| AIM(1)To observe the effect of Anti-cancer prescription 2 on the Progression-free survival(PFS)and recurrence and metastasis rates of colorectal cancer patients in 1,3 and 5years.(2)To observe the difference of immune function between patients with colorectal cancer and healthy people,and the effect of Anti-cancer prescription 2 on immune function of patients with colorectal cancer,and to analyze the related factors that may affect prognosis.Methods(1)Using the method of two-way cohort study,the patients with colorectal cancer who visited Shanghai Traditional Chinese Medicine Hospital and Shanghai Putuo District Central Hospital from January 2010 to December 2017 were collected.The patients were divided into Chinese medicine group and control group according to whether they received the treatment of Anti-cancer Formula 2.Epidata information collection database was designed to collect patients'names,ages,gender and diagnosis.Time,surgery,chemotherapy,radiotherapy,targeted therapy,staging,pathological classification,differentiation,smoking history,drinking history,hypertension history,diabetes history,family history of cancer and other information.Follow-up was carried out every six months through outpatient,in-patient follow-up,telephone and so on.The patients'progress or death were recorded in detail.The last follow-up time was December 31,2018.The difference of PFS,OS,cumulative recurrence and metastasis rates in 1,3 and 5 years was observed by Kaplan-Meier method;the univariate survival analysis of 14 clinical data and tumor-related information was performed;the prognostic risk factors and protective factors were screened by COX proportional risk model.(2)A prospective cohort study was conducted to collect 123 patients who visited the oncology clinic and ward of Shanghai Hospital of Traditional Chinese Medicine.The patients who took Oral Anti-cancer Formula 2 as the Chinese medicine group did not receive other anti-cancer treatments such as radiotherapy and chemotherapy during this period.In addition,healthy people in our hospital were collected as control group.The differences of T lymphocyte level and tumor markers in peripheral blood between patients with colorectal cancer and healthy people before and after treatment were compared.The changes of autoimmune function and tumor markers in Chinese medicine group before and after 6 months of treatment were observed.The patients in Chinese medicine group were screened.Survival period was exceeded by Kaplan-Meier and Log-Rank tests.12 factors including immune function and tumor markers were analyzed by univariate analysis after 2 years.COX proportional hazard model was used for multivariate analysis to screen prognostic factors.Results(1)Before propensity matching,the m PFS and m OS of TCM group were 68 months and75 months respectively,while those of control group were 40 months and 65 months respectively.After matching,the m PFS and m OS of TCM group were 75 months,while those of control group were 28 months and 44 months,respectively,with statistical significance(all p<0.05).The m PFS of patients in stage I was not given in both groups;the m PFS of patients in stage II was 65 months and 56 months in the control group;the m PFS of patients in stage III was 39 months and 25 months in the control group;the m PFS of patients in stage IV was 35 months and 12 months in the control group,the difference was statistically significant(all p<0.001).(2)The cumulative recurrence and metastasis rates of 1,3 and 5 years in the TCM group were 6.0%,35.3%and 45.2%respectively,while those in the control group were21.4%,48.3%and 67%respectively(p<0.001).(3)Single factor analysis by Kaplan-Meier and Log-Rank test showed that the protective factors for prognosis were taking traditional Chinese medicine,women,early stage,moderate to high differentiation,operation,no hypertension,no history of drinking,no intestinal obstruction,no family history of cancer(all p<0.05).The recurrence and metastasis rates of the Chinese medicine group were 6%,35.3%,45.2%and 21.4%,48.3%and 67%respectively in the control group(p<0.001),indicating that the risk of recurrence and metastasis of colorectal cancer patients after oral administration of Chinese herbal medicine is low;the recurrence and metastasis rates of female patients in one year,three years and five years are 13.2%,33.2%,49.1%,male patients are 13%,47.2%,61.3%(p=0.007),indicating that the overall recurrence and metastasis rates of female patients are lower than that of male patients;the recurrence and metastasis rates of hypertension patients in one year,three years and five years are16.9%,48.3%and 60.6%respectively,with no 11.4%,38%,53.9%respectively(p=0.02),indicating that the recurrence and metastasis rates of hypertension patients were higher than those of non-hypertension patients;the recurrence and metastasis rates of patients with drinking history in one year,three years and five years were 15.5%,60.6%and 68.9%respectively,and those without drinking history were 12.3%,35.5%and 52.5%respectively(p<0.001),indicating that the recurrence and metastasis rates of patients with drinking history were higher than those without drinking history;patients with intestinal obstruction history were also associated with intestinal obstruction.The recurrence and metastasis rates in 1,3 and 5 years were 20.5%,77.9%and 87.6%respectively,and those in patients without history of intestinal obstruction were 11.8%,34.1%and 49.5%(p<0.001),indicating that the recurrence and metastasis rates in patients with intestinal obstruction were higher than those in patients without history of intestinal obstruction,16.3%,53.2%and 65.7%in patients with family history of cancer and 11.8%,36.5%and 52.5%in patients without family history of cancer,respectively.(p=0.001),indicating that patients with family history of cancer had a higher risk of recurrence and metastasis than those without family history of cancer.(4)COX multivariate regression analysis showed that surgery,chemotherapy and taking Chinese herbal decoction were protective factors for recurrence and metastasis of colorectal cancer,while intestinal obstruction,drinking history and family history were independent risk factors for recurrence and metastasis of colorectal cancer.Subgroup analysis showed that Chinese herb decoction could reduce the risk of recurrence and metastasis in each subgroup(p<0.05).(5)A total of 123 patients and 76 healthy persons in the Chinese medicine group were collected.The levels of CD4~+%,CD4~+/CD8~+in peripheral blood of patients with colorectal cancer were lower than those of healthy people(p<0.05),while the levels of CD8~+%,NK%cells were higher than those of healthy people(p<0.05);the levels of CD8~+%,NK%cells in patients with colorectal cancer were lower than those before treatment(p<0.05),and the levels of CD4~+/CD8~+were higher than those before treatment(p<0.05).Compared with healthy people,there was no significant difference in CD8~+%cell level after treatment,and it tended to be normal.The results showed that patients with CD3~+%<64.7%,CD8~+%<27.02%,CD4~+/CD8~+>1.52 and those with normal CEA,CA724 and CA242 could obtain longer OS(p<0.05).The COX risk regression results showed that the levels of CA242,CA724 and CEA at diagnosis were independent factors affecting the prognosis of patients with colorectal cancer.The response factor(p<0.05).Conclusions(1)Anti-cancer prescription 2 can improve the m PFS and OS of patients with colorectal cancer,and reduce the risk of recurrence and metastasis of patients with colorectal cancer.(2)The risk of recurrence and metastasis in female patients is lower than that in male patients.The earlier the stage is,the lower the risk of recurrence and metastasis is.The risk of recurrence and metastasis in surgical patients is lower than that in non-surgical patients.The risk of recurrence and metastasis in patients without history of intestinal obstruction is lower than that in patients with history of intestinal obstruction.The risk of recurrence and metastasis in patients without history of hypertension/drinking/family history of cancer is Patients with a history of blood pressure/alcohol consumption/family history of cancer.(3)The prognostic factors of patients with colorectal cancer are whether to use traditional Chinese medicine,whether to operate or not,sex,stage of cancer,degree of differentiation,intestinal obstruction,hypertension,drinking history and family history of cancer.(4)The distribution of T lymphocyte subsets in peripheral blood of patients with colorectal cancer is abnormal compared with healthy people.Anti-cancer prescription 2can improve the immune function of patients with colorectal cancer and inhibit the growth of relevant tumor markers,which may be the mechanism of anti-cancer prescription 2 to prolong the survival of patients with colorectal cancer. |
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