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李扁的网易博客——性是智慧门

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李扁  

我叫李扁。合该倒霉,那年念了书,毕了业,混了一个编辑做。鉴于多年受党教育,大公无私的情怀一直都是那么激烈,所以在被李编李编的叫来叫去之后,决定把编的绞丝除掉,叫个李扁算了。没想到效果就有那样的好,有个姓王的,愣是请我吃了一顿饭,商量把这个字让给他,结果我没有让。后来,过了两年,陈水扁同学出来了,也是一个扁字,根本上就没有请我吃饭,也没有同我商量,自己就叫了。这些年,我是一直都被他抢了风头。木得法子。

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Minimally Invasive Targeted Drug Delivery (MITDD): A Novel Approach to Treatment of Pulmonary Tuberculosis   

2017-07-10 16:41:45|  分类: 默认分类 |  标签: |举报 |字号 订阅

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Minimally Invasive Targeted Drug Delivery (MITDD): A Novel Approach to Treatment of Pulmonary Tuberculosis 

Shenzhen Shan Xia Hospital is one of the designated TB treatment centers in Shenzhen region and the very first non-governmental hospital ever granted such designation for treatment of TB in China. We strongly believe our hospital and our medical teams are fully capable of conducting credible TB-related clinical research in compliance with the guidelines set by China Globle Fundation.

 I. Background 

Based on recent WHO report, about 2 billion people worldwide have been infected with TB. Among those, 20 million people have active pulmonary TB. With one fourth of the entire TB patients living in China, we share the largest burden of TB cases. The TB epidemics in China is also characterized by high incidence, high drug resistant rate, high mortality and low cure rate. Drug resistant cases (MDR-TB and XDR-TB) are becoming a serious threat to public health and social concern. By traditional treatment methods, only 85% of newly diagnosed TB cases have a chance for cure. The recurrent and drug resistant cases have much lower cure rates. Complicated cases have little hope for cure. 

TB is traditionally thought to be a simple infection by TB bacilli. Thus all treatment approaches are focused on eliminating TB bacteria. Our experience and study results show that, besides TB bacilli, other microorganisms also play important roles in creating an optimal environment for the TB bacilli to grow. Without eliminating these supporting coexistent microorganisms, anti-TB therapy along often fails. 

In the last decade, we have treated about 3000 cases of pulmonary TB. These patients were from more than 20 different provinces/regions across mainland China. Among them, 90% had been treated for a prolonged period of time and saw little or no effect. Many of them became drug resistant, shown extensive irreversible pulmonary destruction (such as multiple thick-walled cavities, bronchial stenosis or dilatation, pulmonary failure with anemia). Many of them came to us with a hope to find the last straw. All patients were treated with our MITDD method. Initial treatment protocol consists of 30-day hospitalization with 3-4 injections then followed by 60-day oral medication.98% patients shown complete remission of pulmonary TB by CT and negativity of TB bacilli by sputum analysis. In severe/complicated cases, three cycles of the above treatment were given and 85% of these cases demonstrated closure of cavities and negativity of TB bacilli in sputum.

The current TB treatment protocols (including Drug-resistant TB chemotherapy guidelines – 2009) focus on combinations of fist line and second line anti-TB antibiotics (total less than 20 drugs), dosages and durations of treatment. But the key point here is the therapeutics delivered by oral or intravenous method can not efficiently penetrate through the densely fibrosed cavity wall to reach the target. Therefore, the TB bacilli can survive, continue to grow and become drug resistant. 

Our new concepts of pulmonary TB and 3-D thinking results in the birth of MITDD. This novel approach enables us to deliver highly concentrated drugs directly to the infected lesion. Our clinical results have proven that this new method is indeed superior to the current standard treatments. With the success, we are determined to perfect this new approach through extended basic and clinical studies, to promote new concepts in TB treatment, and to ultimately benefit TB patients worldwide. 

II. Readiness and Advantages 

1. Current Conditions and Advantages 

(1) Shenzhen Shan Xia Hospital is one of the designated TB treatment centers in Shenzhen region and the very first non-governmental hospital ever granted such designation for treatment of TB in China.  There are120 beds specifically designated for the care of TB patients. Of 500 hospital employees, about 100 are actively involved in TB research and patient care. We have 10 senior faculty staffs that are at or above associate professor level and 3 of them are crowned with national distinguished scholar by central government. In the past, we treated about 3000 TB cases. We developed our own recipes, such as “TB No 1”, “Repair No. 1” and “Bronchoplural Fistula Repair No. 1”, to treat TB-related conditions. We also invented a multidirectional drug injection needle and developed a precise cavity/lesion localization method by using a CT film and a mobile ruler. 

(2) Minimally Invasive Targeted Drug Delivery (MITDD) system includes (a) cavity tube in placement; (b) percutaneous needle drug injection; (c) air capsule bronchial catheter injection and (d) pleural tube in placement. 

(3)  Advantages of our MITDD 

(a) Wide Indication: Excluding patients with coagulation disorders and severe heart, pulmonary, hepatic and renal failure, almost all pulmonary TB cases can be safely and effectively treated with MITDD. 

(b) Quick Response and High Efficacy: Newly diagnosed cases can be cured within one month of inpatient treatment. Recurrent and complicated cases can be cured with 2-3 cycles of one month inpatient MITDD therapy. 

(c) Simple Operation: It only requires a CT film, one mobile ruler, one large syringe and a iv catheter pack. The entire procedure can be done in 5-10 minutes, at bedside and with minimal to mild discomfort to the patient. 

(d) Compared with CT/ultrasound or bronchoendoscopy guided drug injection, our MITDD is much more simple, faster, less discomfort to the patient and much less expensive. It also significantly reduces radiation exposure to both patient and medical staffs. In comparison with slow release gel placement, MITDD achieves much higher drug concentration at the lesion. 

(e) Our self-designed multidirectional injection needle allow drugs to diffuse from all directions and more effectively to cover larger area per injection. 

(f) Based on our belief that the TB infected lesion also contains coexistent non-TB microorganisms along with culture and drug sensitivity test results, MITDD allow us to administer individualized therapeutic recipes to a patient. This approach greatly reduces gastrointestinal side effects and hepatorenal toxicities from oral or iv medication. 

(g) By conventional oral or iv drug administration (DOTS), the drugs can not penetrate effectively through the densely fibrosed wall into the lesion where the microorganisms grow. By our MITDD, drugs can be delivered directly into the lesion and be accumulated through multiple injections to reach thousands fold higher concentration than that of DOTS therefore effectively inhibits and kills the organisms. 

2. Goals and Requirements 

(1) Design and conduct basic and clinical studies to build supports for this new treatment method. Establish and optimize microbiology lab and establish culture and drug sensitivity tests. Conduct pharmacokinetics and pharmacodynamics studies to optimize drug schedules. 

(2) Design and conduct clinical trials demonstrate efficacies of different drug delivery methods and treatment recipes. Correlate efficacies with histopathologic findings of cavity wall. Continue to collect, analyze and publish findings and to make necessary adjustment to the future studies.

(3) Attend national and international meetings, collaborate with other authority institutions and experts; promote new methods of TB treatments through on-site seminars and training courses. 

3. Methods 

Once funded, we will start to enroll patients for clinical trials. All patients, before treatment starts, will be subject to a thoracic CT exam, 3 consecutive sputum slide exams, 1 rapid culture and drug sensitivity test. Negative cases will be subject to sputum PCR test to confirm TB infection. If still negative, then needle aspirate directly from the lesion will be used for PCR test. For newly diagnosed cases, 3 sputum exams and 1 sputum culture will be performed at the end of 1 cycle/1 month therapy followed by a repeat CT 2 months after discharge. For drug resistant and complicated cases, there will be additional 3 sputum slides and 1 rapid culture done at the end of each treatment cycle then at two months after discharge at which time a repeat CT will also be done. Drug resistant cases will be followed up for 2 years and cure is defined as 5 consecutive negative sputum tests within the last 6 months of treatment. We plan to select 500 cases per year for the randomized comparison studies. 

III.  Description of the Research Projects 

1. Aims: Through coordinated basic and clinical studies to provide evidence-based support to our new treatment method. To individualize drug schedules based on location and size of the lesion, disease natural history, history of dug exposure and complications. 

2. Plans of Activities: 

a. Activities: Within the first three years, we will (1) establish and optimize basic and clinical labs and standardize rapid TB culture and drug resistant test. (2) Compare the efficacy of our MITDD with the results of Yeager’s method (published in 1976) and of current WHO recommended chemotherapy schedules (DOTS). (3) For drug resistant cases, we will compare our MITDD group with the group treated according to China 2009 Drug Resistant TB Chemotherapy Guidelines. (4) Information exchange and collaboration with other authority institutes and experts; publish study findings; organize on site seminars and training courses to promote new treatment methods. (5) Extend basic and clinical studies and attract more grants/financial supports worldwide. 

b. Table of Planned Activities


Minimally Invasive Targeted Drug Delivery (MITDD): A Novel Approach to Treatment of Pulmonary Tuberculosis - 李扁 - 李扁的网易博客——性是智慧门
 Minimally Invasive Targeted Drug Delivery (MITDD): A Novel Approach to Treatment of Pulmonary Tuberculosis - 李扁 - 李扁的网易博客——性是智慧门
   Minimally Invasive Targeted Drug Delivery (MITDD): A Novel Approach to Treatment of Pulmonary Tuberculosis - 李扁 - 李扁的网易博客——性是智慧门
  

SECOND YEAR (2011) Establish and optimize basic and clinical labs; purchase equipment; lab personnel training; start basic and clinical studies; prepare periodic summery of progress. 

THIRD YEAR (2012) Continue all planned research activities; periodic progress report; review of progress by authority and experts; prepare to apply for National Natural Science Foundation; establish plans for the next three years. 

FOURTH YEAR (2013) Summarize all studies and publish results; continue clinical trials and patient follow-ups; apply grants from  National Natural Science Foundation and other national and international sources. 

FIFTH YEAR (2014) Continue to collect data from clinical trials and patient follow-ups; further stratify patient groups and run more detailed comparison analysis; publish results and  apply grants from  National Natural Science Foundation and other national and international sources. 

SISTH YEAR (2015) Close clinical trials and run comprehensive data analysis; literature search and expert consultation; publish results and apply for science/technology advancement rewards; promote new treatment methods nationally and internationally. 

1. Progress Monitoring and Evaluation 

(1) All funded research activities will be closed monitored by published national standards. Our efficacy comparison studies are readily evaluated. 

(2) Methods of Monitoring and Evaluation: Individual research project team will have a self-exam and self-evaluation every 6 months to identify any problems and propose plans for improvement. Hospital Research Committee will conduct an annual review and evaluation for each project and make necessary recommendations.  

I. Budget 

Total projected cost: $2,031,780.

Note: Besides external funds, we will invest our own money to support the above research activities. 

II. Organization and Research Teams 

Shen Zhen Shan Xia Hospital is one of the largest non-governmental hospitasl in China. The hospital has 400 beds and occupies about 40,000 square meter medical complex. Our Thoratic Disease Department was established in 2008 and was granted as one of the designated TB treatment centers by the health department of Shen Zhen city in May, 2010. We are proud of being the very first non-governmental hospital to become a designated TB treatment center. 

The Department has three sections and 120 beds in total. There are 48 full time medical staffs, of which 10 are at or above associate professor level and three hold distinguished scholar title granted by central government. For the last ten years or so, we have treated over 3000 pulmonary TB cases and achieve overall efficacy of 98% and cure rate of 95%. We are becoming one of the most experienced and reputable institution in the treatment of pulmonary TB in China.  

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