THIRD PARTY CLINICAL STUDIES / NEXT GENERATION PDT

光动力治疗临床病例汇编
NGPDT TREATMENT CLINICAL STUDIES SUMMARY


• 1903年有人将从病人身上取下的癌肿,涂上一种叫伊红的色素,再用光线照射,结果癌细胞死亡。
• 1976年临床上应用一种血卟啉衍生物治疗膀胱癌获得成功,由此开创了光动力学疗法治疗癌症的历史。
• 1996年美国食品药品署批准该疗法用于治疗食管癌;
• 1997年法国和荷兰批准治疗中晚期肺癌和食管癌;德国批准治疗早期肺癌;日本批准治疗早期食管癌以及肺、胃和宫颈癌;
• 1998年美国批准治疗早期支气管内癌,后又批准治疗梗阻型支气管内癌(肺癌)。

• 1903, Danish doctor Georges Dreyer took cancer tissue samples from various patients, applied Eosin and treated the tissues with 630nm wavelength light; His findings were that the cancer cells died shortly after treatment. In 1976 further tests were conducted using a derivative of hematoporphyrin to treat Bladder Cancer successfully; These tests marked the begining of PDT as an effective cancer treatment.
• 1996, PDT treatment is approved to treat Esophageal Cancers by the FDA.
• 1997, PDT is approved to treat late stage Lung and Esophageal cancers in France and Holland; and is approved to treat early stage Lung Cancer in Germany; PDT was also approved to treat early stage Esophageal, Lung, Gastric and Cervical cancer in Japan.
• 1998, PDT is approved to treat early stage Bronchial and Lung Cancers in America.

由于癌细胞能特异性摄取一种叫光敏剂的物质。光敏剂注入人体后,能够定向聚集于癌细胞内,并较长时间停留在癌细胞内。光敏剂本身无毒性,在一种特殊波长的光(常用630nm的激光)照射后,氧分子变成一些活性单态氧离子,进而引起下列四种作用:(1)破坏癌细胞膜及其细胞内线粒体,引起癌细胞凋亡;(2)破坏供血给癌细胞的血管内皮细胞,引起血管阻塞,断绝对癌细胞的血液供应,进而引起癌细胞死亡;(3)促发一种炎症反应,引起白细胞在癌肿内积聚;(4)引发一种抗癌细胞的免疫反应。

PDT Process : After a photosensitizer agent is injected into a patients body, it accumulates only within cancerous cells in the patient. Following agent administration a special frequency light is applied (usually 630nm). Activation of the photosensitizer by the correct frequency light causes oxygen cells within the cancerous tissue to change to singlet oxygen molecules causing the following Four effects:

(1) damaged the cancer cells and caused apoptosis;
(2) damaged the blood vessel around the cancer cell and caused necrosis;
(3) stimulate an inflammation reaction, caused white blood cells to accumulate around the cancer;
(4) the body builds up immunity against cancer cells.

光动力治疗,作为一种具有深厚科学基础的疗法,它具有以下优点:(1)主要破坏癌细胞,不损伤正常细胞;(2)光敏剂无毒性,安全,不会抑制人体的免疫功能,也不会抑制骨髓而引起白细胞、红细胞和血小板减少;(3)可作多疗程,不会产生耐药性;(5)治疗时间短,每次治疗仅需40-60分钟;(6)疗效发生快,一般48-72小时后即可出现疗效。

PDT Treatment was found to have the following advantages to conventional approaches:

(1) only damagse cancer cells, leaving the body's normal cells unharmed;
(2) photosensitizer gent is non-toxic, safe and does not suppress the body's immune system;
(3) PDT can be used many times, the body does not build up resistance;
(5) PDT treatment period is minimal (40-60 minutes per light session);
(6) usually begins to take effect in just 48-72 hours.

妙医斋国医馆是由中山大学老教授协会协办的医疗机构,从2009年开始,引进NGPDT,并组成了以张博均博士为首的科研团队,共治疗了30位患者,根据对治疗进行的观察,结果令人振奋,以下是部分病例汇编。
Miao Yi Zhai clinic is an organization setup by the Old Professors Association of Zhong Shan University. It introduced NGPDT to its clinic in 2009, and has treat over 30 patients to date. The result has been inspiring.

NGPDT 对消化道肿瘤的治疗结果观察
NGPDT TREATMENT RESULT OBSERVATIONS ON DIGESTIVE CANCERS


1临床资料
1.1研究对象
2009年10月至2011年5月,经内镜和病理确诊的食管癌7例、结肠癌4例和直肠癌4例,共15例。其中男8例,女7例,年龄45~76岁,平均年龄55岁。15例均曾接受化疗治疗,且均为不愿手术或已失去手术治疗时机的进展期癌肿。

1. Clinical Information
1.1 Observation Object

From 2009 Oct to 2011 May, a total of 15 patients were treated specifically with NGPDT. Seven were diagnosed with Esophageal Cancers, 4 with Colon Cancers and 4 with Rectal Cancers; 8 males and 7 females at the age of 45-76 years (an average of 55 years old) made up the test group. All 15 patients had received chemotherapy before and were deemed not suitable or were not willing to have surgery.

1.2医疗设备和光敏剂
NGPDT (PASPDT-063型),多波长输出仪器。
所用光敏剂 PHOTOSOFT口服\雾化液。
(不用静脉注射,只需口服或雾化,不需要避光,更安全)

1.2 Medical Device and Agent
NGPDT (PASPDT-063), multi frequency output device.
Oral and Inhalation administration of NGPDT Agent (NGPDT Agent does not need to be intraveneouly administered)

1.3治疗方法
治疗前先进行PET\CT 监测,确定肿瘤位置、大小、及深度。第一天,患者口服光敏剂 PHOTOSOFT 80mg + 20mg 雾化 。24小时以后进行第一次光动力照射。输出光强度为500-1000mw/40-60min。第三天,患者口服光敏剂 PHOTOSOFT 30mg + 20 mg雾化。第四天进行同样的光动力照射。第五天,患者继续口服光敏剂PHOTOSOFT 30mg + 20 mg雾化。第六天进行同样的光动力照射,照射后口服50mg光敏剂。第七天,进行同样地光动力照射以后,口服50mg光敏剂PHOTOSOFT.第八天进行最后一次光动力治疗。整个疗程结束后,患者进行中医康复治疗。

1.3 Treatment Procedure
A PETCT scan was conducted on each patient prior treatment to locate the area, size and depth of the tumor.

Day 1 :Orally administered 80mg of NGPDT Agent, 20mg inhaled.
Day 2 : First light treatment is performed 24 hours after administration of the agent. Treatment Session time of 40-60 minutes.
Day 3 : Oral administration of 30mg and inhalation administration of 20mg of NGPDT Agent.
Day 4 : Second light treatment session.
Day 5 : Oral administration of 30mg and inhalation administration of 20mg of NGPDT Agent.
Day 6 : Light treatment session.
Day 7 : Orally administered 50mg of NGPDT Agent.
Day 8 : Final light treatment is performed.
Day 9 : NGPDT treatment course is complete.

Patients received traditional Chinese medicine as vitamin supplemented recovery program.

1.4疗效评判标准
根据中国光动力会议制订的近期疗效标准判断:
1. 完全效应:肿瘤完全消失,持续超过1个月;
2. 明显效应:肿瘤最大直径和其垂直直径或肿瘤高度的乘积缩小50%以上,并持续1个月以上;
3. 轻度效应:肿瘤体积的最大直径和其垂直直径或肿瘤的高度乘积缩小不足50%,并持续1个月以上;
4. 无效:肿瘤无缩小或增大。

1.4 Result Evaluation Standard
According to the result evaluation standard set by the China PDT conference:

1. complete effectiveness: tumor disappear and last for over a month;
2. obvious effectiveness: the diameter of the tumor has shrunk 50% or more;
3. slightly effectiveness: the diameter of the tumor has shrunk less than 50%;
4. no effect: the tumor has not increased or decreased in size.

2结果
2.1症状改善情况
患者经过1~3个疗程治疗后,上消化道肿瘤患者进食梗阻症状均有不同程度改善,直肠癌患者大部分经过一次照射后,便血消失,其中2例患者治疗前便血1天达0.5L左右,经过2次照射后出血停止,所有患者排便困难均有不同程度改善。

2. Result
2.1 Symptoms

After 1-3 courses of NGPDT treatment, Esophageal Cancer patients who had obstructions and/or difficulties swallowing before the treatment have all experienced different extents of improvement. All Rectal Cancer patients had a cessation of bleeding from the intestines after the first light treatment session; Two patients who experienced stool bleeding of over 0.5 litres/day reported a cessation of bleeding after two light treatments. All the patients who had difficulties with bowl movement reported different extent of improvement after completed treatment course.

2.2肿瘤变化情况
治疗后第2天即见部分肿瘤组织坏死,表面灰白,经过1~3个疗程治疗,4周后行胃肠镜复查,发现病变处管腔扩大,肿瘤消失或大部分体积有不同程度缩小。15例中,完全效应4例,明显效应8例,轻度效应2例,无效1例,总有效率为93.4%.

2.2 Tumors
Tumor tissue in patients was observed to have different levels of necrosis two days after the treatment, tumour surface changed to a grey and white colour. Endoscopy checkup four weeks after treatment showed all tumours had disappeared or had shrunk in size. From the 15 patient trial group, 4 have shown complete effectiveness; 8 have shown obvious effectiveness; two have shown slight effectiveness with one patient showing no effect. Total Effective Rate is 93.4%.

2.3不良反应
1例食管癌患者光动力治疗1周后出现大量呕血,排暗红色血便,急诊胃镜提示为食管活动性出血,考虑为食管癌光动力治疗术后肿瘤溃烂致出血所致,经内镜下止血和积极输血、补液等内科保守治疗无效,患者家属不同意手术治疗,2周后死亡。光动力治疗并发症发生率为5%.

2.3 Side Effects
One Esophageal Cancer patient had hematemesis and dark red colour of stool a week after the treatment. Gastroscopy showed that the bleeding was due to tumour festering after treatment. Blood Transfusion and other methods to stop bleeding were attempted but failed, patients family disagreed to emergency surgery, the patient died two weeks after treatment. PDT Treatment Complication rate of 5%.

2009年5月至2011年2月治疗13例癌患者

1、对象和方法
1.1对象 本组13例患者均经临床症状、内镜检查及活组织病理学检查确认,其中:男性10例,女性3例;年龄62-81岁,平均71.63岁;病程4-11个月,上段食管癌1例,中下段食管癌9例,贲门2例,食管—胃吻合口癌1例;

1. Object and Method
1.1 Object


All patients had condition confirmed via biopsy or scan. 10 male, 3 female; Aged between 62-81 years old with an average of 71.63. All were diagnosed from 4-11 months. One with upper esophageal cancer, 9 with lower part of esophageal cancer; two with cardia cancer; one with gastric cancer;

1.2方法 全部患者入院后查血、尿、便常规,便潜血、肝肾功能、心电图、胸透或胸片等检查,并给于静脉营养,纠正脱水、电解质紊乱、酸碱平衡失调,一般情况改善后,进行光动力治疗。所用设备为:NGPDT (PASPDT-063型),多波长输出仪器,所用光敏剂PHOTOSOFT口服\雾化液。治疗前先进行PET\CT 监测,确定肿瘤位置、大小、及深度。第一天,患者口服光敏剂PHOTOSOFT80mg + 20mg 雾化 。24小时以后进行第一次光动力照射。输出光强度为500-1000mw/40-60min。第三天,患者口服光敏剂PHOTOSOFT 30mg + 20 mg雾化。第四天进行同样的光动力照射。第五天,患者继续口服光敏剂PHOTOSOFT 30mg + 20 mg雾化。第六天进行同样的光动力照射,照射后口服50mg光敏剂PHOTOSOFT。第七天,进行同样地光动力照射以后,口服50mg光敏剂PHOTOSOFT.第八天进行最后一次光动力治疗。整个疗程结束后,患者进行中医康复治疗。

1.2 Method

All patients submitted blood test, stool and urine samples, and ECG, CT scan etc after checked in. They were given IV drips for nutrition and alkaline balance. After their general health condition was stabilized, patients started NGPDT treatment.
Device: NGPDT (PASPDT-063), multi frequency output device;
Orally and/or inhaled NGPDT Agent.

2、结果
2.1疗效标准 CR:吞咽困难消失,可进正常固体食物;PR:吞咽困难基本消失,可进半流质及软食;NR:进食情况无改善者。

2. Result
2.1 Result Standard


CR: Swallowing difficulties disappear; able to consume solid food
PR: Swallowing difficulties partly resolved; able to consume liquid and soft foods
NR: no improvement

2.2治疗效果 本组患者CR7例;PR6例;NR 0例;总有效率100%。且分别于疗程结束第7、14天复查血、尿、便常规,便潜血、肝肾功能、心电图、钡餐透视均无异常发现。

2.2 Treatment Result: Of the patients treated, 7 were present with CR, 6 were present with PR. The total effective rate for NGPDT - 100%. On 7th and 14th days after the treatment, patients submitted new blood, urine, and stool tests, ECG, PET all of which showed no abnormal symptoms.

案例1: 患者 XX 男 81岁,因进食梗阻2个月,确诊为"食管下段鳞癌",放疗后缓解3个月,再次"梗阻",仅能进流食。。2009年接受NGPDT治疗,5天后可进饮食,至今仍存活。

Case study 1: Patient XX, male, 81yo, had eating obstruction for two months, diagnosed with Esophageal Squamous Cell Carcinoma. The obstruction relapsed 3 months after radiation and as a result the patient could only consume liquid food. Patient received NGPDT treatment in 2009, was able to consume food five days after treatment. Currently still alive.

案例2:患者姓名:姜浩,男,43岁,鼻咽癌,广东人。 简要病史:诊断鼻咽癌六年,先后作过多次放疗和化疗,临床诊断为鼻咽癌IV期,而且无法再次进行放疗和全身化疗。 鼻咽镜下所见:右侧鼻腔完全为肿瘤所阻塞,肿瘤组织质地硬,触之极易出血,难以清除,鼻腔内侧以及鼻咽部有肿物浸润,部分阻塞鼻腔。 10天后检查,左侧鼻腔见鼻腔内侧壁、鼻腔内侧以及鼻咽部上壁有肿物有坏死,用活检钳钳出大部分坏死组织。患者治疗后双侧鼻腔通畅,现在进行中医调理,在康复中。

Case study 2: Patient Jiang Hao, Male, 43yo, Nasopharyngeal Carcinoma, Medical history summary: Patient has suffered with Nasopharyngeal Carcinoma for 6 years. Had chemotherapy and radiation multiple times. Clinical diagnosis confirmed he was at late stage of cancer and that he was not suitable for chemotherapy or radiation treatments. Nasopharyngoscopy Report: Right nasal cavity blocked by tumour, bleeds easily when touched. Inside nasal cavity and on wall of the nasal cavity are partly blocked. 10 days after NGPDT treatment, dead tumour cells present in the left nasal cavity, inside and the upper part of nasal cavity. Biopsy confirmed most of the tumour tissue is necrotic. Nose no longer unobstructed. Patient now is in recovery with Natural Herbal Therapy.

案例3: 光动力治疗声带癌一例
患者黄某某,男性,63岁,患者2008年12月起出现声音嘶哑、低沉,随到汕尾市人民医院就诊,行喉部CT检查,未发现异常,行气管镜检查,后因剧烈咳嗽而未成功。给予中医中药治疗声音嘶哑症状一直未能缓解,2009年4月4日于行喉镜检查,诊断为右侧声带新生物,性质待定。2009年5月10 日于南方医院行右声带活检术,病理结果显示:"(右声带)中分化鳞状细胞癌"。

Case study 3: Patient Huang XX, male, Vocal Cord Cancer, 63yo. Patient experienced hoarseness of the throat since 2008 Dec, nothing abnormal was found by CT. A Bronchus check failed due to non-stop coughing. Natural Therapies didn't relieve patients symptoms. 2009 April, Laryngoscope found a node in patients right Vocal Cord . Biopsy in 2009 May confirmed Differentiated Squamous Cell Carcinoma.

2009年12月24日行首次光动力治疗,采取同样地治疗方法,两个月后复查,电子喉镜发现肿瘤组织完全消失,正常声带组织完全修复肿瘤部位,患者保住了声带,可以跟正常人一样交谈,从而达到了消灭肿瘤、保护了器官功能效果。

2009 Dec, patient treated with NGPDT. Checkup two months after treatment, the tumour has completely disappeared, normal tissue replaced the tumor site. Patients vocal cords are intact and patient can talk normally.

本例声带癌患者病变范围涉及右侧声带,但是病变的深度较浅,外科手术切除肿瘤必须行半喉甚至全喉切除方能达到治疗肿瘤的目的,一旦手术切除则患者就要失去自己的声音作为代价,患者为教师,因此失去声音更是难以接受。根据喉镜复查可见:右侧声带肿瘤消失,正常声带组织取代肿瘤组织,因此光动力治疗彻底清除了右侧声带肿瘤,对周围正常组织没有任何损害,还保留了右侧声带及其正常功能。因此光动力治疗可作为早期声带癌的最佳疗法。

This patient's tumor was on the right of the vocal cord, suggested surgery would have removed the patients vocal cords. Treating this patient with NGPDT has resulted in a full recovery while leaving essential organs intact. NGPDT has repeatedly proven to be the best therapy for early stage Vocal Cord Cancers in our clinical studies.