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Clinical study on continuous constant temperature circulation hot infusion therapy for malignant ascites.
Objective: To explore the efficacy of continuous circulating hyperthermic intraperitoneal chemotherapy (HIPEC) at a temperature of 42-43°C for malignant ascites. Method: 45 patients with malignant ascites were randomly divided into two groups. The observation group consisted of 22 patients who underwent conventional puncture to establish a double-channel circulation, first performing peritoneal lavage to replace the intraperitoneal perfusion fluid, and finally maintaining 2500-3500 ml. The continuous circulation at a temperature of 42-43°C began 3-5 minutes later.
Release time:
2022-08-26
Source:
Journal of Bethune Military Medical College
[Keywords] Malignant hydrops; Continuous hyperthermia circulation perfusion; Chemotherapy
The clinical study of using continuous homeothermia circulation perfusion to treat malignant hydrops HU Zengxiang, DU Yulei, ZHAO Qi, et al. Department of Medicine No.1, the 260th Hospital of PLA, Shijiazhuang 050041, China [Abstract] Objective To discuss the therapeutic efficacy of using continuous homeothermia (42～43℃) circulation perfusion chemotherapy to treat malignant hydrops. Methods 45 cases with malignant hydrops were divided into two groups randomly. Double circulation channels were established by using routine puncture needles in the treatment group. After the irrigation of peritoneal cavity and replacement, 2500～3500 ml liquid was left 1000～1500 ml. DDP 40 mg was perfused after circulation had begun for 3～5 min, then continuous hyperthermic perfusion chemotherapy was circulated for 60 min. After treatment, 1000～1500 ml liquid was left 1000～1500 ml. The 23 patients in the control group were perfused the same dose DDP after they were catheterized, drained and flushed. In the control group, the drug was heated to 43℃ before perfusing into the abdominal cavity. Results The total effective rate of the treatment group (86.3%) was obviously higher than that of the control group (P<0.05). Conclusion Compared with the traditional methods, the continuous hyperthermic perfusion circulation can not only improve the effective rate of treating malignant hydrops, but also reduce the recurrence of malignant hydrops and improve the patients’ life quality.
[Key words] Malignant hydrops; Continuous hyperthermic perfusion circulation; Chemotherapy
Malignant body cavity effusion is a common complication in patients with advanced tumors, among which malignant abdominal effusion accounts for about 60%, mainly caused by abdominal metastasis of gastric cancer, colorectal cancer, liver cancer, and ovarian cancer. The treatment methods mainly involve local simple drainage combined with single-agent chemotherapy, which has limited effectiveness, and ascites is prone to recurrence. Although the survival time of patients with advanced tumors is limited, successful palliative treatment can reduce the generation of ascites, alleviate the suffering caused by abdominal pain, and have a positive effect on the patients' quality of life and prognosis. Our hospital has treated 22 cases of cancerous ascites with continuous homeothermic perfusion chemotherapy, achieving good results.
1 Objects and Methods
1.1 Object selection 45 hospitalized patients were randomly divided into the continuous homeothermic circulation chemotherapy group (observation group) with 22 cases and the abdominal simple drainage plus heated chemotherapy group (control group) with 23 cases. Inclusion criteria: Age 38-70 years; Performance status (ECOG) NCI 0-3; All patients were confirmed by ultrasound to have moderate or more abdominal effusion, and for cancerous ascites, no drugs were injected into the abdominal cavity before treatment except for puncture drainage; The last treatment for patients receiving systemic chemotherapy must be more than 4 weeks before enrollment; Liver, kidney function, and blood routine must be within normal range; Expected survival time >3 months. Exclusion criteria: Severe heart failure, decompensated liver cirrhosis, renal insufficiency, etc. The ages of the 22 patients in the observation group ranged from 39 to 65 years, including 8 cases of gastric cancer, 5 cases of colorectal cancer, 6 cases of ovarian cancer, and 3 other cases; The ages of the 23 patients in the control group ranged from 38 to 70 years, including 6 cases of gastric cancer, 9 cases of colorectal cancer, 5 cases of ovarian cancer, and 3 other cases. The two groups of cases were comparable in terms of age, disease type, etc.
1.2 Methods Observation group: Ultrasound localization is required before treatment to determine the puncture point. Double needles are placed at the inlet and outlet. According to the nature of the patient's ascites, one-way thermal perfusion is performed, infusing warm saline 1500-2500 ml, draining fluid while infusing, excluding part of the malignant effusion, diluting the effusion and toxins, and alleviating symptoms. After the thermal perfusion, connect to the TRL 2000 type extracorporeal circulation thermal perfusion chemotherapy machine (produced by Harbin Aerospace Technology Co., Ltd.), set the temperature to 45℃ for heating, adjust the inlet body temperature to 43.5-44℃, and the outlet body temperature to 41.5-42℃, add chemotherapy drugs, and maintain continuous homeothermic circulation for 60 min. After the circulation ends, exclude part of the fluid, leaving a volume of >1500 ml. Once every 72 hours, for a total of 3 times. The control group underwent routine abdominal puncture, with a single-lumen deep venous catheter left in the abdominal cavity for continuous drainage, draining as much ascites as possible and performing flushing, then infusing heated 45℃ perfusion fluid for abdominal hyperthermia chemotherapy, once every 72 hours, for a total of 3 times. During the treatment period, neither group of patients received systemic chemotherapy or immunotherapy such as interferon or interleukin-2, only symptomatic treatment. The thermal chemotherapy regimen for the observation group: 20 ml saline + 40 mg DDP circulated through the circulation machine. The treatment regimen for the control group: the treatment fluid saline 500 ml + 40 mg DDP, heated to 45℃ by soaking the infusion bag in boiling water and quickly dripping into the abdominal cavity. The observation indicators used ultrasound to measure the volume of ascites before and after treatment, and observe the Kamofsky score. Efficacy evaluation was based on WPS standards. Complete remission: Ascites disappears for more than 4 weeks; Partial remission: Ascites reduced by more than 1/2 and lasted more than 4 weeks, with alleviated symptoms; Stable; Progression: Ascites increased by >25%. Effective: Complete remission + partial remission. Safety evaluation was based on the toxicity response standards of anticancer drugs.
1.3 Statistical analysis was conducted using SPSS 11.0 to perform a χ2 test for comparing the rates between the two groups.
2 Results
2.1 Clinical efficacy is shown in Table 1. All patients completed more than 3 treatments. The effective rate of the observation group was 86.3%, and the complete remission rate was 31.8%. The effective rate of the control group was 56.5%, and the complete remission rate was 17.4%. The difference was statistically significant (P<0.05).
2.2 Toxic side effects The side effects such as nausea, vomiting, and leukopenia in both groups of patients were mild, and they quickly returned to normal after symptomatic treatment. Notably, the appetite and mental state of patients in the observation group did not weaken but rather improved compared to the control group. No patients experienced abdominal pain or abdominal infection. All patients had no liver or kidney function damage.
Table 1 Comparison of treatment effects between the two groups (omitted)
3 Discussion
Malignant tumors in advanced stages can lead to cancerous ascites, severely affecting the quality of life of patients. The concentration of drugs in the abdominal cavity during intraperitoneal chemotherapy is 2.5 to 8 times that of plasma concentration within hours, which can create a constant, persistent, high-concentration environment of anticancer drugs in the abdominal cavity, while the amount of drug entering the systemic circulation is minimal. Compared to traditional intravenous chemotherapy, intraperitoneal administration not only increases the concentration of anticancer drugs in the abdominal cavity and prolongs the contact time between the drugs and cancer cells, but also has a stronger killing effect on cancer emboli and cancer cells that have metastasized to the liver via the portal vein, as the drugs are primarily absorbed through the portal vein. Intraperitoneal hyperthermic perfusion chemotherapy is designed based on the anatomical characteristics of the abdominal cavity, the rationality and effectiveness of regional chemotherapy pharmacokinetics, and the principle that hyperthermia combined with chemotherapy has a synergistic anticancer effect. Tumor tissues are more sensitive to heat than normal tissues, and heating has a direct lethal effect on cancer cells; maintaining a temperature above 42°C for 50 to 60 minutes has a significant inactivation effect on malignant tumors. High temperatures increase the drug concentration in local tumor tissues, and high concentrations of chemotherapy drugs can overcome the drug resistance of tumor cells, thereby enhancing their anticancer effects. Heating can increase the sensitivity of tumor cells to certain chemotherapy drugs, while enhancing the permeability of cells, and changes in the tumor cell microenvironment and pharmacokinetics strengthen the effects of anticancer drugs. Warm liquids can increase the permeability of anticancer drugs, with a direct penetration depth of up to 5 mm, enhancing the cytotoxic effects of chemotherapy drugs, inducing apoptosis in tumor cells, and increasing the lethality against cancer cells. Continuous temperature-controlled circulating hyperthermic chemotherapy is a new method in hyperthermia in recent years; it heats the perfusion treatment fluid to 45°C ± 0.5°C, using a standard abdominal puncture needle to establish a dual channel. It maintains an inlet body temperature of 43.5 to 44°C and an outlet body temperature of 41.5 to 42°C, stabilizing the abdominal cavity temperature at around 43°C for 60 minutes. By extending the heating time, the effectiveness of abdominal hyperthermic chemotherapy is significantly enhanced. The effective rate of continuous temperature-controlled circulating chemotherapy for treating cancerous ascites in the observation group was 83.3%, which is significantly higher than that of the simple abdominal hyperthermic chemotherapy group, and the toxic side effects were similar, indicating that continuous temperature-controlled circulating chemotherapy is one of the more effective methods for treating cancerous ascites and is worthy of clinical promotion.
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Internet Drug Information Service Qualification Certificate (Shaanxi)-Non-Operating -2023-0143