| Research Background:The most common tumor of urinary system is bladder cancer. The proportion of superficial bladder cancer in clinical bladder cancer is75%-85%. Gold standard of non muscle invasive bladder cancer (NMIBC) is TUR-BT.10%-67%patients after TUR-BT will have the bladder cancer recurrence within12months with50%-70%recurrence rates. How to prevent or reduce the recurrence rate after TUR-BT is an important issue to be solved.Bladder irrigation chemotherapy drugs are the most common used method for post-TUR-BT recurrence prevention. Bladder irrigation chemotherapy drugs are various, including BCG, mitomycin, pirarubicin hydrochloride, HCPT, etc. The bladder cancer recurrence rate after bladder irrigation BCG, mitomycin and HCPT are24.24%,27.27%and14.70%respectively. While long-term bladder irrigation chemotherapy drugs will cause complications, such as chemical cystitis, bone marrow repression and bladder contracture. A safe and effective treatment for bladder cancer post-TUR-BT recurrence prevention is in need.Compared with the other drugs, HCPT was first adopted as bladder irrigation chemotherapy drugs in1980s. The vitro experiments have confirmed that HCPT have the function of T24anti-proliferative, anti-invasion and RT4, MGH, and T24cancer cells apoptosis induction. HCPT is basically not absorbed by the urinary bladder mucosa. HCPT acts on phase5. At a higher concentration, HCPT is one kind of better bladder irrigation chemotherapy drugs which has the function of nuclear division inhibition. HCPT rarely causes the symptoms such as leucopenia and anemia and its side effects are relatively less. HCPT prevention effect is better than BCG and mitomycin, so this research adopt HCPT as the bladder irrigation chemotherapy drug.Every bladder irrigation chemotherapy drug may inevitably cause side effects such as frequent micturiation, urgency of urination, gross hematuria, low-grade fever and pour appetite. While long-term bladder irrigation chemotherapy drugs will cause complications, such as chemical cystitis, bone marrow repression and bladder contracture. A safe and effective treatment for bladder cancer post-TUR-BT recurrence prevention is in need. Bladder tumor belongs to the categories such as "niaoxue","nixue" and "souxue". The name of bladder tumor doesn’t exist in TCM literatures, while, from the aspect of pathogenesis, etiology, symptoms and treatment methods, there are a lot of related records in ancient books which provide important reference points for bladder tumor diagnosis and treatment. By intensive clinical and experimental study, several effective compounds and preparation appears. Chinese medicine plays more important role in bladder cancer treatment with the toxicity reducing and efficacy enhancing characteristics. For examples, adopting Donglingcao extract as irrigation chemotherapy drug in clinic obtains positive effect. Donglingcao labiatae rabdosia species decoction has obvious inhibition for several cancer cells. Donglingcao systemic administration only has no obvious side effects and no obvious influence for marrow, liver and kidney function.Chinese medicine plays more important role in bladder cancer treatment with the toxicity reducing and efficacy enhancing characteristics. Adopting Xiao zheng decoction in treating bladder cancer has been researched for20years by Guang’an men hospital urology department. Xiao zheng decoction is an experiential prescription by professor Liu youfang from Guang’an men hospital. By repetitious clinical practice, professor Liu consider that pathogenesis of bladder cancer post-TUR-BT recurrence is asthenia in origin and asthenia in superficiality while vital-qi deficiency and intermingled dampness and toxin syndrome are its pathogenesis characteristics. The bladder cancer post-TUR-BT basic treatment is tonifying qi, removing dampness and detoxification. According to the basic treatment Xiaozheng decoction was composited in bladder cancer post-TUR-BT recurrence treatment. In the prescription, coix seed obtains the function of removing dampness and detoxification; radix astragali and polygonatum kingianum have the function of tonifying qi and yin; hedyotis diffusa clears the heat and detoxifies, bolbostemma paniculatum detoxifies and dissipates stagnation, polyporus umbellatus expels dampness by promoting diuresis, zedoary breaks blood stasis and promotes qi circulation. The modem pharmacological researches confirm that anticancer constituent is coix lachrymajobi lactone which obviously restrains solid tumor; radix astragali and polygonatum kingianum can enhance immunity; hedyotis diffusa not only enhances immunity, but also has the anticancer activity; tubeimoside has obvious anticancer fucntions; anticancer constituent in zedoary, curcumol obtains the direct cancerocidal function which restrains the nucleus metabolism of rat sarcoma; polyporus polysaccharide expresses anticancer effects by promoting gluconeogenesis enzyme activities. By observing prophase60clinical cases, on the basis of conventional Hcpt bladder irrigation chemotherapy drugs, combinig applying Xiaozheng decoction will obviously reduce the incidence of side effects after bladder irrigation, such as frequent micturiation, urgency of urination and nausea, reduce the post-TUR-BT recurrence rate, and remarkably improve the patients’life quality.Case studies about Chinese medicine compound are relatively few and so does the reports about strict control group, which cannot provide convincing clinical efficacy evidences and effects the Chinese medicine application in this area. So, enhancing developing clinical efficacy evaluation about treating bladder cancer with Chinese medicine which is instructed by TCM theory, utilizing evidence-based medicine method and obtaining the object of improving efficacy is an important issue to be solved. This research will provide objective evidence about bladder cancer treatment by using Chinese medicine which obtains important academic and practical significance.Research purpose:Observe the prevention of superficial bladder cancer post-TUR-BT recurrence by adopting the combination of Xiaozheng decoction and bladder irrigation chemotherapy drugs.Research method:1. PrincipleAdopt randomized controlled clinical experimental study methods.2. Sample sizeSmall sample observation, western medicine group (bladder HCPT irrigation chemotherapy drugs only), combination of WM and TCM (combined apply of Xiaozheng decoction and bladder HCPT irrigation chemotherapy drugs),60cases per group,120cases in total.3. Diagnostic criteria3.1Western medicine diagnostic criteria (refers to "Chinese urological diseases diagnosis and treatment g uideline"(2011) and "Wujieping urology"(2004))①Symptoms:intermittent or persistent total painless gross hematuria ②TAS shows:intravesical mass or bladder wall localized mass③Pelvic CT scan: Thickening of bladder wall, papillary or cauliflower-like tissue masses on bladder wall. In strengthening early stage (arterial phase) obviously even or uneven strengthening of mass.④Cystoscope examination shows:Solitary or multiple papillary masses in bladder.⑤Pathology confirms bladder cancer, Pathological stage:Ta、T1, pathological grade:G1or G2.All possess⑤、③、④or combining①、②can be diagnosed as superficial bladder cancer.3.2Chinese medicine diagnostic criteria (set Chinese medicine diagnostic criteria and syndrome differentiation criteria of prostate cancer according to "combination of TM and WM urology"(2007)).Intermingled dampness and toxin syndrome combining qi deficiency syndrome:①Total painless gross hematuria②Frequent micturiation, urgency of urination, painful urinationor dysuria③Lower abdominal fall-swell sensation④Fatigue, soreness and weakness of waist and knees⑤Tongue:Pale, greasy tongue coating, slippery or deep thready pulseAll possessing①、②、⑤items and one of the other two can be diagnosed as bladder cancer whose syndrome is the combination of intermingled dampness and toxin syndrome and qi deficiency3.3inclusion criteria①Meet superficial WM diagnosis and TCM syndrome differentiation criteria②age<80③olunteer to participate and sign information consent form3.4cases exclusion criteria①with severe heart, brain blood vessel, liver, kidney and hematopoietic system diseases and mental diseases②Allergic constitution and patients allergic to this decoction③medicate according to the regulation with the factor that effect efficacy or safety judgment such as hardly judged efficacy or incomplete information ④end-stage tumor, multiple organ failure, no therapeutic value3.5excluded cases and off cases criteria①Patients are allergic to the investigational medicine②not be in accordance with the inclusion criteria, medicate not according to regulation with the factor that effect efficacy or safety judgment such as hardly judged efficacy or incomplete information③Off cases have the factors such as bad compliance after experiment, severe adverse events occurring, suspending experiment because of special physiological changes or voluntary withdrawal.4main observation objects and index4.1:reexamine by using B ultrasound and cystoscope, compare the bladder cancer post-TUR-BT recurrence between the2groups.4.2:blood routine, hepatorenal and kidney function4.3:Chinese syndrome score5. Therapeutic method5.1Bladder irrigation chemotherapy drugs group:adopt HCPT for injecting (40mg/time) as recurrence preventive irrigation drugs. Irrigate the chemotherapy drugs solution which is prepared according to instruction into bladder via urinary catheter. Change lying positions in four postures:lie on the right side, lie on the left side, on the back and on the abdomen, then maintain for2hours. Treatment course: once per week,8times in total, later once per month until2years after operation.5.2Chinese medicine Xiaozheng decoction combining HCPT bladder irrigation chemotherapy drugs group:on the basis of HCPT bladder irrigation, take Chinese Xiaozheng decoction (basic prescription:coix seed30g, radix astragali20g, hedyotis diffusal5g; polyporus umbellatus15g, zedoary9g, bolbostemma paniculatum9g) add and subtract:for constipation add Maren10g, rhubarb6g; for insomnia add tuber fleeceflower stem15g, polygala tenuifolia9g; for frequent urination and urgent urination add achyranthes bidentata15g and cluster mallow fruit15g; for hematuria add herb of herba cirsii15g, congongrass rhizome15g and panax notoginseng3g; for nausea add citrus9g and amomum10g. Decoction, one dose daily, until2years after operation.Treatment course:2year. 6. Statistic analysis6.1measurement data①statistical description:be in accordance with the normal distribution, represented by mean±standard deviation (x±S), abnormal distribution was represented by median±interquartile range (M±Q)②statistical inference:comparision among groups which were in accordance with normal distribution and homogeneity of variance performs independent sample t-test, while which were in accordance with abnormal distribution and hetergeneity of variance performs Wilcoxon; Comparision among groups which was in accordance with normal distribution performs independent sample t-test while comparison among groups which was in accordance with abnormal distribution will perform Wilcoxon.6.2enumeration data(1) Statistical description:Statistical description was represented by frequency, frequency rate and constituent ratio.(2) Statistical inference:comparison between groups adopts contingency table X-2.Conclusion:1. Bladder cancer post-TUR-BT recurrence in Xiaozheng decoction combining HCPT bladder irrigation chemotherapy drugs group is lower than in bladder irrigation chemotherapy drugs only group.2. Compared with the HCPT bladder irrigation chemotherapy drugs only group, Xiaozheng decoction combining HCPT bladder irrigation chemotherapy drugs will obviously reduce side reaction and improve patients’life quality.Chinese medicine Xiaozheng decoction combining bladder irrigation HCPT will obviously reduce frequent micturiation, urgency of urination, nausea and incidence of abnormal urine routine, post-TUR-BT recurrence rate and improve patients’life quality. So TCM and WM combination will improve the clinical efficacy and reduce patients sufferings, which is worthy of clinical promotion. |
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