Zhang Fan, Yin Yantong, Xu Tiantian
Department of Pharmacy.
Department of Respiratory Medicine, Liaocheng People's Hospital, Liaocheng, Shandong Province, China.
Medicine (Baltimore). 2019 Aug;98(35):e16969. doi: 10.1097/MD.0000000000016969.
Cinobufotalin injection (CFI), a kind of Chinese medicine, has been considered as a promising complementary therapy option for advanced non-small cell lung cancer (NSCLC), but their efficacy and safety remain controversial. This study aimed to systematically evaluate the efficacy and safety of CFI and chemotherapy-combined therapy for advanced NSCLC.
Clinical trials were searched from Web of Science, Cochrane Library, PubMed, Embase, China National Knowledge Infrastructure (CNKI), Chinese Biological Medicine Database (CBM), Chinese Medical Citation Index (CMCI), Wanfang database and Chinese Scientific Journal Database (VIP). Main measurements, including therapeutic efficacy, quality of life (QoL) and adverse events, were extracted from the retrieved publications and were systematically evaluated.
The 29 trials including 2300 advanced NSCLC patients were involved in this study. Compared with chemotherapy alone, its combination with CFI significantly prolonged the patients' 1-, 2- and 3-year overall survival rate (OS) (1-year OS, OR = 1.94, 95% CI = 1.42-2.65, P < .0001; 2-year OS, OR = 2.31, 95% CI = 1.55-3.45, P < .0001; 3-year OS, OR = 4.69, 95% CI = 1.78-12.39, P = .002) and improved patients' overall response (ORR, OR = 1.84, CI = 1.54-2.18, P < .00001), disease control rate (DCR, OR = 2.09, 95% CI = 1.68-2.60, P < .00001) and QoL (quality of life improved rate, QIR, OR = 2.64, 95% CI = 1.98-3.52, P < .00001; karnofsky performance score, KPS, OR = 10.97, 95% CI = 5.48-16.47, P < .0001). Most adverse events caused by chemotherapy were obviously alleviated (P < .05) when CFI was also applied to patients.
The combination of CFI and chemotherapy is safe, and is more effective in treating NSCLC than chemotherapy alone. Therefore, CFI mediated therapy could be recommended as an adjuvant treatment method for NSCLC.
华蟾素注射液（CFI）作为一种中药，被认为是晚期非小细胞肺癌（NSCLC）一种有前景的辅助治疗选择，但其疗效和安全性仍存在争议。本研究旨在系统评价CFI与化疗联合治疗晚期NSCLC的疗效和安全性。
从Web of Science、Cochrane图书馆、PubMed、Embase、中国知网（CNKI）、中国生物医学数据库（CBM）、中国医学引文索引（CMCI）、万方数据库和中文科技期刊数据库（VIP）中检索临床试验。从检索到的出版物中提取主要测量指标，包括治疗效果、生活质量（QoL）和不良事件，并进行系统评价。
本研究纳入29项试验，共2300例晚期NSCLC患者。与单纯化疗相比，CFI联合化疗显著延长了患者1年、2年和3年的总生存率（OS）（1年OS，OR = 1.94，95%CI = 1.42 - 2.65，P <.0001；2年OS，OR = 2.31，95%CI = 1.55 - 3.45，P <.0001；3年OS，OR = 4.69，95%CI = 1.78 - 12.39，P =.002），提高了患者的总缓解率（ORR，OR = 1.84，CI = 1.54 - 2.18，P <.00001）、疾病控制率（DCR，OR = 2.09，95%CI = 1.68 - 2.60，P <.00001）和生活质量（生活质量改善率，QIR，OR = 2.64，95%CI = 1.98 - 3.52，P <.00001；卡氏功能状态评分，KPS，OR = 10.97，95%CI = 5.48 - 16.47，P <.0001）。当患者同时应用CFI时，化疗引起的大多数不良事件明显减轻（P <.05）。
CFI与化疗联合应用安全，治疗NSCLC比单纯化疗更有效。因此，CFI介导的治疗可推荐作为NSCLC的辅助治疗方法。
