A Randomized Controlled Study On The Effect Of Chinese Medicine On The Clinical Symptoms Of Patients With Chemotherapy For Non - Small Cell Lung Cancer

This thesis consists of two parts:the literature review and the clinical observation.The literature review is made up of two parts:one is about to elaborated the modern medicine for the understanding of the Side effects of chemotherapy drug related adverse reactions, clinical routine treatment, and research progress at present Comprehensively, according to the order of pathological mechanism and sequence of symptoms, diagnosis and treatment, classified by the systems and organs.The other is about to discuss from several aspects:the definition of the protective treatment of TCM (traditional Chinese medicine):traditional Chinese and western’s different understanding of the side effects of chemotherapy:the clinical and Laboratory research of the protective treatment of TCM.All above is to sum up the experiences, promote the treatment mode and make more patients benefit.In the clinical observation, part of the non-small cell lung cancer patients prepare to or undergoing chemotherapy treatment is added with the protective treatment of TCM to observe the effectiveness of attenuated effect, the effectiveness of reducing chemotherapy related NCI clinical symptoms adverse reactions incidenceand and drug safety.Purpose:Observing the attenuated effect,the proportion of clinical symptom remission, the effectiveness of reducing chemotherapy related NCI clinical symptoms adverse reactions incidenceand and safety of the protective treatment of TCM.Object:To choose 96 patients diagnosed non-small-cell lung cancer(NSCLC) by pathology with chemotherapy treatment or prepare to.DOE(Design of experiments):The test is a multicenter.prospective, randomized, controlled clinical study.Through the CHISS software generating random Numbers table, devide 96 patients into two groups randomly:one is the treatment group including 48 patients and the other is the control group including 48 patients.Treatment group of 48 patients are given the protective treatment of TCM on the basis of NCCN guidelines for treatment, based on principles of invigorating spleen and stomach, reinforcing qi and nourishing blood. Nourishing liver and kidney. Including the following aspects:(l) TCM medicine soup A+B or A+C (A:inula flowerlOg Codonopsis pilosula10g gingerlOg OchrelOg Licorice root6g; B: Codonopsis pilosulalOg bighead atractylodes rhizome lOg Poria cocos 15g Licorice root6g Angelica sinensislOg Ligusticum wallichiilOg prepared rehmannia root10g;C:prepared rehmannia rootlOg fructus corni10g Chinese yam10g the rhizome of oriental water plantain10g the root bark of the peony tree10g Poria cocosl5g) Usage:oral, day two, warm water blunt.(2) Proprietary Chinese medicine:Using Jianpi Yishen granule by the first time of chemotherapy, add with Shengxue pill if chemotherapy has been taken many times.(3) traditional Chinese medicine injection:Shenqi Fuzheng Injection or Kangai Injection(Each center fixed use one of them).21-28 days for a period of treatment. In the control group of 48 patients, erchen decoction can be used while other therapies of traditional Chinese medicine are forbideen. Record patients’ name, gender, age. contact information, diagnosis. merger disease, past medical history. vital signs, physical examination and other general situation before the treatment. Evaluate patients’health condition, clinical symptoms and quality of life at the same time.Evaluate NCI adverse reactions, clinical symptoms, weight change, state of the body after each course of treatment. Routine blood test and Liver and kidney function are needed on baseline and after each course to evaluate drug safety. Taking Tumor marker examination after each course while chest CT only after the second course to evaluate the protective treatment of TCM may affect the efficacy of chemotherapy or not.Results:Into the group of 96 cases of patients. Fall off in 16 cases. Two groups of patients’ KPS>70 before treating. And gender, age, KPS score, ECOG score. lung cancer staging, the clinical symptoms were no statistical difference. After using medicine. Two groups of patients KPS score is still no statistical difference. By comparing the proportion of clinical symptom remission between two groups after one and two course of treatmen.X2 values are respectively 1.708,6.267,P values are respectively 0.223,0.015,the latter is statistical different. Compare the clinical symptoms integral after the first and second course of treatment, the P values of the treatment group are both<0.05 while the P values are just<0.05 after the second course in the control group. The incidence rate of NCI clinical symptoms of adverse reactions were compared between the two groups first and second cycle, the first cycle "xerostomia rate", "appetite decreased incidence of two treatment group was lower than that of control group, but no statistical significance, the second cycle" xerostomia rate "." loss of appetite rate in the treatment group than the control group, the latter p=0.024<0.05 has statistical significance. Two groups of patients before and after medication routine blood, liver and kidney function tests are not seen obvious abnormity, and two groups of patients were not present experimental drug related allergic reactions.Conclusion:First, the protective treatment of TCM can relieve clinical symptoms of patients with cancer chemotherapy effectively; Second, comparing simple chemotherapy, the protective treatment of TCM can relieve the clinical symptoms faster; Third, the protective treatment of TCM can reduce the incidence of adverse reactions of chemotherapy related NCI clinical symptoms;Forth.the experimental drug safety is good; Fifth, the therapeutic modalities used in this experiment has good operability and high clinical reference value.