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1.
BACKGROUND: Colon cancer is curable by surgery, but cure rate depends on the extent of disease. We investigated whether adjuvant active specific immunotherapy (ASI) with an autologous tumour cell-BCG vaccine with surgical resection was more beneficial than resection alone in stage II and III colon cancer. METHODS: In a prospective randomised trial, 254 patients with colon cancer were randomly assigned postoperative ASI or no adjuvant treatment. ASI was three weekly vaccinations starting 4 weeks after surgery, with a booster vaccination at 6 months with 10(7) irradiated autologous tumour cells. The first vaccinations contained 10(7) BCG organisms. We followed up patients for time to recurrence, and recurrence-free and overall survival. Analysis was by intention to treat. FINDINGS: The 5.3 year median follow-up (range 8 months to 8 years 11 months) showed 44% (95% CI 7-66) risk reduction for recurrence in the recurrence-free period in all patients receiving ASI (p=0.023). Overall, there were 40 recurrences in the control group and 25 in the ASI group. Analysis by stage showed no significant benefit of ASI in stage III disease. The major impact of ASI was seen in patients with stage II disease, with a significantly longer recurrence-free period (p=0.011) and 61% (18-81) risk reduction for recurrences. Recurrence-free survival was significantly longer with ASI (42% risk reduction for recurrence or death [0-68], p=0.032) and there was a trend towards improved overall survival. INTERPRETATION: ASI gave significant clinical benefit in surgically resected patients with stage II colon cancer. ASI has minimal adverse reactions and should be considered in the management of stage II colon cancer.  相似文献   

2.
We studied the effects on survival time of postoperative immuno-chemotherapy, including the streptococcal preparation OK-432, in patients with gastric cancer and synchronous peritoneal dissemination. The patients were prospectively randomized and a valid statistical assessment could be made for 109. Patients randomized to group B received therapy that is widely used in Japan to treat patients with gastric cancer: mitomycin C (MMC) and UFT, a combination of tegafur and uracil in a molar ratio of 1:4, for 1 year. Patients randomized to group A received the same drugs as were given to group B patients plus OK-432 i.p. for 7 days, beginning on postoperative day 0, and OK-432 by intradermal injection for 1 year, at 2-week intervals. There were no differences between the two groups in any known prognostic factor or in the dose of any drug administered except for OK-432. There was no difference in the toxicity rate between the groups. In this negative trial, there was no improvement in survival time with the addition of OK-432 to MMC and UFT for patients with gastric cancer and peritoneal dissemination.  相似文献   

3.
A novel method of prophylaxis and treatment for peritoneal carcinomatosis--mitomycin C bound to activated carbon particles (MMC-CH)--was tested in patients with advanced gastric cancer in a prospective randomized study. Activated carbon particles are taken up selectively by lymphatic tissues, which seem to be a primary site of peritoneal carcinomatosis in the peritoneal cavity, and adsorb a large amount of anticancer agent mitomycin C, which is subsequently released slowly and for a protracted period. A group of 113 patients who underwent radical resection for gastric cancer with definite serosal involvement were entered in this trial. Those in the control group received no intraperitoneal anticancer drugs. Patients in the MMC-CH group were given 50 mg mitomycin C as MMC-CH, which was dispersed throughout the peritoneal cavity just before surgical closure. No other anticancer drugs were given to these patients after surgery. The 2- and 3-year survival rates for the MMC-CH group were 42% and 38%, respectively; and the rates for the control group were 28% and 20%, respectively. The difference in survival between the two groups was significant at 2 and 3 years (p < 0.05). For the survival of patients with macroscopic peritoneal carcinomatosis, there was no difference between these two groups. For the survival of patients who underwent histologically curative resection, 2- and 3-year survivals for the MMC-CH group were 66% and 66%, respectively and for the control group 35% and 20%, respectively. The difference between the two groups was statistically significant (p < 0.01) at both 2 and 3 years.(ABSTRACT TRUNCATED AT 250 WORDS)  相似文献   

4.
A new dosage format (MMC-CH) of mitomycin C, which is composed of mitomycin C on activated carbon particles, was efficacious for prevention of peritoneal recurrence of gastric cancer. However, it had no such excellent therapeutic effect on the survival of patients with peritoneal dissemination. Out of 50 patients with peritoneal dissemination of gastric cancer treated by intraperitoneal administration of MMC-CH, 4 patients have survived for long periods of time (39-80 months). However, all of the other 50 patients, who did not receive intraperitoneally administered MMC-CH, died of peritoneal carcinomatosis within two years.  相似文献   

5.
The histoculture drug-response assay (HDRA) was recently evaluated in a retrospective clinical trial and was found to correlate to drug sensitivity, resistance, and patient survival. To further investigate the potential of HDRA to contribute to patient survival, 215 patients with gastric cancer from 45 medical centers were tested with the HDRA in a blinded study after resection of the primary lesion. One hundred sixty-eight patients received at least 20 mg/m2 of mitomycin C and a minimum of 30 g UFT, a mixture of tegafur and uracil at a molar ratio of 1:4, thereby making them eligible for the study. Of these cases 128 were evaluable by the HDRA. The evaluable patient tumors were tested by the HDRA with the [3H]thymidine incorporation end point measured by microautoradiography to be drug "sensitive" or "resistant." The in vitro conditions for distinguishing sensitivity and resistance that matched the response rates for historical controls for gastric carcinoma were 90% inhibition rate and 0.12 microgram/ml for mitomycin C and 70% inhibition rate and 1 microgram/ml for 5-fluorouracil, respectively. Most importantly in the blinded study, the overall and disease-free survival rates of the HDRA-sensitive group were found to be significantly higher than those of the HDRA-resistant group tested under the above conditions. The data further indicate the importance of three-dimensional tumor culture for obtaining accurate clinical information. The results demonstrate that the HDRA response correlates to patient survival, which suggests the potential of the HDRA to contribute to patient survival in gastric cancer when used prospectively.  相似文献   

6.
We report 42 cases of gastric cancer with peritoneal carcinosis treated with intraperitoneal chemohyperthermia. Intraperitoneal chemohyperthermia was achieved with a closed sterile circuit containing mitomycin C, 10 mg/l producing an input temperature varying from 46 to 49 degrees C for 90 minutes. There were three postoperative deaths: one pulmonary embolism at day 4, one multiple organ failure et day 4, and one septic shock at day 25 due to a colonic fistula. Two patients suffered complications: one opening of the duodenal stump requiring reoperation on day 5, and one prolonged postoperative ileus lasting to day 10. Of the 12 patients with ascites, resorption was achieved in 8. In patients with early-stage peritoneal carcinosis (granulations less than 5 mm) survival at 1, 2 and 3 years was 90%, 61% and 41% respectively. For those with more extensive carcinosis, survival at 1 year was 10%. Five patients survived more than 30 months, three have survived to 34, 43 and 73 months. Intraperitoneal chemohyperthermia is a new treatment for carcinosis of gastric origin. These early results must be assessed further with larger controlled.  相似文献   

7.
Since April 1986, a prospective clinical trial for testicular cancer has been underway by our Nara Uro-Oncology Research Group. One hundred and forty-eight cases of germ cell tumor were entered into this study between April, 1986 and August, 1995. They included 99 cases (66.9%) of seminoma and 49 cases (33.1%) of non-seminomatous germ cell tumor (NSGCT). The mean age of seminoma cases (39.7 yrs) was higher than that (30.2 yrs) of NSGCT cases. One hundred and twenty-three cases were treated according to our protocol. In the treatment group, one patient with stage I seminoma died of other diseases and one patient each with stage II and stage III seminoma died of cancer. Three patients with stage III NSGCT died of cancer. The 5-year survival rate was 100% for stage I seminoma, and stage I and stage II NSGCT, 75.0% for stage II seminoma, 0% for stage III seminoma and 66.7% for stage III NSGCT. These findings suggest that new treatment modalities should be introduced into our protocol in the future.  相似文献   

8.
BACKGROUND/AIMS: Early gastric cancer in the remnant stomach is rare. Periodical endoscopic examinations are mandatory for patients with partial gastrectomy for a good prognosis. Our goal is to improve the surgical management of gastric cancer in the remnant stomach. We have retrospectively investigated a total of 15 rare cases of early gastric cancer after partial gastrectomy. METHODOLOGY: From 1976 to 1994, a total of 2,102 cases of gastric cancer were resected in our Department. Among these resected cases, 845 cases were histologically diagnosed as having early gastric cancer of the stomach. Of these, 15 patients had previously undergone a partial gastric resection. The time interval between the initial partial gastrectomy and the second resection of the remnant stomach, was more than 10 years for 8 patients (Group 1) and less than 10 years for 7 patients (Group 2). Here we investigate these rare cases of remnant early gastric cancer. RESULTS: The incidence of early gastric cancer in the remnant stomach was 1.8% (15/845). The cancer location in the remnant stomach was around the stoma and suture line in 75% of Group 1 and in 28.6% of Group 2. The incidence rate of mucosal cancer (m-cancer) was 87.5% for Group 1, and 14.3% for Group 2. Total gastrectomy was selected for 37.5% of Group 1, and for 100% of Group 2. No lymph node metastasis was discovered in both groups. The postoperative mortality was zero in both groups. One patient from Group 2, later died of liver metastasis 2 years after the second total gastrectomy, while the other 9 patients continued to live for more than 5 years with no gastric cancer recurrence to date. CONCLUSIONS: The outcome for patients with gastric cancer in the remnant stomach is generally considered poor. However, the outcome of early gastric cancer in the remnant stomach was good without major postoperative complications. Therefore, to improve surgical management of remnant-stump gastric cancer, early diagnosis is most important, using periodic endoscopic follow-up examinations, especially around the stoma. When mucosal cancer around the stoma is diagnosed, subtotal gastrectomy can be selected even in gastrectomized patient for a good prognosis.  相似文献   

9.
In order to evaluate clinical effects of intraperitoneal hyperthermic chemoperfusion (IHCP) to prevent peritoneal recurrence in gastric cancer patients with serosal invasion, the clinical outcome was studied in 126 gastric cancer patients with macroscopic serosal invasion. Results of 59 patients who had surgery combined with IHCP (IHCP group) were compared with those of 67 patients who had surgery alone (control group). IHCP was performed for 120 minutes just after surgery under hypothermic general anesthesia with perfusate containing 10 micrograms/ml of mitomycin C. The inflow temperature and the outflow temperature of the perfusate were controlled to be 44.5 approximately 45 degrees C, and 43 approximately 44 degrees C, respectively. The 2-, 4- and 8-year survival rates for the IHCP group were 86%, 74% and 66%, respectively, against 78%, 59% and 50%, respectively, in the control group. The survival rates of the IHCP group were significantly better than those of the control group. Peritoneal recurrences after surgery were encountered in one of 59 patients in the IHCP group and 17 of 67 patients in the control group. The peritoneal recurrence rate of the IHCP group was significantly lower than that of the control group. These results suggest that IHCP treatment is effective in prevention of peritoneal recurrences after surgery for gastric cancer patients with serosal invasion.  相似文献   

10.
PURPOSE: Chemotherapy is widely used in patients with locally advanced bladder cancer but until now there has been no conclusive evidence that this therapy improves survival. The Nordic Cooperative Bladder Cancer Study Group conducted a randomized phase III study to assess the possible benefit of neoadjuvant chemotherapy in patients with bladder cancer undergoing radical cystectomy after short-term radiotherapy. MATERIALS AND METHODS: Our trial included 325 patients with locally advanced stage T1 grade 3 or stages T2 to T4aNXM0 bladder cancer allocated randomly into a chemotherapy or no chemotherapy group (control). The chemotherapy schedule consisted of 2 cycles of 70 mg./m.2 cisplatin and 30 mg./m.2 doxorubicin with a 3-week interval between the cycles. RESULTS: After 5 years the overall survival rate was 59% in the chemotherapy group and 51% in the control group (p = 0.1). The corresponding cancer specific survival rate was 64 and 54%, respectively. In regard to treatment, no difference was observed for stages T1 and T2 disease, while there was a 15% difference in overall survival for patients with stages T3 to T4a disease (p = 0.03). In a multivariate analysis only chemotherapy and T category emerged as independent prognostic factors. The relative death risk for patients who received chemotherapy was 0.69 (95% confidence interval 0.49 to 0.98) compared to the control group after adjustment for the other tested factors. CONCLUSIONS: Neoadjuvant chemotherapy seems to improve long-term survival after cystectomy in patients with stages T3 to T4a bladder carcinoma, while no survival benefit was found for stages T1 to T2 disease.  相似文献   

11.
BACKGROUND/AIMS: Gastric cancer in the young is relatively uncommon, but it carries important clinical significance. This study was designed to determine the clinicopathological characteristics of young patients who underwent a gastrectomy for gastric cancer in order to improve clinical management. METHODOLOGY: From January 1977 to December 1994, 997 patients underwent surgical treatment for gastric cancer in the Department of Surgery of the National Taiwan University Hospital. All of these patients were classified into 6 groups based on their age at the time of surgery. Of these, 52 patients (5.2%) were 35 years of age or younger. The clinicopathological data of these patients were reviewed and compared to the data of the other age groups. RESULTS: There was a female predominance, with a male:female ratio of 1:1.36. In the majority of patients, the time period from the onset of symptoms to the time of diagnosis was less than one year (76.9%). Epigastralgia was the most common complaint (65.4%). Six patients (11%) were diagnosed as having a benign peptic ulcer during the first endoscopy. Histologically, there were more diffuse (65.4%) and scirrhous types of gastric cancer in the young group. Half of the patients (49.9%) were at TNM stage III or IV at the time of surgery. Curative resections were performed on 49 patients. The cumulative 5-year survival rate was 36.1% among the young patients, which was no different from the survival rates of the other age groups. While the 5-year survival rate of patients with stage I gastric cancer was 90% in the young age group, of the 26 patients with stage III or IV, only one survived more than 5 years. Four female patients (13.3%) were found to have metastases to the ovaries during follow-up. CONCLUSION: The clinicopathological characteristics of young patients with gastric cancer are as follows: 1) female dominance; 2) more diffuse and scirrhous types of gastric carcinoma; 3) the prognosis after surgery depends on the stage rather than the age; 4) free use of endoscopy and clinical alertness are important for the early diagnosis of malignancy in young patients.  相似文献   

12.
The aim of this study was, (1) to characterize the serum protein binding of lerisetron, a new 5-hydroxytryptamine (5-HT3) receptor antagonist under investigation as an antiemetic agent, and (2) to measure the percentage of unbound lerisetron in cancer patients. The binding parameters were determined in human serum albumin (HSA), alpha1-acid glycoprotein (AAG) and in pooled serum from six healthy volunteers. Concentrations of lerisetron ranging from 50 ng/ml to 2 microg/ml were used. The serum protein binding of 14C-lerisetron (2 microg/ml) was determined by ultrafiltration in three groups of individuals. Group I comprised healthy subjects (n = 11), group II comprised cancer patients undergoing radiotherapy (n = 9), and group III comprised cancer patients receiving chemotherapy (n = 18). The unbound concentration of lerisetron was measured in all samples by liquid scintillation counting. Concentrations of both AAG and HSA were also measured in all serum samples. The drug was extensively bound in pooled serum, involving a nonsaturated process. In HSA, lerisetron was also highly bound (4.04+/-0.8% unbound) and the protein binding was essentially unchanged within the studied concentration range of lerisetron. The extent of binding to AAG was high but significantly lower than in serum and in HSA and was also independent of lerisetron concentration. The unbound lerisetron was significantly decreased in group II cancer patients when compared with group I subjects (2.38+/-0.64% vs 3.70+/-0.70%; P < 0.001). No significant changes in lerisetron binding were observed in group III patients. HSA was diminished in both groups of patients and AAG was only significantly increased in group II. Unbound lerisetron was correlated with AAG in group II and with HSA in group III.  相似文献   

13.
We investigated the influence of extravariceal collateral channel pattern on the recurrence of esophageal varices after sclerotherapy. One hundred and fifteen patients with cirrhosis and esophageal varices were studied. They were divided into four groups according to extravariceal collateral pattern on portal venography. Group 1 patients had neither paraesophageal veins nor gastrorenal veins (n = 49); group 2 patients had paraesophageal veins only (n = 30); group 3 patients had gastrorenal veins only (n = 25); and group 4 patients had paraesophageal veins plus gastrorenal veins (n = 11). Sclerotherapy was repeated to eradicate esophageal varices and follow-up endoscopic examination were performed. The overall recurrence-free rate at 36 months was 68%. The log-rank test showed the recurrence-free rate to be significantly higher in group 3 (76%) and group 4 patients (89%) than in group 1 patients (51%; P < 0.05 and P < 0.05, respectively). Although the recurrence-free rate was higher in group 4 than in group 2 patients (59%), this did not reach the level of significance (P = 0.10). No significant differences were found between other pairs of groups. These results suggest that gastrorenal veins play an important role in the protection against recurrent esophageal varices after sclerotherapy, while the protective role of paraesophageal veins appears to be small.  相似文献   

14.
PURPOSE: The Southwest Oncology Group (SWOG) coordinated an Intergroup study with the participation of Radiation Therapy Oncology Group (RTOG), and Eastern Cooperative Oncology Group (ECOG). This randomized phase III trial compared chemoradiotherapy versus radiotherapy alone in patients with nasopharyngeal cancers. MATERIALS AND METHODS: Radiotherapy was administered in both arms: 1.8- to 2.0-Gy/d fractions Monday to Friday for 35 to 39 fractions for a total dose of 70 Gy. The investigational arm received chemotherapy with cisplatin 100 mg/m2 on days 1, 22, and 43 during radiotherapy; postradiotherapy, chemotherapy with cisplatin 80 mg/m2 on day 1 and fluorouracil 1,000 mg/m2/d on days 1 to 4 was administered every 4 weeks for three courses. Patients were stratified by tumor stage, nodal stage, performance status, and histology. RESULTS: Of 193 patients registered, 147 (69 radiotherapy and 78 chemoradiotherapy) were eligible for primary analysis for survival and toxicity. The median progression-free survival (PFS) time was 15 months for eligible patients on the radiotherapy arm and was not reached for the chemo-radiotherapy group. The 3-year PFS rate was 24% versus 69%, respectively (P < .001). The median survival time was 34 months for the radiotherapy group and not reached for the chemo-radiotherapy group, and the 3-year survival rate was 47% versus 78%, respectively (P = .005). One hundred eighty-five patients were included in a secondary analysis for survival. The 3-year survival rate for patients randomized to radiotherapy was 46%, and for the chemoradiotherapy group was 76% (P < .001). CONCLUSION: We conclude that chemoradiotherapy is superior to radiotherapy alone for patients with advanced nasopharyngeal cancers with respect to PFS and overall survival.  相似文献   

15.
BACKGROUND: In our previous experience with chemotherapy for non-small-cell lung cancer (NSCLC) the combination of mitomycin, ifosfamide and cisplatin (MIC) showed the highest activity in a three-arm randomized trial; the MIC regimen also yielded the most toxic effects, with 8% WHO grade 2-4 nephrotoxicity, 21% grade 3-4 leukopenia and 10% grade 3-4 thrombocytopenia. In that study cisplatin (120 mg/m2) was delivered on day 1 and ifosfamide and mitomycin on day 2. In an effort to reduce MIC toxicity a modified regimen was tested in a phase II trial: cisplatin 100 mg/m2 was given on day 2 and ifosfamide on day 1 with mitomycin. PATIENTS AND METHODS: From November 1993 to December 1995, 70 advanced NSCLC patients entered the trial. RESULTS: Twenty-nine of 70 patients achieved major response (41%) with 6 complete (9%) and 23 partial remissions (33%). We recorded 4% of WHO grade 3-4 anemia, and 2% of leukopenia and thrombocytopenia. CONCLUSION: We confirmed the activity of the MIC regimen in NSCLC, and the modified schedule seems to substantially improve the safety of the combination.  相似文献   

16.
The Authors in this work study a comparison between 27 patients who underwent total gastrectomy with "regional" lymphadenectomy for gastric cancer during the period 1986-1991 (Group A), and 27 patients who underwent total or sub-total gastrectomy associated to D2 or D3 lymphadenectomy (Group B) according to the rules of the Japanese School (localization of the neoplasia and node involvement). No statistically relevant differences were shown in the overall long term survival, although in the group B there were both an high number of patients with stage III neoplasia and more invasive carcinomas. Extended lymphadenectomies, regional and D2 or D3, gave good results as far as long term survival was concerned in early stage cancers, but the same success was not achieved in advanced cancers especially in stage III. In order to improve the survival in advanced neoplasias since one year a D4 lymphadenectomy is performed in T2 or T3 and/or N2+ cases.  相似文献   

17.
OBJECTIVES: In an effort to critically examine the antitumor activity of altretamine (hexamethylmelamine) as salvage therapy of platinum-refractory ovarian cancer, the Gynecologic Oncology Group initiated a Phase II trial of the agent administered in this clinical setting. METHODS: Altretamine was administered at a dose of 260 mg/m2 orally for 14 days in a 28-day course. Treatment was continued until disease progression or unacceptable side effects prevented further therapy. A total of 36 patients (median age: 56.5) were treated on this trial, of whom 33 were evaluable for toxicity and 30 for response. All patients had previously received either cisplatin or carboplatin and paclitaxel. RESULTS: The major side effect was emesis (grade 3-4, 7/33, 21%). The objective response rate was 10% (one complete response, two partial responses). CONCLUSION: We conclude that altretamine has limited activity in platinum-refractory ovarian cancer.  相似文献   

18.
Forty-eight patients with non-resectable cancer of the oesophagus and oesophagogastric junction (Group A: Stage I/II, 32; Group B: Stage III/IV, 16) underwent intraluminal Iridium-192 high dose-rate afterloading therapy (5-7 Gy/session, total dose: 5-21 Gy, mean: 12.4 Gy) and external beam irradiation (Karnofsky > or = 80% 50-60 Gy/2 Gy per day; Karnofsky 60-79%: 30 Gy/3 Gy per day). Durable satisfactory palliation (intake of at least semi-solid food) was demonstrated in 96% of patients. The mean survival for group A was 19.1 months and that for group B, 6.9 months, with a 12-month survival rate of 66% (group A) and 0% (group B) (P < 0.001). Local tumour response and complication rate were significantly dose-related with a predicted response rate of 70.5%, and a complication rate of 50% at ERD 129.3 Gy.  相似文献   

19.
JA Witjes  CT Caris  NA Mungan  FM Debruyne  WP Witjes 《Canadian Metallurgical Quarterly》1998,160(5):1668-71; discussion 1671-2
PURPOSE: We study toxicity and efficacy of sequential intravesical therapy with mitomycin C and bacillus Calmette-Guerin (BCG) in patients with intermediate or high risk superficial bladder cancer compared to the use of intravesical mitomycin C alone. MATERIALS AND METHODS: Patients with intermediate and high risk papillary superficial bladder cancer and carcinoma in situ were randomized after transurethral resection between 4 weekly instillations with 40 mg. mitomycin C followed by 6 weekly instillations with BCG (group 1, 90 patients) or 10 weekly instillations with mitomycin C (group 2, 92 patients). RESULTS: The frequency of bacterial and chemical cystitis, and other local side effects was similar in both groups. Allergic reactions, including skin rash, were more frequent in the mitomycin C only group (12 of 92 patients versus 5 of 90, p = 0.08), and other systemic side effects were more frequent in the sequential group (16 of 90 versus 8 of 92, p = 0.07). After a median followup of 32 months the number of recurrences (sequential 35 of 90 patients versus mitomycin C only 42 of 92, p = 0.36) and progression (5 of 90 versus 4 of 92 respectively, p = 0.70) were similar in both groups. CONCLUSIONS: We did not find any major differences in toxicity or treatment efficacy with intravesical mitomycin C and the sequential use of BCG or mitomycin C for intermediate and high risk superficial papillary bladder cancer.  相似文献   

20.
BACKGROUND/AIMS: It is crucial to improve the postoperative prognosis of patients with gastric cancer in geographic regions where the incidence of gastric cancer is high. This study compared the efficacy of surgical treatment in patients with gastric cancer detected by a mass screening survey with that of patients diagnosed in accordance with standard medical practice. METHODOLOGY: The subjects included 189 patients with gastric cancer detected by a mass screening survey (screening group) who underwent surgical treatment from 1988 to 1995, and 517 patients who underwent a standard medical work-up (non-screening group). RESULTS: The incidence of early gastric cancer, curative resectability rate, and 5-year survival rates between the screening and non-screening groups were 73.0% versus 48.4% (p < 0.01), 90.5% versus 66.7% (p < 0.01), and 86.2% versus 61.0% (p < 0.01), respectively. CONCLUSIONS: Surgical treatment for patients with gastric cancer identified by mass screening is effective in saving lives and reduces the mortality from gastric cancer in the target population of mass screening. However, a further prospective randomized controlled study of this screening method will be necessary in the future.  相似文献   

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