Graduate School, Henan University of Chinese Medicine, Zhengzhou, 450046, China.
The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, 450099, China.
J Ethnopharmacol. 2023 Dec 5;317:116778. doi: 10.1016/j.jep.2023.116778. Epub 2023 Jun 14.
Compound Kushen (Sophora flavescens Aiton) Injection (CKI) is a Chinese herbal injection made from extracts of Kushen and Baituling (Heterosmilax japonica Kunth), containing matrine (MAT), oxymatrine (OMT) and other alkaloids with significant anti-tumor activity, and is widely used as an adjuvant treatment for cancer in China.
The existing systematic reviews/meta-analyses (SRs/MAs) were re-evaluated to provide a reference for the clinical application of CKI.
SRs/MAs of CKI adjuvant therapy for cancer-related diseases were searched in four English language databases: PubMed, Embase, Web of Science, and Cochrane Library, all from the time of database construction to October 2022. 5 researchers independently conducted literature search and identification according to the inclusion criteria, and the data of the final literature were independently extracted, and finally the AMSTAR 2 tool, PRISMA statement and GRADE classification were used to evaluate the methodological quality of the included SRs/MAs, the degree of completeness of reporting and the quality of evidence for outcome indicators. Database registration: PROSPERO ID:CRD42022361349.
Eighteen SRs/MAs were finally included, with studies covering non-small cell lung cancer, primary liver cancer, gastric cancer, colorectal cancer, breast cancer, head and neck tumors, and cancer-related bone pain. The evaluation showed that the methodological quality of the included literature was extremely low, but most of the literature reported relatively complete entries; nine clinical effectiveness indicators for non-small cell lung cancer and digestive system tumors were rated as moderate in the GRADE quality of evidence, and the quality of other outcomes was low to very low.
CKI is a potentially effective drug for the adjuvant treatment of neoplastic diseases and may be more convincing for the adjuvant treatment of non-small cell lung cancer and digestive system tumors; however, due to the low methodological and evidentiary quality of the current SRs, their effectiveness needs to be confirmed by more high-quality evidence-based medical evidence.
苦参(苦参)注射液(CKI)是一种中药注射液,由苦参和贝图灵(日本异叶菝葜)提取物制成,含有苦参碱(MAT)、氧化苦参碱(OMT)和其他具有显著抗肿瘤活性的生物碱,在中国被广泛用作癌症的辅助治疗。
重新评估现有的系统评价/荟萃分析(SRs/MAs),为 CKI 的临床应用提供参考。
在四个英文数据库中搜索 CKI 辅助治疗癌症相关疾病的 SRs/MAs:PubMed、Embase、Web of Science 和 Cochrane Library,均从数据库建立时间到 2022 年 10 月。5 名研究人员根据纳入标准独立进行文献检索和鉴定,独立提取最终文献的数据,最后使用 AMSTAR 2 工具、PRISMA 声明和 GRADE 分类评估纳入的 SRs/MAs 的方法学质量、报告的完整性程度和结局指标的证据质量。数据库注册:PROSPERO ID:CRD42022361349。
最终纳入 18 项 SRs/MAs,研究涵盖非小细胞肺癌、原发性肝癌、胃癌、结直肠癌、乳腺癌、头颈部肿瘤和癌症相关骨痛。评估结果表明,纳入文献的方法学质量极低,但大多数文献报告的条目较为完整;9 项非小细胞肺癌和消化系统肿瘤的临床疗效指标在 GRADE 证据质量中被评为中度,其他结局的质量为低至极低。
CKI 是一种治疗肿瘤疾病的潜在有效药物,对于辅助治疗非小细胞肺癌和消化系统肿瘤可能更有说服力;然而,由于当前 SRs 的方法学和证据质量较低,其有效性需要更多高质量的循证医学证据来证实。