| 俞仪萱,李嘉,张旭,等.中医药治疗抗肿瘤分子靶向药物相关腹泻的Meta分析[J].浙江中医药大学学报,2022,46(7):805-815. |
| 中医药治疗抗肿瘤分子靶向药物相关腹泻的Meta分析 |
| Traditional Chinese Medicine in Treating Molecular Targeted Drug-induced Diarrhea: a Meta-analysis |
| DOI：10.16466/j.issn1005-5509.2022.07.020 |
| 中文关键词: 中医药 恶性肿瘤 靶向药物 靶向药物相关腹泻 随机对照试验 系统评价 Meta分析 GRADE评价 |
| 英文关键词: traditional Chinese medicine malignancy targeted drug targeted drug-induced diarrhea randomized controlled trial systematic review Meta-analysis GRADE evaluation |
| 基金项目:国家自然科学基金项目(81873396) |
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| 中文摘要: |
| [目的] 系统评价中医药治疗抗肿瘤分子靶向药物(以下简称靶向药物)相关腹泻的有效性和安全性，为临床治疗提供循证依据。 [方法] 检索中国期刊全文数据库(China National Knowledge Infrastructure，CNKI)、万方数据平台(Wanfang Data)、中国科技期刊数据库(China Science and Technology Journal Database，VIP)、中国生物医学文献服务系统(China Biomedical Literature Database，SinoMed)、PubMed、Cochrane Library、Web of Science等数据库，获取中医药治疗靶向药物相关腹泻的随机对照试验(randomized controlled trial，RCT)。使用Cochrane风险偏倚评估工具对研究进行质量评价，使用Stata 15.0和TSA 0.9软件进行Meta分析和试验序贯分析，依据推荐等级的评估、制定与评价(Grading of Recommendations Assessment，Development and Evaluation，GRADE)标准进行证据质量评价。[结果] 最终纳入9项研究，共484例患者。Meta分析显示，在常规西药治疗的基础上加用或单用中医药，可以明显提高治疗的总有效率[相对危险度(relative risk，RR)=1.347，95%可信区间(confidence interval，CI)(1.212，1.497)，P=0.000]，降低腹泻症状积分[RR=1.527，95%CI(1.287，1.812)，P=0.000]与分级[RR=1.218，95%CI(1.064，1.393)，P=0.004]，改善患者生活质量(Karnofsky physical status，KPS)评分[RR=1.116，95%CI(1.039，1.198)，P=0.003]，并能改善腹痛[标准化均数差(standardized mean difference，SMD)=-1.050，95%CI(-2.016，-0.083)，P=0.033]、腹胀[SMD=-0.942，95%CI(-1.865，-0.018)，P=0.046]、食欲不振[SMD=-1.534，95%CI(-2.682，-0.385)，P=0.009]等症状，且未增加不良反应。试验序贯分析进一步说明，中医药治疗靶向药物相关腹泻具有确切疗效。但根据GRADE标准，提高有效率的证据为低质量，改善生活质量及降低中医症状积分为极低质量。[结论] 中医药能提高靶向药物相关腹泻的临床疗效，且安全性良好。但由于样本量小及文献质量低，相关证据有赖于更多高质量的临床试验。 |
| 英文摘要: |
| [Objective] To systematically evaluate the effectiveness and safety of traditional Chinese medicine(TCM) in the treatment of molecular targeted drug(hereinafter referred to as targeted drug)-induced diarrhea， so as to provide evidence-based for clinical practice. [Methods] The randomized controlled trials(RCTs) of TCM for targeted drug(hereinafter referred to as targeted drug)-induced diarrhea were acquired from China National Knowledge Infrastructure(CNKI)， Wanfang Data， China Science and Technology Journal Database(VIP)， Chinese Biomedical Literature Database(SinoMed)， PubMed， Cochrane Library and Web of Science. The quality of literature was evaluated by the Cochrane Collaboration‘s risk assessment tool. Stata 15.0 software was used for Meta-analysis， TSA 0.9 software was used for trial sequential analysis， and the Grading of Recommendations Assessment， Development and Evaluation(GRADE) system was used to evaluate the evidence level of the analysis results. [Results] A total of 9 RCTs and 484 patients were included in the study. Meta-analysis results showed that the addition of TCM or TCM alone can improve the total effective rate[relative risk(RR)=1.347， 95%confidence interval(CI)(1.212，1.497)， P=0.000]， decrease diarrhea symptom scores[RR=1.527， 95%CI(1.287，1.812)， P=0.000] and Common Terminology Criteria for Adverse Events(CTCAE) grades[RR=1.218， 95%CI(1.064，1.393)， P=0.004]， improve patients’Karnofsky performance status(KPS) score[RR=1.116， 95%CI(1.039，1.198)， P=0.003] and relief the syndromesuch as stomachache [standardized mean difference(SMD)=-1.050， 95%CI(-2.016，-0.083)， P=0.033]， abdominal distention[SMD=-0.942， 95%CI(-1.865，-0.018)， P=0.046] and inappetence [SMD=-1.534， 95%CI(-2.682，-0.385)， P=0.009]. There was no increase in adverse reactions. The TSA results further indicated that TCM showed a definite effect on treating the targeted drug-induced diarrhea. However， according to the GRADE system， the evidence level of effective rate was low quality， and the level of improving patients‘ quality of life and the reduction of Chinese medicine syndrome score were extremely low quality. [Conclusion] The use of TCM can effectively improve the efficacy of targeted drug-induced diarrhea with the safety profile. However， due to the small sample size and poor literature quality， reliable evidence depends on more high-quality clinical trials. |
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