Meta AnalysisID 5636
中药注射剂（艾迪注射液）控制恶性胸腔积液的证据框架：一项聚类系统评价与Meta分析
CRD42022337611
(1)Can Aidi injection be used to control malignant pleural effusion？ (2)Can Aidi alone improve the clinical effectiveness and safety in MPE and is Aidi injection superior or equal to chemical agents? (3)Can Aidi combined
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Record Fields
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- Meta Analysis Id
- 5636
- Evidence Id
- 14194
- Core Evidence Id
- 14194
- Source Meta Analysis Id
- 5619
- Herb2 Meta Analysis Id
- HBMA005619
- Crd Id
- CRD42022337611
- Title
- The evidence framework of traditional Chinese medicine injection (Aidi injection) in controlling malignant pleural effusion: a clustered systematic review and meta-analysis
- Review Question
- (1)Can Aidi injection be used to control malignant pleural effusion？ (2)Can Aidi alone improve the clinical effectiveness and safety in MPE and is Aidi injection superior or equal to chemical agents? (3)Can Aidi combined with chemical agents improve the clinical effectiveness and safety in MPE？How to combine Aidi and chemical reagents？What are their indications and optimal pathway and usage?
- Study Type Included
- Randomized controlled trials (RCTs)
- Condition Being Studied
- Malignant pleural effusion (MPE), a frequent complication of patients with intrathoracic and extrathoracic malignancies often leads to a poor quality of life (QOL), prognosis and survival. Effective control of pleural fluid is the key strategy to eliminate the symptoms, improve the QOL and reduce the mortality. As a cornerstone of treatment for symptomatic MPE, the pleurodesis is often achieved through intrapleural perfusion with chemical agents, biologic response modifiers (BRMs) or traditional Chinese medicine injections (TCMIs). Aidi injection (Aidi) is a commonly used TCMI, which is recommended for anti-cancer by the national basic medical insurance, industrial injury insurance and maternity insurance in China (ZC01, 2020). Clinically, except for adjuvant treatment in multiple malignant tumors, Aidi is often used to control the MPE. Previous systematic review and meta-analyses (SRs/meta-analyses) failed to confirm whether Aidi alone is superior or equal to chemical agents, and the clinical role of Aidi in MPE remains unclear. In addition, they did not clarify the combinations of Aidi and chemical agents (therapeutic regimens) and their indications and optimal pathway and usage. These questions have become the key reasons that hinder scientific decision-making and rational drug use.
- Participant
- All patients had symptomatic pleural effusion resulting from malignant tumor (of any type and stage) which was diagnosed by chest imaging, pleural fluid analysis, cytology or pleural biopsy. No intrapleural administration was given to the patient within one month before the treatment. During the treatment, none of the patients received the BRMs, hyperthermia, other TCMIs, systematic chemotherapy, or chemo-radiotherapy.
- Animal
- Human Disease Modelled
- Intervention
- The Aidi is a commonly used TCMI, which is recommended for anti-cancer by the national basic medical insurance, industrial injury insurance and maternity insurance in China (ZC01, 2020). Aidi is composed of cantharidin, ginsenoside, astragaloside (Re, Rb1 and Rg1), elentheroside E and syringin, which are extracted from Mylabris (Mylabris phalerata Pallas), Ginseng Radix Et Rhizoma (Panax ginseng C.A. Mey), Astragalus membronoceus (Fisch) Bunge and Eleutherococcus senticosus (Rupr & Maxim) Maxim. The intervention is Aidi injection (Aidi) which is used to control the MPE through intrapleural or intravenous administration. The experimental group received administration with Aidi alone or in combination with chemical agents.
- Comparator Control
- The control group only received intrapleural administration with chemical agents alone such as Cisplatin (DDP), Bleomycin (BLM), Cyclophosphamide (CTX), Carboplatin (CBP), Mitomycin-C (MMC) and etc.
- Main Outcome
- The main outcomes were clinical responses, survivals and QOL. Clinical responses include complete response, pleurodesis failure and disease progression. (i) the complete response is a pleural fluid disappeared for more than four weeks, or the lack of accumulation of fluid; (ii) the partial response is a fluid reduced more than 50% for more than four weeks; (iii) the no response or stable disease is fluid reduced less than 50% or increased less than 25% or the fluid recurred but required no further treatment; (iv) the disease progression is fluid increased more than 25% along with other signs of progression or symptomatic re-accumulation of the fluid requiring treatment again. We defined the pleurodesis failure as no response/stable disease plus disease progression. Besides, we analyzed the survival using overall survival (OS), progression-free survival (PFS), OS and PFS rates. When a KPS score increased ≥ 10 after treatment, the QOL was improved. Measures of effect The odds ratio (OR) or hazard ratio (HR) and 95% confidence interval (CI) was used to quantify these outcomes.
- Outcome Measure
- Additional Outcome
- The additional outcomes were ADRs and thoracentesis-related adverse events (TRAEs). We defined the ADRs as myelosuppression, neutropenia, thrombocytopenia, anemia, hepatotoxicity, nephrotoxicity, gastrointestinal reaction, chest pain, and fever. The TRAEs are a variety of syndromes like the treatment related death, respiratory failure, dyspnea, pneumothorax, chest infection, catheter-related infection, or cutaneous emphysema, and among others. Measures of effect The odds ratio (OR) or hazard ratio (HR) and 95% confidence interval (CI) was used to quantify these outcomes.
- Study Method
- Intervention, Meta-analysis, Systematic review
- Keyword
- Carcinoma, Non-Small-Cell Lung; Humans; Lung Neoplasms; Medicine, Chinese Traditional; Pleural Effusion, Malignant
- Contact
- Zheng Xiao [email protected]
- Organisational Affiliation
- Affiliated Hospital of Zunyi Medical University
- Funding Source
- Special funds for academic seedlings training and innovation at Zunyi Medical College [Qian Kehe Pingtai Rencai No. (2017) 5733-034] Special funds for science and technology research into traditional Chinese and national medicine in Guizhou (No QZYY 2017-084) The innovation talent team of Guizhou science and Technology Department (Qian Kehe Platform Talents [2020] 5007) A high-level innovative talent program in Guizhou (No. fzc 120171001)
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- China
- Review Stage
- Review Ongoing
- First Submission Date
- 2022-06-08
- Registration Date
- 2022-06-19
- Anticipated Start Date
- 2022-03-01
- Anticipated Completion Date
- 2022-09-01
- Title Cn
- 中药注射剂（艾迪注射液）控制恶性胸腔积液的证据框架：一项聚类系统评价与Meta分析
- Title En
- The evidence framework of traditional Chinese medicine injection (Aidi injection) in controlling malignant pleural effusion: a clustered systematic review and meta-analysis
- Bilingual Status
- complete