Home About us Editorial board Ahead of print Current issue Search Archives Submit article Instructions Subscribe Contacts Login 

 Table of Contents  
Year : 2014  |  Volume : 10  |  Issue : 4  |  Page : 1030-1032

Investigation on immune function and chest drainage in patients with thoracic malignancies using the streptococcal agent Sapylin

Department of Thoracic Surgery, Afflicted Hospital of Medical College, Qingdao University, China

Date of Web Publication9-Jan-2015

Correspondence Address:
Kaihua Tian
16 Jiangsu, Qingdao266003
Login to access the Email id

Source of Support: None, Conflict of Interest: None

DOI: 10.4103/0973-1482.137983

Rights and Permissions
 > Abstract 

Purpose: To investigate the influence of Sapylin used during the operation on immune function and chest drainage in patients with thoracic malignancies in early postoperative period.
Patients and Methods: Seventy-one patients with thoracic malignancies including lung cancer and esophageal carcinoma who underwent tumor resection were divided into two groups, 36 cases of observation group and 35 cases of control group. In observation group, Sapylin were locally laid in operation field during the operation. The control group was not given Sapylin. Drainage volume of chest cavity after operation, and the levels of CD4, CD8, CD4/CD8 and natural killer (NK) cell were recorded.
Results: The level of CD4+, CD4+/CD8+ and NK cell in observation group were higher than that in control group (P < 0.05) wholly in early postoperative period. Drainage volume of chest cavity in observation group was less than that in control group postoperatively, 1160.2 ± 437.2 ml vs. 1363.3 ± 472.9 ml, but the change in two groups had no significance statistically (P = 0.064).
Conclusions: The local application of Sapylin during operation can improve immunity of patients with thoracic malignancies significantly and decrease the drainage volume of chest cavity probably in early postoperative period. So it is worthy of popularizing in clinical practice.

 > Abstract in Chinese 






结果:术后早期,观察组的CD4 +水平,CD4+/CD8+和NK细胞水平明显高于对照组(P<0.05)。观察组术后胸腔引流量少于对照组,1160.2±437.2毫升vs 1363.3±472.9毫升,但无统计学意义(P = 0.064)。



Keywords: Drainage volume, immune function, postoperative period, Sapylin, thoracic malignancies

How to cite this article:
Tian K, Han B, Shen Y, Li C, Xuan Y. Investigation on immune function and chest drainage in patients with thoracic malignancies using the streptococcal agent Sapylin. J Can Res Ther 2014;10:1030-2

How to cite this URL:
Tian K, Han B, Shen Y, Li C, Xuan Y. Investigation on immune function and chest drainage in patients with thoracic malignancies using the streptococcal agent Sapylin. J Can Res Ther [serial online] 2014 [cited 2020 May 26];10:1030-2. Available from: http://www.cancerjournal.net/text.asp?2014/10/4/1030/137983

 > Introduction Top

Thoracic malignancies mainly consist of lung cancer and esophageal carcinoma. At present, in China, chest malignancies are considered as the worst prognosis disease for the high level of relapse after surgery. [1] As we know, the function of immune system was descended in the cancer patients. The treatment of enhancing the function of immune system, which can activate the body barrier against metastasis of cancer cell, is used widely in tumor treatment. Sapylin (OK-432), considered as cancer immunotherapy auxiliary drug, had been proved of having nonspecific immunity anti-tumor function. [2] Besides, Sapylin was considered to reduce pleural effusion efficiently in some benign pulmonary diseases by improving serous osmotic pressure of chest cavity. To assess the effect of Sapylin on surgical treatment and regulation of the immune function in patients with thoracic malignancies, we investigated the clinical data of 71 cases who took Sapylin in operating field in the early stage after the operation.

 > Patients and methods Top


From December 2009 to August 2010, at our department, total consecutive 71 patients with thoracic malignancies were eligible for the following criteria that include: (1) All patients were diagnosed or speculated lung cancer or esophageal carcinoma, preoperatively. (2) All the patients underwent tumor resection. (3) The penicillin skin test was negative within 24 hours before operation. (4) Lung cancer patients underwent single lobectomy only. (5) Esophageal cancer patients underwent esophagectomy by left chest one-incision approach only. (6) All patients did not undergo hemostatic thoracotomy and severe complications such as acute respiratory distress syndrome (ARDS) in the early postoperative period. All the patients were divided into observation group and control group at random as presented in this report [Table 1].
Table 1: Demography of patients in this study

Click here to view

Approval for the study was issued from the Ethics Committee of our hospital before initiating the study, and informed consent was obtained from all the patients.


Seventy-one cases undergoing resection of thoracic tumors were divided into 36 cases of observation group and 35 cases of control group, at random. The Sapylin was locally applied in operating field of lymph node dissection and tumor resection using gelatin sponge containing it during operation in the observation group. The control group did not take Sapylin locally. The daily changes of drainage volume of chest cavity and the level of CD4, CD8, CD4/CD8 and NK cell were recorded after the operation. FACSCalibur flow cytometer and fluorescent mouse antihuman IgG monoclonal antibodies of CD4, CD8, CD4/CD8 were provided by BD company.


Statistical analysis using the Chi-squared test was performed to determine the significance of difference between two groups. For all analyses, statistical significance was set at P < 0.05 (Two sides, 95% credibility interval). Statistical Package for the Social Sciences software (SPSS) software (version 13.0) was used for all calculations.

 > Results Top

1. The levels of CD4+, CD4+/CD8+ and NK cell in control group was lower than that in observation group within 4 days after the operation. (P < 0.05) [Table 2]
Table 2: The data of immune cell in peripheral blood of patients within 4 days after operation

Click here to view

2. Drainage volume of chest cavity after operation in observation group was 1160.2 ± 437.2 ml, and 1363.3 ± 472.9 ml in control group. The difference in postoperative drainage volume of chest cavity between observation group and control group had no significance (P = 0.064).

 > Discussion Top

As we know, there is a close relationship between body's immune function and pathogenesis of cancer. A person is very easy to undergo malignant tumors when his immune functions decline. Researches indicated that immune dysfunction was widespread in the patients with thoracic malignancies. [3] Therefore, the immune dysfunction might be one of important factors in the process of chest malignant tumor occurrence and development.

Being proved by modern researches, the main anti-tumor reaction was the body's cellular immunity. T cells, mainly composed by CD4 and CD8, play very important role as regulation factor in anti-tumor immune. CD4 and CD8 can play anti-tumor effect when their activity, quantity and ratio are in normal level. [4] We can measure the values of CD4, CD8 and their ratios to reflect body's cellular immunity directly. Natural killer (NK) cells, belonging to the lymphocyte pedigree is different from T cell and B cell for being non-specific immune cells. NK cell does not need contact with antigen in advance to kill target cell (for instance, tumor cell). NK cell is referred as an important anti-tumor factor. [5],[6]

In thoracic surgery, resecting tumor completely and clearing up regional lymph nodes could undoubtedly improve the prognosis of patients. Meanwhile, surgical procedures could damage body's immune function. Metastatic tumor cell in circulation could be easier to implant in targeted organs for dramatic decline of immune function in the early stage after operation than other periods. Therefore, using anti-tumor immune drugs regionally during operation could improve the function of immune system, suppress the residual cancer cells in the body, and reduce the chance of local recurrence and metastasis.

Sapylin (OK-432), group A of streptococcus preparation given by injection, is considered as an anti-tumor biological response immunity regulator which can enhance the human immunity and play a specific anti-tumor effect by a variety of biological pathways. [7] Its local use usually leads to a strong regional inflammation that can promote the activation and multiplication of T cells, and T cells (including CD4 and CD8) produce chemicals called lymphokines, such as interferon and interleukin. [8] Sapylin has been applied in numerous kinds of human malignancies and produced satisfactory results since its use in clinics. [9],[10] In our study, the level of CD4+, CD4+/CD8+ and NK cell in observation group were wholly higher than that in control group significantly (P < 0.05). It demonstrated that local application of Sapylin during operation could improve the immunity of the patients in early postoperative period. We would further investigate whether or not the change could benefit the prognosis of the patients in observation group in the future.

Some studies proved that local application of Sapylin during operation could lead to regional aseptic inflammation in the chest, which can further reduce pleural effusion. Some authors suggested a mechanism that Sapylin could reduce pleural effusion efficiently through improving serous cavity osmotic pressure. [11] Furthermore, Sapylin was believed capable to kill the residual cancer cell in chest postoperatively. [12] In the study, a tendency showed that the drainage volume of chest cavity in observation group has reduced evidently compared with control group (1160.2 ± 437.2 ml in observation group vs. 1363.3 ± 472.9 ml in control group), though the difference between two groups was not significant statistically (P = 0.065). The possible reasons includes: The proportion of esophagus cancer in observation group (33.3%) was higher than that in control group (11.4%). Compared with lung cancer operation, surgical trauma of esophagectomy was usually bigger (Bigger wounds lead to more pleural effusion). We will make efforts on decreasing the bias of design in the future large sample study.

 > Conclusion Top

In summation, the local application of Sapylin (OK-432) during operation could improve immunity of the patients with thoracic malignancies in early postoperative period, which may promote postoperative recovery and improve prognosis. It implies that it could reduce drainage volume of chest cavity postoperatively, shorten the time of intubation and hospital, and reduce the suffering of patients. We will further verify the surgical treatment effect of Sapylin by large example clinical trial in the future.

 > References Top

Schlansky B, Dimarino AJ Jr, Loren D, Infantolino A, Kowalski T, Cohen S. A survey of oesophageal cancer: Pathology, stage and clinical presentation. Aliment Pharmacol Ther 2006;23:587-93.  Back to cited text no. 1
Chao QZ. Hemolytic Streptococcus Preparations OK-432 (Sapylin). Oncology. Tianjin China: Tianjin Science and Technology Press; 1998.  Back to cited text no. 2
Chadwick D, Pido-Lopez J, Pires A, Imami N, Gotch F, Villacian JS, et al. A pilot study of the safety and efficacy of thymosin alpha 1 augmenting immune reconstitution in HIV--infected patients with 10W CD4 4-T counts taking highly active antiretroviral therapy. Clin Exp Immunol 2003;134:477-81.  Back to cited text no. 3
Waymack JP, Gallon L, Barcelli U, Trocki O, Alexander JW. Effect of blood transfusions on immune function llI. Alterations in macrophage arachidonic acid metabolism. Arch Surg 1987;122:56-60.  Back to cited text no. 4
García-Suárez J, Krsnik I, Reyes E, De Miguel D, Hernanz N, Barr-Alí M. Elderly haematological patients with chemotherapy--induced febrile neutropenia have similar rates of infection and outcome to younger adult: A prospective study of risk--adapted therapy. Br J Haematol 2003;120:209-16.  Back to cited text no. 5
Min HW, Rong YC, Lin ML. Effect of thymosin α1 for advanced non-small-cell lung cancer in chemotherapy patients. Zhong Guo Zhong Liu 2005;15:244-7.  Back to cited text no. 6
Kimura I, Ohnoshi T, Yasuhara S, Sugiyama M, Urabe Y. Immunochemotherapy in human lung cancer using the streptococcal agent OK-432. Cancer 1976;37:2201-3.  Back to cited text no. 7
Kitsuki H, Katano M, Ikubo A, Morisaki T, Anann K, Tanaka M. Induction of inflammatory cytokines in effusion cavity by OK-432 injection therapy for patients with malignant effusion: Role of interferon-gamma in enhancement of surface expression of ICAM-1 on tumor cells in vivo. Clin Immunol Immunopathol 1996;78:283-90.  Back to cited text no. 8
Maehara Y, Okuyama T, Kakeji Y, Baba H, Furusawa M, Sugimachi K. Postoperative immunochemotherapy including streptococcal lysate OK-432 is effective for patients with gastric cancer and serosal invasion. Am J Surg 1994;168:36-40.  Back to cited text no. 9
Matsubara N, Itoh K, Mukai H, Nagai S. Long-term outcome of pleurodesis with OK-432 in metastatic breast cancer: A new risk model for success from an analysis of 75 cases. Int J Clin Oncol 2012;17:470-6.  Back to cited text no. 10
Miao XY, Lin ML. The drug therapy of malignant pleural effusions at present. Qilu Zhong Liu Xue Za Zhi 2001;6:326-8.  Back to cited text no. 11
Katano M, Morisaki T. The past, the present and future of the OK-432 therapy for patients with malignant effusions. Anticancer Res 1998;18:3917-25.  Back to cited text no. 12


  [Table 1], [Table 2]


Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
Access Statistics
Email Alert *
Add to My List *
* Registration required (free)

  >Abstract>Introduction>Patients and methods>Discussion>Conclusion>Results>Article Tables
  In this article

 Article Access Statistics
    PDF Downloaded52    
    Comments [Add]    

Recommend this journal