Biomedical Research

Abstract

Purpose and significance: By observing the clinical efficacy, adverse reactions and improvement of the quality of the patients' life of the study that The Shunqi Tongluo Cream combined with the Aidi explore new ideas and methods of treatment of lung cancer patients and provide the basis for the treatment of lung cancer and ultimately to improve the quality of life of patients with pleural effusion of lung cancer and prolong survival purposes.

Methods: The patients diagnosed as lung cancer by means of the theory and / or histological examination and accompanied with the symptoms of chest tightness and shortness of breath were randomly divided into treatment group and control group, and each group included 20 cases of patient. The patients in the control group were intervened by the Aidi injection alone while the patients in the observation group were intervened by the Shunqi Tongluo Cream combined with the Aidi injection, and the treatment efficacy and adverse reactions of the two groups were recorded.

Results: After treatment, 20 cases of patients of the treatment group included 15 patients of Complete Response (CR), 15 patients of SD and 5 patients of No Response (NR), of which the total effective rate was 75.0%, while 20 cases of patients of the treatment group included 0 patients of Complete Response (CR), 11 patients of Stable Disease (SD) and 9 patients of No Response (NR), of which the total effective rate was equal to 55.0%. There was statistical significance (P=0.01<0.05) between the total effective rates of two group.

Conclusion: 1. For the lung cancer patients with the symptom of chest tightness and shortness of breath, the efficacy of Shunqi Tongluo Cream combined with the Aidi injection is better than that of the Aidi injection alone. 2. The Shunqi Tongluo Cream combined with the Aidi injection can better relieve the symptoms. The observation demonstrated that the therapy by means of the Aidi injection combined with the TCM Shunqi Tongluo Cream topical application plus heat irritation possesses unique therapeutic advantages and has the value of clinical promotion and application.

Keywords

Shunqi Tongluo cream, Chest tightness, Shortness of breath

Introduction

Primary bronchial lung cancer, or lung cancer, is a malignant tumor originating in the bronchial mucosa or gland. According to the World Health Organization (WHO) published in 2008, according to the number of years of lung cancer incidence is 1.6 million, 1.4 million deaths, the world cancer first, in our country, lung cancer has become the leading cause of cancer death, caused by a lack of early diagnosis of the lung cancer prognosis is poor, 80% of patients died within 5 y after the diagnosis, only 15.8% of lung cancer patients confirmed can survive more than five years [1].

After thousands of years of clinical practice of traditional Chinese medicine and herb tea logos, self-contained, the individualized treatment, compared with western medicine has its unique characteristic and advantage, to improve patients' physical fitness, tolerance and immune ability, reduce the adverse reaction of the radiotherapy, enhanced radiation and chemotherapy effect, and make a long-term survival with tumor patient, significantly improve the patient's quality of life. TCM clinical practice for a long time, has accumulated rich experience in the treatment of, these experiences is the combination of theory and practice of traditional Chinese medicine essence, from generation to generation, accumulate over a long period, the use of traditional Chinese medicine treatment can effectively improve the quality of survival in patients with lung cancer and level, long-term treatment of patients with reduced cost, reduce the economic burden of patients.

Our department treated the symptoms of chest tightness, shortness of breath resulting from the lung cancer by means of the Shunqi Tongluo Cream topical therapy plus the Aidi injection. Compared with the Aidi injection therapy alone, the combination therapy provided a more satisfactory effect. Now we reported the effect in following.

General Information

Case source

All of 40 cases of patients of this group were the Hospitalized patients between June 2014 and December 2015. All of the cases were advanced lung cancer patients diagnosed by means of the Cytology and/or histopathology examination and who can’t receive or didn’t agree the Radiotherapy, chemotherapy, and all of these patients had the symptoms such as chest tightness, shortness of breath and in whom a large number of pericardial effusion and a large number of pleural effusion weren’t detected. These patients didn’t have the history of allergies based on the color ultrasound or CT examination, and it is primarily expected that their survival period should be longer than three months. All the cases were numbered according to the patient's visit order. The random numbers were extracted according to the random numbers table, and then the patients were divided into control group and treatment group which included 20 patients and 20 patients respectively. The treatment group included 12 cases of male patient and 8 cases of female patient in the age of 39 to 75 y old and in the average age of 58.9 y old; and included 5 cases of small cell carcinoma, 4 cases of squamous cell carcinoma and 11 cases of adenocarcinoma. The control group included 13 cases of male patient and 7 cases of female patient in the age of 49 to 71 y old and in the average age of 58.3 y old; and included 6 cases of small cell carcinoma, 5 cases of squamous cell carcinoma and 9 cases of adenocarcinoma. There wasn’t significant difference between the patients of the two groups after the statistical treatment for gender and ages (P>0.05), and the data of the two groups had the comparability.

General information

The comparison of the general information of two groups of patients, including the comparison of information such as gender, age, history of smoking, grade of the Chinese medicine symptoms, etc., was listed detailed in the Tables 1-4.

Table 1. Comparison of the gender constituent of the two groups (case). Note: After the statistical treatment using χ² test, the gender constituents of the two groups were comparable (P>0.05).

Table 2. Comparison of the age constituent of the two groups years old (%). Note: After the statistical treatment using the rank sum analysis, the age constituents of the two groups were comparable (P>0.05).

Table 3. Comparison of the histories of smoking of the two groups before treatment. Note: After the statistical treatment using the rank sum analysis, the histories of smoking of the two groups were comparable (P>0.05).

Table 4. Comparison of the grades of the Chinese medicine symptoms of the two groups before treatment (case, %). Note: After the statistical treatment using the rank sum analysis, the grades of the Chinese medicine symptoms of the two groups were comparable (P>0.05).

The Tables 1-4 showed that the genders, ages, histories of smoking, grades of the TCM symptoms, etc. of the two groups before treatment were comparable and there weren’t significant difference between the general information of the two groups (P>0.05).

Research methods

The efficacy was studied using the randomized controlled method. The patients of control group were symptomatically treated using the anti-cancer strategy mainly consisting of TCM Aidi injection alone; while the patients of treatment group were symptomatically treated using the anti-cancer strategy including the Shunqi Tongluo Cream combined with the TCM of Aidi injection.

The Shunqi Tongluo Cream consists of the following compositions: Citrus reticulata, Magnolia officinalis, Magnolia, Astragalus, Citrus, Asparagus, Asarum, Medical rosin, Pepper, Borneol, Azone, Chuanxiong, Perilla, Dilong, Corydalis, Poria, etc.

The above compositions were cooked and prepared as the cream, the cream was pasted evenly onto the sterile gauze and the sterile gauze was externally applied at the position of Shan Zhong acupoint once every day, and about eight hours every time. During the treatment, topical local skin was exposed, and the magnetic-heat therapy was used as the assistant therapy in which the magnetic-heat energy vertically irradiated the position applied with the Chinese medicine in the distance of 30 cm~50 cm where the patients had the most comfortable feel of warm and heat, the position applied were irradiated for 30 min every time, once every day, and four weeks constituted a course of treatment.

Grouping: 40 cases of patient with chest tightness caused by lung cancer were included into this study.

All related drugs and therapies able to affect the clinical efficacy observation were discontinued.

(i) The patients in the treatment group were topically treated by administrating the Aidi injection accompanied with the TCM of Shunqi Tongluo cream in one dose per day for one course of treatment, and one course of treatment included four continuous weeks.

(ii) The patients in the treatment group were administrated 1.2 g of the Aidi injection (consisting of Cantharides, Ginseng, Astragalus, acanthopanax, and produced by the Guizhou Yibai pharmaceutical co. LTD and using the number of GZYZ of Z52020236) 50 ml included two continuous weeks. The patients were treated for one course of treatment.

Diagnostic criteria for the syndromes of TCM: All the cases were confirmed by pathological examination or cell line examination, which was in line with the diagnostic criteria and clinical staging criteria of lung cancer in the diagnosis and treatment of common malignant tumor in China (lung cancer branch). Standard syndromes of traditional Chinese medicine with reference to the state food and drug administration "traditional Chinese medicine new medicine clinical research guiding principle" and "national standard of the People's Republic of China. The term clinical diagnosis and treatment of traditional Chinese medicine syndromes parts". Mucus [2]

(i) Main symptoms: The chest and epigastric parts being blocked, discomfort, ruffian hard, swelling, and depressed, feeling nausea, loss of appetite, coughing and secreting sputum.

(ii) Minor symptoms: chest tightness, asthma and suffocating, face and limb being swollen, abdominal and belly being hard and swelling, dizzy, nausea and vomiting, stool being loose, and having the sputum with tuberculosis.

(iii) Pulse manifestation of the tongue: the tongue being pale, white and thick, the pulse moving and sliding.

If two of the main symptoms were satisfied, and the pulse manifestation was seen in tongue, we can ensure that the patient had this disease; If two of the main symptoms and one of the minor symptoms were satisfied, and the pulse manifestation was seen in tongue, we can ensure that the patient had this disease; if two of the main symptoms and more than one of the minor symptoms were satisfied, and the pulse manifestation was seen in tongue, we can ensure that the patient had this disease.

Grading standards for the condition of symptoms of TCM: The efficacy was evaluated using the TCM symptom integral method (See Table 5 for the TCM Symptoms Grading Quantification Table), and was divided into three levels:

Table 5. Graded quantification of the symptoms of primary lung cancer. Note: The score for the patients without symptom should be 0 [3].

(i) Mild: the integral of TCM symptom is less than or equal to 9.

(ii) Moderate: the integral of TCM symptom is between 10 and 18.

(iii) Severe: the integral of TCM symptom is greater than or equal to 19.

Safety observation: (i) General physical examinations: including items of weight, body temperature, breathing, pulse, heart rate, blood pressure and so on.

(ii) Routine examinations: including the examination items of blood, urine, urine and stool, etc.

(iii) Test of the liver function and renal function

(iv) Adverse reactions such as allergic reactions, gastrointestinal reactions may occur during the course of the experiment.

Evaluation standard

(I) Diagnostic criteria for the efficacy to the clinical syndrome: The partial improvement meant that the integral value for the clinical syndrome after treatment decreased greater than or equal to 70% than the integral value before treatment, the partial improvement meant that the integral value greater than or equal to partial improvement meant that the integral value greeter’s change.

(II) Diagnostic criteria for the efficacy to the Chinese medicine syndrome: (i) excellent: The clinical symptoms and signs are significantly improved and the integral value for the clinical syndrome decreased greater than or equal to 70%. (ii) Effective: The clinical symptoms and signs are improved and the integral value for the clinical syndrome decreased greater than or equal to 30%. (iii) Failure: The clinical symptoms and signs didn’t improved and the integral value for the clinical syndrome decreased less than 30%. (iv) Exacerbations: The clinical symptoms and signs exacerbated and the integral value for the clinical syndrome decreased less than 0.

Statistical methods

All the data were analysed by using the SPSS19.0 statistical software. The differences among the clinical general data is usually compared using the χ² test, rank sum analysis and ttest, and the clinical efficacy is usually judged using the t-test, rank sum analysis and other test methods. The value of P when comparing the data before and after treatment less than 0.05 presents the significant difference (^ΔP<0.05), while ^▲P<0.01 presents the very significant difference; and The value of P when comparing the data between the two groups after treatment less than 0.05 presents the significant difference (*P<0.05).

Analysis on the treatment result

(i) Comparison of the Chinese medicine syndromes of the patients in two groups before and after treatment (Table 6).

Table 6. Comparison of efficacy to the Chinese medicine syndromes of the patients in two groups before and after treatment case (%). Note: In the comparison of efficacy to the Chinese medicine syndromes of the patients in two groups before and after treatment, the value of P through the treatment of statistical rank sum analysis was less than 0.05 (*P<0.05).

The Table 6 showed that the efficacy to the Chinese medicine syndromes of the patients in the treatment group was equal to 90.00% versus that in the control group was equal to 70.00%; and there was significant difference between the two groups (P<0.05) when comparing the two groups and the efficacy of the treatment was better than the that of the control group.

(ii) Comparison between the total integral of the TCM syndromes of the patients in two groups before and after treatment (Table 7).

Table 7. Comparison of the total integrals of the Chinese medicine syndromes of the patients in two groups before and after treatment case (͞x ± s). Note: In the comparison of the total integrals of the Chinese medicine syndromes of the patients in two groups before and after treatment, the value of P through the treatment of Statistical t test was less than 0.01 (P<0.01), and in the comparison of the total integrals of the Chinese medicine syndromes of the patients in two groups after treatment, the value of P was less than 0.05 (*P<0.05).

(iii) Comparison of the integrals of the Chinese medicine syndromes of the patients in two groups before and after treatment (Table 8).

Table 8. Comparison of the integrals of the Chinese medicine syndromes of the patients in two groups before and after treatment (͞x ± s). Note: In the comparison of the integrals of the Chinese medicine syndromes of the patients in two groups before and after treatment, the value of P through the treatment of Statistical t test was ^∆P<0.05 and P<0.01, and In the comparison of the integrals of the every items of Chinese medicine syndromes of the patients in two groups after treatment, the value of P was *P<0.05 for up to five items.

Table 8 showed that the integrals of the Chinese medicine syndromes of the patients in two groups after treatment were obviously less than those before treatment, and the differences were P<0.01 or P<0.05 respectively which showed very significant difference or significant difference; while compared with the control group, the integrals of the Chinese medicine syndromes such as Chest tightness, shortness of breath, etc were significant different from those of the control group (P<0.05), this showed that the improvements on all the Chinese medicine syndromes in treatment group were better than those in the control group.

Comparison of the overall efficient rate of the patients

Table 9 showed that the overall efficient rate of the treatment group was 75.0% versus that of the control group was 55.0%. Through the statistical processing, there was significant difference between the overall efficient rates of the two groups (P=0.01<0.05). It demonstrated that the control rate to chest tightness and shortness of breath increased significantly, which demonstrated that the efficacy of the treatment group was significantly better than that of the control group.

Table 9. Comparison of the overall efficient rate of the patients.

Discussion

The pathological mechanism of the disease: this disease results from that the chest is short of Yang gas, the thick sputum blocks in the chest, and thus the blood won’t run smoothly and concentrates at the chest position and become the semi-solid. Weak Yang gas in the chest can result in that the body fluid can’t be well distributed and thus concentrate to form the sputum; thus the gas in the blood can’t run smoothly , the sputum and gas will be mixed in the chest to form clot, and will present the symptom of chest tightness and uncomfortable; the gas is unable to reach to the deep part of the lung and will go upward and result in the sound at the lung and thus will hurt body, and will present the symptom of coughing, having sputum, wheezing, and shortness of breath; the shortage of Yang gas in the chest will cause the cool gas to go up, and thus will present the symptom that the gas run upward from the position under the rib and invade into the chest. This disease should be treated using the measurement of making the Yang gas clear, spreading out the clogs, expectorating, and thus making the gas in the blood go down.

This formula may be explained as following: the Fructus trichosanthis tastes sweet, has the nature of cold, is able to penetrate the lung meridian, remove the accumulation of sputum, and disperse the foreign body blocking in the lung position; Allium macrostemon has the spicy and warm nature, can promote the Yang gas run clear, disperse the clogs blocking, decompose the concentrated thick sputum, disperse the cold, staining in the chest concentrated, dilute and clear the accumulated turbid phlegm at the position of Shang-Jiao, relax the Yang gas in the lung, and make the Yang gas run smoothly and distribute the Yang gas widely and is the important drug composition used for treating the thoracic obstruction. The two compositions act as the monarch drug in a prescription together. Immature bitter orange has the effects of promote the gas to go down and get rid of the concentrated pathogemetic qi, and eliminate the gasteremphraxis and blocking in the stomach; Mangnolia officinalis has the effects of eliminating dampness and reducing phlegm, and can make the gas from the stomach go down, remit asthma and gasteremphraxis; Radix astragali has the effects of nourishing our vitality, killing the virus and excluding the pus, and can facilitate the water metabolism and reduce the edema; Ramulus cinnamomi can promote the Yang qi to run smooth, disperse cold, and put down and quiet the uprushing lung gas. These four drug compositions may be formulated as a preparation with the effects of enhancing the amount of the Yang qi in the chest, making the Yang gas circulate, excluding the thick phlegm and gasteremphraxis, thus may assist the monarch drug in a prescription. Pericarpium citri reticulatae is able to relieve the gasteremphraxis and blocking at the position between the chest and stomach; Rhizoma acori graminei has the effect of reducing the wet gas, discomposing the phlegm and inducing resuscitation; Asarum sieboldi Mig has the effects of warm the lung, discomposing the phlegm; Zanthoxylum bungeanum Maxim has the effects of facilitating the water metabolism, relieving edema, excluding the thick phlegm and relieving asthma; Ligusticum chuanxiong Hort has the effects of invigorating the circulation of blood and facilitating the gas circulation in blood, relieving pain, and removing depressed mood; Fructus perillae can make the lung gas uprushing go down, eliminating phlegm, relieving asthma; lumbricus has the effects of dredging the channels and collaterals, relieving asthma, and facilitating the urine procution; cortex Mori radicis has the effects of removing the heat in lung, relieving asthma, facilitating the water metabolism and eliminating the edema. The these seven drugs may cooperate with each other, and have the effects of has the function of removing the wet, running the gas and dredging the channels and collaterals, and may be used for the treatment of the cough caused by the dry and hot in lung, edema and gasteremphraxis, and they are the adjuvant drug. Poria cocos have the effects of promoting the dehumidification and excretion of unhealthy wet gas in the body and are the conductant drug in this formula.

In the process of disease progress, the patients with advanced lung cancer often present the symptoms of chest tightness, shortness of breath, palpitation and other symptoms and at the present Western medicines are often used for relieve the above symptoms. However the western medicines have rather strong side effects, and thus more contraindications for their application. And long-term application of glucocorticoid may result in the resistance and osteoporosis, so the combination of a variety of therapies to relieve the symptoms, reduce adverse reactions and risk factors have become the current trend. Chinese medicine treatment for cancer has formed a complete and effective theoretical system [4]. For the method, this cream presents the advantage for the Chinese medicine of treat externally, and has been promoted into clinical gradually, of which the application scope have included the indirect tumor removing method based on the topical and external treatment [5]: the drug can penetrate the skin, function at the diseased region of tumor and eliminate the tumor. And the Chinese Tumor Treatment Efficacy Evaluating System proposed by Hongsheng and Daihan may exhibit the distinguishing feature and advantages of the Chinese medicine in tumor treatment [6,7]. The proofs of modern medical science are confirming the complicated pathogenesis and mechanism of the lung cancer. Wan [8] found that there were statistical differences among the distributions of three gene types of the MsP I location of the CYPIAI gene in the syndrome of phlegm-dampness due to spleen deficiency, syndrome of phlegm heat accumulation, the syndrome of deficiency in both spleen and lung, the syndrome of lung heat caused by deficiency of lung yin (P<0.01), which demonstrated that there is relationship between the types of Chinese medicine syndrome of lung cancer and the metabolic enzyme gene polymorphism. The researches of many scholars confirmed that there were correlation between the cellular immune and humoral immune parameters and the different Chinese medicine syndromes. So the Chinese medicine syndromes may reflect the state of Zheng, Xu, Xie and Shi [9-11]. The main limit to the Chinese medicine therapies promotion is the difficulty in grasping the expertise of treatment based on syndrome differentiation. The treatment based on syndrome differentiation is the key to embody the advantage of Chinese medicine individualized diagnosis and treatment, however it has the deficiency of shortage in the objectivity, quantification, standardization. Wang et al. [12,13] developed an information collection and management system for Chinese medicine facial complexion diagnosis, pulse manifestation digital analysis instrument and the information acquisition system for diagnose through interrogation and sound diagnosis which promoted the objective developments of the four methods of diagnosis. At the same time, many scholars carried out the researches on the correlation between syndromes differentiation for lung cancer treatment and the TNM staging, iconography, and physical and chemical indicators, etc., and explored the substantial nature of the different syndromes of TCM [14,15].

In recent years, we have sufficiently developed the theory of TCM tumor therapy and its actual application, the action mechanisms of TCM drug in inhibiting the tumor angiogenesis, inhibiting the maturation and migration of DC cells, inhibiting the growth of hormone-dependent tumor, inducing the differentiation and apoptosis of tumor cells, etc. were illustrated gradually [16-19], the database of Information on Four TCM diagnosis indicators, the establishment of the database of lung cancer structural clinical information, etc. provided the more advanced platform for TCM prophylaxis and treatment of lung cancer [20,21].

Many advanced patients with lung cancer are accompanied with the syndromes of chest distress and shortness of breath. The topical therapy using the TCM administrates the drug through the body surface, in which the drugs are absorbed through surface of skin or mucosa, can excert effect directly on the ill location, and has many advantages in treatment, and its clinical application may enhance the patient’ s compliance. The topical treatment using TCM manifested more advantages. The safety parameter observation showed that the adverse reaction such as cutaneous pruritus, etc. didn’t occur after treatment using the above mentioned TCM cream. There were many reports related to the therapy of cooking the TCM, then applying the cream on the ill location and supplementing with the infrared light local hyperthermia, however the usage of supplemented with the thermomagnetic therapy is still uncommon. This clinical observation still didn’t contain the report related to the clinical observation on the large sample double-blinded controls. Considering that more cases should be included in late clinical observation study, the observation designed more detailed and in multi-dimension will be used to verify the treatment efficacy of this therapy.

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