| ObjectiveLiteratures on Traditional Chinese Medicine treatment of primary liver cancer were studied. (1) We analyze the internal and external characteristics of literature to summarize regularity, which can guide the clinical and scientific research. (2) To evaluate the effect of ancient prescription as the important components of Traditional Chinese Medicine treatment of liver cancer using evidence-based medicine meta-analysis.MethodMake normative search strategy, and we electronic retrieve the MEDLINE Database, EMBASE Database, SCI Database, COCHRANE LIARARY Database, CBM Database, VIP Database, CNKI Database and WanFang Database combined with manual searching and other supplement to collect controlled trials on Traditional Chinese Medicine treatment of liver cancer. By using EXCEL software according to the form designed in advance, we extracted the data from included literature one by one and analyzed the data by SPSS 17.0 software to describe the growth trend, core authors, core journals and research type of literature on Traditional Chinese Medicine treatment of liver cancer. Based on the analysis of literature metrology, according to the inclusion and exclusion criteria of systematic review, we respectively screened the randomized controlled trials of ancient prescriptions treatment of liver cancer and ancient prescription combined with interventional therapy treatment of liver cancer from controlled trials on Traditional Chinese medicine treatment of liver cancer. And information of these documents was extracted and methodological quality of them was evaluated. Then we use the Cochrane Revman5.1 software to Meta-analysis.ResultFinally it was included 550 articles published in both English and Chinese on controlled trials of Traditional Chinese medicine treatment of liver cancer. Literature on Traditional Chinese medicine treatment of liver cancer research is in exponential growth. The core journal of Traditional Chinese medicine treatment of liver cancer has 22 kinds, of which,19 belong to the sort of Traditional Chinese Medicine or integrated Chinese and western medicine. The IF of core journal of Traditional Chinese Medicine treatment of liver cancer is in 0.2-0.5 and the average is 0.522. It belongs to the medium to low level in in traditional Chinese journal. The core authors of Traditional Chinese Medicine treatment of liver cancer have 15 persons,12 of which come from southern district,3 from northern district. With 550 references retrieved accords with a condition, the most is advanced liver cancer with the number of 243. Traditional Chinese medicine treat of liver cancer often cooperate with western medicine, of which, the most is interventional therapy with the number of 310. In 550 literatures,227 articles are about Chinese patent medicine,318 articles is about Chinese herbal decoction. Of all literatures,265 articles are about proved recipe, of which, the most one is Chinese patent medicine with the number of 133. Of all the articles, the most one is about randomized controlled trials with the number of 466.This systematic review included 34 studies,2447 patients. Of which the palliative treatment one included 17 studies,994 patients and the interventional therapy one included 17 studies,1453 patients.The methodological quality of included studies is general low, of which only one is high quality article(JADAD=4 point).The result show that:(1)The ancient prescriptions combination group and the single best support care group have significant difference on short time effective rate,6 months/1 year survival rate,the stability rate of quality of life,the KPS score after treatment and the TCM effective rate.The short time effective rate,6 months/1 year survival rate,the stability rate of quality of life,the KPS score after treatment and the TCM effective rate of the former increased respectively by 28%,28%,59%,23%,4.59 point and 29% than the latter.The ancient combination group and the single interventioanl group have significant difference on the ORR,1-year/2-year/3-year survival rate,KPS score after treatment,the TCM score after treatment,the proportion of NK cell and CD3 cell and the CD4/CD8 after treatment.Those indicators above of the former respectively increased 17%,22%,105% and 161%,increased averagely by 4.81 point,reduce by an average of 0.57 point,increased by an average of 3.54 percent point and 16.19 percent point and 0.15.(2)The ancient prescriptions group which is major in Jian Pi Shu Gan and the single symptomatic and supportive treatment group have significant difference in 3-months/6-months/1-year survival rate,stability rate of quality of life,the KPS score after treatment,TCM syndrome effective rate.The indicators above of the former increased respectively by25%,58%,81%,41%,3.64 point and 45% than the latter.The ancient prescriptions which is major in Jian Pi Li Qi and the single interventional therapy group have significant difference in ORR, 1-year/2-y ear/3-year survival rate,the KPS score after treatment.The indicators of the former increased respectively by 26%,29%,211%,395% and 5.13 point than the latter.(3)The ancient prescriptions combination group which is major in Jian Pi Fu Zheng and the single supportive and symptomatic treatment have significant difference in KPS score after treatment and TCM syndrome effective rate.The indicators above of the former increased averagely by 6.12 points and 44% than the latter.(4)The ancient prescriptions combination group which is major in Jian Pi Bu Shen and the single supportive and symptomatic treatment group have significant difference in TCM syndrome effective rate.The TCM syndrome effective rate of the former increased by 59% than the latter.(5)The ancient prescriptions combination group which the observation time is one month or the sample size is 50-100 or> 100 and the single interventional therapy group have significant difference in ORR. The ORR of the former increased respective by 51%,30% and 17% than the latter. (6)The ancient prescriptions combination group which is major in Jian Pi Xiao Ji and the single supportive and symptomatic treatment group have no significant difference on short-term response rate,6-months/1-year survival rate,stability rate of quality of life,the KPS score after treatment and the TCM syndrome effective rate.Conclusion(1)Cumulative amount of literature on Traditional Chinese Medicine treatment of liver cancer is increasing exponentially. And it was in the middle and preliminary stage to accelerate development. And in 2021 the number is expected to increase to 2847. (2)Journals on Traditional Chinese Medicine and Integrated Chinese and Western medicine are the mainstream journals for spreading of Traditional Chinese Medicine treatment of liver cancer. Study on Traditional Chinese medicine is still backward, low level compared with the western medicine research. Study on Traditional Chinese Medicine treatment of liver cancer is low, remains to be improved compared with other fields of Traditional Chinese Medicine.(3)Southern district is the research hotspots of traditional Chinese medicine treatment of liver cancer, the enthusiasm of researchers in north China should be improved. (4)Research of Traditional Chinese medicine treatment of liver cancer is given priority to advanced liver cancer patients as study object, to Traditional Chinese Medicine combined with interventional therapy as interventional measures, to proved recipe and ancient prescriptions according to the classification of traditional Chinese medicine and to randomized controlled trials as type of study. Ancient prescriptions are used in clinic in the form of traditional decoction. Proved prescriptions are used in clinic in the form of Chinese patent medicine. Randomized controlled trials of ancient prescription combined with interventional therapy or ancient prescription treatment of advanced liver cancer is the hot field of traditional Chinese medicine treatment of liver cancer. There are sufficient conditions and also be necessary to evaluate the effect of ancient prescription as the important components of Traditional Chinese Medicine treatment of liver cancer using evidence-based medicine meta-analysis.Based on the result of bibliometric analysis,we make an systematic review on the efficacy of ancient prescriptions treatment of advanced liver cancer. According to the two systematic reviews,we can get the general conclusion:Palliative therapy or the interventional therapy is the major curative method for advanced liver cancer and Traditional Chinese Medicine,especial the ancient prescriptions,play an important role in the palliative therapy or interventional therapy of liver cancer.We find that:(1)The ancient prescriptions may alleviate the tumor burden of liver cancer patient with palliative treatment or interventional therapy by increasing the ORR or short-term effective rate,especially may reduce the tumor burden of liver cancer patient after interventional therapy within 1 month. (2)The sample size may be a important factor to ORR in RCT study about liver cancer.When the sample size is larger than 50,the ORR may tend to positive result.(3)The ancient prescriptions may improve the the survival rate of patient,of which it may improve the 6-month/1-year survival rate of liver cancer with palliative therapy and may improve the 1-year/2-y ear/3-year survival rate of liver cancer with interventional therapy. (4)The ancient prescriptions may enhance the quality of life of liver cancer with palliative therapy or interventional therapy by improve the KPS score after therapy or stability rate of quality of life.(5)The ancient prescriptions may relieve clinical symptoms of liver cancer patients with palliative or interventional therapy by decrease the TCM syndrome score after treatment or improve the TCM syndrome effective rate.(6)The ancient prescriptions may enhancing immune function of patients with interventional therapy by increase the proportion of NK cell and CD3 cell and the CD4/CD8.(7)The ancient prescriptions which is major in Jian Pi Shu Gan and represented by Chai Shao Liu Jun Zi decoction,Modified Liu Jun Zi Decoction,Si Jun Zi decoction and Chai Hu Shu Gan powder,or Bu Zhong Yi Qi decoction and Shen Ling Bai Zhu Powder in this paper,may improve the survival rate of patients. Of which,it may improve the 3-month/6-month/1-year survival rate of patients with palliative therapy and the 1-year/2-year/3-year survival rate of patients with interventional therapy. (8)The ancient prescriptions,which is major in Jian Pi Shu Gan and represented by Chai Shao Liu Jun Zi decoction,Modified Liu Jun Zi,Si Jun Zi decoction and Chai Hu Shu Gan Powder OR Bu Zhong Yi Qi decoction and Shen Ling Bai Zhu powder,may enhance the quality of life of patients with palliative or interventional therapy by increase the KPS score after treatment and stability rate of quality of life.(9)The ancient prescriptions,which is major in Jian Pi Shu Gan and represented by Si Jun Zi decoction and Chai Hu Shu Gan Powder,Chai Shao Liu Jun Zi Decoction,Liu Jun Zi and Si Ni Powder,may relieve clinical symptoms of patients with palliative therapy by improve the TCM syndrome effective rate.(10)The ancient prescriptions,which is major in Jian Pi Shu Gan and represented by Chai Shao Liu Jun Zi Decoction,Modified Liu Jun Zi decoction,Modified Si Jun Zi decoction,Jian Pi Pill and Si Ni Powder,may relieve tumor burden of patients with interventional therapy. (11)The ancient prescriptions,which is major in Jian Pi Fu Zheng and represented by Liu Jun Zi decoction,may relieve clinical symptoms and improve quality of life by increase the KPS score after treatment and the TCM syndrome effective rate.(12)The ancient prescriptions,which is major in Jian Pi Bu Shen and represented by Si Jun Zi decoction And Liu Wei Di Huang decoction,may relieve clinical symptoms by improve the TCM syndrome effective rate.(13)The ancient prescriptions,which is major in Jian Pi Xiao Ji and represented by Jian Pi Wan,shows effectiveness on short-term effective rate,6-month/1-year survival rate,stability rate of quality of life,the KPS score after treatment and the TCM syndrome effective rate in patients with palliative therapy.(14)The ancient prescriptions included in this systematic review is major in Jian Pi and cooperate with Shu Gan,Huo Xue,Xiao Ji,Hua Ji,Jie Du,Qing Re,Qu Shi,Yi Liu,Fu Zheng or Bu Shen, Zi Yin and so on.Of which,the treatment of Jian Pi Shu Gan is most commonly used.The curative effects of ancient prescriptions which is major in Jian Pi Shu Gan in this systematic review is more outstanding. And this is echoed by the common syndrome type of liver-stagnation and spleen-deficiency.From the relationship between liver and spleen,this conclusion explained that Jian Pi Shu Gan conform to the physiology characteristic of liver and spleen reinforcing each other in blood and digestive function and the pathological rule of mutual forbearance of liver and spleen.From the curative theory,this conclusion is also verified the truth of "see liver disease,know will spread to spleen,should reinforce spleen firstly" proposed by Huangdi Neijing.From the curative theory, making Jian Pi as the main treatment reflect the important place of spleen as the foundation of after-birth and the source of qi and blood.According to bibliometric analysis and repeat study,we know the study of Traditional Chinese Medicine treatment of liver cancer is in a period of accelerated development.it shows that the subject theories has been continuously breaking through and the environment of this subject has been continuously improving. The RCT on ancient prescriptions combined with interventional therapy or ancient prescriptions palliative treatment of liver cancer is the hot fields of Traditional Chinese Medicine treatment of liver cancer.Because there are many deficiencies,like low methodological quality of studies included,it make a low level evidence for outcome indicators in this systematic review.So we can’t give a quite sure answer about the curative efficacy of ancient prescriptions treatment of liver cancer.It still needs clinical researchers make effort in related study to provdide more evidence of high quality for verifying the curative efficacy of ancient prescriptions treatment of liver cancer further. |
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