1.Post-marketing clinical safety assessment of Shenmai injection based on active monitoring and passive monitoring in large data background.
Lian-xin WANG ; Yan-ming XIE ; Qing-hua AI ; Nian-bin SONG
China Journal of Chinese Materia Medica 2015;40(24):4752-4756
This paper adopted a series of related analysis methods to comprehensively analyze post-marketing clinical safety data of Shenmai injection from 4,220 cases of SRS and 32,358 cases of multicenter, prospective, registered hospital centralized monitoring in large data background, calculated ADR incidence rate was 0.93 per 1,000, main symptoms of ADR includes chest pain, chills, skin itching, palpitations, fever, nausea, dizziness, vomiting, flushing, numbness, allergic reaction, cyanosis, rash, low back pain, and "breath", "anaphylactoid reaction" and "flush" were the safety warning signals of Shenmai injection. Primary disease for chronic pulmonary heart disease, thyroid disease, and combined with cerebral vascular disease, prior to the injection and continuous use of alprostadil, cyclic adenosine monophosphate, combined with quinolones, penicillins were suspicious influence factors of ADR of Shenmai injection, these promot the clinical safety.
Drug Combinations
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Drugs, Chinese Herbal
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adverse effects
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Humans
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Injections
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Product Surveillance, Postmarketing
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Prospective Studies
2.Effects of early Xuebijing injection(血必净注射液) treatment on the change of prognosis in patients with multiple traumas
Jing-En WANG ; Jin-Fang CAI ; Zhi-Hua WANG ; Xiao-Hong XIE ; Wei QU ; Nian ZHU ; Bo GAO ; Ying SHENG ; Jia-shi GU
Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care 2006;0(05):-
15 scores were randomly divided into therapeutic group (30 cases)and control group(30 cases).The two groups were treated with the same conventional therapy. From the 1st day of admission,Xuebijing injection 80 ml was given by intravenous drip once for every 12 hours for 7 days to the therapeutic group.The level of tumor necrosis factor-?(TNF-?),interleukin-1?(IL-1?),IL-6,IL-10,and APACHEⅡscore were tested on 1,3,5 and 7 days after admission.The case fatality and incidences rates of sepsis and MODS in both groups were recorded.Results Compared with the control group,APACHEⅡscore,TNF-?,IL-1?,IL-6 and IL-10 of the therapeutic group were lower significantly on the 3rd day after admission,especially on the 5th day(all P
3.Hepatitis B e antigen from chronic hepatitis B patients induces Th1/Th2 cytokine imbalance in vitro.
Ya-ping HAN ; Jun LI ; Long-feng JIANG ; Qing-qing XU ; Bo LIU ; Li DONG ; Nian CHEN ; Lian-hua KONG ; Fa-ren XIE ; Zu-hu HUANG
Chinese Journal of Hepatology 2013;21(8):584-589
OBJECTIVETo study the immunoregulatory effect of hepatitis B virus (HBV) e antigen (HBeAg) on peripheral blood monocytes (PBMCs).
METHODSPBMCs were isolated from patients with chronic hepatitis B (CHB; both HBeAg- and HBeAg+) and healthy controls, and cultured with recombinant HBeAg. The HBeAg-induced changes in expression of PD-1/PD-L1 were measured by flow cytometry of the cells and in secreted cytokines were measured by enzyme-linked immunosorbent assay of the supernatants. Comparisons between two groups were made by the independent-samples t-test; the relationship between PD-1/B7-H1 level and HBV DNA copy number was evaluated by Spearman's correlation analysis.
RESULTSExposure to HBeAg led to a significant decrease in CD3+CD4+ T lymphocyte-specific expression of IFNa for both the CHB patients' and healthy controls' samples (t = 2.382 and -4.190 respectively, P less than 0.01). For the HBeAg- CHB patients' and healthy controls' samples, the HBeAg exposure led to increased levels of secreted cytokines IL-6, IL-10 and TNFa (t = 2.504, 3.583 and 4.324, P less than 0.01 and t = 3.542, 6.246 and 5.273, P less than 0.01 respectively) and of CD14+ PBMC-specific expression of PD-L1 (t = 4.815 and 3.454, P less than 0.05 respectively). Compared to the HBeAg-negative CHB patients' and healthy controls' samples, the HBeAg+ CHB patients' samples had significantly lower CD3+CD4+ T cell-specific expression of IFNa (t = -3.177 and -4.541, P less than 0.01 respectively), but significantly higher levels of secreted IL-4 (t = 3.382 and 4.393, P less than 0.01 respectively), of CD3+ T cells-specific expression of PD-1/PD-L1 (t = 4.755, 2.942 and 4.518, 4.595, P less than 0.01 respectively), and of CD14+ T cells-specific expression of PD-L1 (t = 5.092 and 5.473, P less than 0.01 respectively). The CD3+ T cells-specific expression of PD-L1 was significantly higher in the samples from HBeAg- CHB patients than from the healthy controls (t = 3.214, P less than 0.01).
CONCLUSIONHBeAg was able to down-regulate the production of Th1-type cytokines (IFNgamma), and up-regulate the secretion of Th2-type cytokines (IL-6, IL-10) and the expression of PD-1/PD-L1on monocytes. These changes are conducive to the formation of immune tolerance to HBV. Therefore, HBeAg may play an important role in immune tolerance to chronic HBV infection.
Adult ; Case-Control Studies ; Cells, Cultured ; Female ; Hepatitis B e Antigens ; genetics ; immunology ; Hepatitis B, Chronic ; blood ; immunology ; Humans ; Interferon-gamma ; immunology ; Interleukin-10 ; immunology ; Interleukin-6 ; immunology ; Leukocytes, Mononuclear ; immunology ; metabolism ; Male ; Middle Aged ; Recombinant Proteins ; immunology ; Th1 Cells ; immunology ; Th1-Th2 Balance ; Th2 Cells ; immunology
4.Antimicrobial resistance surveillance among nosocomial pathogens in 13 teaching hospitals in China in 2009
Qiwen YANG ; Hui WANG ; Yingchun XU ; Minjun CHEN ; Danhong SU ; Zhidong HU ; Kang LIAO ; Ji ZENG ; Yong WANG ; Bin CAO ; Yunzhuo CHU ; Rong ZHANG ; Wenen LIU ; Chunmei ZHOU ; Yongzhong NING ; Xiuli XU ; Chao ZHUO ; Bin TIAN ; Dongmei CHEN ; Yan XIONG ; Ping LI ; Yingmei LIU ; Hua NIAN ; Lihong LI ; Mingxiang ZOU ; Hongmei XIE ; Peihong YANG ; Hongli SUN ; Xiuli XIE
Chinese Journal of Laboratory Medicine 2011;34(5):422-430
Objective To investigate distribution and antimicrobial resistance among nosocomial pathogens from 13 teaching hospitals in China in 2009. Methods Non-repetitive pathogens from nosocomial BSI, HAP and IAI were collected and sent to the central lab for MIC determination by agar dilution method.WHONET5.6 software was used to analyze the data. Results A total of 2 502 clinical isolates were collected. The top three pathogens of BSI were Escherichia coli [27. 1% (285/1 052 )] , coagulase-negutive staphylococcus [12. 6% ( 133/1 052)] and Klebsiella pneumoniae [10. 8% ( 114/1 052)]. The top three pathogens of HAP were Acinetobacter baumannii [28. 8% (226/785)], Pseudomonas aeruginosa [16. 1% (126/785)] and Klebsiella pneumoniae [14.6% (115/785 )] . The top three pathogens of IAI were Escherichia coli[31.0% ( 206/665 )], Klebsiella pneumonia [11.3% ( 75/665 )] and Enterococcus faecium [10. 8% (72/665)]. Against Escherichia coil and Klebsiella spp. , the antimicrobial agents with higher than 80% susceptibility rate included imipenem and meropenem (98. 1%-100% ), tigecycline (95.3%-100% ), piperacillin-tazobactam ( 88.6% -97. 1% ) and amikacin ( 88. 3% -92. 5% ). Against Enterobacter spp. , Citrobacter spp. and Serratia spp. , the susceptibility rates of tigecycline were 93.5% -100% whereas the value of imipenem and meropenem were 92.9% -100%. Other antimicrobial agents with high activity included amikacin ( 85.2% -96. 7% ), pipcracillin-tazobactam ( 82.4% -96.4% ), cefepime ( 79. 6% -96. 7% ) and cefoperazonc-sulbactam (78. 7%-90. 0% ). Polymyxin B showed the highest susceptibility rateagainst Pseudomonas aeruginosa ( 100% ), followed by amikacin ( 81.9% ) and piperacillin-tazobactam (80.1% ). Polymyxin B also showed the highest susceptibility rate against Acinetobacter baumannii (98. 8% ), followed by tigecycline (90. 1% ) and minocycline (72. 0% ). The incidence of carbapenemresistant Acinetobacter baumannii was 60. 1%. The MRSA rate was 60. 2% and the MRSCoN rate was 84. 2%. All Staphylococcus strains were susceptible to tigecycline, vancomycin, teicoplanin and linezolid except for one isolate of Staphylococcus haemolysis with intermediate to teicoplanin. Two Enterococcus faecalis isolates which were intermediate to linezolid and one Enterococcus faecium isolate which was resistant to vancomycin and teicoplanin was found in this surveillance, while the MICs of tigecycline against these three isolates were 0. 032-0. 064 μg/ml. Conclusions Tigecycline, carbapenems, piperacillin-tazobactam,amikacin and cefepime remain relatively high activity against nosocomial Enterobacteriaceae. Pseudomonas aeruginosa exhibite high susceptibility to polymyxin B, while Acinetobacter baumanni shows high susceptibility to polymyxin B and tigecycline. Tigecycline, vancomycin, teicoplanin and linezolid remain high activity against nosocomial gram-positive cocci.
5.Correlation of Skp2 overexpression to prognosis of patients with nasopharyngeal carcinoma from South China.
Hui-Min XU ; Yi LIANG ; Qiong CHEN ; Qi-Nian WU ; Yun-Miao GUO ; Guo-Ping SHEN ; Ru-Hua ZHANG ; Zhi-Wei HE ; Yi-Xin ZENG ; Fang-Yun XIE ; Tie-Bang KANG
Chinese Journal of Cancer 2011;30(3):204-212
S-phase kinase-associated protein 2 (Skp2), which plays a role in cell cycle regulation, is commonly overexpressed in a variety of human cancers and associated with poor prognosis. However, its role in nasopharyngeal carcinoma (NPC) is not well understood. In this study, we examined the clinical significance of Skp2, with a particular emphasis on overall survival (OS) and disease-free survival (DFS), in NPC cases in South China, where NPC is an epidemic. Additionally, we explored the function of Skp2 in maintaining a cancer stem cell-like phenotype in NPC cell lines. Skp2 expression was assessed for 127 NPC patients using tissue microarrays and immunohistochemistry and analyzed together with clinicopathologic features, OS, and DFS. Skp2 expression was detectable, or positive, in 75.6% of patients. Although there was no correlation between Skp2 and any clinicopathologic factor, Skp2 expression significantly portended inferior OS (P = 0.013) and DFS (P = 0.012). In the multivariate model, Skp2 expression remained significantly predictive of poor OS [P = 0.009, risk ratio (RR) = 4.06] and DFS (P = 0.008, RR = 3.56), and this was also true for clinical stage (P = 0.012 and RR=3.201 for OS; P = 0.002 and RR=1.94 for DFS) and sex (P = 0.016 and RR=0.31 for OS; P = 0.006 and RR = 0.27 for DFS). After Skp2 knockdown, a colony formation assay was used to evaluate the self-renewal property of stem-like cells in the NPC cell lines CNE-1 and CNE-2. The colony formation efficiency in CNE-1 and CNE-2 cells was decreased. In Skp2-transfected CNE-1 and CNE-2 cells, side population (SP) proportion was increased as detected by flow cytometry. Skp2 is an independent prognostic marker for OS and DFS in NPC. Skp2 may play a role in maintaining the cancer stem cell-like phenotype of NPC cell lines.
Adolescent
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Adult
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Aged
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Carcinoma
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Cell Line, Tumor
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China
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Disease-Free Survival
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Female
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Follow-Up Studies
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Gene Knockdown Techniques
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Humans
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Male
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Middle Aged
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Nasopharyngeal Neoplasms
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genetics
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metabolism
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pathology
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Neoplasm Staging
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Neoplastic Stem Cells
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pathology
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RNA, Small Interfering
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genetics
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S-Phase Kinase-Associated Proteins
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genetics
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metabolism
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Sex Factors
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Survival Rate
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Tissue Array Analysis
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Transfection
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Young Adult
6.Progress in the Role of Mechanical Stimulus in Cardiac Development.
Ming-Hui XIE ; Wei-Hua QIAO ; Hong CAO ; Jia-Wei SHI ; Nian-Guo DONG
Acta Academiae Medicinae Sinicae 2022;44(1):164-172
Mechanical stimulus is critical to cardiovascular development during embryogenesis period.The mechanoreceptors of endocardial cells and cardiac myocytes may sense mechanical signals and initiate signal transduction that induce gene expression at a cellular level,and then translate molecular-level events into tissue-level deformations,thus guiding embryo development.This review summarizes the regulatory roles of mechanical signals in the early cardiac development including the formation of heart tube,looping,valve and septal morphogenesis,ventricular development and maturation.Further,we discuss the potential mechanical transduction mechanisms of platelet endothelial cell adhesion molecule 1-vascular endothelial-cadherin-vascular endothelial growth factor receptor 2 complex,primary cilia,ion channels,and other mechanical sensors that affect some cardiac malformations.
Animals
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Heart/embryology*
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Humans
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Mechanotransduction, Cellular
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Myocytes, Cardiac/physiology*
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Vascular Endothelial Growth Factor A/metabolism*
7.Feasibility and effectiveness of application of internet-based HIV testing in men who have sex with men.
Xue Jiao HU ; Yun Chun MIN ; Nian Hua XIE ; Cong LIU ; Rong HU ; Min ZHANG ; Quan Lin DONG ; Xia WANG
Chinese Journal of Epidemiology 2022;43(11):1773-1777
Objective: To evaluate the feasibility and effectiveness of the application of internet-based HIV testing in men who have sex with men (MSM) in practical application and provide evidence for its application in the future. Methods: MSM who visited the internet-based intervention platform for at least one time from June to December 2020 were selected for the study. The information about platform visit, the number of self-test kits provided, the basic characteristics of the MSM and their satisfactory level were collected. And multivariable logistic regression analyses were conducted to identify the potential factors associated with the reporting of self-test results. Results: By the end of December 31th, 2020, a total of 132 267 platform visits had been recorded, and 3 511 HIV self-test kits had been provided upon the MSM's requests, and 3 237 MSM (92.2%) reported self-test results. The HIV positive rate was 2.4% (69/2 855) and the confirmation rate of positive HIV test results was 86.7% (52/60). The MSM who asked for self-test kits online were mainly aged ≤30 years, had education level of college or above, and found their sexual partners through internet or dating software. Multivariable logistic regression analyses showed that repeat of online HIV self-test kits application (OR=3.50,95%CI:2.10-5.83), guarantee deposit of 50 yuan at application (OR=2.55,95%CI:1.33-4.89), monthly economic income 1-3 000 yuan (OR=1.54,95%CI:1.05-2.28) or no income (OR=1.71,95%CI:1.20-2.42) and online sexual partners finding (OR=1.49,95%CI:1.13-1.95) were associated with higher reporting rate of self-test results. The satisfactory rate the MSM to the service of platform was 99.5% (217/218). Conclusions: The study confirmed the feasibility and effectiveness of internet-based intervention for HIV tests in MSM, which could promote the self-test of HIV in MSM and facilitate the early detection of HIV infection through social media platforms and multi-channel promotion.
Male
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Humans
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Homosexuality, Male
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HIV Infections/prevention & control*
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Feasibility Studies
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Sexual and Gender Minorities
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HIV Testing
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Internet
8.Herbal Textual Research on Qizhu
Chang-jiang-sheng LAI ; Hua-sheng PENG ; Xu-ya WEI ; Jin-long CHEN ; Si-hui NIAN ; Ming ZHAO ; Jun-bo XIE ; Bin YANG
Chinese Journal of Experimental Traditional Medical Formulae 2020;26(18):133-138
Qizhu, the dried rhizome of
9.Prevalence, awareness, treatment, and control of hypertension in the non-dialysis chronic kidney disease patients.
Ying ZHENG ; Guang-Yan CAI ; Xiang-Mei CHEN ; Ping FU ; Jiang-Hua CHEN ; Xiao-Qiang DING ; Xue-Qing YU ; Hong-Li LIN ; Jian LIU ; Ru-Juan XIE ; Li-Ning WANG ; Zhao-Hui NI ; Fu-You LIU ; Ai-Ping YIN ; Chang-Ying XING ; Li WANG ; Wei SHI ; Jian-She LIU ; Ya-Ni HE ; Guo-Hua DING ; Wen-Ge LI ; Guang-Li WU ; Li-Ning MIAO ; Nan CHEN ; Zhen SU ; Chang-Lin MEI ; Jiu-Yang ZHAO ; Yong GU ; Yun-Kai BAI ; Hui-Min LUO ; Shan LIN ; Meng-Hua CHEN ; Li GONG ; Yi-Bin YANG ; Xiao-Ping YANG ; Ying LI ; Jian-Xin WAN ; Nian-Song WANG ; Hai-Ying LI ; Chun-Sheng XI ; Li HAO ; Yan XU ; Jing-Ai FANG ; Bi-Cheng LIU ; Rong-Shan LI ; Rong WANG ; Jing-Hong ZHANG ; Jian-Qin WANG ; Tan-Qi LOU ; Feng-Min SHAO ; Feng MEI ; Zhi-Hong LIU ; Wei-Jie YUAN ; Shi-Ren SUN ; Ling ZHANG ; Chun-Hua ZHOU ; Qin-Kai CHEN ; Shun-Lian JIA ; Zhi-Feng GONG ; Guang-Ju GUAN ; Tian XIA ; Liang-Bao ZHONG ; null
Chinese Medical Journal 2013;126(12):2276-2280
BACKGROUNDData on the epidemiology of hypertension in Chinese non-dialysis chronic kidney disease (CKD) patients are limited. The aim of the present study was to investigate the prevalence, awareness, treatment, and control of hypertension in the non-dialysis CKD patients through a nationwide, multicenter study in China.
METHODSThe survey was performed in 61 tertiary hospitals in 31 provinces, municipalities, and autonomous regions in China (except Hong Kong, Macao, and Taiwan). Trained physicians collected demographic and clinical data and measured blood pressure (BP) using a standardized protocol. Hypertension was defined as systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg, and/or use of antihypertensive medications. BP < 140/90 mmHg and < 130/80 mmHg were used as the 2 thresholds of hypertension control. In multivariate logistic regression with adjustment for sex and age, we analyzed the association between CKD stages and uncontrolled hypertension in non-dialysis CKD patients.
RESULTSThe analysis included 8927 non-dialysis CKD patients. The prevalence, awareness, and treatment of hypertension in non-dialysis CKD patients were 67.3%, 85.8%, and 81.0%, respectively. Of hypertensive CKD patients, 33.1% and 14.1% had controlled BP to < 140/90 mmHg and < 130/80 mmHg, respectively. With successive CKD stages, the prevalence of hypertension in non-dialysis CKD patients increased, but the control of hypertension decreased (P < 0.001). When the threshold of BP < 130/80 mmHg was considered, the risk of uncontrolled hypertension in CKD 2, 3a, 3b, 4, and 5 stages increased 1.3, 1.4, 1.4, 2.5, and 4.0 times compared with CKD 1 stage, respectively (P < 0.05). Using the threshold of < 140/90 mmHg, the risk of uncontrolled hypertension increased in advanced stages (P < 0.05).
CONCLUSIONSThe prevalence of hypertension Chinese non-dialysis CKD patients was high, and the hypertension control was suboptimal. With successive CKD stages, the risk of uncontrolled hypertension increased.
Adult ; Aged ; Awareness ; Female ; Humans ; Hypertension ; complications ; epidemiology ; therapy ; Male ; Middle Aged ; Prevalence ; Renal Insufficiency, Chronic ; complications
10.Comprehensive treatment with Chinese medicine in patients with advanced non-small cell lung cancer: A multicenter, prospective, cohort study.
Jie LIU ; Hong-Sheng LIN ; Wei HOU ; Bao-Jin HUA ; Pei-Tong ZHANG ; Jie LI ; Shen-Yu WANG ; Ying XIE ; Yue ZHANG ; Guang-Ru XIE ; Mei-Ying ZHANG ; Wen-Guang SHI ; Nian-Bo GUAN ; Tian-Yu GUAN ; Cong-Huang LI ; Li-Yuan LU ; Ying ZHANG ; Dao-Rui LI ; Hao LIU
Chinese journal of integrative medicine 2017;23(10):733-739
OBJECTIVETo determine whether additional Chinese medicine (CM) could prolong survival and improve the quality of life (QOL) in patients with advanced non-small cell lung cancer (NSCLC) compared with Western medicine (WM) alone.
METHODSThis was a multicenter, prospective cohort study. A total of 474 hospitalized patients with stage III-IV NSCLC were recruited and divided into 2 groups. Patients in the WM group received radiotherapy, chemotherapy, and optimal supportive therapy according to the National Comprehensive Cancer Network (NCCN) guidelines. In the integrative medicine (IM) group, individualized CM (Chinese patent medicines and injections) and WM were administered. The primary end point was overall survival, and the secondary end points were time to disease progression, adverse events, and QOL. Follow-up clinical examinations and chest radiography were performed every 2 months.
RESULTSThe median survival was 16.60 months in the IM group and 13.13 months in the WM group (P<0.01). The incidences of loss of appetite, nausea, and vomiting in the IM group were significantly lower than those in the WM group (P<0.05). The QOL based on Functional Assessment of Cancer Therapy-Lung in the IM group was markedly higher than that in the WM group at the fourth course (P<0.05).
CONCLUSIONSAdditional CM may prolong survival and improve the QOL patients with NSCLC. The adverse effects of radio- and chemotherapy may be attenuated as CM is used in combination with conventional treatments.