肛瘘膏：“中医药献给世界的一份礼物”

肛瘘膏治疗小儿肛瘘取得重大进展

山东中医药大学附属医院黄乃健

1.创新与发展

几个世纪以来，手术疗法一直是治疗肛瘘的最佳方法。但小儿患者由于年龄和生理功能等情况，采用手术疗法必须在适宜的麻醉下进行。临床选择适应症时，一般3岁以下的小儿为了安全,以延期手术为宜，最好采用一般保守疗法。为此，设想使用一种药物涂敷于肛瘘内口处，使内口闭合而使肛瘘痊愈，从而取代手术疗法。此法为原创性研究，国内外首创，临床治疗已取得成功，试验室研究正继续进行。

黄乃健教授在长期的临床实践中发现，小儿肛瘘偶有自愈的病例，基于此种情况，采用具有祛风胜湿、活血等作用的复方中药，以膏剂方式注入肛管，使药物敷于肛瘘内口区，经过多次给药，在药物的作用下，使肛瘘内口自行闭合，从而达到治愈肛瘘的目的。通过15年余的临床研究，已治愈800余例，取得了良好效果。特别是近3年的系统观察，治愈率达100%,开创了中药局部涂敷治愈小儿低位肛瘘之先河，在小儿肛瘘以药物治疗的非手术疗法中取得了突破性进展，打破了肛瘘非手术不可治愈的论断，是肛瘘治疗学上的重大革新。此法完全符合肛瘘治疗中不损伤任何组织，完好保护肛门功能的要求，同时消除了患者家人畏惧手术心理，在肛肠病的治疗中有重要意义。另外此法还可治疗直肠阴道瘘、骶尾部窦道等病，同样有很好的疗效。

2.应用方法及注意点

（1）应用方法：取上药少量放入一较小容器内，以凉白开水适量滴入容器中将药粉调成膏状（状如牙膏），然后用棉棒取药膏放入注射器内，用注射器芯将药膏推至注射器前端，如用5ml注射器其前端针嘴部长约1cm，与患儿肛瘘内口距肛缘的距离相差5mm。为规范操作，我们特制了与5ml或10ml注射器配套的专用接头，此接头长13mm。将特制接头安放至注射器前端针嘴上，注射用具已备好。小儿肛瘘的内口距肛缘约15mm，特制接头短2mm，当加压注药时药膏前移，比较准确地覆盖于内口区。注药前患儿取适宜体位，一般左侧肛瘘取左侧卧位，右侧肛瘘取右侧卧位，将药膏由注射器推出少许，使特制接头前端有少许药膏，此可起润滑作用，将接头由肛门中央缓缓插入患儿肛管内，轻柔缓慢注药，注毕退出注射器。

（2）注意点：①药膏浓度。应足够稠，越稠越好，但能够从注射器推出。药膏不能稀，不能以注射器从盛药容器中将药膏抽吸至其内。②注药深度。小儿肛瘘的内口约距肛缘1.5cm。使用特制注射器接头，与肛瘘内口距肛缘深度比较适合，一般用5ml注射器。将特制接头插入肛管内后即可注药，注药时应无药膏从肛门溢出。如有药膏从肛门外溢，则表明注药深度尚浅，可将整个注射器轻轻前推，此时注药如不再有药膏外溢，注药深度已适宜，可继续注药。③注药后如药膏从肛门溢出，即刻用卫生纸将药膏彻底擦净。④不能将药膏注入肛瘘管道内。⑤此法不要求无菌操作，故注药前无需进行局部清洁消毒和肠道准备等。⑥治疗过程中注意肛瘘管道粗细的变化，由粗变细是肛瘘渐愈的明显标志。⑦小儿感冒、发热、腹泻时不能用药，肛门局部如有裂损、溃疡亦不宜用药。用此法治疗期间不宜行疫苗接种。⑧有无饮食禁忌应咨询本课题医师。

（3）用药量及次数：1岁以内小儿每次用量1.5ml，一日注药2次。为使药膏顺利注入肛管，应睡觉时注药，晚上睡觉时给药1次，白天排大便后睡眠时给药1次。成人用药，每次2ml，每日2次，给药时间晚上睡前给1次，其他时间自定。

3.痊愈标准和疗程

按现代医学的观点，肛瘘内口为较硬的瘢痕组织，不可能用药物使其愈合。肛瘘内口和管道由结缔组织形成，肛瘘手术后所形成的瘢痕亦是结缔组织；即使手术后的瘢痕时日已久可以变软，但不可能消失。令人惊奇的是，本疗法用药后小儿肛瘘不仅内口逐渐愈合，而管道由粗变细，由原来的硬度变的更硬，最后管道完全消失。但其机理尚不明确，这也许是人体机能之奥妙。如肛瘘管道有外口者，一般外口闭合后3个月如不复溃，这是明显进步的征象。疗程：1岁以内小儿如其肛瘘管道粗约1mm，一般1个月左右可愈合，如肛瘘管道粗约2mm、3mm、4mm、5mm或5mm以上，则疗程较长。

4.有关问题

（1）关于给药部位：根据要求，应将药膏在直视下直接涂敷于肛瘘内口区，这样给药部位准确，药物易作用于局部，收效理想。在临床实践中发现，小儿易哭闹，很难配合治疗，故采用此方法注药，这种给药方法不强调药物确切地涂敷于内口区。因为在给药方式上对药物如何涂敷于肛瘘内口区确实存在着盲目性，即药物涂敷部位不够准确。但临床实践证实，本研究之注药方法能完全治愈小儿肛瘘，且对局部的刺激小，患儿易于接受。（2）本疗法的优缺点：此法操作简便，无痛苦，无副作用，疗效确切，患儿及家人易于接受。由于给药方式的不足，患儿疗程较长，有待进一步改进。

说明：

1.《肛瘘膏治疗小儿肛瘘取得重大进展》一文，可登录“梅笑玲主任医师好大夫在线”查看。

2.深圳一QQ群介绍小儿肛瘘较详细。此群全称：肛周脓肿宝宝群，肛瘘膏群号：197035028

3.黄乃健教授电话：0086+0531-82978751，请于下午3点以后拨打。

邮箱：naijianhuang@163.com

Great Progress of “Anal Fistula Ointment” in the Treatment of Infantile Anal Fistula

The Hospital Affiliated to Shandong University of TCM

HUANG Nai-Jian

1. Innovation and Development

For centuries, surgery has long been the optimal way for treating anal fistula. However, considering the infantile patients conditions such as age, physiological functions, and etc, surgical therapy should only be carried out under the appropriate of anesthesia. During selecting the indications clinically and considering the safety of the infant, under the age of three years old would better delay their time of operation and only could be general conservative therapy. So, I assume that by using a particular drug to coat the internal openings of anal fistula for making it closed can also cure the disease. Therefore avoiding surgical therapy. This method belongs to original research, which is the first at home and abroad. Clinical practices have already achieved success and further laboratory researches are in progress.

Through long-term clinical practices, Professor Huang has noticed that infantile anal fistula could occasionally be self-curing. Based on this discovery, by selecting compound formula of Chinese drugs with the efficacy of expulsing wind, eliminating dampness and promoting blood circulation and prepared a paste can be used as a form of treatment.Then injected the paste into the anal canal to cover the internal opening area of anal fistula. Due to the effect of this medical paste, internal opening closed after multiple administrations and therefore achieving the goal of curing anal fistula without surgery.

Demonstrating significant efficacy,800 cases have been cured through more than 15 years of clinical research.Especial near three years of system observation has also indicated that the curative rate is up to 100%, which is the first time to locally use traditional Chinese medicine to cure infantile low anal fistula. This form of treatment has made breakthrough progress in the treatment of infantile anal fistula with non-surgical medication. This form of non-surgical treatment is an excellent innovation in treating anal fistula. It successfully broke the widely accepted traditional theory in which that non-surgical therapy could not cure anal fistula.

This form of therapy not only completely meets the requirements without damaging any tissues but can also protect the anal function while in treatment. Non-surgical treatments such as this can also eliminate the fear of surgery not only from the patient but also their relatives. Considering these benefits, this breakthrough is truly important significant in the treatments of anorectal diseases.

In addition, this therapy can also cure rectovaginal fistula and sacrococcygeal sinus, etc.,which has also best efficacies.

2. Application Method and Points of Attention

1) Application method: Put a small amount of the drugs powder into a smaller container and drip the appropriate amount of cool boiled water into the drug-powder to make it becoming paste form (as toothpaste). Then put some of the paste into a syringe with cotton swab and by syringe core push the drug paste to the front end of injector. The length of needle holder for 5ml syringe is about 1.0cm, which is 5mm shorter comparing to the depth from the internal opening of infantile anal fistula to anal edge.

In order to normalize therapy-manipulation, we specially designed a special purpose complete set joint to the syringe of 5ml or 10ml. This joint is 13mm in length and is placed it on needle holder of syringe.At this time the injection tool has been prepared completely. The length of joint (13mm) is 2mm shorter than the distance of the internal opening of infantile anal fistula to anal edge. When pressing to pash the drug paste,it moves forward just to cover the internal opening accurately. The patient should take appropriate position before injecting the medicine. Left side anal fistula should take the left decubitus position while for right side anal fistula the patients should take the right decubitus position. When applying, first push a little of drug paste out of the syringe to act as lubrication then slowly insert the joint into the infant’s anal canal along the center site of anus and gently infuse the drug paste into the anal canal completely. Withdraw the syringe when finished.

2) Points of Attention:

(1) The concentration of the drug paste should be as thick as possible while can still be pushed out from the syringe smoothly. The drug paste should not be so thin that it can be aspirated into the syringe from the container directly.

(2) The infusion depth should be appropriate and no spillage of the medication should occur. Given the distance from the internal opening of infantile anal fistula to anal edge is about 1.5 cm therefore the 5ml syringe is recommended. The addition of the specially made joint the injection device will just be suitable for the distance. Immediately infuse the drug paste after completely inserting the joint into the anal canal. No drug paste should leak out from the anus when infusing. Spillage will occur if the injection depth is still shallow. Gently push the syringe forward again if spillage occurs to stop the leakage. The injection may continue the injection depth has been appropriately adjusted. Repeat the process if necessary.

(3) Immediately wipe off the leakage with toilet paper if spillage occurs after the infusion.

(4) The drug paste cannot be infused into the anal fistula tract.

(5) This therapy does not require aseptic operation. Therefore it does not need the local clean and disinfection and bowel preparation before injecting.

(6) The degree of thickness of the anal fistula tract should be noticed during treatment. If the anal fistula tract becomes thinner then it indicates that the anal fistula is gradually healing.

(7) If the infant is currently suffering from cold, fever or diarrhea then this drug is not applicable. The drug is also not applicable if the infant is suffering from local anal fissure and ulcer, and etc. Vaccination is not recommended during the treatment with this therapy.

(8)Consult the relative physician of this study on diet taboo during treatment.

3) The Dosage and Times of Administration

Use 1.5ml at a time and apply twice per day for children under one year old. Application of the medication should occur at the time of sleep to guarantee the drug paste can be smoothly infused into the anal canal. Apply once before sleep at night

and once before sleep during the day after defecation. For adults, use 2ml at a time and apply twice per day. Apply once before going to sleep and the other time decided by patient-self.

3.The Standard for Recovery and the Treatment Course

According to the view of modern medicine, the natural state of internal opening of anal fistula is of harder scar tissues, which cannot be healed by using drugs. Anal fistula internal opening and tract is formed by connective tissues and postoperative scar is also formed by connective tissues. Though the scar can become softer longtime after operation but it still not disappear.Surprisingly, after using the drug-paste of this therapy, the internal opening not only gradually healed, but also the tracts of infantile anal fistula changed from thick to thinner, from original hard to harder, and finally completely disappear, namely the anal fistula is cured.

The mechanism of this therapy is unclear yet, which maybe the secret in function of human body. If the anal fistula tract having external opening and also the opening does no longer recurrent 3 months after it closed, which show the sign of significant progress.

Treatment course: Generally speaking, infants under one years old whose tract is about 1mm in diameter could be cured in about one month. If the tract is up to 2mm, 3mm, 4mm, 5mm, or more than 5mm in diameter then the treatment course will be longer.

4. Relevant Issues

1) Administration Site of the Drug-Paste: According to the essentials, the drug paste should be directly applied and covered over the internal opening area under direct vision to guarantee accurate coverage of the administration site. Once accurately located and covered the drug can easily affect the internal opening area thus achieving ideal efficacy. Clinical practices have found that children are likely to cry and not cooperate with the treatment therefore the author adopted the above administration approach. This approach does not emphasize so accurately on coating the drugs on internal opening areas because there really is the blindness in the process of coating the drug paste on internal opening area, namely the drug application site is not accurate enough. However clinical practice verified that the therapy of this study can fully cure infantile anal fistula with milder local stimulation and is easy to be accepted by the patient.

2) Advantages and Shortcomings of This Therapy: Manipulation of this therapy is simple and easy. It is painless and has no side effects. The effect is certain thus easy to be accepted by the infants and their relatives. Due to the disadvantage in administrating drug manner so that treatment course lasting longer,which needs to be further improved.

Notes:

1)Search for the paper “The Great Progress on the Treatment of Infantile Anal Fistula” with Ganglou Gao (Ointment for Anal Fistula), Please log in “MEI Xiao-Ling Chief Surgeon. good doctor on line”

2)Shenzhen QQ(Ganglou group No.197035028,Gangzhou nongzhong baobao group): on infantile anal fistula in detain.

3)Professor Huang Nai-jian, Tel: 0086+0531-82978751. Please call on after 3pm. Email: naijianhuang@163.com