Purposes: This study will meet the conditions for the group of locally advanced pancreatic cancer patients respectively on liver principle spleen integrated traditional Chinese medicine(TCM) with ultrasonic focusing therapy or chemotherapy, and conduct clinical observation. Exploration of locally advanced pancreatic cancer new treatments or pattern, in order to improve the quality of patients with advanced pancreatic cancer control, survival, prolonging survival period, not only focus on improve the treatment effect, more important is to explore to establish new models of pancreatic cancer treatment, better service to the clinical patients.Materials and Methods: Using randomized, parallel-group study design, collection in May 2014- December 2014, Beijing Chinese medicine hospital outpatient and the inpatient and the Chinese people’s liberation army general hospital inpatient, Chinese academy of medical sciences cancer hospital inpatient were lost the chance of operation in accordance with the set of conditions, a total of 60 patients with locally advanced pancreatic cancer, according to 1:1 divided into treatment group(adjustable liver principle spleen integrated traditional Chinese medicine combined therapy with ultrasonic focusing) 30 cases and control group 30 cases(chemotherapy). The Beijing Chinese medicine hospital into the group of 31 cases, 17 cases in treatment group,control group 14 cases; Hospital of the Chinese people’s liberation army into the case group 19 cases, 9 cases of treatment group and control group in 10 cases; Chinese academy of medical sciences cancer hospital into the group of 10 cases, 4 cases of treatment group and control group in 6 cases. Two groups of patients were lost the chance of operation of locally advanced pancreatic cancer patients, the clinical benefit rate between two groups, control situation of tumor, survival time and the safety of the ultrasonic focusing treatment to observe, to obtain objective data, after comprehensive intervention measures to evaluate "the liver spleen and integrated traditional Chinese medicine combined ultrasonic focusing on" mode of therapy in the treatment of locally advanced pancreatic cancer efficacy and safety.Results: The treatment group and control group patients’ age, gender, height, KPS score, QOLC- 30 and tumor site has no obvious difference(P > 0.05). Pain score: 1, 3,6 months observation period NRS pain score of treatment group were: 3.01±1.03ã€4.21±1.81ã€5.00±0.89,in the control group, respectively is: 4.13±1.22ã€4.80±1.15ã€5.50±0.58, P values are: < 0.01, 0.231, 0.356. KPS score: 1, 3, 6 months of treatment group KPS score: 77.33±9.44 〠70.00±12.02 〠68.33±9.83,in the control group,respectively is: 64.33±8.58ã€62.50±8.01ã€60.00±8.17,P values are::0.01ã€0.03ã€0.20. QOL- C30 grade: 1, 3 and 6 months treatment group of QOL- C30 grade are:59.62±9.93 〠64.42±12.08 〠71.67±14.72,in the control group, respectively is:63.60±3.67 〠77.89±9.23 〠81.75±7.50,P values, respectively, 0.039, 0.01, 0.025.Weight changes: 1, 3, 6 months of treatment group weight respectively: 61.28±1.83ã€58.89±2.17 〠64.22±2.87, in the control group, respectively is: 63.25±2.02 ã€59.55±3.13ã€63.06±2.74. CBR: Observed during the treatment group 1, 3, 6 months clinical yields are 66.22% 〠61.82% 〠53.07%; Control group clinical yields are:47.50%ã€40.34%ã€38.55%. P values are: 0.031ã€0.048ã€0.087. Progression-free surial(PFS): the treatment group of progression-free surial was 136.73±16.22 days, the control of progression-free surial was 120.00±15.03 days, P value is 0.801. Observe the expiry of the 1 in the treatment group the mean survival time was 253.90±18.06,the median of 219.00±27.91; The control group the mean survival time was 246.77±17.31, the median of 220.00±25.96, P value is 0.636. Survival: the treatment group3 months, 6 months, 1 year survival rates were 83.33%, 46.33%, 33.33%. In the control group for 3 months, 6 months, 1 year survival rates were 96.67%, 60% and36.67% respectively. P values are: 0.095ã€0.053ã€0.246. CA199: during the study period 1 to 6 months treatment group CA199 numerical respectively: 1298±336.64ã€1352.11±368.48ã€1099.45±474.96ã€945.10±570.311ã€434.27±170.47ã€166.4±114.06,in the control group, respectively is: 1152.02±599.19 〠1334.02±463.30 ã€1263.40±486.31ã€789.95±396.89ã€399.53±180.99ã€227.18±83.01, P value is 0.104ã€0.533ã€0.081ã€0.104ã€0.776ã€0610. CEA: during the study period 1 to 6 months treatment group CEA values are: 11.72±4.85ã€18.46±6.61ã€7.45±2.73ã€12.01±4.21ã€25.14±8.53ã€9.98±3.71,in the control group, respectively is: 16.42±4.97ã€16.65±6.80ã€11.11±4.58ã€32.56±10.05ã€41.28±16.55ã€11.40±5.40,P values are: 0.036ã€0.251ã€0.035ã€0.017ã€0.022ã€0.017.Treatment group, there was no skin burns, adverse events such as bleeding, after treatment of blood routine, liver meritorious service is series examination results before the treatment has no obvious change.Conclusion:1. HIFU combined traditional Chinese medicine in the treatment of locally advanced pancreatic cancer for 3 months, 6 months, 1 year survival rate was slightly lower than chemotherapy group, but not lower than chemotherapy group,progression-free surial for treatment when the patient’s life is significantly higher than chemotherapy group.2. Chinese traditional medicine the liver ultrasonic focusing principle spleen chemical product method is effective and safe treatment for locally advanced pancreatic cancer, is worth further promotion in the clinical practice. |