ABSTRACT
This study aims to evaluate the effectiveness and safety of Suhuang Zhike Capsules in treating chronic obstructive pulmonary disease. The Chinese and English databases were searched(from the establishment to July 2021) for randomized controlled trials(RCTs) on the treatment of chronic obstructive pulmonary disease with Suhuang Zhike Capsules, yielding 130 articles and finally 12 eligible RCTs. The 12 RCTs enrolled a total of 1 159 patients(579 in experimental group, 580 in control group), with 728 males(62.8%) and 431 females(37.2%). Meta-analysis showed that the conventional western medicine combined with Suhuang Zhike Capsules increased clinical efficacy(OR=4.31, 95%CI[2.88, 6.46], Z=7.08, P<0.000 01), forced expiratory volume in one second(FEV1)(SMD=0.88, 95%CI[0.60, 1.16], Z=6.24, P<0.000 01), forced vital capacity(FVC)(SMD=0.96, 95%CI[0.38, 1.55], Z=3.22, P=0.001), forced vital capacity rate of one second(FEV1/FVC%)(SMD=0.85, 95%CI[0.51, 1.19], Z=4.92, P<0.000 01), and maximum voluntary ventilation(MVV)(SMD=0.61, 95%CI[0.39, 0.83], Z=5.40, P<0.000 01) compared with the conventional western medicine alone. The differences in residual volume/total lung capacity(RV/TLC)(SMD=-0.93, 95%CI[-3.38, 1.53], Z=0.74, P=0.46) and adverse reactions(OR=1.39, 95%CI[0.76, 2.56], Z=1.07, P=0.28) are insignificant. The study showed that the conventional western medicine combined with Suhuang Zhike Capsules could improve clinical efficacy and lung functions in the treatment of chronic obstructive pulmonary disease. In addition, the combination had been verified to be safe. However, in view of the uneven method quality, small sample size, and inconsistent outcome indicators of the included studies, higher-quality, multi-center, and large-sample RCTs are needed for further verification.
Subject(s)
Female , Humans , Male , Capsules , Forced Expiratory Volume , Lung , Pulmonary Disease, Chronic Obstructive/drug therapy , Respiratory Function TestsABSTRACT
The physical properties of powder and granules are the critical quality attributes for the process control of Suhuang Zhike Capsules, a big brand traditional Chinese medicine. This paper took the production of 25 batches of real-world Suhuang Zhike Capsules dry extract powder and granules intermediates as the research object. Firstly, a method for testing the physical properties of Suhuang Zhike Capsules powder and granules with 19 physical indicators was established. The results showed that the granules of dry extract powder after granulation had a smaller particle size, wider particle size distribution range and poor fluidity, which easily caused the problem of over-limit capsule loading. Secondly, correlation analysis, principal component analysis and cluster analysis were used for mathematical statistics. The correlation analysis showed that the density of dry extract powder could affect the chroma and fluidity. At the same time, the particle size in the granules had a stronger effect on the chroma and fluidity than the density. The study also found that the particle size and hygroscopicity of dry extract powder were potentially key physical properties that affected the physical properties of granules. Furthermore, the results of principal component analysis and cluster analysis showed that the consistency of the physical properties between the dry extract powder and intermediate granules was relatively poor. To this end, similarity analysis was carried out, and the quality control method of powder and granules based on physical fingerprint was established. The results showed that the physical fingerprint similarity of 25 batches of dry extract powder was 0.639-0.976, and the physical fingerprint similarity of the gra-nules was 0.716-0.983. With the similarity of 0.85 as the threshold, the batches with abnormal physical properties could be identified. In this study, the process quality control method of Suhuang Zhike Capsules based on the physical properties of powder and granules was established finally, which realized the identification of abnormal batches, and provided a reference for the process quality control of Suhuang Zhike Capsules.
Subject(s)
Capsules , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Powders , Quality ControlABSTRACT
Objective:To evaluate the clinical efficacy of Suhuang Zhike capsules combined with montelukast in the treatment of cough caused by upper respiratory infection. Methods:Totally 120 patients with cough after upper respiratory infection were randomly divided into the treatment group (64 cases) and the control group (56 cases) by the random number table. The control group received Montelukast chewable tablets alone(10 mg,po qn), while the treatment group received Suhaung Zhike capsules(1. 35 g,po,tid) com-bined with Montelukast chewable tablets. The treatment course was 2 weeks, and the efficacy and adverse reactions between the two groups after the treatment were compared. Results:The significant efficiency and the total efficiency of the observation group were sig-nificantly highter than those of the control group, and the difference was statistically significant(P0. 05). The incidence of adverse reactions of the two groups had no significant differencet(P<0. 05). Conclusion: As for the clinic efficacy, the combination of Suhaung Zhike capsules and Montelukast is significantly better than Montelukast therapy, and the combina-tion is an effective and safe treatment for cough after upper respiratory infection and worthy of promotion in clinical practice.
ABSTRACT
Objective To observe the effects of Suhuang Zhike capsules(SZC) on the guinea pig model of cough variant asthma(CVA), and to explore its therapeutic mechanism. Methods Fifty guinea pigs were randomly divided into normal control group, model group, prednisone acetate tablets group, and high-and low-dose SZC groups. With reference to the related literatures, we set up the guinea pig model of CVA. The observation indexes included cough frequency, lung histopathology, the percentage of eosinophils in bronchoalveolar lavage fluid (BALF), and the serum levels of interleukin 4(IL-4), interferon gamma(IFN-γ), tumor necrosis factor alpha (TNF-α), and immunoglobumin E(IgE). Results Compared with the normal control group, the cough frequency of the model group was significantly increased(P<0.05); compared with the model group, the cough frequency of high-dose SZC group was reduced obviously(P < 0.05). Compared with the normal control group , the percentage of eosinophils in BALF of the model group was significantly increased(P < 0.05); the percentage of eosinophils of the three medication groups was lower than that of the model group (P<0.05). The pathological changes of lung tissue in the medication groups were relieved compared to the model group. Compared with the normal control group, the serum IL-4, TN F-α and IgE levels of the model group were increased significantly (P < 0 . 05); compared with the model group , the serum IL-4 and TN F-α levels of prednisone acetate tablets group were significantly decreased, and the serum TNF-α and IgE levels of high-dose SZC group were decreased significantly (P < 0.05). Conclusion SZC could reduce the serum, TNF-α and IgE levels , and relieve the cough symptom, airway inflammation and the lung tissue pathology in CVA guinea pig, so as to achieve the therapeutic effect on CVA.