placebo injection IM, and Group B (14 patients) received meperidine 75mg and hydroxyzine 75mg IM and a placebo injection IV. MAIN OUTCOME MEASURES: Patients rated their headaches on a scale of 0-3 prior to treatment and again at 30 and 60 minutes. RESULTS: Both groups experienced improvement in headache severity. (Group A P = 0.001 and Group B P = 0.003). Improvement in pain scale score was greater for Group A than Group B. (P = 0.006). The number of patients having a mild or no headache in Group A (13/14) was significantly greater than Group B (3/14). (P < 0.001) CONCLUSIONS: The combination of dihydroergotamine and metoclopramide IV should replace the standard IM narcotic and anti-emetic as the parenteral treatment of choice for severe migraine headache  

文献 PubMed−ID

PMID: 8294195

エビデンスレベル

Ib

文献タイトル (日本語)

重症片頭痛発作の最新救急治療

目的

制吐剤メトクロプロマイド静注とジヒドロエルゴタミン静注の併用療法がメペリジンとヒドロキシジン筋注の併用療法と比較し，片頭痛頓挫薬として効果的かどうか決定すること．

研究デザイン

無作為二重盲検二重ダミー試験（ randomized double-blind, double-dummy study ）

対象患者

今までの頭痛治療がうまくいかなかった重症片頭痛患者 28 人．

介入

Group A(14 人 ) ジヒドロエルゴタミン 1.0mg + メトクロプラミド 10mg 静注とプラセボ筋注
Group B(14 人 ) 　メペリジン 75mg + ヒドロキシジン 75mg 筋注とプラセボ静注

主要評価項目とそれに用いた統計学的手法

治療前と治療 30 分後， 1 時間後の頭痛の程度をスケールで記録

結果

両群で治療後有意に症状改善あり（ Group A P=0.001, Group B P=0.003 ） ．頭痛程度のスコアは Group B に比べ Group A で改善．頭痛消失人数も Group B (3/14) に比べ Group A(13/14) で有意に多かった（ P<0.001 ）．

結論

ジヒドロエルゴタミンとメトクロプラミド静注療法は片頭痛頓挫薬として有効であった．

備考

Publication Types:
・Clinical Trial
・Randomized Controlled Trial

MeSH Terms:
・Dihydroergotamine/administration & dosage
・Dihydroergotamine/therapeutic use
・Double-Blind Method
・Drug Therapy, Combination
・Emergencies
・Human
・Hydroxyzine/administration & dosage
・Hydroxyzine/therapeutic use
・Injections, Intramuscular
・Injections, Intravenous
・Meperidine/administration & dosage
・Meperidine/therapeutic use
・Metoclopramide/administration & dosage
・Metoclopramide/therapeutic use
・Migraine/drug therapy*
・Pain Measurement
・Support, Non-U.S. Gov't

Substances:
・Metoclopramide
・Dihydroergotamine
・Meperidine
・Hydroxyzine  

作成者

井尻珠美

 

10) MacGregor EA, Wilkinson M, Bancroft K . Domperidone plus
　paracetamol in the treatment of migraine. Cephalalgia 1993; 13: 124-
　7

論文抄録

This study was designed to evaluate the safety and efficacy of domperidone in combination with paracetamol in the treatment of migraine. Severity of headache, duration of migraine attack and overall efficacy of treatment were amongst the variables assessed in a randomized, double-blind, three-way cross-over comparison of 1 g paracetamol plus either domperidone 30 mg, domperidone 20 mg or placebo, taken at onset of headache. Forty-six patients attending the City of London Migraine Clinic completed the study. A significant difference was observed in the duration of the migraine attack: a median of 17.5 h with paracetamol alone was reduced to 12.0 h with the addition of domperidone 20 mg, and to 12.0 h with domperidone 30 mg. No significant adverse events were reported. A reduction in pain intensity and nausea was noted but this was not statistically significant. It was concluded that domperidone shortens the duration of a migraine attack and may help reduce headache and associated symptoms  

文献 PubMed−ID

PMID: 8495454

エビデンスレベル

Ib

文献タイトル (日本語)

片頭痛治療におけるドンペリドン＋ アセトアミノフェン

目的

制吐剤ドンペリドンと鎮痛剤 アセトアミノフェン の併用が片頭痛治療薬として効果的かつ安全かどうか決定すること．

研究デザイン

無作為二重盲検三元交差比較試験（ randomized, double-blind, three-way cross-over comparison ）

研究施設

ロンドン　片頭痛クリニック ( the City of London Migraine Clinic ）

対象患者

18 歳〜 70 歳の片頭痛患者 50 人．

介入

片頭痛急性期にアセトアミノフェン 1g にドンペリドン 30mg or ドンペリドン 20mg or プラセボを併用．

主要評価項目とそれに用いた統計学的手法

頭痛の程度，頭痛持続時間

結果

ドンペリドン併用にてプラセボ併用と比較し持続時間の有意な短縮がみられた ( ドンペリドン 30mg p=0.019 ，ドンペリドン 20mg p=0.001) ．
悪心の減少がみられたが有意ではなかった．
有害事象は 4 人のみにみられ，重篤なものはなかった．

結論

アセトアミノフェンにドンペリドンを併用することで片頭痛急性期の治療効果が上がると考えられた．

コメント

比較的うまくデザインされた中規模の RCT．
レポートの質は高い．

備考

Publication Types:
・Clinical Trial
・Randomized Controlled Trial

MeSH Terms:
・Acetaminophen/adverse effects
・Acetaminophen/therapeutic use*
・Adolescent
・Adult
・Aged
・Domperidone/adverse effects
・Domperidone/therapeutic use*
・Double-Blind Method
・Drug Combinations
・Female
・Gastrointestinal Diseases/etiology
・Human
・Male
・Middle Aged
・Migraine/complications
・Migraine/drug therapy*
・Nervous System Diseases/etiology
・Time Factors

Substances:
・Drug Combinations
・Acetaminophen
・Domperidone  

作成者

井尻珠美，竹島多賀夫