外用Lidocaine為慢性經痛帶來治療希望


May 13, 2005 (舊金山) - 一項於美國婦產科醫學會第53屆年會上發表的研究指出,5% lidocaine凝膠以外用的方式使用於陰道內,經證實可以有效治療慢性經痛。
  
  本項研究招募的試驗者,皆以模擬慢性經痛的方式接受治療;對於確定為慢性經痛的婦女,以抗利尿激素誘發子宮抽搐後,再以lidocaine作治療試驗;結果顯示,以這項治療方式,研究人員對於真正的經痛治療表示樂觀。
  
  阿斯匹靈及其他的非類固醇類抗炎藥物(NSAIDs)為傳統的經痛治療藥;但是,許多婦女無法奈受NSAIDs,因為這類藥物會導致胃腸道方面的副作用、過敏反應,及其他方面的問題。
  
  資深研究人員George Creasy醫師表示,對於慢性經痛的治療,我們對這項外用藥的療效保持樂觀的態度;患有致衰性經痛的婦女,在每個月的月經來臨時,可以使用此藥讓疼痛顯著降低,並不需要使用全身性的口服藥物;對於無法使用阿斯匹靈或NSAIDs的患者,這會是一項很好的選擇;在未來的研究裡,我們將會對這項藥物處方在於人體的吸收程度作測試。
  
  Creasy醫師為Columbia Laboratories, Inc公司的研究人員,該公司為這項試驗凝膠的生產者及本研究的資助者;他強調,該凝膠為一黏著性生物載體,可以被吸收,不會在月經時流出而增加患者的痛苦。
  
  參與試驗的24位婦女皆有著慢性經痛的病歷,並以口服避孕藥作過治療;在口服避孕藥停用後的第一天,經靜脈投予0.2IU的抗利尿激素,藉此引發2分鐘的子宮抽搐。
  
  每15到60分鐘,研究人員對患者的子宮內壓及疼痛程度進行監控;在抗利尿激素第一次投予後,子宮內壓增加超過40%,並在60分鐘內回復到基線值的15%以內,如此才能符合經痛的定義;這24位婦女中,有19位符合。
  
  在參試者中,以隨機的方式分配10位至5% lidocaine陰道凝膠組(COL-1077),9位為安慰劑組;在凝膠滴入後,試驗者休息4到5小時,之後再繼續第二次的抗利尿激素注射。
  
  安慰劑組的子宮內壓增加4.72 mmHg,子宮收縮次數每10分鐘減少0.39,疼痛指數降低1.39,子宮有感收縮次數每10分鐘增加2.94次;試驗組中,所有的症狀皆消失了,子宮內壓平均降低18.25 mmHg,子宮收縮每10分鐘降低8.75,疼痛指數降低12點,子宮有感收縮次數每10分鐘平均降低3.1次。
  
  亞特蘭大城,聖喬瑟夫醫院的婦科醫師Magdi Hanafi表示,這是一項重要的研究,因為經痛常見於婦女之間,這些婦女必須使用大量的NSAIDs或其他的麻醉性藥物,而外用的lidocaine則代表了一種新的治療方式;若能在未來獲得確認,本項治療法將會作出莫大的貢獻。

Topical Lidocaine Shows Promis

By Paula Moyer, MA
Medscape Medical News

May 13, 2005 (San Francisco) — A 5% topical lidocaine gel that is administered intravaginally has promise for treating chronic dysmenorrhea, according to investigators whose findings were presented here at the 53rd annual meeting of the American College of Obstetricians and Gynecologists.

The study design called for the participants to be treated in a situation simulating dysmenorrhea. The lidocaine preparation was used after uterine cramps were induced with vasopressin in women who had been diagnosed as having dysmenorrhea. However, the investigators are optimistic that the treatment would be effective with true dysmenorrhea.

The conventional treatment for dysmenorrhea is aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs); however, many women cannot tolerate NSAIDs due to gastrointestinal tract adverse events, hypersensitivity reactions, or other problems.

"We are optimistic that many women could benefit from a topical treatment for chronic dysmenorrhea," said senior investigator George Creasy, MD. "Women who have debilitating dysmenorrhea every month could start treating themselves at the onset of menses and get significant pain relief without taking a systemic medication, and women who cannot take aspirin or NSAIDs would have an option. In future studies, we will test to see the extent to which the topical formulation is absorbed systemically."

Dr. Creasy is an investigator at Columbia Laboratories, Inc., which is manufacturing the investigative gel and funded the study. He added that the gel is a bioadhesive vehicle that is absorbed and therefore will not drain and add to patients' woes while they are menstruating.

The 24 prospective subjects had a history of chronic dysmenorrhea and had been treated with oral contraceptives. They received an intravenous dose of 0.2 IU of vasopressin for a two-minute period to induce cramping episodes on the first day after discontinuing treatment with oral contraceptives.

The investigators monitored the participants' intrauterine pressure and pain every 15 minutes for 60 minutes. To qualify as dysmenorrheic, the subjects had to have intrauterine pressure increases of greater than 40% after the first vasopressin infusion and return to within 15% of baseline within 60 minutes. Among the prospective subjects, 19 qualified.

Among the qualified participants, 10 were randomized to receive the investigative agent, 5% lidocaine vaginal gel (COL-1077), and nine were randomized to received placebo gel. After the gel was instilled, the subjects then rested for four to five hours before receiving the second vasopressin infusion.

The placebo patients had an increase in intrauterine pressure of 4.72 mm Hg, a decrease in uterine contractions of 0.39 per 10 minutes, a decrease in 1.39 points in pain, and an increase in perceived uterine contractions of 2.94 per 10 minutes. In the women receiving the study treatment, all measures were diminished. Their intrauterine pressure decreased an average of 18.25 mm Hg (P = .012), uterine contractions decreased an average of 8.75 per 10 minutes (P < .001), their pain decreased an average of 12 points (P = .001), and perceived uterine contractions decreased an average of 3.1 contractions per 10 minutes (P = .008).

"This is an important study because dysmenorrhea is a common problem for women, who typically must use significant amounts of NSAIDs or other systemic analgesics," said Magdi Hanafi, MD, in an interview seeking independent comment. "Topical lidocaine represents a new approach. This strategy would make a significant contribution if it is validated in further studies." Dr. Hanafi is a consultant gynecologist at St. Joseph's Hospital in Atlanta, Georgia.

Obstet Gynecol. 2005;105(4 suppl):68S. Presented May 10, 2005.

Reviewed by Gary D. Vogin, MD

    
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