Abstract：
BACKGROUND: In China, Shenqi Fuzheng injection (SFI) has been used as an adjuvant therapy to treat all kinds of cancer for many years. A large number of systematic reviews or meta-analyses (SRs/MAs) were published to assess its efficacy and safety in the past few years. However, the quality of SRs/MAs was unclear and did not generate high-quality clinical evidence.
OBJECTIVE: We conducted an overview to integrate relevant SRs/MAs published in the past with the aim of providing new clinical evidence for SFI in combination with chemotherapy in the treatment of cancer.
OBJECTIVE: We conducted an overview to integrate relevant SRs/MAs published in the past with the aim of providing new clinical evidence for SFI in combination with chemotherapy in the treatment of cancer.
METHODS: A comprehensive search of PubMed, Web of Science, Embase, the Cochrane Library, CNKI, VIP, WanFang, and CBM was performed from the database inception to September 30, 2023. SRs/MAs of randomized controlled trials (RCTs) on SFI combined with chemotherapy for cancer were included. Four reviewers screened the literature and extracted relevant information. Five reviewers assessed the quality of reporting, methodological quality, risk of bias, and quality of evidence for SRs/MAs. We used corrected covered area (CCA) to assess the degree of overlap among the RCTs included in SRs/MAs. We performed a descriptive analysis for the results of the included SRs/MAs.
RESULTS: A total of 32 SRs/MAs of SFI combined with chemotherapy for cancer were included. We assessed the reporting quality of SRs/MAs using the PRISMA 2020 statement. 1 SR/MA had relatively complete reports, 20 SRs/MAs had some deficiencies in reporting, and 11 SRs/MAs had serious deficiencies in reporting. We assessed the methodological quality of SRs/MAs using the AMSTAR 2 tool. The methodological quality of all SRs/MAs was very low. We assessed the risk of bias for SRs/MAs using the ROBIS tool. The risk of bias was low for 19 SRs/MAs and unclear for 13 SRs/MAs. We assessed the quality of evidence for SRs/MAs using the GRADE evidence quality evaluation system. 50 items were moderate quality, 46 items were low quality, 27 items were very low quality, and 85 items were unclear. SFI combined with chemotherapy played a role in increasing efficacy and decreasing toxicities in all kinds of cancer, including clinical efficacy (except liver cancer), quality of life, immune function (except CD8+), leukopenia, thrombocytopenia, hemoglobinopenia, nausea and vomiting, liver damage, kidney damage, neurotoxicity, alopecia, and diarrhea.
CONCLUSIONS: The overview showed that SFI combined with chemotherapy may improve clinical efficacy (except for liver cancer), quality of life, and immune (except for CD8+) function in all types of cancer, as well as adverse events (AEs) such as leukopenia, thrombocytopenia, etc. Since most of the clinical evidence was low, higher quality clinical trials will be expected to improve the reliability of the above conclusions in the future.
OBJECTIVE: We conducted an overview to integrate relevant SRs/MAs published in the past with the aim of providing new clinical evidence for SFI in combination with chemotherapy in the treatment of cancer.
OBJECTIVE: We conducted an overview to integrate relevant SRs/MAs published in the past with the aim of providing new clinical evidence for SFI in combination with chemotherapy in the treatment of cancer.
METHODS: A comprehensive search of PubMed, Web of Science, Embase, the Cochrane Library, CNKI, VIP, WanFang, and CBM was performed from the database inception to September 30, 2023. SRs/MAs of randomized controlled trials (RCTs) on SFI combined with chemotherapy for cancer were included. Four reviewers screened the literature and extracted relevant information. Five reviewers assessed the quality of reporting, methodological quality, risk of bias, and quality of evidence for SRs/MAs. We used corrected covered area (CCA) to assess the degree of overlap among the RCTs included in SRs/MAs. We performed a descriptive analysis for the results of the included SRs/MAs.
RESULTS: A total of 32 SRs/MAs of SFI combined with chemotherapy for cancer were included. We assessed the reporting quality of SRs/MAs using the PRISMA 2020 statement. 1 SR/MA had relatively complete reports, 20 SRs/MAs had some deficiencies in reporting, and 11 SRs/MAs had serious deficiencies in reporting. We assessed the methodological quality of SRs/MAs using the AMSTAR 2 tool. The methodological quality of all SRs/MAs was very low. We assessed the risk of bias for SRs/MAs using the ROBIS tool. The risk of bias was low for 19 SRs/MAs and unclear for 13 SRs/MAs. We assessed the quality of evidence for SRs/MAs using the GRADE evidence quality evaluation system. 50 items were moderate quality, 46 items were low quality, 27 items were very low quality, and 85 items were unclear. SFI combined with chemotherapy played a role in increasing efficacy and decreasing toxicities in all kinds of cancer, including clinical efficacy (except liver cancer), quality of life, immune function (except CD8+), leukopenia, thrombocytopenia, hemoglobinopenia, nausea and vomiting, liver damage, kidney damage, neurotoxicity, alopecia, and diarrhea.
CONCLUSIONS: The overview showed that SFI combined with chemotherapy may improve clinical efficacy (except for liver cancer), quality of life, and immune (except for CD8+) function in all types of cancer, as well as adverse events (AEs) such as leukopenia, thrombocytopenia, etc. Since most of the clinical evidence was low, higher quality clinical trials will be expected to improve the reliability of the above conclusions in the future.
摘要：
背景：在中国，参芪扶正注射液(SFI)多年来一直被用作辅助治疗各种癌症。在过去的几年中，发表了大量的系统评价或荟萃分析（SRs/MA）来评估其有效性和安全性。然而,SRs/MA的质量尚不清楚,也未获得高质量的临床证据.
目的：我们对过去发表的相关SRs/MA进行了综述，旨在为SFI联合化疗治疗癌症提供新的临床证据。
目的：我们对过去发表的相关SRs/MA进行了综述，旨在为SFI联合化疗治疗癌症提供新的临床证据。
方法：对PubMed的全面搜索，WebofScience,Embase,Cochrane图书馆,CNKI,VIP,万方,从数据库开始到2023年9月30日进行CBM。纳入SFI联合化疗治疗癌症的随机对照试验（RCTs）的SRs/MA。四位评审员对文献进行了筛选，并提取了相关信息。五名审核员评估了报告的质量，方法学质量，偏见的风险，和SR/MA的证据质量。我们使用校正的覆盖面积（CCA）来评估SRs/MA中包含的RCT之间的重叠程度。我们对纳入的SRs/MA的结果进行了描述性分析。
结果：共32例SFI联合化疗的SRs/MA。我们使用PRISMA2020声明评估了SRs/MA的报告质量。1SR/MA有相对完整的报告，20个SR/MA在报告方面存在一些缺陷，11个SR/MA在报告方面存在严重缺陷。我们使用AMSTAR2工具评估了SRs/MA的方法学质量。所有SRs/MA的方法学质量都很低。我们使用ROBIS工具评估了SRs/MA的偏倚风险。19个SRs/MA的偏倚风险较低，13个SRs/MA的偏倚风险不明确。我们使用GRADE证据质量评估系统评估了SRs/MA的证据质量。50个项目质量适中，46个项目是低质量的，27件物品质量很低，85个项目不清楚。SFI联合化疗在各种癌症中发挥了提高疗效和降低毒性的作用，包括临床疗效（肝癌除外），生活质量,免疫功能（CD8+除外），白细胞减少症,血小板减少症,血红蛋白减少症,恶心和呕吐，肝损伤,肾损伤,神经毒性，脱发,和腹泻。
结论：概述显示SFI联合化疗可提高临床疗效（肝癌除外），生活质量,和免疫功能（除了CD8+）在所有类型的癌症，以及白细胞减少等不良事件（AE），血小板减少症,等。由于大多数临床证据都很低，更高质量的临床试验有望在未来提高上述结论的可靠性。
目的：我们对过去发表的相关SRs/MA进行了综述，旨在为SFI联合化疗治疗癌症提供新的临床证据。
目的：我们对过去发表的相关SRs/MA进行了综述，旨在为SFI联合化疗治疗癌症提供新的临床证据。
方法：对PubMed的全面搜索，WebofScience,Embase,Cochrane图书馆,CNKI,VIP,万方,从数据库开始到2023年9月30日进行CBM。纳入SFI联合化疗治疗癌症的随机对照试验（RCTs）的SRs/MA。四位评审员对文献进行了筛选，并提取了相关信息。五名审核员评估了报告的质量，方法学质量，偏见的风险，和SR/MA的证据质量。我们使用校正的覆盖面积（CCA）来评估SRs/MA中包含的RCT之间的重叠程度。我们对纳入的SRs/MA的结果进行了描述性分析。
结果：共32例SFI联合化疗的SRs/MA。我们使用PRISMA2020声明评估了SRs/MA的报告质量。1SR/MA有相对完整的报告，20个SR/MA在报告方面存在一些缺陷，11个SR/MA在报告方面存在严重缺陷。我们使用AMSTAR2工具评估了SRs/MA的方法学质量。所有SRs/MA的方法学质量都很低。我们使用ROBIS工具评估了SRs/MA的偏倚风险。19个SRs/MA的偏倚风险较低，13个SRs/MA的偏倚风险不明确。我们使用GRADE证据质量评估系统评估了SRs/MA的证据质量。50个项目质量适中，46个项目是低质量的，27件物品质量很低，85个项目不清楚。SFI联合化疗在各种癌症中发挥了提高疗效和降低毒性的作用，包括临床疗效（肝癌除外），生活质量,免疫功能（CD8+除外），白细胞减少症,血小板减少症,血红蛋白减少症,恶心和呕吐，肝损伤,肾损伤,神经毒性，脱发,和腹泻。
结论：概述显示SFI联合化疗可提高临床疗效（肝癌除外），生活质量,和免疫功能（除了CD8+）在所有类型的癌症，以及白细胞减少等不良事件（AE），血小板减少症,等。由于大多数临床证据都很低，更高质量的临床试验有望在未来提高上述结论的可靠性。
