1) 대한한방부인과학회지 THE JOURNAL OF ORIENTAL OBSTETRICS & GYNECOLOGY VOL.25 NO.4 : 066-080 (2012) 경희대학교한의과대학부인과학교실김은경, 황덕상, 이진무, 이창훈, 장준복, 이경섭 ABSTRACT Investigation of Clinical Research of Acupuncture Treatment on Hyperemesis Gravidarum in Medline Eun-Gyung Kim, Deok-Sang Hwang, Jin-Moo Lee Chang-Hoon Lee, Jun-Bok Jang, Kyung-Sub Lee Dept. of Oriental Hospital, College of Oriental Medicine, Kyung-Hee University Purpose: The purpose of this study is to examine treatment suggested on the papers of hyperemesis gravidarum(hg) in medicine journals and to establish the future direction. Methods: The papers which were associated with and HG published between 2000 and 2012 in Medline were searched. Results: 14 studies met the condition. They were 13 randomized controlled trial (RCT)s and 1 clinical study. 13 studies revealed that has efficacies in HG. 1 study was shown to have no statistically significant efficacy. 2 studies revealed that was safe treatment, and 1 study revealed that was reliable treatment. Conclusions: From the paper research, treatment seems to be effective on HG. However, due to the lack sufficient research of HG, it would be necessary to fulfill further study about the period of treatment on HG and the selection of acupoint through well-designed study and establish standard of evidence of them. Key Words: hyperemesis gravidarum, nausea and vomiting in pregnancy, HG, NVP, Corresponding author(kyung-sub Lee) : 서울시강남구대치2동 994-5 강남경희한방병원여성의학센터 Tel : 02-3457-9003 E-mail : kyungsl@nate.com 66
The Journal of Oriental Obstetrics & Gynecology Vol.25 No.4 November 2012 Ⅰ. 서론 임신중구토하고메슥거리며, 어지럽고음식을싫어하거나가리는것을姙娠惡阻라한다 1), 千金要方 에서는 阻病, 經效産寶 에서는 子病, 坤原是保 에서는 病食 이라하였다. 임신에의한오심및구토는임신초기에발병하는소화장애로서모든임신부의과반수이상에서발생하는흔한증상이다. 그러나흔히말하는입덧 (morning sickness) 과는달리오심과구토가아침뿐만아니라하루종일있고밤까지도지속되어식사가곤란하고체중의감소와수분, 전해질, 영양및신진대사의불균형을초래할만큼심한정도에이르게되는경우를임신오저 (hyperemesis hravidarum) 라한다 2). 오저로인해경구섭취장애가초래된경우에는부분적인기아상태에빠지게된다 3). 이러한경우임신부를힘들게할뿐만아니라, 입원치료의필요성과태아에게영향을미칠가능성에대한염려때문에신체적, 정신적으로상당히부담이되는질환이다 4). 임신오저는단순한오심, 구토에서출발하여상당히중한상태로발전할수있다. 환자가체중감소및탈수를일으킬정도의빈번하면서도지속적인구토, 대사성산증, 케톤뇨증, 저칼륨성알칼리증, 빈뇨, 혈액농축, 변비등이나타나면임신오저로진단한다. 더진행하면체온상승, 황달, 토혈, 점상출혈, 망막출혈이올수있고, 병의최종악화단계에서는혼수에빠지게된다 2). 따라서임신오저증을호소하는임신부의경우정확한진단과적절한치료가 중요하다. 실제임상에서시행되고있는치료로는경구섭취의격려, 정서적지지, 정맥수액요법, 비타민보충요법등이있고, 이를통해호전되지않으면약물치료를시도하게된다. 하지만구토억제제와같은약물은태아에게미치는영향때문에제한적으로사용되며, 효과및안정성이확보되지않은경우도많아 3,5) 임신오저의치료에있어한계가있다. 한의학적으로 金匱要略 의當歸散, 東醫寶鑑 의保生湯등한약물치료가오저의치법으로제시되고있으며다양한임신오저의임상치험례 6-9) 가보고되고있다. 이렇듯국내에서임신오저에있어임상연구로는한약치료및침구치료의효용성및안전성이보고되고있으나, 한약치료를주로한전반적임상케이스연구보고가많으며침을이용한임상시험연구는장경호등 10) 의이침료법의효과가보고되었을뿐이다. 침을이용한임신오저의치료에대한연구는국내보다국외에서많이이루어져있으며이들연구에대한 systematic review 또한다양하게보고되고있다. 그러나연구대상은임신오저를비롯한여러가지오저증과침치료 11), 침치료를비롯한다양한임신오저중재방법 12) 으로임신오저와침치료에국한된연구는아직보고되지않고있다. 침치료는임신오저의치료로서임상에서활용도가높음 6-10) 에도불구하고임상시험을통한효용성및안정성은아직확보되지않고있다. 따라서 Medline 을통해임신오저에대한침치료연구동향을살펴보아태아에대한영향을염려하여약물치료에대한불안을가질수있는임신부의임신오저증의실제임상에 67
서의치료및관리에대한한의학적침치료의임신오저증진료지침의기초를마련하고자하였다. Ⅱ. 연구방법 1. 연구대상 2012년 6월 11일부터 13일까지 Medline 에서 hyperemesis gravidarum와, emesis gravidarum와, nausea and vomiting in pregnancy와, NVP(nausea and vomiting during pregnancy) 와, morning sickness와, nausea pregnancy와, vomiting pregnancy와 을검색어로하여검색하였다. 언어는제한하지않았으며, 연도는 2000년부터 2012년으로한정하였고. 사람, 여성을대상으로한논문을선별하였다. 학술지에게재된논문을대상으로하며논문의형식은 letter 와 review 를제외한임상연구논문을선별하여분석하였다. 2. 연구방법선별된논문은원문을분석하여각논문에대해임상연구방법, 연구경혈, 방법, 효과, 연구국가, 연도를조사하여, 침이임신오저에미치는영향에대해분석하였다. 3. 최종선택논문검색된논문중임상연구논문으로침치료및임신오저증과직접적인관련이있는것만을선택하였다. 내용이불충분하거나, 임신오저를주로다루지않는논문은배제되었다. 최종적으로 Randomized controlled trial(rct) 13개와 Clinical study 1개로총 14개의논문이선택되었다. Ⅲ. 결과 임신오저와관련한침치료임상시험연구는 RCT 13개, Evaluation Studies 1개가조사되었다 (Table 1). Carisson 등 13) 은내관에깊이자침을한실험군이 placebo 침을이용한대조군보다오심과구토에대한 visual analogue scale(vas) 이유의하게빨리감소했다고보고하였다. Werntoft 등 14) 은건강한임신여성과 NVP 가있는여성을내관지압군과 placebo 지압군, 아무치료도받지않은군으로나누어 NVP의증상변화를보았다. NVP의증상은내관지압군이다른대조군에비해유의하게감소하였다. 오심의경감은치료군과 placebo 군모두나타났지만, placebo 군은치료후 6일만지속된것에비해치료군은이후 14일간지속되었다. Knight 등 15) 은임신 6주에서 10주의여성을대상으로전통적인침술을사용한실험군과칵테일스틱으로지압하는샴대조군을설정해오심증상의 VAS와불안및우울의정도를파악하였는데, 오심증상은실험군과대조군모두유의하게감소하였다. 그러나군간의차이는유의하지않았으며, 불안및우울증상도마찬가지였다. Smith 등 16-18) 은 NVP를호소하는 593 명을대상으로전통적인침치료군, 공식화된침치료군 (P6), 샴침치료군, 비침치료군을무작위로선정하여 4주간시행한임상시험을통해 3가지결과를도출해냈다. Smith 등 16) 임신초기침치료의 68
The Journal of Oriental Obstetrics & Gynecology Vol.25 No.4 November 2012 부작용에대해알아보고자하였으며, 주산기결과, 선천적기형, 임신부와신생아의합병증을확인한결과임신초기에행해진침치료와관련하여심각한부작용은없었다. Smith 등 17) 은 NVP의침치료효과를알아보고자하였으며, 전통적침치료를받은여성의오심은치료시행 2주차에유의하게경감되었고, 내관침치료군은비침치료군에비해오심은 2주차에, 헛구역질은 3주차에유의하게감소하였다. 샴치료군은비침치료군에비해오심과헛구역질이 3주차에유의하게감소하였다. 구토는군간의차이가없었다. Smith 등 18) 은 Rhodes Index(RI) 와 Credibility Rating Scale을이용하여샴치료군이대조군으로서신뢰성이있는지알아보고자하였으며, 침치료군과샴치료군중재의신뢰성은차이가없는것으로나타났다. Rosen 등 19) 은내관에저강도신경자극을통한 NVP의치료효과를 RI와약물복용, 체중증가, 케톤뇨를통해평가한결과, 시간의경과에따라 RI 결과가실험군이대조군에비해유의하게좋았으며, 실험군의체중증가또한대조군보다유의하게늘었다, 그러나약물복용과케톤뇨측정은양군간의차이가없었다. Habek 등 20) 은내관에침술과지압을했을때불안및우울, 전해질정맥주사, 구토제인 metoclopramide 정맥주사, 항히스타민제인 promethazine의복약에서침술과지압을한군에서 hyperemesis gravidarum(hg) 에유의한효과를보였다. Neri 등 21) 은침과지압치료를받은실험군과 metoclopramide, vitamin B12를 제공받은대조군과비교했을때두군모두식사률은증가했으나, 실험군에서보다증상이강하고지속적으로개선되었고, 생활기능적인면의향상에서유의한효과를보였다. Shin 등 22) 은내관의지압을한실험군이 HG 여성에게있어오심및구토증상과케톤뇨정도가정맥주사처치를받은대조군이나 placebo 군에비해통계적으로유의하게낮았다고보고하였다. Gükan 등 23) 은내관에 3일간지압밴드를착용한실험군과 placebo 군및아무처치를하지않은대조군과비교했을때실험군과 placebo 군에서통계적으로유의한증상경감이나타났다. Puangsric 등 24) 은임신오저여성에게 4일간이압요법을실시하였을때, RI 점수가대조군에비해적게나타났으며특히이압요법실시후 4일에서 6일까지점수가낮았다고보고하였다. 그러나두군의평균점수는통계학적으로유의한차이는없었으며구토제복용량도두군간에통계학적으로유의한차이가없었다. Mao 등 25) 은 90개의임상케이스를침치료군, 중의학적치료군과양의학적치료군의 3군으로각 30케이스씩나누어케톤체, CO 2 결합능, 전해질균형을확인하였다. 대저, 상거허, 내관그리고공손등에자침을한침치료군, 진정제를투여한양의학치료군과한약물을투여한중의학치료군에서침치료군이다른두군보다통계적으로유의하게전체적인효과가좋았으며, 침치료군에서케톤체의유의한향상이있었고, CO 2 결합능과전해질균형은모든군에서나타났다. Slotnick 등 26) 은내관전기자극전과후의증상정도, 전기자극의사용용이 69
성을스케일로확인하고, 신생아의선천성기형을파악한결과, 선천성기형은 없었으며내관전기자극이유의한치료임을보고하였다. Table 1. Acupuncture and Clinical Trials on HG RE Subjects Acupoint 13 14 15 16 17 33 women with hyperemesis 60 healthy women with normal pregnancy an suffering from NVP 55 women between 6 and 10 weeks' gestation genuine, 593 women with nausea and vomiting in early pregnancy 593 women less than 14 weeks' pregnant with symptoms of nausea or vomiting PC6 P6 Chinese medicine diagnosis P6, Chinese medicine diagnosis P6, acupoint Method of stimulation or placebo (superficial) at PC6 and at a placebo point or no treatment -style or sham treatment with a cocktail stick on three or four occasions over 3 weeks Patients were given either, formula, sham or no. 593 women were randomized into 4 groups:, pericardium 6 (p6), sham, or no Measurement Results Country Year Study design Checking VAS (degree of nausea) daily Count the perieod of relif from nausea Nausea score as VAS daily and anxiety and depression were also assesssed Data were collected on perinatal outcome, congenital abnormalities, pregnancy complications and the newborn. Treatment was administered weekly for 4 weeks. The primary outcomes were nausea, dry retching, vomiting, and health status. significantly reduction of nausea VAS, more womnen who stopped vomiiting after active than after placebo Relief from nausea appeared one day after starting treatment in both the PC6 and plcebo groups but lasted longer in PC6 groups than the other two groups Nausea scores decreased from a median of 85.5(interquartile range 71.25-89.75) to 47.5(interquartile range 29.25-69.5) in the group and from 87.0(interquartile range 73.0-90.0) to 48.0(interquartile range 14.0-80.0) in the sham treatment group. No differences were found between study groups in the incidence of perinatal outcome, congenital abnormalities, pregnancy complications and other infant outcomes. Women receiving reported less nausea (p<0.01) throughout the trial and less dry retching (p<0.01) from the second week compared with women in the no control group. Women who received p6 (p<0.05) reported less nausea from the second week of the trial, Sweden 2000 Sweden 2001 UK 2001 Australia 2002 Australia 2002 Single-blind, cross over comparison, Randomized Controlled Trial Randomized, placebocontrolled, pilot study a subjectand observermasked Randomized Controlled Trial Randomized Controlled Trial single blind randomized controlled trial 70
The Journal of Oriental Obstetrics & Gynecology Vol.25 No.4 November 2012 18 19 593 women with NVP in early pregnancy Pregnant volunteers (n=230) with symptoms of mild to severe nausea and vomiting between 6 and 12 weeks' gestation. A total of 187 women (81%) completed the trial. P6, acupoint P6 (control) 593 women were randomized into 4 groups:, pericardium 6 (p6), sham, or no (control) low-level nerve stimulation therapy over the volar aspect of the wrist at the P6 point to treat NVP in a 21-day clinical trial. Participants were randomly assigned to receive a device for nerve stimulation therapy or an otherwise identical but nonstimulating placebo device. Women completed the Rhodes Index of Nausea and Vomiting and the Credibility Rating Scale. The primary outcome measure was self-recorded symptoms according to the Rhodes Index of Nausea, Vomiting, and Retching (Rhodes Index). Secondary outcome measures were medication use, weight gain, and presence of urinary ketones. and less dry retching (p<0.001) from the third week compared with women in the no control group. Women in the sham group (p<0.01) reported less nausea and dry retching (p<0.001) from the third week compared with women in the no group. No differences in vomiting were found among the groups at any time. The credibility of the and sham interventions were not different. The relative change in nausea at the end of the first week of the study was estimated to be 28% attributed to a time effect and 7% to the placebo response. At the end of the third week, there was a further small increase in time effect(32%) and the placebo response(17%). The time-averaged change in Rhodes Index total experience of 6.48 for the study group was significantly better than the control value of 4.65 (P=.02).Study patients gained more weight than controls(2.9 versus 1.2 lb, P=.003). There were no statistically significant differences in medication use or urinary ketone measurements. Australia 2002 USA 2003 Randomized Controlled Trial 71
20 36 pregnant women with HG Pc6 bilateral manual AP of the Pc 6 (Neiguan) acupoint (group 1, n=10) and bilateral APr of the Pc 6 acupoint (group 2, n=11); furthermore, superficial intracutaneous placebo AP (Acupuncture) (group 3, n=8) and placebo APr (Acupressure) (group 4, n=7) was carried out. Anxiodepressive symptoms evaluate the antiemetic effect of AP and APr The efficiency of the HG treatment with AP of the point Pc 6 was 90%, with APr of the Pc 6 63.6%, with placebo AP 12.5%, and with placebo APr 0%. Anxiodepressive symptoms occurred in 9 pregnant women with HG from group 1, 8 women from group 2, 7 women from group 3, and 5 women from group 4 (p < 0.001). Croatia 2004 prospective, placebocontrolled trial 21 88 women suffering form HG were divieded 2 groups- Acupuncture group (Acupuncture plus ) or metoclopramide group (metoclopramide infusion and vitamin B12 complex supplement) Acupuncture sessions were performed at the hospital twice a week for 2 weeks according to the Chinese medicine criteria. Acupression was applied for 6-8 h/day. In the metoclopramide group, patients received at hospital metoclopramide infusion (20 mg/500 ml saline for 60min) twice a week for 2 weeks. An oral supplementation with vitamin B12 complex (30 mg/day) was also prescribed. improvement in the rate of food intake Both treatments reduced vomiting episodes and then nausea intensity with a consequent improvement in the rate of food intake. The effect of seems to be progressive, increasing at the end of treatment whereas pharmacological approach has a prompt effect in responders remaining stable thereafter. Moreover, was significantly more effective than drugs in improving functioning. Italy 2005 randomized controlled trial 72
The Journal of Oriental Obstetrics & Gynecology Vol.25 No.4 November 2012 22 23 24 25 66 women with HG The treatment group comprised 26 women; 25 in the control arm and 24 women were assigned to the placebo arm. 98 women with VNP 90 women in HG were randomly devided into an P6 P6 Auricular BL11, ST37, PC6, SP4 a Nei Guan point group, a placebo group and a control group which received only conventional intravenous treatment. For 9 days, the treatment group applied bands to P6 point on days 4 6 of the study with the placebo group receiving bands to a sham point, on the upper side of their wrists. treatment group and control group in the treatment group received magnet pellets, placed at both auricles. from the third to the sixth day. Participants were treated with same supplement of water and nausea, vomiting and ketonuria levels use VAS to evaluate nausea and vomiting symptoms daily for 9 days Outcome measurement were Rhodes index score and the amount of antiemetic drug taken. The therapeutic effect, ketone bodies, carbon dioxide The degree of nausea and vomiting was statistically significantly lower in the Nei Guan point group in comparison with the placebo and control groups. Ketonuria levels were reduced over time and, on days three and four of hospitalization, levels in the treatment group were statistically significantly lower than in the placebo or control groups(p<0.005). Acupressure would appear to be effective in symptom control, and alleviation and placebo effects in reducing the symptoms of nausea and vomiting during pregnancy. The Rhodes index scores of the treatment group were lower than that of the control group especially in day 4-6 after intervention. However when comparing the mean score between the two groups, there were no statistically significant differences (p>0.05). The total amount of anti-emetic tablets in day 4-6 after intervention was compared and there were no statistically significant differences (p>0.05) between the groups. After treatment for 7 days, the total effective rate of 96.7% in the group was better than 46.7% in the western Korea 2007 Turkey 2008 Thailand 2008 China 2009 randomized controlled trial Randomized controlled trial Randomized Controlled Trial Randomized Controlled Trial 73
26 group, a western medicine group and a Chinese medicine group, 30 cases in each group. 41 patients with NVP P6 electrolyte, with at BL11, ST 37, PC 6, SP 4. etc. added in the group, with oral administration of Luminal 30 mg thrice each day added in the western medicine group and with oral administration of Chinese herbal decoction according to syndrome differentiation of TCM added in the Chinese medicine group. 41 patients were treated with a P-6 acustimulation device Hyperemesis gravidarum(hg) Reference(RE) Nausea and vomiting in pregnancy(nvp) Visual Analogue Scale(VAS) Traditional Chinese medicine(tcm) combining power (CO2-CP) and electrolyte imbalance situation in all the groups were observed. Pretreatment nausea severity, posttreatment nausea relief and device effectiveness were patient rated using a 1-5 scale. medicine group and 60.0% in the Chinese medicine group(both P<0.01). There were significant improvements in ketone bodies in the group compared with those before treatment and those in the western medicine group(both P<0.05), and improvements in CO2-CP and electrolyte imbalance in all the groups were following the recovery of disease. Pretreatment nausea severity scores for treated patients averaged 4.2, with most severe and debilitating nausea rated 5. Posttreatment device effectiveness averaged 4.2, with significant or complete relief rated 5. 4.3, with very easy to use rated 5. Device ease of use averaged No congenital abnormalities were found. USA 2001 Clinical trial; Evaluation Studies 총 14개의연구중가장많이사용된혈위는 PC6( 내관 ) 으로 11개의논문 13,14,16-20,22,23,25,26) 에서사용되었다. 그외에는이침의위점 24) 과 BL11( 대저 ), ST37 ( 상거허 ), SP4( 공손 ) 등 25) 이각 1편씩 있었고, 그외전통적인침치료혈자리도있었다 15,16,18). 혈자리자극법은침요법이 6편 13,16-18,20,25), 침요법과지압요법을함께한것이 2편 15,21), 지압요법만한것이 3편 14,22,23), 전침을이용한것이 2편 74
The Journal of Oriental Obstetrics & Gynecology Vol.25 No.4 November 2012 19,26), 이압요법을사용한것이 1 편 24) 에해당하였다 (Table 2). Table 2. The Acupoints Used for Clinical Trials RE AD Acupoint 13, 20 AP 14, 22, 23 APr PC6 19, 26 EA 15 AP, APr Chinese medicine diagnosis 16, 17, 18 AP PC6, Chinese medicine diagnosis 21 AP, APr 24 AAr Auricle at the concha ridge zone(stomach) 25 AP BL11, ST36, PC6, SP4 reference(re) addition(ad) acupucture(ap) (APr) electro(ea) auricular (AAr) 임신오저증상의개선은오저증상의정도를 VAS, RI 등의 scale 을이용해측정한것이 7편 13,15,17-19,23,26), 오저증상의지속기간을측정한것이 1편 14) 이있었으며, 체중증가, 케톤체, CO₂결합능, 전해질균형등신체생리상태를통해파악한것 19,21,22,25) 이 4편있었고, 약물치료상태로확인한것이 2편 19,20) 이였다. 침치료의안전성을주산기결과, 임신부와신생아의합병증, 신생아의선천성기형발현을통해파악한연구가 2편 16,26) 이있었다. 검색한논문의연도는 2000년부터 2012 년까지로제한한바있었다. 검색된연구는 2000년부터 2009년까지의논문으로 2000년에 1편 13), 2001년 14,15,26), 2002년에각 3편 16-18), 2003년 19), 2004년 20) 과 2005년 21) 에매해 1편, 2007년 1편 22), 2008년 2편 23,24), 2009년 1편 25) 으로 2010년부터 2012 년까지는검색되지않았다. 국가별논문을살펴보면스웨덴 13,14) 2편, 영국 15) 1편, 호주 16-18) 3 편, 미국 19,26) 2 편, 크로아티아 20) 1편, 이탈리아 21) 1편, 한국 22) 1편, 터키 23) 1편, 태국 24) 1편, 중국 25) 1편이였다 (Table 3). Table 3. Amount of Clinical Trials by Year and Country of Clinical Trials Year Clinical Clinical Country trial (n) trial (n) 2000 1 Sweden 2 2001 3 UK 1 2002 3 Australia 3 2003 1 USA 2 2004 1 Croatia 1 2005 1 Italy 1 2006 0 Korea 1 2007 1 Turkey 1 2008 2 Thiland 1 2009 1 China 1 2010 0 2011 0 2012 0 Total 14 14 75
연구자의직업군은산부인과의사 10 편 13,15-21,24,26), 간호사 3편 14,22,23), 침구과중의사 1편 25) 이였으며, 논문발표지는통증관리관련잡지 1개 13), 생식및출산의학관련잡지 3개 14,17,26), 산부인과관련잡지 3개 15,19,21), 보완대체의학관련잡지 4 개 16,18,20,23), 간호관련잡지 1개 22), 의학관련잡지 1개 24), 중의침구관련잡지 1개 25) 로조사되었다. Ⅳ. 고찰 임신초기에발병하는소화장애를임신오저라한다. 千金要方 에서는 阻病, 經效産寶 에서는 子病, 坤原是保 에서는 病食 이라하였다. 오심과구토가아침뿐만아니라하루종일있고밤까지도지속되어식사가곤란하고체중의감소와수분, 전해질, 영양및신진대사의불균형을초래할만큼심한정도에이르게되는경우를일컫는다 2). 오저로인해경구섭취장애가초래된경우에는부분적인기아상태에빠지게되고 3), 이는임신부를힘들게할뿐만아니라, 입원치료의필요성과태아에게영향을미칠가능성에대한염려때문에신체적, 정신적으로상당히부담이되는질환이다 4). 임신오저는단순한오심, 구토에서출발하여상당히중한상태로발전할수있다 2). 임신오저가지속되는경우탈수와체중감소가일어나며대사성산증또는위액구토로인한알칼리증등산-염기불균형과전해질이상이발생할수있다 3,5). 대표적인전해질이상은저칼륨혈증인데심한경우급성신부전이될수 있다 27). 간기능손상이나타날수있으며, 비타민결핍으로인한베르니케뇌병증이나타날수있다. 태아에게미치는영향으로는전자간증, 조기수축, 질출혈의빈도가높다는보고 28) 와선천성기형과의연관성 29) 이보고되고있다. 따라서임신오저증을호소하는임신부의경우정확한진단과적절한치료가중요하다. 실제임상에서시행되고있는치료로는경구섭취의격려, 정서적지지, 정맥수액요법, 비타민보충요법등이있고, 이를통해호전되지않으면약물치료를시도하게된다. 항우울제를쓸수있으며, 오심및구토에효과가있는것으로알려진 pyridoxine(vitamin B6) 을쓸수있고, 항히스타민제인 doxylamine 을함께사용하기도한다. 이에반응이없을경우태아에게미치는영향때문에제한적이기는하지만 promethazine, prochlorperazine과같은구토억제제를시도해볼수있다. 최근세로토닌길항제, 도파민길항제, 스테로이드의사용에대한연구가보고되고있는데그효과에대한증거는아직불충분하다 3,5). 이렇듯임신오저에대한의약물치료는효과나안전성에대해의견이분분하며임신부와태아에게원치않는부작용이나기형유발위험이증가하기때문에 26) 이를대체할만한안전하고효과적인치료가필요하다. 임신오저의보안대체의학적치료로서침치료가부각되고있다. National Evidence -based Clinical(NICE) Guidelines에서는생강과함께내관의침치료가임신오저에근거가있다고추천하고있다 30). 하지만 Ezzo 등 11) 은내관의침치료가긍정적인효과도있지만모호한결과를보인연구도있다고하였다. 76
The Journal of Oriental Obstetrics & Gynecology Vol.25 No.4 November 2012 임신오저에대한침치료는국내임상에서많이활용되고있으나 6-10), 장경호 등 10) 외에침치료에대해집중적으로고 찰한연구는아직이루어지지않고있다. 임신오저에있어침치료는선천성기형이유발되기쉬운임신초기에시행되기때문에효과와더불어치료의안전성이더욱중요하다. 이에저자는임상에서임신오저의침치료의효과및안전성에대한근거확보및진료지침을마련하기위해국외의임신오저의침치료에대한임상시험연구동향을살펴보았다, 수집된논문은총 14편으로 RCT 13편과 Clinical study 1편이채택되었다. 14 편의논문중연구에이용된혈자리는 PC6이 12편으로월등히많았다. 이침혈위중위점을이용한논문이 1편이였으며, TCM의진단기준에따라변증하여혈위를채택한논문이 4편이였다. 혈위자극방법은자침과지압, 전기자극의방법이있었다. 전기자극은 2편, 자침은 9편, 지압은 7편이였다. 내관외에선택된혈위는대저, 상거허, 공손이있었으며오심및구토와관련하여비경과위경을위주로채택한것으로보인다. TCM 변증에따른경우도 ST36( 족삼리 ). SP4( 공손 ), ST44( 내정 ), CV12( 중완 ) 등 15) 과같이소화기에관련된혈위가많았다. 침치료의효용성은오심및구토증상의경감을통해알수있었으며, VAS, RI 등의측정을통해유의한효과가있다는연구결과가 6편이였다. 증상의정도뿐만아니라증상이지속되는기간이단축되었다는연구가 1편있었으며, 체중증가, 케톤체, CO 2 결합능, 전해질균 형등신체생리상태의개선이나타났다는연구가 4편있었다. 약물사용량의감소로확인한것이 2편이였다. 총 14편의연구중 13편이긍정적인효과를보여주었고, 1편에서효과가유의한차이가없었다고하였다. 침치료의안전성을확인할수있었는데, 주산기결과, 임신부와신생아의합병증, 신생아의선천성기형발현을통해파악한연구가 2편이있었으며, 두연구모두침치료의안전성을보여주었다. 침치료의신뢰성에대한연구도 1편있었으며, 신뢰도가타당한것으로보고하였다. 침치료의효용성은오심증상의경감이많았으며, 이를통해식사가용이하게되는것으로보인다. 치료효과의지속시간도다른치료에비해긴것으로나타났다. 또한다른치료법과다르게단순오심및구토증상을줄이는것뿐만아니라전반적인생활기능을높여주는결과도나타났다. 임상시험에서침치료기간및방법은 3주간 3-4회 15), 4주간주 1회 ( 첫주는 2 회 ) 16), 주 2회를 2주동안 21), 4일간매일 24) 자침하거나 30초간매일 4회를 4일간지압 19) 하거나, 3일간지압밴드를차는식 22) 으로행해졌다. 이러한중재를통해오저증상의완화가나타난것을보아실제임상에서의치료기간의지침을정하는데도움이되리라본다. 임신오저치료에있어한약물의단독치료보다침단독치료에서오저의경감이더크게나타났다는연구 25) 과한약물만치료했을때보다침치료를함께할때호전도가높았다는연구 9) 를보아도임상에서침치료가주요함을알수있 77
다. 본연구에서살펴본연구에서도연구자의직군중간호사인경우가 3편이였으며, 최근간호및조산관련잡지에임신오저관련침치료에대한연구가많이실리고있다. 조산간호에서침치료의효용성에대한연구 31,32) 가있으며이보다앞서분만전후간호에침, 뜸, 지압, 안마치료적용에대한논의를다루는연구가있었다. 임상연구결과와교과서에서효과를기재하고있으며, 임신오저, 태위변경, 분만전후통증경감에관련한침구치료등에있어자격을갖춘임상가와인증된조산사가필요하다 33) 고하였다. 반면에스웨덴에서조산사들이효과에대한의학적근거가약함에도불구하고침치료를널리사용하고있는데, 침치료는침효과에대한체계적인평가가이루어진후에시행되어야한다 34) 는연구도있었으며, 이탈리아에서침치료는의료기술이기때문에 1982년부터오직의사들만이할수있으며 1977년국립보건원 (NIH) 에서 수술후, 화학치료로인한임신구토와임신오저에침치료가효과있다는명확한근거가있다 고하였다 35) 는연구도있다. 침치료의효과는이렇듯주장이여러가지로나타나고있지만, 침의효용성에대한의료인의관심은크다고보인다. 때문에실제치료의적용에있어서임상연구를통한의학적근거확보가중요하다할수있다. 이상살펴본연구들을통해임상에있어임신오저에대한침치료의진료지침을확립하는데기초를마련하며, 동시에이를바탕으로의학적근거확보를위한임신오저에대한침관 련국내임상시험연구가필요하겠다. 또한기존의연구가검증된혈위의유효성을평가하는연구가대부분이였음을고려할때앞으로의연구는한의학적진단기준에따른혈위선정이필요할것으로사료된다. V. 결론 2012년 6월 11일부터 13일까지 Medline 에서임신오저와침치료에관련된임상시험연구를검색하여총 14편의임상연구보고를수집하였다. 이상의임상연구보고들은주로내관의침술, 지압또는전기자극을통해오저증상의중재를꾀하였으며내관외에도귀의위점, 대저, 상거허, 공손, 그리고 TCM 변증을통한혈위선정을통해임신오저의침치료의효과와안전성및신뢰성을확인하였다. 임신오저의침치료관련한 14편의연구중유의한효과를보고한논문은 13 편, 유의성이없는경우가 1편이였다. 침치료의신뢰성에대한연구는 1편으로신뢰성이있음을보고하였고, 안전성에대한연구는 2편으로임신부와태아에대한위험은없는것으로확인되었다. 이상의결과를통해보았을때침치료는약물에대한감수성이높은시기인임신초기에태아에게보다안전하고효과적인치료라할수있을것이다. 이를통해임신오저의침치료에대한진료지침확립의기초를마련하며, 향후국내임신오저환자를대상으로변증을통한다양한혈위를바탕으로한임상시험연구가시행되어야할것으로사료된다. 78
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