| Object i ve1.With strictly estimation of quality and comprehensive analysis of "regulation the lung and the kidney simultaneously" treatment for randomized controlled trials published in treatment of stable COPD patients, to obtain the evidence-based medicine basis for the safety and clinical efficacy of "regulation the lung and the kidney simultaneously" treatment in stable COPD patients. At the same time, it can provid reference to find valid traditional Chinese herbal medicine and formula by the regulation the lung and the kidney simultaneously for the next step.2. The purpose is to obtain the preliminary assessment of safety and clinical efficacy in different doses of traditional Chinese medicine Gu Shen Tong Fei tablets in the treatment of stable COPD with "regulation the lung and the kidney simultaneously" treatment (lung and kidney deficiency) through the clinical observation,thus provide sufficient evidence to support the development of new drugs of traditional Chinese medicine.Methods1. Systematic ReviewThe major databases were searched until September2013and supplemented with a manual search. Chinese databases were searched from CBM, CNKI, CQVIP and WANFANG; foreign database from:PubMed, Cochrane Central Register of Controlled Trials, EMBASE. To search these databases for randomized controlled trial of regulation the lung and the kidney simultaneously treatment in stable COPD. According to the inclusion/exclusion criteria screening test and the Cochrane risk of bias table to assesse the study quality, the extraction and statistical analysis was extracted and performed by using RevMan5.2software. 2. clinical studySelect72patients as the research object that meets the requirements of COPD class level II-IV, with lung and kidney Deficiency in TCM. Then using Gu Shen Tong Fei tables0.51g/piece)for the treatment of patients. Subjects were divided into three goups:high dose, low dose and placebos by using random double-blind and double simulation as clinical research methods. The duration of this trail concluded three month treatment period and follow-up period of3months.Quality of life, acute episode frequency, BODE index,6min walking distance, pulmonary function in COPD(FEV,, FEVt%Pred, FVC after using Bronchodilators), changes of TCM syndrome curative effect and clinical curative effect index and safety index were observed in three groups before and aftertreatment.Results1. Systematic reviewA total of32documents, including3,224cases of patients were included in the study. Meta-analysis showed that "regulation the lung and the kidney simultaneously" treatment can significantly reduce the number of acute exacerbation of COPD and CAT and BODE index scores, increase exercise tolerance, improve prognosis and ameliorate the clinical symptoms than control group. The treatment of "regulation the lung and the kidney simultaneously" combined with conventional therapy shows significant improvement in FEV, better than conventional therapy group. The same situation also occurred in the comparison between "regulation the lung and the kidney simultaneously" treatment and placebo/control group.Four study describes the treatment group had mild gastrointestinal discomfort, diarrhea or constipation, but the patient’s condition finally relieve itself without any treatment. One study reported the treatment group had allergies on musk cream, with skin rashes and itching in patients, but the symptoms disappear after changing the paper tape.2. Clinical study2.1Patients included in the study had six cases falling and qualified cases were66, including23cases in the placebo group,22cases of high-dose group and low dose group21cases.2.2The impact of Gu Shen Tong Fei tablets on CAT:After three months’ treatment, both high-dose group and low-dose group showed significantly decreased in CAT scores when compared with the placebo group, and the degree of decline was lower in the high-dose group than the low-dose group(P<0.001). In follow-up, In follow-up, CAT sores of high and low dose group were lower than the placebo group (P<0.001). In high dose group, the CAT score were decreased between the3months treatment and follow-up comparison(P<0.001); In the placebo and low-dose group, there was no significant statistical difference (PH=0.996,PL=0.077)2.3The impact of Gu Shen Tong Fei tablets on exacerbations affect:After three months’treatment, the frequency of exacerbations both in high and low dose group were reduced compared with the placebo(P=0.010);The frequency of exacerbations were increased in placebo group after3months treatment compared with1month treatment and follow-up period (P=0.013)2.4The impact of Gu Shen Tong Fei tablets on BODE index:After three months’treatment, both high-dose and low-dose group showed significantly decreased in BODE index when compared with the placebo group, and the decline in average was more than1score(P=0.010). The BODE index was decrease after3month treatment and follow up compared with treatment before both in high-dose and low-dose group(PH=0.044,PL=0.004).2.5The impact of Gu Shen Tong Fei tablets on exercise tolerance:After three months treatment and follow up, both high-dose and low-dose group showed significantly increased in six-minutes walk distance compared with the placebo group (P<0.001). Six-minutes walk distance was declined progressively in placebo group (P<0.001); Six-minutes walk distance was increased after3month treatment compared with pre-treatment and follow up period(P=0.001).2.6The impact of of Gu Shen Tong Fei tablets on TCM Syndromes efficacy: After one and three months’treatment, both high-dose group and low-dose group showed significantly improvement of higher degree of TCM Syndromes efficacy compared to the placebo group(P<0.001). The TCM Syndromes efficacy between high-dose and low-dose group continued to decline after1month and3month treatment(P<0.001). After three months treatment, the effective rate of TCM symptoms was17.39%,81.81%,61.90%respectively among three group.2.7The impact of of Gu Shen Tong Fei tablets on pulmonary function in patients with stable COPD:High-dose group showed improvement in FEV, level compared placebo group (P=0.041). FEV1in high-dose group was increased compared with low-dose group at follow up period (P=0.035).Although FEV1、 FVC had no significant statistical difference among three groups after treatment (P>0.05), a slightly increased in FEV1, FVC levels of high and low dose group.3.Safety EvaluationThe placebo group had a total of two cases of adverse events:One patient had ulcers after a month of treatment and recovered after taking Consumers oral ulcers. One patient had leukocytosis, mild nasal congestion duing three months treatment, which considered caused by catching cold. After five days the review of WBC turned normal. In High-dose group, one patient had mild skin itching and lasting for three days duing one month treatment.After continuing the treatment, all symptoms disappear without any treatment. In Low-dose group one patienthad was suffered mild diarrhea duing one month treatment, but all symptoms disappeared without any treatment. In other cases, the patients’ blood situation, liver and kidney function, urine and ECG were in the normal range before and after treatment.Conclusion1. System evaluation evidenceAlthough there were some flaws of metho-dological quality included in the studiy, the results were encouraging. The therapy of "regulation the lung and the kidney simultaneously" had a certain advantages on reducing the number of acute exacerbation of COPD, improving Clinical symptoms as well as the quality of life and lung function to some extent. There were no serious adverse reactions during the treatment.The therapy of "regulation the lung and the kidney simultaneously" has a greater potential value, so more high-quality, large-scale randomized controlled trials are necessary in the future. At the same time, considering this systematic Review includes oral Chinese medicine, acupuncture, acupoint sticking therapy, etc, so it is important and urgent to find the measures of curative effect of COPD with different TCM intervention.It can also provide the reference for screening effective traditional Chinese herbal medicine and formula by the regulation the lung and the kidney simultaneously.2. Clinical trials evidenceResults showes that different doses of GuShenTongFei tablets have a certain advantages on improving clinical symptoms of Lung and kidney deficiency, improving both quality of life, and exercise tolerance, reducing the number of exacerbations and BODE index compared to placebo group. There were no serious adverse events and had a better safety during clinical trials. Superior to the low-dose group,High dose group proved to have better improvement of clinical symptoms, quality of life and reduction of the frequency of of acute exacerbations. To a certain extent, the high doses of Gu Shen TongFei tablets can improve the level of pulmonary ventilation function (FEV1), but low dose has no this effect... |
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