1) 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

Ib

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

2) 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

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

3) 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

Ib

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座薬の安全性と有効性

目的

メトクロプロマイド座薬が片頭痛頓挫薬として安全か，有効か否かを決定すること

研究デザイン

無作為二重盲検プラセボ対照試験（ Randomized, double-blind, placebo-controlled study ）

研究施設

Emergency department of an inner-city university hospital.

対象患者

救急外来を受診し片頭痛と診断した患者 20 例

介入

プロクロペラジン 25mg 座薬（ 10例）or プラセボ（10例）を片頭痛急性期に挿肛，30，60，120分後に頭痛の程度，鎮静効果，副作用などを評価．

主要評価項目とそれに用いた統計学的手法

プライマリーエンドポイントは 120 分後の 10 ポイント評価スケールにおける 5 ポイント以上の頭痛改善，あるいは 50 ％以上の頭痛強度の減弱

結果

プロクロペラジン座薬症例では，有意に片頭痛の改善を認めた．

結論

プロクロペラジン 25mg 座薬は， 2 時間以内の急性期片頭痛治療においてきわめて高い有効効果を示した．

備考

Publication Types:
* Clinical Trial
* Randomized Controlled Trial  

作成者

古和久典

4) Di Monda V, Nicolodi M, Aloisio A, Del Bianco P, Fonzari M, Grazioli
　 I, Uslenghi C, Vecchiet L, Sicuteri F.Efficacy of a fixed combination
　 of indomethacin, prochlorperazine, and caffeine versus sumatriptan
　 in acute treatment of multiple migraine attacks: a multicenter,
　 randomized, crossover trial. Headache. 2003 Sep;43(8):835-44.

論文抄録

OBJECTIVE: To compare the efficacy of a fixed combination of indomethacin, prochlorperazine, and caffeine suppositories with sumatriptan suppositories in the treatment of 2 consecutive migraine attacks of moderate or severe intensity in a multicenter, randomized, crossover study. BACKGROUND: A fixed combination of indomethacin, prochlorperazine, and caffeine is the most commonly used drug for the acute treatment of migraine in Italy . No studies have been published comparing the efficacy of this combination with sumatriptan, the most widely prescribed of the triptans. METHODS: One hundred twelve patients with migraine with or without aura according to the diagnostic criteria of the International Headache Society were randomized to treat 2 migraine attacks with a fixed combination of indomethacin, prochlorperazine, and caffeine and 2 migraine attacks with sumatriptan. Both drugs were rectally administered in a single dose for each attack. Patients were asked to take study medication as soon as possible at the onset of a headache. RESULTS: Of the 112 patients, 88 were compliant to the protocol. More attacks became pain-free at 2 hours postdose (primary end point) on the combination than on sumatriptan (49% versus 34%; P<.01), while there was no difference in the relief of headache at 2 hours postdose (71% versus 65%). The combination was statistically superior to sumatriptan in the time to a pain-free response (a higher percentage of attacks became pain-free from 0.5 hours postdose to 5 hours postdose), in alleviation of nausea, and in a sustained pain-free response (pain-free at 2 hours postdose with no use of rescue medication or relapses within 48 hours). Moreover, a significant consistent response was achieved for the combination compared with sumatriptan across (higher percentage of patients pain-free at 2 hours postdose in the first, second, third, and fourth treated attack) and within patients (pain-free in 2 of 2 treated attacks in 35% of patients taking the combination and 20% of patients on sumatriptan). Both drugs were well-tolerated. CONCLUSIONS: This study, analyzed according to the more recent guidelines for controlled trials in migraine, showed that a fixed combination of indomethacin, prochlorperazine, and caffeine is significantly more effective than sumatriptan in the acute treatment of migraine attacks. It is notable that the combination is less expensive than sumatriptan per unit dose.

文献 PubMed−ID

PMID: 12940804

エビデンスレベル

Ia

文献タイトル (日本語)

片頭痛発作に対するインドメタシン，プロクロルペラジン，カフェイン合剤とスマトリプタンとの有効性：マルチセンター無作為化交差試験

目的

片頭痛急性期治療における インドメタシン，プロクロルペラジン，カフェイン合剤座薬とスマトリプタン座薬との有効性の比較

研究デザイン

マルチセンター無作為対照交差試験（ Multicenter, ｒ andomized, open, crossover study ）

研究施設

イタリアの 6 医療機関

対象患者

片頭痛患者 112例（93%が前兆のない片頭痛）

介入

観察期（ screening ）；　 4 ｗ
引き続き 8 週間以内に生じた 4 回の片頭痛発作に対して， インドメタシン，プロクロルペラジン，カフェイン合剤座薬 2回あるいはスマトリプタン座薬2回ずつ使用

主要評価項目とそれに用いた統計学的手法

プライマリーエンドポイントは 2 時間後の頭痛消失

結果

合剤座薬において，有意に 2 時間後の頭痛消失を得た（ 49% 　対　 34 ％， p<0.01 ）．
２次エンドポイントの， 2 時間後の頭痛軽減効果は両者に有意差を認めなかった（ 71% 　対　 65 ％）
頭痛消失反応時間、嘔気緩和効果，頭痛消失維持時間で合剤座薬の有効性が支持された．
有害事象は両者で差が無かった．

結論

片頭痛急性期治療において インドメタシン，プロクロルペラジン，カフェイン合剤座薬はスマトリプタン座薬に比して有効かつ経済的であった．

コメント

イタリアでは，片頭痛急性期治療薬として，インドメタシン，プロクロルペラジン，カフェイン合剤が最もよく用いられている

備考

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

作成者

古和久典

5) Tanen DA, Miller S, French T, Riffenburgh RH. Intravenous sodium
　 valproate versus prochlorperazine for the emergency department
　 treatment of acute migraine headaches: a prospective, randomized,
　 double-blind trial. Ann Emerg Med. 1995 Nov;26(5):541-6.

論文抄録

STUDY OBJECTIVE: We compare the efficacy of intravenous sodium valproate versus prochlorperazine for the emergency department treatment of acute migraine headache. METHODS: We performed a randomized, prospective, double-blind trial performed at a tertiary care military ED. Forty patients, aged 18 to 65 years, presenting with typical migraine symptoms were enrolled. Patients were randomized to receive either 10 mg of prochlorperazine or 500 mg of valproate intravenously over 2 minutes. Pain, nausea, and sedation were assessed by using a standard visual analog scale (VAS). Changes in VAS scores were compared between groups from baseline to end point by using a rank sum test, over time by using 2-way repeated-measures analysis of variance, and by requirement for rescue at 60 minutes by using the Fisher exact test. RESULTS: Comparison of the change in median VAS scores over 60 minutes revealed that sodium valproate was significantly less effective than prochlorperazine in reducing pain or nausea (P <.001). Median improvements in VAS pain scores (binomial confidence intervals) were as follows: 64.5 mm (48.1 to 75.6 mm) for prochlorperazine versus 9 mm (-3 to 39.6 mm) for sodium valproate. Median improvements in VAS nausea scores were as follows: 35.5 mm (13.2 to 47.9 mm) for prochlorperazine versus 2 mm (-1.3 to 11 mm) for sodium valproate. There was no significant difference (P =.603) detected in the median changes in VAS scores for sedation: -4 mm (-29.9 to 8.6 mm) for prochlorperazine versus 0 mm (-6.6 to 6 mm) for sodium valproate. Comparison of the mean VAS time curves for pain and nausea also demonstrated a significant difference (both P <.001) but not for sedation (P =.232). In post hoc analysis, valproate failed to elicit significant improvement in pain or nausea scores over time, whereas prochlorperazine improved pain by 30 minutes (P <.001) and nausea by 15 minutes (P =.002). At the conclusion of the study, 15 (79%) of 19 patients receiving valproate required rescue treatment compared with 5 (25%) of 20 patients receiving prochlorperazine (P <.001). CONCLUSION: Prochlorperazine was statistically and clinically superior to sodium valproate for the treatment of the pain and nausea associated with acute migraine headaches.

文献 PubMed−ID

PMID: 12764341

エビデンスレベル

Ib

文献タイトル (日本語)

片頭痛の救急診療におけるバルプロ酸とプロクロルペラジン静注療法の前向き無作為対照評価

目的

バルプロ酸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

無作為二重盲検対照試験（ Randomized, double-blind study ）

研究期間

2002 年 1 月から 2002 年 8 月

対象患者

救急外来を受診した 18 歳〜 65 歳の片頭痛患者 40 人．

介入

片頭痛急性期に プロクロルペラジン 10mg またはバルプロ酸 500mg を 2 分以上かけて静注．

主要評価項目とそれに用いた統計学的手法

プライマリーエンドポイントは 60 分後の VAS

結果

60 分後の VAS は，バルプロ酸において有意に改善効果が得られなかった．
バルプロ酸治療を受けた 15 例（ 79% ）が二次治療（ rescue treatment ）を要したのに対して，プロクロルペラジン治療では， 5 例（ 25% ）と有意に少なかった．

結論

バルプロ酸と比較してプロクロルペラジンの片頭痛急性期治療における，統計学的，臨床的優越性が示された  

コメント

バルプロ酸との比較試験

備考

Publication Types:
* Clinical Trial
* Randomized Controlled Trial  

作成者

古和久典

6) Bigal ME, Bordini CA , Speciali JG. Intravenous chlorpromazine in
　 the emergency department treatment of migraines: a randomized
　 controlled trial. J Emerg Med. 2002 Aug;23(2):141-8.

論文抄録

The aim of this study is to assess, in a double blind randomized clinical trial, the effect of chlorpromazine (CPZ) on the pain and associated symptoms in patients with migraine. Sixty patients with migraine with aura and 68 patients with migraine without aura were assigned at random to receive IV 0.1 mg/Kg CPZ or placebo. We assessed pain intensity, nausea, photophobia, and phonophobia at baseline, 30 min, and 60 min post-IV administration. End-point efficacy at 60 min was used to calculate the number needed to treat (NNT). We also recorded adverse effects, need for rescue medication at 24 h, and recurrence of headache at 24 h. We found clinically and statistically significant (p < 0.01) improvement associated with CPZ in pain scores, nausea, photophobia, phonophobia, and need for rescue medication, all at 60 min, and in rate of recurrence at 24 h, both in patients with and without aura. NNT = 2. Those allocated to CPZ had less nausea and dyspepsia, but more drowsiness and postural hypotension than those receiving placebo. CPZ is an excellent option for the treatment of migraines, with and without aura, in the Emergency Department.

文献 PubMed−ID

PMID: 12359281

エビデンスレベル

Ib

文献タイトル (日本語)

片頭痛の救急診療におけるクロルプロマジンの静注療法：無作為対照試験

目的

クロルプロマジン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

無作為二重盲検プラセボ対照試験（ Randomized, double-blind, placebo-controlled study ）

研究施設

ブラジルの 2 医療機関

対象患者

救急外来を受診した 18 歳以上の片頭痛患者

介入

片頭痛急性期に クロルプロマジン 0.1mg/kg またはプラセボを静注．

主要評価項目とそれに用いた統計学的手法

静注前， 30 分後， 60 分後の頭痛強度，嘔気，光過敏，音過敏を評価項目とし， 60 分時点での有効性を NNT として求めた．
あわせて，副作用， 24 時間以内の治療の必要性， 24 時間以内の頭痛再発に関して検討した．

結果

前兆のある・なしにかかわらず， 60 分後の頭痛強度，嘔気，光過敏，音過敏， 24 時間以内の治療の必要性， 24 時間以内の頭痛再発において，クロルプロマジンは統計学的に有意に有用であった．（ NNT=2 ）
クロルプロマジンは嘔気は少なかったが，意識混濁や起立性低血圧は多く認められた．

結論

クロルプロマジンの片頭痛急性期治療における，統計学的，臨床的有用性が示された  

備考

Publication Types:
* Clinical Trial
* Randomized Controlled Trial  

作成者

古和久典

7) Monzillo PH, Nemoto PH, Costa AR, Sanvito WL.[Acute treatment of
　 migraine in emergency room: comparative study between
　 dexametasone and haloperidol. Preliminary results] [Article in
　 Portuguese] Arq Neuropsiquiatr. 2004 Jun;62(2B):513-8. Epub 2004
　 Jul 20.

論文抄録

We studied the efficacy of dexamethasone (4 mg) and haloperidol (5 mg) in the treatment of migraine in the emergency room. Twenty nine patients who had diagnosis of migraine according to the International Headache Society criteria and were evaluated for a painful episode at the emergency room of Santa Casa of Sao Paulo were included. All the patients scored their pain in 10 when evaluated, even after the use of intravenous analgesia (dipyrone). Fourteen patients were treated with haloperidol and the remaining 15 received dexamethasone. The patients were asked about pain intensity at 30, 60, 90 and 120 minutes after the use of either the drugs. Both drugs were equally efficient in pain relief after two hours. Patients who were treated with haloperidol showed an important improvement (more than 50% of improve in the analogic pain scale) in the first 30 minutes. The dexamethasone treated patients only reached this grade of analgesia after 120 minutes. Although we studied a small series of patients, our data suggest that both drugs are efficient in the treatment of a refractory migraine attack. Haloperidol seemed to work quickly in pain relief. No important side effects were observed in neither groups.

文献 PubMed−ID

PMID: 15273854

文献タイトル (日本語)

片頭痛の救急診療におけるデキサメタゾンとヘロペリドール静注の有用性 . 予備的検討．

目的

デキサメタゾンとハロペリドール静注が片頭痛頓挫薬として効果的かどうか決定すること．

研究施設

ポルトガル

対象患者

片頭痛急性期患者

介入

デキサメタゾン 4mg （ 15例）or ハロペリドール5mg（14例）を片頭痛急性期に静注，30，60，90，120分後に頭痛の程度を評価．

主要評価項目とそれに用いた統計学的手法

プライマリーエンドポイントは 2 時間後の頭痛程度

結果

投与 2 時間後の頭痛に対する効果は両者で差が無かった．
ハロペリドール投与群では， 30 分後の 50% 以上改善率が顕著であった．デキサメタゾン投与群では， 120 分後に鎮痛効果が認められた．難治性の頭痛症例に対して両者ともに有用であった．
重要な副作用は両者ともに認められなかった．

結論

デキサメタゾンとハロペリドール静注が片頭痛頓挫薬として有効であった．

コメント

ポルトガル語論文（抄録のみ英文）のため，精読困難

備考

Publication Types:
* Clinical Trial  

作成者

古和久典

8) Cete Y, Dora B, Ertan C, Ozdemir C, Oktay C. A randomized
　 prospective placebo-controlled study of intravenous magnesium
　 sulphate vs. metoclopramide in the management of acute migraine
　 attacks in the Emergency Department. Cephalalgia. 2005
　 Mar;25(3):199-204.

論文抄録

A randomized prospective placebo-controlled study of intravenous magnesium sulphate vs. metoclopramide in the management of acute migraine attacks in the Emergency Department. Cephalalgia 2004. London . ISSN 0333-1024The objective of this randomized, placebo-controlled, double-blind study was to determine the effectiveness of intravenous magnesium sulphate and intravenous metoclopramide in the treatment of acute migraine attacks in the Emergency Department when compared with placebo. Adult patients who presented to the Emergency Department with a headache that met International Headache Society (IHS) criteria for acute migraine were infused with either 10 mg of intravenous metoclopramide, 2 g of intravenous magnesium sulphate or normal saline over 10 min. At 0, 15, and 30 min, patients were asked to rate their pain on a standard visual analogue scale. At 30 min, patients were asked in a standard manner about the need for rescue medication. Adverse affects were also recorded. Patients were followed up by telephone within 24 h for any recurrence after discharge. The primary endpoint of the study was the difference in pain relief between the groups at 30 min. Of the 120 patients who met IHS criteria, seven were excluded from the study due to insufficient data. The number of patients, gender, age and initial visual analogue scale (VAS) scores were comparable between groups. Each group experienced more than a 25-mm improvement in VAS score at 30 min. However, there was no significant difference detected in the mean changes in VAS scores for pain. The rescue medication requirement was higher in the placebo group. The recurrence rate in 24 h was similar between the groups. Although patients receiving placebo required rescue medication more than the others, metoclopramide and magnesium have an analgesic effect similar to placebo in migraine attacks.

文献 PubMed−ID

PMID: 15689195

エビデンスレベル

Ib

文献タイトル (日本語)

片頭痛発作急性期の救急診療における硫酸マグネシウムとメトクロプラミド静注の無作為前向きプラセボ対照試験

目的

硫酸マグネシウムとメトクロプラミド静注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

無作為二重盲検プラセボ対照試験（ Randomized, double-blind, placebo-controlled study ）

研究施設

トルコ

対象患者

片頭痛急性期患者

介入

硫酸マグネシウム 2 g 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10分かけて静注，15，30分後に頭痛の程度を評価．

主要評価項目とそれに用いた統計学的手法

VAS
プライマリーエンドポイントは 30 分後の頭痛消失．
副作用， 24 時間後の頭痛の程度， 24 時間以内の医療の必要性を調査．

結果

いずれの群においても頭痛改善効果が認められ， 3 群間で片頭痛に対する効果に有意差は認められなかった．
プラセボ群において 24 時間以内の医療の必要性が有意に高かった．

結論

片頭痛に対する硫酸マグネシウム，メトクロプラミド静注の治療効果は．プラセボと同等である．  

備考

Publication Types:
* Clinical Trial
* Randomized Controlled Trial

作成者

古和久典

9) Blanda M, Rench T, Gerson LW, Weigand JV. Intranasal lidocaine for
　 the treatment of migraine headache: a randomized, controlled trial.
　 Acad Emerg Med. 2001 Apr;8(4):337-42.

論文抄録

OBJECTIVE: To evaluate the effect of intranasal lidocaine for immediate relief (5 minutes) of migraine headache pain. METHODS: A randomized, double-blind, placebo-controlled clinical trial at two university-affiliated community teaching hospitals enrolled patients 18-50 years old with migraine headache as defined by the International Headache Society. Patients who were pregnant, lactating, known to abuse alcohol or drugs, or allergic to one of the study drugs, those who used analgesics within two hours, or those with a first headache were excluded. Statistical significance was assessed by using chi-square or Fisher's exact test for categorical variables and Student's t-test for continuous variables. Patients rated their pain on a 10-centimeter visual analog scale (VAS) prior to drug administration and at 5, 10, 15, 20, and 30 minutes after the initial dose. Medication was either 1 mL of 4% lidocaine or normal saline (placebo) intranasally in split doses 2 minutes apart and intravenous prochlorperazine. Medications were packaged so physicians and patients were unaware of the contents. Successful pain relief was achieved if there was a 50% reduction in pain score or a score below 2.5 cm on the VAS. RESULTS: Twenty-seven patients received lidocaine and 22 placebo. No significant difference was observed between groups in initial pain scores, 8.4 (95% CI = 7.8 to 9.0) lidocaine and 8.6 (95% CI = 8.0 to 9.2) placebo (p = 0.75). Two of 27 patients (7.4%, 95% CI = 0.8, 24.3) in the lidocaine group and three of 22 patients (13.6%, 95% CI = 2.8 to 34.9) in the placebo group had immediate successful pain relief (p = 0.47), with average pain scores of 6.9 (95% CI = 5.9 to 7.8) and 7.0 (95% CI = 5.8 to 8.2), respectively. No difference in pain relief was detected at subsequent measurements. CONCLUSION: There was no evidence that intranasal lidocaine provided rapid relief for migraine headache pain in the emergency department setting.

文献 PubMed−ID

PMID: 11282668

エビデンスレベル

Ia

文献タイトル (日本語)

片頭痛における経鼻リドカインの治療効果：無作為対照試験

目的

リドカイン経鼻投与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

無作為二重盲検プラセボ対照試験（ Randomized, double-blind, placebo-controlled study ）

研究施設

合衆国内の 2 医療機関

対象患者

18 歳〜 50 歳の片頭痛患者．

介入

4% リドカイン 1ml （25例）or プラセボ（生理食塩水）（22例）を片頭痛急性期に点鼻し，プロクロペラジンを静注する．5，10，15，20，30分後に頭痛の程度を評価．

主要評価項目とそれに用いた統計学的手法

プライマリーエンドポイントは 50 ％以上の頭痛軽減あるいは VAS 2.5cm 以下．

結果

投与前の頭痛の程度に有意差は無かった．投与後の改善効果は両群間に有意差を認めなかった．

結論

片頭痛に対するリドカイン点鼻の治療効果は．プラセボと同等である． 

備考

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

作成者

古和久典