| Background:Prostate cancer (CaP) is a common cancer threatening men’s health. Its incidence has been the top one in the US. It is estimated by American Cancer society (ACS) that the number of new cases is240890and the number of died cases is33720in2011. The incidence has a growing tendency in China recently. Because of the limitation of people’s health awareness and economic condition, most patients belong to end stage of CaP in China when they are diagnosed. The main treatment is androgen deprivation therapy (ADT) for this kind of patients and most of them can get the benefit from ADT. However, the majority of patients will develop into hormone refractory prostate cancer (HRPC) after they undergo ADT about18to30months. The western medicine just shows limited effect for HRPC. So HRPC is a hard challenge for urologists. According to the theory of traditional Chinese medicine (TCM), HRPC belongs to the category of Long Bi and Ji Ju. Its etiology is the deficiency in origin and excess in superficiality and the organs including liver, spleen, kidney and bladder are involved in. In other words, the cause of CaP is that Qi of spleen and kidney is too weak to push the blood to flow and the pathogen remains in the body.Professor Liu and Professor Zhang in our department created the Qian Lie Xiao Zheng (QLXZ) decoction, integrating the western medicine and TCM, according to their experiences. QLXZ decoction is composed of Coix seed, Astragalus, Rhizoma polygonati, Oldenlandia diffusa, Bolbostemma paniculatum, curcuma zedoary and Agaric. Of those, Coix seed is the sovereign drug. It can improve the function of the spleen to increase the excretion of water, relieve arthralgia by relaxing muscles and tendons, and clear away heat and eliminate pus. Astragalus and Rhizoma polygonati are ministerial drugs. They can help the Coix seed to increase the function of spleen and kidney. Oldenlandia diffusa, Bolbostemma paniculatum, curcuma zedoary and Agaric are adjuvant drugs. On one hand, They can clear away heat and toxic material. On the other hand, they can break blood stasis and resolve mass. Modern pharmacology has showed that all the drugs had the function of anti-cancer and regulating the immunity. Some studies have showed QLXZ decoction can inhibit the survival and growth of CaP cells in vitro. Our previous study also presented that QLXZ decoction can inhibit the growth of transplanted CaP cell in nude mice and C57mice. The clinical study showed that it can decrease the PSA level in patients with CaP and improve their quality of life. In current study, we focused on the patients with HRPC and tried to find the advantage of TCM in treating this disease. We hope some new ideas and methods can be found by our study.Purpose:To observe the effect of QLXZ decoction in treating HRPC.Materials and Methods:Study population:57patients with HRPC who were the inpatients and outpatients diagnosed in Guang’an Men hospital, China academy of Chinese medicine science, from November,2009to December,2011were selected and were divided into standard western medicine (SWM) group and integration of SWM and TCM (IST) group. There were27and30patients in SWM group and IST group respectively.Methods of treatment:In our study, the patients in SWM group received the treatment of western medicine, including LHRH-a (goserelin3.75mg or triporelin3.6mg once a month), anti-androgen therapy (Bicalutamide50mg, once a day, Flutamide250mg,3times a day or Megace160mg,3times a day) and Bisphosphonates for patients with bone metastases (Pamidronate90mg, once a month), while the patients in IST group received QLXZ decoction (150ml, twice a day) which made by Chinese herb medicine room, Guang’an Men hospital, besides the treatment of western medicine. The QLXZ decoction contained raw Coix seed40g, Sunburn Astragalus15g, Rhizoma polygonati15g, Oldenlandia diffusa15g, Bolbostemma paniculatum15g, Curcuma zedoary10g and Agaric10g.Observation indexes:patients in both groups were asked to test serum PSA before and after3-month treatment. The patients’ quality of life was evaluated by FACT-P (Functional Assessment of Cancer Therapy-Prostate) questionnaire (version4) and the TCM syndrome was evaluated by TCM syndrome questionnaire before and after3-month treatment respectively. Of those, the FACT-P questionnaire contains39questions, including physical well-being (7questions), social/family well-being(7questions), emotional well-being(6questions), functional well-being(7questions) and additional concerns(12questions). Each question have5answers. Of these,0indicates "not at all",1indicates "a little bit",2indicates "somewhat",3indicates "quite a bit" and4indicates "very much". Patients were asked to finish it based on his condition in past1week. Results:In our study,57patients were selected and54of them finished the study.2patients and1patient didn’t finish the study in SWM group and IST group respectively. The patients’age, course of disease, stage of disease and Gleason score in two groups didn’t have significant difference. So the data can be compared.After3-month treatment, the serum PSA level elevated in SWM group from49.7±8.7ng/ml to64.5±20ng/ml. The possible reason is that ADT cannot delay the progression of HRPC. In contrast, the serum PSA level kept stable (P>0.05) in IST group. They were51±9.4ng/ml and53.4±11.8ng/ml respectively before and after3-month treatment. The IST group presented a lower PSA level compared to SWM group after treatment (P<0.001). It indicates that QLXZ decoction can delay the progression of HRPC temporary.As shown in table1, patients’ quality of life in different domain were improved significantly (P<0.05) in IST group after3-month treatment, which presented in the relieving of bother symptoms, the improvement of social and family relationship, the reduction of negative emotions, the improvement of physical functions and symptoms related to prostate. In SWM group, patients’ physical well-being, emotional well-being and additional concerns were also improved (P<0.05). In terms of physical well-being and emotional well-being,IST presented a better effect compared with SWM (P<0.05). With the conversion of medical pattern, the focus on cancer has changed from the cure rate to the period of survival with tumors and the improvement of patients’quality of life in global society. The FDA has indicated that the effect of treatment of cancer should be evaluated from the two aspects, the increase of survival rate and the improvement of quality of life. So when a doctor face a patient, he should think about the patient’s health condition not only from the patient but from the social environment. Once CaP develops to HRPC, patients’ quality of life is cut down seriously. On one hand, the various symptoms bother the patients. On the other hand, ADT also influence patients’ quality of life. A recent study showed that ADT can not only bring about the physical symptoms including sexual dysfunction, hot flashes, fatigue and breast pain, but also produce mental symptoms, such as helplessness and depression. In our study, FACT-P (version4) questionnaire was used to evaluate patients’quality of life. It contains5domains (physical well-being, social/family relation, emotional well-being, functional well-being and additional concerns) and39questions, which can reflect patients’ quality of life completely by assessing both the physical function and mental status. From the result of our study, QLXZ decoction can improve all the domains in patients’quality of life significantly compared to SWM including the regulation of emotion and mental status. The reason it that the TCM focus on the balance of Yin and Yang, which demonstrate the balance of Qi and blood, body and mind, and so on. Therefore, TCM has advantages for treatment of cancer in current medical pattern.After3-month treatment, patients’TCM syndrome scores were improved significantly in both groups (P<0.05). Of those, the TCM syndrome scores dropped from17.1±2.6to16.1±2.8in SWM group while they decreased from17.3±2.6to14.1±2.2in IST group. If we centre on the difference between two group, we can find IST presented a better effect on decreasing the TCM syndrome scores than SWM (P<0.05), which indicate that QLXZ decoction can regulate the functions of organs and the prognosis of disease is changed potentially. It is interesting that the TCM symptoms in patients with SWM were regulated partly. Maybe it come from the change of patients’ mind. Other reasons will rely on more studies in future.In a word,IST has superiority in treating HRPC compared with SWM.Conclusion:QLXZ decoction can delay the progression of PSA in patients with HRPC, elevate patients’quality of life and improve the TCM syndrome, so it is worth popularizing in clinical practice. |
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