回生口服液对非小细胞肺癌患者凝血功能、疗效及安全性影响的系统评价  

Systematic Review of Huisheng Oral Liquid on Coagulation Function, Efficacy and Safety of Patients with Non-Small Cell Lung Cancer

作　　者：张金华 田园 杨晓萍[3] 张翼 ZHANG Jinhua;TIAN Yuan;YANG Xiaoping;ZHANG Yi(Dept.of Oncology,Jingmen First People’s Hospital,Hubei Jingmen 448000,China;Traditional Chinese Medicine Phenomics Research Center,Traditional Chinese Medicine Hospital Affiliated to Southwest Medical University,Sichuan Luzhou 646000,China;Dept.of Internal Medicine of Traditional Chinese Medicine,Shanghai Seventh People’s Hospital,Shanghai 200137,China;Dept.of Internal Medicine of Traditional Chinese Medicine,Shanghai Tongren Hospital,Shanghai 200336,China)

机构地区：[1]荆门市第一人民医院肿瘤科,湖北荆门448000 [2]西南医科大学附属中医医院中医药表型组学研究中心,四川泸州646000 [3]上海市第七人民医院中医内科,上海200137 [4]上海市同仁医院中医内科,上海200336

出　　处：《中国医院用药评价与分析》2022年第10期1237-1243,共7页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：上海市卫生健康委员会中医药科研项目(No.2020LP016)。

摘　　要：目的:系统评价回生口服液对非小细胞肺癌患者凝血功能、疗效及安全性的影响。方法:计算机检索中国知网、万方数据库、中国生物医学文献数据库、维普数据库、PubMed、the Cochrane Library、Embase和Web of Science中建库至2021年9月收录的回生口服液对非小细胞肺癌患者凝血功能、疗效及安全性影响的随机对照试验(研究组患者采用回生口服液联合其他治疗或者回生口服液治疗;对照组患者采用其他治疗)。对纳入文献进行质量评价和数据提取,应用RevMan 5.3软件进行Meta分析。结果:纳入24项随机对照试验,1 783例研究对象(研究组908例,对照组875例)。Meta分析结果显示,研究组患者的D-二聚体水平升高值(SMD=-1.46,95%CI=-2.75~-0.18,P=0.03)、纤维蛋白原(Fib)水平升高值(MD=-0.81,95%CI=-1.14~-0.48,P<0.000 01)和血小板计数(PLT)(MD=-82.91,95%CI=-147.72~-18.11,P=0.01)均明显低于对照组,差异均有统计学意义;两组患者凝血酶原时间(MD=-0.71,95%CI=-1.71~0.30,P=0.17)、活化部分凝血酶原时间(MD=3.67,95%CI=-15.15~22.48,P=0.70)的差异均无统计学意义。研究组患者在客观缓解率(RR=1.28,95%CI=1.09~1.51,P=0.003)、疾病控制率(RR=1.15,95%CI=1.06~1.25,P=0.000 9)和卡诺夫斯凯计分改善率(RR=1.72,95%CI=1.39~2.13,P<0.000 01)方面均明显优于对照组,差异均有统计学意义。两组患者恶心呕吐发生率(RR=0.49,95%CI=0.20~1.20,P=0.12)、白细胞减少发生率(RR=0.59,95%CI=0.29~1.20,P=0.15)的差异均无统计学意义。结论:回生口服液可能通过降低D-二聚体、Fib和PLT水平,改善非小细胞肺癌患者的凝血功能;并可提高非小细胞肺癌患者的近期临床疗效、生活质量,但还需要更多高质量临床研究加以验证。OBJECTIVE: To systematically evaluate the effects of Huisheng oral liquid on coagulation function, efficacy and safety of patients with non-small cell lung cancer. METHODS: CNKI, Wanfang Data, CBM, VIP, PubMed, the Cochrane Library, Embase and Web of Science were retrieved to collect the randomized controlled trial of effects of Huisheng oral liquid on coagulation function, efficacy and safety of patients with non-small cell lung cancer(the study group was treated with Huisheng oral liquid combined with other treatment or Huisheng oral liquid;while the control group received other treatment) till Sept. 2021. Quality evaluation and data extraction of the included literature were performed, and RevMan 5.3 software was used for Meta-analysis. RESULTS: Totally 24 RCT were enrolled, including 1 783 patients(908 cases in the study group and 875 cases in the control group). Meta-analysis showed that the elevated values of D-dimer level(SMD=-1.46,95%CI=-2.75--0.18,P=0.03), fibrinogen(Fib) level(MD=-0.81,95%CI=-1.14--0.48,P<0.000 01) and platelet count(PLT)(MD=-82.91,95%CI=-147.72--18.11,P=0.01) in the study group were significantly lower than those in the control group, and the differences were statistically significant. There was no significant difference in prothrombin time(MD=-0.71,95%CI=-1.71-0.30,P=0.17) and activated partial prothrombin time(MD=3.67,95%CI=-15.15-22.48,P=0.70) between two groups. The objective response rate(RR=1.28,95%CI=1.09-1.51,P=0.003), disease control rate(RR=1.15,95%CI=1.06-1.25,P=0.000 9) and improvement rate of KPS(RR=1.72,95%CI=1.39-2.13,P<0.000 01) in the study group were significantly better than those in the control group, the difference was statistically significant. There was no significant difference in the incidence of nausea and vomiting(RR=0.49,95%CI=0.20-1.20,P=0.12) and leukopenia(RR=0.59,95%CI=0.29-1.20,P=0.15) between two groups. CONCLUSIONS: Huisheng oral liquid may improve the coagulation function of patients with non-small cell lung cancer by reducing the levels of D-dimer,

关 键 词：回生口服液 非小细胞肺癌 凝血功能 META分析 

分 类 号：R932[医药卫生—生药学]